Dr Gerard Panting discusses the importance of the safe management and use of controlled drugs, and the functions and responsibilities of accountable officers


There have been several changes in legislation regarding controlled drugs since the Shipman Inquiry and the revelation that Dr Harold Shipman was able to acquire large stocks of controlled drugs for over 20 years without detection. In the review of his methods of amassing these drugs, the Shipman Inquiry noted that there had been virtually no revision of the relevant legislation since the early 1970s, and that the requirements relating to prescribing and record keeping were out of date.1 In response to this, the Government published Safer management of controlled drugs in 2004, detailing its plans to bring the legislation up to date.2

New regulations

The Government fully accepted the need to strengthen arrangements for the management of controlled drugs, without hindering patients from accessing necessary treatments.2
The result is the Controlled drugs (supervision of management and use) regulations 2006,3 which contains measures that underpin the safe management and use of controlled drugs in England and Scotland.

Primary care trusts (PCTs) and a number of other healthcare bodies (e.g. health boards, NHS trusts) are defined by the regulations as designated bodies that are required to appoint accountable officers who must be adequately resourced by the healthcare body appointing them.2,3

Accountable officers

Accountable officers are required to carry out a number of functions, including:3

  • the establishment and operation of procedures to ensure safe management and use of controlled drugs by the healthcare body
  • ensuring that an organisation or person acting on behalf of (or providing services under arrangements made with) the healthcare body establishes and operates appropriate arrangements for securing the safe management and use of controlled drugs by that organisation or person
  • ensuring that up-to-date standard operating procedures (SOPs) regarding the management and use of controlled drugs are in place for the healthcare body and any person or organisation acting on their behalf or providing services for them (see Box 1).

Accountable officers are required to introduce audit procedures that include monitoring and analysing health-service and private prescribing of controlled drugs. In England, this will make use of electronic prescribing analysis and costs (ePACT) data, and in Scotland, prescribing information system for Scotland (PRISMS) data.3

For an accountable officer in a PCT, all of these arrangements and procedures cover GPs and other healthcare professionals, as well as others whose work the PCT is responsible for. The responsibilities of the accountable officers include maintaining records of any concerns raised, their investigation, and the taking of appropriate action if well-founded.

Accountable officers for PCTs and health boards also have particular responsibilities for setting up local intelligence networks, and for sharing information regarding the management and use of controlled drugs. Among others, the local intelligence network will include the counter fraud service and the police.3

The National Prescribing Centre has launched a website for accountable officers (www.npci.org.uk/cd/public/home_page.php). This website will provide additional resources for all accountable officers, such as relevant legislation, a handbook, training materials, a ‘what is new’ section, and frequently asked questions.4

Box 1: Framework for standard operating procedures relating to the management and use of controlled drugs

Standard operating procedures must cover:3

  • who has access to controlled drugs
  • where controlled drugs are stored
  • secure storage and transport of controlled drugs
  • disposal and destruction of controlled drugs
  • who is to be alerted when problems occur
  • record keeping, including maintenance of controlled drugs registers and a record of the controlled drugs that have been returned by patients
    (as specified in Schedule 2 to the Misuse of drugs regulations 2001)

Controlled drug registers

Misuse of drugs regulations 2001 requires records of the receipt, supply, and stock holding of Schedule 2 controlled drugs to be kept in a controlled drug register (CDR).5 General practitioners and other healthcare professionals who hold Schedule 2 controlled drugs are personally responsible for keeping an accurate and up-to-date CDR, in either a paper-bound or electronic format.

Entries into electronic CDRs must be attributable and capable of being audited, and there must also be safeguards in place to ensure that CDRs cannot be altered at a later date.6 Controlled drug registers, requisitions and orders for controlled drugs must be preserved for at least 2 years,6 but as these documents may be important as evidence in both civil and criminal cases, it is prudent to keep them for 11 years.6,7

As part of the SOP on record keeping, relevant controlled drugs registers and records of drugs that have been returned by patients must be maintained.

Records for controlled drug registers

Separate records should be kept for each drug and different doses of controlled drugs. Electronic registers must be capable of displaying the name, form, and strength of the drug so that the details appear at the top of each display or printout.6

The headings/fields to be used in the CDR are ‘entries to be made in cases of obtaining’ controlled drugs and ‘entries to be made in cases of supply’ of controlled drugs. The entries can be made on the same or separate pages (previously, entries had to be made on separate pages).6

When controlled drugs are obtained (from 1 February 2008), the regulations require information to be recorded in the CDR, under the following specified headings:6

  • date supply obtained
  • name and address from whom obtained (e.g. wholesaler, pharmacy)
  • quantity obtained.

