Controlled drugs are defined and governed by the Misuse of Drugs Act 1971 ('the Act') and associated regulations. Controlled drugs are managed and used in a variety of settings by health and social care practitioners and by people who are prescribed them. Controlled drugs are closely regulated because they are susceptible to being misused and can cause harm. To ensure that they are managed and used safely, legal frameworks for governing their use have been established.

Since the Shipman Inquiry's Fourth Report in 2004, the government have introduced significant legislative changes to the Act to strengthen the governance arrangements for controlled drugs. Arrangements have been established to encourage good practice in the management of controlled drugs, as well as helping to detect unusual or poor clinical practice, criminal activity or risk to patients. Organisations have variable systems and processes in place for obtaining, storing, supplying, recording, monitoring, disposing of and destroying controlled drugs. It is important that these systems and processes allow controlled drugs to be managed and used safely, while helping to ensure appropriate and convenient access for those people who need treatment with controlled drugs.

A lot of work has been done to help ensure that controlled drugs are managed and used safely at a local and national level. However, ongoing activity and vigilance is needed to sustain the positive developments that have been achieved. This guideline provides further clarity and good practice recommendations for the safe use and management of controlled drugs across all NHS settings. It supports organisations and health and social care practitioners to minimise harms associated with controlled drugs by having robust systems and processes in place. The recommendations were developed with the aim of bringing together legislation, policy advice, good practice advice and published evidence.

Managing and using controlled drugs in care homes is not included because this is covered the NICE guideline on managing medicines in care homes.

Legislation for managing and using controlled drugs

This guideline looks at systems and processes for using and managing controlled drugs in Schedule 2, 3, 4 and 5 of the 2001 Misuse of Drugs Regulations. The recommendations should be read alongside current legislation, in particular the legislation (and subsequent amendments) highlighted below: