Directorate: Medical Due for Review: June Ope Owoso, Medicines Optimisation Pharmacist. Table of Contents

Transcription

1 Provider Community Services v Title: Injectable Medicines Policy for Registered Professionals Ref No: Version 2.0 Directorate: Medical Due for Review: June 2017 Responsible for review: Ratified by: Applicability: Ope Owoso, Medicines Optimisation Pharmacist Care and Clinical Policies Sub Group All skilled staff involved in supporting people with medicines Table of Contents Introduction... 2 Purpose... 2 Scope of this Policy... 2 Duties... 2 Duties within the Organisation... 2 Consultation and Communication with Stakeholders... 3 Definitions... 3 Development... 3 Prioritisation of Work... 3 Responsibility for Document Development... 3 Body of Document... 3 Risk Assessment... 3 Roles and Responsibilities... 5 Persons Authorised to Administer an Injectable Medicine... 6 Registrant Checking... 6 Preparation of Injectable Medicines (see also SOP on page 38)... 7 Administration of Injectable Medicines (see also SOP on page 45)... 7 Education and Training... 8 Monitoring, Auditing, Reviewing & Evaluation... 8 References... 8 Appendices Appendix A : NPSA Risk Assessment Appendix B : Medicines Calculation Record Appendix C : Training Plan following the dissemination of the Trust Injectable Medicines Policy Appendix D : NPSA Competency 1 Prescribing Injectable Medicines Appendix D : NPSA Competency 2 Preparation of Injectable Medicines Appendix D : NPSA Competency 3 Administration of Injectable Medicines Appendix D : NPSA Competency 4 Monitoring the Administration of Injectable Medicines Supporting Standard Operating Procedures SOP : Prescribing of Injectable Medicines v SOP : Preparation of Injectable Medicines v SOP : Administration of Injectable Medicines v Version 2.0 June 2015 Page 1 of 48

2 Provider Community Services v Introduction This policy is a corporate framework that directs Torbay and Southern Devon Health and Care Trust (hereafter called the Trust) practice fulfilling statutory and organisational responsibilities, and is contractually and legally binding on all employees. Practitioners must work safely and accurately according to their professional scope of practice. 2. Purpose The aim of this policy is to reduce the risk associated with the administration of injectable medicines. The policy will provide Trust staff with a framework when prescribing, preparing and administering medication via an injectable route. The policy should be read in conjunction with supporting policies, guidelines and protocols. 3. Scope of this Policy This policy relates to all staff employed by the Trust who prescribe, prepare and administer medication via an injectable route. 4. Duties 4.1 Duties within the Organisation The Trust directors are accountable for the implementation of this policy across all clinical services where injectable medication is administered The Trust Information technology team will assist in the distribution of the policy and the ratified document is posted on the relevant Trust icare Individual line managers are responsible for informing staff to this policy and any associated policies, Standard Operating Procedures (SOPs), guidelines and protocols Staff prescribing, preparing and administering medication via an injectable route must ensure they have an up to date working knowledge of the medication to be prescribed, prepared and/or administered Staff working under this policy are responsible for identifying their training needs and attend required training and education sessions relating to this policy Staff are accountable for their practice and must work within this policy and professional codes. Version 2.0 June 2015 Page 2 of 48

3 Provider Community Services v Consultation and Communication with Stakeholders This policy has been adapted from the previous NHS Devon PCT Injectable Policy and Torbay Care Trust Medicines Policy and standard operating procedure, which has had wide consultation across both trusts Consultation included podiatry services, modern matrons, prescribing advisers midwifery services, infection control teams, specialist services, non-medical prescribing leads, community nursing teams, children s services, dental services, physiotherapy services and learning and development. 5. Definitions Injectable medications are defined as a sterile medicine, which is intended for administration by bolus injection, perfusion or infusion by any of the following routes: intravenous (IV); intramuscular (IM); intrathecal; epidural; subcutaneous (SC); intra-arterial; intradermal; intraventricular; intravesicular; intravitreal; intrapleural; intraocular and intralesional. The word patient used in this document refers to the individual that the medication may be administered to. 6. Development 6.1 Prioritisation of Work 6.1. This policy has been developed to in response to National Patient Safety Alert 20; Promoting safer use of injectable medicines. 6.2 Responsibility for Document Development The Medical Director, in conjunction with the Director of Professional Practice is responsible for the development of this policy The Care and Clinical Policy Sub Group will ratify this policy. 7. Body of Document 7.1 Risk Assessment An annual risk assessment will be carried out in areas where injectable medicines are prepared and administered. The National Patient Safety Agency (NPSA) Risk assessment tool for the preparation and administration of injectable medicines in clinical areas will be used for the assessment. See Appendix A Proforma 1, pages 13 and 14. Version 2.0 June 2015 Page 3 of 48

