Controlled Drugs Standard Operating Procedure (With the exception of St John s Hospice and DCIS Community Services)

Controlled Drugs Standard Operating Procedure (With the exception of St John s Hospice and DCIS Community Services) DOCUMENT CONTROL: Version: 4 Ratified by: Quality and Safety Sub-Committee Date ratified: 30 January 2017 Name of originator/author: Senior Pharmacist on behalf of the Trust Medicines Management Committee Name of responsible Medicines Management Committee committee/individual: Date issued: 27 March 2017 Review date: January 2020 Target Audience All staff

1. Aim This Standard Operating Procedure (SOP) represents the practice for safe completion of ordering, prescribing, receiving, storing, administration and where necessary disposal of Controlled Drugs. 2. Scope The contents of this procedure apply to ALL clinical staff working in RDaSH (with the exception of St John s Hospice and DCIS Community Services) that in the course of their employment will prescribe, administer, or dispose of controlled drugs. The procedure is made up of a series of At a Glance documents covering various areas of managing Controlled Drugs which are pertinent to the inpatient and community mental health services and DCIS wards. Where a service s processes cannot conform to the Trust level guidance advice must be sought from the Trust pharmacy department. This SOP covers Schedules 1 and 2 controlled drugs: o additionally the schedule 3 controlled drugs Temazepam, Tramadol and Midazolam are to be treated as a schedule 2 Controlled Drug Schedule 3 Controlled Drugs such as Barbiturates. Strong Potassium Chloride Solution BP 15% Therefore each of these is subject to Trust regulations regarding ordering, storage, administration, recording and destruction of controlled drugs. While the legal requirements for all Schedule 3 Controlled Drugs do not require secure storage or recording in a CD register, current RDASH practice for inpatient settings for schedule 3 Controlled Drugs is that they are secured in a CD cupboard and their use is recorded in the CD register. In named localities storage, administration, recording and destruction of midazolam may be different and they will follow their own locality agreed SOP (e.g. Heatherwood school). This is done with the agreement of the CD Accountable Officer. 3. Link to overarching policy and/or procedure This SOP links to Safe and Secure Handling of Medicines Policy Page 2 of 34

4. Procedure 4.1 General Controlled drugs are legally defined by the Misuse of Drugs Act 1971 as drugs which are dangerous or otherwise harmful and have the potential for abuse or misuse. Due to the nature of these drugs their use is regulated through legislation such as the Misuse of Drugs Regulations 2001 (with associated amendments) and this legislation dictates how they are to be prescribed, ordered and stored. In addition to these legal requirements, the Trust also requires certain additional safeguards to be in place which are not specified by law, and Trust employees are expected to adhere to these requirements as set out in these procedures in addition to their legally defined responsibilities. The practical guidance proved by this SOP is contained within a series of At a Glance documents which form the attachments to this SOP. At the time of communication (Version 1) there are seven documents 01 - Ordering Controlled Drugs 02 - Prescribing Controlled Drugs 03 - Receiving and Storing Controlled Drugs 04 - Record Keeping Controlled Drugs 05 - Reconciliation of Controlled Drugs 06 - Administering and transferring Controlled Drugs 07 - Returning and destroying Controlled Drugs and Unknown Substances Additional documents may be produced as services develop, regulations change or to reflect changes in the Safe and Secure Handling of Medicines Policy. Each document consists of guidance and a sign off form. o The guidance section is drawn up into three columns The left hand column identifies various tasks within the relevant Controlled Drugs domain The middle column details the minimum expected steps to be taken when carrying out that aspect. It is this column which has been approved through the Medicines Management Committee and Quality and Safety Sub-committee. This column is not available for teams to amend. The right hand column allows wards/teams to make points of clarification or additional requirements so that the resultant document bespokely describes the processes in place in their team. Staff identified to be able to carry out particular tasks may be named individually or by role or staff group (i.e. qualified nursing staff etc) Where a service s processes cannot conform to the Trust level guidance advice must be sought from the Trust pharmacy department. Page 3 of 34

o The sign off form is for individual staff members to indicate that they have read and understood the document and indicates their intention to comply with the Trust and team processes as they apply to managing Controlled Drugs All staff working in the team who handle medicines must sign off against those documents relevant to their role. This SOP should o Form part of the new staff member s induction into the service o Form part of a competency assessment following a medicines error 4.2 Service/team managers It is the service/team manager s responsibility to: review and ensure that the At a Glance documents forming this SOP have been amended as described above to detail the services processes around medicines ensure all staff members who are handle medicines within their service have signed AT a Glance documents which are relevant to their role maintain the SOP to be accurate for the processes in place in the service. Where a process may have changed within the service o the existing At a Glance document(s) should be archived (with signatures) o a new At a Glance document amended to detail the revised process and circulated to staff for information and signoff ensure adequate stocks of order pads, drug cards and other relevant paperwork are available to support continuous adherence to these SOPs processes are in place to ensure secure storage of medicines and appropriate monitoring of that storage (i.e. fridge and room temperatures, CD registers etc) ensure staff have received and are up to date with medicines training as mandated by the Trust identify where services do not comply with the Trust standards and either rectify the process or contact the Trust pharmacy department for support 4.3 Staff members It is the responsibility of Trust staff to Read and sign-off against all At a Glance documents, as part of this SOP, which are relevant to their role Comply with the guidance as detailed within this SOP Exhibit professional judgement to identify those exceptional instances where a departure from this guidance is required to ensure a patient s Page 4 of 34

