MEDICINE MANAGEMENT POLICY

Transcription

1 MEDICINE MANAGEMENT POLICY NWAS Medicine Management Policy Page: Page 1 of 43

2 Approved by Quality Committee Approval date January 2014 Version number 3.0 Review date January 2016 Responsible Director Responsible Manager (Sponsor) For use by Medical Director Assistant Director, Clinical Practice All Trust employees This policy is available in alternative formats on request. Please contact the Senior Clinical Quality Manager on NWAS Medicine Management Policy Page: Page 2 of 43

3 Change record form Version Date of change Date of release Changed by Reason for change 0.1 Mar 2008 Apr 2008 M Peters Draft document 1.0 Apr 2008 Apr 2008 M Peters Final document 1.1 Oct 2010 Oct 2010 M Peters NHSLA Monitoring 0.2 Apr 2011 Apr 2011 M Peters Document Review 0.3 May 2011 May 2011 M Peters Document Review Jun Sep 2011 M Peters Board approved version 0.4 Dec 2013 M Peters Document Review 3.0 Jan 2014 Jan 2014 M Peters Document Review NWAS Medicine Management Policy Page: Page 3 of 43

4 Medicine Management Policy Contents Section A: Medicine Management Policy Introduction Purpose of Policy Duties Risk Assessment of Medicines Medicines Procurement Vehicle and station storage Medicines Administration Documentation Standards and Audits Security Standard Operating Procedures (SOPs) Waste Management Section B: Legal Framework Introduction Medicines Act Misuse of Drugs Act Misuse of Drugs Regulations 2001 (MDR) Misuse of Drugs (Safe Custody) Regulations Health Act NWAS Medicine Management Policy Page: Page 4 of 43

5 Section C: Patient Group Directions: Legal Framework Introduction Section D: Controlled Drugs: Legal Framework Controlled Drugs Classification of Controlled Drugs Authority to Possess and Supply Storage of Controlled Drugs Governance Arrangements Controlled Drugs: Accountable Officer Section E: Policy Review Equality and Diversity Policy Review Monitoring NWAS Medicine Management Policy Page: Page 5 of 43

6 Appendix 1: Patient Group Directions General Information Content of PGD Authorised Persons Distribution Changes Responsibilities PGD Template Appendix 2: Accountable Officer Report Template Appendix 3: Accountable Officer Procedures Management of Concerns Serious Concerns Remedial Actions: Dealing at local level Support for Health Care Professionals Closure of Cases NWAS Medicine Management Policy Page: Page 6 of 43

7 Section A: Medicine Management Policy 1. Introduction The purpose of this policy is to provide a series of standards and procedures to ensure the safe and secure handling of medicines, including Controlled Drugs, within the North West Ambulance Service NHS Trust (NWAS). The policy will ensure compliance with current legislation and national guidance, while meeting the needs of the service. It is not the intention of this policy to inform staff of the clinical indications for use of specific drug protocols. 1.1 Policy Aims To ensure that all healthcare professionals involved with the use of medicines are fully conversant with the standard procedures for dealing with medicines. To set out safe systems for procuring, requisitioning, handling, storing, transporting, administering and disposing of all medicines used by NWAS whilst at the same time ensuring the protection of patients and staff by reducing risk and the potential for error. To act as a reference source for guidance. Standard Operating Procedures dealing with detailed aspects of the dayto-day management of medicines are available in the A-Z Guide 2. Purpose of Policy The Medicine Management Policy is intended as a working document for all individuals dealing with medicines within NWAS NHS Trust. It offers a framework of processes for all aspects of medicines management including supply, administration, storage, disposal and adverse incident reporting. It is a multidisciplinary document that is intended to be as comprehensive and as inclusive as possible. 2.1 Scope This policy should be read and the guidance must be followed by all staff who are working for NWAS (on a paid or voluntary basis) and who administer medicines to patients. This includes the North West Air Ambulance, and where appropriate voluntary personnel such as Staff and Community First Responders. NWAS Medicine Management Policy Page: Page 7 of 43

8 The policy relates to the operational management of all medicines used by the Trust. All staff should be aware that any failure to adhere to this policy may result in disciplinary action or in cases where a criminal offence may have been committed referral to the Police or the Counter Fraud and Security Management Service. 3. Duties The Chief Executive has the overall statutory responsibility for the safe and secure handling of medicines. The Trust Board are responsible for ensuring that adequate resources are made available to facilitate Medicines Management, including the provision of a Trust Pharmacist Advisor. The Chief Executive has devolved responsibility for the day to day management of medicines to the Trust s Medical Director. The Medical Director with specialist advice from the Trust s Pharmacist Advisor and the Medical Directorate Senior Management Team will determine the medicines management strategy for the Trust and will determine the standards to be used for the administration of all medicines used by the Trust. The Medical Director is the named NWAS Controlled Drugs Accountable Officer (AO). Responsibilities as AO are: To ensure the safe and effective management and use of CDs within the Trust To share information about concerns regarding CDs with other agencies through the Local Intelligence Networks (LIN), The Medical Director is also responsible for: The production of policies and procedures advising on the day to day safe and secure handling of medicines throughout the Trust. Ensuring that the policy is reviewed every 2 years. Any necessary amendments to these documents should reflect and take account of changes in the legal framework relating to medicines management. Monitoring and review of the formulary drugs to be used by NWAS staff. Ensuring Patient Group Directions (PGDs) are in place and kept up to date. Ensure that the NWAS Drug Formulary medicines are used according to current legislation. NWAS Medicine Management Policy Page: Page 8 of 43

