MEDICINES CODE 2017/18 (Replaces Policy No. TPCL/ /17 V.2)

Transcription

1 A member of: Association of UK University Hospitals MEDICINES CODE 2017/18 (Replaces Policy No. TPCL/ /17 V.2) GUIDELINE NUMBER TPCL/014 GUIDELINE VERSION V.4 RATIFYING COMMITTEE Clinical Policy Forum DATE RATIFIED 29 November 2017 DATE OF EQUALITY & HUMAN RIGHTS IMPACT ASSESSMENT (EHRIA) 14 July 2016 NEXT REVIEW DATE 29 November 2018 GUIDELINE SPONSOR Chief Medical Officer GUIDELINE AUTHOR Chief Pharmacist - Strategy This policy undergoes at least an annual review in order that the Trust works within national compliance standards for provision of secure inpatient services. KEY DOCUMENT ISSUES: To state the Trust s position with regard to medicines management, medicines optimization and New Ways of Working. To ensure safe and secure handling of medicines. To help ensure the safe and secure prescribing and administration of medicines. Important note: Throughout this document the term patient s care notes or a similar term has been used. These terms should now be interpreted as meaning a patient s Carenotes until the appropriate section is reviewed and the term amended. If you require this document in another format such as large print, audio or other community language please contact the Corporate Governance Office on Tel: or policies@sussexpartnership.nhs.uk Page 1 of 141

2 SUSSEX PARTNERSHIP NHS FOUNDATION TRUST M E D I C I N E S C O D E 2017/18 (Version 1) POLICIES AND PROCEDURES TO MANAGE THE CLINICAL RISKS ASSOCIATED WITH THE USE OF MEDICINES Originally based on the Southern Derbyshire Mental Health NHS Trust Medicines Code (2002). Provided and shared by kind permission of Dr. Dave Branford via the United Kingdom, Psychiatric Pharmacists Group Website. Ratified by the Trust s Professional Practice Forum. This should be read in conjunction with local polices and procedures relating to medicines management where they are available. If there are any contradictions in these with this Medicines Code then these should be drawn to the attention of the Chief Pharmacist. The document can be accessed via the medication section of the Trust s website. Archived versions are held by the medication section web editor and the Chief Pharmacist Strategy. Significant changes since the last version Please note that the changed text from the last version is printed in italics. Chapter/section Main changes Throughout reference to gender has been removed and replaced with terms such as their or person a list of supplementary drug charts has been added with advice on how to use them. 5.4 new guidance in the remote prescribing chapter relating to patients needing a new section 62 when a medicine is prescribed remotely reminder that patients need to be told where to get further medication supplies from post discharge or after an outpatient appointment if needed new guidance on dealing with blank administration discovered following a medicines round and another person has to deal with it. All subsequent numbering in this section has moved up one reference added to the new Medicines Refrigerator & Clinic Room Temperature Log (appendix 20) 15.9 new guidance on storing staff s own medication on wards when it is essential it is brought in to work New guidance on managing CD register index The minimum levels of monitoring at stage 3 when patients are self-administering medicines has been relaxed to every two days during the first three weeks on satge 3, reducing to every week if the MDT thinks the risks are low Updated guidance to clarify the CD key holding arrangements on wards. Page 2 of 141

3 Updated guidance on recording the weekly CD checks at the back of the CD register instead of or in addition to signing each entry checked Updated guidance on recording the monthly ward or department CD checks at the back of the CD register instead of or in addition to signing each entry checked New guidelines to clarify the holding and carrying of anaphylaxis packs in community teams Reference to the new appendix 20 the Trust s standard temperature monitoring form form ward drug storage , , , , additional statements on when considering covert administration the impact on the therapeutic alliance must be considered when patients have fluctuating capacity Judgement from a court case on DoLS added to provide clarity and clarifies the difference between physical and mental health medicines when it comes to covert administration in patients under the MHA and now includes a reminder that when considering covert adminstration an best interest meeting needs to take place. Appendix 6 self administration stage 3 monitoring chart has been amended to reflect above. Appendix 20 recently introduced Medicines Refrigerator & Clinic Room Temperature Log added as an appendix Page 3 of 141

4 Place the cursor over the chapter title that you want to read and using Ctrl + click you can go straight to that chapter or appendix 1. INTRODUCTION DEFINITIONS RELEVANT TO THIS CODE GENERAL PRINCIPLES PRESCRIBING OF MEDICINES REMOTE PRESCRIBING MEDICINES ADMINISTERED UNDER PROTOCOL (MAUP) PATIENT GROUP DIRECTIONS ORDERING AND RECEIPT OF MEDICINES BORROWING OF MEDICINES PATIENT AND CARER INFORMATION TRUST PHARMACY SERVICES PHARMACY OUT-OF-HOURS SERVICE ADMINSTRATION AND PREPARATION OF MEDICINES TRANSPORT OF MEDICINES STORAGE OF MEDICINES STORAGE AND HANDLING OF FLAMMABLE LIQUIDS, GASES AND AEROSOLS LOSSES OR DISCREPANCIES DISPOSAL OF MEDICINES NO LONGER REQUIRED PATIENTS OWN MEDICINES DAY HOSPITALS AND RESPITE CARE SELF-ADMINISTRATION OF MEDICINES CUSTODY AND SAFE-KEEPING OF MEDICINE KEYS CHECKING OF STOCK BALANCES USE OF COMPLEMENTARY MEDICINES AND ESSENTIAL OILS USE OF UNLICENSED MEDICINES AND LICENSED MEDICINES OUTSIDE THEIR LICENCE CLINICAL TRIALS INVOLVING PHARMACEUTICAL PRODUCTS MEDICINES RELATED DUTIES PERFORMED BY AUTHORIZED EMPLOYEES USING MEDICAL GASES PHARMACEUTICAL INDUSTRY REPRESENTATIVES MEDICATION ERRORS AND NEAR MISSES MEDICINE DEFECT REPORTING COMMUNITY BASED PRACTITIONERS CONSENT TO TREATMENT ILLICIT SUBSTANCES COMPLIANCE AIDS (e.g. dosette boxes and monitored dosing system (MDS)) SAFE HANDLING OF MEDICINES REQUIRING COLD STORAGE CONTROL OF FP10 (NC) PRESCRIPTION COVERT ADMINISTRATION OF MEDICINES ADVERSE DRUG REACTIONS DRUG ALERTS AND RECALLS NURSE DISPENSING OF LEAVE AND DISCHARGE MEDICATION OCCUPATIONAL THERAPISTS INVOLVED WITH MEDICINES ADMINISTRATION OF PATIENTS OWN MEDICATION FROM A MULTI-DRUG COMPLIANCE AID REFERENCES LINKED TRUST POLICIES AND GUIDANCE Appendix Self-administration Flowchart Appendix Self-administration: Patient Agreement / Consent Form Page 4 of 141

5 Place the cursor over the chapter title that you want to read and using Ctrl + click you can go straight to that chapter or appendix Appendix Patient Risk Assessment and Decision Form for the Self administration of Medicines Appendix Self-administration of Medicines Patient Information Leaflet Appendix Daily Self-administration Progress Record Stages 1 & Appendix Self-administration Progress Record Stage Appendix Patient Self-administration Assistance Sheet Appendix Patient Self-administration Aide Memoire Appendix Compliance Aid Assessment and Request Form Appendix Medication Not Considered Suitable for Self-Administration Appendix Covert Administration of Medicines Appendix One Stop Dispensing (OSD) Risk Assessment Form Appendix Sussex Partnership NHS Foundation Trust Patient s own medication checklist Appendix Glasgow Antipsychotic Side-effect Scale (GASS) Appendix Nurse Dispensing Procedure for Urgent Discharge and Leave Medication in Exceptional Circumstances Appendix Checklist for Ward Managers to Assess the Competence of Care Assistants to Check the Administration and Recording of Controlled Drugs (CDs) in the Absence of a Second Qualified Nurse Appendix Algorithm - Procedure for the administration of a patient s own medication from a multi-dose compliance aid (MDCA) in the ward environment in exceptional circumstances Appendix Weekly Medicines Security and Safe Handling Check List for Ward Managers and Team Leaders Appendix Three Monthly Medicines Security and Safe Handling Audit Sheet for Matrons or a Nominated Deputy Appendix 20 Medicines Refrigerator & Clinic Room Temperature Log The Appendices listed above may be printed off from the medication related charts and forms section of the Trust website: Page 5 of 141

6 1. INTRODUCTION 1.1 New Ways of Working in Medicines Management The Trust will embrace the principles of New Ways of Working ( to improve our cost effective use of medicines for patients, carers and staff. These principles will also be key in assisting patients to recover. The following principles will be applied: 1.1 Patients(and carers if appropriate) will be put at the centre of all our thinking into how medicines are used and handled, by asking them about their concerns and beliefs in mediciation. 1.2 A medicines management team will be developed that supports medication use across all localities and specialties. To improve cost effectiveness the roles of pharmacy technicians, pharmacy assistants and nurses will be explored to work alongside pharmacists. 1.3 The clinical roles of both pharmacists and pharmacy technicians will be recognized by the Trust. Further information can be obtained by clicking on the link: The principle of prevention is better than cure will be adopted with continuing developments in medicines management related training. This will include: Induction training for junior medical staff. Online drug chart, rapid tranquilization and clinical scenario training for all junior medical staff on appointment.. Online drug chart training on appointment and every three years for all trained nurses administering medicines from the Trust s drug chart. Three yearly medicines management training for all qualified nurses. Three yearly online dosage calculation training for all qualified nurses. Three yearly online training rapid tranquilization training for all inpatient nurses. 1.5 Staff will be continually encouraged to report medication errors and near misses. Lessons learned will be fed back to staff and used to improve systems and identify training needs. The medicines management team will work closely with other partnership trusts in the Region to develop region-wide solutions. 1.6 Patients, carers and staff will be supported by a range of easily accessible medication related information and guidance. This will be accessible via the Trust s website Services will be developed to provide greater access to individualized advice on medicines for patients and carers by utilizing the Trust s website, by running medication education groups and providing one to one consultations with members of the medicines management team for those patients identified as having complex problems or concordance issues. Access to interpreter and translator services and information in other formats is available on request. 1.8 Patients will be able to get more timely access to the medicines they need by utilizing the options provided by the development of the role of non-medical prescribers and the use of patient group directions and group protocols for homely remedies (MAUPs). Training and support will be provided non-medical prescribers to support their role. Page 6 of 141

7 1.9 Greater emphasis will be put on ensuring medication is accurately reconciled, at or soon after admission with systems in place to ensure that there is accurate and timely medication information provided to primary care or the receiving unit at the time of discharge or transfer Systems will be in place to allow appropriate inpatients to self-administer their own medication to either stop them losing skills they already have or to provide them with skills to aid their recovery. Why have a Medicine Code? The NHS England requires that NHS trusts establish, document and maintain an effective system to ensure that medicines are handled in a safe and secure manner. In order to meet this requirement, the Trust must ensure that: Professional practices concerning the use of medicines are current and up-to-date and that they remain subject to review and further development. All healthcare practitioners dealing with medicines remain aware of current policy. The concepts of patient focused care and patient empowerment are acknowledged and, where possible, are built in to policy and practice. Medicines Management is seen as a high priority within Clinical Governance. This Medicines Code defines the policies and procedures to be followed within the Trust for the prescribing, ordering, dispensing, storing and administering of medicines. The Trust s Medicines Code is not intended to apply to any other NHS Trust. Other legal requirements and standards laid down by professional bodies must also be followed. All staff working within the Trust who are involved in some way with the use of medicines, must familiarise themselves with the correct procedures contained in the Code. Those in charge of wards and departments are responsible for ensuring that their staff, especially new starters and locum staff, follow procedures in the Medicines Code, which may differ from procedures elsewhere. Copies of the Code will be available on the Trust s website. If staff have any concerns about the handling and use of medication by another healthcare professional, these concerns would usually be raised with their manager or their manager s manager if more appropriate. However designated officer can be approached instead. A copy of the Trust s policy on raising matters of concerns (whistleblowing) is available at the link below detailing what to do: freedom-to-speak-up-whistleblowing-policy The procedures in this Code also apply to medical staff, nursing staff and other types of staff from other NHS trusts or from private practices, who are contracted to work in the Trust on a temporary basis. Managers who contract for these services must make it explicit within the written contract that these temporary staff must follow the procedures described in this Code. The aim of the Medicines Code is to ensure that all patients requiring medication receive their medication correctly and that the proper procedures have been followed. The Code assists Trust staff in complying with legal requirements and standards laid down by their professional bodies. The Trust provides treatment to a diverse range of individuals and this has been written to ensure that their individual requirements are met. This Code provides a Page 7 of 141

8 common core upon which the procedures for specific areas or treatments can be based. It must be read, together with any local procedures or protocols, and adhered to when carrying out care. In a number of instances throughout this Code specific training requirements have been highlighted as necessary to perform certain tasks. As a principle, all training provided will be subject to regular review and the participants will be offered refresher and update training as necessary to ensure continued quality of care for all patients. Implementation, Monitoring and Review of the Code Implementing this Code is the responsibility of all staff who are involved in any aspect of the prescribing, supplying or administrating of medicines. Team leaders, home leaders, modern matrons and ward managers in conjunction with the Trust s directors, heads of service and integrated team managers have additional responsibilities to ensure that staff, working in services for which they have responsibility, are adhering to the standards laid down in the Code. The code will form the basis for local and trust-wide audits or checks to monitor implementation. As a minimum annual trust-wide audits or checks will be undertaken of some aspect of: Prescribing The administration of medicines The storage, recording and disposal of controlled drugs Self administration Compliance with medicines management training The Code will be reviewed regularly, at least every year, and revised as appropriate in consultation with all relevant staff. Medicines Management Training All registered nursing staff working in clinical practice should attend a structured fullday training course on Medicines Management every three years. This will be provided at several venues across the Trust and will cover aspects such as the Medicines Code and the Drug chart; together with clinical updates on medication in common use and there will be some tailoring depending on the area of practice. All new nurses should attend a relevant course within the first 6 months of appointment (unless one for their speciality is run less frequently) and all nurses must attend for an update every three years. Following attendance at the Medicines Management full-day training course, all nurses must complete the online dosage calculation course. Nurses on wards all must undertake the Trust s online rapid traquilization training programme within three months of appointment onto their first ward and then at least ever three years. Nurses administering medicines using the Trust s drug chart must undertake the Trust s online drug chart training programme prior to doing unsupervised drug rounds or equivalent if in the community and then at least ever three years. New junior medical staff must undertake the Trust s online traing programmes for rapid tranquilization, using the drug chart and mental health clinical scenarios. The expectation is for new juniors to successfully complete all the specified training prior Page 8 of 141

9 to taking up their position with the Trust or at the latest by the end of their first week in post. All junior doctors are expected to attend a structured induction programme on taking up their position with the Trust. This programme contains a module on pharmacy services and medicines management. For further details of training the Trust considers essential, staff should refer to the current Trust training policy. 2. DEFINITIONS RELEVANT TO THIS CODE 2.1. Staff Definitions Throughout this Code, certain specialist titles describe healthcare staff who have defined responsibilities regarding the management of medicines. Only staff with contracts (or honorary contracts) of employments to work in The Sussex Partnership NHS Foundation Trust are recognised as having any involvement with medicines. Throughout, the term Practitioner is used. This is a general term used to describe a qualified medical practitioner, nurse, pharmacist or other authorised healthcare employee. Prescriber A registered professional authorised through training registration to prescribe medication. Independent Prescriber Doctor, dentist, nurse or pharmacist who has completed the non-medical prescribing course as an independent prescriber or who qualified as a supplementary prescriber and has undertaken the conversion course. Supplementary Prescriber A registered professional, other than a doctor or dentist, who through training and registration can prescribe in accordance with a clinical management plan agreed between the supplementary prescriber, independent prescriber and patient Appointed Practitioner in Charge The senior practitioner appointed in charge of a ward or department e.g. Ward Manager, Superintendent Physiotherapist. The Chief Pharmacist, together with senior managers, must agree and authorise named individuals to be given these responsibilities. NB. In situations where the person in charge is not from a professional background appropriate to take such responsibility (e.g. community team leader with a social work background) another member of the team must undertake the role of Appointed Practitioner in Charge. Assigned Practitioner in Charge The senior practitioner on duty for the ward or department, who has been rostered as the professional in charge for the shift. Designated Practitioner (e.g. Registered Nurse) Any registered practitioner identified by the Appointed Practitioner in Charge as competent and appropriate to perform a specific function. The designation as such has been communicated to and accepted by the Designated Practitioner. If the practitioner is based in the community the term used is Designated Community Practitioner. Designated Complementary Therapist Any practitioner of a complimentary therapy (see index) who has obtained the appropriate qualification from a recognised organisation, and is approved by The Sussex Partnership NHS Foundation Trust. Page 9 of 141

10 Authorized Pharmacy Staff Any qualified pharmacist or pharmacy technician authorised as competent and appropriate to perform a specific function by the Chief Pharmacist of their employing trust. Authorized Employee (e.g. Nursing Assistant or assessed carer) A member of staff who following training, (which may take place locally), has been authorised by the Appointed Practitioner in Charge to undertake specific duties in relation to medication, (e.g. witnessing the administration of controlled drugs). Note: Any additional unit-specific policy must be taken into consideration Other Definitions Patient A person prescribed medicines irrespective of the environment in which they are residing. Medicine/drug Any substance or combination of substances presented for treating or preventing disease. Any substance or combination of substances which may be administered with a view to making a medical diagnosis or restoring, correcting or modifying physiological or psychological functions. Prescribe To authorize in writing the supply and if appropriate administration of a medicine. Dispense To prepare a clinically appropriate medicine for a patient for self administration or administration by another. The act of dispensing includes supply and also encompasses a number of other cognitive functions (e.g. checking the validity of the prescription, the appropriateness of the medicine for an individual patient, assembly of the product). Only pharmacy staff, doctors or designated practitioners should perform these functions. Supply/Issue To supply a medicine to a patient/carer for administration. Only pharmacy staff, doctors or designated practitioners should perform these functions. Administer To give a medicine by either introduction into the body, (e.g. orally, inhaled or by injection) or by external application (e.g. cream, ointment or application of a patch). Administration Supervised Administration Self Administration In this situation the drugs are fully administered by staff. In this situation patients will exercise varying degrees of responsibility for the administration of their own drugs short of self administration and staff will provide varying degrees of assistance short of full administration. In this situation the patients manage their own drugs with appropriate monitoring by staff. Drug chart The Trust s official Drug Prescription and Administration Chart Patient Group Direction (PGD) - A written procedure for the supply and/or administration of a specific medicine, including prescription only medicines, in an identified clinical situation, to a clearly identified group of patients, by named competent practitioners in the absence of a written prescription. It has been drawn up within the Page 10 of 141

11 Trust by doctors, pharmacists and other professionals and approved on behalf for the Trust by the Medical Director. Medicines administrated under Protocol (MAUP) - A written instruction for the administration of named non prescription-only medicines to provide patients with symptomatic relief in an identified clinical situation in the absence of a written prescription. It has been drawn up within the Trust by doctors, pharmacists and other professionals and approved by the Medical Director on behalf of the Trust. 3. GENERAL PRINCIPLES 3.1. Medicines, whether for internal or external use, will be regarded for the purpose of the Code, as comprising the following categories: Controlled Drugs controlled under the provisions of the Misuse of Drugs Act 1971, with stringent requirements for supply, storage and administration. All other medicines and medicinal products prepared for administration to patients and which are controlled by the Medicines Act This also includes many diagnostic agents, X-ray contrast agents and medical gases. Whilst less stringent regulations apply than in the case of controlled drugs, they must be treated with care. All complementary medicines e.g. aromatherapy, herbal or homeopathic remedies. These products are used for therapeutic purposes and require the same safeguards as other medicines. Other pharmaceutical preparations: Disinfectants, reagents and other preparations not used directly to treat patients. The use of these products in hospital is still subject to certain rules. It is important to understand that procedures listed in this document apply to all medicines used in The Sussex Partnership NHS Foundation Trust. These include topical lotions, applications, intravenous infusions, medicated dressings and complementary medicines. Full attention must also be given to the requirements of current Control of Substances Hazardous to Health (COSHH) Regulations The responsibilities of the various practitioners associated with the prescribing, ordering, storing, dispensing, issuing and administration of medicines are as follows: It is a requirement that all Health Authorities designate a senior pharmacist to be responsible for the organising, monitoring and reporting of a system for assuring the safe and secure handling of medicines. In The Sussex Partnership NHS Foundation Trust the designated senior pharmacist is the Chief Pharmacist. In most situations medical staff are responsible for prescribing medicines for patients. They and any other authorised prescriber must comply with legislation, any agreed formulary, drug application procedures and the Medicines Code when performing these duties. A record showing appointment and signature of all prescribers (including locum appointments) should be notified to the appropriate mental health pharmacist and updated upon any change by Medical Staffing. The Assigned Practitioner in Charge of the ward or department is responsible for the stock of medicines held in the ward or department and for ensuring that stocks Page 11 of 141

12 of controlled drugs, if held, correspond with the details shown in the register. The Appointed Practitioner in Charge is responsible for ensuring that accurate CD records are maintained. Pharmacists and pharmacy technicians are responsible for the stock of medicines held in the pharmacies, their manipulation and preparation into user ready presentations and for their supply to wards and departments. They are also responsible for advising on the safe, effective and economic use of medicines. These responsibilities include advising practitioners on the storage of medicines in clinical areas. Authorised pharmacy staff will inspect the stocks of medicines held on the ward or department at any time to ensure the medicines are in date and stored under the proper legal and environmental conditions. This will occur at least annually. Where units receive a regular pharmacy top-up service, this will occur at least every four weeks. The administration of medicines is the responsibility of the Assigned Practitioner in Charge of the ward or department who may delegate these duties to a Designated Practitioner, but must exercise supervision as is necessary. It is the responsibility of the Appointed Practitioner in Charge to ensure that the Designated Practitioner or Authorised Employee has received the relevant training and experience before being allowed to take on responsibility for medicine procedures. If any nurse administering medicines becomes concerned that the drug chart has become tatty or the seams torn, they should ensure that the drug chart is rewritten, even if it has several days or weeks of adminstration spaces unused. Practitioners in training must be given every opportunity to become proficient in medicines related activities under appropriate supervision. The supervising practitioner has responsibility for medicine procedures at such times. The responsibilities for medicine procedures that may be held by various grades of practitioner are indicated in this document. Practitioners must be aware of the tasks they may or may not perform Cultural issues may arise when prescribing or administering medicines, particularly with regard to: The use of animal products in medicines, particularly the source of gelatin in capsules and other formulations. Information for Muslims concerned about animal products in medicines is available on the Trust s external website: Taking medicines during the Muslim religious festival of Ramadan. Though patients are allowed to take their medication during daylight hours with a little water medication, related queries may occur because: A patient still wishes to avoid taking medicines during the hours of daylight and concerns arise because of the legth of time between doses, particularly when Ramadan falls in the Summer months A patient is happy to take their medication during daylight hours with a little water, but the advice given is that the medicine is taken with or just after food. This may be because of local side-effects on the stomach if empty, e.g. taking NSAIDs or because the medicine isn t adsorbed on an empty stomach, e.g. lurasidone. Page 12 of 141

13 The pharmacy team is available to advise on the implications of changing the times medication is taken during Ramadan or the impact of taking a medicine on an empty stomach when advised not to. 3.4 Access to all medication related documentation is essential whenever medicines are prescribed or administered. All relevant documents in use must be kept together, including: The main drug chart Supplementary drug charts, including: o Alcohol detoxification chart o Anticoagulant prescribing and administration chart o Clozapine initiation chart o Insulin prescribing and administration Mental Health Act prescribing forms T2, T3, S62, etc. One stop risk assessment forms Covert administration form Antipsychotic high dose monitoring form 3.5 Responsibility for the secure and safe handling of medicines on wards and in team bases is that of the ward manager or team leader. To help ensure that medicines are being securely handled, the following needs to take place: New permanent or acting ward managers will be sent an information sheet on appointment explaining their responsibilities for the safe and secure handling of medicines by the Chief Pharmacist. A weekly medicine security and safe handling check to be done on each ward by the ward manager/team leader or a nominated deputy. A checklist must be used see appendix 18. A quarterly medicine security and safe handling check should usually be undertaken by the Matron on each of their wards/team bases. If the ward manager/team leader has a nominated deputy doing the weekly checks, the Matron can, however, use the ward manager/team leader as their nominated deputy. A checklist must be used see appendix 19. The Matron must still assure themselves that these medicine security and safe handling checks are all taking place if the ward manager or team leader is acting as their deputy. The ward manager/team leader must ensure that their staff are reporting medication related incidents and that any lessons learned are shared with the whole team and if appropriate within the wider organization. 4. PRESCRIBING OF MEDICINES 4.1. Inpatient prescribing Medicines may only be prescribed on official Trust prescription stationery. Details that must be included on the drug chart are: Patient s name, including aliases on every page. Date of birth or age Ward or clinic name, or number, or name of department or patient s address Patient s hospital number and/or NHS number. Known allergies or sensitivities to medicines Page 13 of 141

14 Where more than eight medicines have been prescribed in the regular section of the drug chart, a second chart may be used, which must remain with the first. In such circumstances both drug charts must indicate the existence of a second chart. When a patient is re-admitted, including for respite care, a new drug chart must be used. The drug chart of patients transferred from one trust site to another does not need to be rewritten. When patients are transferred from other organizations, the duty doctor must rewrite the drug chart at the time of clerking in, or at the earliest opportunity. In addition to the main drug chart there may be other charts e.g. clozapine initiation chart, the main drug chart must make reference to any therapy indicated on the other chart Initiation of Treatment It is important to recognise that in most situations only medical staff have the authority to prescribe medicines for hospital inpatients or for patients attending day hospitals or clinics. However if authorised by the Trust in certain situations non-medical prescribers may undertake this role. Medicines must only be administered where they have been authorised by a prescriber. This authorisation must be in writing, in the form of a prescription in advance of the administration of the medicine. The recognised exceptions to this are listed as follows: In areas where there are no resident prescribers and in cases of clinical urgency a verbal instruction may be acceptable (see Chapter 5). Certain medicines may be administered at the practitioner s discretion against an agreed PGD or MAUP. In each instance a record of the administration must be entered on the drug chart in the appropriate section. Specialist practitioners and clinical pharmacists involved in certain services may be authorised to modify dose regimens and, in certain instances, to initiate or stop medicines therapy in accordance with protocols approved by the Drugs and Therapeutics Group or following prior agreement with individual prescribers. Foundation 1 grade doctors are not permitted to prescribe controlled drugs for patients being discharged or on FP10s, but may write them up under supervison by a more senior doctor on the Trust s drug chart. They are also not allowed to prescribe cancer medication, including cancer medication used for other indications, e.g. methotrexate for rheumatoid arthritis, under any circumstances. Medical students are not permitted to prescribe medicines Range of medicines to be prescribed Only the following medicines, including complementary and homeopathic medicines, can be prescribed to patients: Psychotropic medicines approved for use by the Trust s Drugs and Therapeutics Group. Physical drugs approved on the local acute trust s formulary. Medicines prescribed prior to admission by the registered doctor, dentist, nurse prescriber or authorised supplementary prescriber. Medicines being taken within a formal clinical trial. Page 14 of 141

15 Over the counter medicines, including complementary and homeopathic medicines following a review by medical staff. If there is any doubt about their safety then the advice of a pharmacist should be sought. A defined procedure must be followed in order to request a new medicine or new indication for use within the Trust. Details of the procedure are available from the local mental health pharmacist or the Chief Pharmacist Range of medicines not to be prescribed New medicines, new indications and/or unlicensed medicines unless approved by the Trust s Drugs and Therapeutics Group Function of the drug chart To provide a permanent record of the patient s treatment with medicines. To indicate the patients sensitivity to medicines. To direct and record the administration of the medicines to the patient. A well-written drug chart enables the rapid and accurate interpretation of the medicines required by the patient. All prescriptions must be in black ink to facilitate legible faxing and scanning Prescribing on the drug chart Prescriptions must clearly identify the patient for whom the medication is intended and, whenever possible, be based on the patient s choice, awareness of the purpose of the treatment and informed consent. The prescription must be clearly written in BLOCK LETTERS, typed or computer-generated and be indelible. The prescription must indicate the drug, dose, variable does (if required), timing, frequency, route of administration, original start date, stop date, stopped by (see later) and date. Controlled Drugs must be written clearly and indelibly, by the prescriber, on the in-patient prescription chart. There is no requirement for the quantity of the controlled drugs to be written in words and figures. For drugs given as required additional information of max dose/24hrs and a clear indication for use must be stated. Allergy status or sensitivities to medication must be recorded on the drug chart, ideally by the prescriber when first writing up the chart. If this cannot be ascertained at the time of first writing up the chart the prescriber must complete the second section of the allergy box stating the allergy status is not yet ascertained. The medical team is ultimately responsible for completing the allergy status box as soon as possible, but another healthcare clinician involved in the medicines management process may ascertain the status and sign instead of the prescriber, including their designation e.g. pharmacist. (see also below). The patient s weight and height should be recorded on admission on MEWS and further weights measurements should be taken as necessary. When rewriting drug chart allergies or sensitivities, weight on admission and start dates or before admission must be carried forward. Page 15 of 141

16 When prescribing oral cancer medication, access is needed to the written protocol and treatment plan from the hospital where treatment was initiated and advice obtained if needed from a pharmacist with experience in cancer treatment in that hospital. When prescribing insulins it is imperative that the correct type of insulin is prescribed. Patients on insulin should have been issued with an insulin passport or an equivalent local pateint record to help provide accurate identification of their current insulin products. This should be used to check the accuracy of the prescription. If the patient is admitted without an insulin passport and there is any concerns about the product they are on, then confirmation must be obtained from the patients GP as soon as possible Name and Form of the Medicine A medicine may have numerous brand names but only one approved or generic name, therefore the approved or generic name rather than brand name/s should be written clearly in BLOCK LETTERS. However if the medicine is a compound (with no approved name) or has a unique release property or bioavailability, then the brand name should also be used e.g. Priadel. Non-approved abbreviations of the name of the medicines e.g. CBZ for carbamazepine must not be used. When prescribing oral medicines, tablets or capsules will be supplied unless another formulation is specified e.g. liquid. In situations where confusion may arise e.g. creams and ointments, the form should be specified. When a liquid preparation is required the prescriber should usually just prescribe the dose and add the word liquid. The only exceptions should be when the dose strength is critical e.g. methadone liquids or the liquid formulation does not have equivalent doses to the tablet or capsule e.g. phenytoin Dose and Route of Administration The dose must be expressed in metric units, avoiding decimal points wherever possible by using whole units, i.e. 125 micrograms rather than 0.125mg. The word micrograms must be written in full and not abbreviated to mcg, to avoid confusion with milligrams (mg). The word Unit must be written in full rather than abbreviated to U, which can frequently be confused with the number O and may lead to 10 times the dose of e.g. insulin or heparin, being administered in error. Roman numerals (e.g. ii) are also the cause of medication errors and must not be used. No more than one route can be specified against an entry. Ext External use PR Per Rectum IM Intramuscular PV Per Vagina Inh Inhalation SC Subcutaneous IV Intravenous SL Sublingual Neb Nebulisation Top Topical, indicating the specific area or eye/ear. O/PO By Mouth All other routes of administration must be written out in full. Page 16 of 141

17 4.2.7 Times of Administration The times of administration must be specified by the prescriber in the appropriate column on the drug chart. Abbreviations such as bd tds are only to be used for as required (PRN) medicines and on take home/outpatient prescription charts. The following abbreviations are standard means of indicating a dose regimen: OD OM ON BD TDS QDS Mane Nocte PRN Once a day Each morning Each night Twice daily Three times daily Four times daily Morning At bedtime As required (with indication and interval stated). All other dose regimens must be written out in full Signature of Prescriber Prescription item must be validated by the full signature of the prescriber. The signature should be legible or the printed name of the prescriber should be written next to the signature. If the prescriber is a non-medical prescriber then the following letters must be written after the signature: SP - if prescribing as a supplementary prescriber. IP - if prescribing as an independent prescriber Date Each prescription on the drug chart carries three dates. The original start date is the date the drug commenced if initiated on the ward. If the drug was started prior to admission put before admission in the original start date box. This box only relates to the drug and not the dose. This start date or before admission must be carried forward to any rewritten prescription charts in the future. The stop date is either specified in advance and administration will stop on the completion of that day unless administration boxes are crossed (X) or the stop date should be completed on discontinuation of the drug. The date is the date the prescription was written on that chart. Allergies or Sensitivities The following procedure must be followed Ideally, allergy status should be confirmed before the first drug chart is completed after admission. This is not always possible and it is the responsibility of the medical team to ensure it is completed as soon as possible, but all staff involved in the Page 17 of 141

