Reviewed by Shameer Deen, ST5 Urology Registrar
Controlled drugs (CDs) are substances subject to legal restrictions on prescribing, dispensing, and record-keeping under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 [1,2]. These regulations exist to prevent diversion for non-medical use while ensuring that patients with legitimate clinical need can access these often essential medicines. Every prescriber who handles controlled drugs must understand the regulatory framework.
The Schedule System
The Misuse of Drugs Regulations 2001 divide controlled drugs into five schedules based on their therapeutic utility and misuse potential [2]:
- Schedule 1 (CD Lic) — no recognised therapeutic use; production and supply only with a Home Office licence (e.g. cannabis without a specific licence, LSD). Research use requires a separate licence.
- Schedule 2 (CD) — high therapeutic utility but highest misuse potential. Includes opioids (morphine, oxycodone, fentanyl, methadone, pethidine), amphetamines, and cocaine. Subject to the full range of prescription requirements, safe custody, and register entries.
- Schedule 3 (CD No Register) — includes buprenorphine, midazolam, tramadol, and temazepam. Prescription requirements apply but no register entry needed for most (buprenorphine and diethylpropion are exceptions).
- Schedule 4 (CD Benz / CD Anab) — divided into Part I (benzodiazepines and z-drugs) and Part II (anabolic steroids). Prescription requirements are less stringent.
- Schedule 5 (CD Inv) — preparations containing small amounts of controlled drugs (e.g. low-dose codeine preparations). Minimal restrictions; invoices serve as records.
Prescription Requirements for Schedule 2 and 3 Controlled Drugs
Prescriptions for Schedule 2 and most Schedule 3 controlled drugs must comply with specific legal requirements under the Misuse of Drugs Regulations 2001 [2]. A valid CD prescription must include:
- The patient's full name and address
- The date of signing
- The prescriber's name, address, and signature (in ink)
- The form and strength of the preparation
- The total quantity of the drug to be supplied, written in both words and figures
- The dose
A prescription for a Schedule 2 or 3 controlled drug is valid for 28 days from the date of signing. Instalments may be specified on the prescription.
Safe Custody
Schedule 2 controlled drugs (and some Schedule 3 drugs) must be stored in a locked CD cabinet that meets the requirements of the Misuse of Drugs (Safe Custody) Regulations 1973. The cabinet must be fixed to a wall or floor and only accessed by authorised persons. Schedule 2 CDs must be recorded in a CD register with entries made in indelible ink, showing running balances.
Who Can Prescribe Controlled Drugs
In the UK, independent prescribers who may prescribe all controlled drugs for medical purposes include doctors, dentists, and appropriately registered nurse and pharmacist independent prescribers [1]. Supplementary prescribers may prescribe CDs within a clinical management plan. Certain restrictions apply: for example, nurse and pharmacist independent prescribers cannot prescribe diamorphine, cocaine, or dipipanone for the treatment of addiction.
MedNext Controlled Drug Formulary
MedNext Formulary includes 64 controlled drug monographs within the MedNext Audited Proprietary Dataset. Each monograph details the drug's schedule classification, clinical indications, dosing, contraindications, and specific prescribing considerations. This information is available at the point of care, supporting prescribers in making safe and legally compliant decisions when managing patients who require controlled drugs.
References
- Misuse of Drugs Act 1971. Her Majesty's Stationery Office, London, 1971.
- Misuse of Drugs Regulations 2001 (SI 2001/3998). Her Majesty's Stationery Office, London, 2001.