9 Ensuring that any identified medicines related risks are placed on the Directorate and, if applicable, the Trust Risk registers. The day to day responsibilities can be devolved to a named member of staff, the Head of Clinical Governance. The Assistant Clinical Director is responsible for ensuring that the Trust has the necessary policies and procedures in place for the safe management of medicines, The Head of Clinical Governance is responsible for the corporate development, implementation and performance management of policies and procedures, including the provision of expert advice on the management of Medicines within the Trust. The Head of Clinical Governance (HoCG) is responsible for managing and supporting the development process of all PGDs. The day to day responsibilities of the Accountable Officer (AO) are devolved to the HoCG who will ensure that the AO has sufficient access to and support from the Trust Pharmacist Advisor, Clinical Governance Co-ordinator and Clinical Governance & Safety Manager. The HoCG is responsible for the dissemination and follow up of defective medicines reports in a timely manner. The Head of Clinical Education is responsible for ensuring that suitable and sufficient education and training is developed to support the implementation of any PGDs and medicine management procedures. The Senior Clinical Quality Manager (SCQM) is responsible for coordinating the implementation and performance management of medicine management related policies and procedures across the Trust. The SCQM will also be responsible for managing day to day medicine management issues at a corporate level such as Drug Alerts. The SCQM will hold a register of all PGDs in development and must therefore be notified once the PGD development process is started, and is responsible for ensuring that the appropriate pharmaceutical support is provided via the Trust Pharmacist Advisor. The Clinical Governance Manager is responsible for supporting the operational implementation and performance management of policies and procedures, including the day to day provision of advice and support for medicine management issues. The Medicines Performance Facilitator is responsible for managing the day to day medicine management issues at local level such as Drug Alerts. The facilitator will be responsible for conducting independent medicines management audit at sector level and a point of contact about day to day local medicine issues or concerns. At NWAS Medicine Management Policy Page: Page 9 of 43

10 local level the facilitator will be responsible for co-ordinating the PGD development process. The Sector Managers and Operational Managers within Service Delivery are responsible for: Supporting the operational implementation and performance management of policies and procedures. Making checks to ensure compliance with the Medicine Management Policy at least every 3 months. Such checks are to be recorded and retained for audit purposes for at least 2 years. Ensuring that the Head of Clinical Governance and the Senior Clinical Quality Manager are made aware in a timely manner of any adverse incidents regarding medicines management. The Advanced Paramedics within Service Delivery are responsible for: Supporting all Trust personnel, who are responsible for medicines, in familiarisation and maintenance of the standards identified in the policy and procedures. Supporting the Sector Managers and Operational Managers in their role with regard to the management of medicines. Undertaking random audit checks of Controlled Drugs Support the local implementation of PGDs by being responsible for ensuring staff are informed at local level. Paramedics, Student Paramedics, EMT2, and EMT1s are trained according to their profession and level of competency in good practice and legislative requirements in the supply, administration, storage and disposal of medicines. It is their responsibility to remain up to date and to attend any training provided by the Trust maintaining full CPD records. It is the responsibility of all Trust personnel, who are responsible for medicines: To be familiar with the policy and procedure and adhere to them at all times. To be personally responsible for the security safe storage and management of all medicines whilst they are in their possession. The Clinical Governance Group is accountable to the Trust Board and operates within agreed terms of reference. The group will: NWAS Medicine Management Policy Page: Page 10 of 43

11 Monitor standards and performance in relation to medicine management and provide assurance to the Trust Board with regards to Medicine Management standards. It is the responsibility of Organisational Performance Group to: Monitor standards and area performance in relation to agreed medicine management quality indicators. Ensure that any issues relating to medicines management are appropriately managed with necessary actions. 4. Risk Assessment of Medicines Risk assessments should be carried out (in accordance with the Trust s Risk Management Policy) in connection with the drug products and procedures (including the use of delivery devices) to determine potential risks to patients and staff. The Head of Clinical Governance and Trust Pharmacist Advisor are responsible for ensuring a risk assessment is completed when a new drug related product is introduced. In the event of staff identifying a drug product specification change locally, the Governance Manager is responsible for ensuring a risk assessment is complete with appropriate control measures put in place. The Clinical Governance Manager must communicate local risk assessment information to the Senior Clinical Quality Manager for dissemination via the Healthcare Governance Alert and Review procedure. 4.1 Adverse Drug Reactions Adverse drug reactions are unwanted or unintended effects of a medicine that occur in normal clinical use. Adverse reactions occur relatively frequently and many have a significant impact on the patient s life. A standard operating procedure is in place to manage adverse drug reactions (ADR). All serious reactions to drugs administered by ambulance staff must be reported via the Trust Incident Reporting and Investigation Policy. The Yellow Card Scheme is used for the reporting of ADRs nationally. NWAS Medicine Management Policy Page: Page 11 of 43

12 If an ADR occurs staff must contact an Advanced Paramedic for support in completing the process; and the NWAS Incident Reporting and Investigating Policy followed. 4.2 The reporting of Defective Medicines and Drug Alerts Health Service Guidelines HSG (93) 13 requires Chief Executives to ensure prompt reporting of adverse incidents and reactions, and defective medical products. The Trust has a system for the dissemination of hazard/recall notices issued by the Medicines and Healthcare products regulatory Agency (MHRA), via Quality Control North West (QCNW based at Stepping Hill Hospital) together with a procedure for the identification and assessment of these untoward events. All incidents must also be reported through the Trust NWAS Incident Reporting and Investigating Policy. Further information or guidance can be obtained from the following sources: Web: Telephone: (weekdays ) Telephone: (other times) Fax: [email protected] Address Information Centre 10-2, Market Towers 1 Nine Elms Lane London SW8 5NQ 4.3 Control of Substances Hazardous to Health (COSHH) In addition to the acknowledged side effects of medicines or drug reactions in some patients and can be hazardous if misused; certain medicines have additional inherent risks to staff handling them. COSHH assessments should be carried out for hazardous substances used. 5. Medicines Procurement Only medicines that form the NWAS drug formulary will be purchased. The medicines stocks will be obtained from an approved supplier at NHS contract prices. The mechanisms for ensuring that medicine are appropriately procured, stored and destroyed (if necessary) are detailed in Trust SOPs. NWAS Medicine Management Policy Page: Page 12 of 43