18 medication management process may confirm the allergy status, recording it in the patient s care notes and on the drug chart. If not signed by a prescriber when first writing the chart the signature and the designation of the person completing the Drug chart s allergy box should be included, e.g. pharmacist. The medical team must take ultimate responsibility for ensuring that the drug allergy boxes on all drug charts are completed and signed. If there is a known allergy, the following signed and dated entries must be made in the patient s care notes and on all drug charts: - Generic name(s) of medicine(s), unless otherwise recommended by the BNF - Nature of reaction(s) to ensure a true allergy is being described. Otherwise one of the following designations must be utilised. (The use of abbreviations is not recommended as they may be confusing); No Known Drug Allergies the patient/carer, case notes or GP are clear that the patient has never experienced an allergic reaction or severe adverse reaction to any medication. Not Yet Ascertained only to be used in exceptional circumstances where it has not been possible to ascertain allergy status on admission. The reason why must be documented in the patient s care notes by the medical team, e.g. a new admission requiring rapid tranquillisation. Allergy status must be confirmed as soon as possible. Guidance Notes If the allergy status is not documented on the drug chart, prescribing, administering and supplying medicines carries a significant risk. Take particular care with co- named drugs, checking that the patient is not allergic to either constituent. Also take particular care with penicillin, (e.g. coamoxiclav/augmentin is a penicillin). The above principles apply equally to adverse/untoward reactions and severe side effects this may include previous incidence or suspicion of neuroleptic malignant syndrome (NMS) or neutropenia associated with clozapine. Avoid the use of any other means of documenting or highlighting allergy status. Counsel patients on the need to inform all healthcare professional of their allergy status. Newly identified allergies must be communicated to primary care by documenting in CPA and Discharge Letter. When predictable allergic reactions result from the prescribing and administration of medicines, the most likely causes are: Incomplete documentation of allergy status Inconsistent location of documentation of allergy status Using brand name of medicines rather than generic (approved) names Information on allergy status not being available to relevant healthcare professionals Lack of clinical knowledge Page 18 of 141

19 Alterations Prescribers should not attempt to alter existing instructions. Any change in medication must be written as a new entry. Correction fluid such as tip-ex must not be used. Incorrect prescriptions should be crossed through with a single line, signed in the stopped by box and dated Cancellation of Treatment It is important that a suitable means of cancellation of the prescription is adopted, such as a bold line being drawn diagonally across the prescription. The stop date and stopped by boxes must be completed. When the stop date is specified in advance and administration will stop on the completion of that day unless administration boxes are crossed (X) Length of Treatment Drug charts are valid for a maximum of eight weeks and community prescriptions for 6 months. After this period, treatment must be re-written if it is to be continued. If the prescription is considered ambiguous at any time, the practitioner responsible for the administration of the medicine or the pharmacist must request the prescriber to rewrite it. If prior agreement has been obtained from the prescriber, drug charts may be written or re-written by designated practitioners or pharmacists. However, overall responsibility for the prescriptions remains with the prescriber who signs them. Nurses must not administer medicines from prescriptions, which have not been signed by the prescriber, other than against remotely prescribed orders (see index) Once Only Doses (Stat doses) Medicines that are intended to be given once only must be prescribed in the once only section of the drug chart. This includes test doses of long acting intramuscular injection As Required Prescriptions (PRN) The as required section of the drug chart must only be used for those medicines to be given at the practitioner s discretion according to the needs of the patient. An entry in the patient records should give reasons for administration and outcomes. The reason should also be documented on the drug chart. The minimum interval between doses and indication for administration must be clearly specified by the prescriber. The maximum dose or frequency to be given in a 24-hour period must also be stipulated. Different routes must be prescribed separately on the PRN side of the chart. If more than one route is prescribed that maximum dose should include all routes and must state all routes. If different routes have different maximum doses this also must be clearly stated. Care must be taken not to duplicate medicines being taken regularly and thus overdose the patient. Combination analgesics frequently contain paracetamol, which may already be prescribed in the regular section of the prescription chart. Rapid dose escalation using combinations of PRN and regularly prescribed Page 19 of 141

20 antipsychotic drugs is one of the most commons causes of sudden death and neuroleptic malignant syndrome in patients suffering from schizophrenia. The as required prescription must be reviewed regularly by a doctor to determine its continuing clinical need. To prevent the accumulation of unnecessary as required prescriptions the following guidelines should be observed: o Any as required prescription that has not been administered for 4 weeks should normally be cancelled, unless specific rules apply or continued clinical need is established. o No more than two as required medicines should be prescribed together for the same indication. If two are, then the one to be used first line should be clearly stipulated along with information on when the second would be used. Medicines originally prescribed as required, but which are needed regularly as indicated by the administration record, must be reviewed and if appropriate rewritten in the regular prescription section. If there is any doubt or concern, or the member of staff is unsure of the criteria given for the administration of as required medication, then advice must be sought from the prescriber, a senior colleague or pharmacist. Reasons for not administering as required medication when requested by the patient should also be recorded in the patient s care notes Review of the drug chart It is good practice to review medication and prescriptions must be reviewed and re-written by the authorised prescriber at least every eight weeks in hospital settings. As a minimum standard all medication must be reviewed within 12 months in all non-hospital settings. Older people who are on more than 4 drugs should have their medication reviewed at least every 6 months regardless of setting Cancelling a drug chart All pages of the drug chart should be diagonally scored through so that no one is in any doubt that the chart is finished. One line per page is sufficient so that prescriptions and administration records are not obscured. The finish date for the chart should be written in the space provided at the top right hand corner of the front page. The patient photograph must be removed and attached to the new chart if still suitable for use or destroyed if it needs replacing Archiving of the drug chart Once the drug chart has been cancelled it must be scanned into Carenotes and the quality checked for readability before being shredded in line with the Trust s Scan and Shred protocol. Page 20 of 141

21 If it is not possible to scan in a readable version, the original drug chart should be stored in line with the protocol and a note made in Carenotes to say a hard copy is available Supplementary drug charts The Trust has a number of supplementary drug charts to support safe prescribing; o Clozapine initiation o Warfarin prescribing o Alcohol detoxification (both chlordiazepoxide and diazepam versions) o Insulin prescribing If prescribing on a supplementary drug chart a reference must be made in the regular section of the main drug chart to the supplementary drug chart, e.g. Warfarin see supplementary drug chart or Alcohol detoxification see supplementary drug chart. The supplementary drug chart must be clipped to the main drug chart. 4.3 Outpatient prescribing 4.3.1Prescribing using FP10 Prescriptions Only prescribers authorized by their consultant can hold FP10 prescriptions. On appointment a form will be provided by Medical Staffing to record the prescriber s signature and initials for use by the local pharmacy department. It will also have space for the consultant to authorise the holding of a pad of FP10s if they wishes. This form must be held locally in line with local agreements. Any collecting a FP10 pad from a central site holding them, either in their own right or on behalf of a team, must provide proof of identity. See index for further details on pad security. The use of FP10s is restricted to prescribing for patients of the Trust. Unless there are concerns about patient safety, the usual length of treatment prescribed should be as agreed by the local PCT. In East Sussex and Brighton & Hove this is 14 days and in West Sussex this is 28 days. This will ensure the community pharmacist or dispensing doctor provides a patient information leaflet. Prescriptions for controlled drugs, which are subject to prescription requirements must be indelible, and must be signed by the prescriber, be dated, and specify the prescriber s address. The prescription must always state: o The name and address of the patient o In the case of a preparation, the form and where appropriate the strength of the preparation o The total quantity of the preparation, or the number of dose units, in both words and figures o The dose Page 21 of 141

22 Stationery used for requesting medicines must be kept in a secure place when not in use. Prescription pads (i.e. FP10s), must be locked away when not in use; the responsibility for this lies with the person to whom they are issued. Except in the following circumstances the use of FP10s should be restricted to initiating treatment or when a dose change has been made: o Patients of the Substance Misuse Service o A hospital only medicine is being prescribed e.g. clozapine o For a drug currently under evaluation by the Drugs and Therapeutics Group o During the initiation phase of a drug later prescribed by GPs under a shared care agreement o For exceptional patients who would otherwise disengage from all services. Whenever a prescription is written for a patient, a record of the prescription must be put in the patient s care notes along with onformation on why it was prescribed and any future plans for stopping or continuing with the medication. This information must also be communicated to the patient s GP. 4.4 Prescribing long acting antipsychotic injections in the community The Community Depot Injection Prescription Sheet should be used for prescribing and recording the administration of depot injections in the community. The maximum validity for any one prescription sheet is 6 months. The patient must be reviewed at least six monthly by the prescriber, using the patient s multidisciplinary notes. 4.5 Monitoring side effects Ideally, all patients should be given information in a suitable format, e.g. in large print leaflets, on the possible side effects of a medication prior to it being prescribed, to inform their choice and make them aware of the side effects they may encounter All patients prescribed medication must be monitored for side-effects after starting a medication, when initiating or changing medication, including dose changes, at least annually but more frequently if appropriate Medication care plans must include details of how long-term side effects will be minimized by regular monitoring e.g. regular weighing following initiation of antipsychotics to identify rapid weight gain The Glasgow Antipsychotic Side-effect Scale (GASS) (see appendix 14) should normally be given to patients prescribed antipsychotics to self report side effects after initiating or changing medication, including dose changes and at least annually and more frequently if appropriate. Page 22 of 141

23 5. REMOTE PRESCRIBING 5.1. It is not acceptable for a nurse to take a verbal order on its own, without follow-up confirmation In exceptional circumstances, where the medication has been previously prescribed and the prescriber is unable to issue a new prescription but where a change of dose or re-prescribing of a drug is considered necessary, a remote prescription can be accepted In very exceptional circumstances, a doctor (but not a non-medical prescriber) may need to prescribe remotely for a previously unprescribed medicine, for example, in palliative care or remote and rural areas Until the on-line s.62 form on Carenotes becomes available, the on-call Responsible Clinician can access Carenotes remotely and make an entry authorising use of section 62 Mental Health Act The fact it is the on-call Responsible Clinician logging into Carenotes is as effective as a signature The person due to receive the remote prescription must inform the prescriber of all other medicines being taken by the patient. They should request and receive information from the prescriber regarding contra-indications and side effects of the remotely prescribed medications In all instances of remote prescribing the prescriber must confirm the prescription either by making an entry in Carenotes or using information technology. If the prescriber doesn t have access to Carenotes then ideally fax or should be used to transmit information between the prescriber and the inpatient unit. In exceptional circumstances text messaging can be used If an entry in Carenotes is not used a copy of any fax or must be stapled to the patient s drug chart until the entry in the drug chart has been countersigned by the prescriber or their deputy. The original must be placed in the patient s care notes. A note must also be made in the patient s care notes detailing the prescriber s name, date and time and the name(s) and signature(s) of the staff receiving the remote prescription If a text message has had to be used, the message should be retained on the receiving mobile-phone until the entry in the drug chart has been countersigned by the prescriber or their deputy. In addition a record must be made in the patient s care notes stating that a text message was received along with a verbatim transcription of the text message and details of the mobile phone that received the text. A note must also be made in the patient s care notes detailing the prescriber s name, date and time and the name(s) and signature(s) of the staff receiving the remote prescription Only qualified nurses and pharmacists may accept remote prescriptions. However, qualified nurses and pharmacists retain the right to refuse to accept remote orders from prescribers if they do not feel competent to do so, if there are communication problems so the intentions of the prescriber are not clear, if they feel the order is inappropriate, or if they feel it is not in the patient s best interests If the medication is for an as required medication it would usually be prescribed remotely for one dose only and written up in the once only section of the drug chart. In exceptional circumstances it can be written in the as required section but a stop date must be written that does not exceed the next normal working day. Page 23 of 141

24 5.11. If the medication is to be given regularly this must be written in the regular medication section of the drug chart If the transmitted prescription does not match the medication discussed verbally with the nurse or pharmacist, the prescriber must be contacted again to clarify the remote prescription The remote prescription must be recorded in the appropriate section of the drug chart and the additional information written in the additional instructions box. Additional information: The maximum number of doses if more than one (to a maximum of 72 hours) This is a remote prescription by (name of doctor) who has (made an entry in Carenotes/sent a fax/ /text message to confirm the prescription. The name of the member of staff who has received the remote prescription The entry must be countersigned by a prescriber, ideally by the originating prescriber, on the next normal working day and no longer than 72 hours after the remote order was given, to safeguard patient welfare and minimise risk Any active remote prescription not yet signed by a prescriber must be reported to the next shift at handover and/or recorded in the patient s care notes There must never be more than one medication prescribed remotely for any patient at any one time. If further prescriptions are required the patient must be seen by a prescriber Controlled Drugs cannot be prescribed remotely except those in Schedule 4 & 5 e.g. most benzodiazepines, but not temazepam When a pharmacist identifies a possible medication error, any alterations should ideally be made by the prescriber or their deputy. However, the pharmacist may accept a verbal order from a prescriber to add a missing item or amend a prescription, in line with the prescriber s instructions, if not doing so would put the patient at greater risk. Once taken the pharmacist must: Read the intended alteration back to the prescriber who must then confirm it verbally. Sign all alterations and explain in the additional instructions box why the alteration has been made noting the name of the prescriber contacted. If the patient s clinical notes are available, make an entry (signed and dated) detailing the alteration made, the reason for it and, the name of the remote prescriber. 6. MEDICINES ADMINISTERED UNDER PROTOCOL (MAUP) 6.1. The contents of the Protocol must include the following information: Details of the condition or situation to which the Protocol applies. Details of which patients are included and excluded from treatment under the Protocol Page 24 of 141

25 Characteristics of the staff authorised to take responsibility for the administration of the medicine under the Protocol Details of recording requirements. The management and monitoring of the Protocol. An expiry date before which Protocol must be reviewed. Details of who drew up and who signed off the Protocol It is the responsibility of the Appointed Practitioner in Charge of each ward, department or area to ensure that if medicines are administered without a written prescription then a valid and current Protocol is available to guide practitioners in their area and that the person administering the medicine has receive training about the protocol and is eligible to work under it The practitioner must assess the need for the use of medication and judge themself competent, (and therefore accountable), to administer them Hard copies of approved Protocols must be available in each area where they are used. Copies of all MAUPs will be available on the Trust website A record of this type of administration must be entered in the Medicine administered under protocol (MAUP) section of the drug chart and signed by the Designated Practitioner A Designated Practitioner can only administer a medicine following their own assessment and not under the directions of another practitioner The Trust Drugs and Therapeutics Group is responsible for ensuring that Protocols are reviewed every two years. New editions, revisions and deletion of Protocols must be approved by the Trust Drugs and Therapeutics Group. A record of the review must be on the documentation. 7. PATIENT GROUP DIRECTIONS It is usually necessary that all medicines administered or supplied to a patient by a practitioner be done so on the authority of an authorised prescriber. Patient Group Directions allow named practitioners to administer and/or initiate a supply of medicines without the authority of an authorised prescriber. Patient Group Directions must be authorised by the Medical Director on behalf of the Trust The contents of a Patient Group Direction (PGD) must comply with the requirements in Health Services Circular (2000/026, including: Details of the condition or situation to which the PGD applies. Details of which patients are included and excluded for the PGD and what action to take if patients are excluded. A description of the treatment available under the PGD including dose, frequency and the aims of the treatment. Characteristics of staff authorised to supply or administer treatment. Details of records to be kept for audit purposes. Page 25 of 141

26 Details of practitioners responsible for drawing up the PGD. Signatures of the lead doctor, chief pharmacist, Head of Profession(s) eligible to work under the PGD and the Medical Director on behalf of the Trust It is the responsibility of the appointed practitioner in charge of each ward, department or area that if medicines are administered or supplied under a Patient Group Direction that the PGD is valid, the practitioner is authorised to work under the PGD and all appropriate documentation is completed Copies of approved PGDs must be available in the areas they are to be used A practitioner working under a PGD cannot delegate responsibility for administering and/or supplying a medicine under the PGD The Trust Drugs and Therapeutics Group is responsible for monitoring all Patient Group Directions in use and for ensuring the Patient Group Directions are reviewed before they expire (usually two years) Individual practitioners are responsible for ensuring that their team manager or Appointed Practitioner in Charge is told three months before their assessed competency to work under a PGD is due to expire so appropriate training, if needed, can be accessed. 8. ORDERING AND RECEIPT OF MEDICINES Where appropriate, a list of medicines to be held for stock purposes, including controlled drugs, will be drawn up by Pharmacy Staff in consultation with the Appointed Practitioner in Charge. This list should be reviewed at least annually and revised according to actual usage since the last review. Once agreed, a copy of the stock list must be printed, signed and dated by the Appointed Practitioner in Charge and the member of the pharmacy team involved in agreeing the stocklist. This copy must be held on the ward in the pharmacy folder. Only nurses authorized by the Appointed Practitioner in Charge to order drugs can do so. Before a nurse can order any medication a sample signature must be sent to the pharmacy, countersigned by the Appointed Practitioner in Charge Controlled Drugs The responsibility for ordering, receipt, storage and recording of controlled drugs is that of the Assigned Practitioner in Charge of the ward/department. The ordering of stock and temporary stock controlled drugs will use the documentation and standards of the SLA acute trust providing the pharmacy supply service Controlled Drugs can only be ordered from the pharmacy by submitting a requisition from the official Controlled Drugs Requisition Book. Ordering is restricted to an Assigned Practitioner in Charge. All Assigned Practitioners who may order controlled drugs must provide the supplying Pharmacy Department with specimen signatures Unless the Controlled Drug order is for an agreed stock controlled drug, the Controlled Drugs Requisition Book must be accompanied by the drug Chart (or a photocopy for off site pharmacies) to confirm the reason for the temporary stock supply All controlled drugs must be delivered to wards or departments in a tamper evident package. The tamper evident package can be a locked box such that the person delivering the box has no access to the key. Page 26 of 141

27 Or a package sealed by a tamper evident closure that has a unique serial number recorded Where appropriate a porter, driver or courier may deliver controlled drugs in a tamper evident package The porter, driver or courier must sign a drugs delivery record sheet or book. A Designated Practitioner must receive the package and sign a drugs delivery record sheet or book. The Designated Practitioner signs for receipt of a tamper evident pharmacy container. If the controlled drugs are to be collected by a Designated Practitioner, the appropriate part of the Controlled Drugs Requisition Book must be signed and the medicines transported back to the ward in a sealed package A Designated Practitioner must check the contents of the package containing controlled drugs against the requisition. Any discrepancy must be reported to the appropriate pharmacy IMMEDIATELY. If correct, the Designated Practitioner must sign the requisition. The Designated Practitioner must enter the new stock into the controlled drugs register on the appropriate page, witnessed by another Designated Practitioner, Authorized member of the Pharmacy Staff or an Authorized Employee who must verify the stock level and sign the register. The medicines must then be immediately locked away Where sealed packs of controlled drugs are supplied with tamper evident seals, there is no requirement to open these packs for stock checking purposes Controlled Drugs must be stored in a locked medicines cupboard, approved by pharmacy and reserved for the sole storage of controlled drugs. Access must be limited to Designated Practitioners, Pharmacists or Authorised Pharmacy Technicians Registers and Requisition Books for controlled drugs are controlled stationary and obtainable only from the pharmacy. Requisition books must be locked away Orders and records must be in permanent ink and must be retained for two years All Other Stock Medicines Ordering of stock medicines A designated Practitioner or authorised member of the pharmacy staff shall be responsible for ordering medicines from the pharmacy for the purposes of maintaining ward stocks. Stock medicines may be ordered by: Supplying a written requisition from the appropriate order book, or an order sheet signed by a Designated Practitioner. Using a fax machine to send a copy of the above. By means of the pharmacy top-up service Non-Stock Medicines Ordering of non-stock medicines Non-stock medicines for individual patients may be ordered by: Submitting a signed order plus the patient s drug chart. Using a fax machine to send a copy of a signed order and the patient s drug chart. Page 27 of 141

28 By means of the ward pharmacy service. If a patient s own medicines are available, they may be used with the patient s or their carers (if appropriate) consent, providing they comply with the standards set out in this Medicines Code Medicines for Short Term Leave or Discharge Short term leave or discharge medication can be ordered by: Completing the Short Term Leave section of the drug chart, or completing a discharge prescription. Depending on local arrangements, a copy of the drug chart may also have to be submitted to the pharmacy. Using a fax machine to send copies of the above (if agreed locally) Controlled Drugs cannot be supplied to a patient until the original prescription has been received by the Pharmacy Once the leave/discharge medicine is delivered to the ward the supplied medication and its labeling should be carefully checked by a designated practitioner against a copy of the drug chart or discharge prescription. Special care must be taken to ensure any medicines not supplied by pharmacy but already on the ward are labeled for leave or discharge e.g. inhalers, are added to the bag of medicines. (See below) When checking delivered discharge / leave medication, the designated practitioner must: Check the labels, including the quantity / number of doses issued, against the prescription chart / discharge prescription. Make a visual check of the approximate quantity of medication supplied and compare against the expected quantity / number of doses. Mark the TTO bag as checked and add their initials and date checked. Record receipt of the medication in the patient s care notes, including a record of any errors and action taken to correct these. Report any errors to the ward / unit manager and / or the Modern Matron If a problem with a discharge/leave medication is discovered after it has already been taken from the ward/unit, this must be reported to the ward/unit manager or Modern Matron and they must decide on what action to take All errors relating to the supply of leave or discharge medication must be recorded in the patient s care notes and must also be reported via the Trust s incident reporting scheme If the leave/discharge medicines have been supplied well in advance of the leave/discharge then extra care must be taken to check that no prescription changes have taken place in the interim Delivery of Medicines All medicines must be delivered to wards/departments in a secure container. Where appropriate, a porter, driver of courier may deliver medicines in a tamper Page 28 of 141

29 evident package or locked box. The porter, driver or courier must sign a drugs delivery record sheet or book. A Designated Practitioner or authorized employee must receive the package or box and sign the drugs delivery record sheet or book. The Practitioner is signing for the receipt of a tamper evident pharmacy container or locked box and not the contents If there is a central receipt point then an authorized member of staff may sign for it but a local audit trail needs to be established for onward distribution Medicines may be collected from Pharmacy by a Designated Practitioner or approved messenger and transported back to the ward in a tamper evident pharmacy package or locked box On arrival the Designated Practitioner must: Sign for the tamper evident package or locked box in the delivery book. Check the contents against any delivery note, signing and retaining it for a minimum of 12 months. Lock the medicines in the medicine cupboard, fridge or trolley immediately. Report any discrepancies or errors to the Pharmacy as soon as possible One stop Dispensing Where one stop dispensing has been introduced, supplies of inpatient medicines dispensed for the individual patient can be issued for short term leave or discharge, provided: There are sufficient supplies. The patient has been deemed suitable to receive one stop dispensing supplies following assessment by the primary nurse and a member of the pharmacy team using the One Stop Dispensing Risk Assessment Form. (Appendix 12). This form should be checked prior to using one-stop supplies for short term leave or discharge. The decision has been recorded in the patient s care notes along with a copy of the assessment. The medicines stored in their individual tray(s) within the ward medicine trolley correspond to those prescribed on the discharge or leave prescription. The medicines have a label including the name of the medicines, the directions for use and the name of the patient that correspond to those on the prescription, along with the date of dispensing. The Designated Practitioner checking the inpatients medicines for use has been deemed competent to check one stop medicines for short term leave or discharge use. Where the short term leave or discharge prescription differs from the medicines in the patient s cabinet or when there are insufficient supplies of medicines, the ward staff must contact the Pharmacy Department to make arrangements for the required discharged medicines to be dispensed. The patient s suitability or unsuitability must be reviewed if the patient s condition or circumstance change. Page 29 of 141

30 8.7. Controlled Drugs to Take Out Controlled drugs to take out should be ordered on a short term leave or discharge prescription which has been completed and signed by the prescriber in accordance with current legal requirements. The prescription must include the patient s name and address, drug name, the form, the dose, the frequency, and the total quantity (in words and figures). The original prescription must be sent to pharmacy for dispensing Delivery and receipt of controlled drugs for short term leave or discharge TTO purposes should be as for other medicines, but storage on the ward/department should be in the controlled drug cupboard It is not usually necessary to enter the TTO into the Controlled Drug Register although individual units may choose to do so if it is felt that additional administrative safeguards are required. However, if a patient s discharge is delayed beyond the planned discharge date or one of the CDs supplied for discharge needs to be administered while the patient is still on the ward, then the CDs supplied as a TTO must be stored in the CD cupboard, entered into the CD register and booked out when the patient is discharged or the TTOs are destroyed if not needed. 9. BORROWING OF MEDICINES 9.1 Medicines must not be borrowed from a ward or department unless a supply cannot be obtained directly from the pharmacy during normal working hours. If the unit has an emergency cupboard, this must be checked first. Most wards have access to a small number of FP10 prescriptions that can be dispensed at a local community pharmacy. These should be used in preference to borrowing when local community pharmacies are open. Only medicines dispensed by the hospital pharmacy service may be borrowed and usually the complete container should be transferred to the receiving ward. If only one container is available and the drug is needed on the original ward the full container must be taken and the dose administered from it, and then return the container to the original ward. 9.2 Only in exceptional circumstances may medicines be transferred into another container in order to be transferred. In these circumstances an appropriate, clean medicines container must be used, and must be labeled with all details of the medication including batch number and expiry date. Where such transfer occurs, it is the responsibility of the assigned practitioner in charge. 9.3 A signed record of the transfer of medicines must be kept in both wards diaries involved in the borrowing transaction. The signatures must be those of the Assigned Practitioners in Charge of both wards. 9.4 Controlled Drugs must not be borrowed expect in an extreme emergency. Where this does occur, full records of the transaction must be made in both wards Controlled Drugs Registers and both signed and countersigned by the Assigned Practitioners in Charge of both wards. 9.5 If borrowing occurs, Pharmacy should be informed at the earliest opportunity so that the stock can be replenished. 10. PATIENT AND CARER INFORMATION 10.1 It is important that the patient (or carer if appropriate) receives adequate information about their medicines prior to discharge unless their care plan deems it inappropriate. Page 30 of 141

31 10.2 The patient should know as a minimum: The purpose of the medicine How to take it. For how long it is to be taken for. What side-effects they may experience. How they will get further supplies of their medication, if needed This is the responsibility of the prescriber who may choose to involve authorized pharmacy staff in this process and the actions taken should be documented in Carenotes Best use should be made of any patient information leaflets supplied with the medicines and any additional leaflets endorsed by the Trust and are available via the Trust website Patient information is available on request in other formats including large print and electronically. Interpreter and translation services are also available. 11. TRUST PHARMACY SERVICES 11.1 Medicines will be procured supplied and dispensed in accordance with the relevant legislation, professional standards and NHS recommended practice So far as possible, pharmacists will monitor the use of medicines for patients in their care, and place special emphasis on complex; potentially toxic and high risk medicines that require higher levels of monitoring. Monitoring will include the need for the medicine, the medicine selected, the dose regimen including the duration of treatment, the medicine formulation and the route of administration In addition pharmacists will monitor for medicine interactions and adverse reactions and whether the therapy is achieving the desired therapeutic end points Continuing medicine treatment will be reviewed as necessary Authorized pharmacy staff will annotate the prescription. This annotation must ensure the approved name (where appropriate); does, route and cautions and any additional information is included on the prescription, to guide practitioners when they administer the medicine Where an authorized pharmacy staff member wishes to make a recommendation to change or modify a patient s therapy and the prescribe is not immediately available and the advice is not deemed to be urgent, they will liaise directly with the assigned practitioner in charge and, where considered appropriate, will record the recommendation in the patient s care notes and if available the doctors communication book. If urgent another member of the medical team should be contacted Authorized pharmacy staff will make and maintain their own record of any significant interventions for future reference Inpatients (or their carers where appropriate) should be advised about their medicines by authorized pharmacy staff during their admission stay or period of admission unless their car plan deems it inappropriate. This should be a part of an agreed programme for each ward. The Appointed Practitioner in Charge should Page 31 of 141

32 agree with the pharmacist and consultant the arrangements for advising patients (or their carer) about their medicines Where practicable and appropriate, practitioners may request the authorised pharmacy staff advise patients about their medication during the course of their inpatient stay, attendance at clinic, outpatients or in discussion or educational groups Alternative arrangements for advising patients about their medicine may be provided if: The nature of the hospital stay is less than one week. There is a need for a rapid discharge Patients are identified who may need further advise post discharge The care plan indicates that such discussions would be inappropriate. There is insufficient availability of suitably trained pharmacy staff. The patient requires the information in another format or language. Such alternative arrangements must identify the person responsible for the provision of information and the nature of the information to be provided Authorized pharmacy staff must be involved in advising on security and medicine storage conditions on the ward/unit or department. 12. PHARMACY OUT-OF-HOURS SERVICE 12.1 Only in cases of clinical urgency will the on-call pharmacist supply items. The supply of the vast majority of medicines will not be clinically urgent and can usually be safely left to the next time the pharmacy is open. However, when in doubt the on-call pharmacists may be contacted and will assist ward staff to determine the degree of urgency It may not always be possible to have individual medicine supplies available from the pharmacy for the next medicine administration round. Nursing/practitioner staff must make maximum use of patients own medicines and emergency drug cupboards (where provided). If the medicines have been ordered and have not yet been supplied by the pharmacy the Designated Practitioner must record N on the medicine administration chart. Medicines brought in by patients at the time of their admission must never be used for other patients The Pharmacy out of hours service is also available for urgent medicines information advice and for reporting suspected significant adverse reactions to medicines or suspected faulty medicines. 13. ADMINSTRATION AND PREPARATION OF MEDICINES The preparation, checking or administration of medicines to a patient must only be undertaken by the following categories of healthcare staff: A Designated Practitioner. A Medical Practitioner. Authorized Pharmacy Staff. A practitioner in training or an employee training to administer medicines, but only under the direct supervision of a Designated Practitioner. The Designated Practitioner remains responsible for ensuring that the correct procedure takes place. Page 32 of 141

33 In addition a designated practitioner may delegate the role of assisting the patient to ingest or apply the medicine, to an unregistered employee or carer who has been assessed as being competent to carry out the task. The Designated Practitioner in Charge is accountable for the assessment of this competency, which may be delegated to another Designated Practitioner to undertake Preparation of Medicines It is during the preparation of medicines for administration that errors frequently occur, particularly where some form of dose calculation is involved. In the majority of cases, medicines will be presented to ward areas from the Pharmacy Department in a ready-to-use form, where no further dilution or dose calculation is required Where the preparation of medicines is performed outside the Pharmacy Department, the following points must be observed: Read the prescription carefully; determine the name, dose, diluents, route for administration and expiry date. If a dose calculation is required this information must be included as part of the prescription either by the doctor or the pharmacist so that the Designated Practitioner administering the dose is clear about the actual amount to administer. It is strongly recommended that the Designated Practitioner checks all calculations with a second practitioner or pharmacist before administration. Where a calculation is involved and where the medicine is intended for parental administration, a second practitioner must check all aspects of the preparation of the medicines and sign and date the entry. If the practitioner is unclear as to the correct medicine diluent or precise method for medicine preparation, they must obtain this information from the Summary of Product Characteristics (SPC), BNF, appropriate Pharmacy Department or on call pharmacist before proceeding. Most SPC can be obtained from Administration of Medicine The Assigned Practitioner in Charge is responsible for ensuring that prescribed medicines are administered at the prescribed time. Minimum time intervals between doses must always be checked if doses are delayed or need to be given early. If the timing has to be significantly exceeded or brought forward, advice should be sought from the prescriber or authorized pharmacy staff. For patients who repeatedly request to delay their medication the pharmacy team can provide advice that can be incorporated into the patient s care plan Before administration of a medicine, a practitioner must check: Legibility and correct completion of all details on the drug chart. Authorization and administration (Form T2 or T3) if the patient is detained under the Mental Health Act. All sections of the drug chart to get an overview of all the medicines being administered to identify any prescribing or administration errors. Page 33 of 141