safety. Where such an action has been taken, staff must annotate in the patient record the rationale for the departure and the action taken. It must be reported to the service/team manager. 4.4 Responsibilities, Accountabilities and Duties 4.4.1 Accountable Officer The Accountable Officer for the Trust is the Chief Pharmacist who is responsible for all aspects of the safe and secure handling of CDs within the Trust. This includes: Having safe systems in place for the management and use of CDs. Monitoring and auditing the management systems which are in place for controlled drugs. The Chief Pharmacist may instigate actions/investigations in the event of suspected misuse of any drug. These actions may be instigated Trust wide or limited to defined areas as specified by the Chief Pharmacist/Accountable Officer. In the event of suspicion of misuse of CD medications covered in schedules 3 to 5 (e.g. Benzodiazepines) instigating special recording and storage procedures for specific drugs. 4.4.2 Appointed practitioner (AP) in charge of a ward or team The appointed practitioner in charge of a ward, unit or team is responsible for: The safe and appropriate management of CDs in that area. The assigned practitioner in charge can delegate control of access (i.e. key holding) to the CD cupboard to another authorised professional, such as a designated practitioner, however legal responsibility remains with the appointed practitioner in charge. A task may be delegated but the responsibility may not. Any staff working under their direction being aware of these standard operating procedures and any amendments made by the Trust. Providing the dispensing pharmacy and Trust pharmacy department with a copy of all authorised signatures for the ward or unit and keeping the list up to date when staff leave or join the team. 4.4.3 Authorised Prescribers Authorised Prescribers are responsible for: Prescribing controlled drugs appropriately, responsibly and legally. Correcting any problems with CD prescriptions that prevent legal supply occurring. Page 5 of 34

4.4.4 All other Clinical Staff Any member of staff who has concerns over possible misuse of medications on their ward should speak in the first place to the Ward or Unit Manager or in their absence contact the Accountable Officer 4.4.5 Counter-signatory (CS) The following staff groups may be counter-signatory: - Registered nurses - Doctors - Pharmacists - Pharmacy Technicians (directly employed by the Trust) - Appropriately trained healthcare professional - Student nurses under supervision by a someone other than the first signatory - Nurse assistant, Healthcare assistant or Clinical Support Worker* The above members of healthcare staff are permitted to witness specific tasks that they are competent with and sign to confirm that the task has been performed accurately and correctly. For the purposes of witnessing Controlled Drug tasks the scope of the tasks are: Receipt of controlled drugs As a second person check of the correct administration of the controlled drug (i.e. right patient, right drug, right dose and dose form) and ensure an accurate entry is made in the register with regard to drug, dose, dose form, quantity and resultant balance Stock balance checks Destruction of controlled drugs Signing out Controlled Drugs of the CD register at the point of the discharge *Nurse assistant, Healthcare assistant or Clinical Support Worker can be only a counter-signatory on the receipt, administration and balance checks of Controlled Drugs (they will check the accuracy of the CDs received, administered and reconciled, but are not responsible for checking the appropriateness of CD prescriptions). Please refer to appendix B. 4.4.6 Controlled Drug Stationary Controlled Drug Requisition Book This is a requisition book containing preprinted pages, each suitable for the ordering of a single controlled drug preparation and the generation of a carbon copy. Page 6 of 34

The CD requisition books are available from the Regional Distribution Centre (RDC) and must be ordered using the code WOP100. Controlled Drug Register Each ward, unit or team that holds stocks of CDs or holds CDs on behalf of service users must keep a record of all CDs received, d i s p o s e d, administered or supplied to service users in an appropriate CD register. This is a bound register suitable for the recording of all controlled drug transactions for a specific ward, unit or team. Within the Trust the only approved form of register is that printed by HMSO (Her Majesty s Stationery Office) for the purpose. The CD Registers are available from the Regional Distribution Centre (RDC) and must be ordered using the code WOP105. The appointed practitioner in charge of the ward, unit or team is responsible for keeping the CD register up to date and in good order and must ensure it is kept locked securely in a cabinet, cupboard or draw between episodes of recording. All receipt, destruction, administration or supply of CDs by the ward, unit or team must be recorded in the CD register. All removal of CDs from the ward, by any means, must be recorded in the CD register. Community Nursing Service Controlled Drug Record This is the Controlled Drug Stationary that Community Staff in DCIS Business Divisions use. FP10 This is a NHS prescription form that can be dispensed by a registered community pharmacy. Those used by General Practitioners and Secondary Care are termed FP10. Those used by specialist drug misuse centers in secondary care are FP10MDA- SS. Drug card This is a drug prescription and administration record that must be used in the inpatient settings to record the administration of medication. 5.0 Review and Version Control The At a Glance documents that form the basis of this SOP will be formally reviewed every two years. Interim updates will be produced to reflect changes to the Safe and Secure Handling of Medicines Policy and will be evident through version numbers. The pharmacy department have responsibility for: Page 7 of 34

the formal reviews and generation of new versions resulting from changes to the content of the At a Glance documents (with the exception of the right hand column, which will remain the responsibility of the service/team manager). Dissemination to teams and intranet availability of the most current version of the SOP. Page 8 of 34