13 The quantity of each medicine to be carried in each vehicle will be determined from usage patterns. Medicines stocks on each vehicle will be checked at the beginning of each shift. 6. Vehicle and Station Storage It is the responsibility of paramedic staff and EMT staff (for medicines they are authorised to administer) whilst on duty to ensure correct storage of medicines. A list of formulary medicines will be published by the Head of Clinical Governance. The list will specify the stock levels and storage requirements for each medicine. Copies of the list will be available on each vehicle. It is the responsibility of the person administering the medicine to ensure that the medicine is restocked as soon as possible whilst ensuring the vehicle remains available for responding to incidents. Medicines must be restocked to the levels specified in vehicle documentation. 7. Medicines Administration All medicines administered or supplied within NWAS are solely for use by patients of the Trust. All medicines supplied and/or administered within NWAS are done so in accordance to this policy. Medicine administration follows the advice detailed in the Joint Royal Colleges Ambulance Liaison Committee s (JRCALC) Guidelines. NWAS has adapted the relevant sections of these guidelines for the needs of the population served by the Trust into a concise operational guide Clear Vision. This is used by all trained ambulance staff in the pre-hospital treatment of patients. The guide details the procedures for the use of medicines by trained and registered paramedics and in restricted circumstances by EMT staff. Sufficient information about the medication stored on the vehicles should be available to enable correct identification and use of the product All ambulance crew members will record the administration of medicines to patients using the appropriate documentation, which should be conveyed to appropriate staff on arrival at hospital. NWAS Medicine Management Policy Page: Page 13 of 43

14 Medicines refused, wasted or disposed of should be recorded. 8. Documentation Standards and Audit It is essential that NWAS is able to trace all medicines from receipt through to administration or disposal. All staff must complete the necessary documentation in order to maintain a full audit trail. The Trust Clinical Governance & Safety Sub-committee is responsible for determining specific audit requirements in relation to Medicine Management Standards. The Clinical Governance Department is responsible for facilitating the audit process and the production of the subsequent reports. The audit will be a specified part of the Annual Trust Clinical Audit Plan. The Service Delivery Management Team are responsible for ensuring that adequate resources are made available via the supervisory/management structure, to support the audit process and subsequent quality improvements, led by the Advanced Paramedic Teams, at an operational level. 9. Security It is the responsibility of staff while on duty to maintain adequate security for all medicines. Station and pharmacy medicines cupboards must be securely locked at all times. Drug packs or advanced medicine bags must be stored securely on ambulance vehicles within lockable cabinets or storage devices, where available. Drug packs or advanced medicine bags must be stored securely within the designated storage area or boot of response vehicles and managers cars. While outside the physical confines of the station, all vehicles carrying drugs must be completely locked when left unattended this includes while parked at hospital sites. If a vehicle, station or pharmacy cupboard security mechanisms are found to be inoperable, it must be reported to the appropriate Emergency Control Centre immediately and the appropriate line manager informed. The Trust Incident reporting procedures must be followed in these instances. NWAS Medicine Management Policy Page: Page 14 of 43

15 In the case of a vehicle security issue, the appropriate line manager must assess the level of risk and if necessary make arrangements for an alternative vehicle to be utilised. In all circumstances of security mechanism failure, arrangements must be made with workshops or an appropriate maintenance team to ensure that repairs are completed as soon as possible. 10. Standard Operating Procedures (SOPs) A SOP is an unambiguous document, describing the responsibilities and the procedures, including audit, necessary to safely manage any set of processes, in this case around the management of medicines, including controlled drugs. A SOP is a working document detailing the current agreed working practice that takes account of all areas that are applicable to the management of medicines and controlled drugs in an individual setting. SOPs are designed to: Improve governance of medicines and controlled drugs within the Trust Provide clarity and consistency for all the staff handling medicines and controlled drugs Define accountability and responsibilities and clarify where responsibility can be delegated Ensure practice is in line with regulatory frameworks Act as a training tool for new and existing staff SOPs are required for every stage of the medicine or controlled drug journey from procurement (ordering, receipt and transport), safe storage, supply, administration, destruction, including guidance for dealing with an adverse incident. The Trust will ensure that there are suitable and sufficient SOPs in place for the management of all medicines within the Trust, including Controlled Drugs. The SOPs are contained in the A-Z Toolkit. The Trust SOPs will be reviewed on a 3 yearly basis unless there are any identified risks or learning from adverse incidents in which case a review of the specific SOPs will be undertaken sooner. 11. Waste Management Medicines disposal will be according to Trust procedures and in line with waste regulations NWAS Medicine Management Policy Page: Page 15 of 43

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17 SECTION B: Legal Framework 12. Introduction For the purpose of this policy, medicines are defined as substances included in the 1968 Medicines Act as medicinal products. The MHRA defines a medicinal product under Article 1 of Directive 2001/83/EC as: a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting in modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. 13. Medicines Act 1968 The Medicines Act 1968 and associated regulations set out the requirements for and regulates the general sale, supply and administration of medicines. Each medicine is assigned to one of three legal categories: General Sales List (GSL) Pharmacy (P) or Prescription Only Medicines (POM) The classifications determine how medicines can be supplied to the public. The general rule is that Pharmacy medicines and POMs may only be sold or supplied through registered pharmacies (registered with the General Pharmaceutical Council); and unless self administered injectable POMs may only be administered or supplied under the directions of a prescriber or patient group direction. The Medicines Act applies different legal requirements to the sale, supply, dispensing, labelling and administration of each class. The majority of medicines used in the ambulance service are Prescription Only Medicines. Ambulance Paramedics are able to administer certain POMs due to the exemptions SI 2004 No 1189; and SI 1997 No Ambulance Paramedics may also administer POMs, Pharmacy Medicines and General Sale List medicines under PGDs. NWAS Medicine Management Policy Page: Page 17 of 43