34 Extreme care is required to confirm the patient s identity. Use a photograph if available and verbal questioning to confirm the patient s identity before proceeding to administer the dose. The record of the administration of medicines that the prescribed dose has not already been given. The name, form and strength, and prescribing period of the drug to be administered against the drug chart. The time of administration and the time the last dose was administered, if appropriate. The route of administration. Any special guidance relating to the drug e.g. dilution with water, before or after food. The expiry date of the medicine. Before signing the administration chart ensure that the medication has been taken To reduce the risks of inadvertently administering an oral drug, intravenously: Only use labeled oral syringes that cannot be connected to intravenous catheters or ports, to measure and administer oral medicines. Do not use intravenous syringes to measure and administer oral liquid medicines. Make sure stocks of oral/enteral syringes are available in all clinical areas that may need to measure and administer oral liquid medicines in syringes. When patients or carers need to administer oral liquid medicines with a syringe, supply them with oral or enteral syringes To reduce the risk of inadvertently administering an enteral drug, intravenously: Only use labeled enteral syringes that cannot be connected to intravenous catheters or ports, to measure and administer enteral medicines. Enteral feeding systems should not contain ports that can be connected to intravenous syringes or that have end connectors that can be connected to intravenous or other parenteral lines. Enteral feeding systems should be labeled to indicate the route of administration. Three-way taps and syringe tip adaptors should not be used in enteral feeding systems because connection design safeguards can be bypassed To prevent cross infection, following administration, single use medicines pots and oral syringes must be destroyed. Non-disposable items must be thoroughly washed in hot soapy water, rinsed in clean water and allowed to dry. Oral syringes, even if manufactured for multiple use, must be labeled for use by an individual patient. Because of the inaccuracy of medicine pots the majority of oral liquid medicines must be measured using oral syringes or medicine spoons. Page 34 of 141

35 Medicine pots can only be used for measuring; senna liquid, antacids, lactulose, Gaviscon Advance and Peptac Liquid Prior to administering intramuscular or subcutaneous injection, if the skin is clean, no further cleaning is necessary. Only visibly dirty skin needs to be washed with soap and water. In the event that alcohol or chlorhexidine swab is used to disinfect the skin before an injection, the skin should be in contact with the swab for 30 seconds and the area allowed to dry completely for at least a further 30 seconds. Breaking the skin before the alcohol has completely dried can affect the outcome/result and cause pain to the patient Medicines dispensed by the hospital pharmacy for an individual patient should only be administered to that patient (supplies labeled for individual patients must not be shared). In exceptional circumstances e.g. out of hours individual doses can be used for another patient (see chapter 9). Medicines brought in by patients at the time of their admission must never be used for other patients The Practitioner who has administered or supervised the administration of the medicine must, at the time of administration, sign with initials in the appropriate column of the drug chart. To avoid confusion with omission codes, the initial must consist of at least two letters If an unexpected blank administration box is discovered after a drug round has been completed, the following steps should be taken: If the person doing the drug round is still on duty they should be asked to clarify what has happened as soon as possible. If the dose has been omitted in error, they should administer it and initial the drug chart in the normal manner. If already administered, the person should initial the drug chart. If they did not administer the drug and it was a deliberate omission, they should complete the empty drug chart box with the appropriate omission code. If the person who undertook the drug round has left the site, but is contactable, they must confirm what has happened and send a confirmatory or text to that effect. If they confirm that they have administered the dose, put an asterisk (*) in the administration box and put your own initials beside it. You must not initial the drug chart on behalf of another person using their initials. Drug charts in future may have an asterisk printed as an official administration or omission code but until then use a suitable free space on the drug chart administration page, to put * see the patient s Carenotes. Make an entry in Carenotes in the Medication section with the title Administration incident explaining what has happened, scanning in the or text message from the person, to provide an audit trail and then complete an incident form. If the person(s) who undertook the drug round cannot be contacted or if contacted, cannot be sure whether the medicine was administered, never assume that the dose has not been given as it risks doubledosing the patient. Sensible steps should be taken to try and ascertain what has happened, e.g. ask the patient if competent, look at other records (e.g. CD register or main drug chart if using a supplementary Page 35 of 141

36 drug chart), check blood sugars if on insulin. If there is any uncertainty get advice from the medical or pharmacy team on what to do next. Whatever the outcome, put an asterisk (*) in the administration box and put your own initials beside it. Drug charts in future may have an asterisk printed as an official administration or omission code but until then use a suitable free space on the drug chart administration page, to put * see the patient s Carenotes. Make an entry in Carenotes in the Medication section with the title Administration incident explaining what has happened and then complete an incident form. An unintended blank administration box is a medication incident and should be reported on Ulysses The Designated Practitioner must observe the patient has taken their medicines. Prepared medicines must never be left unsupervised If the patient is absent from the ward, or has missed a dose for some other reason, the delayed dose can be administered at a later time provided a doctor or pharmacist has confirmed that it is appropriate to do so or that it is according to an agreed protocol. The actual time of administration must be clearly recorded in the administration record by the Designated Practitioner and appropriate entry into the patient s record is made. There is a missed dose card available to highlight missed doses on the drug chart Patients classified Nil by Mouth prior to a diagnostic procedure or receiving an anesthetic and undergoing ECT must have all their prescribed oral medicines administered to them at the prescribed time unless specifically advised otherwise by ECT staff and these omissions must be marked on the drug chart as E. The medicines should be taken with a small amount of water to enable the patient to swallow these medicines. Only medicines that have been clearly marked on the prescription sheet may be omitted. It is the responsibility of the prescriber to provide clear written instructions to the nursing staff concerning the omission of prescribed doses Patients receiving medication via a PEG feeding tube must only have their drugs administered by a nurse or authorized employee who has been formally trained by a member of a specialist team responsible for inserting PEG feeding tubes. If a patient is admitted and no formal training has been provided, specialist advice must be sought. Advice should be also be sought from the pharmacy team if any doubts exists with regard to administration of any medication via this system To reduce the risks of spreading or prolonging an eye infection due to contaminated eye drops the following steps must be taken when a patient is diagnosed with an eye infection: If the patient is already on regular eye drops (e.g. for glaucoma) or as required eye drops (e.g. artificial tears) these must be replaced immediately with a fresh supply, a separate bottle for each eye (if used in both eyes), until the infection has been treated. The drops must be given an expiry date of just one week once opened until the infection is successfully treated, instead of the usual 28 days. Page 36 of 141

37 If the infection is in both eyes, a separate bottle of antibacterial/antiviral eye drops should be dispensed for each eye and each bottle given an expiry date of one week until the infection is treated If when administering or supervising the administration of insulin you are unsure of the type of insulin that has been prescribed, every patient should have in their possession an insulin passport or equivalent local patient record to help provide accurate identification of their current insulin products. This should be used to check the accuracy of the prescription and if there are any concerns the medical team should be contacted to clarify the prescription The self-administration of insulin by competent patients should be actively encouraged, to help themmaintain their skills during an admission If a medicine is omitted (see also 13.8 below), covert administartion is occuring or a patient is self-administering the following codes must be entered on the administration record. A must be recorded for absence without leave. C must be recorded for covert administration along with the initial of the practitioner administering the medicine. E must be recorded for omitted prior to ECT. L must be recorded for on leave. N must be recorded if there is no stock. P must be recorded if the patient is managing their own medicines* R must be recorded if the patient refuses. S must be recorded when a patient is sleeping. SA must be recorded for supervised self administration along with the initial of the practitioner supervising the administration. X must be recorded for a prescribed omission (e.g. alternate days dosing). O must be recorded if a medicine is omitted for any other reason, which must be recorded in the patient s care notes. * Assuming the nurse supervising self administration is confident that the prescribed medication has been self-administered either the administration code P (patient managing own medicines) can be written in the appropriate administration box or other suitable wording written across over the appropriate administration boxes on the drug chart to indicate self-administration is taking place e.g. patient selfadministering Refusal of medication by any route or of their aspects of care (e.g. blood tests or physical observation) may have a serious detrimental effect and should be reported to the senior nurse or doctor. Failure to record the administration of a medicine or an omission code constitutes a medication error and must be reported. The scrutiny of such records will be the subject of regular audit. Page 37 of 141

38 13.3 Two person checking procedure All designated practitioners are authorized to administer medicines without involving a second practitioner. However, it is recognized that certain circumstances exist where involving a second person in the process may enhance safety e.g. when instructing a student or where the patient s condition or conditions on the ward indicate that a greater staff presence at the point of administration is required Except in extreme emergency, two practitioners must check the following (including calculations and measured doses) All medicines given by continuous administration, e.g. IV infusion, syringe drivers. There should be a record of the individual practitioner setting up and replenishing each intravenous infusion. All bolus injections, IV additives and injections via drip tubing. All injections taken from multi-dose vials, including insulin pens. When a patient has proven competent to self-administer the medicine (e.g. insulin) the checking of administration need only involve one practitioner with the patient. All medicines administered to a child less than 12 years of age Where a two person administration takes place, the following roles and responsibilities will be assumed: The administering practitioner takes sole responsibility for the safe administration of the medication (unless that practitioner is a student or trainee). The administering practitioner will read the prescription, prepare and administer the medication, and sign the administration record. This role should not be shared. The second person will ensure that medication pots etc. are clean, dry and ready for use and that water is available for patients. The second person will assist in the identification of patients unknown to the administering practitioner. The second person may offer a checking role to the administering practitioner where any uncertainty occurs, but must do so if the administering practitioner is a student or trainee or the two person checking criteria above apply. The second person will deflect any possible disruption, which may occur during the administration process, to allow the administering practitioner to fully concentrate on the task of administration Controlled Drugs In in-patient areas a registered nurse must administer controlled drugs and all aspects of administration must be checked by a second authorized person, including authorized employees, doctors and pharmacists. This second authorized person may also be a student nurse assessed as competent by the Assigned Practitioner in Charge, to undertake this role safely. A checklist is available for assigned practitioners in charge to help them assess the competency of care assistants to witness the administration of controlled drugs (appendix 16) and be designated authorized employees for this role. In other settings local protocols will apply. Page 38 of 141

39 In the community controlled drugs can be administered and checked by one registered nurse The administration will be noted on the patient medication record and signed by the administering nurse On inpatients units an entry must also be made in the ward or department Controlled Drugs register, including: Date and time of administration. Name of patient. Dose administered. Full signature of both authorized persons. Remaining stock balance must be checked (this must be physically checked other than for liquids see below) On completion of the register any discrepancies must be dealt with immediately (see the Losses and Discrepancies chapter) Any medicine prepared and not used, or only partly used must be destroyed by the designated practitioner in the presence of an authorized employee. An entry must be made in the Controlled Drug register and signed by both persons Special Provision for liquid controlled drugs This special provision addresses the need to avoid any excessive decanting of liquid medication, (in order to check stock balance), as this can lead to discrepancies in the balance due to loss during measurement Liquid CD preparations include: Concentrated morphine sulphate solutions (Oramorph and Oramorph concentrated). Diamorphine solution and linctus. Methadone solution and linctus Whenever possible the measurement of doses of oral liquid medication should be by oral syringe, rather than by spoon (which can easily be spilt) or for larger volumes calibrated measures provided by pharmacy, and not by plastic medicine pot. (Such pots are readily available and are in common use but are not accurate) Before the preparation of each dose the persons responsible for the procedure must make a visual check and estimate of the stock balance held. Only if they consider the balance appears inaccurate do they need to physically measure the stock in order to accurately confirm its quantity The record of stock balance in the CD register must be made routinely. During normal use it will be based simply on the calculation of balance remaining after removal of the dose The Appointed Practitioner in Charge remains responsible for balancing the stocks of all controlled drugs at least weekly. Provided no discrepancies have occurred in the preceding period, and particularly where use of a drug has Page 39 of 141

40 been limited, this again may be carried out by visual estimate. However, weekly balance by measurement should be considered where usage is heavy An accurate measurement of stock balance, preferably using a calibrated glass measure, must be made whenever a discrepancy occurs, is suspected or a bottle is finished. If significant loss is detected, greater than 5ml per 100ml (e.g. less than 25ml per 500ml bottle), this must immediately be brought to the attention of the unit manager and the unit pharmacists If the discrepancy is less than 5ml per 100ml then the actual stock balance should be recorded in the controlled drug register and endorsed stock adjustment signed and dated by the designated practitioner in charge and a second nurse or an authorized employee. If the adjustment is due to an overage, which is normally the case, the additional quantity of controlled drug added to the stock balance should also be written in the left hand section of the register as a an additional supply. Instead of writing in the requisition number, put the word Overage instead. These small adjustments do not need reporting as an incident Accurate measurement of stock balance may also be carried out by the unit pharmacist at their discretion The administration of medicines by authorized pharmacy staff and by designated practitioners other than nurses and medical officers Authorized pharmacy staff may carry out medicine administration procedures only with the prior approval of the medical team Authorized employees other than nurses and medical officers, may only carry out medicine preparation and medicine administration procedures with the full approval of the medical team and only after a written procedure has been approved by the Drugs and Therapeutics Group and the appropriate intergrated governance team Medication to be given as required The administration of the medicine must be recorded on the drug chart to include time, date, dose and the initials of the member of staff administering the medicine The reason for administration should be recorded on the drug chart and the patient s record If there is any doubt or concern, or the member of staff is unsure of the criteria given for the administration of as required medication, then advice must be sought from the patient s doctor, a senior colleague or pharmacist There should be a review procedure in place, which ensures that frequent or regular use if highlighted and brought to the attention of the patient s doctor Reasons for not administering as required medication when requested by the patient should also be recorded in the patient s care notes Reducing harm from omitted and delayed medicines in hospital Medicine doses may be omitted or delayed in hospital for a variety of reasons, eg: Medication not available Administration overlooked In-patient chart lost or unavailable Page 40 of 141

41 Whilst occasionally these events may not seem serious, for some critical medicines or conditions delays or omissions can cause serious harm or death It is therefore important that nursing staff seek advice from pharmacy and/or medical staff and follow Trust policies and procedures when any drug is going to be omitted or delayed for whatever reason, or if it is discovered that a dose or several doses of a drug have already inadvertently been omitted The senior nurse on duty should decide whether the clinical risks warrant getting advice during the night or whether this can wait until the following morning The following table gives examples of the consequences of omitting some of the medication seen in an inpatient setting; these include psychotropic drugs and physical drugs. The severity of the consequences may depend on the length of delay, half-life of the drug, etc. Medication (This is not a comprehensive list) Analgesics Anticoagulants Anticonvulsants / mood stabilisers Antidepressants Anti-infectives / antibiotics Benzodiazepines (alcohol detox) Regular benzodiazepines (shortacting) Buprenorphine Clozapine Immunosuppressants Insulin Lithium Lofexidine Methadone Oral contraceptives (especially progestogen only) Parkinson s disease medication Procyclidine Resus / emergency medication Possible consequence of omission or delay Loss of pain control INR reduced, resulting in increased blood clotting and the possibility of DVT or PE Loss of seizure control / loss of symptom control Withdrawal symptoms (especially with paroxetine and venlafaxine) Treatment failure and / or development of resistance Alcohol withdrawal symptoms e.g. risk of convulsions Withdrawal symptoms, agitation / insomnia Withdrawal symptoms Loss of symptom control; if omitted for more than 48 hours dose must be retitrated from 12.5mg to avoid serious adverse effects e.g. hypotension, seizures. Rejection of organ transplant Hyperglycaemia Loss of symptom control, invalid test results Opioid withdrawal symptoms increased Withdrawal symptoms Unwanted pregnancy, exposure of foetus to teratogenic medication Loss of symptom control Antipsychotic side effects exposed Increased mortality Omission or delay of medicines, for inpatients or on discharge from hospital, are patient safety incidents and should be reported. Page 41 of 141

42 13.9 Administration of medication to members of staff On duty staff occasionally requesting paracetamol tablets for mild pain relief may be supplied with one dose, (one to two 500mg tablets), from ward/unit stock at the time of their request, and up to a maximum of two doses may be supplied within the working shift. The current edition of the BNF should be referred to for information on dosage, precautions, interactions etc The Assigned Practitioner in Charge must respond to a request for paracetamol and must not recommend it A record must be kept on the ward/unit in a note book especially kept for the purpose and must include: Date and time of the paracetamol supply Name of staff member requesting medication Number of tablets supplied Reason for the paracetamol supply Name and signature of designated practitioner undertaking supply The Assigned Practitioner in Charge is responsible for supply and must ensure, so far as is possible, that it will not result in the individual taking more than 8 paracetamol tablets within a 24 hour period, and that at least 4 hours have elapsed since any previous dose. Consideration should be given to the possibility of the staff member already taking other medication, either prescribed or purchased, which may contain paracetamol Where the Assigned Practitioner in Charge requests paracetamol for themself, another designated practitioner must take responsibility for the supply and record The Appointed Practitioner in charge must monitor the record book regularly for any evidence of excessive use or misuse This does not allow the discretionary supply of any other medication to staff. Nor does it allow the provision of prescribed medication where staff may have forgotten to take or bring in their own supply. 14. TRANSPORT OF MEDICINES The transport of medicines by community practitioners is covered in the Community Based Practitioner chapter When transferring patients Medicines needing transfer All medicines already labeled for the transferring patient must be transferred with them. This includes controlled drugs. If controlled drugs are included in the medicines being transferred they should booked out of the discharging ward s CD register and a descriptive statement added, e.g. Transferred by taxi to ward B. The receiving ward must be called and given specific details of the CD being transferred and how many doses to expect. On arrival of the transferred patient the receiving ward must ring the discharging ward to confirm safe arrival of the CD. If there are any concerns about them going missing the pharmacy team or on-call pharmacist should be called for advice. On receipt, the receiving ward must immediately record the delivery in the CD register putting something like Transferred from ward A by taxi, before storing the controlled drug in the CD cupboard. Page 42 of 141

43 If a controlled drug is being transferred in the a taxi or in the possession of a carer, the sealed bag with the controlled drug in must not indicate the bag contains contolled drugs. If some or all of the medicines for the transferring patient were being administered from stock the receiving unit must be contacted to check whether these stock drugs are held by them. If not: During normal pharmacy hours advice should be obtained about arranging appropriate supplies. Outside normal pharmacy hours the principles for borrowing medicines (Chapter 9) should be followed Transfers within hospitals Authorized members of staff must transport medicines within hospitals and must not delegate to patients or carers. Medicines must not be left unattended at any time during transport. When medicines are received at their final destination they must not be left unattended or unsecured. They should be handed to a Designated Practitioner and locked away in medicine cupboards, drug trolley or fridge at the earliest opportunity. If controlled drugs are included in the medicines being transferred they should booked out of the discharging ward s CD register and a descriptive statement added, e.g. Transferred to ward B. On receipt, the receiving ward immediately book them into their CD register and store the CDs in the CD cupboard Transport of medicines between health services premises Medicines accompanying a patient and being transferred from one hospital to another may be transported between hospitals with the patient in an ambulance or by authorized hospital transport, or taxi in a sealed bag. It is important that medicines are packaged securely and are labeled with the final destination. The packaging must not indicate the contents of the sealed package. If the patient is being escorted by ward staff or transferred by ambulance the medicines must remain in the possession of the ward staff or the ambulance crew and dealt with as though transferring a patient within a hospital. If a relative or taxi driver is ever given responsibility to escort a patient between units, unless there are concerns about security, medicines and documents can be transported by them in a sealed package clearly marked with the addressee s name and address but not indicating what is inside the package. The addressee must be asked to confirm by phone if the medication/documentation has arrived safely within an agreed deadline. Page 43 of 141

44 14.2 Transport of medicines from the pharmacy department Transportation using hospital transport All medicines must be transported in locked boxes or tamper evident containers. Controlled drugs must be transported in locked boxes or tamper evident containers with uniquely numbered tamper evident seals with the number recorded in the CD requisition book and the top copy kept in pharmacy. Containers shall be kept securely or under surveillance whilst awaiting collection from or on receipt at the designated areas. On arrival on the wards/departments/clinics, containers should be placed in a designated area. Once delivered to the ward/department/clinic the responsibility for the security of the medicines rests with the Assigned Practitioner in Charge who will arrange that the contents be unpacked, checked against any delivery note and put away securely as soon as possible. The delivery note must be signed and stored for a minimum of 12 months. Report any discrepancies or errors to the Pharmacy as soon as possible. The driver shall carry a record book stating the destination and the number of containers for each destination with any unique seal numbers recorded if appropriate. The authorized person accepting the delivery must sign the record book. Where the medicines are delivered to a central distribution point local audit trails need to be established. The containers must be securely stored while waiting to be distributed to the wards/departments/clinics. The responsibility for the security rests with those transporting the medicines until the delivery is completed and the necessary signatures obtained Transportation from pharmacies by Taxis All items should be transported in locked boxes or tamper evident containers. Containers with controlled drugs in them must not have any special marks to indicate controlled drugs. If tamper evident seals are used. The seal number of the container must be recorded in the transport book. A suitable record must be completed and a copy must be retained in the pharmacy department or on the ward. The driver takes two copies. The taxi driver should be asked for an approximate time of arrival at their destination. The ward, department or clinic due to receive the delivery must be telephoned to forewarn them of the delivery and be given a time after which they should chase the delivery if it has not arrived. This will either be via the pharmacy, or the pharmacist on-call if out of hours. Only hospital contract taxis with drivers able to produce identification bearing a photograph shall be used. Items must be collected from the pharmacy or an agreed designated manned area, e.g. A & E, and delivered to the addresses or an agreed designated manned area, e.g. ward reception. Page 44 of 141

45 If items are not delivered directly to the addressee the responsibility for security rest with those receiving the container until delivery is completed and documentation countersigned. On arrival the driver must obtain a signature from addressee or agreed representative. After obtaining a signature for receipt of the medicines, one copy is kept by the driver. The ward, department or clinic must retain their copy for 2 years Transport of medicines to individual patients at home Patients who have left the hospital before all their medicines have been dispensed must be instructed to return to the hospital later to collect their medicines unless other approved arrangements have been made Medicines may be delivered by a member of the community team to the patient s home In exceptional circumstances medicines may be delivered to a GP practice, health care clinic or community pharmacy by authorized hospital transport, taxi or by post, for collection by the patient. Arrangements must be agreed with the receiving premises and the Assigned Practitioner in Charge of the ward needs to authorize it. It is important that medicines are packaged securely and are labeled with the final destination Collection of medicines by voluntary drivers, relatives or representative of the patient Voluntary drivers, relatives or representatives of the patient may collect medicines from a hospital pharmacy on behalf of a patient provided the appropriate pharmacy has received prior notification of their impending arrival by the ward, day unit or department and the person collecting the medicine has proof of identity e.g. driving licence Voluntary drivers who receive medicines on behalf of a patient must deliver the medicines to the patient and not pass the medicines to another voluntary driver Voluntary drivers must carry identification of their role. 15. STORAGE OF MEDICINES (see also chapter 22 Custody and safe keeping of medicine keys) The appointed Practitioner in Charge is responsible at all times for the safekeeping of all medicines on their ward, department or team base. The design and location of all ward, department or team base medicine storage cupboards must be approved by Authorized Pharmacy Staff and regularly monitored. All internal and external medicines, disinfectants, and reagents must be stored in locked rooms, cupboards, trolleys or other secure cabinets all reserved solely for medicinal products. The only exceptions to this requirement are medicines for clinical emergencies. Intravenous fluids, sterile topical fluids and nutritional products and some bulky medicated dressings, which because of their bulk are Page 45 of 141

46 stored in a clean area (as agreed between the Appointed Practitioners in Charge and an Authorized member of the Pharmacy staff). Internal medicines must be stored separately from other medicines. Under no circumstance must medicines be transferred form one container to another, nor must they be taken out of their container and left loose. Medicines should be arranged in a way to ensure clear identification and efficient stock control. A nominated person should perform regular checks to identify medicines that are approaching their expiry date. Waste medicine containers on inpatient units when in use and not sealed must be locked away in a cupboard whose key is held with other medicine keys. Once sealed, ready for collection by the waste contractor, they should ideally be stored in a locked cupboard whose key is held with other medicine keys, but under exceptional circumstances be held in a locked clinic room until collected. Waste medicine containers in community clinic bases when in use and not sealed should ideally be locked away in a cupboard whose key is held with other medicine keys. In exceptional cases were there is no space for additional cupboard storage, they can be held in a locked clinic room as long as the access to the medcines within the waste box is restricted (speak to pharmacy for advice if unsure). These medicine waste boxes should not be holding anything but stock medicines as patients own medicines must be taken to a community pharmacy for destruction (see sections , and for more information). Once sealed ready for collection by the waste contractor, the medicine waste bin should ideally be stored in a locked cupboard whose key is held with other medicine key, but under exceptional circumstances may be held in a locked clinic room until collected Positioning of cupboards and trolleys Cupboards and trolleys must be sited where most convenient for staff, allowing adequate space and permitting surveillance to afford maximum security against unauthorized entry. Medicine cupboards must generally be sited in a clean clinic room to which patients and visitors do not have access. Cupboards must not be sited where they may be subjected to higher than average humidity or temperatures greater than 25 C. Reagent cabinets may be sited in areas where testing is carried out Review of storage of Medicines The authorized Pharmacy Staff and Appointed Practitioner in Charge will regularly review the quantities, range and storage of medicines to be stocked Controlled Drugs No ward or department will store controlled drugs unless there is an Appointed Practitioner in Charge responsible for their storage and use Sample Medicines or dressings Medicines or dressings samples must not be left on or accepted by wards, clinics or departments, including pharmacy or with any member of staff. Representatives of commercial companies wishing to leave samples must be told that the Trust will purchase the product should it wish to use it. Page 46 of 141

47 15.5 Storage Accommodation The room used to store medicines should usually be at a temperature below 25 o C. A thermometer should be (ideally a maxium/minimum) one should be monitored daily and the results recorded on the Medicines Refrigerator & Clinic Room Temperature Log (see appendix 20). If the ambient temperature exceeds 25 o C for a short period during a heatwave and this results in the clinic room temperature rising above 25 o C for a few days, this will not have an overall damaging effect on the medicines. However, if the temperatures above 25 o C are recorded for any other reason, the reason should be investigated immediately and the advice of the local pharmacy team sort. Clinical areas may have some or all of the following medicine storage units: Controlled Drug Cupboards reserved solely for the storage of controlled drugs and other high risk medicines following specific agreements with authorized pharmacy staff. These cupboards must be made of metal and may be separate from others or be inside other locked metal medicines cupboards used to store internal medicines. These cupboards must be secured to the wall. The lock must not be the same as any other lock in the hospital or unit. controlled drugs must not be stored in trolleys. Internal Medicine Cupboard(s) for the storage of tablets, liquid medicines, injections, patches etc. and must be made of metal. External Medicine Cupboard(s) for the storage of creams, lotions etc (May also be used for the storage of reagents and tests). Medicine Refrigerator medicines are not to be stored together with food or pathological specimens, but in a separate locked fridge. Medicines requiring storage below room temperature will be marked Store between 2 C and 8 C, in a refrigerator. All medicines fridges will be fitted with a digital thermometer (maximum/minimum type) and an audible alarm. The assigned practitioner in charge is responsible for ensuring that max/min temperatures are monitored and recorded daily. Pharmacy should be informed if these temperatures are outside the range. See Chapter 36 for more extensive guidance on handling medicines requiring cold storage. Reagent Cupboard(s) situated in the area where urine testing is carried out. Some wards may not require a separate cupboard if urine testing is only very rarely carried out but in such circumstance there should be a ward agreement about where such testing is to take place. A Clean Storage Room for intravenous fluids and sterile topical fluids, if no suitable cupboard is available. Medicine Trolley for storage of medicines in current use on the medicine administration round. When not being used the medicine trolley must be locked and secured to the wall. The trolley must not be left unattended during the medicine round. If the Designated Practitioner leaves the trolley, it must be locked immediately. Medicines for Resuscitation these must only be held where an acute trust crash team is available or in an ECT suite for use by the anaesthetist. They must be in a position to afford supervision to prevent unauthorized access. These must be held in a tamper evident box and must not be in a locked cupboard. Once opened the box must be returned to the appropriate pharmacy for replacement. (See Sussex Partnership NHS Foundation Trust resuscitation and anaphylaxis policy). Page 47 of 141

48 Individual Patient Medicine Cupboards medicines dispensed for individuals (together with the patient s own medicines) can be stored in an individual locked medicine cupboard at the side of the patient s bed. These cabinets must be kept locked when not in use and the keys held by a Designated Practitioner. Where self-medication takes place, the individual patient may also keep keys to this cupboard. (See self administration policy). Waste medicine containers on inpatient units when in use and not sealed must be locked away in a cupboard whose key is held with other medicine keys. Once sealed and ready for collection by the waste contractor, they should ideally still be stored in a locked cupboard whose key is held with other medicine keys, but under exceptional circumstances may be held in a locked clinic room until collected. Waste medicine containers in community clinic bases when in use and not sealed should ideally be locked away in a cupboard whose key is held with other medicine keys. In exceptional cases where there is no space for additional cupboard storage, they can be held in a locked clinic room as long as the access to the medicines within the waste box is restricted, (speak to pharmacy for advice if unsure). These medicine waste boxes should not be used for the disposal of anything but stock medicines. Patients own medicines must be taken to a community pharmacy for destruction (see sections , and for more information). Once sealed and ready for collection by the waste contractor, the medicine waste bin should ideally be stored in a locked cupboard whose key is held with other medicine key, but under exceptional circumstances may be held in a locked clinic room until collected Closure of a Ward or Department If a ward or department is due to close, the controlled drugs must be handed over by an Assigned Practitioner in Charge to an Authorized member of the Pharmacy Staff who will sign the appropriate section of the register and return the controlled drugs to the pharmacy. All other medicines must be returned to the appropriate pharmacy in a locked box that has been sealed and the seal signed by assigned practitioner in charge on the day the ward or department closes. Items requiring refrigeration must be stored separately in an appropriately sealed tamper evident container. If the closure is only for a short period, (e.g. just one or two days), all medicines may stay on the ward (other than controlled drugs) provided there is adequate security to prevent unauthorized access to the cupboards Medicines Requiring Additional Security The Trust has identified a list of non- schedule 2 and schedule 3 CD medicines with greater abuse potential that may be at greater risk of diversion. To avoid diversion additional pharmacy monitoring will take place and, where a specific need is identified, some wards / units may introduce additional storage safeguards. The medicines covered are: Alprazolam Codeine Diazepam Dihydrocodeine Flurazepam Loprazolam Lorazepam Lormetazepam Page 48 of 141

49 Midazolam Nitrazepam Oxazepam Zapelon Zolpidem Zopiclone Any request to add one of these medicines to a ward/eam stock list must be supported by a written request on a special proforma available from the pharmacy team. The Appointed Practitioner in Charge must complete it and give it to their pharmacist who will need to support the request Stock medicines on this list should be reviewed regularly and removed from stock if use is low and it is not needed for emergency use Pharmacy staff checking stocks will pay particular attention to the usage patterns of these medicines, reconciling usage with administration records if there are any concerns. Pharmacy staff will record in the ward diary when these checks have taken place If any of these medicines are not needed and returned to pharmacy or go out of date or are wasted (e.g. spat out, only half a tablet used) and need destroying, a record of the return or the destruction should be witnessed by a pharmacist and an entry made in a book held on the ward or team base specifically to record the destruction or return to pharmacy of these listed medicines Breach of Security Any suspected incident must be reported immediately and investigated by the Appointed Practitioner in Charge together with an Authorized member of the Pharmacy Staff. If a breach of security is confirmed the Chief Pharmacist (or in his absence the most senior pharmacist on duty at the local acute trust) and the Trust Head of Security (or his deputy) must be contacted and a decision made on whether to call the police. In the case of an obvious break in or theft then the police must be called immediately. Following a breach of security the Appointed Practitioner in Charge may agree with the local clinical pharmacist heightened monitoring and increased security measures for a limited or extended period Storage of Staff Medicines Although it should be avoided whenever possible, there may be occasions when staff need to bring medication into the workplace for personal use, eg. inhalers; courses of antibiotics etc. Wherever possible these medicines should be kept on the person. However, for clinical staff, when this may not be possible, they should be kept in a secure personal locker if such storage is available. Where it is not, individual arrangements for secure storage must be made with the ward or team manager. In such cases the medication may be stored in the nursing / team office provided others cannot gain access to it. Alternatively, the medication can be stored in the clinical room, but again access must be restricted and the medicines must be clearly labelled and segregated from all medicines intended for patients. Page 49 of 141

