Correspondence

Circular 007/2023: The Misuse of Drugs (England and Wales and Scotland) (Amendment) (No.2) Regulations 2023

Published 31 December 2023

Applies to England, Scotland and Wales

© Crown copyright 2023

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This publication is available at https://www.gov.uk/government/publications/circular-0072023-the-misuse-of-drugs-no2-regulations-2023/circular-0072023-the-misuse-of-drugs-england-and-wales-and-scotland-amendment-no2-regulations-2023

The Misuse of Drugs (England and Wales and Scotland) (Amendment) (No.2) Regulations 2023 (SI 2023/1345) (“these Regulations”) amend the Misuse of Drugs Regulations 2001 (SI 2001/3998) (“the 2001 Regulations”) to enable the prescribing of five specified controlled drugs by paramedic independent prescribers and six specified controlled drugs by therapeutic radiographer independent prescribers, and the supply of three codeine products by registered chiropodists and podiatrists. The changes also include amendments related to podiatrist independent prescribers and physiotherapist independent prescribers and make amendments to specify that possession of ketamine by healthcare professionals acting under patient group directions, including paramedics, is lawful.

Introduction

This circular draws attention to the contents of the below Statutory Instrument (SI) which will come into force at 00.01 on 31 December 2023:

  • The Misuse of Drugs (England and Wales and Scotland) (Amendment) (No.2) Regulations 2023

These Regulations:

  • Enable prescribing of five specified controlled drugs by paramedic independent prescribers;
  • Enable prescribing of six specified controlled drugs by therapeutic radiographer independent prescribers;
  • Allow supply of three codeine products by registered chiropodists and registered podiatrists;
  • Make technical amendments in relation to podiatrist independent prescribers and physiotherapist independent prescribers; and
  • Specify that possession of ketamine by healthcare professionals acting under patient group directions, including paramedics, is lawful.

The SI is available at www.legislation.gov.uk, at the following link The Misuse of Drugs (England and Wales and Scotland) (Amendment) (No. 2) Regulations 2023 (legislation.gov.uk).

SIs are also published by the Stationery Office. Telephone orders and general enquiries: 0330 202 5070.

Background

The Home Office has legislative responsibility for the Misuse of Drugs Act 1971 (“the 1971 Act”) and its associated regulations, which govern controlled drugs. However, policy concerning the use of medicines which are also controlled drugs in healthcare is shared with the Department of Health and Social Care (DHSC) and these Regulations have been developed in consultation with DHSC. These amendments to the 2001 Regulations are being made to ensure the regulatory framework on controlled drugs is effective, reflects current policy and complements the Human Medicines Regulations 2012 (“the 2012 Regulations”).

The 2001 Regulations enable lawful access to controlled drugs under the 1971 Act for legitimate uses, such as in healthcare. Drugs that are controlled under the 1971 Act are generally placed in Schedules 1 to 5 of the 2001 Regulations. The Schedule into which a drug is placed primarily dictates the circumstances in which it is lawful to import, export, produce, supply, administer and possess the drug. This includes provisions relevant to specific healthcare professionals. The 2001 Regulations also impose requirements about the form of prescriptions, record-keeping, labelling, destruction, disposal and safe custody.

These Regulations are made under sections 7, 10, 22 and 31 of the 1971 Act, which received Royal Assent on 27 May 1971. Section 31(3) of the act provides that the Secretary of State may not make regulations under the 1971 Act except after consultation with the Advisory Council on the Misuse of Drugs (ACMD).

These amendments follow consultation with the ACMD and two public consultations by NHS England with a wide range of stakeholders including professional and regulatory bodies. These Regulations implement the changes by inserting Regulation 6D and amending regulations 2, 6, 7, 8, 9, 10, 18 and 26.

Prescribing by paramedic independent prescribers and therapeutic radiographer independent prescribers

Independent prescribing by paramedic independent prescribers and therapeutic radiographer independent prescribers of medicines within their individual competence was enabled under the 2012 Regulations in 2018 and 2016 respectively.  

