STANDARD OPERATING PROCEDURE FOR SAFE AND SECURE MANAGEMENT OF CONTROLLED DRUGS WITHIN PRIMARY CARE DIVISION.

STANDARD OPERATING PROCEDURE FOR SAFE AND SECURE MANAGEMENT OF CONTROLLED DRUGS WITHIN PRIMARY CARE DIVISION. Issue History Oct 12 Issue Version Two Purpose of Issue/Description of Change To ensure implementation of national guidance and legislation on the safe and secure management of Controlled Drugs with Primary Care Division Planned Review Date 2015 Named Responsible Officer:- Approved by Date Medicines Governance Pharmacist Quality, Patient Experience and Risk Group June 2013 Section:- Medicines Management MMSOP34 Target Audience Staff working within Primary Care Division Including GP Out of Hours, but excluding Leasowe Primary Care Centre UNLESS THIS VERSION HAS BEEN TAKEN DIRECTLY FROM TRUST WEB SITE THERE IS NO ASSURANCE THIS IS THE CORRECT VERSION

CONTROL RECORD Title Standard Operating Procedure (SOP) for safe and secure management of Controlled Drugs within Primary Care Division. Purpose To ensure implementation of national guidance and legislation on the safe and secure management of Controlled Drugs within Primary Care Division Author Quality and Governance Service (QGS) and L Knight Impact Assessment Incorporated into procedure Yes No Subject Experts Dr Kathy Ryan, Clinical Director of Primary Care Division Medicines Governance Pharmacist Document Librarian QGS Groups consulted with :- Medicines Management Group Infection Control Approved Not Appropriate Date formally approved by June 2013 Quality, Patient Experience and Risk Group Method of distribution Email Intranet Archived Date Location:- S Drive QGS Access Via QGS VERSION CONTROL RECORD Version Number Author Status Changes / Comments Version 1 L Knight H Dare New Safe and Secure Handling of Controlled Drugs within Primary Care Version 2 L Knight H Dare Revised Division To outline the responsibility of non clinical staff who have been authorised by the clinical director to check CDs Status New / Revised / Trust Change 2/11

NAME OF DISCIPLINE: PRIMARY CARE DIVISION OBJECTIVES To ensure implementation of national guidance and legislation on the safe and secure management of Controlled Drugs within Primary Care Division To outline the correct procedure, for recording critical incident, errors and near misses. To outline the correct procedure, in the event of loss or suspected theft of controlled drugs SCOPE To cover all aspects of obtaining controlled drug stock, handling responsibilities, storage, access, stock checks and record keeping within Primary Care Division. This standard operating procedure excludes Leasowe Primary Care Centre, as Leasowe do not obtain control drugs from Wirral University Teaching Hospital TARGET GROUP All staff working within Primary Care Division who are involved in handling Controlled Drugs, with the exception of Leasowe Primary Care Staff. All agency staff must receive a copy of this SOP on their first shift and sign to confirm they have read the SOP and agree to work in accordance with it. EVIDENCE TO SUPPORT PROCEDURE Safer Management of Controlled drugs: Guidance on standard operating procedures for controlled drugs Department of Health February 2007 A Guide to Good Practice in the Management of Controlled Drugs in Primary Care (England) Third Edition National Prescribing Centre December 2009 Safer Practice Notice No 12: Ensuring Safer Practice with High Dose Ampoules of Diamorphine and Morphine National Patient Safety Agency December 2009 The Safe and Secure Handling of Medicines: A Team Approach Royal Pharmaceutical Society March 2005 Standards for Medicines Management Nursing and Midwifery Council 2010 IT IS THE RESPONSIBITITY OF ALL STAFF TO COMPLY WITH RELEVANT TRUST POLICIES, PROCEDURES AND PROTOCOLS IN CONJUNCTION WITH THIS PROCEDURE PROCEDURE ACTIVITY RATIONALE RESPONSIBILITY 1. ORDERING Controlled drugs (CDs) must be ordered from Wirral University Teaching Hospital NHS Foundation Trust Pharmacy (WUTH) by the Lead GP for GP Out of Hours or the Clinical Director for Primary Care Division (PCD) WUTH require a specimen signature for both the Clinical Director for Primary Care Division Controlled drug requisitions need to be signed by a doctor who is employed by the Trust To enable WUTH to check the validity of the requisition and the Lead GP for GP Out of Hours. 3/11 Clinical Director PCD/Lead GP for GP Out of Hours Clinical Director /Lead GP for GP Out of Hours