50 16. STORAGE AND HANDLING OF FLAMMABLE LIQUIDS, GASES AND AEROSOLS Very small quantities of these may be kept in the external medicines cupboard. Where larger quantities are held, advice must be obtained from the Trust Fire Safety Officer Medical Gases Oxygen cylinders should be stored in a dry, clean and well-ventilated area and secured in a safe position where they cannot fall over. Cylinders must never be used or stored where there are naked flames or high temperatures. Where necessary, the Fire Officer should be consulted on the safe sue and storage of oxygen cylinders No Smoking signs should be displayed where oxygen is in use or being stored near areas where smoking is allowed Where cylinders are held they should be in specifically designed trolleys or wall racks to prevent them from falling over. Their storage position on the ward should be agreed with the Trust Fire Safety Officer Staff involved in the use of oxygen should receive approved and documented training regarding the safe use of equipment including checking, maintenance and storage of oxygen cylinders When not in use the cylinders should be closed at the cylinder head (with the appropriate spanner) as well as at the flow meter Flow meters seals ( O rings) must be replaced every 2 years to prevent leakage which is a fire risk When changing cylinders hands must be clean as the mixture of oil or grease e.g. butter with oxygen is combustible More details on the storage and use of medical gas cylinders, and the issues associated with medical gases together with Health and Safety information will be found in the guidance set out in Health Technical Manual, HTM A local written procedure should be available which details the ordering, receipt, handling, storage, issue and use of medical gases. 17. LOSSES OR DISCREPANCIES In the case of an obvious break in or theft then the police must be called immediately Controlled Drugs In the event of a discrepancy between the stock balance and register for controlled drugs, the Appointed Practitioner in Charge must immediately and thoroughly investigate the loss. A missing or incorrect entry or arithmetical error must be investigated first and if found corrected. When correcting the error in the register no crossing out or Tippex must be used on previous entries. A full explanation should be recorded in the register. Any recording must be signed and dated by the Appointed Practitioner in charge and an authorized witness If this investigation is unsuccessful the discrepancy must be reported immediately to the senior manager responsible for the ward or department and the local mental health pharmacist to investigate further If after further investigation a breach of security cannot be ruled out the Controlled Drugs Accountable Officer (or in his absence the most senior Page 50 of 141

51 pharmacist on duty in the Trust) and the Trust s Counter Fraud Specialist (or deputy) must be contacted and a decision made whether to call the police In all cases of a confirmed discrepancy involving controlled drugs, an incident report form must be completed Other Medicines Any loss of other medicines must be reported to the senior manager responsible for the ward or department (via the Appointed Practitioner in Charge) and the local mental health pharmacist who can then decide on a further course of action. 18. DISPOSAL OF MEDICINES NO LONGER REQUIRED 18.1 Controlled Drugs Important Note for the purposes of destruction all controlled drugs in schedule 4 are included, which includes all benzodiazepines and the Z drug hypnotics. These are not usually subject to other restrictions, e.g. special ordering and storage In date stock controlled drugs Controlled drugs no longer required by a ward or department must only be removed or destroyed by a pharmacist. The pharmacist must be authorized to remove or destroy controlled drugs on behalf of the Sussex Partnership Trust. Those pharmacists authorized will carry an authorization letter, signed by the Trust s Accountable Officer for Controlled drugs. Upon removal of the controlled drugs, the pharmacist will record the appropriate stock balance and sign the Controlled Drugs Register. The transaction should be witnessed by a designated practitioner who will also sign the register. The drugs must remain securely stored in the CD cupboard prior to their removal. Any controlled drug removed from the ward, department or clinic by a pharmacist must be returned to the pharmacy department where an appropriate entry will be made in the pharmacy s Controlled Drugs Register if required. If the quantity or value of in date controlled drug stock is minimal a decision can be made by the pharmacist to destroy it on site instead of returning it. If a decision is made to destroy the controlled drug on site the procedure laid down for out-of-date stock controlled drugs must be followed, (see below) Partly used or opened controlled drug Any dose of a controlled drug that is prepared or opened but not administered, including partly used syringes used in syringe driver pumps, or ampoules, and oral doses spat out by the patient must be destroyed on the ward or department immediately. Although CDs are usually destroyed in a DOOP kit, these single doses or part used doses can be disposed of in the general medicines waste bin. Solid dosage forms should be wetted in a small amount of soapy water before tipping everything into the general medicines waste bin. Once emptied, any syringe or ampoule can then be disposed of in the sharps bin. The destruction of the controlled drug must be in the presence of a second designated practitioner or if not available, an authorized employee. The appropriate entry must be made in the Controlled Drug Register (see for schedule 4 CDs), which includes the signatures of the two individuals involved in the destruction. Page 51 of 141

52 Out of date stock controlled drugs Any dose of a controlled drug that is out of date must be destroyed where appropriate. The destruction of the controlled drug must be in the presence of a pharmacist and the Assigned Practitioner in Charge using a DOOP kit (except for patches) and the DOOP kit can then be disposed of in the waste medicines container. DOOP kits can be ordered on the stores catalogue. The pharmacist must be authorized to destroy controlled drugs on behalf of Sussex Partnership Trust. Those pharmacists authorized will carry an authorization letter, signed by the Trust s Accountable Officer for controlled drugs. The appropriate entry must be made in either the Controlled Drug Register for schedule 2 and 3 controlled drugs stored in the CD cupboard or, if from schedule 4, (e.g. lorazepam or zolpidem), then an entry must be made in a book specially held on the ward/team base to record the destruction or return of medicine requiring additional security. The drug name, formulation, dose and number of dose units destroyed must be recorded with the entry signed and dated by both the pharmacist and nurse involved. If the controlled drug is a transdermal patch e.g. fentanyl patch, these should be folded over onto themselves so that the drug layer is sealed within the outer film skin and it may then be disposed of in the waste medicines container. The method of destruction must be recorded in the Controlled Drugs Register Patient s own controlled drugs Controlled drugs brought in to the hospital by a patient may be: Used by the ward staff for administration to the patient (see Patient s Own Medicines section). Stored for subsequent destruction on the ward as in above. In both scenarios the controlled drug must be stored in the controlled drug cupboard, and entered in the Controlled Drug Register on a new page specifically allocated for that patient s own medicine. Patient s own controlled drugs can be returned to the patient on discharge if appropriate. However, if the controlled drugs are no longer required they should (ideally) be destroyed on the ward rather than returned to the patient or carer. If they require destruction they must be dealt with in the same way as out of date controlled drugs (see above). Patients own controlled drugs held in a community base must not, when no longer required, be put in the clinic medicines waste container, but instead must be returned to a community pharmacy for destruction. A signed record must be obtained from the pharmacy for the dose units returned to ensure an audit trail. On the death of a patient on the ward: Patient s own CDs must never be returned to a relative or carer and must be kept on the ward in quarantine in the controlled drugs cupboard for a minimum of two weeks in case they are requested by the coroner. While on the ward they must be put in a sealed bag and labelled with the patient s name and the date after which they can be destroyed. If the relatives or carer insist on collecting the medicines after the two weeks, advice should first be sought from the Chief Pharmacist. Page 52 of 141

53 Used transdermal patches containing controlled drugs If the controlled drug is a used transdermal patch e.g. fentanyl patch, these should be folded over onto themselves to that the drug layer is sealed within the outer film skin and disposed of in the medication waste bin. No record need be made in the Controlled Drugs Register Managing the CD register index Once a CD stock reaches zero and no further stock or patient s own controlled drug is on order, the index must be updated and the appropriate entry cancelled by puttung a thin line with an indelible pen through the entry in the index Auditing correct destruction of controlled drugs During their six monthly controlled drug stock checks, pharmacists will audit the destruction of controlled drugs in the Controlled Drugs Register to ensure compliance with this guidance Other Medicines All in date stock medicines, other than controlled drugs and medicines requiring additional security (see section 15.7 for more details) that are no longer required by the ward, department or team must be returned to the appropriate pharmacy either by Authorized Pharmacy Staff or in a locked box. In community bases, to avoid medicines requiring additional security (see section 15.7 for more information) going out of date in team bases, any such stock will be have an early warning date label added to it by pharmacy so the stock can be transferred to another unit or pharmacy before it expires and becomes waste All inpatient labelled medicines, including patients own medicines (see chapter 19), that are no longer required must be put in the medication waste bin Any oral dose that is spat out, doses prepared or opened but not administered, including partly used syringes used in syringe driver pumps, or ampoules, must be destroyed on the ward, department or clinic usually by placing the medicine in the medicine waste container. If the medicine wasted is a medicines requiring additional security (see section 15.7 for more information) then the destruction should be recorded in a book kept on the ward/team base to record their destruction and the destruction witnessed. Once emptied, syringes or ampoules can then be disposed of in the sharp s box. Failure to dispose of the excess drug before placing the syringe or ampoule into the sharps box will render the sharps box medication waste requiring special disposal and additional costs. For used transdermal patches, these should be folded over onto themselves to that the drug layer is sealed within the outer film skin. They may then be disposed of in the medicine waste container Patients own medicines held in a community base that require additional security (see section 15.7 for more information) must not, when no longer required, be put in the clinic s medicines waste container, but instead must be returned to a community pharmacy for destruction. A signed record must be obtained from the community pharmacy for the dose units returned to ensure an audit trail. Page 53 of 141

54 Other patients own medicines held in community bases, excluding CDs or medicines requiring additional security (see section 15.7 for more information), must not, when no longer required, be put in the clinic s medicines waste container, but instead must be returned to a community pharmacy for destruction. A signed record need not be obtained from the pharmacy for the dose units returned unless the practitioner has concerns and wants to maintain an audit trail Waste Medicine Containers Waste medicine containers on inpatient units when in use and not sealed must be locked away in a cupboard whose key is held with other medicine keys. Once sealed and ready for collection by the waste contractor, they should ideally still be stored in a locked cupboard whose key is held with other medicine keys, but under exceptional circumstances may be held in a locked clinic room until collected Waste medicine containers in community clinic bases when in use and not sealed should ideally be locked away in a cupboard whose key is held with other medicine keys. In exceptional cases where there is no space for additional cupboard storage, they can be held in a locked clinic room as long as the access to the medicines within the waste box is restricted, (speak to pharmacy for advice if unsure). These medicine waste boxes should not be used for the disposal of anything but stock medicines. Patients own medicines must be taken to a community pharmacy for destruction (see sections , and for more information). Once sealed and ready for collection by the waste contractor, the medicine waste bin should ideally be stored in a locked cupboard whose key is held with other medicine key, but under exceptional circumstances may be held in a locked clinic room until collected. 19. PATIENTS OWN MEDICINES 19.1 All medicines brought into the hospital by patients remain their own property and must not therefore be destroyed or otherwise disposed of without their agreement or, if this is not possible, their relatives agreement. A best interest decision may have to be made. In all cases the decision should be recorded in the patient s care notes Medicines brought into hospital by patients must be reviewed by the admitting doctor who may or may not wish to prescribe them Patient s own medicines brought into the hospital may, with the patient s permission, continue to be used provide: The admitting doctor wishes the medication to continue and has prescribed the medication on Trust drug chart The ward has a procedure to routinely use patients own medicines The medication is examined by the Trust doctor, authorized pharmacy staff, or a designated practitioner and is considered suitable for use If patient own medicines are not routinely used they may still be used if: Alternative supplies are not available (e.g. because of night time, weekend, or bank holiday admission) Ward stock or named patient supplies remain unavailable for the supplying pharmacy. Page 54 of 141

55 19.5 In the case of a patient maintained on a medicine not approved by the Trust the following options can be considered: The patient s prescription can be modified to the nearest equivalent approved medicines The patient can agree that their own medicines can be used including supplies kept at home In no circumstances should Trust staff contact an inpatient s general practitioner to receive a further supply of a medicine. These items may be supplied on FP10 (NC) by special arrangement with the local mental health pharmacy team. The FP10 (NC) must be provided by the team wishing to prescribe it Inpatients are not eligible to pay prescription charges, but dispensing an FP10 (NC) in a community pharmacy will incur a dispensing fee unless the patient would have been exempt from prescription charges in the community, e.g. over 60. If a fee is applicable this must be paid to the community pharmacy out of the ward s petty cash. This prescription charge will eventually be credited back to the Trust A Designated Practitioner or Authorized Pharmacy Staff member must check any patient s own medicines, including controlled drugs, before they can be used in the hospital. A Patient s own medication checklist (appendix 13) must be completed by nursing staff for each medicine used before the pharmacy team have had a chance to check them. The following criteria must be used: There is confirmation that the medicines have been stored appropriately, e.g. items that require refrigeration, such as insulin, have been stored in a refrigerator The overall appearance of the bottle, label and medicine is acceptable e.g. the container must be intact and clean. The medicine must be without visible sign of deterioration The medicine in the container is all of the same type. If the appearance of the medicine is not uniform it must not be used. Loose solid dosage forms in bottles should be tipped out onto a tablet counting triangle for inspection to avoid the need for handling. The triangle should be washed and dried after use and between patients, if admitting more than one patient at the same time, to avoid the risk of triggering an allergic reaction with cross contamination Medicines such as glyceryl trinitrate and eye drops, which have a short shelf life once opened, must not be used unless the date that the medicine container was opened is clear and within the accepted expiry date Liquid medication should not be used unless presented in an unopened, sealed bottle as contamination may not be apparent Items that require refrigeration should not normally be used unless previous correct storage conditions can be confirmed by the patient or carer. Please note insulin retains potency for at least one month at normal room temperature within its overall expiry date The medicine must be clearly labeled with: The name of the patient. Name and strength of the medicine. Method and frequency of administration. Date dispensed (do not use if dispensed more than 6 months ago). Name and address of supplier. Page 55 of 141

56 19.9 If the medicine has no dispensing label, it must not be used unless: It is clearly identifiable in the manufacturer s original container and it is within it expiry date Controlled Drugs must be stored in the CD cupboard and recorded as detailed in the procedure for making entries onto the Register. (Wherever possible, a separate register should be maintained for patient s own drugs) If the patient s own medicines are in a compliance aid they must not be used to administer the medicines to the patient. The compliance aid must be stored on the ward/unit until a full assessment is carried out by a member of the pharmacy team. Patients admitted on compliance aids must be drawn to the attention of the pharmacy team When the brand name is the only name appearing on the label and generic name appears on the prescription the pharmacist must annotate the inpatient prescription sheet with brand name used on the label If the use of patient s own medicines is the agreed policy of the ward the medicines should be stored in an individual section of the medicine trolley or if fully self-medicating in the patients locked medicine cabinet on the ward If patient s own medicines are received but not used, they must be kept in a sealed bag in a separate section of the medicines cupboard, or in a separate locked cupboard. Such medicines must not be stored in the medicines trolley Where medicines are labeled for an individual s use it is the responsibility of the Designated Practitioner to ensure that if a patient is moved to a new location all of their medicines move with them The patient s own medicine if not required can be disposed of in one of several ways: If a medicine is no longer required, then with the patient s or their relatives consent or a best interest decision, the medicines must be disposed of safely in a medication waste bin and the consent or best interest decision recorded in the patient s care notes If the patient insists, the medicines may be returned home. The patient and/agent shall be advised if the medicines are not safe for use The designated practitioner may still make a best interest decision not to return them if they feel it would be dangerous to do so. This decision must be recorded in the patient s care notes and reported immediately to the Trust prescriber and to the assigned person in charge In the event of a death of a patient while on the ward: Patient s own medicines must never be returned to a relative or carer and must be kept on the ward in quarantine for two weeks in case they are requested by the coroner The patient s own medication, including any CDs, must be placed in a sealable bag with the patient s name on it.. A list of these medicines, along with their quantities, must be made in the ward diary and the entry dated, witnessed and signed by two nurses or a nurse and a member of the pharmacy team. The bag should then be sealed and the two people involved in witnessing the sealing should sign across the seal along with the date. The Page 56 of 141

57 bag should then be stored in the drug cupboard or if it contains CDs, in the CD cupboard. (However, as any CDs will have been booked out of the CD register they do not need checking when the weekly CD check is done) If any of the patient s own medicines are controlled drugs, these must be booked out of the CD register and an entry made stating Patient deceased and their medication has been put into quarantine. This should be witnessed and dated by either two nurses or a nurse and an authorized member of the pharmacy team If the Coroner asks for the medicines they can be released to their approved representative. The wording Handed over to the Coroner along with the date handed over should be written against original entry in the ward diary and this should be signed by the coroner s representative removing them and by a nurse who must witness the removal If after two weeks the Coroner has not asked for the medicines they can be disposed of in a medicines waste bin. The wording Medicines disposed of., along with the date disposed, should be written against the original entry in the ward diary and this should be signed by by the two nurses who witnessed the disposal If the relatives or carer insist on collecting the medicines after the two weeks, advice should be sought from the Chief Pharmacist Guidance on the handming of patients own medicines in community teams is available in Chapter DAY HOSPITALS AND RESPITE CARE A variety of arrangements may be in place to prescribe and provide medicines for patients who attend day hospitals or who receive respite care. Special arrangements are in place for Learning Disability Services (see Learning Disability Services Administration of Medication Policy). Good liaison is vital to ensure that at all times both Primary and Secondary Care are aware of all the medicines to be received by the patient and, who is responsible for the prescription, the supply and the administration of each medicines. Day hospitals 20.1 The prescribing of medicines for patients who attend day care is usually the responsibility of the general practitioner. In exceptional situations a hospital prescriber may wish to take responsibility for part or all of the prescribing. These situations include: If the hospital prescriber wishes to start a new medicine an stabilize the patient on that medicines before requesting the general practitioner to take over the responsibility. If the patient remains on a hospital only drug, e.g. clozapine. If arrangements to continue supervision of the prescribing of medicines still remains with the hospital prescriber. If the prescription is subject to continual change. If there is no other reliable method of ensuring that the patient receives the medicine. Page 57 of 141

58 20.2 There may be occasions where someone may need to receive medicines whilst attending the day hospital. In such circumstances it is preferable that the hospital prescriber prescribes the medicines on the Trust s Drug prescription chart. It can also be used to provide a record of medicines administration. Respite care 20.3 For patients admitted for respite care, it is usual for the patient or home carers to provide the medicines from the patient s own supply. The Designated Practitioner must: Confirm with the carers, prior to admission, that the necessary medicines to span the period of respite care will be provided by the carer Confirm with the patient s general practitioner, prior to admission, the medicines to be prescribed for the patient Confirm with the hospital prescriber that the patient s own supply agrees with the details provided by the carer and the general practitioner. Once the confirmation has taken place the medicines will be prescribed using a hospital prescription sheet If all attempts to receive a supply from the carer fail or the supply of medicines is thought unsuitable to use, arrangements must be made to receive further supplies from the GP and/or the community pharmacy, Alternatively, (and temporarily), ward stock may be used, or named patient medicines obtained from the supplying pharmacy. 21. SELF-ADMINISTRATION OF MEDICINES 21.1 Philosophy and Aims The Trust is committed to the safe administration of medicines through the provision of a service, which is effective and responsive to the needs, and wishes of individual patients, in a variety of care settings throughout the Trust The practice of self-administration is an opportunity that allows for the continuation or promotion of patient independence, responsibility and autonomy during their in-patient stay. Patient involvement in care regimes not only assists in the rehabilitative aspects of care but is also believed to promote patient satisfaction and compliance through improved knowledge and understanding of their treatment The aims of a self-administration scheme should include: Establishing a standardised approach for determining the ability of patients to take their own medication reliably. Promoting and maintaining a patient s independence and autonomy. Improving adherence through education and personal involvement to help improve outcomes and reduce hospital re-admissions. Assessing the patient s long-term adherence with their medication regimen by: o Reviewing their adherence formally when on the ward. o Reviewing their adherence with carers and relatives if appropriate, while on leave. Page 58 of 141

59 o Exploring their level of insight and attitude to their medication. Preparing patients with the skills and knowledge to be independent and responsible in the safe and effective self-administration of medication after their discharge Scope Self-administration will not be appropriate for all patients. Participation must therefore be based upon assessment of suitability, safe systems of practice and informed choice and consent of the patient (See the Trust s Consent Policy) Self-administration requires agreement and commitment by medical, nursing and pharmacy staff Each unit should look at the feasibility of implementing self-administration from their different care perspectives. Each care environment must have safety measures in place, to allow safe practice of self-administration to be carried out. These will include a clear understanding of roles and responsibilities, the assessment of patient suitability, education, monitoring and supervision and assessing risk factors, including the risk that other service users may pressurise the patient to hand over their medication Some degree of modification may be considered in order to adapt these guidelines to local specific conditions. Under no circumstance must these adjustments result in a reduction in the security of the processes relating to medicines safety Clear documentation, safe storage of medication and lines of communication within the multidisciplinary team (MDT) and with the individual patient must also be carefully considered Patients must agree and consent to participation in self-administration before any self-administration takes place. The patient must sign a consent form (appendix 2) prior to entering into stage 2. The completed form must be scanned into the patient s care notes Patients must be informed that they may withdraw consent at any time and choose not to self-administer without their care being affected It is important to remember that a patient s participation in self-administration does not mean that all responsibility for medication administration has been transferred from the nurse to the patient The Self-administration of Medicines patient leaflet (appendix 4) should be given to all patients for information purposes All self-administration programmes must be subject to monitoring, supervision and review by registered nursing staff and the findings reviewed with the MDT on a regular basis. This must include exploring their levels of insight and attitude to their medication and if self-administering while on leave, feedback if available from carers and relatives. Increases in side effects or worsening of symptoms may be a sign of non-compliance; therefore this must be investigated before considering changes in treatment. Summaries of any reviews and decisions made must be recorded in the patient s care notes Any decision to move a patient from one level of responsibility to another, must be made by the MDT, taking into account feedback on their adherence, insight and attitude. An updated risk assessment should be completed if the proposed change does not concur with a previously documented plan. Page 59 of 141

60 When patients are at early stages of the self-administration programme (stages 1 & 2), each dose administered must be signed for on the drug chart, by the supervising nurse. A Daily Self-administration Progress Record Form - Stages 1 & 2 must also be completed (appendix 5) All medicines must be prescribed by a doctor or appropriate non-medical prescriber, on a current drug chart, in the normal manner At all stages of self-administration the recording section of the drug chart must be clearly annotated to show that the patient self-administers medication (see section 8 for codes/wording) A lockable medicine locker or drawer must be made available to each selfadministering patient at levels 2 & 3 for storing their own medicines. Either a key-lock or a keypad-lock is acceptable. Where keys are used, a duplicate key must be available to nursing and pharmacy staff but this should not be used routinely. The patient s key may be removed if nursing staff consider it necessary in the interests of safety to the patient and/or others. Where keypads are used the lock code must be changed after a patient stops using the cupboard or locker or if there are any concerns that an unauthorized person has become aware of the lock code It is not acceptable to rely on a locked patient s room for the safekeeping of medicines. A lockable cupboard or locker must be provided In the absence of lockable cupboards or lockers then the self-administration process cannot progress beyond stage Where quantities of medication are given to the patient for their own safekeeping and administration (stages 2 & 3), patients should be encouraged to keep their own record of self-administration (appendix 7) In the latter stages of self-administration, if the patient goes on leave they may take their One Stop Dispensed supply of medication with them, thus preventing the need to obtain leave prescriptions If at any point it is felt that the patient s mental state has deteriorated, there are concerns about their insight or attitude to medication or they are no longer capable of self-administering at a particular level, the patient must drop to a lower level or cease self-administration. Nurses may take this decision autonomously The continuous monitoring of the patient s mental state, their insight and attitude to medication and ward dynamics are paramount for the safety and success of the self-administration programme Patient recruitment for self-administration The decision to accept a patient into a self-administration of medication programme is a highly responsible one, which requires an assessment of risk to be taken into account. The clinical condition, along with the behavioural reliability of the patient must always be considered. Account must also be taken of other patients on the unit and their ability to influence the individual; this will need to be reviewed as and when new patients are admitted to the unit. It is considered best practice for these considerations to be discussed within the multi disciplinary clinical review meeting. Page 60 of 141

61 Inclusion It is suggested that the patient needs to meet both of the following criteria: Exclusion Patients who will be expected to assume responsibility for taking their medication at home, including those patients who may have some level of support from a carer. Patients who are expected to remain on the ward for a period long enough to complete at least one stage of the process If any of the following apply, then self-administration may not be feasible or reasonable, though the decision should be reviewed if circumstances change: The patient is confused or has an unstable mental state. The patients insight and attitude to medication causes concern. The patient has a history of alcohol/drug abuse although it may be possible for them to undertake stages 1 and 2 subject to agreement of the multidisciplinary team. The patient does not consent to take part in the programme. After discharge the patient will definitely be going to an environment where their medication will be administered to them by a carer. When the ward dynamics and or environment are not appropriate or conducive to safe self-administration practices stage 3 may not be possible; including the influence other patients may exert The following drugs SHOULD NOT be self-administered: Those prescribed in variable dosages (e.g. detox regimens). Once only ( STAT ) doses, with the exception of pessaries and suppositories. Injectable drugs (except when these will be self-administered at home following discharge, e.g. insulin) The following drugs SHOULD NOT be self-administered unless approval as been given by the Trust's Controlled Drugs Accountable Officer (currently Chief Pharmacist - Strategy) and special monitoring agreed for the individual's situation. Schedule 2 and Schedule 3 controlled drugs (as defined by the Misuse of Drugs Act 1971), with the exception of phenobarbital and temazepam. (See Appendix 11) Definitions of the roles Medical Staff To record in the notes the MDT s agreement that the patient is suitable for self- administration To initially sign the Patient Risk Assessment and Decision Form for the Selfadministration of Medicines (appendix 3) on behalf of the MDT. This form must also be countersigned for subsequent decisions to move up a stage. Page 61 of 141

62 To offer education or information as indicated in the initial assessment, either independently or in collaboration with pharmacy or nursing staff as appropriate To involve patients in decisions to change their medication To inform nursing staff of any prescription changes To review the patient s status on a regular basis; acute wards minimum weekly, non-acute wards minimum monthly. Pharmacy Staff To review the medication and dosage schedule prior to starting the selfadministration process, and whenever possible assist in simplifying the medication regimen To provide patient information leaflets To ensure that the patient is supplied with the required medication If necessary: To produce medication reminder charts, large font labels or other aide memoire as appropriate in suitable formats for certain patients. To provide examples of compliance aids that may be suitable for use for certain patients To provide medicine education for patients, either in group sessions run in conjunction with nursing staff or on an individual basis, utilizing information in other formats and translation services when appropriate. Nursing Staff To undertake an assessment of the patient s readiness to start/progress in the programme, noting day to day attendance/attitude/insight and knowledge of the medication regimen, notifying the MDT of findings to inform the decision to commence and to move the patient through the different stages of the selfadministration programme To discuss the process with the patient using appropriate formats following the MDT decision to commence the programme, addressing any queries or concerns about the programme, offering an explanation of the stages and ensuring consent is fully informed To ensure the Patient Risk Assessment and Decision Form for the Selfadministration of Medicines (appendix 3) is completed and agreement reached on what stage of self-administration to start the patient. The completed form (and any subsequent updates) must be kept in the patient s care notes and also attached to the drug chart To offer education or information in suitable formats, e.g. large font print, as indicated at the initial assessment, either independently or in collaboration with pharmacy or medical staff as appropriate To monitor, supervise, and record the patient s progress on the programme, reporting back to the MDT at least weekly To liaise with the pharmacy team regarding the patient s movement through the stages, ensuring medication requests reflect the current and to ensure continuous supplies of medication To check and to document their findings in the Daily Self-administration Progress Record Form Stage 3 (appendix 6) that patients at stage 3 have Page 62 of 141

63 self-administered their medicines correctly and completed their Selfadministration Aide Memoire (appendix 8 - this can be provided in another format if appropriate, e.g. larger print or if appropriate another recording system can be agreed e.g. audio recording). If there are any concerns about the patients attitude or insight these must also be discussed with the MDT and a record made in the patient s care notes of those concerns and any action agreed To continually monitor the environmental risks, particularly when new patients are admitted to the unit, with respect to the risks of them pressurizing the patient to divert their medication It is the responsibility of the ward manager to ensure that those doctors looking after patients on their ward are aware of the procedure and their responsibilities as above Storage of medication The maintenance of a safe storage system is essential. If full selfadministration is a treatment goal, the provision of an individual lockable storage area in the patients rooms (either a drawer or cupboard) is essential to prevent access by unauthorised individuals, such as other patients or visitors. Apart from the individual patient only nursing or pharmacy staff should have access to a key or the key-code Written consent must be gained if patients move beyond stage 1 (appendix 2). It must be made explicitly clear to the patient that nursing and pharmacy staff will be undertaking spot checks (along with regular checks) of the medication to ensure that safe self-administration is being undertaken. It is best practice to do these checks in the presence of the patient, but should this not be possible, two nurses or one nurse and one member of the pharmacy team should then carry this out Patient information, teaching and supervision The information given and the period of supervision should be tailored to the individual patient s needs and should be provided in a suitable format, including large print or another community language. Interpreting services are available to that effect. The following information should be provided to patients before commencing self-administration: The name and reason why the drug has been prescribed. The dose, frequency and potential side effects. A Patient Self-medication Assistance Sheet (appendix 7) completed by a registered nurse or a qualified member of the pharmacy team in conjunction with the relevant medication information leaflets. If a nurse has completed the Patient Self-medication Assistance Sheet (appendix 7), a qualified member of the pharmacy team must check the card and initial it at the earliest opportunity The level of retained knowledge relating to the individual patient s medicines should be regularly checked as part of the monitoring process and reinforced as necessary by the patient s primary nurse or a qualified member of the pharmacy team Any alterations to therapy must be discussed with the patient (see doctor s role), altered on the drug chart and on the Patient Self-medication Assistance Sheet (appendix 7), then initialled and dated. The Patient Self-medication Assistance Page 63 of 141

64 Sheet (appendix 7) should be kept by the patient and should be taken into the community on discharge Assessment of the patient s understanding, insight and attitude to their current medication regimen should be undertaken by the primary nurse, another designated nurse or a qualified member of the pharmacy team on a regular basis to inform any MDT review. Education/information provided needs to be recorded in the patient s care notes along with any special communication requirements. A programme of information provision can be devised by the primary nurse in conjunction with a qualified member of the pharmacy team, which will be noted in the patient s care plan Information leaflets or links to information leaflets can be found on the Sussex Partnership website: The site includes links to some medication leaflets in other European languages, in easy read format and access to formats suitable for patients with impaired sight Suggested Stepped Approach to Self-administration Multi-stage self-administration programmes are well tried and tested in many different care settings and have been shown to be effective, whilst also being considerate of risk. The following is a suggested programme, although MDTs must remain aware that considerable flexibility of approach will be required according to each patient s abilities and capacity. Variation from this suggested programme is therefore permitted, but teams must ensure that appropriate risk assessments are carried out and recorded in the patient s care notes and that the safety of the self-administering patient (and that of others) is never compromised The MDT may identify a patient as potentially appropriate for self-administration and discussion and risk assessment will then take place. If agreed as appropriate, a record will be made in the care plan and written consent from the patient will be sought (appendix 2) if they move beyond stage The consultant must sign the Patient Risk Assessment and Decision Form for the Self-administration of Medicines (appendix 3) on behalf of the MDT. Stage 1 must be successfully completed before any decision is made to move to stage 2 (with the exception of patients who have been fast tracked to stage 2) When considered appropriate by the MDT (see exclusions section 3 above) and in order to minimise the risk of patient s skills being lost, patients admitted to the ward on stable treatment who were responsible for their medication prior to admission and compliance was not an issue may be fast tracked onto selfadministration stage Stage 2 must be successfully completed before any decision is made to move to stage 3. This decision must be documented in the patient s care notes and in the Patient Risk Assessment and Decision Form for the Self-administration of Medicines (appendix 3). The form must also be countersigned by the Consultant on behalf of the MDT The patient should then be issued with the form Patient Self-medication Assistance Sheet (appendix 7) and a nurse or a member of the pharmacy team should explain the reasons why and the benefits derived from their inclusion in the self-administration scheme. Consideration must be given to providing forms or information in other formats, including using the services of an interpreter. Page 64 of 141

