Standard Operating Procedure - Medicine Management CD storage and transport V1a
Note: this document is electronically controlled. The master copy is maintained by the author. If this document is printed will no longer be controlled and may not be the current version
Standard Operating Procedure Medicine Management
Handling of Controlled Drugs
Storage, Access and Transport
Version 1a
Note: this document is electronically controlled. The master copy is maintained by the author. If this document is printed will no longer be controlled and may not be the current version, it is the responsibility of the user to ensure that they are following the most recent procedures which can be located on the Swindon PCT intranet.
Every effort has been made to ensure that the information provided in this procedure is accurate and up-to-date. However, the legal and regulatory framework governing CDs is continuing to change significantly and readers should always check that they are referring to the most up-to-date version of this guide, as well as cross-checking with other recognised sources of information.
The NPC website www.npc.co.uk, the Department of Health (DH) website www.dh.gov.uk/controlleddrugs, the Home Office websites www.homeoffice.gov.uk and www.drugs.gov.uk/drugs-laws/ and the Royal Pharmaceutical Society of Great Britain (RPSGB) website www.rpsgb.org.uk should be referred to regularly, amongst others.
Document Control
Purpose / To ensure that all medicines which are required in the service are available and are in date.Policy Application / Organisation wide
Author / Toni Lloyd
Job Title / Medicine Governance Pharmacist
Version / Version 1a
Date of Implementation / October 2007 reviewed May 2008, June 2010
Ratification Committee / Medicines Management Committee
Date of Review / May 2011
Responsibility for implementation / Service Managers
Race Equality & Diversity / This policy has been assessed against the Equality Impact Assessment Tool as required by the Race Relations (Amendment) Act 2000.
Policy Statement / It is the responsibility of staff at all levels to ensure that they are working to the most up to date and relevant policies and procedures. By so doing, the quality of services offered will be maintained and the chances of staff making erroneous decisions, which may affect patient, staff or visitor safety, will be reduced.
Contents
Document Control 2
Contents 3
Purpose 4
Scope 4
Responsibilities 4
Review Procedure 5
Introduction 5
Stages of the Process 6
Storage of Controlled Drugs 6
Access to Controlled Drugs Cabinet Keys 7
Access to Controlled Drugs Cabinet 7
Controlled Drugs in ‘doctors bag’ 8
Transporting Controlled Drugs to and from Patients by Healthcare Professionals. 9
Transporting Controlled Drugs by Other Methods 10
Transporting of prescriptions for Controlled Drugs 10
Training for this Standard Operating Procedure. 11
Monitoring and Auditing for this Standard Operating Procedure. 11
Purpose
To ensure legal, secure, safe and appropriate handling of controlled drugs within the service. Readers should also be aware of the Legal and Good Practice information contained in The National Prescribing Centre’s “A Guide to Good Practice in the management of controlled drugs in primary care”.
Scope
This procedure aims to safeguard the access to, handling of, and supply at or from the service of Schedule 2 controlled drugs.
Responsibilities
Only the following persons are legally permitted to possess schedule 2, 3 or 4 Controlled Drugs:-
· Medical practitioners (this includes doctors, dentists and veterinary surgeons)
· Pharmacists or a person lawfully conducting a retail pharmacy business
· Supplementary prescribers where CDs form part of an agreed Clinical Management Plan
· Nurse independent prescribers, but restricted to a specified range of CDs for specific medical conditions
· Any person administering under the direction of a doctor or dentist
· Midwives acting in their capacity as such (only those CDs that she / he may administer in accordance with Medicines Act)
· Paramedics acting in their capacity as such (Only those CDs which are the subject of the Group Authority issued by the Secretary of State under the 2001 Regulations)
· Health professionals supplying or administering certain categories of CDs under a PGD
· Individuals and bodies corporate licensed by the Home Office Drugs Branch
· Persons in charge of a hospital or care home with nursing
· Someone who is transferring, with permission, a CD to another person who is lawfully allowed to have it in their possession. This permission may be granted by the person authorised to possess and should be in writing
· Someone who has legally been prescribed a CD
· Constables when acting in the course of their duty as such
· Persons engaged in the business of a carrier when acting in the course of that business
· Persons engaged in the business of a postal operator when acting in the course of that business
· Customs and excise officers when acting in the course of their duty as such
· Persons engaged in the work of any laboratory to which the drug has been sent for forensic examination when acting in the course of their duty as a person so engaged
· Someone who has found a CD and is immediately taking it to a person who may lawfully possess it, e.g. a pharmacist for a medicinal product, a police officer for illicit drugs
· Someone who has removed a CD from someone else to stop them offending and is immediately taking it to a person who may lawfully possess it.
