MEDICINE MANAGEMENT PROCEDURES TOOLKIT

Transcription

1 MEDICINE MANAGEMENT PROCEDURES TOOLKIT MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 1 of 117

2 Recommended by Approved by Clinical Governance Management Group Executive Management Team Approval date March 2015 Version number 1.3 Review date March 2017 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 MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 2 of 117

3 Change record form Version Date of change Date of release Changed by Reason for change 0.1 May 2011 May 2011 M Peters Draft document 0.2 Sep 2011 Sep 2011 M Peters Service Delivery Review 1.0 Sep 2011 Sep 2011 M Peters EMT approved version 1.1 July 2012 July 2012 M Peters 1.2 Sep 2012 Sep 2012 M Peters 0.3 March 2015 March 2015 M Peters Addition of ECFR SOPs Addition of Commercial Courier, Community Pharmacy and HART (MCV) SOPs Updated document following feedback from Senior Clinical Leadership Team 1.3 March 2015 April 2015 M Peters EMT approved version MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 3 of 117

4 Medicines Management Procedure Toolkit Contents 1 Introduction Duties Legal Framework Toolkit Layout Summary to changes to the SOPs A1.1. Daily Stock Checks: Ambulance Vehicles A2.1. Daily Stock Checks: Pharmacy and Station Cabinets A3.1. Damaged, Expired & Used Medicines Disposal (Excluding Controlled Drugs) A4.1. Documentation for Administration and Receipt of Medicines and Fluids A5.1. Management of Documentation: Medicine Management Audit Trail A6.1. Drug Alerts A8.1. Procedure for reporting Adverse Drug reactions (ADR) for Medicines administered by ambulance staff A9.1. Reporting of Defective Medicines A11.0 Transportation of Patients own Medicines A12.0. Administration of Patients own Medicines B1.1. Authorised Signatures B2.1. CD Daily Stock Check B3.2. EOC Procedure requisition of CDs from nominated community pharmacies B4.2. Requisition of vehicle stock CDs from Community Pharmacy B7.1. CD Security: Ambulance Vehicles B8.1. CD Security: Key Management B9.1. CD Security: Key Cabinet Management access codes MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 4 of 117

5 B10.1. CD Security Station CD Cabinet Management -access B CD Security: Rapid Response Vehicles Stock Checks B Damaged Stock Disposal Controlled Drugs B13.1. Expired Stock Disposal Controlled Drugs B14.1. Suspected or Known Theft or Loss of Controlled Drugs B15.1. Suspected or Known Theft or Loss of Controlled Drugs cabinet Key B Patient Administration of Controlled Drugs: B17.1. Pool/ Reserve or Spare Vehicles B18.1. Events Stadia CD Cabinet Stock Checks and Requisitions B19.1 Decommissioned or Re-Designated Vehicles B20.1: Issue of MD07: AP Procedure B21.1: Unique Procedures: New Vehicles into the NWAS Fleet C1.0: ECFR Medicine Management D1.1 HART: Mass Casualty Vehicle Check Daily/Weekly requirements D2.1: HART: Mass Casualty Vehicle Refrigerator Monitoring E1.1: Commercial Courier: Deliveries of Pharmaceutical Supplies from Lancashire Teaching Hospitals NHS Trust E2.1: Commercial courier: Delivery of General and Controlled Drugs to Prisons E3.1: Commercial Courier: Transportation of Cytotoxic Pharmaceuticals MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 5 of 117

6 1 Introduction 1.1 The purpose of this toolkit is to provide a series of standard operating procedures to ensure the safe and secure handling of medicines, including general medicines, controlled drugs, fluids and medical gases within the North West Ambulance Service NHS Trust (NWAS). The procedures will ensure compliance with current legislation and national guidance, while meeting the needs of the service. It is not the intention of this toolkit to inform staff of the clinical indications for use of specific drug protocols. The standards of clinical quality will be assessed against the NWAS Drug Formulary, the Trust s Patient Group Directions, the British National Formulary and the JRCALC pre hospital clinical guidelines. 2 Duties 2.1 A full description of the duties is located in the Medicine Management policy, a summary is presented here. 2.2 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 Clinical Leadership Board, 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). The day to day responsibilities can be devolved to a named member of staff, the Head of Clinical Quality. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 6 of 117

7 2.2.5 The Assistant Clinical Director is responsible for ensuring that the Trust has the necessary policies and procedures in place, including sufficient resources to support their implementation and performance management The Head of Clinical Quality is responsible for the corporate development, implementation and performance management of policies and procedures, including the provision of expert advice. The Head of Clinical Quality (HCQ) is responsible for managing and supporting the development process of all Patient Group Directions (PGDs). The day to day responsibilities of the AO are devolved to the HCQ 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 at corporate level for managing day to day medicine management issues, to coordinate the development and registration of PGDs and is responsible for ensuring that the appropriate pharmaceutical support is provided via the Trust s Pharmacist Advisor Medicines Performance Facilitator is responsible for the day to day provision of advice and support for medicine management issues and supports the operational implementation and performance management of policies and procedures. 2.3 Operational Summary Responsibilities Consultant Paramedics Service Delivery are responsible for ensuring that the service delivery Areas have the necessary policies and procedures in place, monitoring trends and identifying reporting and acting on areas of risk Sector and Operational Managers are responsible for: Supporting the operational implementation and performance management of policies and procedures Making quarterly checks to ensure compliance with the medicine management policy and procedures such checks are to be retained for MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 7 of 117