The requisition must be written on an official Controlled Drug Requisition Book. Provided by WUTH and include the following: Be signed and dated by the Doctor/Clinical Director or Lead GP for GP Out of Hours. State the doctor s name and address State the doctor s title Specify the drug, form and strength Specify the total quantity of the drug Specify the purpose for which it is required, such as for use in GP Out of Hours, Primary Care Division The Doctor must also ensure that the carbon copy paper is in place correctly and that all details of the requisition have been copied onto the subsequent page of the requisition book WUTH Pharmacy will only process the original document. The requisition book must therefore be delivered to WUTH pharmacy in a blue controlled drug bag and personally delivered by the Lead Nurse or designated deputy ( clinical or non-clinical) To comply with best practice and legal requirements To ensure robust audit trail requirements Clinical Director /Lead GP for GP Out of Hours Lead Nurse/designated deputy 2. RECEIVING STOCK FROM WUTH WUTH Pharmacy will contact Primary Care Division Lead Nurse or Operational Manager at Arrowe Park site when the order is ready for collection. The Lead Nurse or designated deputy (clinical or non-clinical) with their Wirral Community NHS Trust ID badge will pick up the order from Arrowe Park Pharmacy. The Lead Nurse or designated deputy must check the CD bag s seal at WUTH Pharmacy and sign. WUTH Pharmacy will not release the order unless the staff has a valid ID badge To sign to accept delivery of a sealed container. Lead Nurse or designated deputy Lead Nurse or designated deputy 3. ENTERING STOCK CDS INTO PRIMARY CARE DIVISION On receipt of CDs into Primary Care Division, they must be immediately handed to an Assigned Practitioner who must record the CDs into the CD register; and place them in the CD cabinet. This must be witnessed by a suitably Assigned Practitioner who may be a doctor or a registered nurse 4/11

trained nominated staff. The following details must be recorded in the CD register: The date on which the CD was received The name and address of the supplier, e.g. WUTH Pharmacy The quantity received Batch number and expiry date. The name, form and strength of the CD The assigned practitioner must verify the stock level and sign the CD register witnessed by a nominated staff The CD register must: Be bound (not loose leaved) Contain class sections for each individual drug Have the name of the drug specified at the top of each page Have entries in chronological order and made on the day of the transaction Have entries in black ink Not have cancellations, obliterations or alterations. Corrections must be made by a signed and dated entry in the margin or at the bottom of the page Be kept at the Primary Care Division base where the controlled drugs are located Although there is provision in law for computer generated CD registers, there are no systems in place for computer generated CD registers within the Trust at present Assigned Practitioner who may be a doctor or a nurse, this must be witnessed by a nominated staff For auditing purposes, a spreadsheet should be completed to include all controlled drug registers and requisition books used by the service, including dates issued and the date logged out when full. Controlled drug registers and requisition books must be kept for a minimum of two years after the date of the last entry, once complete. To ensure irregularities are identified as quickly as possible. A running balance of stock CDs should be maintained. To be carried out daily by a registered nurse, GP or authorised staff and witnessed by another authorised staff. Registered nurse or Authorised staff. The authorised staff must be authorised to check CDs by the clinical To provide evidence the staff is appropriately trained 5/11