4 Provider Community Services v The risk assessment will be undertaken by the senior clinical practitioner with Medicines Optimisation team support where necessary from the area requiring assessment on an annual basis Individual injectable medicinal products used within the clinical area will be risk assessed when introduced and reviewed on an annual basis, using the NPSA Proforma 2. See Appendix A, proforma 2 page 15: Risk assessment of individual injectable medicine products prepared in clinical areas. In all instances please use the Injectable Medicines Guide (Medusa) website (see section 7.1.9) and consult the monographs. Each monograph has been pharmaceutically risk assessed, however further risk assessment to reflect the environment where administration may need to be considered. NB: risk assessments may differ for the same product if given in a different clinical environment or if the same product is administered by a variety of different routes e.g. SC, IM or IV consult monographs on Medusa For medicinal products identified through the Injectable Medicines Guide website: Green low risk - administer following the monographs and related policies, standing operating procedures Amber moderate risk - risk reduction methods should be taken as suggested in NPSA document and the risk reassessed e.g. follow a specific guideline and seek advice from the Medicines Optimisation Team. Risk minimisation measures need to be considered (see and 7.1.6) Red - high risk - do not administer seek advice from Medicines Optimisation Team. Risk minimisation measures need to be considered (see and 7.1.6) Risk should be documented by completing the NPSA Proforma 3. See Appendix A, Proforma 3 page 17: Risk assessment summary for high and moderate-risk injectable medicines products Following risk assessment, methods should be identified and introduced to minimise the associated risks as identified in Appendix A,page 16: Suggested risk reduction methods that can be used to minimise risks with injectable medicines A further risk assessment should be undertaken when the risk reduction measures have been implemented. This will be in line with steps and If the risk remains high refer back to the senior nurse on duty, prescriber, senior clinician or medicines Optimisation team for additional advice (see for risk grading) All strengths and dilutions of the following injectable medicines should be regarded as high risk (i.e. RED) on initial assessment. Risk reduction measures must then be taken to enable safe use. Cytotoxic medicines these must be provided in a ready to use form. Anaesthetics Version 2.0 June 2015 Page 4 of 48

5 Provider Community Services v 2.0 Cardioplegia solutions Chemotherapy Epidural injections and infusions Intra-ocular injections Intrathecal injections Further guidance is available on intrathecal chemotherapy in HSC 2008/001 Updated guidance on the safe administration of intrathecal chemotherapy Monographs to support injectable medicines policy preparation and administration may be obtained from the injectable medicine guide. The website is available on icare on the Medicine Management Optimisation Team page (password not required). For those medicines not listed please contact the Medicine Optimisation Team or on call pharmacist for advice during out of hours. The website is also available on icare on the Medicines Optimisation Team page (password not required) 7.2 Roles and Responsibilities The Prescriber is responsible for ensuring that the medicines are only administered by the injectable route when no other route is suitable. The decision will be based upon: The clinical condition of the patient. The available formulations of the specific medication required and the suitability of routes The prescriber, where appropriate, will prescribe within local and national formulary Non medical prescribers will prescribe in accordance with their prescribing status All injectable medications will be prescribed on Trust approved documentation It is the responsibility of the prescriber to ensure that the injectable route is reviewed regularly and changed to a less hazardous route at the earliest clinically appropriate opportunity The prescriber will operate in conjunction with the Standard Operating Procedure Prescribing of Injectable Medicines Staff responsible for the storage of injectable preparations will store them in accordance with the summary of product characteristics The prescriber will ensure the patient details are correct on the instruction to administer including the current allergy status of patient The prescriber will ensure the weight of the patient is recorded on documentation if the dose of the medication is related to weight. Version 2.0 June 2015 Page 5 of 48

6 Provider Community Services v Persons Authorised to Administer an Injectable Medicine Only practitioners who have and continue to demonstrate that they are competent to undertake injectable medicine preparation and administration may do so Practitioners administering injectable medicines must be able to demonstrate a working knowledge of the preparation being administered Practitioners administering injectable medicines must have available: A signed instruction to administer e.g. patient medication administration chart, patient specific direction, allergy status, treatment card, relating to the individual to whom the medication is to be administered. A Patient Group Direction or Patient Specific Direction which the practitioner has signed as competent to operate under. Be working within exemption rules under their professional code A second person is required to check medication given by the intravenous route and all injectable controlled drugs. The exception will be in the patient s home environment where a second person is not always available to check the medication. If a second person is available then they will be required to check the injectable controlled drug or the medicine being administered by the intravenous route Where a dose calculation is required the practitioner administering the injectable medication must undertake the calculation independently and record the result on Trust documentation (Appendix B Medicine Calculation Record) Where required a second person will undertake the calculation independently and record the results. If there is a discrepancy in the results the prescriber or a senior practitioner should be contacted for guidance and the outcome recorded prior to administration Staff administering an injectable medicine using medical devices i.e. a syringe driver must be competent to use the approved equipment. 7.4 Registrant checking In circumstances where a second registered practitioner is required to check the preparation it is their responsibility to check: The medicine is prescribed on the Trust approved prescription form. The correct medicine is selected. Expiry dates The calculation must be repeated independently and recorded. The medicine and dose are prepared for use correctly. Version 2.0 June 2015 Page 6 of 48