8 audit purposes for at least 2 years. Ensuring the HCQ and the SCQM are made aware in a timely manner of any adverse incidents relating to medicines management Advanced Paramedics are responsible for: Supporting all Trust personnel who are responsible for medicines through familiarisation and maintenance of the standards 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 procedures 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 2.4 Management Group Summary Responsibilities The Clinical Governance Management Group (CGMG) is accountable to the Trust Board and operates within agreed terms of reference. The CGMG will: Monitor standards and performance in relation to Medicine Management and provide assurance to the Trust Board with regards to Medicines Management Standards Organisational Performance Group is required to: Monitor standards and area performance in relation to agreed medicine management quality indicators. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 8 of 117

9 Ensure that any issues relating to medicines management are appropriately managed with necessary actions. 3 Legal Framework 3.1 For the purpose of these procedures, medicines are defined as substances included in the Human Medicines Regulations 2012 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. Further details with regard to the Legal Framework within which NWAS operates are located in the Medicine Management Policy. 4 Toolkit Layout 4.1 The medicines Management Toolkit is split into a number of sections: Section A contains Standard Operating Procedures (SOPs) for General Medicines that is all medicines with the exception of Controlled Drugs. Section B contains SOPs for Controlled Drugs. Section C contains SOPs for ECFRs Section D contains SOPs for HART MCVs Section E contains SOPs for Commercial Couriers The SOPs are in the order that they might be used by a clinician during a shift. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 9 of 117

10 The most frequently used SOPs such as vehicle stock checks located in the front part of each section and the less frequently used SOPs such as Reporting of Defective Medicines, located towards the back of the section. 5 Summary to changes to the SOPs 5.1 A10.0 EZIO Requisition Procedure: Lignocaine 1% has been removed from circulation following a decision made by the Clinical Leadership Board (formerly the Medical Directorate SMT). MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 10 of 117

11 A1.1. Daily Stock Checks: Ambulance Vehicles SOP Title: Vehicle Stock Checks Reference Number: A1.1 Author Name & Designation: Clinical Quality Directorate: Medical Directorate Version Number & Date: A1.1 December 2014 Supersedes: A1.0 (2011) Changes made: Format revision Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION: OBJECTIVES To provide assurance that NWAS will have the correct drugs in the appropriate formats in place at all times to be able to treat the patient effectively and safely. SCOPE All general medicines and fluids stocked on the vehicle. All NWAS Emergency vehicles including: Ambulances, RRVs, Cycle Response and HART vehicles. Manchester Airport Team Staff Responders and Manager Responders North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 11 of 117

12 PROCEDURE At the commencement of Duty it is the responsibility of the crew members and response vehicle personnel (including Managers with drug packs) to perform the following checks on all medicines on the vehicle: Medicine stock levels will be checked and recorded using the MD01 form located in the monthly vehicle clinical check book. A new MD01 form should be used at the start of each week (for the purpose of recording medicines the start of the week is Monday). 1. Correct drug, strength and presentation is present 2. Drug is within its expiry date. 3. Drug is stored in its original pack including a patient information leaflet. 4. Drugs of mixed batches and expiry dates should not be stored in one packet, each batch /expiry should have its original box present. 5. Where the MD01 form is marked with a a minimum stock level check must be performed. Open each box and verify that the minimum stock level is present for that drug. If the minimum stock level is not present i.e. salbutamol 5mg x 4 nebules, the box should be marked with an X and the stock replenished at the earliest opportunity in the shift. 6. Perform a stock count on all other drugs indicated in the MD01 form. This requires all stock to be individually counted and recorded on the MD01 form. Note: manufacture sealed boxes do not need to be opened to verify the contents count these as the full stock indicated on the box. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 12 of 117

13 STOCK VERIFICATION: SIGNATURES The number of signatures should reflect the number of staff present and wherever possible 2 signatures should be obtained. Best practice: is for 2 members of staff to conduct the medicines checks with one member of staff checking the stock with the second witnessing and conducting the documentation aspect. RRV and solo responders should always try to obtain a witness verification signature wherever possible. EXPIRY CHECKS Within the first 7 days of each month that a vehicle is operational the expiry dates of all medicines (including Controlled drugs) will be checked and recorded on the MD03 expiry check sheet located in the Monthly Vehicle Clinical Check Book. Any medicines due to expire before the following month should be replaced and the expiring stocks discarded at the earliest opportunity within the month the MDO2 should reflect the disposal of medicines in this way. UN-RESOURCED AND POOL VEHICLES A stock check of all drugs / fluids as detailed above must be performed on un-resourced (i.e. Spare or Pool vehicles) and vehicles off the road for repair. The drugs checks must be performed as a minimum once each week. Local arrangements must be made by the local Service Delivery team to ensure that this takes place even if the vehicle is not normally located at the station. You must not delay an Emergency due not having performed a medicine stock check. REPORTING DISCREPANCIES Any medicines discrepancies must be reported via the Datix online incident reporting system under incident type Clinical Incident or if appropriate Clinical Near miss referencing in either case category type Medicines Management. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 13 of 117

