Correspondence

Circular 009/2012: nurse and provisions pharmacist independent prescribing for schedule 4 part II drugs

Published 16 April 2012

The Misuse of Drugs (Amendment No. 2) Regulations 2012 amends the Misuse of Drugs Regulations 2001 (as amended) (the 2001 Regulations) (SI 2001/3998) as follows:

• removes the restrictions on the prescribing of Schedules 2-5 controlled drugs by nurse independent prescribers
• introduces pharmacist independent prescribing for Schedules 2-5 controlled drugs
• authorises the supply of morphine and diamorphine by registered nurses and pharmacists under PGDs in any setting
• regularises the compounding  of medicines that include controlled drugs prior to administration
• authorises the possession of specific controlled drugs - such as ketamine and midazolam - by healthcare professionals, including paramedics, under PGDs
• makes legislative provisions relating to drugs listed in Part II of Schedule 4 to 2001 Regulations by restricting importation and exportation of these drugs to circumstances where it is carried out in person and removing the term ‘medicinal product’

The SI together with explanatory memoranda can be found at Legislation.gov.uk. They are also published by The Stationery Office. Telephone orders/general enquiries 0870 600 5522 or online at www.tso.co.uk/bookshop. 

1. Legislative background 

Whilst the Home Office has the legislative responsibilities for the Misuse of Drugs Act 1971 and its associated legislation, the policy area is shared with the Department of Health and this instrument has been drawn up in consultation with them. These amendments to the 2001 Regulations are being made to ensure the regulatory framework on controlled drugs is effective, reflects current policy and complements changes already made to the medicines legislation, including the Prescription only Medicines (Human Use ) Order 1997 (as amended) (the POM Order).

This SI is made under sections 7, 10 and 31 of the Misuse of Drugs Act 1971 (‘the act’). The act 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 act except after consultation with the Advisory Council on the Misuse of Drugs (ACMD).

The amendments were drawn up in consultation with the ACMD and a wide range of stakeholders including key professional and regulatory bodies. The changes relating to independent prescribing were subject to a three-month public consultation in 2007. 

This statutory instrument implements the changes by amending regulations 2, 4, 6, 6A, 6B, 7, 8, 9, 10, 14, 18, 26, Schedule 4 and making additions to Schedule 8.

2. Policy context

In 2006 the White paper ‘Our health, our care, our say: a new direction for community services’ (2006) set out the then government’s commitment to increased flexibility and responsiveness in health and social services. In support of this commitment, and as part of the Department of Health’s non-medical prescribing programme, the scope of prescribing by nurses and pharmacists has been expanded further. The aim of this policy is to:

• improve the quality of service to patients without compromising patient safety
• make it easier for patients to get the medicines they need
• increase patient choice in accessing medicines
• make better use of the skills of healthcare professionals
• contribute to the introduction of more flexible team working across the NHS

Independent prescribing by nurse and pharmacist prescribers of all medicines within their individual competence was enabled under medicines legislation in May 2006 in support of this policy. However, restrictions around controlled drugs have remained. Controlled drugs are subject to special legislative controls provided by the misuse of drugs legislation as they are considered sufficiently ‘dangerous or otherwise harmful’, with the potential for diversion and misuse. However, this legislation is not intended to impede the legitimate use of controlled drugs where clinically appropriate, but rather to regulate and govern it for reasons of patient and public safety. Both the Commission on Human Medicines and the ACMD have advised that there is no evidence that expanding the prescribing of controlled drugs to nurse and pharmacist independent prescribers will lead to increased diversion or misuse.

Subject to robust governance, monitoring and training arrangements being in place, it is the government’s position that prescribing by qualified nurse and pharmacist prescribers should be treated in the same way as prescribing by doctors. The changes in May 2006 now form the bulwark of Department of Health policy on non-medical prescribing for nurses and pharmacists. The current inability of pharmacist independent prescribers (PIPs) to prescribe independently any controlled drugs and nurse independent prescribers (NIPs) to prescribe a very limited range independently is at odds with this, and is seen as a potential barrier to patient choice and local innovation in providing services for patients. This SI removes the current barriers by implementing changes to controlled drug legislation to achieve the full policy intent on independent prescribing. Nurse and pharmacist independent prescribers are to be authorised to prescribe all controlled drugs listed in schedules 2 to 5 within their competence, except cocaine, diamorphine and dipipanone for the treatment of addiction.

Similarly, the SI implements changes to the supply of controlled drugs by nurses and pharmacists under patient group directions (PGDs) by removing the current restrictions limiting the supply of drugs to certain conditions and locations to provide flexibility and improve patient access to controlled drugs in emergencies. 