7 Provider Community Services v 2.0 The patient to whom the medication is to be administered is identified correctly using the prescription administration form/treatment card, identification bracelet (where appropriate). Consent is obtained by the person administering the injection. The selected route is correct. Allergy status of patient is established 7.5 Preparation of injectable medicines: Medicines to be given via the injectable route must be prepared in accordance with the manufacturers guidelines contained with the summary of product characteristics usually accompanied with the drug or at Staff must adhere to trust infection control guidelines and aseptic technique on the preparation of injectable medicines. For further details, please consult with the infection control team Staff must be aware of regulations relating to Control of Substances hazardous to health (COSHH) Staff must follow the Standard Operating Procedure Preparation of Injectable Medicines Staff working within day case units must follow the Standard Operating Procedure Prescribing, Preparing and Administering Injectable Medicines in Day Case Theatres. 7.6 Administration of Injectable Medicines Staff administering medicines via an injectable route must be authorised to undertake this procedure Staff must be able to demonstrate competencies in the administration of an injectable medication Staff will be aware of the medication being administered, including dose range, side effects, contra-indications, route and method of administration Staff must administer the injectable medication in accordance with the Standard Operating Procedure for Administration of Injectable Medicines Staff administering the injectable medicine must record the administration on approved Trust documentation Following administration: All equipment must be disposed of in accordance with infection control policy, waste management policy and manufacturers guidelines. The patient must be monitored for any adverse reaction. If this occurs, the following immediate action will be taken: Version 2.0 June 2015 Page 7 of 48

8 Provider Community Services v 2.0 Medical practitioner informed. Yellow Card to be completed reporting the adverse drug reaction. Document the event. Document the administration of medication. In the event of any incident, complete an incident reporting form. 7.7 Education and Training Competent team leaders will disseminate training to team members Staff should also identify any training needs on this topic as part of their Knowledge and Skills Framework (KSF) review, or sooner, if appropriate Staff prescribing, preparing and administering injectable medicines should be able to demonstrate the competencies required. Appendix C, page 19 (Training Plan following the dissemination of the Trust Injectable Medicines Policy). 8. Monitoring, Auditing, Reviewing & Evaluation The Medical Director and Director of Professional Practice in conjunction with the Head of Medicines Optimisation will put in place a programme to monitor compliance and effectiveness of this policy through the Medicines Governance Group and Care Quality & Safety Committee. The programme will include reviewing incidents reported through the incident reporting process, be part of the process relating to maintenance of medical devices identified in the medical devices policy and regular audits. 9. References - Torbay and Southern Devon Policy for the Administration of Medication using a McKinley T34 Syringe Pump Device - Torbay and Southern Devon Provider Community Services Medicines Policy for Registered Professionals Version 2 - Torbay and Southern Devon Waste Management Policy Version 1National Patient Safety Agency Patient Safety Alert 20 Promoting safer use of injectable medicines, March Department of Health 2008 HSC 2008/001 Updated national guidance on the safe administration of intrathecal chemotherapy - Injectable medicine guide ( [accessed on 14/04/2015] - NMC 2015, the Code professional Standard of practice and behaviour for nurses and midwives. Nursing and Midwifery Council, London - RCN 2013, Delegating record keeping and countersigning records. Royal College of Nursing, London Version 2.0 June 2015 Page 8 of 48

9 Provider Community Services v NMC 2006 Standards of Proficiency for Nurses and Midwife Prescribers. Nursing and Midwifery Council, London - NMC 2010, Standards for Medicines Management. Nursing and Midwifery Council, London - Mental Capacity Act Torbay and Southern Devon Consent Policy: Consent to examination, assessment, intervention, treatment and care Version 1 - Department of health 2007 Safer Management of Controlled Drugs: (1) Guidance on Strengthened Governance Arrangements - The Misuse of Drugs Act 1971 (Amendment) Order Torbay and Southern Devon and South Devon Healthcare The Control of Substances Hazardous To Health (COSHH) Version 1 - Torbay and Southern Devon Incident Reporting and Management Policy Including Serious Incidents Version 2Torbay and Southern Devon Infection Control Operating Policy Version 3- Torbay and Southern Devon Medical Devices Management Policy Version 2 - Torbay and Southern Devon and South Devon Healthcare Aseptic Techniques Version 3 Amendment History Issue Status Date Reason for Change Authorised v 0.1 Draft Amalgamation of Trust Policies Paul Humphriss V 1.0 Ratified Paul Humphriss V 1.1 Draft April 2015 Two year review Ope Owoso V 2.0 Ratified June 2015 Two year review Lynda Price Version 2.0 June 2015 Page 9 of 48

10 APPENDIX A Risk assessment tool for the preparation and administration of injectable medicines in clinical areas The risk assessment process 1. Carry out a risk assessment in all clinical areas where injectable medicines are prepared and administered 2. A pharmacist and a senior clinical practitioner from the area being assessed should carry out the risk assessment 3. Risk assessments should be conducted annually, and when new injectable products or practices are introduced 4. Risk assess local practice, i.e. how injectable medicines are prepared and administered (see proforma 1) 5. Risk assess individual injectable medicine products used in the clinical area (see proforma 2) there are examples to assist with this 6. A summary of products with high and moderate risk assessments should be completed (see proforma 3) 7. Identify risk reduction methods to minimise these risks (see guidance) 8. Where possible, implement appropriate risk reduction methods 9. Re-assess high and moderate-risk practices and products, and record the new scores following the introduction of risk reduction methods (see proformas 1 and 3) 10. Identify any remaining high-risk products and practices for consideration by the Drugs and Therapeutics Committee (or equivalent) and, if these risks cannot be minimised, they should recorded in the organisation s risk register Version 2 April 2015 Page 10 of 48