14 A2.1. Daily Stock Checks: Pharmacy and Station Cabinets SOP Title: Management of Documentation Reference Number: A2.1 Author Name & Designation: Clinical Quality Directorate: Medical Directorate Version Number & Date: A2.1 December 2014 Supersedes: A2.0 (2011) Changes made: Format revision Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION: OBJECTIVES To ensure there are sufficient medicines stocks available to re-stock vehicles as and when required. The pharmacy/station cabinet stocks are monitored /audited on a daily basis to ensure a robust audit trail of issue and receipt. SCOPE All general drugs/medicines held in the cabinets. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 14 of 117

15 PROCEDURE Emergency Department Pharmacy Cabinets and Station Drug Cabinets are both utilised across NWAS NHS Trust for the re-stocking of drugs. The principles of managing these cabinets are the same from a Trust perspective. It is the responsibility of the designated supervisory/management lead for medicine management to ensure that: there are nominated staff member(s) assigned to checking the pharmacy cabinet(s) within their station group nominated member(s) details are communicated to the appropriate stations the nominated members provide liaison with the NWAS Medicines Performance Facilit ator and with the local pharmacy departments within their sector or station group. HOSPITAL & STATION BASED MEDICINES CABINETS: RESPONSIBILITIES It will be the responsibility of the nominated staff member(s) to: Perform a stock check of the medicines cabinet on a twice weekly basis. Complete the MD04 (medicine cabinet stock check form) and wherever possible signed by a co- signatory. The number of signatures required must reflect the number of Emergency Service personnel present at the time of the audit. Inform the pharmacy department if: o pharmacy cabinet stock levels are considered to be insufficient to last until the next pharmacy top up, or o incorrect stock presentations are present in the medicines cabinet MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 15 of 117

16 STATION BASED MEDICINES CABINETS: RESPONSIBILITIES It will be the responsibility of the nominated staff member(s) to manage the stock levels within the station cabinets. STATION BASED MEDICINE CABINETS: STOCK REQUISITION Inform the pharmacy department if station cabinet stock levels are considered to be insufficient by completing a pharmacy order stating the quantity of each medicine required. Sign, Print and Date each order sent and keep the original copy for the station medicines records. STATION BASED MEDICINE CABINETS: STOCK VERIFICATION When medicines are received on station from a pharmacy order, they must be checked against the pharmacy supply record. Any discrepancies must be reported to the supplying pharmacy immediately. STATION BASED MEDICINE CABINETS: STOCK RECEIPTS Once pharmacy orders have been checked, medicines must be secured without delay within the station drug cabinet. The received medicines must be recorded within the Medicines received section of the MD05 form. The pharmacy supply record should also be signed as received, including the date, and the record stored within the station cabinet s medicine folder. The number of signatures should reflect the number of staff present and wherever possible 2 signatures should be obtained. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 16 of 117

17 MEDICINES ISSUING: PHARMACY AND STATION MEDICINE CABINETS It is the responsibility for all PES staff when restocking their vehicle from a hospital or station cabinet to follow this process in full: 1. Complete the Medicine Issues section of MD05. The medicine(s) must be booked out to a vehicle call sign and registration number. 2. The remaining stock balance on the MD05 must be double checked against the remaining stock in the medicines cabinet. Any stock discrepancies should be reported immediately to your line manager for further investigation and reported via DATIX online incident reporting system. 3. Sign the MD05 form for confirmation of stock issue to the vehicle. The number of signatures required must reflect the number of Emergency Service personnel present. END OF MONTH PROCESS: PHARMACY AND STATION MEDICINE CABINETS The designated supervisory/management lead for Medicine Management is responsible for: 1. Collecting the MD04 and MD05 forms for each drug from the hospital or station cabinet (including pharmacy supply sheets). 2. Filing the MD04 and MD05 together for each hospital or station cabinet. The paperwork must be stored securely at an agreed central location within each sector or station group. All medicines documentation must be stored securely for a minimum of 2 years. The documentation archive location should be identified and documented by the staff member responsible for medicines management for each sector and notified to the Medicines Performance Facilitator for NWAS. REPORTING DISCREPANCIES Any medicines discrepancies must be reported via the Datix online incident reporting system under incident type Clinical Incident or if appropriate Clinical Near miss referencing in either case category type Medicines Management. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 17 of 117