18 The Act provides that certain injectable products may be administered by way of parenteral injection for the purpose of saving life in an emergency; and these drugs may be administered by persons other than a Paramedic. 14. Misuse of Drugs Act 1971 The management of Controlled Drugs (CDs) is governed by the Misuse of Drugs Act (1971) and its associated regulations (in England and Wales). There are additional statutory measures for the management of CDs in the Health Act 2006 and its associated regulations. The primary purpose of the Misuse of Drugs Act is to prevent misuse and makes it unlawful to possess or supply a CD unless and exception of an exemption applies. Paramedics are authorised under Group Authority (under an exemption to the POM order (part III to Schedule 5)) to possess and supply to another person authorised to possess Controlled Drugs, morphine and diazepam for the immediate and necessary treatment of sick and injured persons. They are authorised to administer morphine or diazepam to patients in the course of their duty and in line with agreed guidelines. Any other CD must be prescribed by a Doctor or independent prescriber. 15. Misuse of Drugs Regulations 2001 (MDR) The use of CDs is permitted by the MDR The MDR classify CDs in five schedules according to the different levels of control required. Schedule 1 CDs are subject to the highest level of control, whereas Schedule 5 CDs are subject to a much lower level of control. MDRs are periodically amended and reviewed; further information can be obtained via See also Section D Controlled Drugs 16. Misuse of Drugs (Safe Custody) Regulations 1973 The Misuse of Drugs (Safe Custody) Regulations 1973 (SI 1973 no. 798), cover the safe custody of CDs in certain specified premises. The regulations included certain standards for safes and cabinets used to store CDs. All NWAS vehicles are fitted with complying CD cabinets in accordance with these regulations NWAS Medicine Management Policy Page: Page 18 of 43

19 17. Health Act 2006 The Health Act 2006 placed a duty of collaboration on healthcare organisations and others including professional regulatory bodies, police forces and the Care Quality Commission (CQC). Included in the Health Act 2006 are monitoring and inspection arrangements for controlled drugs. These are designed to work within and alongside existing governance systems and should be seen as an integral part of the overall drive to improve quality in healthcare. To this end NWAS has introduced standard operating procedures for the use and management of controlled drugs. The CQC has the overall monitoring responsibility for ensuring healthcare organisations comply with the CD regulations and will periodically require assurance statements from the Trust along with associated evidence to validate them. NWAS Medicine Management Policy Page: Page 19 of 43

20 Section C: Patient Group Directions: Legislative Framework 18. Introduction Patient Group Directions (PGDs) allow named healthcare professionals, other than medical practitioners, to supply and or administer but not prescribe- medication without having to call upon a doctor to prescribe medication in each individual case. PGDs must meet the requirements set out in the Health Services Circular 026/2000; and should meet the signatory requirements specified in 9(b)(iv) of the Prescription Only Medicines (Human Use) Amendment Order This policy outlines the processes to assist with the development and approval of Patient Group Directions (PGD) within the Trust. The document also acts as a guide for the supply and administration of medicines under Patient Group Directions (PGD). (See Appendix 2) NWAS Medicine Management Policy Page: Page 20 of 43

21 SECTION D: CONTROLLED DRUGS 19. Controlled Drugs State Registered Paramedics are authorised under a Group Authority to lawfully possess and administer morphine sulphate and diazepam to patients within their care due to the Prescription Only Medicines (Human Use) Amendment (No.2) Order 200 SI 2000, No and the issuing of a group authority to NHS Ambulance Paramedics under the Misuse of Drugs Regulations 1985 on 15 January Classification of Controlled Drugs Misuse of Drugs Regulations 2001 (2001 Regulations) divide CDs into 5 schedules. For the purposes of NWAS, the relevant schedules are as follows:- Schedule 2: includes diamorphine and morphine Schedule 3: includes midazolam Schedule 4: o Part 1: (CD Benz POM) contains most of the benzodiazepines including diazepam and ketamine o Part 2: (CD Anab POM) contains most of the anabolic and androgenic steroids. Schedule 5: CD preparations exempted from full control when present in medicinal products of low strength including dihydrocodeine. The schedules relate to the different levels of control over the supply, documentation, record keeping, preservation of records and procedure for destruction of the medications contained in each schedule. 21. Authority to Possess and Supply It is unlawful for any person to be in possession of a Controlled Drug in Schedule 2, 3 and 4 unless: That person holds appropriate Home Office License That person is a member of a class specified in the regulations e.g. State Registered Paramedics The regulations provide that possession of that drug or group of drugs is not unlawful e.g. anabolic steroids in a medicinal product. They have been lawfully prescribed for that person. NWAS Medicine Management Policy Page: Page 21 of 43

22 Possession or supply is not lawful unless the person is acting in his capacity as a member of his class, or in accordance with the terms of his licence or group authority. Paramedics have group authority to possess and administer morphine (schedule 2) and diazepam (schedule 4). These are the only CDs that may be held in stock within Ambulance Stations, Ambulances and other Trust vehicles. The Misuse of Drugs Act 1971 provides an exemption to allow for a person engaged in conveying (or courier) to bring the drug to a person authorised by the regulations to have it in his/her possession, such as a Paramedic. Non-paramedic staff are authorised to assist Paramedics for the purposes of stock control and preparation for patient administration. Note: Non-paramedics are not authorised to possess CDs. Other ambulance staff are not permitted to have morphine in their possession at any time. 22. Storage of Controlled Drugs Schedule 2 Drugs are subject to safe custody requirements (under the Misuse of Drugs Safe Custody Regulations 1973). They must be stored in a locked receptacle, such as an appropriate CD cabinet or approved safe, which can only be opened by the person in lawful possession of the CD or a person authorised to use them. 23. Governance Arrangements The Health Act 2006 introduced a number of strengthened governance arrangements for the management of CDs. The key provisions of the Act are: All designated bodies such as healthcare organisations and independent hospitals are required to appoint an Accountable Officer. A duty of collaboration placed on responsible bodies, healthcare organisations and other local and national agencies, including professional regulatory bodies, police forces, (in England Care Quality Commission) to share intelligence on CD issues; NWAS Medicine Management Policy Page: Page 22 of 43