SOP 1 AT A GLANCE 1.0 ORDERING (REQUISITIONING) CONTROLLED DRUGS ON INPATIENT (EXCEPT ST. JOHN S HOSPICE) AND COMMUNITY SERVICES (EXCEPT DCIS COMMUNITY SERVICES) [v1.0] ROLE TRUST WIDE [WARD, TEAM NAME] WARD, TEAM SPECIFIC 1,2 REQUISITION of CDs INPATIENTS (non - Hospice) LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 All controlled drugs are to be ordered in one of two ways STOCK (unlabelled supply) to be ordered on a Ward CD Order Book (WOP100). The following MUST be completed: o Name of the hospital or site o Ward, unit or team o Full drug name, strength and quantity details. Quantity MUST be in words and figures for Stock Use. o Signed and dated by a doctor (F2 or above) who MUST also print their name next to the signature o Completed requisition book must be sent to Lloyds Pharmacy in a sealed tamper proof pouch which will be placed inside the blue collection box (in Grimsby, CD order book is delivered to Lloyds Pharmacy) TTO (or labelled supply) to be ordered on the TTO pad (WZT 697). The following MUST be completed o Patient name, address and unit number o Full drug name, strength and quantity details o Quantity MUST be in words and figures o Signed and dated by a prescriber The original TTO form must be sent in the box to Lloyds Pharmacy for dispensing. Last Reviewed: [enter date] Ward CD Order Book (WOP100) is controlled stationary and kept locked separate to the CD cupboard. On the ward the CD Order Book is kept in Drug Cupboard. Staff identifying that CD s need ordering should bring it to the attention of Shift Senior Qualified. Ward CD Order book (WOP100) are ordered via NHS Supplies TTO forms (WZT697) MUST be kept securely on the ward and are INSERT LOCATION Local pharmacy provider for this ward is INSERT LOCATION Only authorised Trust prescribers can sign TTO forms. TTO pads (WZT 697) are ordered via Print Services. REQUISITION of CDs COMMUNITY MENTAL HEALTH SERVICES All controlled drugs should be supplied as labelled medication and are to be ordered on the Trust TTO pad (WZT 697) o Patient name, address and unit number o Full drug name, strength and quantity details o Quantity in words and figures o Signed and dated by a prescriber The original TTO form must be sent in the box to Lloyds Pharmacy for dispensing. Staff identifying that CD s need ordering should bring it to the attention of the shift senior qualified staff. TTO forms (WZT697) MUST be kept securely on the team and are INSERT LOCATION Local pharmacy provider for this team is INSERT LOCATION Staff authorised to complete Trust TTO forms are (xxxxxx) TTO pads (WZT 697) are ordered via Print Services. 1. Ward/team managers should update this column with Ward/team name and last review date complete the suggested specific details of the SOP for the team/ward add any further details of clarification to support a member of staff carrying out this particular aspect of managing medicines. 2. Where a task is carried out within the ward/team which is either not covered by the SOP or cannot conform to the guidance within the middle column then the Trust pharmacy department should be contacted for guidance Page 9 of 34

AT A GLANCE ORDERING CONTROLLED DRUGS ON INPATIENTS AND COMMUNITY SERVICES [v1.0] Staff members should sign below to indicate that they have read and understand the process required to order Controlled Drugs for this ward/team STAFF MEMBER S NAME STAFF MEMBER S SIGNATURE DATE Page 10 of 34

SOP 2 AT A GLANCE 2.0 PRESCRIBING CONTROLLED DRUGS ON INPATIENT (EXCEPT ST. JOHN S HOSPICE) AND COMMUNITY SERVICES (EXCEPT DCIS COMMUNITY SERVICES) [v1.0] ROLE TRUST WIDE [WARD, TEAM NAME] WARD, TEAM SPECIFIC 1,2 INPATIENT (non - Hospice) PRESCRIBING of CDs onto drug card LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 CDs can be prescribed on the inpatient medication chart in line with relevant Trust policies and guidelines. The prescriber must check they have the correct drug card and then taking in to account other prescribed medication fill in the relevant sections stating: o Drug o Dose form o Strength where appropriate (e.g. Morphine sulphate 2mg/ml) o Dose o Route o Start Date o Frequency of dosing o Stop date if appropriate o If PRN indication and maximum frequency/total daily dose. o Signature of the prescriber Last Reviewed: [enter date] Medication chart in use on the ward is form INSERT FORM CODE. Drug cards are kept in the files in the INSERT LOCATION. Additional Drug cards are order from the print room. CDs can be prescribed on the inpatient medication chart by (xxxxx) INPATIENT (non - Hospice) PRESCRIBING CDs for leave or discharge Prescriptions for CDs for patients who are going home must be completed on the appropriate Trust prescription paperwork. These prescriptions must be on INTERNAL RDASH Discharge/Leave prescriptions for dispensing at the SLA pharmacy 1. Select the appropriate Trust documentation. 2. The prescriptions MUST conform to all requirements of the Misuse of Drugs Regulations for a CD prescription and MUST include: Patient name, address and where appropriate, age The name and form of the drug The strength of the preparation required where appropriate (if multiple strengths are available). For example MST 110mg should be prescribed as 60mg, 30mg and 20mg tablets. The dose to be taken of each preparation. The frequency or equivalent directions for as required doses. It is not appropriate to use the direction as directed. The total quantity of the preparation, or the number of dose units, to be supplied in both WORDS and FIGURES. If a medication is to be supplied in daily or single dose packs this should be clearly written on the prescription. E.g. Seven by 1 day rather than 7 day s supply. Similarly if for a liquid preparation for example methadone then 30ml thirty mls in single daily supplies for 3 days not 90mls. The TOTAL quantity to be supplied is still required in words and figures. Signed and dated by a prescriber with appropriate registration. 3. Quantities of up to a maximum of 28 days leave or discharge supply must be prescribed as a matter of good INTERNAL RDASH Discharge/Leave prescriptions (for dispensing at the SLA pharmacy) on the ward is form INSERT FORM CODE. These prescriptions MUST be kept securely on the ward and are INSERT LOCATION Additional prescriptions are ordered from print room. INTERNAL RDASH prescriptions can also be written by xxxxxx. Page 11 of 34