18 A3.1. Damaged, Expired & Used Medicines Disposal (Excluding Controlled Drugs). SOP Title: Disposal of Medicines (Excludes CDs) Reference Number: A3.1 Author Name & Designation: Clinical Quality Directorate: Medical Directorate Version Number & Date: A3.1. December 2014 Supersedes: A3.0 (2011) Changes made: Format revision Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION: OBJECTIVES To ensure the disposal of general medicines is in line with relevant legislation including the provision of a robust audit trail. SCOPE All general medicines and fluids stocked on the vehicle. All NWAS Emergency vehicles including: Ambulances, RRVs, Cycle Response and HART vehicles. Hospital and Station General Drug Cabinets Manchester Airport Team Staff Responders and Manager Responders North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 18 of 117

19 PROCEDURE When a medicine has been used, expired or become damaged it must be disposed of in the appropriate yellow clinical waste receptacle situated on each vehicle and recorded on the MD02 Medicine Issue & Receipt Record located in the monthly vehicle clinical check book. ISSUES AND RECEIPTS: 1. The MD02 Medicines Issue and Receipt Record must be completed with the following details: o The date, name of the medicine and strength, incident number (if administered or refused), quantity issued, quantity administered to the patient / quantity being disposed of and batch number / expiry date. o Tick the reason for medicine issue i.e. used expired or damaged. o Complete the signature and witness signature for each transaction. The number of signatures should reflect the number of staff present and wherever possible 2 signatures should be obtained. o Record the final stock level remaining of each medicine administered/disposed. NEW MEDICINES STOCK: If the current stock level indicates more stock is to be added to the vehicle the new medicine stock must be obtained from the local hospital or station cabinet following SOP A2.1. Daily Sock Checks: Pharmacy and Station Cabinets and SOP A4.1 Documentation for Administration and Receipt of Medicines and Fluids. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 19 of 117

20 A4.1. Documentation for Administration and Receipt of Medicines and Fluids SOP Title: Documentation of Medicines and Fluid Administration and Receipt Reference Number: A4.1 Author Name & Designation: Directorate: Clinical Quality Medical Directorate Version Number & Date: A4.1 December 2014 Supersedes: A4.0 (2011) Changes made: Format revision Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION: OBJECTIVES To ensure that there is a robust and easily identifiable audit trail and record of all drugs on the vehicle at all times, and to provide assurance that a full and complete patient record is maintained SCOPE All general medicines and fluids held on the vehicle. All NWAS Emergency vehicles including: Ambulances, RRVs, Cycle Response and HART vehicles. Manchester Airport Team Staff Responders and Manager Responders North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 20 of 117

21 PROCEDURE When a medicine has been administered to a patient, it is the responsibility of the person who has administered it to record its use on both the: 1. Patient Report Form (PRF) /epr and 2. MD02 form located in the monthly vehicle clinical check book. MEDICINE OR FLUID ADMINISTRATION: MDO2 DOCUMENTATION On preparing a medicine or fluid for administration the following must be completed on the MD02: The date, name of the medicine and strength, incident number (if administered or refused), quantity issued, quantity administered to the patient / quantity being disposed of and batch number / expiry date. Tick the reason for medicine issue i.e. used expired or damaged. Complete the signature and witness signature for each transaction. The number of signatures should reflect the number of staff present and wherever possible 2 signatures should be obtained. Record the final stock level remaining of each medicine administered/disposed. Where the administering staff member is working on the RRV and does not travel with the patient then the attending ambulance crew must ensure that the medicine is recorded on the PRF/ePR. The MD02 must be completed prior to clearing from the incident. NEW MEDICINES STOCK: If the current stock level indicates more stock is to be added to the vehicle the new medicine stock must be obtained from the local hospital or station cabinet following SOP A2.0.The re-stocking of medicines should be undertaken as soon as practicably possible before the end of the shift. Note: Notwithstanding the above it is the responsibility of the senior clinician to be assured paperwork is completed adequately, correctly, contemporaneously and as fully as possible. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 21 of 117

22 A5.1. Management of Documentation: Medicine Management Audit Trail SOP Title: Management of Documentation Reference Number: A5.1 Author Name & Designation: Clinical Quality Directorate: Medical Directorate Version Number & Date: A5.1. December 2014 Supersedes: A5.0 (2011) Changes made: Format revision Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION: OBJECTIVES To monitor the quality and compliance of documentation completion and take action as necessary; to ensure that there is an easily identifiable audit trail and record of all drugs on the vehicle at all time. Documentation is to be stored for a minimum of 2 years from the last dated entry. SCOPE All general drugs/medicines held on the vehicle. All NWAS Emergency vehicles including: Ambulances, RRVs, Cycle Response and HART Manchester Airport Team Staff Responders and Manager Responders North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 22 of 117