65 Consideration should be given on how best to obtain consent if written consent is needed, but cannot be obtained If the patient agrees to proceed with self administration beyond stage 1, the patient must sign the Self-administration: Patient Agreement / Consent Form (appendix 2). This should be also recorded in the patient s care notes. If verbal consent (stage 1) or written consent (stages 2 and 3) is not given, the patient cannot be entered into the programme, but information regarding their medicines and what to do after discharge should still be provided. Their decision not to consent should also be recorded in their care notes All consenting patients should be entered into stage 1 of the programme and the prescription chart annotated accordingly (unless it is considered appropriate by the MDT to fast track the patient to stage 2) Self-administration Stages Stage 1 Supervised administration Patients who are suitable for inclusion in the programme should usually be entered into stage 1. When considered appropriate by the MDT (see exclusions section 3 above) and in order to minimise the risk of patient s skills being lost, patients admitted to the ward on stable treatment who were responsible for their medication prior to admission and compliance was not an issue, may be fast tracked onto self-administration stage 2. In all other circumstances the progress to stage 2 will be dependent on the patient s ability to self-medicate successfully at stage The decision to progress up to the next level should be made by the MDT and should be recorded and signed by the Consultant in the patient s care notes and the Patient Risk Assessment and Decision Form for the Self-administration of Medicines (appendix 3), which should be kept in the patient s care notes and also a copy attached to the patient s drug chart Where necessary, and where possible, rationalisation of the patient s medication regimen should be carried out at this stage to minimise the frequency of dosing and to help with adherence Assessment of the patient s ability to read medicine labels and manage child resistant tops (click locks) must be carried out by a member of the team, (e.g. an OT or a member of the pharmacy team) (appendix 9). Ordinary screw-tops are available where necessary, as well as other compliance aids. The pharmacy team will also be able to offer further advice and information at this stage Individual supplies of medication will be dispensed by the pharmacy in TTO format ( One stop dispensing), with each bottle, box or blister pack, labelled with the patient s name and full directions on how to take the product. The medication will be retained in the medicine trolley, which will be securely stored in the clinic room Patients will be expected to ask nurses for access to their medication at the prescribed times. The nurse will place the patient s drug tray on top of the trolley and allow the patient to self-medicate. Nursing staff or a qualified pharmacy technician should closely monitor the medication and dosage taken from the container by the patient, and must intervene or prompt as necessary to ensure medication is taken as prescribed. Daily Self-administration Progress Record Form - Stages 1 & 2 (Appendix 5) must be used to record progress and the drug chart must be endorsed with SA (for supervised administration) and initialled by the nurse or pharmacy technician once the medication has been taken. Page 65 of 141

66 In an informal manner during the process, nurses or pharmacy technicians should establish a conversation regarding medication in order to assess the patient s insight, attitude to and understanding of the prescribed drugs and to ascertain whether the patient may be suffering from side effects due to the prescribed treatment This stage should continue for as long as is felt necessary for each individual. Information gathered during monitoring, will indicate each patients readiness to move to stage 2 or suitability to remain on the programme. Before moving on to stage 2, there should be good evidence of unprompted attendance for medication If the patient is having difficulty with stage 1, the difficulties must be recorded and reported back to the MDT and a decision made on whether continued work at stage 1 is appropriate Patients can be maintained on stage 1 until discharge if the ward environment is not suitable for further progress or the patient does not give written consent to moving to stage The MDT should discuss the progress at stage 1 and if appropriate a decision made to ask the patient to provide written consent to moving to stage 2. Patient Risk Assessment and Decision Form for the Self-administration of Medicines (appendix 3) must be signed again by the Consultant on behalf of the multidisciplinary team to allow progress to stage 2. Stage 2 The patient is supplied with original packs of medication and is responsible for its storage and administration. Keys remain under nurse s control The patient is supplied with medication dispensed by the supplying pharmacy with full administration instructions. Under no circumstance may stock drugs be used Drugs (see exclusions section 3) will be stored in a locked medicine cabinet in the patient s room and the key (or lock code) will be held by a nurse or kept in a safe place Whenever possible, medication should be taken at times that will suit the patient s home routine and the drug chart should take account of this. These administration times have to be recorded on the Patient Self -medication Assistance Sheet (appendix 7), prescription chart and care plan The patient will be given written and verbal instructions in a suitable format on how and when to take medication (see appendix 7) At administration times, it is the patient s responsibility to ask nurses for access to their medication at the appropriate time. Nurses will observe the patient selecting and taking medication, any progress or if the patient requires prompting, this should be recorded in the Daily Self-administration Progress Record Form - Stages 1 & 2 (appendix 5) In an informal manner during the process, nurses or pharmacy technicians should establish a conversation regarding medication in order to assess patient s insight, attitude to and understanding of the prescribed drugs and to ascertain whether the patient may be suffering from side effects due to the prescribed treatment. Page 66 of 141

67 Once the medication has been self-administered the nurse or pharmacy technician must annotate in the drug chart s administration box SA (for supervised administration) and add their initial This stage should continue for as long as is felt necessary for each individual. Information gathered during monitoring, will indicate each patients readiness to move to stage 3. Before moving on to stage 3, there should be good evidence of unprompted regular and accurate self-administration If the patient is having difficulty with stage 2, the difficulties must be recorded and reported back to the MDT and a decision made on whether continued work at stage 2 is appropriate Patients can be maintained on stage 2 until discharge if the ward environment is not suitable for further progress The MDT should discuss the progress at stage 2 and if appropriate a decision made to move the patient to stage 3. Patient Risk Assessment and Decision Form for the Self-administration of Medicines (appendix 3) must be signed again by the Consultant on behalf of the MDT to allow progress to stage 3. Stage 3 The patient is supplied with original packs of medication (unless the original pack contains more than 30 days supply, when a maximum of 30 days should be supplied) and is responsible for its storage and administration. Patient keeps the keys The aim of this stage is to promote full patient responsibility for their medication Medication (see exclusions section 3) will be stored in a locked medicine cabinet or locker in the patient s room and the patient will hold a key or be given a lock code. The importance of keeping the cabinet locked and the key or lock code safe must be stressed to the patient. Nurses will also hold a key or the lock code for the cabinet. If a lock code is used this must be changed every time a patient stops using the cabinet or locker, or if there are any concerns that an unauthorized person has got hold of the lock code At all times the ward situation should be assessed paying special attention to other inpatients who may be liable to coerce the patient into handing over medication The patient must be given written and verbal instructions in an appropriate format on how and when to take their medication. See Patient Self-medication Assistance Sheet (appendix 7) Nurses should try to ensure that the patient is not interrupted while selfmedicating The patient will be also given the Self-administration Aide Memoire (appendix 8). This can be provided in another format if appropriate, e.g. larger print or if appropriate another recording system can be agreed e.g. audio recording, for the recording of their self-administered medication The drug chart must be endorsed in the special consideration box at the front of the chart with the words self-administration stage 3. Nurses do not need to initial the prescription chart at the time the patient self-administers. Assuming the nurse checking is confident that the prescribed medication has been self-administered either the administration code P (patient managing own medicines) can be written in the appropriate administration box when the daily checks are performed by nursing staff or other suitable wording written across over the appropriate Page 67 of 141

68 administration boxes on the drug chart to indicate self-administration is taking place e.g. patient self-administering A check to ensure that the cabinet or locker is secure and that the medication has been taken as prescribed must be performed at least every other day for the first three weeks and then at least weekly thereafter. This should be documented on the progress chart (appendix 6). If it is discovered that the cabinet is being left open/unlocked or the medication has not being taken as prescribed then the MDT must decide whether to get the patient to drop back to stage 2 or introduce more regular checks until confidence in the patient s ability to manage their own medicines is restored At this stage the patient will also be expected to request fresh supplies of their medication at the appropriate times, either via nursing staff or, (where it can be arranged), direct from the supplying pharmacy Self-administration Progress Record Record Stage 3 (appendix 6) should be used to annotate any comments on the patient s progress regarding any of the aspects of the self administration scheme, including any changes to their insight or attitude to their medication. This should be discussed weekly at the MDT meeting and a record made in the patient s care notes. Self-administring while on leave If the patient is self-administring while on leave, then where possible, feedback should be obtained from carers and relatives on how well they are coping as well as getting feedback from the patient themself. NOTE: Patients may drop to a lower stage of self-administration if continuation or further advancement proves problematic for any reason, including a change in the risk environment involving another patient. Nurses may take this decision autonomously. Further assessment and monitoring will then continue but need not necessarily result in a return to a higher stage. It is very important that staff have a flexible approach to the self-administration process, but safety must never be compromised Recording Procedures for Trust Staff This applies to the 3-stage programme described above If the patient is assessed as suitable to move to stage 2 of the scheme and asked to take part but withholds written consent then the appropriate section of the Selfadministration: Patient Agreement/Consent Form (appendix 2) must be signed. This form must be filed in the patient s care notes. This does not mean that they cannot remain at stage 1 or that they can be asked to reconsider their decision at a later date Stage 1 A Patient Risk Assessment and Decision Form for Self-administration of Medicines (appendix 3) must be completed prior to self-medication; it should be presented in the multidisciplinary team meeting and signed by the Consultant. This form should be attached to the drug chart. Patients should be given the Self-administration of Medicines (appendix 4) document when included in the self-administration scheme. At each administration overseen by a nurse or a pharmacy technician the drug chart has to be annotated in the appropriate administration box with the code SA Page 68 of 141

69 (for supervised administration) and initialled by the supervising nurse or pharmacy technician. Daily Self-administration Progress Record Form - Stages 1 & 2 (appendix 5) should be attached to the drug chart. Nurses, pharmacists or pharmacy technicians will record on this form any comments on the patient s insight and attitude to their medication and any problems arising during the selfadministration process. This form should inform any MDT review. Doctors must sign The Patient Risk Assessment and Decision Form for the Self Administration of Medicines (appendix 3) when the patient is to move from stage 1 to stage Stage 2 The prescriber will write Self-administration or use a sticker produced for the purpose, in the additional instructions box on the front of the drug chart and add their signature and date. "Supervised Self-administration" will be written in the additional instructions box of the drug chart for each medication to be selected by the patient and a note will be made in the patient's care plan. On each successful self-administration, the nurse or pharmacy technician will enter the code SA as well as her initials (underneath) in the normal manner. Where self-administration is not successful and nurse administration takes place, or where no administration takes place, the nurse will complete the chart in the normal manner. Adequate recording must be maintained (see appendix 5) Stage 3 The prescriber will write "Self-administration" or use a sticker produced for the purpose, in the additional instructions box on the front of the drug chart and add their signature and date. The number of days supply of medication held by the patient will be written in the appropriate column s of the drug chart and a note will be made in the patient's care plan. If at the routine check the nurse is confident that self-administration has taken place, the nurse can either enter the administration code P (patient managing own medicines) can be written in the appropriate administration box or use other suitable locally agreed wording written across the appropriate administration boxes on the drug chart to indicate self-administration is taking place e.g. patient self-administering. Adequate records must be maintained (see appendix 6), with each sheet being scanned into the patient s care notes when complete Responsibility It is the responsibility of the clinical team manager to ensure that where selfadministration is indicated, that safe, professional, risk-assessed procedures are implemented Summary The decision to accept a patient into a self-administration scheme is a highly responsible one, which requires a comprehensive assessment of risk. The clinical condition of the patient, their insight and attitude to medication, their behavioural Page 69 of 141

70 reliability and the ward dynamics must be considered at all times. The views of the MDT must be obtained and all members should be in agreement before proceeding Cross-reference These guidelines must be read and implemented alongside the standards of practice described in: The Trust s Medicines Code (other chapters) The Trust s Consent Policy In addition, nurses must remain aware of the Medicines Management Standards (April 2010 (accessed 19/12/16 to confirm still current)) published by the Nursing and Midwifery Council. In particular, in relation to self-administration, these state: As a registrant you are responsible for the initial and continued assessment of patients who are self-administering and have continuing responsibility for recognising and acting upon changes in a patient s condition with regards to safety of the patient and others. 22. CUSTODY AND SAFE-KEEPING OF MEDICINE KEYS Overall responsibility for controlled drugs throughout the Trust lies with the Designated Accountable Officer (the Chief Pharmacist - Strategy). Wards 22.1 Controlled drug keys Keys for controlled drug cupboards must be kept on a separate key ring that can be readily identified. If there are no CDs being stored on the ward, these keys can be kept with the other drug cupboard keys but must be separated again once any controlled drugs start being stored The controlled drug key must be kept on the person of the Assigned Practitioner in Charge of the shift at all times, except when access to the controlled drug cupboard is needed by another authorized person. Once the task as been completed the key should be returned to the Assigned practitioner in Charge as soon as possible If a second authorized person needs the controlled drug key immediately after the first person, this should only be handed over once the Assigned Practitioner in Charge has been informed of the transfer The controlled drug key must not be held in a digital key safe as an alternative to the key being held by the Assigned Practitioner in Charge There is no restriction on the Assigned Practitioner in Charge holding both the controlled drug key and the general medication keys at the same time The controlled drug key must not be handed over to medical staff or non-medical prescribers In the event of the person in charge being inappropriately qualified, the controlled drug key must be handed to an Assigned Practitioner in Charge of a ward or department in the near vicinity. This information must be made known to the staff in the ward or department and to the manager in charge of that section. Page 70 of 141

71 22.2 Keys for Medicine Cupboards, Medicine Trolleys and Refrigerators The keys for the external cupboard, internal medicine cupboard, medicine trolley, medicine refrigerator and pharmacy transport box (general medicine keys) must be kept together on one key ring reserved solely for these keys. The keys must be clearly identified The general medicine keys must be kept on the person of a Designated Practitioner. In the event of no Designated Practitioner being on duty in a ward or department, the keys shall be handed to Designated Practitioner on a ward or department in the near vicinity. This information must be made known to the staff on both wards or departments and the manager in charge of that section. In a learning disability residential home the keys may be held by an Authorized Employee competent to administer medicines In community team bases a digitally accessed key cupboard reserved solely for the purpose of storing the medicine keys must be provided. Alternatively a drug cupboard with a digital lock may be used. The digital combination must only be known by Designated Practitioners or suitably trained Authorized Employees who may require access to the medicine cupboards. To maintain security the combination must be changed when a member of the team who knows the combination leaves or if there are any concerns someone unauthorized has discovered the combination Keys to individual patient s medicine cupboards The master key for individual patients medicine cupboards will open all such cupboards on the ward. The master key must be kept on the ward medicine cupboard key ring at all times and must never be issued to a patient Keys that open individual patient medicine cupboards must be individually numbered and stored in a locked cupboard on the ward when not in use If a patient is to fully self-medicate the appropriate numbered key may be issued to the patient who signs for receipt of this key. The key that is issued to an individual patient must only open their designated medicine cupboard and must be kept securely by the patient. On discharge or when the patient is no longer selfadministering their own medicines, the key must be returned to safekeeping and a record made Loss of a Medicine Cupboard Key If theft of the keys is suspected then the on-call manager and the police should be called. The supplying pharmacy department must also be notified when the department is next open In the event of a lost key every effort must be made to find the key or retrieve it from off duty staff. Should access to the medicine cupboard be required before the keys are retrieved the duty manager must be informed and duplicate key may be obtained. A local policy must exist for securely accessing duplicate keys. The keys must be clearly identified and easily accessible to the duty manager If there is no duplicate key and access to the cupboard is needed immediately, the duty manager will arrange for the cupboard to be broken open and a new lock fitted If the cupboard keys are not located before the end of the shift on which they were found to be missing, a new lock must be fitted to the cupboard. Any loss of keys resulting in new locks must be recorded as an incident. Page 71 of 141

72 23. CHECKING OF STOCK BALANCES 23.1 Controlled Drugs It is good practice to check stock balances of all controlled drugs with every shift change involving a change of Assigned Practitioner in Charge However, the audit minimum and Trust standard is that the stock balance of all controlled drugs requiring entry in the controlled drugs register, including patients own controlled drugs, must be checked at least once a week against the actual stock held in the ward/department. This audit minimum does not apply if no controlled drugs are entered in the controlled drug register, but should be reintroduced as soon as controlled drugs requiring entry into the controlled drug register are held There is no need to open packs with intact tamper evident seals for stock checking purposes. It is also good practice to carry out occasional verification of entries in the register against entries made on individual inpatient prescriptions Two Designated Practitioners, or one Designated Practitioner and one Authorized Employee must perform the check A record indicating this check has been carried out must be made to confirm the stock, including patients own controlled drugs, is correct. A record must be made on a page set aside for the purpose at the back of the CD register. If local practice dictates, the weekly checks can still be recorded in the CD register on each page in use, but this must be in addition to the record at the back of the CD register. The record must be dated and signed by both Practitioners or the Practitioner and the Authorized Employee undertaking the stock check. The Appointed Practitioner in Charge must ensure that these checks are carried out The Appointed Practitioner in Charge must undertake a random check at least once a month to ensure the weekly stock checks are taking place. This check must be recorded at the back of the CD register on a page set aside for the purpose. They must also check at least one drug in their controlled drug cupboard and record the check in the ward Controlled Drug register at the back of the register on the page set aside for for the manager s checks. Where possible this random check must reconcile recorded administrations with the appropriate drug charts, if available. Particular attention must be taken of liquid medicines and any stock adjustments made when bottles are emptied and controlled drugs stocked but not in current use Stock balances of individual preparations must be checked after every administration with the exception of liquids (see below) Liquid medicine stock balances must be undertaken whenever a bottle is finished. Due to filing inaccuracies small discrepancies occur with liquid medicines. Stock record adjustments for small discrepancies of less than 5ml per 100ml (e.g. less than 25ml in 500ml bottles) must be made when a bottle is emptied (see Administration and Preparation of Medicines chapter) In the event of a discrepancy between the stock balance and register for controlled drugs, the Appointed Practitioner in Charge must immediately and thoroughly investigate it. The possibility of a missing or incorrect entry or arithmetical error must be investigated first and if found corrected. When correcting the error in the register no crossing out or Tippex must be used on previous entries. A full explanation should be recorded in the register. Any Page 72 of 141

73 recording must be signed and dated by the Appointed Practitioner in charge and authorized witness (see Losses and Discrepancies chapter) Any need for more frequent checks will be decided by the Appointed Practitioner in Charge in liaison with the Chief Pharmacist A designated member of pharmacy staff must check the controlled drugs balance and all register pages used since the last pharmacy check, at a minimum of six monthly and when overall responsibility for the medicines change e.g. change of appointment of the Appointed Practitioner in Charge including: A record must be made on every page with a stock balance or where a stock has reduced to zero. Where possible there should be verification of entries in the register against entries made on individual inpatient prescriptions. That all appropriate weekly and appointed Practitioner in Charge stock checks have been done. At least one supply from pharmacy has been selected and checked against the CD register. Assuming there are no unresolved discrepancies, once the stock is checked as correct by the designated member of pharmacy staff they must annotate each relevant page below the last entry with the statement, Pharmacy stock check done, along with the date, time and their signature. The designated practitioner in charge must also confirm the stock is correct by countersigning this entry as a witness Other Medicines Local agreements to check other medicines may apply. Any need for checking stock balances of other medicines must be left to the discretion of the Appointed Practitioner in Charge. If, however, there is suspicion of abuse of medicines this must be reported to the integrated team manager and the Chief Pharmacist. In such cases it is advised that a stock balance must be recorded and regular checking introduced. If this shows discrepancies the medicine must be made subject to similar procedures as Controlled Drugs register entries must be made whenever the medicine is administered. It may subsequently be reported to the Service Manager and the Trust s Security Adviser, and systems introduced (either openly or covertly), to identify further losses etc. 24. USE OF COMPLEMENTARY MEDICINES AND ESSENTIAL OILS The patient may receive complementary therapies that may be used in conjunction with orthodox medical, nursing and paramedical treatments to enhance patient wellbeing, quality of life and symptomatic relief Patient s own complementary medicines or essential oils brought onto an inpatient unit Complementary medicines or essential oils must be brought to the attention of the patient s doctor, this is particularly important with herbal medicines, which can in some circumstances produce marked physiological and psychological effects Before allowing the patient to use complementary medicines or essential oils the safety of the product and the risk of interactions, should be assessed by pharmacy. Page 73 of 141

74 Ideally those complementary medicines then deemed not to be harmful to the patient should be written up inside the drug chart with a note in the Additional Information box that the product has been checked by pharmacy and the patient has requested to take it Complementary medicines or essential oils are not generally available from hospital pharmacies and therefore patient s own should be used. If necessary the patient may have to purchase their own supply New treatments initiated by the Trust The Drugs and Therapeutics Group must approve any complementary medicines or essential oils before they can be initiated by Trust staff Even when the complementary medicines or essential oil is approved it can only be used within the guidance of any Trust complementary therapy code Consent The patient must usually give informed consent for the initiation of treatment including essential oils or complementary medicines. If an adult is unable to give informed consent the relatives or carers should be involved in the decision and a best interest decision made and recorded in the patient s care notes Information in suitable formats must be available for patients, and relatives and carers if appropriate. 25. USE OF UNLICENSED MEDICINES AND LICENSED MEDICINES OUTSIDE THEIR LICENCE (see separate policy and the Trust s Formulary) 26. CLINICAL TRIALS INVOLVING PHARMACEUTICAL PRODUCTS 26.1 Liability issues relating to clinical trial medicines When a prescriber takes part in a clinical trial initiated by a pharmaceutical company, it is the responsibility of the company to obtain a Clinical Trials Certificate or Clinical Trials Exemption When a prescriber initiates a clinical trial using an unlicensed medicine they must notify the Licensing Authority giving details of the trial and the method of supply of the medicines to be used. The Licensing Authority has 21 days to raise objections, although the Authority may extend this to up to 63 days if required. If no objections are forthcoming the trial can start Before starting a trial, and only when the study has been approved by the Local Research and Ethics Committee and the Trust Research and Development Committee, prescribers must seek no fault compensation cover from the Trust for the research subject, ensure that their medical defence organization membership permits the proposed activity, and if the study is sponsored by a pharmaceutical company, that it will comply with the ABPI s guidelines on compensation At the end of a study a prescriber may wish to continue to prescribe the trial medicines for those patients who have benefited, but such a provision must be included in the original protocol and have been supported by the Drugs and Therapeutics Group. If there is no agreement to allow continued prescribing of the trial medicines, patients must be made fully aware of this fact in the patient information sheet when they are recruited. Page 74 of 141

75 26.2 Responsibilities for the Supply of Medication The legal and indemnity issues surrounding supply of clinical trial materials are complex. Before a medicines trial has received Local Research and Ethics Committee and Trust Research and Development Committee approval, the Trust Commercial Trials Facilitator, or the local trial coordinator, must ensure that appropriate arrangements are in place regarding the management and supply of trial medication The Default Position Use of a Hospital Pharmacy Dept. Unless specific, alternative arrangements have been agreed with the Trust Chief Pharmacist (Governance & Professional Practice), the Senior Pharmacy Manager of the local acute trust must be approached and agreement sought for their department to facilitate the management of clinical trial materials and for supplies of trial medication to be made from that department. The acute trust Senior Pharmacy Manager will then be responsible for ensuring that all legal, indemnity and professional issues relating to medicines management are adequately addressed before agreeing to the trial proceeding Use of a Community Pharmacy If, for whatever reason, the local acute trust pharmacy department does not agree to facilitate the management of medication for a particular clinical trial, or if that pharmacy s location is not convenient for a significant number of the trial participants, a local community pharmacy may be approached to fulfil the role. The Trust Commercial Trials Facilitator will be able to provide the principle investigator and sponsor of the trial with a list of community pharmacies in the local area that have expressed an interest in providing this service for the Trust and the Trust Chief Pharmacist (Governance & Professional Practice) will act as a liaison point between the Trust and the community pharmacy if this is required. Where a community pharmacy is used, the responsibility for legal, indemnity and professional issues relating to medicines management will rest with the manager or superintendent of the community pharmacy Management of Clinical Trial Material on Trust Premises Other than in exceptional circumstances, this may only take place in Trust bases that regularly undertake clinical trial activity and that have been inspected and approved for such activity by the Chief Pharmacist (Governance & Professional Practice) or another member of the pharmacy team with delegated responsibility. Bases that are considered as regularly undertaking clinical trials activity will be agreed by the Chief Pharmacist (Governance & Professional Practice), the Trust s Medical Lead for Research & Development, and the Commercial Trials Facilitator. Premises and operating procedures for medicines management (for each commercial trial) will be assessed (and approved) by the Chief Pharmacist (Governance & Professional Practice). A member of the pharmacy team will inspect these premises at least annually in order to ensure that storage facilities and conditions are suitable and sufficient and to ensure that operating procedures relating to medicines management are being fully adhered to. Other Trust bases may not be used for the storage and management of clinical trial materials other than in exceptional, individual circumstances, and only in cases where attempts to recruit an acute trust pharmacy department or a community pharmacy to facilitate the trial have failed. Where this is the case, and before the trial commences or any trial materials are delivered, the Trust premises must first be inspected by a member of the pharmacy team and the Commercial Trials Facilitator to assess the suitability of the facilities for the storage and management of trial materials. Whenever possible, this assessment visit should also include the trial sponsor and the trial s Page 75 of 141

76 principal investigator. In addition, operating procedures relating to medicines management must be approved by the Chief Pharmacist (Governance & Professional Practice). Only when this inspection has taken place and when facilities and procedures have been assessed as being satisfactory, (in relation to the specific trial in question), will the trial be confirmed and agreed. Beyond the baseline approval of facilities and operating procedures, the trial premises will be subject to on-going inspections during the course of the trial, (usually quarterly, or at 6-month intervals as a minimum). Further to the points above, medical staff must ensure that specific authorization for the management of clinical trials materials on Trust premises has been given, before they issue (or oversee the issue of) any such materials to patients. Trust indemnity arrangements may not extend to this practice if such authorization has not been given Responsibilities of Research Nurses & Other Nursing Staff Before working with clinical trial materials, nursing staff must ensure that the Trust fully supports and indemnifies them for this area of practice. This must be confirmed by the Commercial Trials Facilitator, where necessary in liaison with the Executive Director of Nursing. All nursing staff working with clinical trial materials must work in accordance with a trial-specific protocol or trial-specific operating instructions. Trust nursing staff may only issue clinical trial materials to patients in their original container as provided by the trial sponsor and such containers must be fully labelled and clearly coded in accordance with the trial protocol before delivery to the Trust premises. Where agreed with trial sponsors, nursing staff may add the trial participant s name, the date of issue and the name and address of the trial centre to the trial material before issue to the trial participant. However, nursing staff may not undertake any formulation, secondary dispensing or additional labelling of trial materials (beyond that listed above) as the Trust would not indemnify them for these activities. Other than in exceptional circumstances, and in addition to the points above, the receipt, selection, issue and recording of trial materials must involve two members of the nursing team who will then have joint responsibility for the management of materials. All records and logs should include two signatures. All nursing staff involved in the handling and management of clinical trial materials must be individually named within site-specific operating procedures or a site-specific protocol for the trial. Nursing staff that are not individually specified and authorised may not be covered by Trust indemnity Storage of Clinical Trial Materials The high level of medicines management employed by the Trust for its prescribed medication and its stock medication must also be applied to clinical trial materials. When trial materials are stored on Trust premises, they must be stored in a locked room or locked metal cupboard that is reserved solely for the storage of trial materials. Facilities must be sufficient in size to allow tidy, uncluttered storage that allows materials to be easily identified. Wherever possible, materials for each trial must be clearly segregated and labelled in order to assist in accurate identification and selection. Page 76 of 141

77 Wherever possible, trial materials should be stored separately to any associated items such as syringes, lancets and blood tubes etc. Access to trial material storage areas must be restricted to practitioners who are directly involved with the trial. Access to room / cupboard keys must also be similarly restricted. The temperature of trial material storage areas must be constantly monitored via a digital maximum / minimum thermometer or data device. A daily record of temperatures must be maintained and be available for inspection by members of the pharmacy team and by trial sponsors. 27 MEDICINES RELATED DUTIES PERFORMED BY AUTHORIZED EMPLOYEES 27.1 Authorized employees who have successfully completed certain assessments e.g. NVQ in care; may be authorized by the Trust to assist a Designated Practitioner to perform the following: Check the medicine label with the prescription sheet as a second check. (This does not apply to injectable medicines Administer oral and topical medicines (including inhaler, eye and ear drops) to a patient once prepared and checked by a Designated Practitioner Check controlled drugs with a Designated Practitioner Check the patient s name and hospital number against the prescription sheet with a Designated Practitioner Check discharge medicines with a Designated Practitioner against a discharge prescription Check ward-supplied leave/discharge medicines with a designated practitioner against the patient s drug chart Witness the self administration of medicines either in a ward or in a patient s home following patient specific assessment and training Authorized employees may be authorized by the Trust to perform the following duties independently. Administer medicines to a particular patient following training and successful assessment Authorized employees may hand out medication, collected by service users from community units if: The medication is in a sealed bag with the name and address of the service user The service user or agreed deputy is expected The authorized employee asks the service user or agreed deputy the address of the service user and they must know it without any prompting Where communications problems are envisaged e.g. English is not spoken, alternative arrangements to confirm the identity of the patient or their representative must be agreed in advance The authorized employee will not be put at risk by the service user or agreed deputy should they decline to hand over the medicines Authorized employees may deliver medication to service users in the community without delay, detour or temporary storage if: Page 77 of 141

78 The medication is in a sealed bag with the name and address of the service user that has been checked by a qualified nurse or pharmacy staff member The service user or agreed deputy is expecting the delivery Unless the service user or agreed deputy is known to the authorized employee they must be asked for proof of identity It has been made clear to the service user or agreed deputy that the person handing over the medicine cannot answer any clinical questions and is not authorized to make any alteration to the contents of the bag The authorized employee has the right to refuse to undertake this task if they have concerns about a service user or agreed deputy If the medication handed out or delivered to a service user is new to them the authorized employee must ensure that: There is a patient information leaflet provided with the medication The service user is advised that further information can be obtained on the medication from their care co-ordinator 27.6 Duties that cannot usually be performed by authorized employees: Preparation and supply of medicines. Administration of medicines by injection, vaginally or rectally. Administration of controlled drugs. Supply of discharge medicines from a ward. Delivery of new medication to patients with significant communication problems, e.g. does not speak English. NB. The development of future training courses may provide opportunities for Trust approved changes to some of the above. 28. USING MEDICAL GASES All medical gases used in the Trust are Licensed Medicines and as such are subject to the Medicines Act and must be treated in the same way as any other medicines. See also the chapter Storage and Handling of Flammable Liquids, Gases and Aerosols Under normal circumstances written authority from a prescriber must be obtained before a medical gas is administered to a patient. This authority must include the name, and concentration of the medical gas (where appropriate), the method of administration and the rate of flow. This must be recorded on the patient s prescription record. This can be achieved by: An inpatient prescription for an individual patient A Medicine Administered Under Protocol (MAUP) for oxygen in an emergency. 29. PHARMACEUTICAL INDUSTRY REPRESENTATIVES This section should be read in conjunction with the Trust and Employee Relationships with Commercial Organizations Policy and the Working Formally with Commercial Organizations Policy Representatives of the Pharmaceutical Industry must not be allowed to visit patient areas unless agreement has been given by the relevant manager Casual visits to wards, clinics or other patient units are unacceptable and appointments should be made with the relevant manager, head of department or consultant. Page 78 of 141

