2. The proposed changes to medicines legislation would permit the sale, supply or administration of medicines under PGDs in specified healthcare establishments throughout the United Kingdom provided through the private, charitable or voluntary sector, and in certain UK Crown establishments.

3. The first report of the Crown Review of Prescribing, Supply and Administration of Medicines concentrated on the supply and administration of medicines under what were then known as group protocols. As well as recommending criteria for the development, implementation and review of such protocols, the report also recommended that the law should be clarified to ensure that health professionals who supply or administer medicines under approved group directions are acting within the law and that all such directions comply with specified legal criteria. While concluding that the majority of patients should continue to receive individual care, it was recognised that carefully constructed group directions would bring advantages to patient care, including timely access to treatment, a reduction in patient waiting times and an appropriate use of professional skills.

4. Following a public consultation in March 2000 (MLX260), medicines legislation was amended - by way of the Prescription Only Medicines (Human Use) Amendment Order 2000 (the POM Order), the Medicines (Pharmacy and General Sale – Exemption) Amendment Order 2000, the Medicines (Sale and Supply)(Miscellaneous Provisions) Amendment (No 2) Regulations 2000 and the Prescription Only Medicines (Human Use) Amendment (No 2) Order 2000 – to clarify the law concerning the use of PGDs by NHS bodies and by NHS funded services provided through the private, charitable or voluntary sector.

5. Section 52 of the 1968 Act covers the sale or supply of medicines which are not on the general sale list, section 53 covers sale or supply of medicinal products on general sale list and section 58 covers the sale or supply of prescription only medicines. The existing PGD exemptions apply only to the NHS; further amendments, as outlined in paragraph 2, will be required to permit the sale, supply and administration, or administration, of medicines under sections 52, 53 and 58 under PGDs in the private sector (which in this context includes police custody suites). The Defence Medical Services (as the responsibility of the Secretary of State for Defence) and medical services in prisons (the responsibility of the Home Secretary) are probably not bound by Sections 52 or 53, but they are bound by Section 58. If those services are to be able to make use of PGDs which include POM products, amendments to the POM Order will be required.

6. During the March 2000 consultation the Agency received requests from independent sector healthcare providers, the Police Service, the Prison Healthcare Task Force and the Defence Medical Services that they should also be able to develop PGDs. However, as it was not possible to replicate exactly the "NHS requirements" (whereby the Direction must be signed on behalf of the appropriate NHS health organisation), the Agency and the Department of Health agreed to consider those requests at a later date. The proposals for the extension of PGDs to these sectors (referred to collectively on occasion as the private sector) are outlined in greater detail below.

7. A PGD is a written instruction for the sale, supply and administration, or administration, of named medicines in an identified clinical situation. It applies to groups of patients who may not be individually identified before presenting for treatment. The majority of clinical care should continue to be provided on an individual, patient-specific basis and the use of PGDs should be reserved for those limited situations where this offers a distinct advantage for patient care and where it is consistent with appropriate professional relationships and accountability. PGDs are drawn up locally by doctors, pharmacists and other health professionals, signed by a doctor or dentist, as appropriate and a pharmacist and approved by an appropriate body.

8. We propose to modify section 55(1)(b) of the Act to allow medicines to be sold, supplied and administered, or administered, under the authority of a PGD within specified independent health care sectors and within certain Crown establishments. Those are set out in Annex A. The proposals do not extend to independent and public sector care homes or to those independent sector schools that provide healthcare entirely outside the NHS. Such organisations have a stable and well-known population and the sale, supply and administration of medicines in those establishments should continue to be provided on a patient-specific basis in accordance with the directions of a doctor or dentist or nurse prescriber.

9. We propose to specify the particulars which must be contained in a PGD in order for it to be lawful. Those particulars are set out at Annex B - apart from the exceptions proposed in paragraphs 17 to 23 below, they are the same as those required of the NHS.

10. We expect many of the medicines which will be sold, supplied or administered under PGDs to be prescription only medicines. Therefore, we propose to amend the POM Order to allow health professionals supplying such medicines in accordance with a PGD to do so without the need for an appropriate practitioner’s prescription and to allow health professionals administering such medicines to do so under PGDs.