11 Proforma 1: Risk assessment of injectable medicine procedures how medicines are prepared and administered Clinical area: Clinical directorate: Hospital site: Date of first assessment: Date of second assessment: High-risk practice Tick when high-risk practice is found Suggested risk reduction method Comments/revised score Tick if high-risk practice remains unchanged 1 Inadequate technical information or written procedures for preparing and administering injectable medicines Provide essential technical information and written procedures 2 Use of unlabelled bolus syringes (including flushes) and infusions see guidance in multidisciplinary standard Reinforce and audit policy to ensure all syringes and infusions containing injectable medicines that leave the hands of practitioners during use are labelled 3 Use of open systems. Is the injection or infusion transferred into an open container? Introduce closed systems 4 Preparation of a cytotoxic drug outside of the pharmacy department Prepare all cytotoxic drugs in the pharmacy department or use closed system products designed for use in clinical areas Version 2 April 2015 Page 11 of 48

12 5 Preparation of, or addition to, total parenteral nutrition (TPN) outside of the pharmacy department Prepare and make all additions to TPN in the pharmacy department or use closed system products designed for use in clinical areas High-risk practice Tick when high risk-practice is found Suggested risk reduction method Comments/revised score Tick if high-risk practice remains unchanged 6 Administration of an injectable medicine, prepared more than 24 hours previously in the clinical area Introduce procedures to ensure that all injectable medicine products prepared in clinical areas have expiry dates of 24 hours or less to minimise the risk of microbial contamination unless specifically permitted by a written organisationally approved protocol 7 Admixture of two or more active medicines without information from the pharmacy service concerning compatibility of the medicines Obtain compatibility information or administer as separate infusions 8 Failure to use infusion pump or syringe driver for injectable medicines that require their rate of infusion to be controlled Ensure that adequate numbers and types of infusion pumps and syringe drivers are available for use, and users have knowledge and training of when and how this equipment should be used 9 Use of an injectable medicine ampoule, vial or infusion to prepare more than a single dose (unless the product is specifically licensed for use in this way) Reinforce and audit policy to ensure that single-use products are only used to prepare a single dose (unless specifically permitted by an organisationally approved protocol) 10 Unauthorised use of unlicensed medicines or off-label use of licensed medicines (unless specifically permitted by a written organisationally approved protocol or BNF-C) Reinforce and audit policy on the use of unlicensed or offlabel injectable medicines. Ensure approved protocols are used, include BNF-C recognised off-label usage Version 2 April 2015 Page 12 of 48

13 Total number of high-risk practices identified in baseline assessment Total number of high-risk practices remaining after risk reduction initiatives Proforma 2: Risk assessment of individual injectable medicine products prepared in clinical areas Clinical area: Directorate: Hospital site: Date: Name and strength of prepared injectable product Diluent Final volume Bag or syringe Risk factors Description 1 Therapeutic risk Where there is a significant risk of patient harm if the injectable medicine is not used as intended. 2 Use of a concentrate Where further dilution (after reconstitution) is required before use, i.e. slow iv bolus not appropriate. 3 Complex calculation Any calculation with more than one step required for preparation and/or administration, e.g. microgram/kg/hour, dose unit conversion such as mg to mmol or % to mg. 4 Complex method More than five non-touch manipulations involved or others including syringe-to-syringe transfer, preparation of a burette, use of a filter. 5 Reconstitution of powder in a vial Where a dry powder has to be reconstituted with a liquid. 6 Use of a part vial or ampoule, or use of more than one vial or ampoule Examples: 5ml required from a 10ml vial or four x 5ml ampoules required for a single dose. 7 Use of a pump or syringe driver All pumps and syringe drivers require some element of calculation and therefore have potential for error and should be included in the risk factors. However it is important to note that this potential risk is considered less significant than the risks associated with not using a pump when indicated. 8 Use of non-standard giving set/device required Examples: light protected, low adsorption, in-line filter or air inlet. Version 2 April 2015 Page 13 of 48

14 Total number of product risk factors Six or more risk factors = high-risk product (Red). Risk reduction strategies are required to minimise these risks. Three to five risk factors = moderate-risk product (Amber). Risk reduction strategies are recommended. One or two risk factors = lower-risk product (Green). Risk reduction strategies should be considered. Risk assessment undertaken by: Name of pharmacist: Name of clinical practitioner: Version 2 April 2015 Page 14 of 48