The Service/Practice Manager is responsible for ensuring that only persons legally permitted to handle controlled drugs do so within their service. They should also appoint a named authorised designated person to be responsible for the storage within the service. It would also be sensible to appoint a deputy to cover the absence of the designated person.
Review Procedure
This procedure will be reviewed after one year, then every two years or when there is a major change in the procedure. If a document requires a very minor change the author does not need to send it through the whole consultation/ratification system. They must ensure that one ‘expert’ peer has agreed the change prior to sending the revised version to the policy co-ordinator. If major changes are required a full consultation/ratification will be required.
Introduction
The Controlled Drugs (Supervision of Management and Use) Regulations 2006 came into effect on the 1st January 2007 as a result of the Government’s response to the Fourth Report of the Shipman Inquiry. It is a requirement that of these regulations that the service should have approved Standard Operating Procedures for handling of controlled drugs (CDs). In addition for all it is a requirement for all PCT Services to have a Standard Operating Procedure’s (SOP’s) for all medicine related activities within their service.
The Misuse of Drugs (Safe Custody) Regulations 1973 imposes controls on the storage of Schedule 1, 2 and Schedule 3 CDs. The Regulations apply to all Schedule 2 medicines (except quinalbarbitone) and the Schedule 3 drugs Buprenorphine, Diethylpropion, Flunitrazepam and Temazepam.
Schedule 2 of these Regulations fully applies to the storage of CDs at retail pharmacies but has not been amended to take account of the change in status of nursing and residential homes to care homes. In residential and healthcare settings it is recommended that the specifications of cabinets and safes set out in Schedule 2 of the Safe Custody Regulations should be regarded as a minimum standard for the storage of CDs.
Regulation 5 of the Safe Custody Regulations requires CDs (other than those specified in Schedule 1 of that Regulation) to be kept in a locked receptacle which can only be opened by the person to whom the Regulation applies (or a person authorised by him / her). The exceptions to this are drugs prescribed to persons for treatment purposes and carriers (including the Post Office).
The Controlled Drugs (Supervision of Management and Use) Regulations 2006 specify that storage arrangements for CD storage must be covered within SOPs.[1]
10 Storage of controlled drugs
Stages of the Process
Storage of Controlled Drugs
1. CD’s requiring safe custody should be stored under lock and key in a safe/cabinet. This safe/cabinet will conform to the requirements of the Misuse of Drugs (Safe Custody) Regulations 1973.
2. The locked safe/cabinet should preferably be as follows:-
· made of steel
· with suitable hinges
· fixed to a wall or the floor with rag bolts (these bolts should not be accessible from outside the cabinet).
3. Ideally the safe/cabinet should be within a cupboard or some other position to avoid easy detection by intruders.
4. If a safe is used to store CDs, then there should be a separate receptacle within the safe that keeps the CDs apart from other items, e.g. money, valuables, etc. Nothing should be displayed outside to indicate that CDs are kept within the container.
5. The room containing the safe/cabinet should be lockable and tidy around the safe/cabinet area to avoid drugs being misplaced.
6. The walls of the room should be constructed to a suitable thickness using suitable materials.
7. The room should not normally be accessible to patients or other members of staff who are not permitted to have access to CD’s. However, if others do have to enter the area where CDs are stored, it is good practice that they should be continuously supervised until such time as they leave the area.