ROLE TRUST WIDE [WARD, TEAM NAME] WARD, TEAM SPECIFIC 1,2 LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 practice within the Trust. Where the prescriber believes that it is the clinical interest of the service user to prescribe less than 28 days then this should be done, but primary care should be informed, along with the appropriate reasons. 4. The information must be in indelible ink. SAMPLE CONTROLLED DRUGS PRESCRIPTION John Smith NHS number 123 456 1234 DOB 30/05/62 Address 123 High Street Any town South Yorkshire S602UD Please supply Methadone 1mg in 1ml Solution 30ml each morning 3 x 30mL bottles required 90 (ninety) ml of 1mg in 1ml solution James Coburn 457657 Dr James Coburn 01/08/08 Last Reviewed: [enter date] OUTPATIENT and COMMUNITY PRESCRIBING of CDs 1. Prescriptions for CDs for outpatients must be written in accordance with the requirements of the Misuse of Drugs Regulations. The prescription document can either be a Trust outpatient prescription form (for dispensing by the SLA pharmacy) or a FP10 (for dispensing by a community pharmacy). 2. See section 2 above for prescription writing details and example. 3. National guidance: CD prescriptions should not exceed 30 days supply. Longer supply periods may be used in exceptional circumstances however the reason for this should be annotated in the patient notes. Trust outpatient prescription form (for dispensing by the SLA pharmacy) or a hospital FP10 (for dispensing by a community pharmacy) in use on the team is form INSERT FORM CODE. Trust outpatient prescription form or a hospital FP10 MUST be kept securely on the ward and are INSERT LOCATION Additional Trust outpatient prescriptions are ordered from xxxxxx. Trust outpatient prescriptions can be written by xxxxxx. 1. Ward/team managers should update this column with Ward/team name and last review date complete the suggested specific details of the SOP for the team/ward add any further details of clarification to support a member of staff carrying out this particular aspect of managing medicines. 2. Where a task is carried out within the ward/team which is either not covered by the SOP or cannot conform to the guidance within the middle column then the Trust pharmacy department should be contacted for guidance Page 12 of 34

AT A GLANCE PRESCRIBING CONTROLLED DRUGS ON INPATIENTS AND COMMUNITY SERVICES [v1.0] Staff members should sign below to indicate that they have read and understand the process required to prescribe Controlled Drugs for this ward/team STAFF MEMBER S NAME STAFF MEMBER S SIGNATURE DATE Page 13 of 34

SOP 3 AT A GLANCE 3.0 RECEIVING AND STORING OF CONTROLLED DRUGS ON INPATIENTS (EXCEPT ST. JOHN S HOSPICE) AND COMMUNITY SERVICES (EXCEPT DCIS COMMUNITY SERVICES) Including WARD CLOSURE and CD KEY MANAGEMENT [v1.0] ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 RECEIVING CDs INPATIENT (non - Hospice) LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] 1. RDASH REQUISITIONED CDs Staff authorised to sign the All CD items will be delivered in either a sealed box delivery note are (xxxxxx) or satchel. There should be a tamper evident Staff authorised to receive and closure. This will be separate to other stock. record CDs are (xxxxxx) The delivery note MUST be signed and given to the Ward CD Register book driver as proof of delivery for the pharmacy. (WOP105) are ordered via NHS The order is to be opened, with the contents Supplies checked and stored immediately in the CD Staff authorised to act as cupboard. witness for the CD register are At no time following delivery is the order of (xxxxxx) controlled drugs to be left unattended 1a. STOCK CDs (unlabelled supply) o Stock MUST be checked against the CD requisition book and the delivery note. o As a matter of good practice, the person receiving the controlled drugs should not be the same person who ordered them unless this is unavoidable. o Receipt of the CDs MUST be entered into the CD register (see SOP4 Record Keeping below) o Stock should be stored in the CD cupboard ensuring all stock is rotated such that stock with the shortest expiry date is available for first use. 1b. PATIENT DISPENSED (leave/discharge) o Each such CD received must be checked, against the prescription o Receipt of the CDs MUST be entered into the CD register (see SOP4 Record Keeping below) o Individually labelled CDs MUST be clearly separated from stock in the CD cupboard 2. PATIENT S OWN MEDICINES (POM) This applies to CDs brought in by the patient Each such CD received must be checked for accuracy of drug, strength, form and quantity Receipt of the CDs MUST be entered into the CD register (see SOP4 Record Keeping below) Patient s own CD s MUST be clearly separated from stock in the CD cupboard 3. DISCREPANCIES Any discrepancies should be reported Immediately to o the shift manager and o the supplying pharmacy if not rectified to the Trust CD Accountable Officer (via the pharmacy department). Appropriate records must be made in the CD register and all necessary action taken to resolve the discrepancy. Page 14 of 34

ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 STORAGE of CDs and CD stationary INPATIENTS (non - Hospice) RECEIVING patient s own controlled drugs - COMMUNITY MENTAL HEALTH SERVICES STORAGE of CDs and CD stationary COMMUNITY MENTAL HEALTH SERVICES WARD AND SERVICE CLOSURES LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] CD stationary must be stored by the ward in a locked cabinet, cupboard or drawer. It must not be kept in CD cupboard. CD cupboards MUST be reserved solely for the storage of Controlled Drugs and be secured to a wall. CD cupboards used by wards must conform to the British Standard reference BS2881 or be otherwise approved by the Chief Pharmacist. CDs (stock, patients dispensed and patient s own drugs) must be locked away not in use. Each such CD received must be checked for accuracy of drug, strength, form and quantity Receipt of the CDs MUST be entered into the CD register (see SOP 4 Record Keeping below) The storage of Patient s Own Drugs remains the services user s responsibility, except New Beginnings where storage is maintained on service user s behalf. See Storage of CDs and CD stationary inpatients above. 1. Temporary Closure (7 days or less): All CDs to remain locked in the CD cupboard. The security of the ward and its CD cupboard must be satisfactory to both the appointed practitioner in charge and to the Trust Chief Pharmacist. If there is any doubt about security then follow the guidance for long term closures. 2. Long term Closure (more than 7 days): All CDs recorded in the CD registers must be reconciled with the actual stock held (see SOP 5 Reconciliation of CDs below). All CDs must be returned to the SLA pharmacy dispensary. All CD registers and order books both current and archived should be sent securely to RDASH Pharmacy Department for storage. Team CD Register book (WOP105) are ordered via NHS Supplies Staff authorised to act as witness for the CD record are (xxxxxx) KEYS 1. Possession of Keys: CD cabinet keys must be kept in the possession of the appointed practitioner in charge (or deputy). 2. Missing Keys: If the keys go missing and cannot be found then urgent efforts must be made to retrieve them as quickly as possible. If the keys cannot be retrieved then Appointed Practitioner in Charge and Accountable Officer (Chief Pharmacist) on 01302 796262 must be informed as soon as possible. If the Accountable Staff authorised to keep the keys are (XXXXXX) Page 15 of 34

ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] Officer is unavailable contact RDASH pharmacy services for advice on 01302 798307/798308. The Accountable Officer will decide whether to call police. The loss of keys must not impede service user care. In such cases any necessary staff must be informed to arrange a supply of medication. A set of spare CD keys must be kept in a ward close-by. 1. Ward/team managers should update this column with Ward/team name and last review date complete the suggested specific details of the SOP for the team/ward add any further details of clarification to support a member of staff carrying out this particular aspect of managing medicines. 2. Where a task is carried out within the ward/team which is either not covered by the SOP or cannot conform to the guidance within the middle column then the Trust pharmacy department should be contacted for guidance Page 16 of 34

AT A GLANCE RECEIVING AND STORING OF CONTROLLED DRUGS ON INPATIENTS AND COMMUNITY SERVICES Including WARD CLOSURE and CD KEY MANAGEMENT [v1.0] Staff members should sign below to indicate that they have read and understand the process required to receive and store Controlled Drugs Including WARD CLOSURE and CD KEY MANAGEMENT for this ward/team STAFF MEMBER S NAME STAFF MEMBER S SIGNATURE DATE Page 17 of 34

SOP 4 AT A GLANCE 4.0 RECORD KEEPING CONTROLLED DRUGS ON INPATIENTS (EXCEPT ST. JOHN S HOSPICE) AND COMMUNITY SERVICES (EXCEPT DCIS COMMUNITY SERVICES) [v1.0] ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 RECORD KEEPING INPATIENTS (non - Hospice) LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] 1. RDASH REQUISITIONED CDs The index page at the front of the register must be kept up to date to allow staff to identify the appropriate page to use for a particular CD preparation. All entries are to be made in permanent black ink. Receipt, administration, reconciliation and destruction of CDs must involve TWO members of staff- a qualified member of staff and a Counter-signatory to ensure the total balance is correct. On reaching the end of such a page in the CD register, the balance must be transferred to a fresh page in the register. The new page number must be added the bottom of the finished page and the index updated. The transfer must be witnessed. When a stock balance reaches zero it must be recorded as nil in words and not as 0. All wards should have a record of signatures and initials of staff eligible to act as either a primary signatory or a counter signatory. This record should be kept with the CD register for audit purposes. 1a. STOCK CDs (unlabelled supply) Stock CDs MUST be recorded at the beginning of the CD register book 1b. PATIENT DISPENSED (Leave/Discharge) Patient dispensed (leave or discharge) MUST be recorded in the CD Register. Each preparation must be recorded on a page specific to both the preparation and the patient and should be stored in the CD cupboard. 2. PATIENT S OWN MEDICINES (POM) 2a. Wards who do NOT utilise POMs Each such CD MUST be registered at the back of the CD register book. Each such CD that is not suitable for use on the ward must not routinely be stored and arrangements must be made to either have them destroyed, as per the SOP, or for them to be returned to the patient if appropriate. 2b. Wards who do utilise POMs Each such CD MUST be registered at the back of the CD register book. Each preparation must be recorded on a page specific to both the preparation and the patient and should be stored in the CD cupboard. 3. RECORDING WHEN A PATIENT REFUSES ADMINISTRATION Page 18 of 34

ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] OF CDs The patient s drug card should be annotated to indicate that the dose was refused. The refused medicine must be stored in a separate container in the CD cupboard. An entry should be made in the register as per guidance (this will allow reconciliation against the remaining useable doses). An additional entry should be made in the back of the register for the refused dose detailing date, patient s name, drug name, strength, form and quantity and signature. The refused doses will be destroyed by pharmacy staff 4. RECORDING OF WASTED OR SPILLAGE OF CDs Any wasted and spillage of CDs must also be recorded in the CD register and witnessed. 5. CORRECTING ERRORS IN A CD REGISTER If an error is made when making an entry in the register the following procedure must be followed: o Do not cross out the entry. o Bracket the error in such a way that the original entry is still legible. o Explain immediately below the error. o Sign, date and witness in the same way as any other entry. o Correct the stock balance. o Complete an IR1 if required.- SAMPLE OF RECORDING CONTROLLED DRUGS IN CD REGISTER BOOK (Patient s Own Medicines registered at the back of the book) Name, Form of Preparation and Strength Amounts obtained Patient s Own Medicines Annie Smith Tramadol Hydrochloride 50mg tablets Amounts Administered Amoun t Ten tablets Date receive d 18.10.1 5 Serial No of Requisitio n Date Time Patient s name 18.10.1 5 19.10.1 5 19.10.1 5 19.10.1 5 20.10.1 5 8:10a m 8:15a m 8:18a m 8:25a m 8:20a m Annie Smith (Maria Smith) S.Harris 19.10.15 Typing error wrong patient s details Annie Smith Annie Smith refused one dose of tramadol. Amoun t Given Given by (Signature) Witnesse d by (signatur e) Stock Balanc e 50mg A.Daw C.Harrios 9 n S.Harris A.Daw 9 S.Harris A.Daw 9 50mg S.Harris A.Daw 8 M. Smith S. Morrison 7 Page 19 of 34

ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] One tablet kept in a sealed envelope, signed and dated. Ready in the CD locked cupboard for RECORD KEEPING COMMUNI TY MENTAL HEALTH SERVICES destruction 21.10.1 5 8:30a m Annie Smith 50mg 22.10.1 9:00a Destroyed 5 m by Pharmacy - one tablet from a sealed envelope and 6 tablets Patient s Own. Tramadol has been discontinue d Staff must record the receipt, administration, destruction and maintain a running balance of stock as part of the Medicines administration record using the Community Nursing Service Controlled Drug Record. A separate sheet must be used for each drug s preparation. All entries must be signed by a designated practitioner and witnessed by a second member of staff. C.Robertso L.Reynold 6 n s J.Fox S. Harris NIL 1. Ward/team managers should update this column with Ward/team name and last review date complete the suggested specific details of the SOP for the team/ward add any further details of clarification to support a member of staff carrying out this particular aspect of managing medicines. 2. Where a task is carried out within the ward/team which is either not covered by the SOP or cannot conform to the guidance within the middle column then the Trust pharmacy department should be contacted for guidance Page 20 of 34

AT A GLANCE RECORD KEEPING CONTROLLED DRUGS ON INPATIENTS AND COMMUNITY SERVICES [v1.0] Staff members should sign below to indicate that they have read and understand the process required to record keeping Controlled Drugs for this ward/team STAFF MEMBER S NAME STAFF MEMBER S SIGNATURE DATE Page 21 of 34

SOP 5 AT A GLANCE 5.0. RECONCILIATION OF CONTROLLED DRUGS ON INPATIENTS (EXCEPT ST. JOHN S HOSPICE) AND COMMUNITY SERVICES (EXCEPT DCIS COMMUNITY SERVICES) [v1.0] ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 RECONCILIATION of CDs INPATIENT (non - Hospice) LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] 1 RDASH REQUISITIONED CDs (STOCK CDs, PATIENT DISPENSED (leave/discharge) AND PATIENT S OWN DRUGS These CDs MUST be reconciled against the CD register at least once a week, unless in active use, in which case they are to be checked after each administration. Reconciliation must involve TWO members of staff: 1. The AP along with a CS should get the CD register and take it to the CD cupboard. 2. They must then open the CD register and check the index and ascertain which drugs have a positive stock balance. 3. The two staff must then check the physical stock against the registry entries, however: o It is not necessary to open packs with tamper evident seals. o Stock balances of liquid medicines can be checked by visual inspection against the estimated balance in the register. A variation of less than 3% will be accepted as normal. o The balance must be confirmed to be correct upon completion of a bottle. 4. Unopened bottles should be presumed to contain the indicated quantity. Each time a bottle is opened or the expected quantity indicates opening a new bottle the volume should be formally reconciled. See examples below. 5. All such amendments must be countersigned in the Controlled Drug register by a Counter-Signatory. 6. If correct then an entry must be made that the stock levels have been checked and are correct, this must then be signed and dated by both the AP and the CS. 7. Any discrepancies must be reported to the line manager and an IR1 completed, which will be investigated by the unit or ward manager (or deputy) o If the reason for discrepancy cannot be identified and corrected (such as an arithmetic error in the running balance) then the Trust Accountable Officer must be informed. o If reconciliation reveals that a stocked CD is not being used then the reasons for keeping the CD must be reviewed by the AP. 8. Reconciliation will also be undertaken by pharmacy staff at least once every quarter by: o Checking a sample of CD requisition copies against the relevant entry in the CD register to monitor that that have entered correctly in the CD register. o o Checking the balance in the CD register book against current stock. Visual inspection of liquid balances, periodic Staff authorised to reconcile Controlled Drugs are (XXXXXX) Staff authorised to act as a witness for the CD register are (XXXXXX) Page 22 of 34

ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] volume checks and checks to confirm the o o o o o balance on completion of a bottle. Reviewing the security and quality of record keeping. Checking for exceptional use of CDs. Checking the physical security of CDs, CD stationery and key holding. Checking Patient s Own Drug CDs held on the ward. A report will be provided for the ward/unit/team manager. EXAMPLE OF LIQUIDS RECONCILIATION Example 1 o If CD register book indicates 490ml of methadone but available stock is actually a full bottle plus some remaining, measure the remaining and the new volume should be corrected as detailed below. o If average is greater than 3% then RDASH pharmacy department must be contacted. Example 2 o If CD register book indicates 510ml but a new bottle needs to be opened ward manager must be contacted and the register must be checked for any discrepancies. o Excess volume of stock liquids highlighted due to manufacturer s overage in the bottle must be reported to the RDASH pharmacy department who will amend the records on request. o A member of the pharmacy team will visit the ward or unit within one week to amend the records and will authorize a designated practitioner to amend the records and make an incident report. RECONCILIATION of CDs - COMMUNITY MENTAL HEALTH SERVICES Staff checking the balance shall sign against the stock level and have it countersigned by another member of staff. To ensure an accurate count and retain the integrity of full packs, all sealed packs are presumed to be completed until opened. Liquids may be checked visually. Sealed packs must not be opened as part of the checking process. When a sealed pack is initially opened it is checked to verify the drug, strength and quantity. This must be documented on the appropriate from. Any discrepancies must be reported to the line manager and an IR1 completed, which will be investigated by the team manager/coordinator or a delegated senior member of staff. o If the reason for discrepancy cannot be identified and corrected (such as an arithmetic error in the running balance) then the Trust Accountable Officer (Chief Pharmacist) must be informed and an incident reported on the Trust s incident reporting system. Staff authorised to reconcile Controlled Drugs are (XXXXXX) Staff authorised to act as a witness for the CD register are (XXXXXX) Page 23 of 34

1.Ward/team managers should update this column with Ward/team name and last review date complete the suggested specific details of the SOP for the team/ward add any further details of clarification to support a member of staff carrying out this particular aspect of managing medicines. 2.Where a task is carried out within the ward/team which is either not covered by the SOP or cannot conform to the guidance within the middle column then the Trust pharmacy department should be contacted for guidance Page 24 of 34

AT A GLANCE RECONCILIATION OF CONTROLLED DRUGS ON INPATIENTS AND COMMUNITY SERVICES [v1.0] Staff members should sign below to indicate that they have read and understand the process required to reconcile Controlled Drugs for this ward/team STAFF MEMBER S NAME STAFF MEMBER S SIGNATURE DATE Page 25 of 34

AT A GLANCE 6.0 ADMINISTRATION AND TRANSFER OF CONTROLLED DRUGS ON INPATIENTS 9EXCEPT ST. JOHN S HOSPICE) AND COMMUNITY SERVICES (DCIS COMMUNITY SERVICES) [v1.0] SOP 6 ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 ADMINISTRATION of CDs INPATIENTS (non - Hospice) LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: 1. RDASH REQUISITIONED CDs (STOCK CDs) AND Staff authorised to administer PATIENT S OWN DRUGS Controlled Drugs are (XXXXXX) Consult the patients prescription chart, and ascertain the following: a) Name and form of the drug b) Dose c) Date and time of administration d) Route and method of administration e) Diluents as appropriate f) Validity of prescription g) Signature of prescriber Select the correct drug from the CD cupboard. Check the stock against the last entry in the CD register book, a second person is required to check the stock level and both members of staff are required to sign the CD register book. Check the appropriate dose against the prescription chart. When using liquid medications use an oral syringe to measure the appropriate dose. Return the remaining stock to the cupboard and lock the CD cupboard. Enter the date, time dose, the patient's name in the CD record book and sign the register along with the counter-signatory. Take the prepared dose to the patient, whose identity is to be checked. Administer the drug after checking the prescription chart again. Once the drug has been administered, the prescription chart is signed by the nurse responsible for administering the medication. Record the administration on appropriate charts. The purpose of the second person is as a check of the correct administration of the drug (i.e. right patient, right drug, right dose, right route and dose, and form), and that the appropriate paperwork is completed. Where the second person is a qualified professional they should also review the clinical appropriateness of the dose (this will exclude i.e. nurse assistants and pharmacy technicians) It is the administering nurse s responsibility to observe the service user taking any oral medication. SUPPLYING CDs to patients in the COMMUNITY MENTAL HEALTH SERVICES This includes the following: o Leave medication o Discharge medication o Outpatient medication o Patient s Own Drugs being returned. Staff must only supply medication in original Staff authorise to supply Controlled Drugs are (xxxxxx) Page 26 of 34

ROLE TRUST WIDE [WARD, TEAM NAME] WARD TEAM SPECIFIC 1,2 LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: dispensing containers. It must not be transferred to alternative containers such as compliance aids. The appointed practitioner in charge of the team remains responsible for ensuring that CDs are given to the correct patient or an appropriate adult representative. The task of supplying the CD may be delegated to an authorised nurse. Controlled Drugs may be collected by the following: o Patient o Patient s Representative known to and approved by staff and service user o Member of Staff TRANSFER of CDs between clinical areas No medicines are to be transferred from a ward or department within normal pharmacy opening hours, and even outside of these hours Controlled Drugs may only be used from another area in an extreme emergency. In the event that such an emergency arises the following process MUST be followed: o A nurse from the patient s clinical area must visit the issuing ward with the patient s prescription chart. o A record must be made in the CD register of the issuing ward with the Controlled Drug being booked out directly to the patient on the receiving ward. o A nurse from the issuing ward will then witness the administration of the drug to the patient. 1. Ward/team managers should update this column with Ward/team name and last review date complete the suggested specific details of the SOP for the team/ward add any further details of clarification to support a member of staff carrying out this particular aspect of managing medicines. 2. Where a task is carried out within the ward/team which is either not covered by the SOP or cannot conform to the guidance within the middle column then the Trust pharmacy department should be contacted for guidance Page 27 of 34

