8.1.1. Controlled Drugs (CDs) - Introduction

Controlled Drugs (CDs) are those which are restricted in use by the Misuse of Drugs Act 1971 and associated Regulations. This is due to their desirability and potential for harm. CDs are essential in modern clinical care and many do have a valuable medicinal purpose and the legislation aims to ensure that prescribers and other professionals are not obstructed or prevented from treating patients appropriately. CDs are categorised into 5 Schedules and restrictions are applied depending on which Schedule the CD is in.  

Schedule 1 CDs: hallucinogenic drugs such as lysergide and mescaline and products advertised as ‘legal highs’ have no recognised medicinal use. The production, possession and supply of Schedule 1 CDs are limited to research or other purposes considered of public interest. Only certain persons can be licensed by the Home Office to possess them for these purposes. Practitioners and Pharmacists may not lawfully possess Schedule 1 CDs except under licence from the Home Office. 

Schedule 2 CDs: includes more than 100 drugs such as the opiates, the major stimulants, secobarbital and amphetamine and lisdexamfetamine:

• Supply: Restricted to licensed wholesalers, practitioners, hospitals and registered pharmacies. Wholesalers are permitted to supply only to a person authorised to possess CDs. Practitioners can supply to persons authorised to possess CD’s and to their patients. Hospitals may supply patients and practitioners. Pharmacies may supply on receipt of a valid prescription or signed order. Additional prescription writing requirements exist.

• Record: A record of all Schedule 2 CDs obtained and supplied must be kept in a register, the form of which must comply with the relevant Regulation.

• Storage: Schedule 2 CDs (except quinalbarbitone) are subject to safe custody requirements (The Misuse of Drugs [Safe Custody] Regulations 1973, amended 2007). They must be stored in a locked receptacle, such as an appropriate CD cabinet or approved safe, which can only be opened by the person in lawful possession of the CD or a person authorised by them.
  

• Destruction: The destruction of Schedule 2 stock CDs (see Section 8.8) must only take place in the presence of an appropriately authorised person known as an Authorised Witness (AW)(Community Pharmacy, GP Practices and Hospital Pharmacy Departments). Destruction of patient returns and Ward stock does not have to be witnessed by an AW, these can be destroyed in the presence of two registered healthcare professionals, one must be a Pharmacist or Pharmacy Technician. However, good practice would deem that another person witnesses this and a written record is kept. Schedule 2 CDs must be denatured, using a denaturing kit, before being placed into waste container.

Schedule 3 CDs:  contains a number of substances that are perceived as being open to abuse, but less likely to be so than Schedule 2 CDs. It contains a number of synthetic opioids together with other substances including temazepam. Tramadol was rescheduled as a Schedule 3 CD from 10th June 2014. Gabapentin and Pregabalin were reclassified as Schedule 3 CDs as of 1st April 2019.

• Supply: The Regulations concerning supply (and additional prescription writing requirements) are similar to Schedule 2 CDs. Midazolam is the only Schedule 3 CD that in certain circumstances can be included in a Patient Group Direction (written instructions to help supply / administration of medicines to patients usually in planned circumstances. Only supply or administer medicines under PGDs if there is an advantage for the patient without compromising their safety).

• Record: There is no statutory requirement to record the supply of Schedule 3 CDs.
  

• Storage: The majority of Schedule 3 CDs are exempt from safe custody requirements except temazepam, flunitrazepam, buprenorphine and diethylpropion. These must be stored in a locked receptacle such as an appropriate CD cabinet or approved safe, which can only be opened by the person in lawful possession of the CD or a person authorised by them.
  

• Destruction: The requirements relating to the need for an AW for destruction do not apply to Schedule 3 CDs. Schedule 3 CDs should be denatured before being placed into pharmaceutical waste containers.

Schedule 4 CDs: Split into two parts:

• Part 1 (CDs- Benzodiazepines) contains most of the benzodiazepines (with the exception of flunitrazepam, midazolam and temazepam which are Schedule 3), plus eight other substances including zolpidem and zopiclone.
  

• Part 2 (CD Anabolic steroids) contains most of the anabolic and androgenic steroids such as testosterone, together with clenbuterol (adrenoceptor stimulant) and growth hormones (5 polypeptide hormones).

Drugs in Part 1 (CD -benzodiazepines) are subject to full import and export control and a Home Office licence is also required for the importation and exportation of substances in Part 2 (CD Anabolic steroids) unless the substance is in the form of a medicinal product and is for personal use / administration

• Supply: Supply is restricted to supplies against practitioner’s prescriptions or in accordance with PGDs. There are no additional requirements as to the form of prescriptions other than those that apply to all Prescription Only Medicines (POMs).
  

• Record: There is no statutory requirement to record the supply of Schedule 4 CDs.
  

• Storage: Schedule 4 CDs are exempt from safe custody requirements.
  

• Destruction: The requirements relating to the need for an AW for destruction do not apply to Schedule 4 CDs (unless the CDs are manufactured by the individual). Schedule 4 Part 1 CDs should be denatured before being placed into waste container.

Schedule 5 CDs: Schedule 5 contains preparations of certain CDs, e.g. codeine, dihydrocodeine, pholcodine, morphine (Oramorph), which are exempt from full control when present in medicinal products of low strengths.

• Supply: Certain CDs in Schedule 5 are available for over the counter sale in registered pharmacies. It is for the pharmacist to use their professional judgement to determine the appropriateness of any supply and be alert to potential misuse. The Schedule 5 CD POMs can only be supplied in accordance with a valid prescription or patient group direction.
  

• Record: There is no statutory requirement to record the supply of Schedule 5 CDs.

• Storage: Schedule 5 CDs are exempt from safe custody requirements.

• Destruction: The requirement to have an AW for the destruction or denaturing does not apply to Schedule 5 CDs.

See Controlled Drugs (Supervision of management and use) Regulations 2013.

8.1.2. Controlled Drugs (CDs) - The Controlled Drugs Team