Following a consultation by NHS England in 2015, the ACMD provided advice on independent prescribing of controlled drugs by paramedics on 18th October 2019. The ACMD recommended that the Home Office amend the 2001 Regulations to enable paramedic independent prescribers to prescribe and administer five specified controlled drugs, as follows:

  • Morphine sulphate by oral administration or by injection;
  • Diazepam by oral administration or by injection;
  • Midazolam by oromucosal administration or by injection;
  • Lorazepam by injection; and
  • Codeine phosphate by oral administration.

NHS England consulted on prescribing by therapeutic radiographers in 2015. Following this, the ACMD provided advice on independent prescribing by therapeutic radiographers in correspondence between 5th September 2016 and 22nd April 2020. The ACMD recommended that the Home Office amend the 2001 Regulations to enable therapeutic radiographer independent prescribers to prescribe and administer six specified controlled drugs, as follows:

  • Tramadol by oral administration;
  • Lorazepam by oral administration;
  • Diazepam by oral administration;
  • Morphine by oral administration or by injection;
  • Oxycodone by oral administration; and
  • Codeine by oral administration.

These Regulations implement the necessary changes to controlled drug legislation to achieve the policy intent, in accordance with the ACMD’s advice, in respect of both paramedic independent prescribers and therapeutic radiographer independent prescribers.

These Regulations also make consequential amendments required to give effect to these proposals, including enabling possession and supply of these controlled drugs by paramedic independent prescribers and therapeutic radiographer independent prescribers, requiring that they provide certain information with respect to controlled drugs, and exempting them from the requirement for marking bottles.

Guidance to explain these changes has been produced by the College of Paramedics and the Society of Radiographers and can be found at the following links:

Supply by registered chiropodists and podiatrists

Following consideration of a proposal from NHS England to enable supply of three codeine products by podiatrists, the ACMD provided advice on 14th June 2022 recommending that the Home Office amend the 2001 Regulations to enable podiatrists to supply the following controlled drugs:

  • Co-codamol;
  • Co-dydramol; and
  • Codeine phosphate.

The 2023 regulations implement the ACMD’s recommendation and complement the existing legislative framework in the 2012 Regulations, enabling specified registered chiropodists and podiatrists to supply the codeine products listed above. “Specified registered chiropodists” and “specified registered podiatrists” mean the registered chiropodists and registered podiatrists specified in paragraph 11 of Part 1 and paragraph 2 of Part 4 of Schedule 17 to the 2012 Regulations (against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicine specified). Previously, podiatrists have supplied these medicines under a written authority issued under section 30(1) of the 1971 Act by the Secretary of State and pursuant to regulation 8(4) of the 2001 Regulations. This 2023 Regulations replace the written authority, which will be revoked.

Guidance produced by the Royal College of Podiatry has been updated to reflect these changes to legislation and can be found at the following link: Changes to legislation on Codeine (rcpod.org.uk).This includes guidance on the necessary safeguards, including that no more than a three-day supply should be supplied.

Physiotherapist independent prescribers and podiatrist independent prescribers

The Misuse of Drugs (Amendment No. 2) (England, Wales and Scotland) Regulations 2015 (S.I 891/2015) amended the 2001 Regulations to provide physiotherapist and podiatrist independent prescribers with independent prescribing rights. This was to improve safety and health outcomes for patients through improved access to medicines and more timely treatment.

The 2023 Regulations improve the clarity of the 2001 Regulations by specifying the consequential effect on possession pursuant to a prescription, and the definition of “prescription”, in a manner consistent with other independent prescribers. The 2023 Regulations:

  • clarify that patient possession of a controlled drug pursuant to a prescription by a podiatrist independent prescriber or a physiotherapist independent prescriber is lawful; and
  • amend the definition of “prescription” in the 2001 Regulations to include prescriptions issued by healthcare professionals from either profession.

Healthcare professionals acting under a patient group direction (PGD)

A PGD is a set of instructions which directs the healthcare professional in their assessment of a patient. Paramedics, nurses, pharmacists and other professions are able to use PGDs. The 2023 Regulations specify that possession of ketamine by healthcare professionals acting under PGDs is lawful, as intended. There is no change to guidance under existing PGDs.

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