Crown review paves the way for pharmacists as "dependent prescribers"
Pharmacists working in specialist areas and those carrying out reviews of patients' medications could be among the first to become "dependent prescribers".
Two new classifications of prescriber (dependent and independent) are proposed in the second report of the team reviewing the prescribing, administration and supply of medicines, led by Dr June Crown (past-president, Faculty of Public Health Medicine) and published on March 8. As suggested in The Journal (December 5, 1998, p883), the report proposes that independent prescribers would assess patients and make diagnoses and prescribe, while dependent prescribers would be responsible for continuing care of patients previously diagnosed by independent prescribers. The report notes a difference between prescribing in the sense of writing prescriptions and in authorising supplies at National Health Service expense.
Listing professional groups which might wish to apply at an early stage for authority to prescribe medicines, the report says new independent prescribers could include family planning nurses, tissue viability nurses, chiropodists and podiatrists, specialist physiotherapists and optometrists. New dependent prescribers could include specialist nurses working in diabetes, asthma or palliative care, specialist pharmacists and pharmacists carrying out reviews of patients on multiple drug therapies.
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Pharmacy bodies to work towards prescribing
The Guild of Healthcare Pharmacists has welcomed the publication of the second Crown report and said that it wants to work with the Royal Pharmaceutical Society on preparing proposals which would allow pharmacists to prescribe.
The guild would be seeking to work with the Society, as the profession's regulatory body, to ensure that a proper mechanism for accountability was in place for any pharmacist who took on a prescribing role. The guild said that it was also interested in representing the interests of specialist pharmacists outside hospitals, such as those running anticoagulant clinics or working as part of nutrition teams. These pharmacists would need a nationally recognised body to work with the regulatory body to achieve their aspiration, the guild said, and it was keen to fulfil that role.
The Society's Secretary and Registrar (Miss Ann Lewis) welcomed the report, saying: "The Society looks forward to working with the new UK-wide advisory body. It is not a case of our starting from scratch; the review underpins discussions already taking place with the Secretary of State for Health on the future of community pharmacy."
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The report says that new prescribers would normally be working in specific therapeutic areas and would need access to a limited range of medicines, including appropriate prescription only medicines. One exception to this might be pharmacists who were continuing treatment initiated by another prescriber, where a wider range of conditions and treatments would be covered. The report says that this kind of dependent prescribing would be different from repeat dispensing because the pharmacist would have the discretion to vary some aspects of the prescription, such as the dose, frequency, presentation or active ingredient group, within an individual treatment plan.
Dependent prescribers would be responsible for the appropriateness of any prescriptions they issued, the report says. This could include the initial prescription for an episode of care. Both independent and dependent prescribers would need to have access to complete medication records and necessary medical records.
Approval of new prescribers would be a two stage process, the report recommends. Initially, appropriate professional organisations, or recognised bodies representing the interests of particular groups within a profession, would make an application to a New Prescribers Advisory Committee for suitably trained professionals to be able to prescribe in a defined therapeutic area. If this was accepted by health ministers, then there would be a process of admitting individual professionals with appropriate training to a register of approved prescribers. The Committee on Safety of Medicines and the Joint Formulary Committee of the British National Formulary would advise, respectively, on which prescription only and pharmacy or general sale list medicines these new groups could prescribe. The New Prescribers Advisory Committee (NPAC) should be established under Section 4 of the Medicines Act 1968, the report recommends.
Looking at the supply and administration of medicines, the report says that the separation of the prescribing and supply of medicines to the same patient should continue. Pharmacists would be expected to continue supplying the vast majority of medicines.
The main instances where prescribing and supply to the same patient would be permitted would be: under the existing arrangements for doctor dispensing; where a pharmacist made alterations to incorrect prescriptions; and the sale of over-the-counter medicines ("counter prescribing").
Implementation of the report's recommendations is likely to take some time, since the report recommends that health ministers should first bring forward primary legislation, an Act of Parliament, which would allow them to define subsequently categories of independent and dependent prescribers using secondary legislation.
In a letter to the Secretary of State for Health (Mr Frank Dobson), Dr Crown says that her review team believes that, if implemented, the proposals in the report would provide "a secure means of increasing the range of health professionals who are authorised to prescribe" which would "make a significant contribution to the modernisation of the Health Service".
The Department of Health is now inviting comments on the second Crown report. These should be sent to Mr Paul Robertson, NHS Executive, Room 6/E/58, Quarry House, Quarry Hill, Leeds LS2 7UE by June 7. The Department will shortly be consulting on proposed changes to legislation which would clarify the legal basis of supply and administration under group protocols. This was the subject of the first Crown report published last year (PJ, April 25, 1998, p581).
"Review of prescribing, supply and administration of medicines, final report", Department of Health. Copies are available from the NHS responseline on 0541 555 455.
Crown report: 25 recommendations on prescribing
The second report on the prescribing, supply and administration of medicines makes 25 recommendations. These are listed below in the same way as they appear in the report, ie, grouped by the bodies to which they are addressed.
Health departments (HDs)
- The legal authority in the United Kingdom to prescribe, including authorising National Health Service expenditure, should be extended beyond currently authorised prescribers (Para 6.6).
- Legal authority for new professional groups to prescribe or to authorise NHS expenditure should normally be limited to medicines in specific therapeutic areas related to the particular competence and expertise of the group and may include prescription only medicines within those areas (Para 6.11).
