SAFE HANDLING AND ADMINISTRATION OF MEDICINES POLICY

Transcription

1 SAFE HANDLING AND ADMINISTRATION OF MEDICINES POLICY Issue History Issue Version Purpose of Issue/Description of Change April 2007 Third Issue Planned update incorporating new national guidance Planned Review Date December 2012 Named Responsible Officer:- Approved by Date Medicines Governance Pharmacist (Supported by Service Improvement Unit) Provider Services Governance Group December 2010 Policy:- General Policy Impact Assessment Screening - 5/1/11 Full Impact Assessment Required No No. 11 Key Performance Indicators 1. The number of medicine management incidents reported as per the incident reporting policy. 2. The number of incidents reported involving the disposal of controlled drugs. 3. Auditing of standard operating procedures by Service Heads and the Medicines Management Team.

2 SAFE HANDLING AND ADMINISTRATION OF MEDICINES POLICY Contents 1. Introduction 1.1 Aim of the 1.2 Policy Outcome 1.3 Target Group 1.4 Cross Reference to Related NHS Wirral Policies 1.5 Definitions 1.6 Classification of Medicines and Related Preparations 1.7 Designated Roles to Clarify Clinical Responsibility 2. Standard Operating Procedures 3. Ordering of Medicines (Procurement / Acquisition) 3.1 Ordering of Medicines from Wirral University Teaching Hospital NHS Foundation Trust (WUTH) 3.2 Additions or Deletions of Medicines from the Pharmacy Supplies Order Form 4. Receipt of Medicines 5. Transport of Medicines 6. Storage of Medicines 6.1 Safe Storage of Medicines within Departments 6.2 Security of Medicines and Related Stationery within Departments Lost Prescriptions 6.3 Medical Gases 6.4 Inflammable Liquids Alcohol Gel 7. Prescribing and Dispensing of Medicines 7.1 Prescribing Responsibilities 7.2 Dispensing of Prescriptions 7.3 Verbal Orders 8. Administration 8.1 Consent 8.2 Principles for the Safe Administration of Medicines 8.3 Incident Reporting in the Event of a Medication Error 8.4 Self Administration 9. Disposal of Pharmaceutical Waste 10. Controlled Drugs (CDs) 10.1 Ordering of CDs from WUTH 10.2 Receipt of CDs from WUTH 10.3 Storage of CDs Storage in Departments 2/40

3 Storage in Doctors Bags Storage in Patients Homes 10.4 CD Stock Reconciliation 10.5 Procedure for Missing CDs Procedure for Missing CDs in Departments Procedure for Missing CDs in Community Nursing 10.6 Administration of CDs 10.7 Disposal of CDs Disposal of Expired Stock CDs from Departments Disposal of Patient Returned CDs from a Patient s Home (Not Care Home) Disposal of CDs from Care Homes 11. Patient Group Directions (PGDs) 11.1 Definition 11.2 Legal Framework for PGDs 11.3 Peer Review for PGDs 11.4 PGDs Safety Concerns 11.5 Developing New PGDs within NHS Wirral 11.6 Who Can Administer from a PGD 11.7 Signatures Required for NHS Wirral 11.8 Antibiotics 11.9 What cannot be Included in a PGD Minimum Contents of a PGD Updating a PGD 12. Unlicensed Medicines 12.1 Responsibility of Prescribers 12.2 Responsibility of Supplying Pharmacist (Community or Hospital) 12.3 Responsibility of NHS Wirral Medicines Management Team 12.4 NHS Wirral Staff involved in Administering Unlicensed Medicines Complementary or Alternative Medicines 12.5 Wirral Drug and Therapeutics Committee 12.6 Definition of Off Label Medicines 13. Training and Medicines Information 14. Adverse Drug Reaction Reporting and Yellow Card Scheme 14.1 Who Can Report? 14.2 What Should be Reported? 14.3 Areas of Special Interest 14.4 Where to Find a Yellow Card 14.5 Patient Details 14.6 Copy of Yellow Card in Patients Notes 15. Drug Alerts 15.1 Medicines and Healthcare Products Regulation Drug Alerts 15.2 National Patient Safety Agency Alerts and Rapid Response Reports 16. Monitoring 3/40

4 17. Archiving and Document Retrieval 18. Consultation 19. Ratification References: Appendix 1 NHS Wirral Clinic and Departments Pharmacy Request Form Appendix 2 Example of Audit Tool for Assessing Compliance with Departmental SOPs 4/40

