The NHS has embarked on a journey to become one of the safest healthcare systems in the world as part of the NHS Long Term Plan.

NHS England has a statutory duty to ensure that safe systems are in place for the management and use of controlled drugs. This is to prevent harm to patients and staff from any misuse of controlled drugs.

Controlled drugs are drugs that are subject to high levels of regulation as a result of government decisions about those drugs that are especially addictive and harmful.

This page contains links to resources that will be of use to healthcare professionals who work with controlled drugs.

• Publications
• Opioid prescribing for chronic pain
• Local Intelligence Network (LIN)
• Useful links

The South West controlled drugs team

This team covers:

• Bath and North East Somerset, Swindon, and Wiltshire
• Bristol, North Somerset, South Gloucestershire
• Cornwall and Isles of Scilly
• Devon
• Dorset
• Gloucestershire
• Somerset

We can easily be contacted through our generic inbox england.southwestcontrolleddrugs@nhs.net

Darren Barnett – Interim Controlled Drugs Accountable Officer

Vicky Bawn – Project Co-ordinator

Regulatory context

In 2006, the Health Act was enacted and this formed part of the Government’s response to the Shipman Inquiry’s Fourth Report. The Controlled drugs (Supervision of Management and Use) Regulations 2006 were then introduced and the regulations were renewed in 2013.

Controlled drugs are essential to modern clinical care. The aim of the regulations is to strengthen the governance arrangements for the use and management of controlled drugs. It is essential that NHS England enforces robust arrangements for the management and use of controlled drugs to minimise patient harm, misuse and criminality.

These regulations require NHS England and other ‘designated bodies’ such as NHS trusts and independent hospitals to appoint Accountable Officers for Controlled drugs, and requires those Accountable Officers to ensure safe systems are in place for the management and use of controlled drugs. They also require other organisations (responsible bodies) to share information about the misuse of controlled drugs within healthcare settings.

Reporting of incidents involving controlled drugs

All incidents involving controlled drugs should be reported to the Accountable Officer. This provides assurance that any risks have been mitigated, and prompts any action to be taken if they are not. Reporting also allows for the identification of themes in reported incidents from which learning can take place.

We strongly advocate a ‘Just Culture’ in which healthcare staff are supported to be open about mistakes to allow valuable lessons to be learnt so the same errors can be prevented from being repeated. We help people to investigate, to reflect, to learn and to take action to prevent a recurrence.

Staff in organisations that do not have their own Accountable Officer should report their incidents to the accountable officer at NHS England. You can do this online at www.cdreporting.co.uk.

We share the learning from incidents reported to us and update on relevant topics via our local intelligence networks and via newsletters.

Occurrence reporting

Organisations that do have their own Accountable Officer (designated bodies) are required to send a summary of concerns relating to controlled drugs in an ‘occurrence report’ to the accountable officer at NHS England when requested. This information is requested every three months and can be submitted online at www.cdreporting.co.uk. Guidance for this can be found in our publications page.

Disposal of controlled drugs

Controlled drugs in schedules 2, 3, and 4 (part 1) must be denatured before being disposed of. Healthcare staff that are lawfully in possession of these can do so, but should ensure they have a ‘T28 exemption’ from the Environment Agency that allows this on the relevant premises. All denaturing should be witnessed by another person, and in the case of stocks of schedule 2 controlled drugs it must be witnessed by a person authorised by an Accountable Officer. You can request an authorised witness online at www.cdreporting.co.uk.

Privately prescribing or obtaining Schedule 2 and 3 controlled drugs

Amendments to the Misuse of Drugs Regulations 2001 require private prescriptions or requisitions for medicines containing schedule 2 and 3 controlled drugs to be issued on controlled stationery bearing a unique prescriber identification number (PIN). Practitioners providing such treatment of disease, disorder or injury should ensure they are appropriately registered, indemnified, and where necessary registered with the Care Quality Commission (CQC). More information about the scope of CQC registration is available on the CQC website.

You can obtain a new PIN, or make changes to your PIN record (such as name and address) by contacting the Accountable Officer via the relevant e-mail address (above).

If you have a PIN and need to order controlled stationery for prescribing you can obtain this from Primary Care Support England via their website.

If you wish to obtain rather than prescribe controlled drugs and have a PIN you can download the mandatory FP10CDF form. Please note that in order for an organisation to be in possession of controlled drugs it may need a Home Office license. Further information is available on the GOV.UK website. In most situations controlled drugs can only be supplied by an organisation with both a Wholesale Dealer’s license and a Home Office license.

Declarations and self-assessments of compliance with the regulations by providers of medical, dental, nursing or midwifery services

The regulations require providers to inform the NHS England Accountable Officer whether they use controlled drugs at any premises from which the provider provides health care, and if so, how controlled drugs are managed and used at those premises. This information is requested periodically and can be submitted online at www.cdreporting.co.uk.

Cascade alerts – sharing personal and sensitive information

Incidents of significant concern locally might include patients or healthcare professionals fraudulently obtaining Controlled Drugs, or stolen prescription forms. In these circumstances we sometimes choose to share information through a cascade alert with healthcare professionals including GP Practices, Dental Practices, Hospitals, Community Pharmacies and other relevant healthcare providers. These alerts may contain sensitive personal information to help prevent further fraudulent activity and prevent harm to the public. More information, and the information governance rationale is available on our website.

Further information

Please contact us if you require any advice or support, or have any further queries about the safe use of controlled via the relevant e-mail address (above).

If you are looking for information from the South West local primary care pharmacy team please see our pharmacy pages.