8. Stock should be kept to a minimum and nothing should be displayed outside to indicate that controlled drugs are kept within that receptacle.
9. Other drugs that are liable to misuse can be locked in the cabinet if this is deemed appropriate by the relevant health care professional.
Access to Controlled Drugs Cabinet Keys
10. The named person responsible for the storage of CD’s within the service should take overall responsibility for the keys / codes to the controlled drug cabinet/safe. A written procedure to ensure that the keys to the CD cabinet/safe are secure at all times should be put in place.
11. The keys should always be kept separate from the cabinet/safe and should never be accessible to unauthorised persons.
12. The use of several sets of keys for the CD cabinet/safe should be avoided. However, if there is more than one set available strict controls on who is in possession of these keys should be implemented by the Service/Practice Manager.
13. The number of sets of keys to the cabinet/safe, and who holds them, or who has access codes for digital key pads, must be known at all times by the Service/Practice Manager.
14. Access to key cupboards should be restricted and removal of keys for CD cabinet/safe should be logged, so that it is known at all times who is in possession of the keys.
15. An emergency spare set of keys to the CD cabinet/safe should be available. These should not be stored with the normal set of keys. Access to these should also be restricted and removal from the area should also be logged.
Access to Controlled Drugs Cabinet
16. Only persons who are authorised to handle CD’s will be allowed access to the CD cabinet/safe. The named person remains ultimately accountable for the management of the CDs.
17. Access to the cabinet must always be witnessed by a second authorised person.
18. A controlled drug register will be kept by the service maintained according to Misuse of Drug Regulations and good practice requirements. Details on records required CD can be found in the appropriate standard operating procedure.
19. The CD register should stored safely outside the CD cabinet/safe, in an appropriate location near the CD cabinet/safe, care should be taken to choose a location that does not advertise the location of the CD’s.
20. Each drug, dosage form, and strength should have its own booklet or page within the CD register.
21. For patient own CD;s a separate booklet or page should prepared for each patient and each drug.
22. A running balance of stock will be kept in accordance with the appropriate standard operating procedure on record keeping.
23. Any discrepancies found in the running balance will be brought to the attention of named person responsible for CD’s, who will investigate the discrepancy further, and in accordance with the appropriate standard operating procedure.
Controlled Drugs in ‘doctors bag’
24. A ‘doctor’s bag’ is a locked bag, box or case for home visits, etc. which should be kept locked at all times, except when in immediate use. Legal precedent holds that such a bag is regarded, once locked, as a suitable receptacle for storing CDs, but a locked car is not.
25. The person in lawful possession of this bag, or an individual authorised by them, must always retain the keys.
26. For a bag for home visits, etc, a digital combination lock on a case is often the most practical and convenient solution and avoids problems with keys.
27. Bags containing CDs should not be left in a vehicle overnight, or in a vehicle left unattended for long periods of time.
28. Many doctors only use the CD stock carried in their bag on rare occasions. The stock levels held in this bag should be kept to a minimum and informed by previous requirements.
29. Normally, only one strength of each CD should be kept in a bag for home visits, etc. in order to minimise the risk of confusion, error and inappropriate administration. Oral preparations of CDs would not routinely be considered essential items to be carried in such a bag.
30. When a bag for home visits, etc. containing CDs is in the practice, it should be stored in a safe place away from patient areas in a locked room. This location should be determined by carrying out a risk assessment.
31. A monthly stock check of CDs held within each bag for home visits, should be undertaken. This process provides a good opportunity to check for any out-of-date (or ‘soon to expire’) stock.
32. Each professional should also assess the risks and benefits in relation to where they store CDs and registers in relation to each other. A balance has to be achieved between having the CD register readily available to make an entry at the time of administration, and the possibility of the bag and the register both being stolen, with the consequent loss of both the CDs and the audit trail.