5 1. Introduction NHS Wirral is required to establish, maintain, document and audit safe and effective systems for the handling of medicines via: Compliance with current legislation. Adherence to guidelines for the administration and handling of medicines issued by individual professional bodies and all related NHS documents. Management of the risks to patients and staff arising from the use of medicines. 1.1 Aim of the Policy It is the responsibility of the Head of Medicines Management to ensure systems are implemented to ensure medicines are managed safely and securely throughout NHS Wirral to meet patients needs. The aim of this policy is therefore to inform all health professionals and other NHS Wirral employed staff of the correct procedures for the safe handling, ordering, storage, transportation, administration and disposal of medicines and related preparations. This policy only considers the processes associated with the physical handling of medicines. It is not intended to give guidance on the prescribing of medicines by doctors or other authorised prescribers. However, general advice on the prescribing of unlicensed medicines is included. 1.2 Policy Outcome NHS Wirral employed staff (including self-employed staff contracted to work within NHS Wirral Provider Services) will follow best practice when dealing with medicines. NHS Wirral employed staff will follow all relevant NHS guidance and Medicines Act legislation. NHS Wirral employed staff will adhere to the safe management of all medicines and related products, therefore minimising the risk of errors associated with medicines. This policy will act as a reference source for independent contractors, supporting compliance with, Regulation 13 of the Health and Social Care Act Target Group This Policy is intended to be used as a resource for all NHS Wirral Provider Services employed staff that have any involvement with the handling of medicines and related products. 1.4 Cross Reference to Related NHS Wirral Documents Non Medical Prescribing Procedure 5/40

6 Consent Policy Incident Reporting Policy Syringe Driver Procedure Management of Healthcare waste policy Guidance on the Prescribing and Use of Unlicensed and Off Label Medicines Standard Operating Procedures for each department dealing with medicines 1.5 Definitions The Medicine Trail: The medicine trail covers all the potential activities that are associated with a medical product, from the initiation of the patient treatment through a prescription or a patient group direction, to the administration and the disposal of any waste material. As this is a multistage process there is a need to introduce controlled links between the relevant stages. These links must be included to ensure full consideration of all aspects of the safe use of medicines throughout the trail. Initiation of Treatment: A patient s treatment must be initiated through a formal process. This may be by a doctor or other authorised prescriber s prescription or may be through an approved patient group direction. (See Section 11, Patient Group Directions.) Procurement /Acquisition of Medicines: This is the process through which a medicine is acquired for use in treating a patient. Receipt of Medicines: The formal activities, undertaken when medicines are received by the organisation from an external source or transferred from one department to another. Procedures must be in place to ensure product identity, quantity and quality. Safe Storage of Medicines: Medicines must be stored in a secure manner and in conditions that will not affect their potency. Procedures must be in place to ensure compliance with the manufacturer s storage recommendations and any legislation covering for example the storage of controlled drugs. Administration or Supply of Medicines: The activities undertaken when a medicine is administered to a patient or given to the patient for administration at a later date. Procedures must be in place to ensure the right patient is given the right medicine at the right time. Removal/ Disposal of Surplus/Waste Medicines from Departments: The activities associated with the removal and disposal of medicines that are no longer required or no longer suitable for their intended use. 6/40

7 Appropriate records should be made for a complete audit trail as outlined in each department s standard operating procedure. Standard Operating Procedures: Each department that deals with medicines is required to produce a standard operating procedure (SOP) for any activity undertaken throughout the medicines trail. Patient Group Direction: A Patient Group Direction (PGD) is a specific written instruction for the supply and administration of a named medicine to a group of patients in an identified clinical situation. See Section 11.6 for the professional groups who can be authorised to administer or supply medicines using a PGD Patient Specific Direction: A Patient Specific Direction (PSD) is a written instruction from a qualified and registered prescriber for a medicine including the dose, route and frequency or appliance to be supplied or administered to a named patient. Definition of a Medicine: Any substance or combination of substances presented for treating or preventing disease. Any substance or combination of substances which may be administered with a view to making a medical diagnosis or restoring, correcting or modifying physiological or psychological functions. 1.6 Classification of Medicines and Related Preparations For the purpose of this policy, medicines are classified as follows:- Controlled Drugs - those which come within the Misuse of Drugs Act (1971) and subsequent regulations Licensed Medicines - all medicines, oral, external, prescription only, pharmacy medicines, general sales list medicines, or controlled drugs with a valid Marketing Authorisation for use within the UK. Unlicensed Medicines - any medicine that has not been granted a valid Marketing Authorisation for use within the UK Non-medicines - classified into the following groups Surface disinfectants Urine testing and other reagents Medical gases Medicines Act 1968 Classifies medicines into three main categories 7/40

8 Prescription-Only Medicines (POM) These are medicines, which may only be supplied or administered to a patient:- - On the instruction of an authorised prescriber such as a doctor, dentist, nurse or pharmacist prescriber in the form of a prescription. - Or under the direction of an authorised patient specific direction or a patient group direction. Pharmacy-Only Medicines (P) These medicines can be purchased from a registered primary care pharmacy, provided the pharmacist supervises the sale. General Sale List Medicines (GSL) These medicines need neither a prescription nor the supervision of a pharmacist and can be obtained from retail outlets. 1.7 Designated Roles to Clarify Clinical Responsibilities Department For the purpose of this document a department incorporates any community clinic, primary care centre, Walk-In Centre, GP Out of Hours, intermediate service or clinical service. Practitioner Practitioner in this context is a term used to describe a qualified nurse, medical practitioner, pharmacist or other authorised employee. Practitioner in Charge This is the senior practitioner appointed in charge of a department. The Practitioner in Charge is responsible for ensuring the audit and maintenance of safe systems for the handling of medicines within their department. Assigned Practitioner in Charge The senior practitioner on duty for the department for that shift/day. Designated Practitioner Any registered practitioner whom NHS Wirral has formally identified as competent and appropriate to perform a specific medicines related function. Health Service Authorised Employee A member of staff who has been trained and authorised by NHS Wirral to undertake specific duties in relation to medicines. Accountability for ensuring safe practice remains with the registered health professional who has delegated the task. A record needs to be held of the training the authorised employee has received and their specific competencies, e.g. assistant practitioners in the community or clinic clerks in a department. Community Practitioner Nurse Prescribers 8/40