23 A power of entry and inspection for the police and other nominated people to enter premises to inspect stocks and records of CDs. 24. Controlled Drugs Accountable Officer Regulations made under the Health Act 2006 requires each healthcare organisation to appoint an Accountable Officer (AO); responsible for the safe and effective use of controlled drugs in their organisation. The regulations require AOs to ensure that his or her organisation, or a body or person acting on behalf of, or providing services under contract with his or her organisation, has adequate and up-to-date Standard Operating Procedures (SOPs) in relation to the use of controlled drugs. The Accountable Officer for NWAS NHS Trust is the Trust Medical Director. They must ensure compliance with the Misuse of Drugs Act 1971, Misuse of Drugs (Safe Custody) 1975 and the Misuse of Drugs Regulations 2001 as amended. The AO is registered with the Care Quality Commission and NWAS is required to update the CQC according if personnel changes occur. The AO is responsible for ensuring the safe and effective use and management of CDs within the Trust. In particular the AO is responsible for ensuring: That there are sufficient routine monitoring systems in place for both positive and negative indicators and benchmarking. That the monitoring and reporting systems are robust enough to enable concerns about CDs to be raised and that there are also systems to investigate and manage the concerns appropriately. That declarations and self-assessments required by the CQC are completed and participation in intelligence networks. The day to day responsibilities of the AO can be delegated to a named staff member. However, the AO must ensure that the named staff member understands and accepts the responsibility and duties associated with controlled drugs. In NWAS this is delegated responsibility lies with the Head of Clinical Governance. The Government response to the Shipman Inquiry s Fourth Report was set out in the Safer Management of Controlled Drugs, the Governments response to the Fourth Report of the Shipman Inquiry. NWAS Medicine Management Policy Page: Page 23 of 43

24 The recommendations from the report contributed to the Controlled Drugs (Supervision of Management and Use) Regulations The regulations set out several provisions and these are described below Duty of Collaboration To maximise effectiveness of the monitoring and identification of concerns, it is important that the Trust, police services, inspection bodies (RPSGB, CQC and CSCI), regulatory bodies and others work together to share intelligence on controlled drugs issues. To reinforce this need for co-operation, the Controlled Drug Regulations place a statutory duty of collaboration on healthcare organisations, police forces, social services authorities, National Clinical Assessment Service and the relevant inspection bodies to require them to share information about potential controlled drugs offences and potential or actual systems failures. The duty allows specified organisations to share information which gives rise to concern over the use of controlled drugs by any healthcare professional or care worker employed by a health or social care organisation, or in a contract with it. Under the duty, organisations can ask other organisations whether they have any information related to the concern. In sharing information, the Trust and other organisations must have regard to the Data Protection Act 1998 and codes of practice on confidentiality, in particular the Caldicott principles. Information should be anonymised where possible. In exceptional circumstances, the Trust may determine that it is in the public interest to share patient identifiable information, or that they are required to do so by statute. The patient s consent should be sought or they should be notified of the disclosure unless such action would prejudice an investigation. Care should also be taken with sharing information about identifiable health and social care professionals and where possible, they should be made aware of concerns raised about them. The Trust is also required to co-operate in taking effective action within their individual remits. Action might include the further investigation of issues of concern or the initiation of processes to protect the safety of the public, including professional disciplinary processes. NWAS Medicine Management Policy Page: Page 24 of 43

25 24.2 Intelligence Network To fulfil the duty of collaboration, CCG Accountable Officers will be responsible for establishing and operating an intelligence network for sharing information. Membership of the network will be decided locally. Typical membership of a network may include: Local CCGs, NHS and Foundation Trusts (including ambulance and mental health trusts); General Pharmacy Council Inspectors; CQC (through regional and area teams); CSCI (through regional teams); Local police services; Social service authorities; Strategic Health Authority; Lay involvement, such as a PCT non-executive director NWAS will submit an occurrence report for Controlled Drugs concerns to the Lead Commissioning CCG on a quarterly basis. The local intelligence network for NWAS is chaired by the Lead Commissioning CCG. The CCG s Accountable Officer (or an Accountable Officer on behalf of a cluster of CCGs) acts as the hub of the network and assist with management and establishment of mechanisms to share information quickly between relevant partners. They chair a forum of all members of the network where trends are reviewed Occurrence Reporting As part of the routine monitoring process it is also necessary to establish an Occurrence Reporting Process. The Occurrence Reporting Process will be used to summarise any adverse event information relating to CDs on a monthly basis, including: Missing or stolen CD stock Missing or stolen CD keys Expired stock destruction Any concerns raised in relation to CDs Incident reports in relation to CDs Damaged CD stock NB The occurrence reporting process does not replace any existing Trust adverse incident reporting or management procedures. The occurrence report (see appendix 2) will be managed at Station level by the Service Delivery Manager and /or Team Leader, and the Clinical Governance Manager and corporately by the Senior Clinical Quality Manager. NWAS Medicine Management Policy Page: Page 25 of 43

26 Information from existing adverse incident reporting systems and CD documentation will be used to create the occurrence report on a monthly basis. An Area Occurrence Report will be issued to the Area Head of Service and Sector Managers, and a Trust-wide occurrence report will be presented monthly to the Organisational Performance Group. A Trust-wide occurrence report will be reported at least bi-monthly to the Medical Director (AO) and the Medical Directorate Senior Management Team. The Trust-wide report will also be presented to the Trust Clinical Governance Management Group on a quarterly basis. The occurrence report will be submitted to the lead commissioning CCG as part of the intelligence network. The occurrence report will be used to identify any learning or action required at both Area and Trust level Managing Concerns The AO must ensure that robust systems are in place to enable concerns about controlled drugs to be raised, to log these concerns, to alert themselves, where appropriate, and to initiate investigations. Guidance for managing concerns is located in Appendix 3. NWAS Medicine Management Policy Page: Page 26 of 43

27 SECTION E: POLICY REVIEW 25. Equality and Diversity Health Inequalities within the geographical boundaries of the North West Ambulance Service NHS Trust are challenging. Certain patient population groups experience a significantly higher percentage of serious illness or injury than others which lowers life expectancy and increases morbidity. The Medicine Management Policy is implemented to ensure that the diverse medical needs of the population that the Trust serves are met. All patients will be treated with equity, respect, dignity and empathy regardless of age, gender, race, sexual orientation, disability or religion. Service development and redesign will be evidence based to ensure best practice. An EIA has been undertaken on this policy. A copy of the assessment is available on the Trust website. 26. Policy Review The Medicine Management Policy will be reviewed every three years as will the A-Z SOP toolkit; however should national guidance or legislation change; the policy may be reviewed earlier. As part of the policy review process, the effectiveness of the policy and its application will be assessed. Information and results from audit systems, adverse incidents, user feedback and external audits/reviews will be used to inform this assessment. NWAS Medicine Management Policy Page: Page 27 of 43