When controlled drugs are supplied, similar information is to be recorded in the CDR, under the following specified headings:6

  • date supplied
  • name and address of person or firm supplied
  • detail of authority to possess—prescriber or licence holder’s details
  • quantity and form in which supplied.

Proof of identity

In addition, it is a requirement (from 1 February 2008) to record specific information on the identity of the person collecting a Schedule 2 controlled drug supplied on prescription; the following should be noted:6

  • whether the person who collected the drug was the patient, the patient’s representative, or a healthcare professional acting on behalf of the patient, and
  • if the person who collected the drug was a healthcare professional acting on behalf of the patient, that person’s name and address should also be recorded
  • whether evidence of identity was requested and whether this was provided if the person who collected the drug was the patient or their representative.

Stocks and storage of controlled drugs in general practice

General advice from the Department of Health is that stocks of controlled drugs should be kept to the minimum required to meet the clinical needs of patients. They should be stored securely in a locked cabinet or safe to prevent unauthorised access, with the keys held in a safe place.7 Common sense dictates that nothing should be displayed to advertise where controlled drugs are kept. The best location for a controlled-drug cabinet is an area that is not accessed by patients or other individuals who are not members of the practice staff.8 The CDR should be kept outside the controlled-drug cabinet.

Away from the practice, controlled drugs are more vulnerable to theft, and so must be adequately protected. A doctor’s bag containing controlled drugs should be kept locked.8 While the locked bag satisfies the legislative requirement for safe custody, the bag itself will be easy pickings for a thief if not stored securely.

Prescription requirements

Pharmacists cannot dispense a prescription for a controlled drug unless the prescribing meets the requirements contained in the Misuse of drug regulations 2001. Pharmacists will refer incorrectly written prescriptions back to the prescribing GP. For all drugs in Schedules 2 and 3 (except temazepam), the prescription must:5

  • be in ink or otherwise indelible
  • state the address of the prescriber
  • state the name and address of the patient
  • specify the name of the drug and a dose (‘as directed’ is not sufficient)
  • specify the form (even when indicated by the name of the preparation)
  • state the strength and total quantity (in words and figures)
  • be signed and dated by the prescribing doctor.

Patients travelling abroad with controlled drugs

Patients going abroad for more than 3 months need a personal licence for carrying controlled drugs and, although the licence has no legal status, GPs will be asked to support licence applications.

A personal licence is intended to help patients pass through UK customs with controlled drugs. To prevent problems on entering another country, patients are advised to contact the embassy of that country to check the local regulations on the importation of controlled drugs.

Controlled drugs should be kept in the original packaging and carried in hand luggage, together with a valid personal import/export licence, and a letter from the prescribing doctor confirming the carrier’s name, destination, and drug details (including amounts).9

Criminal offences

Failure to comply with the requirements of the regulations controlling the supply, safe custody, and record keeping for controlled drugs can result in criminal proceedings, with the prospect of fines or imprisonment on conviction. Referral to the General Medical Council is automatic following conviction, but can also be made in the absence of prosecution.

Summary

From the perspective of a GP, the changes do not increase the regulatory burden, but the introduction of accountable officers does mean that practices need to be aware of local requirements set out in SOPs and also to expect periodic inspections.

  1. Shipman Inquiry Fourth Report. The regulation of controlled drugs in the community. The Shipman Inquiry, 2001.Available at: www.the-shipman-inquiry.org.uk/fourthreport.asp
  2. HM Government. Safer management of controlled drugs—The Government’s response to the fourth report of the shipman inquiry. Norwich: The Stationery Office, 2004. Available at: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4097904?IdcService=GET_FILE&dID=15736&Rendition=Web (accessed 14 May 2009).
  3. HM Government. The controlled drugs (supervision of management and use) regulations 2006. London: The Stationery Office, 2006. Available at: www.opsi.gov.uk/si/si2006/20063148.htm
  4. National Prescribing Centre. Controlled drugs: safe management and effective use. www.npci.org.uk/cd/public/home_page.php (accessed 21/05/2009)
  5. HM Government. The misuse of drugs regulations 2001. London: The Stationery Office, 2001. Available at: www.opsi.gov.uk/si/si2001/20013998.htm
  6. Department of Health. Safer management of controlled drugs (CDs): changes to record keeping requirements. London: DH, 2008. Available at: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079574
  7. Department of Health. Safer management of controlled drugs. A guide to good practice in secondary care. London: DH, 2007. Available at: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079618
  8. National Prescribing Centre. A guide to good practice in the management of controlled drugs in primary care (England). Second edition. Liverpool: NPC, 2007. Available at: www.npci.org.uk/cd/public/guidance.php
  9. NHS website. What is a controlled drug (medicine)? www.nhs.uk/chq/Pages/1391.aspx (Accessed 22/05/09).G