15 A summary of all high and moderate-risk injectable products should be completed for each clinical area. (See Proforma 3) Suggested risk reduction methods that can be used to minimise risks with injectable medicines 1. Simplify and rationalise the range of products and presentations of injectable medicines. Where possible, reduce the range of strengths of high-risk products and provide the most appropriate vial/ampoule sizes 2. Provide ready-to-administer or ready-to-use injectable products this will minimise preparation risks and simplify administration 3. Provide dose calculating tools for example, dosage charts for a range of body weights that eliminate the need for dose calculations 4. Provide additional guidance on how to prescribe, prepare and administer high-risk injectable medicines 5. Consider the provision of pre-printed prescriptions or stickers this will help to ensure that information on the prescription about preparation and administration of high-risk products is clearer 6. Provide locally approved protocols that clarify approved unlicensed and off-label use of injectable medicines 7. Use double-checking systems an independent second check from another practitioner and/or the use of dose-checking software in Smart infusion pumps and syringe drivers 8. Use an infusion monitoring form or checklist this will help to ensure that infusions are monitored throughout administration Version 2 April 2015 Page 15 of 48

16 Proforma 3: Risk assessment summary for high and moderate-risk injectable medicines products Name of clinical area Directorate: Date: Injectable Medicines Injectable Medicines Policy v 2.0 April 2015 Risk factors Prepared injectable medicine Strength Diluent Final volume Bag/syringe Therapeutic risk Use of concentrate Complex calculation Complex preparation Reconstitute vial Part/multiple container Infusions pump or driver Non-standard infusion set Risk assessment score Risk reduction method(s) Revised score Risk assessment undertaken by: Name of pharmacist: Name of clinical practitioner: Version 2 April 2015 Page 16 of 48

17 APPENDIX B MEDICINE CALCULATION RECORD Name of Patient: Date of Birth: Drug: Dose: Calculation: NHS Number: Prescriber: Drug: Dose: Calculation: Signature: Time: Signature: Time: Date: Date: Drug: Dose: Calculation: Drug: Dose: Calculation: Signature: Time: Signature: Time: Date: Date: To be attached to the patient s medication administration recording sheet Version 2 April 2015 Page 17 of 48

18 Appendix C Training Plan following the dissemination of the Trust Injectable Medicines Policy Title of Document Following Dissemination to: Senior managers and clinical leads INJECTABLE MEDICINES POLICY Training implications Education needs to include at this stage a briefing of any changes to current policy including setting up and appropriate documentation this will be given to the Matrons, leads and any link trainers. (Via professional forums, matrons and leads forums). Professional leads and team leaders will then cascade the policy to all staff that are involved in the prescribing, preparation and administration of injectable medicines. A record of this for KSF review should be kept. A list of all staff assessed as competent will be kept by the governance team. All new Trust will be assessed against the competencies for the prescribing, preparation and administration of injectable medicines. Learning & Development Department The appropriate leads have been involved in policy formation they now need to ensure all trainers are up to date with current policy. Need to ensure on-going updates arranged as local as possible. Need to ensure regular training days are organised for new staff involved in the prescribing, preparation and administration of injectable medicines. Version 2 April 2015 Page 18 of 48

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32 The Mental Capacity Act 2005 The Mental Capacity Act provides a statutory framework for people who lack capacity to make decisions for themselves, or who have capacity and want to make preparations for a time when they lack capacity in the future. It sets out who can take decisions, in which situations, and how they should go about this. It covers a wide range of decision making from health and welfare decisions to finance and property decisions Enshrined in the Mental Capacity Act is the principle that people must be assumed to have capacity unless it is established that they do not. This is an important aspect of law that all health and social care practitioners must implement when proposing to undertake any act in connection with care and treatment that requires consent. In circumstances where there is an element of doubt about a person s ability to make a decision due to an impairment of or disturbance in the functioning of the mind or brain the practitioner must implement the Mental Capacity Act. The legal framework provided by the Mental Capacity Act 2005 is supported by a Code of Practice, which provides guidance and information about how the Act works in practice. The Code of Practice has statutory force which means that health and social care practitioners have a legal duty to have regard to it when working with or caring for adults who may lack capacity to make decisions for themselves. The Act is intended to assist and support people who may lack capacity and to discourage anyone who is involved in caring for someone who lacks capacity from being overly restrictive or controlling. It aims to balance an individual s right to make decisions for themselves with their right to be protected from harm if they lack the capacity to make decisions to protect themselves. (3) All Trust workers can access the Code of Practice, Mental Capacity Act 2005 Policy, Mental Capacity Act 2005 Practice Guidance, information booklets and all assessment, checklists and Independent Mental Capacity Advocate referral forms on icare Infection Control All staff will have access to Infection Control Policies and comply with the standards within them in the work place. All staff will attend Infection Control Training annually as part of their mandatory training programme. Version 2 April 2015 Page 32 of 48

33 Quality Impact Assessment (QIA) Please select Who may be affected by this document? Patient / Service Users x Visitors / Relatives General Public Voluntary / Community Groups Trade Unions GPs x NHS Organisations Police Councils Carers Staff x Other Statutory Agencies Others (please state): Does this document require a service redesign, or substantial amendments to an existing process? If you answer yes to this question, please complete a full Quality Impact Assessment. Are there concerns that the document could adversely impact on people and aspects of the Trust under one of the nine strands of diversity? Age Disability Gender re-assignment Pregnancy and maternity Marriage and Civil Partnership Race, including nationality and ethnicity Religion or Belief Sex Sexual orientation If you answer yes to any of these strands, please complete a full Quality Impact Assessment. If applicable, what action has been taken to mitigate any concerns? Who have you consulted with in the creation of this document? Note - It may not be sufficient to just speak to other health & social care professionals. Patients / Service Users Visitors / Relatives General Public Voluntary / Community Groups Trade Unions GPs NHS Organisations Police Councils Carers Staff Details (please state): Other Statutory Agencies This is a review of v1.0 of this policy and has been widely consulted on Version 2 April 2015 Page 33 of 48

