STANDARD OPERATING PROCEDURE FOR SAFE AND SECURE MANAGEMENT OF CONTROLLED DRUGS WITHIN MINOR INJURIES UNIT Issue History Issue Version One Purpose of Issue/Description of Change To ensure implementation of national guidance and legislation on the safe and secure management of Controlled Drugs within Minor Injuries Unit. Planned Review Date 2016 Named Responsible Officer:- Approved by Date Medicines Governance Pharmacist Quality, Patient Experience and Risk Group May 2013 Section:- Medicines Management MMSOP38 Target Audience Staff working within Minor Injuries Unit. UNLESS THIS VERSION HAS BEEN TAKEN DIRECTLY FROM TRUST WEB SITE THERE IS NO ASSURANCE THIS IS THE CORRECT VERSION
CONTROL RECORD Title Purpose Standard Operating Procedure (SOP) for safe and secure management of Controlled Drugs within Minor Injuries Unit, Victoria Central Health Centre (VCH). To ensure implementation of national guidance and legislation on the safe and secure management of Controlled Drugs within Minor Injuries Unit. Quality and Governance Service (QGS) and J Edwards Author Impact Assessment Incorporated into procedure Yes No Subject Experts Medicines Governance Pharmacist Document Librarian QGS Groups consulted with :- Medicines Management Group Infection Control Approved Not Appropriate Date formally approved by May 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 J Edwards New Safe and Secure Handling of Controlled Drugs within Minor Injuries Unit VCH. Status New / Revised / Trust Change 2/8
NAME OF DISCIPLINE: MINOR INJURIES UNIT VCH, UNPLANNED CARE DIVISION OBJECTIVES To ensure implementation of national guidance and legislation on the safe and secure management of Controlled Drugs within Minor Injuries Unit (MIU). 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 MIU. TARGET GROUP All staff working within MIU who are involved in the handling of Controlled Drugs. All agency staff must receive a copy of this SOP on their first shift, and sign to confirm they have read the SOP 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 a designated doctor employed by Wirral Community NHS Trust WUTH require a specimen signature for the designated doctor employed by the Trust 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 doctor. Designated doctor Designated doctor 3/8
The requisition must be written on an official Controlled Drug Requisition Book. This is provided by WUTH and must include the following: Be signed and dated by the designated doctor State the doctor s name and service 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 within Minor Injuries Unit 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. 2. RECEIVING STOCK FROM WUTH WUTH pharmacy will deliver the order in a sealed blue controlled drug bag. 3. ENTERING STOCK CDS INTO MINOR INJURIES UNIT On receipt of CDs into MIU, they must be immediately handed to an assigned practitioner. The assigned practitioner must check the CD bag s seal and then sign for the receipt of the CDs. The assigned practitioner must then open the bag, record the CDs into the CD register; and place them in the CD cabinet. This must be witnessed by a suitably trained nominated staff member 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 (having first checked the quantity against the original requisition) 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 another member of clinical staff. To comply with best practice and legal requirements To ensure robust audit trail requirements requirements and good practice To sign to accept delivery of a sealed container requirements and good practice Designated doctor or a registered nurse or a registered nurse, this must be witnessed by an other member of clinical staff 4/8
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 the assigned practitioner with a signed, dated and witnessed entry in the margin or at the bottom of the page Be kept within MIU Controlled drug registers and requisition books must be kept for a minimum of two years after the date of the last entry, once complete. A running balance of stock CDs should be maintained. To be carried out daily (including weekends and bank holidays) by the assigned practitioner and witnessed by another member of the clinical staff. 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 requirements and good practice or a registered nurse, this must be witnessed by another member of clinical staff. 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). The count should be double-checked. A full check of all controlled drugs must also be performed Contact the Divisional Manager for Unplanned Care or the Nurse Consultant for Unplanned Care if the count cannot be reconciled. In the evening, weekends and bank holidays contact the Out of Hours senior manager on call. A Datix incident form must be completed and the Trust s Controlled Drug Accountable officer, and the Medicines Governance Pharmacist within the Quality and Governance Service must be informed by telephone: 0151 514 2202 or internally on 6015, in the same span of duty as the incident, or as soon as possible if the incident To comply with good practice To comply with Trust Policy and procedures. To comply with Trust Policy and procedures Practitioner in charge 5/8
is in the evening, or at the weekend or bank holiday. 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 Stocks of CDs should be kept to a minimum, If stored, high strength opiates must not be stored alongside lower strength products. High strength diamorphine and oxycodone ampoules must be kept in a red plastic high dose opiate bags supplied by WUTH pharmacy. CDs must be kept in the container issued by the supplying pharmacy. requirements and good practice To reduce the risk of error and to comply with Safer Practice Notice No 12 or a registered nurse 6. SECURITY OF MEDICINES AND RELATED STATIONERY Requisition books and 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 practitioners 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 MIU department 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 To ensure security of order forms. To enable authorised staff to locate key to access cupboard requirements and good practice 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 or a registered nurse in conjunction with the authorised witness 6/8
internally on 6015 to arrange a visit by a staff member who has been authorised by the Accountable Officer to witness the destruction of stock CDs A senior practitioner from MIU Service 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 authorised prescriber, to aid correct administration. If administering CDs from MIU stock, a record must be made in the CD register, including the date, name of patient, date of birth, medication /dose/ quantity /route and Adastra number The register must be signed by the authorised prescriber and another member of the clinical staff. 9. CLINICAL INCIDENTS destruction of CDs to a staff member who does not have a day to day involvement with CDs To ensure the correct procedure is followed requirements and good practice Registered doctor in conjunction with an appropriately trained witness who can be a doctor or registered nurse 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 member EQUALITY ASSESSMENT 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 evidence of exclusion of these named groups. If staff become aware of any 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 TRAINING SPECIALIST COMPETENCIES OR QUALIFICATIONS 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 7/8
3. All staff to have an annual appraisal 4. All staff to be made aware of their responsibilities within this procedure CONTINUING EDUCATION & TRAINING ORGANISATION DEPARTMENT (IF APPLICABLE) 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 Wirral Community NHS Trust MINOR INJURIES UNIT, VICTORIA CENTRAL HEALTH CENTRE. STANDARD OPERATING PROCEDURE APPROVED BY: Peer Review Forum Trust Formal Approval Medicines Management Group Quality, Patient Experience and Risk Group 8/8