9 A registered nurse who has completed a nationally recognised nurse prescribing course which has been recorded with the Nursing and Midwifery Council. These nurses can prescribe from a limited list of preparations. This list comprises of a range of medicines, dressings and appliances suitable for use in a community setting. Non Medical Independent Prescribers Health professionals who are qualified to prescribe any licensed medicine (including some controlled drugs for specific medical conditions) and are registered with Provider Services and authorised by the Service Manager within the non medical prescriber s clinical competency. The list of prescribable controlled drugs is available in the Drug Tariff (part XVIIB) and in the current edition of the BNF. Pharmacist Prescriber A pharmacist registered with the General Pharmaceutical Council with an annotation signifying their status as a qualified supplementary or independent prescriber. All prescribers are accountable for their own actions, and must be aware of the limits of their skills, knowledge and competence. Prescribers must also ensure there is an allocated budget prior to initiating any prescribing. Local Security Management Specialist The person employed by NHS Wirral to investigate any breaches of security and report through the governance structure to the board. The Local Security Management Specialist is the person responsible for liasing with the police where necessary. Medicines Management Team The Medicines Management Team is a team of NHS Wirral employed pharmacists, prescribing support technicians and administrative support staff who: Work with a range of healthcare professionals to promote high quality, cost-effective prescribing to improve patient care. Provide information and support to all NHS Wirral employed and staff to ensure safe handling and administration of medicines. Head of Medicines Management The Head of Medicines Management is accountable for ensuring processes are in place across NHS Wirral for safe prescribing, handling and administration of medicines throughout NHS Wirral by employed or contracted staff and commissioned services. Medicines Governance Pharmacist The Medicines Governance Pharmacist is responsible for relevant policy development and provision of support to practitioners in charge of departments in auditing and maintaining safe systems for the management of medicines within their departments. Prescribing Adviser with Responsibility for Governance The Prescribing Adviser with Responsibility for Governance reports to the Head of Medicines Management and line manages the Medicines Governance Pharmacist. 9/40

10 2. Standard Operating Procedures Each department that deals with medicines is required to produce a standard operating procedure (SOP) for any activity undertaken throughout the medicines trail. The Practitioner in Charge is responsible for writing the SOPs for their department, using the NHS Wirral approved standard template. The Medicines Governance Pharmacist will provide advice in finalising the document before ratification. The Practitioner in Charge is also responsible for auditing compliance with their departmental SOPs. SOPs must be comprehensive, reproducible and unambiguous and must indicate who is authorised to perform the relevant tasks. The SOPs must specify any equipment, facilities and data associated with the process. The Practitioner in Charge, the Medicines Governance Pharmacist and the Prescribing Adviser with Responsibility for Governance will formally approve SOPs. SOPs will only be fully operational when formal approval has been given. SOPs will be subject to routine updating and review. A record of such reviews will be maintained by the Medicines Management Team. A copy of the SOPs will be available to any member of staff at the location at which they are used. The master copies will be held by the Medicines Management Team. All SOPs will be dated and the date of review included. Refer to Appendix 2 for an example of an audit tool that can be adapted for assessing compliance with departmental SOPs. Further advice on the contents of SOPs can be found in the revised Duthie Report March The Safe and Secure Handling of Medicines, A Team Approach. 3. Ordering of Medicines (Procurement/Acquisition of Medicines) 3.1 Ordering of Medicines from Wirral University Teaching Hospital NHS Foundation Trust (WUTH) The Practitioner in Charge is responsible for ensuring there is a robust audit trail of all medicines received into their department, administered or supplied to patients, or appropriately destroyed. Medicines and related preparations should be ordered from WUTH pharmacy department. A Designated Practitioner is responsible for ordering medicines from WUTH for the purpose of maintaining clinic stocks. A WUTH Pharmacy Supplies Order Form must always be completed. The form needs to be signed by a named Designated Senior Nurse / Designated Practitioner. The clerical staff within the clinic or department can only sign for the 10/40