PGDs were first introduced in the 2001 Regulations in 2003 to improve patient access to medicines, more particularly in emergencies. No corresponding change was made to the 2001 Regulations at the time to give authority to those acting under a PGD to possess the relevant controlled drugs such as ketamine and midazolam. This means that although specific healthcare professionals listed in Schedule 8 to the 2001 Regulations, including paramedics, are authorised to supply and/or administer drugs such as ketamine and midazolam, they currently have no specific authority under the 2001 Regulations to possess these drugs. The clarifying amendment is being implemented by the Home Office to correct the current anomaly and provide paramedics, and the specific healthcare professionals listed under Schedule 8, with the requisite authority to possess the specific drugs - ketamine and midazolam - under a PGD.

Current provisions under the 2001 Regulations authorise only doctors and pharmacists to ‘manufacture or compound’ any controlled drug before it is administered. In 2008 the Medicines and Healthcare Products Regulatory Agency recognised that the legal position under both medicines legislation and the 2001 Regulations needed to be regularised. In the absence of specific provisions enabling other healthcare professionals or carers to compound or ‘mix’ medicines that also include controlled drugs, the MHRA, in consultation with the Home Office, issued a statement advising that it would not support enforcement action against those prescribing and administering mixtures of licensed medicines in clinical practice, unless it would be in the public interest to do so. The ACMD has considered the need for this change and is supportive of the proposal. The policy aim is to enable controlled drugs to be ‘compounded’ prior to administration to a patient as opposed to the ‘manufacture’ of controlled drugs in general. In practice compounding relates to the ‘mixing’ of two or more drugs which include a controlled drug(s), for instance for palliative care.

The SI also implements changes to anabolic steroid and human growth hormone legislation following ACMD advice. The ACMD recently reviewed the evidence on the misuse and social harms of anabolic steroids and human growth hormones following increasing concerns at the use of anabolic steroids by the general public, and in particular young people. The ACMD concluded that ‘these substances have become “popular” in relation to body building and image enhancement and there is some evidence that such use is increasing.’ The ACMD therefore recommended a tightening of the legislation to reduce the availability and use of these drugs. The government has accepted the ACMD’s recommendations on legislative changes to restrict importation and exportation of these drugs to situations when this is carried out in person, and removal of the term ‘medicinal product’ from the 2001 Regulations, ‘as the term does not serve a recognised purpose’, to make the regulations clearer and support better enforcement of the provisions under the 2001 Regulations.

3. Specific amendments 

3.1 Independent prescribing of schedules 2-5 controlled drugs by nurse and pharmacist prescribers

The SI inserts a new Regulation 6B into the 2001 Regulations and removes the current limitations on the prescribing authorities for NIPs, following similar changes to medicines legislation. NIPs will be able to prescribe any controlled drug listed in schedules 2-5 for any medical condition, except diamorphine, cocaine and dipipanone for the treatment of addiction (NIPs will be able to prescribe other controlled drugs for the treatment of addiction). The authority to prescribe any controlled drug is given on the basis that NIPS, set out in professional guidance, must only prescribe within their competence. NIPs will be able to requisition controlled drugs under Regulation 14 and will be authorised to possess, supply, offer to supply and administer the drugs they are able to prescribe. Persons acting in accordance with the directions of a NIP will be authorised to administer any schedules 2-5 drugs a NIP can prescribe.

This SI also introduces pharmacist independent prescribing of controlled drugs under the new Regulation 6B, with authorities similar to those given to nurse independent prescribers. PIPs are now authorised to prescribe all controlled drugs listed in schedules 2-5 to the 2001 Regulations for any medical condition, except diamorphine, cocaine and dipipanone for the treatment of addiction (PIPs will be able to prescribe other controlled drugs for the treatment of addiction).  This authority is given on the basis, set out in professional guidance, that PIPS must only prescribe within their competence. PIPs will be able to requisition controlled drugs under Regulation 14 of the 2001 Regulations and will be authorised to supply or administer the drugs they are able to prescribe. The existing authorities for pharmacists to possess and supply schedules 2-5 controlled drugs are adequate. Persons acting in accordance with the directions of a PIP will be authorised to administer the schedules 2-5 drugs a PIP can prescribe. PIPs will be able to requisition controlled drugs under Regulation 14. The authorities given to PIPs, particularly to prescribe and requisition, are given on the basis that, as set out in professional guidance - prescribing/requisitioning and dispensing roles of pharmacists must be separate. 

This SI also amends Regulation 6A(2) by adding NIPs to the list of professions authorised to supply articles for administering or preparing controlled drugs. Nurse independent prescribers working in substance misuse now have authority to supply articles for administering or preparing controlled drugs. Pharmacists already have authority to supply articles for administering or preparing controlled drugs. 