11. The modification of section 55(1)(b) and the amendment of the POM Order would exclude the sale, supply or administration of unlicensed medicines under PGDs. This is in line with the legal requirements covering the use of PGDs in the NHS.

12. In line with the use of PGDs in the NHS, the sale, supply or administration of medicines outside their licensed indications will be permitted where, exceptionally, such use is necessary and justified by best practice.

13. The supply and administration of controlled drugs is currently excluded from the scope of PGDs. Such drugs are subject to the Misuse of Drugs Regulations 1985. The Home Office have obtained agreement in principle from the Advisory Council on the Misuse of Drugs on proposals to allow the use of non-injectable substances on Schedules 4 (with the exclusion of anabolic steroids) & 5 to be included in PGDs and for the use of diamorphine (Schedule 2) under PGDs by specialist trained nurses in Accident & Emergency Departments and in Coronary Care Units. The timescale for those proposed changes is not yet finalised and will in any event be subject to a Home Office consultation.

14. The qualified health professionals who may sell, supply or administer medicines under a PGD, as named individuals, are listed at Annex C. That list replicates those eligible to operate under PGDs in the NHS.

15. An amendment to the Medicines (Sale and Supply) (Miscellaneous Provisions) Regulations 1980 will allow wholesale supplies to be made to a body who may supply or administer products in the course of its business.

16. The arrangements by which PGDs are approved are crucial to ensure safe, high quality provision. For PGDs in the NHS, the legislation requires for that final authorisation to be made by a representative of the NHS Trust (etc) and the associated guidance suggests that "Clinical Governance Leads are probably best placed to do this". The rationale behind that authorisation, in addition to the signature of a doctor or dentist and a pharmacist, was that the NHS is legally responsible for the provision of national health services. The NHS is not, however, responsible for providing healthcare services within the independent sector or within the Crown establishments covered by the current proposals. . As it has not proved possible to identify a single authorisation process similar to that of the NHS Trust (etc) to cover all non-NHS sector interests, a range of options are being proposed. Each is discussed in more detail in paragraphs 17 to 23.

17. In the 135 prisons in England and Wales, 16 in Scotland and 3 in Northern Ireland (which include Young Offender Institutes), legal responsibility for providing health care rests with the Prison Service and that responsibility rests in each prison with the Prison Governor. Improving the standard of healthcare in prisons in England and Wales is a joint Ministerial initiative between the Department of Health (DH) and the Prison Service and that work is being undertaken as a joint venture. All prisons in England and Wales now have a formal partnerships with the NHS and each prison has, or is in the process of developing, a Health Improvement Plan. All prisons are required to have a designated nurse who is responsible for nursing leadership and development and a competency framework for nursing staff in prisons is being developed. The use of PGDs in prisons in England and Wales will be monitored by the Regional Prison Health Task Forces.

18. Arrangements differ in Scotland and Northern Ireland. In Scotland, no similar partnership arrangements exist with the NHS although the Scottish Prison Service (SPS) works co-operatively with the NHS in Scotland on many matters. However, the SPS itself has medical, nursing and pharmacy advisors and a National Drug and Therapeutics Committee. The post of Director of Rehabilitation and Care is responsible for health care policy in prisons in Scotland and is also a member of the SPS Board. In the three establishments within the Northern Ireland Prison Service (NIPS), a pharmacy contract is provided by a private company and managed by a senior pharmacist. That contract covers the dispensing of prescriptions, the supply of medicines and the development of a range of pharmaceutical protocols and procedures. The post of Director of Services in Northern Ireland is responsible for health care policy and is also a member of the NIPS Board. In common with the SPS, the NIPS does not have regular partnership arrangements with the NHS, and instead has its own in-house medical and nursing advisers, with additional support being provided by the NI Department of Health, Social Services and Public Safety.