11 ordering of medicines, if there are no health professionals on site or if this task has been specifically delegated to them by a named health professional. 3.2 Additions or Deletions of Medicines from the Pharmacy Supplies Order Form The Practitioner in Charge is responsible for requesting a regular review of the stock medicines listed on the Pharmacy Supplies Order Form, by contacting the Medicines Governance Pharmacist or the Senior Prescribing Support Technician, Medicines Management Team. Requests for additions or deletions of medicines from the Pharmacy Supplies Order Form must be made by the Practitioner in Charge, who must complete a Pharmacy Stock Amendment Request form (Refer to appendix 1). Request forms must then be forwarded electronically or by FAX to the Senior Prescribing Support Technician, Medicines Management Team. (Fax number ) The appropriateness of the request will be considered and if agreed, the request form will be signed by an authorised member of the Medicines Management Team. (Usually the Medicines Governance Pharmacist or where appropriate the Senior Prescribing Support Technician.) The authorised request form will then be forwarded to WUTH pharmacy department for the amendment to the Pharmacy Supplies Order Form to be actioned. WUTH pharmacy department will then send the updated form to the Senior Prescribing Support Technician Medicines Management Team for the amendments to be checked. An updated amended Pharmacy Supplies Order Form will then be sent to the Practitioner in Charge. The Practitioner in charge of the department will be responsible for removing the expired pharmacy supplies order form from circulation. 4. Receipt of Medicines On receipt of medicines from WUTH it is the Designated Practitioner s responsibility to check the order is correct, received in good condition and with a reasonable shelf life. The Designated Practitioner must notify WUTH if there are any discrepancies in the order. The Designated Practitioner must also report any discrepancies to the Practitioner in Charge. A written, signed and dated record must be maintained of stock received into the department. Order forms and delivery records must be kept for a period of two years as a record that the supply was complete. Vaccines and any other medication requiring refrigeration must be placed immediately in a refrigerator specifically designated for the storage of medicines. The cold chain must be maintained. Medications not requiring refrigeration must be stored in a locked cupboard. 11/40

12 Written records, signed and dated, of medication appropriately destroyed must also be kept for a period of two years to maintain an audit trail. (See section 9) Samples of medicines from pharmaceutical company representatives must not be accepted for administration to patients and therefore must not be stored on NHS Wirral premises. 5. Transport of Medicines NHS Wirral employed staff should not collect dispensed medicines from community pharmacies, except in justifiable exceptional circumstances. In such cases a risk assessment should be undertaken and any risks managed accordingly. Patients/carers should collect dispensed medicines themselves. Where this is not possible, the majority of local pharmacies operate a delivery service. There will be specific situations were NHS Wirral employed staff are required to transport medicines to clinic, these activities will be described in standard operating procedures (SOPs) specific to individual departments. Samples of medicines from pharmaceutical company representatives must not be carried by NHS Wirral employed staff in the course of their work. 6. Storage of Medicines 6.1 Safe Storage of Medicines within Departments The recommended temperature for storing medicines will be indicated on the container issued by the manufacturer. Medicines that do not require storage in a refrigerator are usually stored at temperatures up to 25ºC. Cupboards used to store medicines must therefore not be located near radiators or hot water pipes or in areas of high humidity. The room used to store medicines must be monitored with a room thermometer. When temperatures exceed 25ºC advice must be requested from NHS Wirral Medicines Management Team , as to whether the medicines stored in the room are fit for purpose. Any advice given must be documented for audit purposes. Medicines requiring storage in a refrigerator must be stored in a lockable fridge manufactured specifically for the storage of medicines. Medicine fridges must be monitored and temperatures recorded each working day with maximum minimum thermometers to ensure temperatures are maintained between 2 and 8ºC. When temperatures fall outside this recommended temperature range advice must be requested from NHS Wirral Medicines Management Team as to whether the medicines are fit for purpose. Any advice given must be documented for audit purposes. Nursing staff are reminded to follow the SOP for the Safe Storage of Vaccines. Refrigerators and cupboards designated for the storage of medicines and pharmaceutical supplies must on no account be used for the storage of food, valuables or other items. Cupboards designated for medicines must be lockable and the designated area ideally should not be accessible to the public. 12/40

13 Refrigerators and cupboards designated for the storage of medicines and pharmaceutical supplies must be kept locked and the keys kept within a designated safe place, ideally held personally by the Assigned Practitioner in Charge. The Assigned Practitioner in Charge is responsible at all times for the safekeeping of all medicines in their department. The keys for the medicines cupboard must be kept on one key ring solely for this purpose and clearly identified. The Practitioner in Charge must immediately report any breaches of security to the Local Security Management Specialist, an incident form must be completed. All medicines to be taken orally and those for external use, must be stored separately in locked cupboards, reserved solely for medicinal products. It is acceptable for medicines to be taken orally and external products to be stored on separate shelves in the same cupboard. Disinfectants and reagents must be stored separately. No samples of medicines or dressings will be left in clinics to be used by patients. Where premises are shared by a number of clinics, each clinic is responsible for its own stock and this stock must be stored separately. At community bases where a number of Designated Practitioners may require access to the medicines cupboard at different times, a secure system must be agreed between the Designated Practitioners at the base. This system must be outlined in a standard operating procedure. Stock must be rotated to ensure that the stock with the shortest expiry date is used first. There must be no part-used pharmaceuticals, such as creams or ointments, kept in any medicines cupboards. This is because communal use of such products has resulted in outbreaks of infections such as MRSA and it is also an illegal practice to administer pharmaceuticals to any person for whom they were not prescribed. 6.2 Security of Medicines and Related Stationery within Departments The security of medicines and related stationery will be audited regularly by the Practitioner in Charge and periodically by the Medicines Governance Pharmacist or a delegated member of NHS Wirral Medicines Management Team. The Pharmacy Supplies Order Form must be regarded as controlled stationery and kept under lock and key and only accessible to authorised staff. It should be possible to audit the process and account for all movements of stock and to identity any inappropriate losses. Staff in any supervisory position must be aware of the signs that may indicate abuse or diversion of medicines (e.g. changes in an individual s behaviour such as lack of concentration, unexplained absences from work, odd behaviour, loss of stock, excessive ordering.) Appropriate action must then be taken. The security of prescription forms is the responsibility of the prescriber. Under no circumstances should blank prescription forms be pre signed before use. The prescription form must only be produced when needed and never left unattended. 13/40