AT A GLANCE ADMINISTRATION AND TRANSFER OF CONTROLLED DRUGS ON INPATIENTS AND COMMUNITY SERVICES [v1.0] Staff members should sign below to indicate that they have read and understand the process required to administer and transfer of Controlled Drugs for this ward/team STAFF MEMBER S NAME STAFF MEMBER S SIGNATURE DATE Page 28 of 34

SOP 7 AT A GLANCE 7.0 RETURN AND DESTRUCTION OF CONTROLLED DRUGS AND UNKNOWN SUBSTANCES ON INPATIENTS (EXCEPT ST. JOHN S HOSPICE) AND COMMUNITY SERVICES (EXCEPT DCIS COMMUNITY SERVICES) [v1.0] ROLE TRUST WIDE [TEAM NAME] TEAM SPECIFIC 1,2 RETURNING of CDs stock supply INPATIENTS (non - Hospice) LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] 1. RDASH REQUISITIONED (STOCK CDs (unlabelled Staff authorised to dispose of supply) and PATIENT DISPENSED (Leave/discharge) medicines in the ward/team are CDs may not be returned to Lloyds Pharmacy. (xxxxxxxx) Only the authorized trained named personnel Staff authorise to witness the appointed by the Trust Accountable Officer can disposal of medicines are undertake the destruction of CDs in presence of a (xxxxxx) second staff member. All CDs will be destroyed on the ward or team using a proprietary denaturing kit (DOOP), which can be ordered from the SLA pharmacy. The trust Pharmacy Department will order and store these kits at the pharmacy base. The destruction of CDs should be done by mixing the drugs with a solution which destroys the medication in the presence of a second staff member. The resulting solution should be then disposed of, and authorized trained named personnel appointed by the Accountable Officer and a second person complete the CD register book, and sign to confirm disposal. A second sheet will also be completed and kept by the trust pharmacy services. 2. PATIENTS OWN MEDICINES (POM) At the point of discharge or prior to this the AP may ask if an appropriate adult/patient may take the controlled drugs home for storage (the appropriate adult must be approved by the service user and entry to this effect made in the patient s clinical records). The CD register should be accessed. The CDs to be returned should be identified. The AP should make an entry in the register stating the controlled drugs are being returned to the patient/appropriate adult. This should then be signed by the Counter-Signatory along with the signature of the patient/appropriate adult (if other service user details are visible these should be covered). The balance should then be recorded as nil in words and not as 0 in the register. An entry must then be made in the patient s clinical records. Pharmacy contact number 01302 798307/8308 REMOVAL AND DISPOSAL of patient s own CDs COMMUNITY MENTAL HEALTH SERVICES Ideally the patient s carer or patient should be encouraged to return CDs to the pharmacy that originally dispensed them. Disposal of controlled drugs within patients returns MUST be done by an authorised member of pharmacy staff and will require a second signatory The destruction will be performed as stated below Staff authorised to dispose of medicines are (xxxxxx) Staff authorise to witness the disposal of medicines are (xxxxxx) Page 29 of 34

ROLE TRUST WIDE [TEAM NAME] TEAM SPECIFIC 1,2 LAST REVIEW: 01/02/2017 Next Review: 01/02/2020 Last Reviewed: [enter date] and should be recorded and signed in the patient s notes; the record should contain the drug name, strength and quantity destroyed and the signature of any second person. RETURNING of CDs CARE HOMES REMOVAL AND DISPOSAL OF UNKNOWN SUBSTANCES - INPATIENTS All medications are to remain at the care home for 7 days. If the care home is a residential home, then the home makes arrangement for them to be collected by or taken to their pharmacy for destruction. If the care home is a nursing home, it is the responsibility of the home to destroy and dispose of them. Arrangements will need to be in place with pharmacy ASAP for Controlled Drugs to be destroyed. 1. Action if a visitor is in possession of an unknown substance If any visitors are seen to be in a possession of a suspected illicit substance they will be asked to leave the premises. The Nurse in Charge of the ward will then consult with the Modern Matron/Service Manager about the need to report the matter to the Police, and bar any further visits by the person concerned 2. Action if a patient is in possession of an unknown substance If a patient is suspected to have illicit substances on them the nurse in charge of the ward in the company of another member of staff will discuss their suspicions with them and ask that they voluntarily hand over the substance for destruction. Once handed over the illicit substance will be placed in an envelope which will be labelled with reference number linking it to the entry in the CD register. The envelope will be sealed, and both the nurse in charge and the witnessing staff will sign and date across the sealed flap of the envelope. The envelope will then be locked in the ward CD cupboard. An entry will be made in the CD register under the heading of unidentified substance. Trust Pharmacy is to be notified of the illicit substance ASAP and they will make arrangements for the removal and safe disposal of the substance. If the quantity of illicit substance is greater than for personal use, advice should be sought from the Service Matron/Manager as to the need for the matter to be reported to the police. All actions taken are to be recorded in the patient s clinical records or in the event of a visitor on the ward 24-hour report. An incident report will also be made on the Trust electronic reporting system. Staff authorised to dispose of medicines are (xxxxxx) Staff authorise to witness the disposal of medicines are (xxxxxx) Staff authorised to dispose of medicines are (xxxxxx) Staff authorise to witness the disposal of medicines are (xxxxxx) Page 30 of 34