34 Standard Operating Procedure Title: PRESCRIBING OF INJECTABLE MEDICINES Prepared by: Rajitha Ramakrishnan Presented to: Care & Clinical Policies Sub Group Ratified by: Care & Clinical Policies Sub Group Links to policies: Date: 1 st June 2015 Date: 1 st June 2015 Review date: June 2017 Injectable Medicines Policy for Registered Professionals 1. Purpose of this SOP To inform registered healthcare professionals about safe and effective procedures for the prescribing of injectable medicines. 2. Scope of this SOP This SOP relates to all staff employed by Torbay and Southern Devon Health and Care NHS Trust who prescribe medication via an injectable route. 3. Competencies required Registered Health Care Professionals for prescribing medicines. Non-Medical Prescriber must hold relevant NMP qualification and registered as NMP within TSDHCT. 4. Patients covered All patients, service users and clients having injectable medicines administered while receiving treatment and care by TSDHCT staff. 5. Prescribing of Injectable Medicines 5.1 Prescribing must comply with the Medicines Act 1968 and the Misuse of Drugs Regulations 2001 as amended as, the medicines (Pharmacy and General Sale-Exemption) Amendment order 200,S12, 2000,No The choice of medication should be made by the prescriber according to: The clinical condition of the patient. The availability and supply of the medication and formulation required. In line with the relevant formulary South West Devon Formulary ( Licensed by MHRA for use in UK. Version 2 April 2015 Page 34 of 48

35 5.3 The registered prescriber will prescribe the medication to be given by the injectable route on TSDHCT ratified documentation. This may be a patient medication administration record, treatment card or patient specific record. 5.4 The registered prescriber must prescribe within the current legislation. 5.5 Non-medical iindependent prescribers may not prescribe an injectable medication for a patient, where the medication has not been within their scope of practice, they have not assessed the patient and obtained a medical history, except in life threatening situations. 5.6 The prescriptions for injectable medicines should include: The name of the patient; The NHS number of the patient; or hospital number of the patient The date of birth and age of the patient; The allergy status of the patient; The weight of the patient and date weighed, if this is appropriate for the dosing of the drug being prescribed; The approved medicine/medicines name; this include generic name and brand name if necessary The date of commencing the administration of the drug/drugs; The strength of the drug and the dose of the drug to be administered; The frequency of administration of the drug; ; The route of administration of the drug; The signature and printed name of the prescriber The date the prescribed medication is to be reviewed. 5.7 Where relevant, the instruction to administer an injectable medication or readily available local protocol must contain the above information and the following: The approved or generic name, strength and formulation of the medicine; if appropriate the brand name. The total concentration or total quantity of medicines in the final infusion container or syringe; Reconstitution information including the name and volume of the diluent/diluents and /or infusion fluid; The rate and the duration of administration. The stability information (in solution) to determine the expiry of the reconstituted solution; Type of rate control pump to be used; Special handling or specialist technical information where relevant. Review date of the prescription. 5.7 Arrangements for fluid balance or clinical monitoring must be made on an individual basis according to local protocol and the clinical need of the patient. 6. Principles of Prescribing 6.1 Medicines should be prescribed by the approved (generic) name except if the brand name is appropriate. Version 2 April 2015 Page 35 of 48

36 6.2 Medicines should be prescribed in BLOCK LETTERS and indelible ink. 6.3 The dose must be prescribed using the metric system. N.B. micrograms and nanograms should be written in full to avoid confusion. 6.4 Where doses are described in terms of units, e.g. insulin and heparin, then the doses must be written using the word units in full. 6.5 Route: To prevent misunderstanding the following approved abbreviations may be used: I.M. - Intramuscular I.V. - Intravenous S.C. - Subcutaneous 6.6 Signature and Date: Prescriptions must be signed and dated in ink by a registered prescriber. 7. Verbal, Faxed and Telephoned Orders for Prescriptions 7.1 These must only be given in exceptional circumstances when the prescriber cannot attend. 7.2 If a verbal order is received, it must be written down, and a second health professional must repeat the instruction back to the prescriber. 7.3 An electronic confirmation of the prescription/direction to administer must be received prior to administration. 7.4 The prescriber will follow up by countersigning the verbal order on the ward chart, or providing a new prescription within a maximum of 24 hours (72 Hours maximum at weekends and Bank holidays). 7.5 A fax or received to administer an injectable medication in exceptional circumstances must be stapled to the patient medication administration record. 7.6 The administering nurse must identify that the instruction to administer is a verbal faxed order and the circumstance for that order being given in the patient s record. 7.7 Verbal or faxed orders must not be accepted for intravenous (IV) drug administration. 7.8 Verbal or faxed orders must not be accepted for controlled drugs (CDs). Monitoring Tool Standards: Item % Exceptions All registered community staff to have knowledge of this SOP 100% nil How will monitoring be carried out? When will monitoring be carried out? Internal audit and signatory sheet Annually (of sooner if dictated) Version 2 April 2015 Page 36 of 48

