The MDU is often contacted by members seeking advice about the secure storage of controlled drugs (CDs) both at the practice and when on home visits. There have been legislative changes in recent years concerning the storage, prescribing and dispensing of CDs.
Perhaps most significantly, The Controlled Drugs (Supervision of Management and Use) Regulations 2006, came into force in England and Scotland in 2007 and similar regulations came into force in Wales and in Northern Ireland in 2009.
Under the regulations, GP practices holding stocks of CDs are required to draft an appropriate standard operating procedure (SOP).
The DoH advises that SOPs should include information about how CDs are received by the practice, the security arrangements and the names of those with access.1 GPs can also seek advice on producing a SOP from their primary care organisation.
The regulations allow the appointment of accountable officers by PCOs. They ensure the organisation, or those people working on its behalf (such as GPs), have suitable arrangements in place for managing CDs. They may request a periodic declaration from GPs on their medical performers list about their management of CDs, including how they are stored.
Accountable officers can also carry out unannounced visits to GPs to examine CD stocks and records relating to their use.
GPs are responsible for ensuring CDs are securely stored in accordance with the Misuse of Drugs (Safe Custody) Regulations 1973. This requires that all Schedule 2 and some Schedule 3 CDs (including temazepam) should be stored securely in a purpose-built locked metal cabinet or safe, which is fixed to a wall or the floor. The MDU advises that the CD register should be kept separate from the CDs to avoid the loss of both.
Additionally, each doctor is responsible for the CDs held in their own bag during home visits. The National Prescribing Centre (NPC) has produced detailed guidance on managing CDs.2 The key messages include keeping a separate CD register for the controlled drug stock held within a doctor's bag.
Another member of practice staff should act as a witness when the bag is restocked from practice stock and ensure that this has been entered into the practice's CD register.
Doctors' bags should be kept locked at all times, except when in immediate use. The person in lawful possession of this bag, or an individual authorised by them, must always retain the keys. Bags containing CDs should not be left in a vehicle overnight or left unattended for long periods. Instead it is advisable to store the bag in a locked room away from patient areas.
Stocks of CDs held in bags should be kept to a minimum, based on previous experience of need, with only one strength of each CD in a bag to minimise the risk of inappropriate administration. Oral preparations of CDs would not routinely be considered essential items to be carried in a doctor's bag.
Destruction of CDs
When CDs are out of date or unwanted, practices must ensure they are properly disposed of and the destruction is witnessed by an authorised person (Misuse of Drugs Regulations 2001).
Since 2007, accountable officers have had the power to authorise people to witness the destruction of controlled drugs, although accountable officers cannot act as a witness themselves. Authorised witnesses should have appropriate training and be subject to a professional code of ethics and/or have been the subject of Criminal Records Bureau checks. They should also be independent of day-to-day use or management of CDs.3
A record should be kept in the drug register of all CDs that are destroyed, including the name, its form, strength and quantity, the date of its destruction and the signatures of the authorised witness. The authorised witness should also endorse the record with their name, signature and registration number.
Unwanted CDs may have been returned to the practice. In such cases, the DoH says: 'It is good practice to have the destruction of returned CDs witnessed by an authorised person and to make a record of their destruction.'
GPs with queries about the storage or loss of CDs should contact their medical defence organisation for further advice.
- Dr James Armstrong is a medico-legal adviser at the MDU. www.the-mdu.com
|A GP was reported to the GMC for not storing and disposing of controlled drugs appropriately. The doctor had out-of-date ampoules of opiates which he had forgotten to dispose of. However, after further investigation, and with the help of the MDU in responding to the complaint, the GMC decided that it was a genuine oversight by the doctor and no further action was taken.|
1. Safer management of controlled drugs: guidance on Standard Operating Procedures for controlled drugs, DoH, 2 February 2007
2. A guide to good practice in the management of controlled drugs in primary care (England), National Prescribing Centre, February 2007
3. Guidance on the destruction of controlled drugs - new role for Accountable Officers, DoH, 29 August 2007