28 27. Monitoring Areas for Monitoring Arrangement for the administration of medication Procedure for the safe disposal of drugs Process for the recording of adverse drug reactions Arrangements for storage of medicines in all environments Monitoring Process Four times a year, by exception report to the Trust Clinical Governance Management Group via Medicine Management Quality Indicators (MMQI) Ref: Incident Reporting and Investigation Policy Four times a year, by exception report to the Clinical Governance Management Group from the Datix Risk Management system which is monitored by Senior Clinical Quality Manager Ref: Incident Reporting and Investigation Policy Four times a year by exception report to the Clinical Governance and Safety sub Committee from the Datix Risk Management system which is monitored by Senior Clinical Quality Manager. Monthly by exception report to the Organisational Performance Group Reported to the Clinical Governance Management Group at least twice a year Annual report by exception to the Trust Board as part of the Clinical Audit Plan Management of incidents/near misses involving medicines Monthly by exception report to the Organisational Performance Group Reported to the Clinical Governance Management Group at least twice a year NWAS Medicine Management Policy Page: Page 28 of 43

29 APPENDIX 1: PGD Content and Template Patient Group Directions (PGDs) allow named healthcare professionals, other than medical practitioners, to supply and or administer but not prescribe- medication without having to call upon a doctor to prescribe medication in each individual case. NWAS NHS Trust will have Patient Group Directions in place for any medicines to be administered that are not listed as approved within Schedule 5 - Exemption for certain persons from section 58(2) of the Medicines Act General Information The overriding philosophy within the NHS, in relation to PGDs, is that the majority of care should be provided on an individual patient-specific basis i.e. for the provision of medication, through a prescription written by an approved practitioner. A PGD is a document which allows the supply or administration of a medicine to a patient without a prescription. A PGD should only be considered.where this offers an advantage for patients care (without compromising patient safety) and where it is consistent with appropriate professional relationships and accountability. (HSC 2000/026). A useful guide for identifying if a PGD is required can be found at: Legislation relating to PGDs (HSC 2000/026) outlined certain criteria which must be included in all PGDs and a template has been produced to reflect these criteria (see Appendix 1). All sections must be completed for the criteria and thus legal requirements to be satisfied. Professionals working under PGDs must ensure that they work within their professional competence and in accordance with professional guidance. PGDs do not allow prescribing of drugs, where a third party dispenses a medication to be used by the practitioner or patient. Paramedics may supply and/or administer medicines under a PGD. Other healthcare professionals to whom this exemption also applies includes; nurses, pharmacists, midwives, optometrists, radiographers, chiropodists/podiatrists, health visitors, orthoptists, physiotherapists, dieticians, occupational therapists, speech and language therapists, prosthetists and orthotists. NWAS Medicine Management Policy Page: Page 29 of 43

30 Security and Storage of Medicines included in PGDs All medicines included in PGDs must be stored and secured in accordance with the standards set in section A of the Trust Medicine Policy. Labelling of Medicines included in PGDs All medicines included in PGDs, which contain a more than a single dose (a course), must be supplied by the supplying pharmacies in pre-labelled packs as appropriate. Medicines suitable for use under a PGD Only medicines with a product licence should be administered under a PGD and their use will be consistent with the Summary of Product Characteristics. However; NHS Executive guidance states that a medicine being used outside of the terms of its Standard Product Characteristics (SPC) can be included in a PGD in exceptional circumstances and where its use is justified by current best clinical practice. The status of the product must be clearly indicated in the PGD (RPSGB 2004 p.12). When this occurs, the PGD must include the rationale and decision making process, for using the drug outside its therapeutic license. The process should include a full evidence review and risk assessment to ensure efficacy, effectiveness and safety. PGD Approval Process All PGDs proposals must include; a plan for implementation, evidence of any education or training to be provided, costs, and audit and review processes. All developed PGDs must be approved via the Trust Clinical Governance & Safety Sub-committee. The Trust Chief Executive, Medical Director and Pharmacist Advisor will approve and sign all PGDs. All PGDs must carry an implementation, review and an expiry date. NWAS Medicine Management Policy Page: Page 30 of 43

31 PGD Development The development of a proposal for a PGD can be initiated by any healthcare professional within the organisation. However, it is important that proposals are underpinned with an appropriate evidence base, including full consideration of education and training needs, associated risks and financial implications. The Trust Clinical Practice Change Process should be utilised for any proposal development. Local clinical groups (such as Clinical Quality Improvement Forums or Out of Hours Schemes Clinical Governance/Review Groups) should be used to assist with development of the PGD. 2. Content of the PGD The PGD must contain the information detailed below to comply with legislation. 2.1 Management of the PGD: The name of the organisation to which it applies. The name of the medication to which it applies and the legal status of the medicine (POM, P or GSL). The date of approval of the PGD, the review date and the expiry date. The reference for the PGD (normally the title) and the version number. The page number and the total pages e.g. page 1 of 6 etc. The names of the professionals drawing up the PGD should be stated and their signature obtained. It must contain a statement specifying the mechanism for reporting and recording of errors and incidents relating to the activities of the PGD. It must contain details of the mechanism for recording the actions taken during the use of the PGD and the supply/administration of a medicine in accordance with the PGD. 2.2 Clinical Condition or situation to which the PGD applies: A statement of the specific conditions of treatment including the patients to be included. A statement of the specific conditions which would exclude patients from being suitable for treatment under the PGD (this includes any contra-indications to the use of the specific medication). Any criteria for confirming the condition which may need to be assessed NWAS Medicine Management Policy Page: Page 31 of 43