79 29.3 Visits should be limited to the delivery of significant product information. Information relating to price, pack-size, or similar, does not normally warrant a visit and should be dealt with by post Details of new product launches must be discussed with the Trust s Chief Pharmacist before discussion takes place with other clinical staff The introduction of new drugs must only take place in line with the Trust s New Drug Policy Medicine samples must not be accepted. Representatives wishing to supply them should be referred to the Chief Pharmacist Only the Chief Pharmacist may give a Trust commitment to purchase a medicinal product. No other member of staff is authorized to give such commitments, or to give any indication of the potential budget for any further purchase, and /or competitors prices. 30. MEDICATION ERRORS AND NEAR MISSES 30.1 Definition A medication error or near miss is a preventable incident associated with the use of medicines, which has or may have put a patient at risk. Such incidents may be related to any of the steps of the medicine use process. This includes prescribing, dispensing and administration of the medicines and the transfer of information and may result in the patient receiving an incorrect dose of their prescribed medicines, a dose of their medicine being incorrectly omitted or delayed, or their receiving medication which they have not been prescribed Management Successful management of a medication error will include the following: A review of the well-being of the patient and the minimization of further risk. (This is of primary importance). Reassurance for the patient, and where appropriate, their relatives or carers. A full review of the incident and a full record, (using the Trust incident reporting procedure), of the identified cause, the outcome and the measures to be taken to prevent reoccurrence. Where appropriate, counseling for staff involved. Where deemed necessary, further assessment and re-training of staff involved. Avoidance of formal complaints or litigation. Rapid response to any formal complaints received Clinical Management Where medication is incorrectly omitted or significantly delayed, the assigned practitioner in charge must be informed. They should then obtain advice from the patient s doctor or from the unit pharmacist regarding further action to be taken. Any action taken must be recorded in the patient s care notes and the nursing record Where medication is administered in error, the assigned practitioner in charge must be informed. They should then obtain advice from the patient s doctor regarding further action to be taken. Any action must be recorded in the patient s care notes and the nursing record. Page 79 of 141

80 30.4 Informing the Patient/Carer Under normal circumstances the patient should be immediately informed that an error has been made, either by their doctor, their key nurse/worker, or by another member of healthcare staff directly involved with their care. Whilst there is no obligation to inform relatives or carers of the incident, consideration should be given to doing so Where the patient is suffering from a condition which impairs their cognitive or intellectual function, the decision to inform them, and /or their relatives or carers, will rest with their doctor If the patients, relative or carer is subsequently unhappy with the outcome of the incident or the action taken in response, the Trust Complaints Procedure should be followed. A senior manager should be called to see the patient, or their relative or carer, without delay Reporting/Recording the Incident The Trust operates a reporting policy and actively encourages staff to openly report incidents without fear of retribution. The purpose of reporting and recording a drug error is to ensure that processes are reviewed in order to prevent or minimize any change of reoccurrence Whenever possible, review should be followed by the implementation of remedial action and subsequent further review/audit Any drug error incident or near miss which gives cause for concern should be reported, and may be reported by any member of staff. Such incidents and near misses should be reported using the Trust incident reporting procedure The Trust incident reporting procedure must be undertaken as soon as possible following the incident and the form completed fully and in as much detail as needed to properly describe the incident. The form should be completed in liaison with the assigned practitioner in charge or the unit/line manager as appropriate The completed, signed incident report form is sent to the Risk Manager who in the case of incidents relating to medicines will copy the form to the Chief Pharmacist. The Chief Pharmacist will decide if any further action needs to be taken and what lessons can be learnt. Where appropriate lessons learnt will be shared in the Report and Learn Bulletin and the Drugs and Therapeutics Newsletter Where an incident occurs which identifies a significant flaw or failure in current procedures and systems, the Chief Pharmacist will liaise with the appropriate professional lead to review what if any changes need to be made Anonymous reporting If despite the Trust s reporting policy a member of staff observes an incident which they feel should be reported, but feels unable to report it to their manager, or otherwise in accordance with Trust policy, they may report the incident by telephone, or in writing, direct to the Executive Director of Nursing, the Chief Pharmacist or the Executive Medical Director. Anonymity and confidentiality will be maintained and the incident will receive investigation and review in the normal manner. Page 80 of 141

81 30.7 Disciplinary action Introduction To minimize the risks associated with the use of medicines it is essential that lessons are learnt when errors are made. For this to occur a reporting system is needed that encourages staff to record and report significant medication errors or near misses. To help achieve this, staff must feel confident that reporting an error will not automatically lead to someone being disciplined. However there will be a small number of occasions when instigating disciplinary action or the Capability Policy is considered appropriate and necessary. Managers have asked for clarification in this area, both to encourage a more open culture and to achieve a more consistent approach to handling medication errors The default position is that staff will not be disciplined if they are involved in a medication error or near miss. Disciplinary action will be considered in the following circumstances: o An attempt has been made to cover up a medication error or near miss. o The behaviour of the practitioner(s) is deemed to be reckless. Action under the Trust s Capability Policy may also be considered for practitioners making repeated mistakes that are not due to reckless behaviour Definition of Reckless Behaviour will usually be regarded as reckless when the practitioner has: Knowingly gone against a policy or a procedure and/or Made a decision knowing that they needed further information. Examples of reckless behaviour are: A pharmacist is asked to check and issue a dispensed clozapine prescription without checking that an appropriate blood result has been received. A doctor is given a path lab report saying a patient s infection is sensitive to amoxicillin and is prescribed it without checking the allergy status of the patient A new nurse covering a continuing care unit is not absolutely sure of the identity of a resident and relies on the resident confirming their name. It is recognized that here may be occasions when a policy or procedure is ignored in the best interests of the patient. However it must be assessed as to whether a significant body of other practitioners would have considered it reasonable to do so had they been faced with a similar situation Review of Medication Errors The Trends and Lessons Group will meet four times a year to review the clinical incident reports, including medication errors, to establish trends and to propose actions needed to prevent such errors. Action may involve system redesign and improvement and/or education, training and competency assessment of employees on any aspect of medicine related incidents. 31. MEDICINE DEFECT REPORTING The following procedure applies when a defect is found or is suspected in any medicine or if the defect is in the device administering the medicine, e.g. syringe driver. Refer to the Medical Devices Policy. Page 81 of 141

82 During the manufacture, storage or distribution of a medicinal product, an error or incident may occur which alters the specification of that product and which may result in its reduced performance or efficacy. Where the reduced quality of a pharmaceutical product is identified it is important that the product be immediately withdrawn from use. Inform the appropriate pharmacy who will advise on all reporting, recording and investigating on the defect. Out of pharmacy opening hours, if a serious problem has been identified which is considered to present an immediate hazard to patients, staff or the public, the on-call pharmacist must be contacted Retain any remaining product and/or the device and any associated products or equipment (e.g. administration sets, infusion devices etc). Put these into secure quarantine until collected by pharmacy or a nominated responsible person Record the details of the device and product (including batch number if appropriate) If the defective product has been administered to a patient or the faulty device has administered too much or too little medication, inform the doctor responsible for the patient and record the details in the patient s care notes. 32. COMMUNITY BASED PRACTITIONERS For each community team base where medicines are stored, a suitably qualified practitioner must be designated as the Appointed Practitioner in Charge. The Appointed Practitioner in Charge is ultimately accountable for the stock of all medicines held, ensuring that Medicine Code procedures are followed correctly and that the security and safe handling of medicines is maintained. This chapter must also be read in conjunction with the Trust s Core Standards for Medication Handling by Assertive Outreach, Crisis, Home Treatment and other Community Teams with Complex Medication Handling Needs Designated community practitioners must possess a properly authenticated letter stating the right to carry stock medicines. The range of medicines will be specified in the letter which will be signed by the Director of Nursing, the Chief Pharmacist and their local manager. A valid staff identification badge must support the letter All other medicines carried by the community practitioners must be prescribed as a specified dose for a named patient by a prescriber All stored medicines must be kept in a separate locked medicine cupboard to which only designated community practitioners have access (see section for more information). Medicines may be kept for patients that have been prescribed for them by their GP and dispensed It is the responsibility of the appointed practitioner in charge of a community clinic, (e.g. a depot medication clinic), to ensure that a record is kept which details all medicines received from the supplying pharmacy, and all community practitioner transactions. The record should be sub-divided according to product and should show a stock balance at each entry. A full stock check should be carried out each month to ensure that stock is correctly rotated according to shelf-life and that stock levels are appropriate and concur with those recorded The Designated Community Practitioner must keep the medicine: Secure when visiting a patient. Secure and out of sight, e.g. within the locked boot of a car, when traveling between visits. Page 82 of 141

83 32.6 Whenever practicable, unused medicines should be returned to the medicine cupboard at the team base for overnight and weekend storage. Where this is not possible, they may be securely stored but not for longer than 72 hours Medicines must not be left in practitioners cars overnight 32.8 Return any patient s own medicines no longer required to a local community pharmacy or the dispensing doctor who originally dispensed it. Community pharmacies are obliged to take patient s unwanted medicines from domestic enviroments, including residential homes, under their NHS contract. There is a letter on our website explaining this and it can be showed to any community pharmacy When taking unwanted patient medicines to a pharmacy or dispensing doctor to be destroyed on behalf of the patient, there is no obligation to make a record of what has been taken. However individuals may wish to make a record to avoid accusations of theft or misappropriation, particularly if the medicine is a controlled drug or another medicine liable to be abused, e.g. diazepam. A list of medicines that fall into this category are listed in Chapter 15 section 7. Any record made should be countersigned by the person in the pharmacy or dispensing practice receiving the listed medicines. It may also be prudent to get a signature from the patient/carer to confirm they agreed for them to be disposed of Community teams holding patients own drugs on behalf of clients with poor compliance must have a local procedure to ensure medicines are booked into and out of the staff base, though special arrangements may be made to store patients own controlled drugs on a suitable ward if no CD cupboard is available in the base. Whenever practicable these medicines should be stored in the medicine cupboard at the team base. Where this is not possible, they may be securely stored at the practitioner s home but not for longer than 72 hours Each community base must keep sufficient in date anaphylaxis packs to ensure one is always avialable on site and to allow a pack to be carried to any off-site administration when the risk of an anaphylaxis reaction is raised, e.g. when administering a vaccine or the first two doses of a new long-acting antipsychotic injection ( the first dose may cause sensitivity so illiciting an anaphylactic reaction when the second dose is given). On-site administration is always preferable when the risks are higher. 33. CONSENT TO TREATMENT This section should be read in conjunction with the trust policy and the appropriate sections of current version of the Mental Health Act and Mental Capacity Act Wherever possible the medicines proposed to treat a patient should be discussed with the patient. The discussion must be carried out in such a way that the patient is able to contribute and express agreement or disagreement with the proposed treatment. If English is not spoken fluently then appropriate steps should be taken to access the services of an interpreter "Consent" is the voluntary and continuing permission of the patient to receive a particular treatment, based on an adequate knowledge of the purpose, nature, likely effects and risks of the treatment including the likelihood of its success and any alternative to it. Permission given under any unfair or undue pressure is not consent (Mental Health Act 1983 Code of Practice) It is the duty of everyone proposing to give treatment to use reasonable care and skill, not only in giving information prior to seeking a patient's consent, but also in meeting Page 83 of 141

84 the continuing obligation to provide the patient with adequate information about the proposed treatment and alternatives to it. This information must be provided in an appropriate format and the services of translators and interpreters used if appropriate Discussions about the drug treatment and consent to treatment should ideally be when treatment is initiated or, in the case of anticipated emergency situations e.g. rapid tranquillisation, in advance. The nature and outcome of the discussion together with an assessment of the capacity of the patient to consent must be recorded in the patient notes. If the patient is too ill at the time of the initiation of prescribing the prescriber must seek further consent when the patient is well Information given by pharmacists or other practitioners about the treatment should be provided in addition to that provided by the prescriber, rather than as an alternative. A record should be made in the patient s care notes of any significant interventions and the use of alternative communications formats to those usually employed Treatment of those without capacity to consent When a patient is incapable of consenting, medicines can be prescribed for them in their best interests under the common law doctrine of necessity. The treatment must be: Necessary to save life, or prevent a deterioration of, or ensure an improvement in the patient s physical or mental health. Be in accordance with the practice accepted at the time by a reasonable body of medical opinion skilled in the particular form of treatment in question Reviewing treatment of those without capacity to consent Practitioners should remain aware that capacity to consent may be subject to fluctuation. Reassessment of the patient's capacity to consent should be carried out as often as considered appropriate Treatment of those detained under the Mental Health Act The Mental Health Act provides the prescriber with a three month period to develop a treatment programme to meet the patient's needs. Even though the Act allows treatment without consent the prescriber should observe the same principles of seeking consent described above. The three month period starts on the occasion when medicines for mental disorder were first administered to the patient under detention Medicines after three months A system should be in place to remind the approved clinician in charge of the treatment at least four weeks before the expiry of the three month period. The approved clinician must: Seek the patient's consent to continuing medication. Record the discussion on the form for medication from the Part 4 and Part 4A MHA procedure including an assessment of the patient's ability to consent. Complete a form T2+ If the patient consents to continued treatment. Request a second opinion doctor (SOAD) visit from the Mental Health Act Commission if the patient refuses consent or is deemed unable to provide a reliable consent. If the SOAD agrees with the approved clinician that treatment is necessary and can be given, the SOAD will complete a Form T3. Practitioners must not administer medicines to patients detained under the Mental Health Act 1983 after the 3 month period without first ensuring that a valid Form T2 Page 84 of 141

85 or Form T3 has indicated that the treatment can be given under individual BNF sub-groups Pharmacy staff will report any errors relating to Form T2 or Form T3 to local mental health act administrator using an approved form. 34. ILLICIT SUBSTANCES Sussex Partnership Trust is an illicit substance free zone. This includes all substances, drugs and medicines of any category, other than those specifically prescribed or approved for the patient This advice will also apply to legal highs that the Trust has deemed to have the potential to do harm before a decision has been made by the Government on its legal status. A separate policy and procedure exists for dealing with the discovery of suspected illicit substances The procedure for disposing of any substance thought to be of an illicit nature is as follows: The substance must be sealed in an envelope On the envelope there must be a description of the substance, together with where and when it was found. Both the Assigned Practitioner in Charge and a second Designated Practitioner must sign the package across the seal An entry must be made at the back of the Controlled Drug Register describing the substance, together with where and when it was found. Both the Assigned Practitioner in Charge and a second Designated Practitioner must sign the entry If the quantity of the substance has been deemed to be sufficient to indicate dealing or is a class A drug the local police must be notified In other circumstances the local pharmacy department can be asked to witness destruction on the ward The substance must be stored in the Controlled Drug Cupboard until collected by the police or destroyed in the presence of a pharmacist In the absence of a Controlled Drug Cupboard and Register the substance must be stored in the units locked drug cupboard and a similar entry made in the unit diary The Assigned Practitioner in Charge must NOT: Send the substance to the pharmacy. Return the substance to the patient or relative. Attempt to analyse the substance 34.4 Witnessed Destruction Witnessed destruction must only take place in the presence of the Assigned Practitioner in charge and a pharmacist. The sealed envelope must not be opened until both are present. The contents must be disposed of in a DOOP kit after wetting any light material with washing up liquid. A record of the destruction must be made in the Controlled Drug Register or unit diary (if no Controlled Drug Register) against the original entry and countersigned and dated by the Assigned Practitioner in charge and the Pharmacist. Page 85 of 141

86 35. COMPLIANCE AIDS (e.g. dosette boxes and monitored dosing system (MDS)) 35.1 Non-compliance with medicines is a major cause of relapse and admission to hospital. There are many factors that can lead to non-compliance with medicines. These include: A poor understanding of the need for medicines. A poor understanding of how to take the medicines. Forgetfulness. Inability to open the containers. Visual impairment. A complicated regime of medicines. For some people a compliance aid may assist a person to continue self-medication and remain out of hospital Before there is any agreement to provide medicines in a compliance aid, a full assessment of the reason for non-compliance must take place. It may be that the provision of a compliance aid may not be of benefit and other strategies may prove successfully, e.g. larger print labels. This assessment should normally be carried out by the multi-disciplinary team in liaison with Pharmacy staff Compliance aids vary but most require weekly replenishment. Before compliance aids are issued and the patient trained to use them arrangements must be made for their regular replenishment The act of filling a compliance aid involves re-dispensing and re-labeling. Where it is not carried out by authorized pharmacy staff this should only be carried out by a designated practitioner following an agreed procedure. This procedure must include a check by another designated practitioner or an authorized employee who has been assessed as competent to undertake this role Alternatively, designated practitioners who are deemed competent to fill compliance aids may: Assist patients to fill their own compliance aids. Train patients to fill and use a compliance aid as part of a training scheme All compliance aids supplied by the Sussex Partnership NHS Foundation Trust or filled by Trust staff must allow the identification of contents and be fully labeled. 36. SAFE HANDLING OF MEDICINES REQUIRING COLD STORAGE 36.1 General information Unless specific advice states otherwise medicines requiring cold storage that have not been properly distributed and stored should NOT be used. The manufacturer s storage requirements for medicines requiring cold storage (usually 2 to 8C) must be maintained to ensure that the administered medicine is effective. Medicines requiring cold storage will deteriorate and become ineffective if stored outside manufacturer s recommendations. Medicines should also be protected against light Each Clinic/Ward is required to have:- A named, trained individual with overall responsibility for cold stored medicines, including vaccines, with named deputies. A lockable medical refrigerator. Page 86 of 141

87 A maximum/minimum thermometer with an audible alarm with a remote probe or a refrigerator with an integral maximum/minimum thermometer with an audible alarm The designated person must:- Have a good knowledge of this chapter of the Medicines Code. Be able to read the maximum/minimum thermometer and record the temperatures daily. Ensure that medicines requiring cold storage are stored at the correct temperature. Ensure medicines requiring cold storage are not packed too closely in the refrigerator, nor stored against the freezer section or in the door. Ensure that food and drinks are not stored in a medicine refrigerator. Label the power point to the refrigerator to avoid accidental switching off. Have nominated deputies to cover in their absence. Monitor medicine stocks to avoid over-ordering, stockpiling or wastage Receipt of medicines requiring cold storage in clinics and wards All staff likely to receive delivery of medicines requiring cold storage must be aware of this section of the chapter A designated member of staff should have overall responsibility for the receipt and storage of medicines requiring cold storage. Named deputies should also be identified Place the medicines requiring cold storage immediately into the designated refrigerator. Medicines requiring cold storage must not be left at room temperature The refrigerator should be locked with access to it by authorized staff only Store the medicines requiring cold storage in the correct rotational/date order Storage of medicines requiring cold storage For specific information on storage refer to manufacturer s data sheet Store the medicines under controlled conditions. Any deviation from these may reduce the efficacy of the medicines. Medical refrigerators are generally of a higher specification than domestic varieties and may incorporate an integral fan, maximum/minimum thermometer and an alarm. They must be lockable Use medicines with the earliest expiry date first. Check expiry dates regularly and remove time-expired medicines and destroy according to local procedure Medicines should not be packed too closely within the refrigerator - allow for the circulation of cold air Store medicines in the main body of the refrigerator. They must not be stored against the freezer compartment or in the door or bottom drawer Store all vaccines at a temperature between 2C and 8C No medicines must be frozen Store medicines in original packaging to protect from light and temperature change. Page 87 of 141

88 Reconstituted medicines may not remain stable and will have an expiry period following reconstitution - refer to manufacturer s summary of product characteristics for reconstituted expiry dates Cautionary notices should be placed on power plugs or sockets or tape the power point of the refrigerator, to avoid accidental switching off, or use a switchless socket No food or drink or clinical specimens should be stored in the medicines refrigerator Unless a frost-free model, defrost the refrigerator regularly to prevent build-up of ice. Ideally, this should be done when the refrigerator is empty. If this is not possible temporarily store the medicines in another refrigerator on another ward Opening the refrigerator door should be kept to a minimum The refrigerator should not be situated near a radiator or heat source and should be appropriately ventilated Patients taking medicines home should be given written storage instructions Temperature control The temperature of the medicine refrigerator must be continually monitored with a maximum and minimum thermometer with an audible alarm. Digital thermometers are recommended. Reset and replace according to manufacturers guidelines, including the batteries Calibration of thermometers should be checked annually to ensure correct working. Records should be kept for audit in the temperature log book or sheet (see appendix 20) Check and record the maximum/minimum refrigerator temperatures daily when the refrigerator is in use (Monday to Friday in clinics). Record the results in the refrigerator s temperature log book If the temperature is not maintained within the correct range or if a refrigerator is turned off for any length of time, local mental health pharmacy team should be contacted to ascertain the action to be taken. Alternatively telephone the medicine s manufacturer for advice. If out of hours, contact the local on-call pharmacist for advice Ensure a repair engineer can be readily contacted in case of a breakdown. Keep the appropriate number in the front of the temperature log book Ordering and monitoring of stock Medicine stock should be monitored by the designated person to avoid over-ordering or stockpiling 36.6 Advice on medicines following problems with the cold storage chain Where there are queries as to the efficacy of a medicine due to problems with the cold storage chain, the local mental health pharmacy team can usually supply advice on the stability of medicines or contact the medicine manufacturer Equipment list Refrigerators Page 88 of 141

89 Specialised refrigerators are available for storage of pharmaceutical products and must be used for medicines requiring cold storage and diluents. Ordinary domestic refrigerators must not be used. They MUST be lockable. It would be a sensible precaution to validate any refrigerator intended for medical use by means of a thermometer or temperature probes, and also to maintain regular ongoing checks on the temperature to assess suitability for use. The mains electrical lead should ideally be fitted in a spur point, which should be fused but not switched. Contingency plans should be made for defrosting activities Maximum and Minimum Thermometers A digital maximum/minimum thermometer with a remote probe and audible alarm should be used. It is advisable to request a certificate of calibration. If a suitable probe is not provided with the refrigerator a separate thermometer can be obtained. Results should be recorded in the refrigerator monitoring book Health and safety A C.O.S.H.H. data sheet is available in case of spillage or contamination by vaccines on the Trust Intranet. 37. CONTROL OF FP10 (NC) PRESCRIPTION 37.1 Prescription Types FP10 (NC) prescriptions are used by clinical teams. Each team will have printed uniquely coded prescription pads identified for costing purposes against their team. These should normally only be used for that team s patients except in exceptional circumstances when covering on call Substance Misuse Services can use PH10MDAss or FP10MDAss prescriptions for repeat prescribing of methadone, buprenorphine and diazepam and FP10(NC) or FP10ss for all other prescribing Ordering of FP10 Prescriptions by the pharmacy Departments Designated approved staff will be responsible for ordering sufficient quantities of all FP10 prescriptions. These will be ordered by pharmacy staff wherever practical but designated team administrators may take on this role in special circumstances, e.g. SMS services and Hampshire CAMHS. FP10 (NC) prescriptions will be ordered directly from the printers, by or fax, utilising the unique team codes by designated approved staff registered with NHS Forms by the Chief Pharmacist Strategy Ordering of FP10 Prescriptions by Authorised Prescribers Only authorised prescribers who have a completed their locality s Pharmacy Signature Form and FP10(NC) Authority, signed by their consultant, will be eligible to collect and use team prescription pads from the pharmacy or designated collection point. Medical staffing will usually issue this form on appointment, but additional blank forms will be held by the pharmacy or designated collection points for completion. Page 89 of 141

90 Ideally the prescriber should collect their own prescriptions from the appropriate pharmacy or designated collection points. These collection points have a responsibility for ensuring the pads are kept in a locked cupboard or filing cabinet with access limited to essential personnel. To save time a phone call in advance should be made to ensure availability on arrival. If the prescriber is unable to attend in person, they should forewarn the pharmacy or designated collection point that their nominated deputy will be collecting prescriptions on their behalf. In all cases the person collecting the prescriptions must have with them proof of identity in the form of Trust security badge or be known personally to the staff involved in issuing the prescriptions All issues must be recorded by the pharmacy or designated collection points. The record must have the following data as a minimum: The unique numbers of the prescriptions released. The team code on the prescriptions. The date released. The name of the prescriber to whom the pad is being allocated. The signature and printed name of the person collecting the prescriptions. The signature of the person issuing the prescriptions Because some junior doctors move rapidly through teams, it is acceptable for the team administrator to set up a system in which partly used pads are collected in when a junior leaves and are later reissued to their successor on arrival using the process described above. Subsequently when a new pad is required this will need to be ordered/collected by the junior from the local pharmacy or designated collection point as in The record must have the following data as a minimum: The unique numbers of the prescriptions returned/released*. The team code on the prescriptions. The date returned/released. The name of the prescriber returning/issued the prescriptions. The signature and printed name of the doctor returning/collecting the prescriptions. The signature of the administrator receiving/issuing the prescriptions. *If the final digit on the prescription number is ignored, the prescription numbers run sequentially These records should be kept for a minimum of five years Security of Pads in Community Teams It is the responsibility of each individual issued with a pad to keep it secure at all times. Loss of a pad will lead to significant inconvenience to the team, possible misuse and additional costs to the Trust. In substance misuse teams where blank prescriptions are provided for printing, responsibility for secure storage rests with the team manager In the event of a pad being stolen or, misplaced and not found within a reasonable time, the following steps must be taken: Contact the local police station and provide the following details: The number of prescriptions missing. The serial number of the prescriptions missing. Page 90 of 141

91 The team name, address and the Trust identification number (unless substance misuse, this starts with RX2) as printed on the prescription. If there is some uncertainty about the serial numbers involved or the Trust identification number, contact the department supplying the pads at the earliest opportunity. Full details of the circumstance ie location, time last seen, evidence of a break in, etc. Obtain a crime or incident number. At the earliest opportunity contact the Chief Pharmacist, or in his absence, the local mental health pharmacist to agree a change in ink colour for any prescriptions written by the team and the period the change will cover (usually at least a month). The Chief Pharmacist, or in his absence, the local mental health pharmacist, will contact the Shared Service Agency on , West Sussex, or in Brighton and East Sussex to activate the stolen FP10 protocol with local community pharmacies and they will also inform the NHS Counter Fraud Services, who then inform the Prescription Pricing Authority. At the earliest opportunity inform the locality manager and complete a Trust Incident Form It is essential that pads are not left on view, pre-signed or stored unlocked in public building when not in the possession of the prescriber Return of FP10 Prescriptions on termination of employment On termination of employment or a change of team all prescribers have a responsibility to return any unused prescriptions to their local supply point. This department must record, against the original issue record, the number of individual prescriptions returned along with their unique number and the date they were returned In the unlikely event that a prescriber only discovers they have some prescriptions in their possession after leaving the area they must phone the appropriate department to notify them of the prescriptions they have and then destroy them. The department must make a record of the phone call and record, the number of individual prescriptions that will be destroyed along with their unique number and the date the department was notified Use of FP10 Prescriptions Normal out-patient prescription forms are coded FP10(NC), and are coloured green so that they can be easily identified by dispensing pharmacists and by the NHS Prescription Pricing Authority. Those used by the Community Drugs Teams for instalment prescribing are coded PH10MDAss or FP10MDA, and are coloured blue Prescriptions must be written legibly in ink, or otherwise so as to be indelible, should state the full name and address of the patient, the name of the prescriber (in block letters), and be signed and dated It is strongly recommended that the patient s age and date of birth be recorded on the prescription form. For patients under 12 years it is a legal requirement that their age be stated The name of the drugs and preparations prescribed should be written clearly, using approved names whenever possible, and should not be abbreviated. Page 91 of 141

92 Drug strengths and dosages should be written clearly and unambiguously. Great care must be taken if abbreviations of measurements are used and any unnecessary use of decimal point should be avoided, e.g. 3mg not 3.0mg Doses under 1mg should be written in micrograms, which should not be abbreviated. If doses of less than 1 unit are prescribed, decimal points should be protected by a preceding zero, e.g. 0.5units not.5units When writing prescriptions for controlled drugs, the total quantity of the preparation, or the total number of dose units, must be written in both words and figures The cost of the medication, together with the dispensing pharmacist s fees are recharged to the Trust Prescribers may not write prescriptions for themselves or for members of their family. If this should occur, the Trust reserves the right to recover these costs, plus an administration fee, from the prescriber and ultimately may consider criminal proceedings if fraudulent use is suspected. 38. COVERT ADMINISTRATION OF MEDICINES 38.1 Introduction This guidance relates to the administration of medicines to adult inpatients who are detained under the Mental Health Act under section 58 or others in all care settings who are unable to give informed consent to treatment and who subsequently refuse to take oral medication when openly offered to them, and for whom medicines are then administered in a flavoured drink, jam, or other foodstuffs Consideration should be given to the application of the Mental Health Act for appropriate patients. Even where the MHA applies, this does not cover the covert administration of physical medicines and a FACE assessment is still needed to administer these covertly, as is the case for all medication in informal patients. In every case a best interest meeting needs to take place if covert administration is still being considered The Nursing and Midwifery Council (NMC) position statement on the covert administration of medicines (2006) states: Disguising medication in the absence of informed consent may be regarded as deception. However, a clear distinction should always be made between those patients or clients who have a capacity to refuse medication and whose refusal should be respected, and those who lack this capacity. Among those who lack this capacity, a further distinction should be made between those for whom no disguising is necessary because they are unaware that they are receiving medication, and others who would be aware if they were not deceived into thinking otherwise The disguising of medication in food and drink cannot be encouraged as it exposes the patient to risk and can undermine the therapeutic alliance in patients whose capacity fluctuates. Patients with fluctuating capacity may also belive they got better without medication, undermining their understanding of the need for medication Some patients may be willing to take medicines at another time of day or take a smaller number of medicines at different times. Page 92 of 141

93 Every effort must be made to obtain the patient s consent to be administered prescribed medicines in the normal way. Covert medication is an interference with an individual s right to a private life (Article 8 of the Human Rights Act). It is also likely to contribute to someone being deprived of their liberty under Article 5 of the Human Rights Act. The decision to covertly medicate should therefore always be subject to close scrutiny, particularly if that medication will affect someone s behaviour, mental health or act as a sedative. It is essential that any covert medication is done in the least restrictive way possible and that safeguards are in place, for example, regular reviews of the decision to covertly medicate and whether it remains the least restrictive option in that particular patient s case In circumstances where a consenting patient has difficulty in swallowing medication or they find it unpalatable, the medication may be given in food or drink with their knowledge, as a last resort, provided alternative dosage forms such as liquids or dispersible tablets have also been found unsuitable. The ward/unit pharmacist should be asked to advice on alternative preparations, and it may be appropriate to refer the patient to a speech and language therapist for further assessment. In these circumstances, the food or drink is acting as an aid to administration with the patient s consent. This is not covert administration Professional Conduct All practitioners must reflect on the treatment aims of disguising medication and be absolutely confident that they are acting in the best interests of the patient. The treatment must be considered necessary in order to save life, prevent deterioration in health, or ensure an improvement in the patient s physical or mental health status Registered nurses involved in covert administration of medicines must be fully aware of the aims, intent and implications of such treatment. If an authorised employee is involved in covert administration, it is the responsibility of the appointed practitioner in charge to ensure that they are fully aware of their own responsibilities arising from this practice. The administration of covert medication can also present practical problems in that a patient may not fully ingest the substance that carries the medication. This fact is acknowledged in this guidance to recognize the difficulty that nursing staff may encounter using this method of administration. In the event of the patient not fully ingesting the substance containing the medication for a variety of reasons, then the nursing staff should make medical and pharmacy colleagues aware and a note made in the patient s clinical notes Disguising medicines in order to save life, prevent deterioration, or ensure an improvement in the person s health, cannot be taken in isolation from the recognition of the rights of the person not to give consent. It may, in such circumstances, be necessary to administer medicines covertly. If a deprivation of liberty safeguards (DOLS) authorization is in place the covert administratioin of medicines must be clearly identified within the authorization. Applying for a DoLS authorization or the permission of the Court should also be considered if covert admionistration is being considered, particularly if that medication will affect someone s behaviour, mental health or act as a sedative. In such circumstances the Service Manager or the patient s consultant should consider obtaining further advice from the Trust solicitor. Page 93 of 141