19. PGDs within the UK Prison Services will be required to meet the requirements set out in Annexes B and C. The Prison Services, as the bodies responsible in law for providing health care in prisons, will provide the final authorisation of a PGD. However, the representative signing the PGD on behalf of the Prison Service may differ across the UK to reflect specific accountability regimes. The proposals, which have the support of the individual Prison Services, are:

20. In the 43 police forces in England and Wales, 8 in Scotland and 1 in Northern Ireland, legal responsibility for providing health care rests with the Chief Constable and the majority of such care is provided under contract by medical practitioners. PGDs in Police Custody Suites in the UK will be required to meet the requirements set out in Annex B and Annex C. As Chief Constables retain legal responsibility for providing health care in custody suites, the relevant Chief Constable, or a representative of the office of the Chief Constable, should provide the final authorisation of a PGD. In addition, as links with the NHS are less developed than, for example, within the prison services, it is proposed that PGDs for use within police custody suites should additionally be authorised by a doctor of certain seniority and/or with certain experience. That doctor will be required to be from outside the police service. Comments are particularly sought on this proposal and suggestions also sought on how the level of seniority and experience should be defined. The questions posed under paragraph 25 are also relevant to the development of PGDs within the police service.

21. The Defence Medical Services (DMS) encompasses the medical services of the Royal Navy, Army and Royal Air Force and is responsible for providing a full range of primary and secondary medical and dental care to service personnel, service dependants and, where capacity exists, NHS patients. The Defence Secondary Care Agency (DSCA) provides a peacetime secondary care structure within which clinicians and other medical personnel can develop their professional and military skills by treating a full range of patients alongside their NHS colleagues in designated NHS hospitals (Ministry of Defence Hospital Units (MDHUs)) within the UK. The Single Service Medical Directors General and the Defence Dental Agency are responsible for the provision of Primary Medical and Dental care to service personnel and dependants both in the UK and overseas. Single Service Medical Directorates operate in a similar manner to NHS Primary Care Trusts (PCTs) although they lack the legal recognition and constitution of a PCT.

22. In order to allow the DMS to provide levels of patient care similar to those provided by the NHS it is necessary to allow DMS personnel to develop and operate under PGDs. In the interests of ensuring uniformity in the use of PGDs across the mix of NHS and DMS healthcare services, PGDs in the DMS will be required to meet the requirements set out in Annex B and Annex C. The final authorisation, to be made when the PGD has been developed in accordance with those requirements, will be made on behalf of the relevant Single Service Medical Director General or Agency Chief Executive. For overseas locations and deployed operations and exercises the relevant Command or Headquarters Medical staffs will make the authorisation. In practice this authorisation will usually be given by a doctor or dentist. In the case of DMS personnel working within MDHUs in an NHS Trust environment it is likely that PGDs in operation within the parent NHS Trust will be adopted for use by DMS personnel.

23. From April 2002, the National Care Standards Commission (NCSC), and its equivalents in Scotland, Wales and Northern Ireland, will assume responsibility for the regulation of health services provided by the independent sector. The aim is to ensure greater clarity, consistency and quality of standards by regulating and inspecting against national minimum standards. However, it is not feasible, given the numbers involved and anyway doubtful in law, for the NCSC and its equivalents to undertake the authorisation of PGDs. However, the Care Standards Act 2000 (the 2000 Act), the Regulation of Care Act (Scotland) 2001 and the equivalent arrangements in Northern Ireland require that, subject to certain exceptions, a person who ‘carries on’ or manages an independent hospital, clinic or agency must be registered. The proposal for PGDs in independent hospitals, clinics and agencies, is that the PGD should be signed off by both the person registered under the 2000 Act and the Manager registered as such under Regulations to be made under the relevant Acts. (If there is more than one registered manager in relation to a particular establishment, each will be required to sign the PGD.) In all cases the final authorisation is to be made when the PGD has been developed in accordance with the requirements set out in Annex B and Annex C.

24. The guidance shown at Annex D was circulated to the NHS as an adjunct to the law covering the use of PGDs in the NHS in England. Similar advice was provided to the health service in Wales, Scotland and NI. The proposal is for at least the same guidance to be made available to the private sector to encourage consistency between PGDs. Those developing PGDs within the private sector will be encouraged to submit their PGDS for publication, after final authorisation as outlined above, to, for example, the central archive of approved group protocols maintained by the North West Region, Salford Royal Hospitals Trust (www.groupprotocols.org.uk). Comments are particularly sought on the following points:

25. The EC Leaflet and Labelling Directive 92/27 applies to all supplies of medicines, including those supplied under PGDs.