director. This could be in the form of a written statement signed by the clinical director and kept in the staff s file. The staff must also have successfully completed in house competencies and authorised 4. PROCEDURE FOR DISCREPANCY OF CONTROLLED DRUGS In the event of a discrepancy in the amount of CDs, the discrepancy must be investigated by the Practitioner in Charge (present on site) or Assigned Practitioner if he/she is not on duty. The count should be double-checked. A full check of all controlled drugs must also be performed Contact the Operational Manager for the Day within Primary Care Division and the Clinical Director of the Primary Care Division if the count cannot be reconciled. A Datix incident form must be completed and the Trust s Controlled Drug Accountable officer informed in the same span of duty as the incident. Refer to Trust s incident reporting policy for details. If the loss cannot be solved satisfactorily the Local Security Management Specialist must be informed (Trust Security Officer) Once resolved a note should be made in the CD register correcting the discrepancy in the balance 5. STORAGE OF CDS CDs must be stored in a CD cabinet that complies with The Misuse of Drugs Act Regulations 1973 Access must be limited to Assigned Practitioners who must be a registered nurse or doctor or to staff s who have been authorised by the clinical director Stocks of CDs should be kept to a minimum, High strength opiates must not be stored alongside lower strength To comply with good practice To comply with Trust policy and procedures. To comply with Trust policy and procedures To reduce the risk of error and to comply with Safer Practice Notice No 12 Practitioner in Charge or Assigned Practitioner in conjunction with designated deputy Assigned Practitioner who may be a doctor or a nurse or authorised staff 6/11

products. CDs must be kept in the container issued by the supplying pharmacy. High strength diamorphine and oxycodone ampoules must be kept in red plastic high dose opiate bags supplied by WUTH pharmacy. 6. SECURITY OF MEDICINES AND RELATED STATIONERY Requisition books & prescription pads should be locked away in the locked cabinet within a locked room. Keys to the CD cabinet should be kept in a secure locked cupboard when not in use, ensuring access is limited to authorised staff s only 7. DISPOSAL OF EXPIRED OR UNWANTED CD STOCK When stock CDs become expired they should be clearly marked date expired and segregated from other stock. The Primary Care Division Service must obtain controlled drug destruction kits. These kits can be obtained from NHS Supply Chain, the code for the kit is KYA003 The Quality and Governance Service must be contacted on telephone 0151 514 2202 or internally on 6015 to arrange a visit by a staff who has been authorised by the Accountable Officer to witness the destruction of stock CDs A senior practitioner from the Primary Care Division must destroy the stock CDs witnessed by the authorised witness. Refer to the SOP for Witnessing the Destruction of Stock Controlled Drugs within Wirral Community Trust Services for full details 8. ADMINISTRATION OF CONTROLLED DRUGS Dosages and frequencies for all controlled drugs must be written in full by the prescriber to aid correct administration. To ensure security of order forms. To enable authorised staff to locate key to access cupboard To enable the service to denature the CDs, when destroyed and witnessed by an authorised witness The Accountable Officer is able to give authorisation for the destruction of CDs to a staff who does not have a day to day involvement with CDs To ensure the correct procedure is followed Authorised staff s Assigned Practitioner in conjunction with the authorised witness Registered Doctor in conjunction with an appropriately trained witness who can be 7/11

If administering CDs from Primary Care Division stock, a record must be made in the CD register, including the date, name of patient, medication /dose/ quantity /route and Adastra number The register must be signed by a registered doctor and an appropriately trained witness an Registered Nurse, Registered GP or an appropriately trained non clinical staff 9. CONTROLLED DRUGS USED BY HOME VISITING DOCTORS Controlled drugs will be taken out of the department by home visiting doctors A small agreed stock of CDs will be kept in a locked CD Doctor s Bags. See Appendix 1 for full details Each CD contained in the bag will be kept in the original packaging issued by WUTH pharmacy. Each CD Doctor s Bags will have a separate CD register to record the CDs within it. To ensure appropriate CDs are available for patients To comply with good practice To provide a robust audit trail Registered Doctor Each bag will be checked by a Registered Nurse and an appropriately trained authorised staff. The expiry dates will be checked and the stock levels of each CD will be documented for each bag in the relevant CD register. If the stock levels fall below an agreed level they will be replenished from the main stock of CDs. Any stock transferred into the CD Doctor s Bags must be recorded in the appropriate CD registers. To ensure appropriate stock is available for patients To provide a robust audit trail Registered Nurse and an appropriately trained authorised staff The bag will then be sealed with a numbered security seal. The tag number will be recorded in the relevant CD register When the CD Doctor s Bags are issued to on call doctors, the doctor must check that the security seal is in place and put the sealed bag in a further bag locked with a combination lock. Doctors are signing for delivery of a sealed container which has been checked. If the numbered security tag has to be broken the doctor is still able to lock the CD Doctor s Doctor in conjunction with the appropriately trained authorised staff 8/11