14 Prescription pads must not be left on view and must be kept in a designated lockable place, i.e. locked file, drawers or cupboard. A record of prescription form serial numbers must be maintained to ensure a robust audit trail. All prescribers should follow the relevant SOP for Safe Handling of Prescription Forms for their service Lost Prescriptions In the event of a lost or stolen prescription, all prescribers should follow the relevant SOP for Safe Handling of Prescription Forms for their service. Incidents involving the loss, theft or misuse of prescription forms must be reported immediately to the Head of Medicines Management on Outside office hours the police should be contacted directly on or the main police switchboard on All details of the incident should be recorded on the Missing/Lost/Stolen NHS Prescription Form(s) Notification Form. Medicines Management keep copies of this document. An Incident Form should also be completed and sent to NHS Wirral Governance Team. The Head of Medicines Management will liaise with the police, the Local Security Management Specialist and the Local Counter Fraud Specialist and report the incident to Central Operations Mersey, who will alert all pharmacies and the Prescription Pricing Division, providing as much information about serial numbers as possible. The prescriber will be advised to write all prescriptions in a particular colour for the next 2 months. 14/40

15 6.3 Medical Gases Practitioners that use medical gases in the course of their duties must be fully trained and aware of related risks such as fire and manual handling. They must ensure that they follow their departmental SOPs for the handling of medical gases. In addition the following precautions must also be observed:- The number of cylinders held as stock in any department should be as small as possible. Cylinders must be firmly secured at all times to prevent them falling over. They should be stored under cover, preferably inside and not subjected to extremes of heat. Naked lights must not be allowed within the immediate vicinity of a cylinder. No oil or grease should be applied to the cylinder or tap connector, therefore ensure hands are clean before handling cylinders. In particular ensure hands are adequately dried after the use of alcohol gel. Segregate full and empty cylinders and separate the different gases within the store Have warning notices posted prohibiting smoking and naked lights within the vicinity of the store. Allow for a strict rotation of full cylinders to enable the cylinders with the oldest filling date to be used first. The storage should be designed to prevent unauthorised access and to protect cylinders from theft. Excessive force or any tools must not be used to open or close a cylinder valve. Cylinders with damaged valves and defective equipment must be labelled appropriately and withdrawn from use. Allow for Entonox cylinders to be stored at above 10 0 C for 24 hours before use. Where this is not feasible, it is important to consult the Entonox Medical Gas Data Sheet for further information. Notify the emergency services of the location and contents of the medical gas cylinder store. Contact suppliers for more specialist advice where necessary. There is a service level agreement between NHS Wirral and EBME WUTH for the service and repair of medical devices, this includes flow meters and oxygen regulators, each department must ensure these medical devices are serviced on a regular basis and should a problem arise between services to contact Electro Biomedical Engineering (EBME) Tel No: ext Flammable Liquids Flammable liquids are issued from WUTH pharmacy and labelled flammable. COSHH data sheets must be available for all flammable liquids kept on the premises. The data sheets must be kept in a central point available to all staff. To reduce the risk of combustion or explosion:- - Keep stock levels to a minimum. - Avoid spillage. 15/40

16 - Keep bottle closed. Replace the screw cap immediately after use. - Keep well away from naked flame or electrical apparatus. - Do not store in a refrigerator. - Store all flammable liquids in a locked metal cupboard that displays an appropriate hazard notice Alcohol Gel It should be noted that alcohol gel is also a highly flammable substance; the above precautions must be followed. If nursing staff need to store alcohol gel in their car it must not be stored anywhere where it would be subject to direct sunlight. Alcohol gel must therefore be stored in nursing bags, pockets and/or in the boot of the car. 7. Prescribing and Dispensing of Medicines 7.1. Prescribing Responsibilities Medicines will only be prescribed by suitably trained and qualified healthcare professionals (e.g. medical practitioner or authorised non-medical prescriber) according to the terms of their qualification (e.g. within a limited formulary), and acting within their skills, knowledge and competence. Prescribers must also ensure there is an allocated budget prior to initiating any prescribing. See section 1.7 for roles and responsibilities of nurse and pharmacist prescribers Dispensing of Prescriptions NHS Wirral does not operate a dispensing service, so any medicines will normally be dispensed by an external supplier. Prescriptions must be dispensed by a qualified pharmacist from a suitably registered pharmacy. The only exception will be for certain departments such as Sexual Health Services, Wirral Walk-In Centres, or GP Out of Hours Service, where appropriately labelled medicines may be supplied directly to patients. The medicines or prepacks must be ordered via WUTH pharmacy department from a licensed supplier and must be labelled with directions and all legally required information. Prepacks will be given to patients to fulfil a prescription or under the conditions of a patient group direction or patient specific direction. If a member of NHS Wirral staff has a query relating to a specific medication, e.g. product/dose, labelling instructions, quantity supplied, they should contact the dispensing pharmacist or prescriber for clarification. 16/40