32 Details of the action to be followed if patients are excluded, or who do not wish to participate in treatment under a PGD, or who do not adhere to treatment. A description of the circumstances under which further advice would be sought from a doctor and arrangements for referral. 2.3 Medication Details to be included: Names of all medicines to be supplied or administered under the PGD The pharmaceutical form and strength of the medicine and its legal status (within the header) The route/method of administration The dosage of medication to be used; where a range of doses is acceptable, the criteria used to determine which dose is recommended or used. The frequency of administration The duration of treatment The maximum total dose and number of times treatment can be administered, and over what period of time The quantity to supply/administer Contraindications to use should be included within the exclusion criteria for the PGD (see Clinical Condition section above). Relevant cautions or special conditions that apply, including potential adverse reactions and drug interactions Special consideration should be given to any patient who is receiving concurrent medication. Any patient information/advice to be given. Product information leaflets must be supplied where available. If a medicine is being used outside its Product Licence, relevant additional information should be provided (produced in conjunction with pharmacy). The issue of patient information leaflets or other written advice should be recorded. Information about any patient follow-up. 2.4 Staff Characteristics details to be included: The class of health professional (State Registered Paramedic or registered Nurse) who may supply or administer the medicine. A statement specifying the practitioner level/qualification/registration body. Specialist qualifications, training experience and competence required in the clinical context of the PGD and of the medicine(s) to be used. A statement of the mechanism and the timescale for review and updating of knowledge must be included. NWAS Medicine Management Policy Page: Page 32 of 43

33 Details of continuing training or education required. Any additional training required must be agreed by the Head of Clinical Education and the persons approving the PGD. Completion of the individual authorisation form (final page of the PGD). Each staff member signing the form must have access to the PGD, ensuring that it is in operation at all times and must maintain a personal copy 2.5 Referral Arrangements and Audit Trail: A statement of the arrangements for transfer to hospital, referral for further medical advice or self care should be included. Records and audit trail details must be included:- Patient s name, address, date of birth, and consent given; Contact details of GP; diagnosis; dose and form administered; Signature/name of staff supplying/administering medication; details of adverse reactions and actions taken including documentation in the patient s clinical record. 3. Authorised Persons Only State registered Paramedics employed by NWAS, who have received the requisite training for the PGD, are authorised to administer the medicine stated within that direction. Each Paramedic or registered health professional must sign the Patient Group Direction once they have received training and this will be counter-signed by a suitably qualified assessor. A list of signatures for authorised persons must be attached to every original Patient Group Direction for it to be valid. The Head of Clinical Governance will be responsible for the safe and secure storage of original Patient Group Directions and signature lists. 4. Distribution The Clinical Governance Department will retain the original copy of all Trust PGDs and will maintain an electronic copy of the PGD (available on the Trust Intranet site). A copy of the PGD will be held By each authorised professional Within each clinical area to which the PGD applies NWAS Medicine Management Policy Page: Page 33 of 43

34 A list of the names and specimen signatures of all authorised professionals will be held by the Medicines Performance Facilitator. The Medicines Performance Facilitator will be responsible for coordinating the communication of all PGDs, with the support of the Advanced Paramedics in Service Delivery, Education and Training and Communications Teams. 5. Changes Any proposed changes to a PGD must be submitted to the Medicines Performance Facilitator and follow the approval process. Once approved, all previous versions of the PGD are to be destroyed, except for the copy retained by the Clinical Governance Department as an archived record. 6. Responsibilities PGDs should specify clear arrangements for professional responsibility. It must be acknowledged by all staff that patient safety is paramount. All authorised practitioners operating under PGDs must be named and have a professional duty to ensure that they work safely within the constraints of the PGD. This includes participation in training, assessment of competence and continuing education relevant to the clinical situation in which they operate and to which the PGD applies. Each practitioner must determine whether they are willing to participate in the extended role to which the PGD applies and if so, must sign up to operating within the conditions stated in the PGD. During the time the PGD is in operation, the Medical Directorate will be responsible for ensuring that an audit is undertaken of the management of the PGD to ensure that patient safety is not compromised. PGDs must be submitted for review, along with a copy of an audit every two years. The review process should follow stages 3.6 and 3.7 of this policy to ensure that any new evidence is fully considered. 6.1 Authorised Practitioners Responsibility All authorised practitioners must be competent to assess all relevant aspects of patient care to which the PGD applies. They must take responsibility for supply and/or administration under the PGD. NWAS Medicine Management Policy Page: Page 34 of 43

35 Practitioners must act only within the scope of their professional competence. 6.2 Trust Responsibility The Trust accepts vicarious liability for the actions of authorised practitioners acting in the course of their duties within the terms of current PGDs within their area of practice. NWAS Medicine Management Policy Page: Page 35 of 43

36 PGD TEMPLATE: Patient Group Direction Drug Administration Protocol: Insert name of drug here Drug Name: Drug Presentation: Clinicians authorised to use drug: POM YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING UNDER IT Author Name(s) & Designation(s): Directorate responsible for production and review: Version No. Reference No. Approval Date of PGD: Review Date of PGD: Indications/ Inclusion Criteria Contra-indications / Exclusion Criteria Cautions in Use Dosage & Administration Side Effects Additional Information NWAS Medicine Management Policy Page: Page 36 of 43

37 Authorisation Lead Doctor Name: Position: Medical Director Signature: Date: Lead Nurse/Allied Health Professional Name: Position: Consultant Paramedic & Assistant Clinical Director Signature: Date: Lead Pharmacist Name: Position: Trust Pharmacist Advisor Signature: Date: Clinical Governance Lead Name: Position: Head of Clinical Governance Signature: Date: Organisational authorisation by Name: Position: Chief Executive Signature: Date: NWAS Medicine Management Policy Page: Page 37 of 43

38 Individual Authorisation PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance to their own Code of Professional Conduct. Note to Authorising Managers: authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD. Name of Professional Signature Authorising Manager Date NWAS Medicine Management Policy Page: Page 38 of 43

