Standard operating procedure

Controlled Drugs Management Procedure

The step-by-step procedure for ordering, receiving, storing, recording, administering, supplying and destroying controlled drugs safely and lawfully within the GP practice.

For GP SurgeryRef BS-GP-SOP-002See a sample (PDF) →
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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
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What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Equipment and materials
  • 6. Procedure
  • 7. Records
  • 8. Related documents
  • 9. Review and version control
  • 10. Disclaimer

Legislation & standards it maps to

  • Misuse of Drugs Act 1971
  • Misuse of Drugs Regulations 2001 (as amended)
  • Misuse of Drugs (Safe Custody) Regulations 1973 (as amended)
  • The Controlled Drugs (Supervision of Management and Use) Regulations 2013
  • Human Medicines Regulations 2012
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (Safe care and treatment)
  • National Institute for Health and Care Excellence (NICE) Guideline NG46: Controlled drugs - safe use and management

Who it applies to

All GPs, non-medical prescribers, practice nurses, dispensary and pharmacy staff, the practice manager and any locum, bank or agency staff at [Organisation Name] who order, handle, prescribe, administer, supply, witness, record or dispose of controlled drugs.

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

Anabolic steroids
Prescription medicines, related to testosterone, that are sometimes misused to build muscle and are controlled under the law.
Authorised witness
A person formally allowed to watch and confirm the safe destruction of stock controlled drugs.
Benzodiazepines
A group of sedative medicines (for example diazepam) used for anxiety or sleep, controlled because they can be misused.
Buprenorphine
A strong opioid painkiller, also used to treat opioid dependence, that is a controlled drug.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
CD register
The official record of every receipt, supply, use and destruction of Schedule 2 controlled drugs, kept with a running total of stock.
Cold chain
Keeping vaccines and certain medicines within a safe temperature range from delivery to use.
Contemporaneous
Written down at the time the event happens, rather than from memory later.
Controlled drug (CD)
A medicine whose supply, storage and records are tightly restricted by law because of its potential for misuse.
Controlled Drugs Accountable Officer (CDAO)
The senior officer, usually in the Integrated Care Board, responsible for overseeing the safe use and management of controlled drugs across a local area.
Denaturing
Making a controlled drug permanently unusable before disposal, usually with a special denaturing kit, so it cannot be recovered or misused.
Diamorphine
A very strong opioid painkiller (medical heroin), used mainly in palliative care, that is a controlled drug.
Dispensing practice
A GP practice that is allowed to supply medicines directly to its patients rather than sending them to a separate pharmacy.
Diversion
The deliberate redirection of medicines away from their lawful use, for example theft for personal use or illegal sale.
Doctor's bag
The case of medicines and equipment a doctor carries for visits and emergencies away from the practice.
Fentanyl
A very strong synthetic opioid painkiller, available as patches or injections, that is a controlled drug.
FP10PCD
The official form used in England to write a private prescription for a controlled drug.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards of safety and quality that registered care providers must meet.
Home Office
The UK government department responsible for drugs policy, including licences for the most restricted substances.
Instalment prescription
A prescription that authorises a medicine to be supplied in agreed smaller amounts over set intervals rather than all at once.
Integrated Care Board (ICB)
The local body that plans and arranges publicly funded health services for an area.
Methylphenidate
A stimulant medicine used mainly for attention deficit hyperactivity disorder that is a controlled drug.
Midazolam
A fast-acting sedative medicine, used in emergencies and palliative care, that is a controlled drug.
Misuse of Drugs Act 1971
The main UK law that classifies controlled drugs and makes their unlawful possession or supply a criminal offence.
Misuse of Drugs (Safe Custody) Regulations 1973
The law setting the storage and security standards, such as an approved locked cabinet, for keeping controlled drugs safe.
Misuse of Drugs Regulations 2001
The regulations that set out, by schedule, how each controlled drug may lawfully be prescribed, stored, recorded and destroyed.
Morphine
A strong opioid painkiller, widely used in pain relief and palliative care, that is a controlled drug.
National Institute for Health and Care Excellence (NICE)
The national body that produces evidence-based guidance on treatments and good practice in health and care.
Non-medical prescriber
A trained health professional who is not a doctor, such as a nurse or pharmacist, who is qualified to prescribe medicines.
Oxycodone
A strong opioid painkiller that is a controlled drug.
Palliative care
Care that focuses on comfort, symptom relief and quality of life for people with a serious or terminal illness.
Pethidine
An opioid painkiller, sometimes used in labour, that is a controlled drug.
Pregabalin
A medicine used for nerve pain, epilepsy and anxiety that is a controlled drug because it can be misused.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
Quarantine (stock)
Setting suspect or unmatched stock aside, clearly separated, so it cannot be used until the issue is resolved.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Requisition
A formal written order used to obtain controlled drug stock from a supplier.
Running balance
The continuously updated total of how much of a controlled drug should be in stock, used to check against the physical count.
Schedule (controlled drugs)
One of five legal categories that group controlled drugs by how strictly they must be prescribed, stored and recorded.
Standard Operating Procedure (SOP)
A written step-by-step instruction setting out how a particular task must be carried out consistently and safely.
Summary of Product Characteristics (SmPC)
The manufacturer's official document describing how a medicine should be used, stored and handled.
Temazepam
A sedative medicine used for short-term sleep problems that is a controlled drug.
Tramadol
An opioid painkiller that is a controlled drug.
Z-drugs
Sleeping tablets (for example zopiclone and zolpidem) that work like benzodiazepines and are controlled.

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