17 7.3. Verbal orders The use of verbal orders for administration of medication is not supported by NHS Wirral and must not be carried out by NHS Wirral employees. 8. Administration of Medicines 8.1 Consent Valid consent must be obtained before starting any treatment including the administration of medicines. For consent to be valid it must be given voluntarily by an appropriately informed person. No-one can give consent on behalf of an incompetent adult; however such patients can be treated if the treatment would be in their best interest. Refer to NHS Wirral Consent Policy for further details. 8.2 Principles of Safe Administration of Medicines In exercising professional accountability, in the best interests of the patients, staff who are authorised to administer medicines must:- Be certain of the identity of the patient to whom the medicine is to be administered. Ascertain that the prescribed dose has not already been given. Know the therapeutic uses of the medicine to be administered, its normal dosage, side effects, precautions and contra-indications. Where it is appropriate for a care plan to be in place, know the current contents of the patient s care plan. Check that the prescription, patient group direction or the label on a medicine dispensed by a pharmacist, is clearly written and unambiguous with clear information on:- - The name of medication. - The dosage. - The name of the patient for whom the medicine is prescribed (In the case of patient group directions the name of the patient will not be documented on the actual PGD). - Frequency of administration. - Route of administration. - In the case of PGDs ensure that all conditions are fully met (It is therefore essential that practitioners have a copy of the relevant PGD with them during administration or supply and they refer directly to it ). - Have considered the dosage, method of administration, route and timing of the administration in the context of the patient and co-existing therapies. Check the expiry date of the medication to be administered. 17/40

18 Check that the patient is not allergic to the medication before administering it. Administer or withhold in the context of the patient s condition (e.g. digoxin is not usually given to patients if their pulse is below 60) Contact the doctor or another authorised prescriber without delay where contraindications to the prescribed medication are discovered, where the patient develops a reaction to the medication, or where assessment of the patient indicates that the medication is no longer suitable. Make a clear, accurate and immediate record of all medicines administered, intentionally withheld or refused by the patient, ensuring that any written entries including the signature are clear and legible together with the date of administration. Where medication is not given the reason for not doing so must be recorded. When supervising a student nurse in the administration of medicines, clearly countersign the signature of the student. Certain medicines such as cytotoxics or warfarin require special consideration, in the event of NHS Provider Services being requested to administer these medications, departmental SOPs must be followed. When using syringes there is a risk of wrong route errors if the correct syringe is not used. When administering oral or enteral doses ensure that an appropriate purple coloured oral/ enteral syringe is used. When administering insulin ensure that an insulin syringe or commercial insulin pen is used. This is essential, because the use of intravenous syringes to administer insulin has lead to incidences of overdose. When administering medication via the intravenous route, two appropriately trained staff members are required to check the medication to be administered (one of whom must be a registered nurse who then administers the intravenous medication) To reduce the risks of missed medications, a team management system should be in place, for example Community Nursing have an approved system of maintaining a team diary for safe work allocation. 8.3 Incident Reporting in the Event of a Medication Error It is widely acknowledged that errors or near misses may occur. To build a safer NHS for patients all healthcare organisations are being encouraged to develop a culture of openness. Reporting medication errors is essential if underlying problems are to be addressed. Errors can be due to many factors, which can include:- - Poor communication within the clinical team - Lack of supervision - Lack of competence - Insufficient training - System failures - Poor record keeping Everyone can learn from mistakes. A fair blame approach to medication errors will contribute to Continuing Professional Development and a safer environment of care for patients. 18/40

19 When an error occurs the following steps must be taken: Make sure the patient is safe and if necessary call emergency services or the Medical Practitioner as dictated by clinical need. Record any advice given, ensuring suggested monitoring arrangements are followed and documented. Ensure any evidence relating to the error is retained and not tampered with. (Evidence will include any relevant documentation, the remaining medication administered and any packaging or administration equipment.) Inform line manager immediately who will refer to the, Being Open policy, to support communication with patients and / or carers. Inform the General Practitioner or other Medical Practitioner with clinical responsibility. Complete an incident form and fax on the same day to Practitioner in Charge/ Manager. Hard copy to follow in the post. Discuss with line manager and clinical team to identify future prevention systems. In certain circumstances, at the weekend or out of hours, the line manager may need to inform the manager on call if there are critical implications. All completed incident forms must be sent to the Governance Team who will record the incident and forward a copy of the incident to the Head of Medicines Management and the Service Improvement Unit. If an incident involving Provider Staff has caused patient harm, the Service Improvement Unit, will appoint a root cause analysis (RCA) lead within 2 working days. The Medicines Management Team will provide expert medicines information to inform this process as required. The investigation will be completed within 28 days. Recommendations will be considered including reviewing any related policies or procedures. RCA Leads ensure any remedial actions following incidents will be followed up and implemented. Where there is a need for early action, for example for any incident involving controlled drugs, oxygen or where a pharmacy dispensing error is suspected, the Head of Medicines Management (who is also the Accountable Officer for Controlled Drugs) must also be contacted immediately). If a medication error has occurred within a patient s home, the healthcare professional who discovered the error must also ensure that systems are in place to monitor the patient s condition appropriately over the following 24 hours. The GP should be informed at the earliest opportunity and an action plan drafted that defines what service will be responsible for monitoring the patient and keeping other key healthcare professionals updated. An incident form should also be completed For staff members who require legal advice from NHS Wirral following an incident, it is essential that they seek guidance from their immediate line manager. NB In cases where there has been a near miss, it is important to report as an incident as the systems for administering medications may need to be altered. This system is a proactive way of preventing the incident from actually occurring. 19/40

20 For further details refer to NHS Wirral Incident Reporting Policy 8.4 Self Administration It is a patient s right to self-administer their own medicines if willing and able to do so. However, some patients have difficulty managing their medicines safely and sometimes NHS Wirral staff are the only people to see these patients and, therefore, can highlight the need for help. To self administer, the patient needs to be at Level Three, as defined by the Nursing and Midwifery Council The patient accepts full responsibility for the storage and administration of the medicinal products and the level should be documented in the patient s records. Practitioners should be aware that the Mental Capacity Act 2005 requires all those working with potentially incapacitated people to assess the individual s capacity at a particular moment about a particular decision. Any change in the patient s condition would necessitate a review of their self administration status Patients unable to self-administer medication NHS Wirral employees caring for or managing patients who are self-administering medication should be aware of factors affecting patients ability to self-medicate. Self-administration from dispensed containers may not be possible for some patients. In such cases the advice of a community pharmacist or the patient s GP must be sought. The most appropriate form of help can then be identified. If a patient requires a compliance aid such as monitored dose container, this must be dispensed, labelled and sealed by a pharmacist. If there is a delay in allocating a pharmacist to fill a compliance aid, NHS Wirral staff must inform the patient that NHS Wirral staff are unable to fill compliance aids because of the risk of error. This information must be clearly documented in the patient s record. 9. Disposal of Pharmaceutical Waste Pharmaceutical Waste can be divided into three broad groups: Pharmaceutical Hazardous (cytotoxic and cytostatic) Pharmaceutical Non-Hazardous (non-cytotoxic and non-cytostatic) Or not pharmaceutically active and possessing no hazardous properties e.g. sodium chloride or glucose solutions The disposal of pharmaceutical waste must be outlined in SOPs specific to each department. Pharmaceutical hazardous waste must be disposed of in clearly labelled purple lidded waste containers for incineration, ensuring bins are not overfilled. 20/40

21 Pharmaceutical non-hazardous waste must be disposed of in clearly labelled yellowlidded waste containers for incineration, ensuring bins are not overfilled. For information on the classification and labelling of pharmaceutical waste, refer to the Management of Healthcare Waste Policy or alternatively seek the advice of the Medicines Governance Pharmacist. Written records, signed and dated of medication disposed of, must be kept for a period of two years to maintain an audit trail. Patients medication remains the property of the patient. Carers should be encouraged to return any unused medication to their community pharmacy. Community pharmacies may operate a pick up as well as a delivery service for housebound patients. NHS Wirral employees must not remove medicines from the patient s home. For disposal of Controlled Drugs see section Controlled Drugs (CDs) 10.1 Ordering of CDs from WUTH Certain departments such as GP Out of Hours, Minor Injuries VCH and Leasowe Primary Care Centre are able to order stock CDs from WUTH Pharmacy. The responsibility for ordering, receipt and storage of CDs is with the Assigned Practitioner in charge of the department who must also be a registered doctor. CDs can only be ordered from WUTH by submitting a requisition from the official Controlled Drugs Requisition Book. Ordering is restricted to an Assigned Practitioner in charge. All Assigned Practitioners who may order CDs must provide WUTH with specimen signatures Receipt of CDs from WUTH All CDs must be delivered to departments in a secure container or picked up directly from WUTH Pharmacy by a Designated Practitioner with an identification badge. Where appropriate a porter may deliver CDs in a secure container. The porter must sign a Drugs Delivery Record Sheet. A Designated Practitioner must receive the package and sign the Drugs Delivery Record Sheet. The Designated Practitioner is signing for receipt of a secure pharmacy container. The designated practitioner must be a registered nurse or a doctor. A Designated Practitioner must check the amount delivered against the requisition. Any discrepancy must be reported immediately to WUTH. If correct the Designated Practitioner must sign the Requisition. The Designated Practitioner must enter the new stock into the CD Register on the appropriate page, witnessed by another Designated Practitioner or Authorised Employee who must verify the stock level and sign the CD Register. The medicines must then be immediately locked away. For controlled drugs received into stock the following details must be recorded in the CD register: 1. The date on which the CD was received 2. The name of the pharmacy who supplied the CD 21/40