94 Deprivation of Liberty Safeguards Authorisations and Covert Administration In the Court of Protection case, AG v BMBC & Anor [2016] EWCOP 37, the District Judge gave the following non-binding but highly persuasive guidance on this issue for future practice: 1. Any use of covert medication must involve full consultation with healthcare professionals and family 2. The existence of such treatment must be clearly identified within the DoLS assessment and authorisation 3. If the standard authorisation is to be for a longer period than 6 months, there should be clear provision for regular (e.g. monthly) reviews of the care and support plan 4. There should in any event be regular reviews involving family and healthcare professionals 5. Covert administration of medication need not in itself require the standard authorisation to be limited to 6 months 6. Where appointed a Relevant Person s Representative (RPR) should be fully involved in all discussions and reviews 7. Any change of medication or treatment regime should trigger a review of covert administration of medication 8. Appropriate conditions attached to the standard authorisation should be used to give effect to this guidance 9. Before medication is administered covertly there must be a best interests decision/meeting including relevant healthcare professionals and family members 10. If it is agreed that the administration of covert medication is in the person s best interests, this must be recorded in the person s clinical/care home records and there must be an agreed management plan including details of how it is to be reviewed 11. All the above documentation must be easily accessible on any viewing of the person s clinical/care home records 12. If there is no agreement, then there should be an immediate application to the Court of Protection If a patient is lawfully detained under a section of the Mental Health Act, some forms of forced or disguised medication are recognised in law for medicines. However, it must be recognised that such administration under the Act will only apply to treatment for psychiatric conditions and not for physical health problems. The impact on the therapeutic alliance must also be considered and how the patient will perceive their recovery. See Section 38.6 of the Medicines Code for more advice on covert administration under Section 58 of the Mental Health Act In deciding what treatment may be reasonably considered as being in the best interests of a patient who lacks capacity to consent, the General Medical Council recommends that the following be taken into account: Options for treatment which are clinically indicated Evidence of the patient s previously expressed preferences, including any advance statements or directives (see Consent below). Knowledge of the patient s background, including their cultural and religious beliefs. Third party views about the patient s preferences given by those who may have other knowledge of the patient, e.g., partner, relative, carer or advocate. Where more than one option (including non treatment) seems reasonable and in the patient s best interest, consideration should be given to that which least restricts the patient s choice Consent All adults must be presumed to have the mental capacity to consent or to refuse treatment, including medication, unless they: Page 94 of 141

95 Are unable to take in and retain information about their treatment and given by the treating staff, in particular with regard to the consequences of refusal or non-treatment. Or are unable to understand the information. Or are unable to properly consider the information before making a decision Assessing this capacity must be undertaken using an mental capacity decision making checklist, e.g. FACE and is primarily a matter for the responsible clinician and the MDT with input from carers if available, but other practitioners, clinicians and authorised employees may all usefully contribute to discussions about this assessment When patients are capable of giving or withholding consent, no medication may be given without their agreement unless a medication is needed for their mental health condition and they are under the MHA. If withholding consent, staff must ensure that the patient has been given sufficient information in a suitable format about the nature, purpose, associated risks and alternatives to the proposed medication Unless a medication needed for their mental health condition and they are under the MHA, a competent adult has the right to refuse treatment, even if refusal will adversely affect their health or shorten their life. Registered nurses and authorised employees must respect a competent adult s refusal in the same way as their consent Patients who lack capacity may have indicated consent or refusal at some previous time whilst competent, in the form of an advance statement, advance directive or living will. Where these wishes are known, all staff must respect them, provided these advance decisions are still clearly applicable to the patient s present circumstances and there is no reason to believe that the patient has changed their mind The ultimate decision to administer medicines covertly must be fully informed and agreed by the multi-disciplinary team caring for the patient at a best interests meeting No one, not even a spouse or parent can lawfully give consent on behalf of another adult. However, the views of relatives, carers, relevant person s representatives, advocates and close friends may be helpful in clarifying the wishes of the patient and establishing what action is in their best interest In patients who lack the capacity to consent and who are physically unaware that they are taking medication (e.g. unconscious patients), the administration of medication will not need to be carried out covertly. However, if these patients recover awareness their consent must be sought at the earliest opportunity It is important to recognise that mental illness might often cause temporary or fluctuating incapacity. In such cases, regular assessment (and record) of capacity will be required if in truly exceptional circumstances covert administration has been agreed Covert Administration of Medicines Covert administration is only likely to be necessary or appropriate when patients actively refuse medication and are judged not to have the capacity to understand the consequences of their refusal. Page 95 of 141

96 There are certain exceptional circumstances in which covert administration may be considered acceptable in order to prevent a patient from missing essential treatment. In these circumstances and in the absence of informed consent, the following must apply: The best interests of the patient are considered at all times and the medication is considered essential for the patient s health and well-being, (or for the safety of others). All alternative means of administration have been explored and similarly refused. The decision to administer a medicine covertly must not be considered routine but should be considered a contingency or emergency measure. Any such decision must be reached after assessing the care needs of the patient specifically and individually in order to avoid the ritualised administration of medication in this way. There should be a best interest meeting convened for the multi- disciplinary team and if engaged, the patient s relatives or carers, or if appropriate the relevant person s representative, and agreement reached that this approach is required in the specific circumstances. Family and/or carer involvement in the care process should always be encouraged when the initial decision is made and at full reviews. The actual method of covert administration must be agreed with full and mini reviews of the decision must be undertaken regularly and recorded on a Covert administration of medicines form (Appendix 11) On acute wards full reviews should be undertaken at least every two months and mini reviews at least every fortnight and in other areas mini reviews at least three monthly and full reviews at least annually. Ward/team pharmacist and all staff made aware that if medicinal products are to be crushed, dissolved or otherwise administered in a way in which they were not intended, then such administration will be considered off licence. Registered nursing staff must remain aware of the NMC guidance on the administration of unlicensed and off-licence medication. On the ward the drug chart should be annotated to indicate that medication is being covertly administered to the patient. Following covert administration the administration record should be annotated with the letter C alongside the initial of the practitioner administering the medicine. In the community suitable arrangements should be agreed to indicate to everyone involved in administration that a decision has been made to covertly administer the medication and which medicines these are. The decision and action taken, including the names of all parties concerned with that process, should be documented in the care plan and reviewed at appropriate, agreed intervals. A decision on whether regular attempts will be made to encourage the patient to take their medication openly must be documented in the care plan. If the decision is to make regular attempts, this might best be achieved by giving regular information, explanation, and encouragement, preferably via a team member with whom the patient has a good rapport. If the administration is going to be undertaken for the long-term and/or is in the context of any other measures which may be deemed to deprive the person of their liberty, an application to the depravation of liberty safeguards (DOLS) for an authorisation should be sought. Page 96 of 141

97 38.5 Review & Audit A Covert administration of medication care plan (see appendix 11) must be completed for each patient and fully reviewed at least every two months on acute wards and annually on other wards Mini reviews should take place at least fortnightly on acute wards and three monthly on other wards (see appendix 11) This policy and guidance will be subject to audit and review at least bi-annually or in advance of the review date in response to changes in legislation or national professional guidance. This will form part of the trustwide clinical audit programme Mental Health Act (MHA), Sections 58 and Before covert treatment for mental disorder is administered under ss 58 or 63 MHA the Responsible Clinician (RC) should consider: Why it is not practicable to seek the patient s consent. What will the impact be on the therapeutic alliance and the patient s perception of how they might have benefited from medication. Whether the giving of covert medication is a proportionate response to the aim of improving the patient s health or reducing the risk posed by the patient Although it would be lawful to administer medication provided under s63 or s58(b) forcibly (if clinically possible), the RC might consider that the covert administration of the medication would be less invasive of the patient s physical integrity and therefore would be deemed a proportionate response The issues considered and the reasoning behind any decision must be recorded in the patient s care notes. This will help protect from a challenge under the Human Rights Act (see paragraphs , Mental Health Act Code of Practice 2008) If covert medication is being proposed under s58 then it is imperative that this is discussed and made clear to the SOAD so that this can be recorded on the statutory form completed by the SOAD to authorise the treatment. SOADs will look for evidence that the clinical team is aware of the RCPsych and related guidance, that alternatives to covert routes have been thoroughly considered, and that the clinical team have discussed the matter thoroughly at a best interest meeting and with any appropriate relatives, carers and advocates Where a clinical team decide to resort to covert administration of medication that is authorised on an extant Form T3 (i.e. where that extant Form relates to a treatment plan that did not specify covert routes of administration), it is expected that a further Second Opinion to reconsider the authorisation is sought. 39. ADVERSE DRUG REACTIONS Any medicine has the potential to cause unwanted or unexpected adverse reactions. It is very important that such reactions are identified, reported and recorded The incident must first be reported to the assigned practitioner in charge, or member of healthcare staff in charge of the unit. Page 97 of 141

98 39.2 Depending on the severity of the reaction and the health of the patient, consideration must then be given to informing the patient's doctor A record of the incident must be made in the patient s care notes and consideration given to making a report to the Committee on Safety of Medicines (CSM) using the "yellow card" scheme. Report all adverse reactions for black triangle medicines and only serious adverse reactions for other medicines. A report to the CSM may be made by the doctor, the nurse, or the unit pharmacist. Reports can be made electronically via or on the yellow cards found at the back of BNFs Where the reaction is fatal, life-threatening, disabling or incapacitating, it must also be reported as a "clinical incident" following the Trust's incident reporting procedure. 40. DRUG ALERTS AND RECALLS 40.1 The Medicines and Healthcare Products Regulatory Agency (MHRA) are responsible for notifying trusts of defective medicines The supplying pharmacy has a responsibility to notify wards and units of any defective medicines they may have been supplied with via the pharmacy If a ward or unit receives notification of a defective medicine, it must be immediately brought to the attention of the assigned practitioner in charge The assigned practitioner in charge must follow the instructions received regarding the identification and withdrawal of the defective product and the local pharmacy informed if medicines are withdrawn at the earliest opportunity The withdrawn medicines must be quarantined in a locked medicines cupboard, sealed in an envelope clearly warning staff that the contents are quarantined and are awaiting collection by the pharmacy team In the event that all the stocks of a particular medicine are being quarantined a discussion needs to take place with the pharmacy team or on call pharmacist to ensure alternative arrangements are made to ensure patients do not miss doses A record of any action taken must be made in the ward/unit daily diary. 41. NURSE DISPENSING OF LEAVE AND DISCHARGE MEDICATION 41.1 Purpose of this procedure The purpose of this procedure is to ensure a structured approach for nurse dispensing that meets the same standards as would be applied in the pharmacy Scope This procedure will apply to all units where patients/residents go on leave of any length or are discharged requiring medication Only nurses, who have successfully completed a pharmacy run certificated training and competency assessment to dispense, can work under this procedure. For the purpose of this procedure these nurses will be known as competent nurses. Page 98 of 141

99 A separate dispensing procedure for use in exceptional circumstances by nurses who have not successfully completed the certificated assessment and training has been developed. (Appendix 1) In the context of this procedure, the term dispensing includes the selection of appropriate one stop stocks already labelled for use on leave or at discharge It is only applicable if: Or Delayed access to leave medication from the pharmacy would significantly compromise discharge. One stop dispensing supplies are available and the patient (or carer) has been assessed as suitable to use pre labelled containers Principles This procedure has been developed to improve patient care whilst minimising the risks associated with dispensing medication on the ward or unit The Procedure Key Issues Only those nurses that have successfully completed the pharmacy run certificated training and competency assessment to dispense, can work under this procedure. Throughout this document they are defined as a competent nurse. If no such nurses are available then the Nurse Dispensing Procedure for Urgent Discharge and Leave Medication in Exceptional Circumstances may be used. (See appendix 15). In such circumstances, if it is essential that more than 72 hours medication (96 hours over a bank holiday) be dispensed or if more is needed then the duty doctor can be called to write an FP10 prescription If one stop dispensing stocks are available, these should be used in preference to getting new supplies dispensed by pharmacy, provided the patient is deemed able to use them In other situations, leave or discharge medication should be ordered from pharmacy whenever possible. Planned leave or discharge should take into account access to pharmacy services and arrangements to order medication in advance whenever possible Second competent nurse, pharmacist or pharmacy technician trained to final check must check all items dispensed The dispensing record box on the leave section of the drug chart must be initialled by the persons dispensing and checking the medication The Procedure LEAVE MEDICATION Only leave medication ordered on the drug chart by a nurse deemed competent to order leave, or a doctor, can be dispensed. Page 99 of 141

100 41.6 Patients suitable to use one stop stocks One stop dispensing stocks must be used if the patient (or carer) has been assessed as suitable to use them The nurse undertaking the dispensing must take the drug chart to the clinic room to minimise the risks of being disturbed The patient s tray(s) of medication should be removed from the drug trolley and placed with the drug chart Each item ordered should be in the patient s tray(s). If a medicine is unavailable or the quantity is not sufficient to cover the leave period, then a request for the missing drug should be sent to the pharmacy. This should be for an original pack and not just the quantity required for the leave. Dispensing of the leave medication should be delayed until the missing stock is received In the event the patient s medication is missing or insufficient and the leave commences before the pharmacy can supply it, then the medication can be supplied from ward stocks following the procedure described in section On occasions there may be two containers of the same drug, i.e. when the one in use is due to run out. If the stock remaining in the opened container is insufficient to cover the leave period, then the unopened container should be supplied instead Having ascertained that all the medication required is available the following must be checked and confirmed as correct for each item: The drug name, form and strength The directions The patient s name The expiry date Having confirmed that everything is correct, the nurse must initial the drug chart in the dispensing record box of the leave section. A dispensing bag with the patient s name on it must then be placed with the medication and chart, ready for checking A second competent nurse, pharmacist or pharmacy technician trained to final check must then check the medication and if correct, they must initial the drug chart in the pharmacy box and place the medication in the dispensing bag The dispenser or checker are then responsible for ensuring the patient (or carer) is counselled on the medication including: Explicit instructions on when as required medication should be taken. Directions for use. Very common or common side effects to watch out for. The importance of bringing any unused medication back with them when they return to the ward. Interpreters can be booked to assist people who experience communication difficulties in terms of language and visual or hearing impairment. Page 100 of 141

101 If this is the first time the patient/resident has left the ward or unit on the medication then a patient information leaflet should be supplied with the medication. If there is not one in the medication container already one can be accessed via the medication section of the Trust s website using the link to the Choice & Medication website: Information can be made available in other formats and community languages to assist people who experience communication difficulties in terms of language or visual impairment from your local pharmacy team Leave medication dispensed from ward stocks This must only take place when delayed access to the leave medication from pharmacy would significantly compromise the start of the leave Situations in which this will apply are: When the patient is using ward stocks and is not on a one stop dispensing scheme Where one stop dispensing applies but pre-labelled stock is unavailable or is insufficient to cover the leave period The nurse undertaking the dispensing must take the drug chart to the clinic room to minimise the risks of being disturbed Collect the empty containers and blank labels needed from the designated storage place. These are supplied by pharmacy The patient s own medication can be used for dispensing if one stop dispensing does not apply to the patient. Otherwise, collect suitable stock drugs to fill the leave request If the prescription cannot be filled due to unavailable stock; the pharmacy or on call pharmacist must be contacted for advice Prepare the labels needed first, writing clearly the following information: Drug name, form (e.g. tablet) and strength Directions i.e. dose and frequency The patient s name The quantity supplied. Date supplied Ward Dispense each individual drug into an appropriate container and then apply its completed label, before dispensing the next item When all the items have been dispensed, double check all the details before initialling the pharmacy box in the leave section of the drug chart along with the quantity supplied marked against each letter and initialling the dispenser box on the label. A dispensing bag with the patient s name must then be put with the dispensed medication. These bags are supplied by pharmacy. Page 101 of 141

102 A second competent nurse, pharmacist or pharmacy technician trained to final check must then check the supply and if correct, they must initial the drug chart in the pharmacy box, initial the label and place the medication in the dispensing bag The dispenser or are then responsible for ensuring the patient (or carer) is counselled on the medication including: Explicit instructions on when as required medicines should be taken. Directions for use. Very common or common side effects to watch out for. The importance of bringing any unused medication back with them when they return to the ward. Make sure the patient has the ward number to ring for advice. Interpreters can be booked to assist people who experience communication difficulties in terms of language and visual or hearing impairment. If this is the first time the patient has left the ward on the medication then a patient information leaflet should be supplied with the medicine. If there is not one in the stock container to use, one can be accessed via the medication section of the Trust s website using the link to the Choice & Medication website: Information can be made available in other formats and community languages to assist people who experience communication difficulties in terms of language or visual impairment from your local pharmacy team. DISCHARGE MEDICATION 41.8 Patients suitable for one stop medication One stop medication must be used if the patient has been assessed as suitable to use them The nurse undertaking the dispensing must take the drug chart and discharge form & prescription to the clinic room to minimise the risks of being disturbed The pharmacy box in the regular medication and as required medication sections of the drug chart should be checked to see if the patient has additional stocks of some of the drugs already at home. If this is the case, additional medication does not need to be dispensed for these items Before commencing dispensing, check that the medication prescribed on the discharge form & prescription matches those currently being prescribed on the drug chart. Unless there are clear documented instructions by the prescriber, or another member of the medical team, explaining the discrepancy, the discrepancy must be resolved before dispensing commences The patient s tray(s) of medication must be removed from the drug trolley and placed with the drug chart and the discharge form and prescription Each item prescribed should be in the patient s tray(s). If a medicine is unavailable or the quantity is not sufficient to cover at least 10 days post discharge (unless fewer days are specifically requested) then a request for the missing Page 102 of 141

103 medication(s) only, should be sent to the pharmacy. This should be for 10 days (unless fewer days are specifically requested). Dispensing of the remaining leave should be delayed until the missing medication is received In the event that stock is missing or insufficient and the patient leaves the ward before the pharmacy can supply it, then supply the missing drugs from ward stock following the procedure described in section On occasions there may be two containers of the same medication i.e. when the one in use is due to run out. If the stock remaining in the opened container is insufficient to cover at least 7 days, or the days specifically requested if less, then both containers should be supplied, explaining to the patient or carer that they should finish the open container before starting the new one Having ascertained that all the medication required is available the following must be checked correct for each item: The drug name, form and strength The directions The patient s name The expiry date Having confirmed that everything is correct, sign the discharge form & prescription in the pharmacy section of the prescription, also stating that one stop medication have been supplied. A dispensing bag with the patient s name on it must then be placed with the medication, discharge summary & prescription and drug chart, ready for checking A second competent nurse, pharmacist or pharmacy technician trained to final check must then come and check the discharge form & prescription against the drug chart and then the medication. If correct, they must initial the discharge form & prescription in the pharmacy box and place the medication in the dispensing bag The dispenser or checker is then responsible for ensuring the patient (or carer) is counselled on the medication including: Explicit instructions on when as required medication should be taken. Directions for use. Very common or common side effects to watch out for. Providing the patient with the wards telephone number in case they need advice. Interpreters can be booked to assist people who experience communication difficulties in terms of language and visual or hearing impairment If this is the first time the patient has left the ward on the medication then a patient information leaflet should be supplied with the medication. If there is not one in the container already, one can be accessed via the medication section of the Trust s website using the link to the Choice & Medication website: Information can be made available in other formats and community languages to assist people who experience communication difficulties in terms of language or visual impairment from your local pharmacy team. Page 103 of 141

104 41.9 Discharge medication dispensed from ward stocks This must only take place when delayed access to the pharmacy would significantly compromise the discharge Situations in which this will apply are: When the patient is using ward stocks and is not on a one stop dispensing scheme. Where one stop dispensing applies but pre-labelled medication is unavailable or insufficient to cover 10 days, or the period requested The nurse undertaking the dispensing must take the drug chart and the discharge summary & prescription to the clinic room to minimise the risks of being disturbed The pharmacy box in the regular medication and as required medication sections of the drug chart should be checked to see if the patient has additional stocks of some of the drugs already at home. If this is the case, additional medication does not need to be dispensed for these items Before commencing dispensing, check that the medication prescribed on the discharge form & prescription matches those currently being prescribed on the drug chart. Unless there are clear documented instructions by the prescriber, or another member of the medical team, explaining the discrepancy, the discrepancy must be resolved before dispensing Collect the empty containers, blank labels and dispensing bag needed from the designated storage place. These are supplied by pharmacy The patient s own medication can be used for dispensing if partial one stop dispensing applies and the quality being supplied on discharge is being restricted If the prescription cannot be filled due to unavailable stock, the pharmacy or on call pharmacist must be contacted for advice Prepare the labels needed, writing clearly the following information: Drug name, form (e.g. tablet) and strength Directions i.e. dose and frequency The patient s name The quantity supplied Date supplied Ward Dispense each individual drug into an appropriate container and then apply its completed label when all the items have been dispensed, double check all the details before initialling each label in the dispenser box and the pharmacy box in the prescription section of the discharge summary and prescription along with the quantity supplied marked against each letter. A dispensing bag with the patient s name on it must then be placed with the drug chart, medication and discharge summary & prescription ready for checking. Page 104 of 141

105 A second competent nurse, pharmacist or pharmacy technician trained to final check must them come and check the discharge summary & prescription, first against the drug chart, then the medication and if correct they must initial the checker box on each label and initial the discharge summary & prescription in the pharmacy box and place the medication in the dispensing bag The dispenser or checker is then responsible for ensuring the patient (or carer) is counselled on the medication including: Explicit instructions on when as required medication should be taken. Directions for use. Very common or common side effects to watch out for. Providing the patient with the ward telephone number in case advice is needed. Interpreters can be booked to assist people who experience communication difficulties in terms of language and visual or hearing impairment If this is the first time the patient has left the ward on the medication then a patient information leaflet should be supplied with the medication. If there is not one in the stock container used, one can be accessed via the medication section of the Trust s website using the link to the Choice & Medication website: Information can be made available in other formats and community languages to assist people who experience communication difficulties in terms of language or visual impairment from your local pharmacy team Development and Consultation Process The following have been consulted during the development of this procedure. The Trust Drugs and Therapeutics Group The Trust Pharmacy Forum The Matrons Monitoring Compliance and Review Compliance with this procedure will be monitored by the pharmacy team. Any concerns about inappropriate application of the procedure, or practice not in accordance with the procedure, will be discussed with ward / unit managers in the first instance The procedure will be reviewed by the Chief Pharmacists not later than three years from the date of ratification. The procedure may be reviewed at any time in response to failings of the procedure coming to light, or to the availability of new local or national guidance that may influence the effectiveness of the procedure Dissemination and Implementation The procedure will be disseminated via the Partnership Bulletin, by direct mailing to all General Managers and lead nurses, and will be posted on the Trust website. Availability of the procedure will also be announced via the Drugs & Therapeutics Newsletter. Page 105 of 141

106 41.13 Document Control and Archiving Arrangements The pharmacy team will be responsible for uploading this procedure onto the Trust website and for archiving any previous versions Cross reference Medicines Code (latest version). Sussex Partnership NHS Foundation Trust Standards for Medicines Management Nursing & Midwifery Council (latest version) 42. OCCUPATIONAL THERAPISTS INVOLVED WITH MEDICINES The purpose of this guidance is to clarify the legal and professional issues surrounding the involvement in medication issues for occupational therapy staff. This guidance has been developed by the Director of Occupational Therapy in consultation with the lead occupational therapists governance group, as well as the Chief Pharmacist - Governance and Professional Practice. It covers occupational therapy staff in all clinical areas and service within the Trust Regulatory and professional context In July 2009 a report was published scoping the role of allied health professionals in prescribing and managing medication The College of Occupational Therapists (COT) and the Health Professions Council (HPC) make is clear that occupational therapists must act within their professional competence at all times, and ensure they have training if they are taking on new roles and responsibilities Under the Medicines Act 1968 there is nothing to prevent an occupational therapist handling medication after it has been dispensed, but it is vitally important that the occupation therapist acts safely and appropriately within their professional scope of practice The administration and supply of medicines are not basic occupational therapy skills, falling outside the scope of occupational therapy practice. The British Association of Occupational Therapists (BAOT) professional indemnity insurance covers members for occupational therapy practice only. The handling of medication is therefore not covered Clinical Context An independent investigation into SUI2006/8119, commissioned by NHS Yorkshire and Humber highlighted the conflict between guidance provided by the College of Occupational Therapists to its members about medicine management and the role and responsibility of a care coordinator It recommended that the College take a lead role in defining the skills and competencies relating to medicine management that an OT working as a care coordinator would need In October 2010 NHS South East Coast issued an independent investigation into the care and treatment of Mr X. An issue was highlighted in that report about the role of an occupational therapist acting as a care coordinator to a client on clozapine, the recommendation is: Page 106 of 141

107 We consider it would have been more appropriate if Mr X had been allocated a clozapine-trained community psychiatric nurse as his care coordinate, with Occupational Therapist 1 providing regular focused occupational therapy (OT) input. Alternatively, if Occupational Therapist 1 was the allocated care coordinator, a clozapine trained CPN should have had a formal and regular role in monitoring Mr X Principles Within the Trust the concerns and benefits of occupational therapists undertaking certain aspects of medication management as a generic role where it is appropriate to their post, most usually as a member of a multi-disciplinary community team have been considered Occupational therapists are not trained to provide advice about the use or actions of medicines; they are skilled at assessing areas such as a person s attitude to their medication, and identifying people unlikely to adhere to their medication regimen. Also in assisting in identifying side-effects and other compliance issues such as confusion We have determined that to ensure due governance there is a need to provide clarity in job descriptions and appropriate training so that occupational therapists carrying out this role will be covered by the Trust s indemnity insurance rather than through that of their profession. All occupational therapy staff involved in medication isssues must attend a training session on handling medication specially designed for professions other than doctors and qualified nurses Adherence to these principles will ensure: That all occupational therapy staff involved in specific medication issues within the Trust will be appropriately trained and supervised (see Procedure section). That appropriate safeguards are in place to promote the safety of, and protect the rights of, service users, regardless of race, disability, gender, gender identity, age, sexual orientation, religion or belief. Occupational therapy staff employed by the Trust will be covered by Trust indemnity as long as this policy is adhered to Duties The Director of Occupational Therapy will be responsible for the professional governance of occupational therapy staff employed by the Trust Professional lead occupational therapists will work with service managers to identify staff training needs and monitor compliance in attending training, as well as using supervision to monitor and ensure competence in this area Individual practitioners are accountable and responsible for their own practice. All occupational therapists must practice and abide by the code of ethics and professional conduct as set out by the COT and the HPC and within the policies, protocols and guidelines laid down by the Trust Service Managers will work with the lead occupational therapist in identifying practitioners who need additional training to support their role in relation to medication management and ensure that training is provided. Page 107 of 141

108 42.5 Procedure All job descriptions for qualified occupational therapists must contain the following phrase: Have a basic working knowledge of the medication prescribed for people under your care. To include usual dosage, common side effects and the need for any special monitoring. Any reported or observed side effects must be brought to the attention of the prescriber Occupational therapists can convey medication, but if the person has not had that medication before: a patient information leaflet must be provided with the medication. the person must be advised that further information can be obtained on the medication from their care co-ordinator or the prescriber if the occupational therapist is the care co-ordinator and does not feel able to answer any question raised Occupational therapists will provide written information on medication (or direct the person to online resources) to reinforce advice given by the prescriber or a memebr of staff qualified to give such information. They should be able to access and provide standard information available on the Trust website or on other approved websites, eg Choice and Medication website People on clozapine who have an occupational therapist as their main worker must have an identified nurse who is monitoring the medication. This should be documented clearly in the notes. If the patient attends a clozapine clinic the nurse there can act as the identified nurse, but again this must be documented Where medication compliance and monitoring is the main clinical issue and the person also has signfiicant occupational needs, they should be care coordinated by a nurse with the occupational therapist providing targeted interventions Occupational therapy staff involved in medication issues including conveyance must be familiar with the Trust s Medicines Code The Medicines Code defines roles in relation to the handling and administration of medication. Occupational therapy staff will most usually fall into the category of Authorised Employee a member of staff who following training (which may take place locally) has been authorised by the Appointed Practitioner in Charge to undertake specific duties in relation to medication. Any additional unit-specific procedure must be taken into consideration Monitoring Compliance Adherence to this guidance will be monitored through supervision and annual appraisal of the individual occupational therapist. 43. ADMINISTRATION OF PATIENTS OWN MEDICATION FROM A MULTI-DRUG COMPLIANCE AID 43.1 Context The use of a patient s own drugs (PODs) brought in from home is usually acceptable within the Trust (see Medicines Code). Page 108 of 141

109 Medicines in compliance aids, such as blister packs containing multiple medications, have been excluded as suitable for administration. This is due to difficulties in identifying individual doses and concerns over stability of the medication. Only sealed blister packs, which have one medicine per sheet, have been deemed suitable for administration during admission in the Medicines Code In certain circumstances however, it may be advantageous to patient care to administer medication out of a blister pack with multiple medicines This procedure is primarily intended for use by nurses when: Medication to be given is not available from the pharmacy (or if the pharmacy is closed, the emergency drug cupboard). Obtaining the medicine would lead to an unacceptable delay (see Reducing harm from omitted and delayed medicines in hospital in Medicines Code for guidance) Procedure for administration of medications from a blister pack with multiple medicines in each blister (see also Appendix 17) Before using a dose(s) from the blister pack, ensure that medication is essential and is not available as stock, is in the emergency drug cupboard or can be obtained from pharmacy before the dose is needed Ensure that all medicines to be given are prescribed correctly and that the prescription on the drug chart for the medicine(s) needed exactly match(es) the corresponding label on the blister pack. If there are any discrepancies, clarify the prescription with a doctor Check that the blister pack has been dispensed by a pharmacy within the last four weeks Identify the exact blister to be administered from the correct day and time of day as it would be taken if the patient was self-administering (e.g. if a Sunday at 6pm, give Sunday teatime blister) Check that each dose unit needed corresponds with a pharmacy label and the prescription on the drug chart. The blister pack should detail the colour, shape, and any imprint codes for each tablet or capsule contained within. IF IN DOUBT, ABOUT IDENTIFYING THE CORRECT TABLET OR CAPSULE, DO NOT ADMINISTER. Contact THE ward pharmacist (or on-call pharmacist if out-ofhours) for advice/supply Ask another nurse, doctor, or pharmacist (if on ward) to check that the correct blister and medicine has been selected If there are other medicines within the same blister that are not needed, because they have been discontinued or ward stocks are available, these should be disposed of in-line with the Trust s Medicines Code (see chapter 18) See link below: Page 109 of 141

110 Administer each selected dose and initial the drug chart for each dose, both nurse and checker A new supply must be obtained as soon as possible from the pharmacy, though further doses can be used from the blister pack until new stock is available, following the same procedure. 44. REFERENCES 1. Royal Pharmacists Society of Great Britain. The Safe and Secure Handling of Medicines. 2. Nursery and Midwifery Council. Standards for Medicines Management NHS Executive (2000). Patient Group Directions HSC 2000/ Great Britain (1972). Medicines Act 1968 (as amended). The Stationary Office, London 5. NHS Estates (1994) HTM 2002 Medical 6. NHS Executive (1997). Destruction of Controlled Drugs EL (97) Great Britain (1984). Misuse of the Drugs Act 1971 The Stationary Office, London 8. National Patient Safety Agency. Promoting safer measurement and administration of liquid medicines via oral and enteral routes. Patient Safety Alert /2007/PSA Mental Health Act Commission, Risks, Rights and Recovery, 12 th Biennial Report , Published National Patient Safety Agency. The adult patient s passport to the safer use of insulin. Patient Safety Alert/2011/PSA LINKED TRUST POLICIES AND GUIDANCE 1. Mental Capacity Act 2005 Policy 2. Infection Control Policy and Procedure 3. Policy and Procedure for the Management of Alcohol and Drug Misuse by Service Users/Visitors on Trust Premises 4. Training Policy 5. Policy to use Photographs of Adult Inpatients to Reduce the Risk of Medication Errors and for use when Vulnerable Adults go Missing. 6. Consent Policy 7. Derivation of Liberty Safeguards Policy Page 110 of 141