23 PROCEDURE It is the responsibility of all NWAS personnel to ensure the safe storage of medicines documentation in the form of the Monthly Vehicle Clinical Check books. All medicine documentation must remain on the vehicle and be available for inspection until the end of the current month. On completion of the monthly book it should be archived in line with station documentation procedures for a period of 2 years from the last dated entry. MD04 AND MD05 DOCUMENTATION The designated supervisory/management lead for medicines management must 1. Be responsible for collecting the following documents from the local A&E pharmacy cabinet(s)/station drug cabinet(s) that serve their station on the last day of each month: o MD04: Pharmacy/Station Cabinet Stock Check o MD05: Pharmacy/Station Cabinet Stock Issues and Receipts 2. File the MD04 and MD05 forms together for that month. The files must be stored securely at an agreed central location within each sector or station group. 3. Monitor the quality and compliance of documentation completion and if necessary, take appropriate action. All medicines documentation must be stored securely for a minimum of 2 years. The documentation archive location for each vehicle should be identified and documented by the staff member responsible for medicines management for each sector and notified to the Medicines Performance Facilitator for NWAS. OVERALL RESPONSIBILITY: SECURITY AND STORAGE OF MEDICINE DOCUMENTATION The Sector Managers supported by the Advanced Paramedics have overall responsibility for the safe and secure storage of medicine documentation. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 23 of 117

24 A6.1. Drug Alerts SOP Title: Drug Alerts Reference Number: A6.1 Author Name & Designation: Clinical Quality Directorate: Medical Directorate Version Number & Date: A6.1. December 2014 Supersedes: A6.0 (2011) Changes made: Format revision Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION: OBJECTIVES To ensure Trust responds appropriately and robustly to any drug alerts received, reducing the risk to staff, patients and the Trust. SCOPE All general drugs and medicines held by the Trust. All NWAS Emergency vehicles including: Ambulances, RRVs, Cycle Response and HART vehicles. Manchester Airport Team Staff Responders and Manager Responders North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 24 of 117

25 PROCEDURE Manufacturers and importers are obliged to report to the MHRA any quality defect in a medicinal product which could result in a recall or restriction on supply. Other users and distributors of medicinal products are encouraged to do this. Where a defect is considered to be a risk to public health, the marketing authorisation holder withdraws the affected product from use and the MHRA issues a Drug Alert letter. This Alert is classified from 1 to 4 depending upon the risk presented to the public health by the defective product. Class 1 requires immediate recall, because the product poses a serious or life threatening risk to health. Class 2 specifies a recall within 48 hours, because the defect could harm the patient but is not life threatening. Class 3 requires action to be taken within 5 days because the defect is unlikely to harm patients and is being carried out for reasons other than patient safety. Class 4 alerts advise caution to be exercised when using the product, but indicate that the product poses no threat to patient safety. DURING OFFICE HOURS Quality Control North West notifies NWAS of drug alerts by to the Medicines Performance Facilitator and the Senior Clinical Quality Manager. The alert is assessed for its potential impact on NWAS medicines stocks and if necessary, communicated to the Head of Clinical Quality and Trust Pharmacist. Further communication with then be issued to all Operations Managers and Advanced Paramedics for action. The Senior Clinical Quality Manager will ensure that all alerts are recorded. When an action is required the Head of Clinical Quality must ensure that the alert is communicated to all relevant individuals and that all necessary actions are undertaken immediately. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 25 of 117

26 The Medicines Performance Facilitator will liaise with all NWAS supplying pharmacy departments to assess if any affected stocks are currently stocked in the NWAS medicines stock cabinets (hospital based). The designated supervisory/management lead for medicines management will be notified to check station based stock cupboards. Any affected stocks must be notified to the Medicines Performance Facilitator. ALERT CLASS: ACTION REQUIREMENT The classification of the alert will determine the action that will be required where any affected batches of stock is stocked by NWAS. Alert Class Class 1 Class 2 Class 3 Class 4 Timescale Action Notification Immediate Within 48 hours Within 5 days None set Check all stocks of affected product. Remove all affected batches from stock with immediate effect and quarantine. Replacement stocks must be verified to ensure they are not included in the affected batches of stock. Check all stocks of affected product. Source replacement unaffected stocks Exchange all affected stocks from the vehicles / stock cupboards with unaffected stocks. Check all stocks of affected product. Source replacement unaffected stocks Exchange all affected stocks from the vehicles / stock cupboards with unaffected stocks. Check all stocks of affected product. Communicate any cautions in use issued via clinical bulletin to all staff involved in medicine preparation or administration. Immediately notify the Medicines Performance Facilitator if any affected stock is found Notify the Medicines Performance Facilitator if any affected stock is found - within 48 hours. Notify the Medicines Performance Facilitator if any affected stock is found - within 5 days. Communicate to all local staff any cautions in use for the product. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 26 of 117