4. Patient group directions

This SI also amends Regulation 8(8)(a) of the 2001 Regulations to remove the restrictions placed on nurses, when acting in their capacity as such to supply, or offer to supply diamorphine in accordance with the terms of a PGD. Nurses, when acting in their capacity as such under a PGD, are now authorised to supply, or offer to supply diamorphine and morphine where administration of such drugs is required for the immediate, necessary treatment of sick or injured persons (excluding the treatment of addiction). Regulation 8(8)(a) is also amended to provide a similar authority to pharmacists, acting in their capacity as such, to supply, or offer to supply diamorphine and morphine in accordance with the terms of a PGD for the immediate, necessary treatment of sick or injured persons (excluding the treatment of addiction). These amendments remove the restrictions whereby a nurse can only supply or offer to supply diamorphine under a PGD for the treatment of cardiac pain to a person admitted as a patient to a coronary care unit or an accident and emergency department of a hospital. 

This SI also amends regulations 18 and 26 so that the requirements for marking of bottles, packages etc do not apply to the supply of controlled drugs by or on the prescription of a NIP or PIP. Under amendments made to Regulation 26, a NIP is under a requirement to furnish information under subsection (1) of Regulation 26 in the same way as supplementary prescribers. 

4.1 ‘Compounding’ of medicines which include controlled drugs

This SI amends regulations 8 and 9 to regularise the ‘compounding’ of medicines that include controlled drugs prior to administration to a patient. Practitioners - doctors, dentists, veterinary surgeons and practitioners - and pharmacists already have authority to ‘compound’ any drugs in schedules 2-5 to the 2001 Regulations. Nurse and pharmacist independent prescribers and supplementary prescribers are now authorised to ‘compound’ any drugs listed in schedules 2-5 prior to administration as part of a clinical management plan for a patient.

This SI also regularises the compounding of medicines that include controlled drugs by any person acting in accordance with the written directions of a doctor, a dentist, a nurse independent prescriber, a pharmacist independent prescriber or a supplementary prescriber when acting under and in accordance with the terms of a clinical management plan prior to administration to a patient as part of a clinical management plan.  

In practice ‘compounding’ relates to the ‘mixing’ of two or more drugs, which include a controlled drug(s), for instance for palliative care. The authorities given by the SI will complement the authorities provided under the POM Order which enables the ‘mixing’ of medicines in clinical practice by healthcare professionals and persons acting on accordance with their written directions.

4.2 Possession of controlled drugs, including ketamine and midazolam under PGDs

At present a historical  anomaly exists under the 2001 Regulations which means that healthcare professionals, including those listed under Schedule 8 to the 2001 Regulations are authorised to supply, offer to supply or administer specific drugs such as ketamine and midazolam under a PGD, but have no specific authority to possess these drugs. 

This SI corrects the current anomaly under the 2001 Regulations and Regulation 10 is amended to give authority to possess the specific drugs by the healthcare professionals, including those listed in Schedule 8 to the 2001 Regulations under a PGD for the treatment of sick or injured persons. Any person specified in regulations 8(7) - NIPs, 8(8)(a) - nurses and pharmacists, or 9(8) - a registered nurse or a person specified in Schedule 8, including paramedics, will now have the authority to possess the drugs specified in those regulations in accordance with the conditions specified in those regulations. 

4.3 Restrictions on the importation and exportation of Schedule 4 Part II drugs and removal of the term ‘medicinal product’ from the 2001 Regulations

At present the prohibition on importation and exportation of controlled drugs under section 3(1) of the 1971 Act and sections 50(1) to (4), 68(2) and (3) or 170 of the Customs and Excise Management Act 1979 are disapplied in relation to drugs listed in Part II of Schedule 4 to the 2001 Regulations in respect of the importation and exportation of these drugs ‘by any person for administration to himself’ and ‘when contained in a medicinal product’.

This SI amends the current provisions under Regulation 4(2) for drugs listed in Part II of Schedule 4 to the 2001 Regulations - anabolic steroids and human growth hormones - by making it clear that importation or exportation of these drugs must be carried out in person by the user. The importation and exportation of these drugs can no longer be conducted through postal, freight or courier services into or out of the UK. Any such consignments detected by UK Border Force will be seized and destroyed, and the circumstances of each case investigated fully with the possibility of additional enforcement action being taken against the parties concerned. The SI also removes the term ‘medicinal product’ from the 2001 Regulations. The effect is that anabolic steroids and human growth hormones regardless of their origin are treated the same under the legislation.

5. Application to England, Wales and Scotland

The changes to the Misuse of Drugs Regulations 2001 described in this circular apply to England, Wales and Scotland. Northern Ireland will amend its own Misuse of Drugs Regulations separately. The contact there is: 

Karen Savage,
Health Protection Team,
Department of Health, Social Services and Public Health,
C4, 22 Castle Buildings,
Stormont,
Belfast BT4 3SQ

Email - Karen.Savage@dhsspni.gsi.gov.uk