39 APPENDIX 2: Accountable Officer Occurrence Reporting Template NWAS NHS TRUST OCCURRENCE REPORT CONTROLLED DRUGS CONCERNS Report Period: DD/MM/YYYY to DD/MM/YYYY Station(s): Sector: Area: Operational Manager /Team Leader/ Clinical Governance Manager completing the report: Date Report Completed: NWAS Lead Accountable Officer: Received by: Kevin Mackway-Jones Date report received: Senior Clinical Quality Manager I confirm that XX Station/Group/Sector/Area has had the following concerns regarding its management or use of controlled drugs during this period. PCT Date aware of incident ² Summary of concern ¹ Risk Rating Brief details of action taken ³ Case open/closed and learning to date⁴ ¹ Short description of the cause for concern, including date(s). Details may be attached in a separate document. Note: Regulations 25&26 of the Controlled Drugs (Supervision of Management and Use) Regulations 2006, state the need not to disclose information that relates to and can identify the patient. ² Date that the CG&S Manager became aware of the concern. ³ Action already undertaken (if any) within or outside NWAS NHS Trust e.g. as part of internal incident investigation process, including the reference number within the internal investigation process (where relevant), and whether the incident is closed or still open. ⁴Summary of learning from incident NWAS Medicine Management Policy Page: Page 39 of 43

40 APPENDIX 3: Accountable Officer Procedures 1. Management of Concerns Wherever possible, existing Trust mechanisms for identifying and managing concerns about performance should be used. Concerns may be raised through a variety of routes including routine monitoring of pharmacy supply data, administration, a routine audit, a patient complaint, police intelligence or from a health or social care professional. Where concerns are serious, if for example, patient safety is at risk or the professional s fitness to practise may be impaired, they should be passed on to the relevant body immediately. Where concerns appear to be minor, further local investigation may be more appropriate. Care should be taken to ensure that any evidence collected during the course of an investigation is preserved in an appropriate manner, to ensure its integrity in case it is required at a later stage for proceedings instituted by the police, other enforcement agencies and/or regulatory bodies. In such circumstances, early advice should be sought from the police or another appropriate enforcement authority. Criminal investigations will usually take precedence over other investigations. The AO: Needs to ensure that there is a clear separation between investigating and decision-making. Should not be involved with the investigation process, but be part of the decision making process once the investigation is complete. May decide to draw on local sources of advice and expertise as well as the wider network of AO colleagues. NWAS Medicine Management Policy Page: Page 40 of 43

41 2. Serious Concerns There may be occasions where serious concerns come to light, either initially or through further investigation of a minor concern. Depending on the nature of the concern, various options may apply: Immediate action to protect patients Initial consultation with other members of the intelligence network Incident panels Formal inspection/audit 2.1 Immediate action to protect patients If patient safety is thought to be at risk, immediate action should be taken. The Trust Serious Untoward Incident procedures should be followed. Immediate referral to the relevant regulatory body must also be considered where there are serious concerns about an individual s fitness to practise. 2.2 Initial consultation with other members of the intelligence network Where concerns have come to light, initial consultation with other members of the network who may have relevant information may be helpful as an alternative or prior step to establishing an Incident Panel. 2.3 Incident Panels The AO may decide to set up an Incident Panel where it is felt that there is a need to move swiftly because patient safety may be at risk, or that the initial concern is likely to be a symptom of a wider problem. The individual membership would depend on local circumstances and the nature of the concern but should include key members of the local network. The police would normally expect to be involved at this stage if they have not been previously. 2.4 Targeted inspection/audit Either following an Incident Panel or as a direct result of a concern, the AO may decide to ensure a formal inspection or audit of the vehicles or stations takes place. NWAS Medicine Management Policy Page: Page 41 of 43

42 The formal inspection could be undertaken by any Body with the power to inspect the management of controlled drugs: the lead commissioning CCG, CQC, or police. The Health Act gives powers of entry and inspection to examine the arrangements for the safe management of controlled drugs to nominated groups, such as the police, Home Office and AOs. 3. Remedial Actions: Dealing at Local Level Many concerns can be rectified at local level. Examples may be a false positive where an apparent supply or administration anomaly is due to the caseload of a particular clinician. In other cases, a minor error can be corrected locally where, for example, the Trust s storage arrangements for CDs could be improved. If there is a minor concern about a healthcare professional s performance, they may require support or training. Additional advice and support from the Clinical Governance Manager may also help in rectifying any minor issues. 3.1 Remedial Actions: Escalating Concerns There may be cases where concerns cannot be resolved satisfactorily at local level and need to be formally escalated to a corporate level or passed on to another organisation. Table 1, provides some guidance on where to refer particular types of concern. Where there are serious concerns about any element of the management and use of controlled drugs, the SHA should be informed. If a concern is formally passed on to another organisation, the AO should monitor that a decision and any appropriate action is taken. Where an adverse incident or potential adverse incident has or could have taken place, then the Trust Incident Reporting and Management procedures should be followed. The details or the incident or potential incident should also be shared with the NPSA via the National Reporting and Learning System (NRLS) so that wider learning can take place. NWAS Medicine Management Policy Page: Page 42 of 43

43 Table 1: Referring Concerns: Concern: Criminality Suspected Refer to: Police Fraud Suspected NHS Counter Fraud and Security Management Service; Police Individual Fitness to Practice Issue Organisational or Systems Issue Professional Regulatory Body such as the Health Professions Council Care Quality Commission For any of the above, additionally inform the SHA 4. Support for Healthcare Professionals Individuals raising concerns should be supported in doing so. The Trust Whistleblowing Policy provides details of how staff can do this, including the support available. Free and confidential advice on how to raise a concern and the protections provided by the Public Interest and Disclosure Act can be obtained from Public Concern at Work (an independent organisation). Individuals should also be supported where concerns are raised about them, or where they wish to raise concerns about their own performance. 5. Closure of Cases Cases considered by an AO and/or the intelligence network should be recorded with a clear account of the findings and any action taken. The SHA should be informed so that trends can be monitored. Where there has been serious systems failure, the CQC will wish to return to check that action has been taken. Reports containing information about the storage and movement of controlled drugs should not normally be disclosed under Freedom of Information legislation as they could aid criminal activity. NWAS Medicine Management Policy Page: Page 43 of 43