27 All designated personnel dealing with the action of the alert must complete a Drug Alert Action Log. The log, on completion, must be returned via to the Medicines Performance Facilitator. Details to be recorded include the action taken, timescales actions were conducted in and the outcome of the action taken. The Medicines Performance Facilitator will collate all the information received as evidence of the actions being completed for the Trust within the permitted timescales OUTSIDE WORKING HOURS: Quality Control North West will communicate alerts by fax or telephone to the Manchester Area Emergency Operations Centre (EOC). The Emergency Operations Centre Duty Manager will notify the other Control Centres and provide them with the relevant information. The EOCs must notify the relevant on duty Advanced Paramedic who must assess the relevance of the alert and if necessary ensure any immediate actions required are undertaken. ALERTS OR ACTIONS UNDERTAKEN OUTSIDE WORKING HOURS Must be reported to the Medicines Performance Facilitator and the Senior Clinical Quality Manager as soon as practicably possible via at controlled.drugs@nwas.nhs.uk. The Incident Reporting and Investigation Policy must be followed to record the event and actions taken. All designated personnel dealing with the action of the alert must complete a Drug Alert Action Log. The log, on completion, must be returned via to the Medicines Performance Facilitator. Details to be recorded include the action taken, timescales actions were conducted in and the outcome of the action taken. The Medicines Performance Facilitator will collate all the information received as evidence of the actions being completed for the Trust within the permitted timescales MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 27 of 117

28 DRUG RECALL In the event of a drug alert involving a recall, arrangements must be made to return the medicines to the supplying pharmacy; this will be co-ordinated by the Medicines Performance Facilitator. All Drug Alerts received will be recorded, reviewed and reported using the Trust Healthcare Governance Alert and Guidance Review Process. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 28 of 117

29 A7.1. Suspected or known Theft or Loss of Medicines and the reporting of discrepancies SOP Title: Theft or Loss of Medicines and the reporting of discrepancies Reference Number: A7.1. Author Name & Designation: Directorate: Clinical Quality Medical Directorate Version Number & Date: A7.1. December 2014 Supersedes: A7.0 (2011) Changes made: Format revision Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION: Personal Safety is paramount do not obstruct or attempt to stop somebody in the event of being threatened to hand over medicines or when witnessing a person stealing medicines. Comply with demands and offer no resistance. OBJECTIVES To ensure the management of drugs is robust and any discrepancies are identified at the earliest opportunity reducing the Trust risk with regard to the management of medicines. SCOPE All general medicines held on the vehicle or stocked in the hospital / station medicines stock cabinet. All NWAS Emergency vehicles including: Ambulances, RRVs, Cycle Response and HART vehicles. Manchester Airport Team Staff Responders and Manager Responders North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 29 of 117

30 PROCEDURE N.B.: Under no circumstances should you obstruct or attempt to stop somebody in the event of being threatened to hand over medicines or when witnessing person(s) stealing medicines. PERSONAL SAFETY IS PARAMOUNT When being threatened by somebody, offer no resistance, comply with their demands and allow them to leave. IF A MEDICINE IS KNOWN OR SUSPECTED TO HAVE BEEN STOLEN: 1. The appropriate EOC must be informed immediately and request that the Police are contacted. Provide details of the vehicle, crew names, medicines involved and circumstances of the incident. 2. The EOC must contact and inform the on-call Operational Commander (Bronze oncall) or Advanced Paramedic of the incident 3. The on-call Operational Commander (Bronze on-call) or Advanced Paramedic must visit the crew to provide support and identify if any further assistance is required. 4. The relevant on-call Tactical Commander (Silver - on call) must be notified as soon as possible. 5. A DATIX incident report must be completed immediately by the crew involved and assigned to the appropriate Manager for investigation. The incident must be logged under Clinical Incident and the appropriated category type selected as either Medicines Management or Controlled Drugs and the appropriate sub category selected. 6. The Medicines Performance Facilitator, Senior Clinical Quality Manager and the Security & Safety Practitioner must be notified as soon as practicably possible via controlled.drugs@nwas.nhs.uk. 7. The Trust Incident Reporting and Investigation Policy must be followed. The Security & Safety Practitioner will provide advice and support with regard to how the investigation should be conducted. 8. Following the investigation a note must be made in the Clinical Checks Log of the vehicle s Monthly Clinical Check Book. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 30 of 117

31 WHEN A DISCREPANCY IS IDENTIFIED THAT CANNOT BE EXPLAINED: 1. The on-call Operational Commander (Bronze on-call) or Advanced Paramedic must be notified immediately. 2. The discrepancy should be confirmed with another colleague where possible. 3. The vehicle s documentation must be inspected in an attempt to identify the reason for the discrepancy. 4. If the discrepancy remains unresolved, the previous crew to work on the vehicle must be interviewed at the earliest opportunity by a on-call operational (Bronze Commander) 5. A DATIX incident report must be completed immediately by the crew involved and assigned to the appropriate Manager for investigation. The incident must be logged under Clinical Incident and the appropriated category type selected as either Medicines Management or Controlled Drugs and the appropriate sub category selected. 6. The Medicines Performance Facilitator, Senior Clinical Quality Manager and the Security & Safety Practitioner must be notified as soon as practicably possible. 7. The Trust Incident Reporting and Investigation Policy must be followed. The Security & Safety Practitioner will provide advice and support with regard to how the investigation should be conducted. 8. Following the investigation a note must be made in the Clinical Checks Log of the vehicle s Monthly Clinical Check Book. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 31 of 117