22 3. The quantity received 4. The name, form and strength of the CD Where sealed packs of Controlled Drugs are supplied with tamper evident seals there is no requirement to open these packs for stock checking purposes. Registers and requisition books for Controlled Drugs are controlled stationery and obtainable only from WUTH Pharmacy. Requisition books should be locked away. Orders and records must be in permanent ink and must be retained for a minimum of two years from the last entry in the book Storage of CDs Storage of CDs in Departments CDs must be stored in a locked, controlled drug cabinet that complies with The Misuse of Drugs (Safe Custody) Regulations Access must be limited to Designated Practitioners who must also be registered nurses or doctors. Stocks of CDs should be kept to a minimum. High strength opiates must not be stored alongside lower strength products due to known risks from selection errors. CDs must be kept in the container issued by the supplying pharmacy Storage of CDs in Doctor s Bags Where doctors are visiting patients in their own homes, there are occasions when CDs may need to be transported in a doctor s bag. A doctor s bag is a locked bag or case which should be kept locked at all times, except when in immediate use. If CDs are stored in a doctor s bag the details on storage, security and documentation must be outlined in an approved standard operating procedure Storage of CDs in Patients Homes There is no legislation covering how patients should store CDs in their own homes. Community nursing staff however should encourage self medicating patients to store their medicines in a secure location, away from sources of direct heat or high humidity. Consideration must also be given to ensuring vulnerable persons such as children do not have access to the medicines. CDs are medicines of potential abuse, storage should therefore be out of sight of visitors to the patient s home, whilst maintaining access to visiting nursing staff. As there may be several different nursing staff visiting a particular patient, it is advisable for all the patient s medicines to be stored in one area known by all visiting nurses. Controlled drugs administered only by community nursing services should be stored in Envo packs, sealed with a numbered tag, to aid stock control and provide evidence of potential tampering. All advice given to patients or carers on the storage of CDs must be recorded in the patient s record. 22/40

23 10.4 CD Stock Reconciliation Any department stocking CDs must perform a stock reconciliation. The accountability for maintaining the correct balance of CD stock lies with the Practitioner in Charge who may delegate this task to an Assigned Practitioner in Charge. Controlled drug stock reconciliation should be performed at each shift change, or at least every working day. Although community nurses are not involved in the ordering of controlled drugs which are prescribed for patients and administered in the patient s own home, community nurses are required to keep a running balance of the amount of these prescribed controlled drugs stored within the patient s home Procedure for Missing CDs Procedure for Missing CDs in Departments In the event of any discrepancy in the amount of CDs stocked within a department the Appointed Practitioner in Charge must immediately investigate the discrepancy. Double check the count, ensuring all medication has been checked in the manufacturer s packaging. Contact the Practitioner in Charge to report the discrepancy. In addition to completing the incident form, inform the Accountable Officer for Controlled Drugs (the Head of Medicines Management) ideally via or failing that by telephone on the day of the incident. Refer to NHS Wirral incident reporting policy for further details If the loss cannot be resolved satisfactorily the Local Security Management Specialist must be informed Procedure for Missing CDs in Community Nursing In the event of any discrepancy in CDs the Designated Practitioner must immediately investigate the loss. Double check the count, ensuring all medication has been checked in the manufacturer s packaging. Check with the patient / carer to determine if any further information is available. The nurse must record the incident in the patient s records and on the medication chart, including the date, time and signature. Contact the surgery to check the GP has not administered or removed controlled drugs from the patient s home. This action must also be recorded in the patient s notes. Contact the nurses who had previously visited to ensure there was no drug discrepancy at the last visit. Contact the line manger to report discrepancy. All of the above must be reported with a completed incident form which is to be faxed to both the Community Nursing Manager and the Accountable Officer for Controlled Drugs. 23/40

24 The Accountable Officer for Controlled Drugs (the Head of Medicines Management) must be informed ideally via or failing that, via telephone on the day of the incident. Refer to NHS Wirral incident reporting policy for further details. If the loss cannot be resolved satisfactorily the Local Security Management Specialist must be informed Administration of CDs Dosages and frequencies for all controlled drugs should be written in full by the prescriber, to aid correct administration. Particular care must be taken to ensure clarity of dosage instructions where syringe drivers are being used. Two appropriately trained staff members (one of whom must be a registered nurse) are required to be present when setting up and re-priming a syringe driver, refer to the NHS Wirral Graseby MS26 Syringe Driver Procedure for the Administration of Palliative Medicines for full details. There have been cases reported locally where carers who are healthcare professionals have sought involvement in administration of parental opiates. If the community nursing team is involved in the package of care, the Practitioner in Charge should complete a risk assessment, refer to the Clinical Protocol for Self-Administration of Medicines and Administration of Medicines Supported by Family/Informal Carers of Patients in Community Nursing for further details. Patients who have not previously received parental opiates must be observed by the designated practitioner for any signs of adverse effects for a minimum of 15 minutes after administration. The patient or carers must be advised to contact the team, if there is deterioration in the patient s condition. Out of hours and weekend cover contact details must be left with the patient and/or carers. Refer to Section 8.2 to follow the principles of safe administration of medicines 10.7 Disposal of CDs Those healthcare professionals and service providers required by law to maintain a CD register are not allowed to destroy controlled drugs from their stock without the destruction being witnessed by an authorised person. People authorised to witness the destruction of CDs include, Police Constables, Primary Care Trust Chief Pharmacists or Prescribing Advisers who have been authorised by the Accountable Officer. The Accountable Officer will not undertake destruction, as one of the criteria for Accountable Officer is their independence from day to day management of controlled drugs Disposal of Expired Stock CDs from Departments When stock controlled drugs become expired they should be clearly marked as, date expired and segregated from other stock to prevent them from being used in error. The destruction of 24/40