37 Who will monitor compliance with the guideline? Service leads managerially responsible for delivering care References: Devon PCT Medicines Policy 2008 Devon PCT Policy for Waste management 2007 Devon PCT Syringe Driver Policy 2007 Devon PCT Consent Policy 2008 Devon PCT Incident Reporting Policy 2007 Devon PCT Infection Control Policy 2007 Devon PCT Medicines Devices Management Policy September 2007-March 2008 Devon PCT Aseptic Techniques 2007 Devon PCT Control of Substances Hazardous to Health (COSHH) Policy & Procedure March 2008 RD&E Intravenous Therapy Policy September 2006 Devon PCT LATEX Advice October 2007 NMC 2007 Code of Professional Conduct. Nursing and Midwifery Council, London HSC 2008/001 Updated guidance on the safe administration of intrathecal chemotherapy Health Professions Council Standards of Proficiency Physiotherapists November 2007 NPSA 21 Safer Practice with Epidural Infusions 2007 Devon PCT Inoculation Injury Policy 2007 Devon PCT Record Management Policy 2008 Devon Anaphalaxis Policy (to be published) National Prescribing Centre February 2007; A guide to good practice in the management of controlled drugs in primary care (England) NMC October 2007, Standards for Medicines Management. Nursing and Midwifery Council, London NMC 2005, Guidelines for Records and Record Keeping. Nursing and Midwifery Council, London Devon PCT Record Management Policy 2007 NMC 2006 Standards of Proficiency for Nurses and Midwife Prescribers Mental Capacity Act 2007 National Patient Safety Agency Patient Safety Alert 20 Promoting safer use of injectable medicines HSC 2008/001 Updated guidance on the safe administration of intrathecal chemotherapy. Devon PCT Standard Infection Control Precautions July Torbay Care Trust Prescribing SOPs and Medicines Policy. Devon PCT SOPs. University College London Hospital Injectable Medicines Guide Pharmacy Department third edition (October 2010) Amendment History Issue Status Date Reason for Change Authorised V 1.0 Ratified April 2012 Developed for new Provider Paul Humphriss organisation V 1.1 Draft April 2015 Review carried out with minor Lynda Price amendments made V 2.0 Ratified June 2015 Two year review Lynda Price Version 2 April 2015 Page 37 of 48

38 Standard Operating Procedure Title: PREPARATION OF INJECTABLE MEDICINES Prepared by: Jeanne Smith Presented to: Care and Clinical Date: 1 st June 2015 Policies Group Ratified by: Care and Clinical Date: 1 st June 2015 Policies Sub-Group Review date: June 2017 Links to policies: Injectable Medicines Guide (Medusa) Torbay and Southern Devon Health and Care NHS Trust: Administration of medicines Clinical Calculations Assessment for Registered Nurses Policy Version 1 Infection Control Operating Policy Version 3 Waste Management Policy Version 1 Version 1 SOP for Preparation of Injectable Medicines April 2012 SOP for Prescribing of Injectable Medicines April 2012 SOP for Administration of Medicines by Registered Professionals July 2014 SOP for Waste Management of Medicines and Other Pharmaceutical Products in Community Hospitals and Community Clinics April 2013 version3 Needlesticks and Contamination Injuries to Healthcare Workers August 2014 Version 4 Risk Management Strategy June 2014 version3 SOP Controlled Drugs in Community Services July 2014 version 3 1. Purpose of this document To inform healthcare professionals about safe and appropriate procedures for the preparation of injectable medicines. 2. Scope of this SOP This SOP relates to all staff employed by the Trust who prepare medication to be administered via an injectable route. 3. Competencies required - Registered Professionals for preparing medicines - Record of Clinical Calculation Competency. - Registered Professional has undergone training and deemed competent in preparing injectable medicines. 4. Patients covered All patients and clients receiving injectable interventions while receiving treatment and care by Trust staff 5. Preparation of Injectable Medicines 1.1. Injectable medicines should only be prepared by healthcare staff who have been assessed as competent to undertake the preparation. Version 2 April 2015 Page 38 of 48

39 1.2. Preparation should only take place if there is a signed prescription, specific direction, i.e. patient medication administration record / treatment card, Patient Group Direction (PGD) or lies within the medicines exemptions relevant to their professional code of practice Preparation should only take place when the patient is available and ready to receive the medication. 6. General Preparation of Injectable Medicines 6.1 The registered practitioner preparing the injectable medicine must read all the prescription details carefully and confirm they relate to the patient who they are treating. 6.2 Injectable medicines should be administered immediately after preparation. 6.3 If more than one injectable medication is required for a patient the syringes must be labelled. 6.4 Establish a clean and uncluttered environment for the preparation of the injectable medication. 6.5 Reduce the possibility, where practical of any interruptions. 6.6 All equipment required to prepare the injectable medication should be made available. This to include: sharps bin; prescribed medication; diluents; syringe(s); needle(s); alcohol wipes; protective clothing and if appropriate, plastic tray. 6.7 Check the following:- You understand the method of preparation Name of drug, strength, formulation and route of administration The expiry dates; Any damage to the container, vials or packaging Visibly check the solution for contamination and that it is free of haziness, particles and discolouration as specified in the Patient Information Leaflet (PIL) or Summary of Product Characteristics (SPC) provided with the drug. The medication has been stored in accordance with the SPC. The formulation, dose, diluent and infusion rate of administration correspond to the prescription and product information. Check the patient s allergy status either by: questioning the patient if appropriate; consulting the prescription sheet or medical notes. If not able to ascertain allergy status refer back to the prescriber. 6.8 Calculate, where necessary, the volume of the medicine solution needed to give the prescribed dose. Record your calculation on the approved Trust documentation form. The calculation should be recorded on each administration. Version 2 April 2015 Page 39 of 48