32 A8.1. Procedure for reporting Adverse Drug reactions (ADR) for Medicines administered by ambulance staff. SOP Title: Procedure for reporting Adverse Drug Reactions (ADR) for medicines administered by ambulance staff Reference Number: A8.1 Author Name & Designation: Clinical Quality Directorate: Medical Directorate Version Number & Date: A8.1. December 2014 Supersedes: A8.0 (2011) Changes made: Format revision Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION: OBJECTIVES To ensure that any Adverse Drug Reaction (ADR) is managed appropriately in line with legislation, whilst also providing assurance to the Trust with regard to patient safety. SCOPE All medicines (including fluids and medical gases) administered by ambulance staff (including the patient s own medications). All NWAS Emergency vehicles including: Ambulances, RRVs, Cycle Response and HART vehicles. Manchester Airport Team Staff Responders and Manager Responders North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 32 of 117

33 PROCEDURE When an ADR occurs the following procedure must be followed: 1. If the drug is still being administered stop immediately. 2. Assess patient s condition and treat accordingly. 3. Retain a sample of the drug and its container if possible. 4. Transport the patient to hospital. 5. Pre- alert the receiving hospital if required. 6. Record all information on the Patient Report Form/ePRF, including signs and symptoms of the reaction, and their time and duration. 7. Provide a full verbal and written handover on arrival at hospital. 8. Discuss the ADR with an Emergency Department doctor and confirm if a Yellow Card is to be completed. Further advice must be sought from an Advanced Paramedic IF A YELLOW CARD IS TO BE COMPLETED: 1. Provide all necessary information to the doctor completing it. 2. Record the fact that a Yellow Card has been completed and the name of the doctor on the Patient Report Form/ePRF. An ADR is considered to be a clinical incident, therefore a DATIX incident report must be completed and the Trust Incident Reporting and Investigation Policy followed (this should always be completed regardless of whether a Yellow Card was completed or not) MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 33 of 117

34 WHEN COMPLETING THE INCIDENT REPORT THE FOLLOWING INFORMATION MUST BE RECORDED: 1. The drug to which the reaction occurred. 2. The brand / manufacturer, batch no. and expiry date of the drug. 3. The signs and symptoms of the reaction. 4. The date and time the reaction occurred and it s duration. 5. State if a Yellow Card was completed and the name of the doctor who completed it. All adverse medication incidents including administration errors and adverse reactions will be reviewed by the Medicines Performance Facilitator for further learning from incidents to reduce future errors. If deemed necessary the incident will be reported to the National Reporting and Learning System (NRLS). MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 34 of 117

35 A9.1. Reporting of Defective Medicines SOP Title: Reporting of Defective Medicines Reference Number: A9.1 Author Name & Designation: Clinical Quality Directorate: Medical Directorate Version Number & Date: A9.1. December 2014 Supersedes: A9.0 (2011) Changes made: Format revision Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION: OBJECTIVES To ensure the Trust responds appropriately and robustly to any suspected defective medicines reducing the risk to staff, patients and the Trust. SCOPE All general medicines (including fluids and medical gases) held by the Trust. All NWAS Emergency vehicles including: Ambulances, RRVs, Cycle Response and HART vehicles. Manchester Airport Team Staff Responders and Manager Responders North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 35 of 117

36 PROCEDURE WHEN A MEMBER OF STAFF HAS CONCERNS ABOUT THE QUALITY OF A MEDICINE: a) Identified post treatment: Monitor the patient closely for any adverse signs and symptoms Record the concerns on the Patient Report Form/ePRF Inform the Advanced Paramedic and seek further advice if required Refer the matter to an Emergency Department Doctor immediately If possible a sample of the medicine should be retained. If not the manufacturer / brand, batch number and expiry date should be recorded. A full verbal and written handover must be provided to the receiving hospital. The doctor will decide if the Defective Medicines Report Centre needs to be contacted b) Identified pre- treatment: Refer the matter to the Duty Advanced Paramedic who will contact the Medicines Performance Facilitator in the first instance The Medicines Performance Facilitator will inform the Advanced Paramedic what action is required with the product i.e. discarded or sent to the Clinical Governance Department to submit for sampling. If the product is deemed to be defective the Medicines Performance Facilitator will liaise with the local pharmacy department to arrange restocks or unaffected product to be made available to replace any defective medicines located on NWAS vehicles. 1. If a potential risk is identified the member of staff must inform the Duty Advanced Paramedic to activate the Trust Incident Reporting Procedure; and inform the relevant EOC Manager. 2. The EOC Manager will notify the other locality EOC and provide them with the relevant information. 3. The EOC must notify the relevant on-call Operational Commander (Bronze on-call) within their respective areas. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 36 of 117