26. A draft regulatory impact assessment is at Annex E.

27. We plan to implement the changes during 2002, subject to comments received and the views of the Committee of Safety of Medicines, the Medicines Commission and Ministers. You are invited to comment on the proposals contained in this letter and the enclosed regulatory impact assessment. A form at Annex F is attached for your reply. This letter and attachments will also appear on the Agency’s website (www.mca.gov.uk)

28. To help informed debate on the issues raised by this consultation exercise, the Agency intends to make copies of replies received publicly available. It will be assumed that your reply can be made publicly available in this way unless you indicate that you wish all, or part, of it to be treated as confidential and excluded from this arrangement.

29. Comments should be addressed to Mrs Anne Ryan, MCA, 16-142, MCA, Market Towers, 1, Nine Elms Lane, London SW8 5NQ (e-mail to anne.ryan@mca.gov.uk) and arrive no later than 10 April 2002.

2.2 Objective: The proposed changes to legislation will apply to activities undertaken by the independent healthcare sector and the Crown establishments listed above. They are intended to:

2.3 Issues of Equity or Fairness: We want to ensure that patients in both the NHS and the independent healthcare sectors are considered in similar ways with more equitable access to professional skills and timely treatment. This will be achieved through the objective listed above.

3. A PGD is a specific written instruction for the supply and administration of a named medicine, in an identified clinical situation, signed by a doctor or dentist and a pharmacist and authorised by an appropriate body. It is drawn up locally by doctors, pharmacists and other health professionals. It applies to groups of patients who may not be individually identified before presenting for treatment. A PGD is intended to satisfy the requirements of section 55(1)(b) and 58(2)(b) for the directions of a doctor or dentist. However, there remains uncertainty, outside those health services provided by the NHS, whether or not the practice complies with the law particularly where the patient is not specified by name in the direction.

3.1 PGDs are currently operated in an area where there is legal uncertainty about whether or not they comply with the law (hazard). There is potential for persons supplying and administering medicines under such directions to be liable for a criminal offence under the Medicines Act (harm). Furthermore, such PGDs do not presently meet consistent standards (hazard) which may compromise patient safety (harm). Some directions have merely been general guidelines which are not specific about clinical criteria, referral requirements, details of medicines or arrangements for review.

4.1 Three options have been identified

4.2 Option 1: None. Nurses and other health professionals would be operating in a grey area and might be liable to a criminal offence under the Medicines Act. As a result, the use of PGDs might well be reduced together with the advantages they can offer for patients. Patient safety could be compromised by the lack of consistency in PGDs.

4.3 Option 2: None. The supply and administration of medicines are regulated by legislation with criminal sanctions for any breaches. Therefore, it is important that it is clear to persons engaged in these activities that they are complying with the law. The introduction of a voluntary code to ensure that PGDs met the standards set out for those in use in the NHS would not achieve this. Even if relevant healthcare sectors complied with the code, we would, in effect, be encouraging them to operate PGDs in circumstances which we know may not be legal.

4.4 Option 3: Removes uncertainty about the legality of PGDs. Allows current safe and effective practice to continue which has advantages for patients (eg timely access to treatment, a reduction in waiting times) and health care staff (eg maximising use of professional skills). Potential cost savings since resources can be used more appropriately and the need for a doctor or dentist to authorise patient-specific medication is removed. Requires all directions to comply with a specified criteria which benefits both patient safety and those responsible for drawing up and operating the protocol. It would also ensure consistency with the legal requirements regulating the use of PGDs within the NHS.

5.1 Independent hospitals, clinics and agencies providing healthcare outside any arrangements funded by the NHS, HM Police Forces and HM Prison Services in England and Wales, Scotland and Northern Ireland and the Defence Medical Services are not regarded as a "business, charity or voluntary organisation" for the purpose of this Regulatory Impact Assessment

5.4. If the law is not clarified, nurses and other health professionals will continue to operate PGDs in circumstances which we know may not be legal. Doctors will therefore have to spend more time seeing patients for what may be a routine supply or administration of a medicine. This does not make best use of their skills or time - particularly when the task could be carried out by suitably qualified healthcare staff. Costs might therefore increase if the use of PGDs in health services outside the NHS have to cease.

7. Option 3 is recommended. The benefits of this option in terms of public health, future savings, and effective use of resources are judged to outweigh the costs to business. Costs for business should be minimal if voluntary compliance with the recommendations contained in the first Crown Report is already taking place and current PGDs meet the standards of practice required.