GP registrars who may be prescribing controlled drugs (CDs) in the community setting for the first time need to ensure that they prescribe and monitor them according to recently revised guidelines and laws.
Legislative changes have been made and new guidelines issued following the fourth report of the Shipman Inquiry, 'Safer Management of Controlled Drugs', which found that there was insufficient collection or monitoring of information on CDs in the community.
After the amendments to the Misuse of Drugs Regulations 2001, which came into effect in England, Scotland and Wales in January this year, it is a legal requirement for details to be recorded in the register for CDs received into stock or supplied to patients. These include:
- date supplied
- name and address of the supplier or patient supplied
- prescriber's details
- quantity and form supplied
DoH guidance also suggests doctors record their prescriber identification number and/or GMC number.1 Healthcare professionals are also advised to keep a running stock of CDs. Records should be kept for two years at present, but when computerised records are in general use the DoH may require them to be kept for 11 years.
Computerised CD registers should clearly identify the author of each entry, should ensure that entries cannot be altered at a later date and allow for all data to be recalled for audit purposes.
From 1 February 2008 it has also been a legal requirement to record additional information in the CD register about people collecting a Schedule 2 CD.
A record should also be kept of out-of-date or unwanted CDs that are destroyed.2 This should include the name of the drug, its form, strength and quantity, and the signatures of both the authorised witness and perpetrator of the CDs' destruction.
This does not apply to CDs returned by patients, and there is no requirement that returned Schedule 2 and Schedule 3 CDs should be destroyed in the presence of an authorised witness.
But the DoH advises that: 'It is good practice and strongly recommended that doctors and pharmacists have the destruction of these returns witnessed (preferably by a registered healthcare professional) and to make a record of the destruction'.
The requirements regarding monitoring and recording also apply to CDs stored in bags used for home visits. It is advisable to ensure stocks are kept to a minimum, checked regularly and out-of-date supplies destroyed because drugs within the bag may not be used often.
The National Prescribing Centre (NPC) recommends that a separate register should be kept for the CD stock in bags and that the restocking of the bag should be witnessed by another member of the practice staff, as should new entries into the practice's CD register. To minimise the risk of error the NPC recommends that only one strength of each CD should be kept in the bag.3
Monitoring and inspection
PCTs have a statutory duty to appoint an 'accountable officer' - someone who does not usually supply, administer or dispose of CDs - who has a range of responsibilities relating to the safe use and management of CDs.
These include: ensuring there are arrangements in place to monitor the use of controlled drugs, including inspection visits; ensuring there is a system in place for early warning or detection of problems; and investigating and taking action on concerns. If serious concerns are revealed accountable officers can refer the matter to the police, NHS fraud investigators or the GMC.
Accountable officers will require GPs to complete a self-assessment of their management at least every two years and draft a standard operating procedure about their use of CDs.
GPs asked for information on CDs in regards to the monitoring and inspection arrangements should use anonymised data wherever possible.
The GMC states that if anonymised data will not serve the purpose, or it is not practicable to anonymise the data, doctors should seek patient consent for the disclosure of identifiable information for purposes not related to the direct care of the patient or clinical audit within the team providing healthcare.4
There are circumstances where disclosure of patient-identifiable information might be justified in the public interest, without the patient's consent.
Before doing so members should discuss the matter with a medical defence organisation and to note on the patient's record the decision taken.
Dr Devlin is a medico-legal adviser with the MDU
- This topic falls under section 3.2 of the GP Curriculum 'Patient Safety', www.rcgp-curriculum.org.uk
- Contact Emma Quigley at GP Education on (020) 8267 4805 or email GPeducation@haymarket.com
1. It is a legal requirement for GPs to enter the details of drugs prescribed or received into stock into the register for CDs.
2. A record should be kept of the name, form, strength and quantity of any out-of-date or unwanted CDs that are destroyed.
3. GPs are advised to keep stocks of drugs kept in their bags to a minimum, regularly checking for and replacing out-of-date supplies.
4. GPs holding stocks of CDs need to complete a self-assessment of their management at least every two years.
1. Safer Management of Controlled Drugs: Changes to record keeping requirements: Interim guidance (for England only), Department of Health, October 2007.
2. Interim guidance, Safer Management of Controlled Drugs: Guidance on the Destruction and Disposal of Controlled Drugs, Department of Health, October 2006.
3. A guide to good practice in the management of controlled drugs in primary care (England), National Prescribing Centre, February 2007.
4. Confidentiality: Protecting and Providing Information, April 2004.