If the on call doctor wants to check the contents of the CD Doctor s Bag they may open the numbered security seal and check the contents prior to leaving the department. If this is the case, an appropriately trained nominated witness must witness the GP rechecking and resealing the bag with another numbered tag. This must be documented in the relevant CD register Bag using the combination lock Whilst the CD Doctor s Bags are out with the on call doctor they must remain with the security tags in place. If any drugs are required, the seal will be broken Following the use of any CDs within the CD Doctor s Bag the bag must be locked with the combination lock. The bag will then be returned to base. All CDs administered to patients must be recorded in the relevant CD register and recorded on the Adastra system as outlined in section 8. When the service is not operational the CD Doctors Bags will be stored in the CD cabinet. Each bag will have been checked with a witness and sealed with a signature and code. On a daily basis the CD bags will be checked for any tampering or if the seal is broken. It should be noted that it is acceptable for part used boxes of tablets or ampoules to be taken out with the doctor, provided that the CDs are retained in the container issued by the supplying pharmacy and there is sufficient stock as outlined in Appendix 1. The home visiting doctor will sign the CD bag out (ensuring the seal tab is not broken) of the allocated register at the beginning of his/her shift and sign the CDs back into the allocated register at the end of his/her shift. Registered doctor in conjunction with the appropriately trained authorised staff 9/11

The GP should inform the operational or shift Manager if the bag has been opened. If not used, the seal and bag should be checked by the GP and the appropriately trained nominated witness to check for any tampering or seal breakage 10. CLINICAL INCIDENTS Any related incidents arising from carrying Out this procedure which may involve a clinical error or near miss must be reported following the Trust s Incident Reporting Policy. To maintain patient safety and comply with Trust Incident Reporting system for effective clinical governance Health professional or delegated staff EQUALITY ASSESSMENT TRAINING SPECIALIST COMPETENCIES OR QUALIFICATIONS CONTINUING EDUCATION & TRAINING RISK ASSESSMENTS ORGANISATION DEPARTMENT (IF APPLICABLE) During the development of this procedure the Trust has considered the clinical needs of each protected characteristic (age, disability, gender, gender reassignment, pregnancy and maternity, race, religion or belief, sexual orientation). There is no clinical evidence of exclusion of these named groups. If staff become aware of any clinical exclusions that impact on the delivery of care this must be reported using the Trust Incident Reporting System and an appropriate action plan put in place 1. Staff must comply with the Trust s Training Matrix which specifies mandatory training requirements. 2.In addition staff must comply with their service level training matrix for training and competencies as required for role 3. All staff to have an annual appraisal 4. All staff to be made aware of their responsibilities within this procedure Update on SOP when SOP is reviewed Medicines Management Training every 2 years. Controlled drugs are drugs of potential abuse. Risk of Administration Error Wirral Community NHS Trust The Primary Care Division. 10/11

STANDARD OPERATING PROCEDURE APPROVED BY: Peer Review Forum Trust Formal Approval Medicines Management Group Quality, Patient Experience and Risk Group Appendix 1 Minimum Controlled Drug Stock Levels for the CD Doctor s Bags Medication Strength Minimum Quantity Morphine Sulphate ampoules 10mg in 1ml 5 ampoules Midazolam ampoules 10mg in 2 ml 5 ampoules Pethidine tablets 50mg 4 tablets Pethidine ampoules 50mg in 1ml 5 ampoules Naloxone injection 400 micrograms per ml 1 injection Appropriate needles and syringes to also be contained in the CD Doctor s Bag 11/11