40 If possible a second person should check the calculation and an independent calculation should be made and recorded. If discrepancies in the calculations occur further advice should be sought from the prescriber or Pharmacist. 6.9 Cleanse your hands and undertake the procedure employing guidelines from the Trust Standard Infection Control Precautions If a label is required use the approved Trust label. 7. Withdrawing solution from an ampoule (glass or plastic) into a syringe 7.1 Tap the ampoule gently to dislodge any medicine in the neck. 7.2 Snap open the neck of the ampoule, taking care if the ampoule is glass that it does not shatter. 7.3 Attach the appropriately sized needle to a syringe (use a filter needle if drawing up solution from a glass ampoule, to avoid the risk of drawing up particles of glass) and draw the required volume of solution into the syringe. Tilt the ampoule if necessary. 7.4 Invert the syringe and tap lightly to aggregate the air bubbles at the needle end. Expel air with care. 7.5 Remove the needle from the syringe and fit new needle or sterile blind hub. 7.6 Label the syringe if appropriate. 7.7 Keep the ampoule and any unused medicine until the administration to the patient is complete. This enables further checking to be undertaken if required. 7.8 If the ampoule contains a suspension rather than a solution it should be gently swirled to mix the contents immediately before they are drawn into the syringe. 7.9 The neck of some plastic ampoules are designed to connect directly to a syringe without the use of a needle, after the top of the ampoule has been twisted off. 8. Withdrawing a solution or suspension from a vial into a syringe 8.1 Remove the tamper-evident seal from the vial and wipe the rubber septum with an alcohol wipe. Allow to dry for at least 30 seconds. 8.2 With the appropriately sized needle sheathed, draw into the syringe a volume of air equivalent to the required volume of solution to be drawn up. 8.3 Remove the needle cover and insert the appropriately sized needle into the vial through the rubber septum. 8.4 Invert the vial. Keep the needle in the solution and slowly depress the plunger to push the air into the vial. 8.5 Release the plunger so that the solution flows back into the syringe. Version 2 April 2015 Page 40 of 48

41 8.6 If a large volume of solution is to be withdrawn use a push-pull technique, i.e. repeatedly inject small volumes of air and draw up an equal volume of solution until the required total is reached. This equilibrium method helps to minimize the build up of pressure in the vial. Alternatively, the rubber septum can be pierced with a second needle to let air into the vial as the solution is withdrawn. 8.7 The tip of the vent needle must always be kept above the solution to prevent leakage. 8.8 With the vial still attached, invert the syringe with the needle and vial uppermost, tap the syringe lightly to aggregate the air bubbles at the needle end, push the air back into the vial. 8.9 Fill the syringe with the required volume of the solution and in accordance with the dose prescribed. Withdraw the needle from the vial Expel excess air from the syringe. Remove the appropriately sized needle from the syringe and fit new appropriately sized needle or sterile blind hub Label the syringe if appropriate Keep the vial and any unused medicine until the administration to the patient is complete. This enables further checking to be undertaken if required If the vial contains a suspension rather than a solution, it should be gently swirled to mix the contents immediately before they are drawn into the syringe. 9. Reconstituting powder in a vial and drawing the resulting solution or suspension into a syringe 9.1 Remove the tamper-evident seal from the vial and wipe the rubber septum with an alcohol wipe. Allow drying for at least 30 seconds. 9.2 Check the prescribed diluents for the reconstitution and the volume required. 9.3 Inject the diluents into the vial. Keeping the tip of the appropriately sized needle above the level of the solution in the vial, release the plunger. The syringe will fill with the air, which has been displaced by the solution (if the contents of the vial were packed under a vacuum, solution will be drawn into the vial and no air will be displaced). If a large volume of diluent is to be added, use a push-pull technique. 9.4 With the syringe and appropriately sized needle still in place, gently swirl the vial(s) to dissolve all the powder, unless otherwise indicated by the product information. This may take several minutes. Release the plunger so that the solution flows back into the syringe. 9.5 For withdrawing required volume of solution from vial into syringe see section Label, the syringe if appropriate. 9.7 Keep the vial and any unused medicine until the administration to the patient is complete. This enables further checking to be undertaken if required. 9.8 If a purpose-designed reconstitution device is used, the manufacturer s instructions should be read carefully and followed closely. If you are not familiar with the device additional training must be undertaken and competencies assessed. Version 2 April 2015 Page 41 of 48