- Two types of prescriber should be recognised: (i) the independent prescriber who is responsible for the assessment of patients with undiagnosed conditions and for decisions about the clinical management required, including prescribing. At present, doctors, dentists and certain nurses in respect of a limited list of medicines are legally authorised prescribers who fulfil the requirements for independent prescribers and this should continue. Certain other health professionals may also become newly legally authorised independent prescribers, subject to the process described below; (ii) the dependent prescriber who is responsible for the continuing care of patients who have been clinically assessed by an independent prescriber. This continuing care may include prescribing, which will usually be informed by clinical guidelines and will be consistent with individual treatment plans; or continuing established treatments by issuing repeat prescriptions, with authority to adjust the dose or dosage form according to the patients' needs. There should be provision for regular clinical review by the assessing clinician (Para 6.19).
- A UK-wide advisory body, provisionally entitled the New Prescribers Advisory Committee (NPAC), should be established under Section 4 of the Medicines Act to assess submissions from professional organisations seeking powers for suitably trained members to become independent or dependent prescribers (Para 6.27).
- Newly authorised groups of prescribers should not normally be allowed to prescribe medicines in the following categories: (i) Controlled Drugs; (ii) unlicensed drugs, or drugs used outside their licensed indications; (iii) "black triangle" drugs; (iv) drugs over which there is continuing professional concern; (v) drugs which on public health grounds should be subject to particular safeguards, for instance, antibacterial antibiotics (Para 6.54).
- The current arrangements for the administration and self-administration of medicines should continue to apply. Newly authorised prescribers should have the power to administer those parenteral prescription only medicines which they are authorised to prescribe, and to issue directions for the administration of the same medicines (Para 6.62).
- Repeatable prescriptions should be available on the NHS (Para 6.65).
- Limits should be introduced for the number of times a repeatable prescription can be dispensed and the duration of its validity. These restrictions should apply across all sectors, and not be limited to NHS practice (Para 6.65).
- Where particular extensions to prescribing authority could involve significant cost to the NHS, or where the balance of cost and benefit appears to be uncertain, there should be a thorough evaluation of the likely costs and benefits to the NHS before the general adoption is encouraged. This should not be allowed to result in unnecessary delays in improving care (Para 7.9).
- The Government should take general powers in primary legislation enabling ministers, through regulations, to designate new categories of dependent and independent prescriber for the purpose of the Medicines Act, to authorise them to prescribe medicines for reimbursement by the NHS, and to limit or specify the medicines or classes of medicines which they may prescribe (Para 8.7).
- The new arrangements should be subject to evaluation and monitoring, for which appropriate resources should be made available (Para 8.19).
HDs and professional bodies
- There should be adequate arrangements for sharing information between independent and dependent prescribers. In particular, (i) both clinicians should have access to a complete medication record; and (ii) both clinicians should have access to relevant parts of the patient's medical record (Para 6.19).
- Changes to patterns of clinical care using new models for the prescribing, supply and administration of medicines should be introduced only after full consultation with patient interests, and should, wherever possible, increase patient choice (Para 6.23).
- Initial prescribing and supply of medicines should normally remain separate functions in order to protect patient safety and provide other safeguards. Where a prescription cannot be furnished, the current arrangements for the emergency sale or supply of medicines should apply (Para 6.59).
HDs, professional bodies, health authorities and employers
- Where, exceptionally, it is in the interests of patients for the same professional to be responsible for prescription and supply of medicines, this should be subject to clinical audit and probity checks (Para 6.59).
Professional bodies
- Proposals for new professional groups to be considered as potential prescribers will be expected to come from nationally recognised organisations. They should confirm that the group is formally recognised by the appropriate regulatory body and that that body has seen and is content with the proposed arrangements for training in prescribing and for registration (Para 6.33).
- Professional organisations, in putting forward proposals for extensions to prescribing, should consider whether this could result in members prescribing and supplying prescription only medicines to the same patient, and, if so, what safeguards are required to maintain patient safety and ensure probity. The NPAC, in assessing any proposals from professional groups which could result in members prescribing and supplying POMs to the same patient, should consider the adequacy of the safeguards proposed (Para 6.59).
- Professional organisations, in putting forward proposals for new groups of professionals to have the authority to prescribe certain medicines, should consider the implications for administration of medicines and should ensure that all necessary training aspects are covered in their proposals (Para 6.62).
- Professional groups putting forward proposals for extended prescribing should liaise with education providers and bodies responsible for approving training courses to develop suitable training programmes in the required prescribing competencies. All training should include a period of supervised practice, and professional and regulatory bodies should take firm action against supervisors who fail to discharge their responsibilities (Para 8.9).
- The professional regulatory bodies should draw up clear guidelines on the circumstances in which commercial support for training programmes related to prescribing could be acceptable (Para 8.12).
- Professional organisations considering applying for extended prescribing authority should, in consultation with the appropriate professional regulatory organisations, ensure that adequate arrangements would be established for (i) accrediting training programmes for prescribing; (ii) maintaining a register of individuals who have acquired and are maintaining competency as prescribers; (iii) reviewing the results of clinical audit programmes and ensuring that any general lessons are fed back into the content of training; (iv) keeping the content of the prescribing formulary under review and submitting any proposals for change to the Medicines Control Agency (Para 8.13).
Employers
- Employers and managers in all sectors who are responsible for staff who supervise or undertake the administration of any medicines should ensure that those staff have the right training and skills to do so safely and regular opportunities for updating their knowledge (Para 6.62).
Individual practitioners
- All legally authorised prescribers should take personal responsibility for maintaining and updating their knowledge and practice relating to prescribing, including taking part in clinical audit, and should never prescribe in situations beyond their professional competence (Para 8.14).
GMC and GDC and postgraduate deans
The General Medical Council, General Dental Council and postgraduate deans were recommended to make arrangements for prescribing by preregistration house officers and overseas doctors and dentists given temporary registration in the United Kingdom.
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