37 4. The on-call Operational Commander (Bronze on-call) must ensure that the relevant information (drug presentation, batch number, brand, strength etc) is communicated to all vehicles and personnel for checking and removal if necessary via the in vehicle bulletin boards (MDT Screens). 5. Affected batches of the medicine must be withdrawn from use and stored securely on stations. 6. The on-call Operational Commander (Bronze on-call) must also ensure arrangements are made to identify affected medicines within all the Emergency Department Hospital /Station Cabinets. 7. Affected medicines within the Emergency Department Hospital / Station cabinets must be clearly marked DO NOT USE 8. In the event of a drug alert involving a recall, arrangements must be made to return the medicines to the supplying pharmacy. 9. The Medicines Performance Facilitator and the Senior Clinical Quality Manager must be notified at the earliest opportunity. 10. The Medicines Performance Facilitator will follow the North West Drug Defect Reporting Procedure as defined by Quality Control North West, Stepping Hill Hospital. 11. A DATIX incident report must be completed and the Trust Incident Reporting and Investigation Policy followed and a Drug Alert Action Log completed for each station to evidence the actions completed for the checking and subsequent removal of any defective medicines. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 37 of 117

38 A11.0 Transportation of Patients own Medicines SOP Title: Transportation of Patients Own Medications Reference Number: A11.0 Author Name & Designation: Directorate: Clinical Quality Medical Directorate Version Number & Date: A11.0. December 2014 Supersedes: Changes made: Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION OBJECTIVES: To ensure the Trust appropriately and securely transport patients own medications to and from hospital as part of the patient s journey. SCOPE All general and controlled medicines belonging to the patient being conveyed by NWAS staff All NWAS Emergency vehicles including: Ambulances, RRVs, HART vehicles, Urgent Care and Patient Transport Services. Manchester Airport Team North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 38 of 117

39 PROCEDURE The patient or person accompanying the patient should be asked to collect all their current medications and a copy of their most recent prescription list before being transported to / from hospital. 1. The patient s medications should all be placed into a Patients Own Medication bag (usually a green / orange bag). Write on the front of the bag the patient s details i.e. name, date of birth, address. 2. Seal the bag and mark on the front of the bag if any fridge items or controlled drugs are located within the bag. 3. Transport the patient s own medications to the hospital with the patient and the rest of their personal belongings. 4. Document of the PRF/ePRF to confirm the patient s own medications were transferred with the patient. 5. Hand over all patients belongings including patients own medications to the receiving unit staff. IN AN EMERGENCY SITUATION Do not unnecessarily delay any emergency transfer to hospital to collect a patient s own medication. If the situation is an emergency the patient s conveyance to hospital remains the priority. PATIENTS OWN CONTROLLED DRUG MEDICINES Patients own Controlled drugs do not need to be secured in the CD safe on the vehicle. They remain the property of the patient and should be conveyed like all other patient property. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 39 of 117

40 A12.0. Administration of Patients own Medicines SOP Title: Administration of Patients Own Medications Reference Number: A12.0 Author Name & Designation: Directorate: Clinical Quality Medical Directorate Version Number & Date: A12.0. December 2014 Supersedes: Changes made: Approved by EMT (date): March 2017 Review Date: March 2017 Date Obsolete: BACKGROUND INFORMATION There may be occasion when, on arrival at scene, NWAS clinicians are requested to administer the patient s prescribed medication to them. The law currently allows any person to administer a drug to a patient, providing it has been prescribed for them by an appropriate prescriber and the person administering it is trained and competent in the required administration route. OBJECTIVES Ensure that the patient receives the medicine treatment appropriate to their needs SCOPE Patient s own medications prescribed for them and requested for administration by NWAS staff. All NWAS clinicians operational on emergency vehicles including: Ambulances, RRVs, HART vehicles, Cycle Responders. Staff Responders and Manager Responders Manchester Airport Team North West Air Ambulance MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 40 of 117

41 PROCEDURE You must not exceed your clinical scope of practice in terms of drug administration; you may only administer medications according to the NWAS skill level that you have acquired. For example IV access: Paramedics only. YOU SHOULD ONLY ADMINISTER A PATIENT S OWN MEDICATION IF ALL THE FOLLOWING APPLY: a) The circumstance or situation requires you to administer the medication (check that a dose is due). b) The medication is prescribed for the patient you are treating (check the date of dispensing on the label of the item to confirm it is not from an old prescription). c) The medication is clearly labelled so that you are sure of what it is that you are administering. d) The dose administration regimen is written clearly on the medication and, if present, the patient care plan. e) The route of administration is clearly written on the medication and, if present, the patient care plan. Once you have administered the medication to the patient you must document the details fully on the Patient Report Form and include: Drug Name Dose Unit Route of Administration Time of administration Wherever possible, these patients should be transferred to an appropriate treatment centre. MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: Page 41 of 117