111 Appendix 1 Self-administration Flowchart Patient is identified by the MDT as appropriate to commence self-administration of medication programme. Discuss with patient. Nurse (or designated person) undertakes patient risk assessment (appendix 3) Needs Identified: With containers refer to pharmacy (appendix 8) Report to MDT Knowledge lacking about medication regimen? Undertake psychoeducation (offer verbal and/or written information about mental health illness, medication information, whatever needs identified in collaboration with the patient) Needs met Assessed as competent to commence stage 1. Liaise with pharmacy No Needs Identified: Report to MDT Assessed as competent to commence stage 1 or stage 2 if fast tracked and if suitable lockers. Liaise with pharmacy. Commence Stage 1 Patient successfully completes stage 1 Report to MDT liaise with pharmacy Competence recorded on (appendix 5) To commence on stage 2 if suitable lockers. Patient consents to commencing stage 2 Patient has difficulties with stage 1. (appendix 2 if declines consent record Record nature of difficulties (appendix 5) the reason in the notes) and if required withdraw patient participation in the scheme and review at a later stage. See notes below** Commence stage 2 Inform pharmacy (Appendix 3) to be signed by the consultant Complete (Appendix 5) Commence stage 3 If suitable environment and successful completion of stage 2 Complete (appendix 6) **Notes: If the nurse has concerns at any stage or the risk environment changes: Record the nature of the concerns Report back to MDT Identify if need more psychoeducation? Supprotive intervention? Return to previous stage? Page 111 of 141

112 Appendix 2 Self-administration: Patient Agreement / Consent Form Patient s name.. Ward Part 1: I request to be assessed under the requirements of the Sussex Partnership NHS FoundationTrust s self administration scheme. Patient s Signature... Date: Nurse s Signature. Nurse s name Date: Part 2: The self-administration scheme has been explained to me I hereby request the opportunity to self-administer medication during my in-patient stay and take responsibility for ensuring safe storage of these medications in the lockable facility provided. I understand that medications provided for self-administration are for my use only. I undertake to inform the Nurse in Charge if I am experiencing any difficulties. I understand that spot checks of my medication storage cabinet may be undertaken, ideally with me present, by nursing and pharmacy staff. I understand that I can withdraw my consent at any time without any detriment in my care. Patient s Signature... Date: Nurse s Signature. Nurse s name Date: Withdrawal of Consent I do not wish to get/remain involved in the self administration scheme due to:. I therefore refuse/withdraw my consent. Patient s Signature... Date: Nurse s Signature. Nurse s name Date: On completion, this form must be filed in the patient s care notes. If you require this document in an alternative format, ie easy read, large text, audio or Braille please contact the Pharmacy Team on Page 112 of 141

113 Appendix 3 Patient Risk Assessment and Decision Form for the Self administration of Medicines Patient s Name. Ward: 1. Was the patient self administering medication prior to admission? Yes/No (If yes how successfully?) Comments: 2. Is the patient confused, or does they have an unstable mental state or a history of alcohol/drug abuse? Yes/No (If yes patient may only be suitable for stage 1 or should not be included in the self-medication programme at present). Comments: 3. Does the patient have a history of overdose, accidental or intentional? Yes/No (If yes patient may only be suitable for stage 1 or should not be included in the self-medication programme at present). Comments: 4. Has the patient a history of non-compliance with medication leading to a relapse or risk of relapse? Yes/No Comments: 5. Is the patient motivated to commence self-medication? Yes/No Comments: 6. Can the patient open child resistant closures? Yes/No Comments: 7. Does the patient need a compliance aid? Yes/No Comments: Page 113 of 141

114 8. Can the patient read standard medication labels in English? Yes/No If no, what steps have been agreed to overcome this problem? 9. Does the patient have the right attitude to medication and insight into the importance of the prescribed medication and how to take it? Yes/No Comments: 10. Does the patient understand the importance of secure storage for medication and that medication must not be shared, given or sold to others? Yes/No Comments: Assessment completed by... (name). (signature).... (date) Discussed at multidisciplinary meeting Not suitable for self-administration. (date) (date) Consultant s name & signature Or Suitable for self-administration stage 1.. (date) Consultant s name & signature If stage 1 has been successfully completed (or patient fast tracked on admission): Suitable for self-administration stage 2.. (date) Consultant s name & signature If level 2 has been successfully completed: Suitable for self-administration stage 3. (date) Consultant s name & signature Patient and ward have been risk assessed and the patient is holding the key. On completion, this form must be kept in the patient s care notes and a copy must be attached to the drug chart. Page 114 of 141

115 Appendix 4 Self-administration of Medicines Patient Information Leaflet Note: Each unit will need to amend this leaflet to reflect local storage and locking mechanisms used. Make sure all the words in italics and this box are removed. On this ward a self-administration scheme is in place. Its aim is to improve your knowledge about your medicines and to help you take your medicines safely once you return home. Self administration allows you to take more responsibility for taking your own medicines while on the ward. If you agree to take part in the scheme, you will have the chance to look after your own medicines during your admission, under a certain degree of supervision. A qualified nurse or a member of the pharmacy team will give you as much information and support as you require. Eventually your medicines may be kept in a locked (cabinet /locker delete as appropriate) in your room. At first the (key/lock code delete as appropriate) will be held by a nurse. The nurse will supervise you but you will select which medicines you need at different times of the day. The nurse will be there to ensure no mistakes are made and answer any questions you may have. As you become more familiar with your medicines, you may progress to a stage where you will be given the (key/lock code delete as appropriate) so that you can take full control over your medicines without help. At this level it is of the utmost importance to keep your (cabinet/locker locked delete as appropriate) and (the key on your person at all times/the lock code must not be shared with anyone else delete as appropriate). However to ensure you are coping well with your medicines nurses will perform regular and random checks and discuss how you feel you are coping. This is to ensure that you are taking your medication appropriately and that your safety and that of others is not compromised at any time. If there are any patients on the ward who might coerce or threaten you to get your medicines, we may have to (take your key off you/change the lock code and not let you know what it is delete as appropriate) while there is a risk to you. This will not be a reflection on well you are doing. If this occurs you will still be able to store medicines in your room, but you will need to ask the nurse to access your medicines at the times you need to take them. The self-administration scheme is not compulsory, so you do not have to take part. If you choose not to take part, your medicines will be given to you by the nurses in the usual way. If you require this document in an alternative format, ie easy read, large text, audio, Braille or a community language, please contact the the Pharmacy Team on (Text Relay calls welcome). November 2015 Page 115 of 141

116

117 Appendix 5 Daily Self-administration Progress Record Stages 1 & 2 Patient s name: Ward: Week commencing: Date Requests medication at correct time B L T N B L T N B L T N B L T N B L T N B L T N B L T N Reads instructions on bottles Selects correct doses Takes medication Returns meds to appropriate container Leaves medication secure? Is the locker secured (stage 2) Initials Key: = Independently performs task, X = Needed prompting O = Not applicable Comments on how well the patient is coping and on their insight and attitude to medication: (Please continue overleaf if necessary) Signature Date June 16 Page 117 of 141

118 Appendix 6 Self-administration Progress Record Stage 3 Patient s name: Ward: Date sheet started: Drug name and strength Dose and frequency e.g. 2 BD No. of dose units* in client s possession at start of week? Date Number of dose units* remaining ACTUAL PLANNED INITIALS ACTUAL PLANNED INITIALS ACTUAL PLANNED INITIALS ACTUAL PLANNED INITIALS ACTUAL PLANNED INITIALS *Record tablets and capsules as the ACTUAL number of dose units remaining. Assessing liquids is difficult, so measure liquids at the start of the week and record PLANNED volume remaining thereafter, using it as a guide to assess usage. For other formulations; like inhalers or eye drops, assessing how much is left is difficult so you will not usually be able to record either ACTUAL or PLANNED dose units remaining, but look for signs of overuse or no use and then initial the box. December 2016 Page 118 of 141

119 Appendix 7 Patient Self-administration Assistance Sheet Patient s name. Ward.. Name of Medicine Prescribed For When to take it Breakfast Lunch Teatime Bedtime Other Information Completed by... Designation. Date.. Pharmacy check by (if applicable) Date Page 119 of 141

120 Appendix 8 Patient Self-administration Aide Memoire Patient s name: Ward: Week commencing: Put a tick or enter your initials in the correct box each time you take your medicines at the correct time each day* Monday Tuesday Wednesday Thursday Friday Saturday Sunday Breakfast Lunch time Tea time Night time If there is a time when you do not take your medication as you should have done, please be sure to tell a member of nursing staff as soon as you can. If you require this document in an alternative format, ie easy read, large text, audio, Braille or a community language, please contact the Pharmacy Team on (Text Relay calls welcome) Page 120 of 141

121 Appendix 9 This form to be completed and returned to local Pharmacy Department for assessment Compliance Aid Assessment and Request Form Patient s name: DOB:.. Current Location (Ward or Community):... Permanent Address:.. GP Community Pharmacist (if known). Reason for request (more than one box may be ticked) Confused ( ) Poor Memory ( ) Difficulty with containers ( ) Difficulty reading label ( ) Previous concordance problems ( ) Other ( ) Please Specify.. Who will be responsible for administering the patient s medication following discharge? Patient ( ) Carer ( ) Other ( ) Please specify Who will fill the compliance aid after discharge? Patient ( ) Carer ( ) Community Pharmacist ( ) Hospital Pharmacy ( ) Other ( ) Please specify... Request made by Designation. Signed Date. Is the patient aware? What the medication(s) is/are called { } What common side effects may occur { } What to do if side effects occur { } What the medication (s) is/are for { } What dose to take { } Can alcohol be consumed { } How Ability to with take labels: the medication { } How long to take the medication for Page 121 of 141 { } Can read: Computer { } Large print { } Understand instructions { }

122 Ability with Containers: Summary of findings Patient is competent to self medicate YES { } NO { } Signature of Nurse Date. Time... Page 122 of 141

123 Appendix 10 Medication Not Considered Suitable for Self-Administration (See section 3 Exclusion ) Actiq lozenges Amobarbital (Amylobarbitone) capsules and Amytal tablets Buprenorphine tablets and patches Butobarbital (Butobarbitone) tablets BuTrans patches Dexamfetamine (Dexamphetamine) tablets and Dexedrine tablets Diamorphine tablets Diconal tablets and Dipipanone tablets Durogesic patches and Durogesic DTrans patches Eptadone oral solution Fentanyl lozenges and patches Hydromorphone capsules Lisdexamfetamine capsules Matrifen patches Meprobamate tablets Methadone oral solution, oral concentrate, linctus and tablets Methadose oral concentrate Metharose oral solution Methylphenidate tablets and capsules (various brands) Morcap capsules Morphgesic tablets Morphine oral solution, tablets and capsules MST Continus tablets and suspension (sachets) MXL capsules Oramorph oral solution, oral concentrate, and unit dose vials Oramorph SR tablets Oxycodone oral solution, oral concentrate, tablets and capsules (various brands) Pentazocine tablets, capsules and suppositories Pethidine tablets Physeptone oral solution and tablets Ritalin tablets Secobarbital capsules and Seconal Sodium capsules Sevredol oral solution and tablets Sodium Amytal capsules Soneryl tablets Suboxone tablets Subutex tablets Temgesic tablets Tilofyl patches Tramadol capsules and modified release tablets Transtec patches Tuinal capsules Zomorph capsules Note this list may not be exhaustive. Refer to a member of the pharmacy team if in doubt. Date complied: February 2015 Page 123 of 141

124 Affix Patient Label Here Patient Name... Hospital/NHS Number... Date of Birth... Appendix 11 Covert Administration of Medicines To be completed and attached to the front of patient s drug chart* Outdated forms to be scanned or filed in the patient s care notes *In the community it should ideally be attached to the patient s administration record if being used. Date of issue:... Full reviews must take place at least every two months on acute wards and annually in other areas. Mini reviews must take place at least fortnightly on acute wards and three monthly in other areas. List the medicines to be given covertly, including the agreed method of administration, e.g. in fruit juice, in a sandwich, in soup, etc. Please provide patient-specific instructions. When was the patient last encouraged to take their medication? What problems were encountered? What other medication options have been considered, e.g. different route? Continue overleaf Page 124 of 141

125 In what way are the medicines to be given covertly essential and in the patient s best interests? What is the desired outcome? Tick if the provisions of the Mental Health Act (1983) been considered Will regular attempts be made to get the patient to take their medication? If yes, how often? The decision to covertly administer medication has been discussed and agreed with: Role Print Name Signature Date Consultant/RMO Named Nurse Pharmacist Family member/ carer/advocate* *If no engagement by family, carer or advocate, please write No engagement on the form. A full review involving the family/carer/advocate will take place no later than.. Mini reviews by the MDT will take place every.. weeks/months Date Reviewed by Date Reviewed by Date Reviewed by If all parties are NOT in support of the decision, please list names & objections/ concerns: Original version August 2009 New version approved July 2014 Page 125 of 141

126 Appendix 12 One Stop Dispensing (OSD) Risk Assessment Form Patient s Name: Ward/Unit: This form must be completed and signed by the Consultant (or their nominated deputy) and a competency-assessed nurse. Only patients with a fully completed form can be included in the OSD scheme. Please circle the appropriate response: 1. Will a suitable carer be responsible for looking after the patient s medicines during leave and/or following discharge? YES NO If the answer is YES then the service user can be fully included in the OSD scheme. If the answer is NO then go to question 2. Please circle the appropriate response: 2. What is the patient s assessed overdose risk? LOW HIGH If LOW then the patient could be included in the OSD scheme (Go to question 3) If HIGH, please describe the risks that render the patient unsuitable for the OSD scheme at present. Note regardless of assessment result, the patient s eligibility for inclusion in the scheme, (or exclusion from it), must be kept under regular review as it may be subject to change and require reassessment. Please circle the appropriate response 3. Are there any other factors, such as adherence or the patient s vulnerability to exploitation and harassment by others, that need to be considered? YES NO If yes, please indicate what they are and whether they make the patient unsuitable for the scheme. Decision (Tick as appropriate) The patient is suitable for inclusion in the OSD scheme and will have all their stabilised medication included in the one stop dispensing process. The patient is NOT suitable for inclusion in the OSD scheme at present. Leave can be organized by a registered nurse who undertakes the named nurse role. Additional information is provided overleaf? Yes or no Signature of the Consultant or nominated deputy: Signature of the competency-assessed nurse: Date: Date: PTO Page 126 of 141

127 Additional information Version 4 October 2015 Review date October 2019 Page 127 of 141

128 Appendix 13 Sussex Partnership NHS Foundation Trust Patient s own medication checklist see Medicines Code section 19.8 for more details Unit or ward name: Put the medicines name and strength at the top of each set of columns Please tick for each medicine *Medicines in patient filled cassettes, systems with movable partitions (e.g. Medidose) and sealed blisters containing more than one medicine in the blister are not to be used. Only sealed blisters that have one medicine per sheet are suitable. Y N Not applic Y N Not applic Y N Not applic Patient s own medication will be checked against the following criteria: 1. Does the medication have a dispensing label on it from a pharmacy or dispensing doctor? 2. Is the patient s name correct on the container s label? 3. If in a monitored dosing system is the medicine in a separate sealed blister? (see* above) 4. Is the drug name on the label the same as the contents of the container (if identifiable)? 5. Is the drug strength on the label the same as the contents of the container (if identifiable)? 6. Is the drug formulation on the label the same as the contents of the container (if identifiable)? 7. Does the medicine look okay, e.g. not discoloured or cloudy? 8. Is the medication still within the manufacturer s or dispenser s expiry date (if identifiable?) 9. If already open and there is a different shelf life once opened is this in date (e.g. eye drops, insulin)? 10. Are all the medicines in the container identical (if identifiable)? 11. If cold storage was needed can this be confirmed? 12. Was the medication dispensed within the last 6 months? 13. If an oral liquid, was it dispensed within the last 30 days? 14. I have assessed the medication and have no further concerns? If the answer is No to any of the above questions the medication is not suitable for use. Patient s name:.. Medicines checked by:. (Name) Date checked:. Medicines checked by:.. (Signature) August 2009 If the patient brings in more than 3 medicines please start a new sheet and staple them together. Once completed store in the patient s care notes Page 128 of 141

129 Appendix 14 Glasgow Antipsychotic Side-effect Scale (GASS) Page 129 of 141

130 Page 130 of 141

131 Appendix 15 Nurse Dispensing Procedure for Urgent Discharge and Leave Medication in Exceptional Circumstances It is possible that wards /units will occasionally be faced with the problem of patients requiring medication urgently, for hurriedly arranged discharge or for a short period away, and the time available is not sufficient to allow the dispensing and delivery of the drugs from the supplying pharmacy, or the nearest community pharmacy if a doctor is available to write an FP10 prescription. In such exceptional circumstances, and where units do not have nursing staff available that have successfully completed the pharmacy lead certified training and assessment to dispense medication, it is permissible for the assigned practitioner in charge to authorise the dispensing of the necessary medication from ward/unit stock. The exception is controlled drugs that must be prescribed by medical staff. However, nursing staff must remain aware that such dispensing of medication from ward stock is a particularly high-risk activity and one that is not endorsed by the Nursing & Midwifery Council unless nurses have been specifically trained to deliver this activity to the same standard as a pharmacist. 1. Dispensing Key Issues 1.1 The dispensing of urgent discharge or leave medication is the responsibility of the assigned practitioner in charge and may only be undertaken by that practitioner or by another designated practitioner. 1.2 The dispensing process must be checked by another designated practitioner if available, or if not, by an authorised employee. 1.3 Only the patient s current medication may be dispensed, and it must be exactly in accordance with the directions of the prescriber. 1.4 It is vitally important that the patient s medication regime is carefully studied so that all the medicines needed are correctly dispensed. Conversely, there may be occasions when, for the period of absence in question, some medications will not be needed. 1.5 Only that medication due to be taken/used during the period of absence should be dispensed. 1.6 Medications must be dispensed in sufficient quantity, (i.e. sufficient number of doses), to exactly cover the period of leave or absence up to a maximum of 72 hours supply. (Unless supply is needed to cover a bank holiday, when up to 96 hours may be supplied). 1.7 On no account may more than 96 hours supply of medication be issued, either for discharge or for leave. If a larger quantity is required then the patient (or agreed representative) must be asked to return to collect either pharmacy dispensed medication or an FP10 prescription for dispensing in the community. Alternatively, some units may be able to organize the delivery of further supplies of medication to the patient once dispensed by a pharmacy. Page 131 of 141

132 1.8 Where patients normally take variable doses of medication (e.g. "one to two tablets"), then sufficient quantity to allow the patient to take the higher dose should be dispensed unless the prescriber or assigned practitioner in charge considers it unnecessary or inappropriate to do so. (It is very important that variable doses are discussed with the patient or carer in order to ensure that they fully understand the reason for the dosage and what criteria/symptoms will govern selection of the actual dose to be taken). 1.9 The supply of urgent discharge or leave medication from ward / unit stocks may also include as required medication. If this is the case, the assigned practitioner in charge should look back over the record of medicine administration for the last week and use this record to assess whether a discharge supply is necessary, and if so, how many doses should be supplied? In all cases, the decision to supply, or not to supply any recently prescribed as required medication on discharge must be discussed with the patient or carer, and the assigned practitioner in charge must ensure that the patient or carer fully understands which medication is being supplied and how, why and when it should be taken by the patient Each oral medication needed must be dispensed into a separate medicine container and fitted with a child resistant top - (Unless specifically inappropriate, e.g. patient with compromised manual dexterity). Foil packed medicines are classed as child resistant and can be packed in boxes Where patients are using topical preparations (creams, ointments, eye drops, etc) or inhalers then the complete pack should be issued. 2. Dispensing and Labelling Procedure. 2.1 Every medication must be correctly labelled in order to comply with The Medicines Act This must be done by the completion of grid labels, which are supplied specifically for the purpose by the supplying pharmacy or by the local pharmacy team. 2.2 The persons undertaking the dispensing must take the drug chart, and the discharge summary & prescription if applicable, to the clinic room to minimise the risks of being disturbed. 2.3 The pharmacy box in the regular medication and as required medication sections of the drug chart should be checked to see if the patient has additional stocks of some of the drugs already at home. If this is the case, additional medication does not need to be dispensed for these items. 2.4 Before commencing dispensing, the nurse must check that the medication prescribed in the leave section of the drug chart or on the discharge form & prescription matches those currently being prescribed on the drug chart. Unless there are clear documented instructions by the prescriber, or another member of the medical team, explaining the discrepancy, the discrepancy must be resolved before any dispensing takes place. 2.5 The nurse should collect the empty containers, blank labels and dispensing bag needed from the designated storage place. These are supplied by pharmacy. Page 132 of 141

133 2.6 The patient s own medication or if not available, ward stocks, can be used for dispensing. 2.7 If the prescription cannot be filled due to unavailable stock, the pharmacy or on-call pharmacist must be contacted for advice. 2.8 All labels should be prepared ensuring that all are written clearly and all contain the following information. These should be checked by the second person, and both persons must initial the labels. Drug name, form (e.g. tablet) and strength Directions, i.e. dose and frequency The patient s name The quantity supplied The date supplied The name and telephone number of the supplying ward or unit 2.9 Each individual drug must be dispensed into an appropriate container and its completed label applied and the dispenser box initialled before dispensing the next item. The second person must check that the correct medication has been selected, by checking against the original containers used for dispensing, and that the correct quantity has been dispensed. Once checked the checker box on the labelled should be initialled When all the items have been dispensed, both persons must ensure that all details are double-checked. A dispensing bag with the patient s name on it must then be prepared If the checking nurse finds an error in the dispensing or labelling, this must be brought immediately to the attention of the dispensing nurse, the error corrected and the item rechecked. A near miss incident report must then be completed and submitted by the team manager The dispensing record must then be fully and accurately completed by the nurse, and signed by both persons involved with the dispensing process. (See appendix A). The dispensing record must be kept in a ring-binder held on the ward specifically for the purpose The nurse is then responsible for ensuring the patient (or carer) is counselled on the medication including: Full directions for use. Explicit additional instructions on when as required medication should be taken. A description of common side effects to watch out for. Who to contact if the patient has any concerns about the medication. Interpreters can be booked to assist people who experience communication difficulties in terms of language and visual or hearing impairment. If this is the first time the patient has left the ward on the medication, then wherever possible, a patient information leaflet should be supplied with the medication. If there is not one in the medication container used, one can be accessed via the medication Page 133 of 141

134 section of the Trust s website using the link to the Choice & Medication website: Information can be made available in other formats and community languages to assist people who experience communication difficulties in terms of language or visual impairment from your local pharmacy team Units must ensure that they always have adequate supplies of medicine boxes, bottles, tops, labels and dispensing bags, as the issue of medicines to patients in unofficial containers is unacceptable. 3. Record Keeping A signed written record of all such issues must be kept by the unit and should detail the patient's name, medication issued (reference letters from the prescription chart may be used), and quantity, dosage instructions, the date of issue, and the names of staff taking responsibility for the packing and labelling of the medication. 4. Limitations 4.1 No more than a maximum of 72 hours supply of discharge / leave medication may be made from ward stocks. (96 hours is permissible to cover a bank holiday). 4.2 The issue of discharge / leave medication from ward stocks must not include controlled drugs. 4.3 Registered nurses who have received specific training from pharmacy staff and who have successfully completed a structured assessment of competency in this area are not limited by the terms of this interim procedure. February 2014 Page 134 of 141

135 Appendix 16 Checklist for Ward Managers to Assess the Competence of Care Assistants to Check the Administration and Recording of Controlled Drugs (CDs) in the Absence of a Second Qualified Nurse (Version 1 - November 2014) Introduction This checklist has been developed to help ward managers assess care assistants to become authorized employees to be able to second check when CDs are administered in the absence of a second qualified nurse. The underpinning principle should be that this person would make a credible witness in a court of law if they had to back up your version of events when they said they had witnessed you properly administering and recording a CD. They are not expected to have any clinical input into the process. They are only being asked to initial/sign that they have witnessed that the correct medicine and dose was selected, they saw it administered to the correct patient and the proper recording took place on the drug chart and in the CD register. Due to the limited use of CDs on most wards, some of the assessment can take place using non-cd medicines as the process of identification, watching the administration and recording on the drug chart applies equally to all medicines. Additional training on how to record in a CD register will need to be undertaken. Ward: Care Assistant s Name:.. Responsible assessor s name:... The care assistant is able to demonstrate that: They can read drug names on a drug chart, but are confident to refuse to be a witness if they cannot read them? They can correctly select a range of medicines from the drug trolley, including the correct dose? They know how liquid medicines are correctly measured using oral syringes and measuring cups? They know how to witness the administration of medicines, including unusual formulations like fentanyl patches? They know how to record the administration on the drug chart, including when special administration or omission codes need to be used? They know how to match the page in the CD register with the CD administered? They know how to record a dose administered in the CD register? They are aware of the guidance in the front of the CD register how to record CDs and what to do if an error is made recording? They know how to check the CDs stock level after administration and what should happen if there is a discrepancy found with the register? They know that if at any point they are unsure that everything was done correctly, they can refuse to witness the administration? Depending on local circumstances, they know who should be called for advice if they feel they cannot witness the administration? Date demonstrated I confirm that I feel competent to take on the role of second checker when CDs are administered:. (signature) (date) I confirm that.. (care assistant s name) has successfully demonstrated to me that they can undertake the role as second witness when CDs are administered: (signature) (date) Page 135 of 141

136 Appendix 17 Appendix 17 Algorithm - Procedure for the administration of a patient s own medication from a multi-dose compliance aid (MDCA) in the ward environment in exceptional circumstances (Version 1 May 2016) A patient has been admitted to the ward and they have brought a multi-drug blister pack containing all of their medication with them. You require an individual dose of a single medication (or multiple) from the MDCA. Would ordering the medication from pharmacy, checking the emergency cupboard or using an FP10 lead to an unacceptable delay? Yes Was the MDCA dispensed within the last 4 weeks? Yes Compare the labelled directions on the MDCA for the medicine(s) required with the prescription on the drug chart. Are there any discrepancies? No No Yes Order medications from pharmacy or check the emergency cupboard or use an FP10 to obtain a supply. Do not administer as medication may no longer be suitable for use. Contact the pharmacy team (or on call pharmacist) for advice. Clarify prescription with a doctor. No Identify the correct blister for the time and day containing the required dose unit(s). The MDCA label should detail the colour, shape and any imprint codes for each tablet or capsule. If it does not, DO NOT USE Identify the individual dose(s) required and ensure each dose matches the description on the pharmacy label. Are you able to identify the dose(s)? Yes No Do not administer as the medication may not be correct. Contact the on call pharmacist for advice. Ask another nurse, doctor, or pharmacy team member to double check that the correct medication has been identified. Administer the required medication from the MDCA and initial the administration box(es) along with the checker. Asterisk(*) the administration box and write *Given from MDCA in the Additional instructions box of the drug chart for each medicine supplied from the blister pack. Assuming the medication can be identified; doses can be administered from the MDCA until pharmacy opens and a new supply can be obtained. Any dose in an open blister that does not need to be administered should be discarded in-line with the Medicines Code (see chapter 18) Page 136 of 141

137 Appendix 18 Weekly Medicines Security and Safe Handling Check List for Ward Managers and Team Leaders Checks to be undertaken once a week, by the ward manager/team leader or a nominated deputy. Days & times should vary. Each sheet lasts one month. (Initial the boxes as checked). Date: Date: Date: Date: Date: Ward/team: Month and year: 1. All the drug cupboards are locked. 2. The Controlled Drugs (CD) cupboard is locked. 3. The CD order book (unless off the ward) is locked in the CD cupboard. 4. The CD key is held separately from the general medicines keys by the most senior nurse on duty 5. The weekly CD stock check has been done. 6. The drug fridge is locked. 7. The maximum and minimum temperatures of the drug fridge have been recorded daily. 8. The maximum and minimum temperatures of the clinic room have been recorded daily. 9. Any oxygen cylinders are stored securely, are in date and contain enough oxygen Time: Time: Time: Time: Time: Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Page 137 of 141

138 10. The drug trolley is chained to the wall. Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A 11. No medicines are left out pre-prepared for administration. 12. Pharmacy transport bags containing medicines are only left unattended in a locked clinic room 13. All pharmacy deliveries have been checked and put away within one hour of arrival. 14. Self-administration medicines lockers are locked when not in use. 15. Newly admitted patients have a photograph on their drug chart or the correct refusal documentation in their notes. 16. Medicines are not left out in the locked or manned clinic room except: Medicines in pharmacy transport bags Bulky low risk items approved by pharmacy in exceptional circumstances eg Fybogel Anaphylaxis shock packs for emergency use Signature Signature Signature Signature Signature Any weaknesses to be discussed with the Ward or Team Manager before storing for a minimum of 12 months on the ward or in the team base. Version 2 November 2016 Page 138 of 141

139 Appendix 19 Three Monthly Medicines Security and Safe Handling Audit Sheet for Matrons or a Nominated Deputy To be undertaken every three months by the matron or if the weekly checks have be delegated to a nominated deputy, the ward manager or team leader can undertake the three monthly check on behalf of the Matron. Days and times of the check should vary and any previous action plan(s) should be referred to. Initial boxes as checked and sign off any agreed actions. Ward/Team base: How many of the weekly checks have been Missed since the last quarterly audit? 1. All the drug cupboards are locked. 2. The Controlled Drugs (CD) cupboard is locked. 3. The CD order book (unless off the ward) is locked in the CD cupboard. 4. The CD key is held separately from the general medicines keys by the most senior nurse on duty. 5. The weekly CD stock check has been done. 6. The drug fridge is locked. 7. The maximum and minimum temperatures of the drug fridge have been recorded daily. 8. The maximum and minimum temperatures of the clinic room have been recorded daily. 9. Any oxygen cylinders are stored securely, are in date and contain enough oxygen. Date: Time: Yes No N/A Actions agreed on any weaknesses identified Page 139 of 141

140 Date: Time: Actions agreed on any weaknesses identified 10. The drug trolley is chained to the wall. Yes No N/A 11. No medicines are left out pre-prepared for administration. 12. Pharmacy transport bags containing medicines are only left unattended in a locked clinic room. 13. All pharmacy deliveries have been checked and put away within one hour of arrival. 14. Self-administration medicines lockers are locked when not in use. 15. Newly admitted patients have a photograph on their drug chart or the correct refusal documentation in their notes. 16. Medicines are not left out in the locked or manned clinic room except: Medicines in pharmacy transport bags Bulky low risk items approved by pharmacy in exceptional circumstances e.g. Fybogel Anaphylaxis shock packs for emergency use Audit and action plan signed off by (Ward or Team Manager or Matron): Date The completed form must be stored on the ward or team base for a minimum of 12 months and referred to at the next audit. A copy should also be sent to / retained by the matron. Version 2 November 2016 Page 140 of 141

141 Ward:.. Appendix 20 Month:. Year: Medicines Refrigerator & Clinic Room Temperature Log The clinic medicines refrigerator and room temperature should be recorded every day to ensure the medicines are stored appropriately. The refrigerator temperatures should be between 2 C and 8 C. Room temperature should be 25 C or less. DATE TIME CURRENT TEMP ( C) 1 st 2 nd 3 rd 4 th 5 th 6 th 7 th 8 th 9 th 10 th 11 th 12 th 13 th 14 th 15 th 16 th 17 th 18 th 19 th 20 th 21 st 22 nd 23 rd 24 th 25 th 26 th 27 th 28 th 29 th 30 th 31 st MINIMUM TEMP ( C) MAXIMU M TEMP ( C) ROOM TEMP ( C) Page 141 of 141 SIGNATURE ACTIONS (see below for specific considerations) Specific Advice and Required Actions: After recording refrigerator temperatures, please ensure the thermometer is reset (according to user manual). Unless a frost-free model, monitor any build-up of ice. Defrost when ice is visible in the fridge and defrost at least annually to prevent build-up of ice and ensure normal functioning of fridge. Ideally, defrost when the refrigerator is empty; alternatively store any content in another refrigerator temporarily. If medicines are, or have been frozen (<0 C), medicines must not be re-used. Inform local pharmacy staff and estates as a matter of urgency. Use another refrigerator until the issue is rectified for any replacement stock. If the refrigerator temperature is outside required temperature range (between 2 C to 8 C) seek urgent advice from pharmacy staff. If this issue recurs, inform Estates and do not use the refrigerator until resolved. If the ambient temperature exceeds 25 C for a short period during a heatwave, and this results in the clinic room temperature rising above 25 C for a few days, this will not have an overall damaging effect on the medicines. However, if the temperatures above 25 C are recorded for any other reason or if high temperatures are continually recorded, the reason should be investigated immediately and the advice of the local pharmacy team sought. Refer to Sussex Partnership NHS Foundation Trust Medicines Code: section 36, for further guidance on Handling of Medicines Requiring Cold Storage. Version 2 - November 2017