This site is intended for health professionals only!
BPharm MSc PhD
Pharmacy Academic Practice Unit
University of Derby
One of the fundamental issues for pharmacy in debating its professional standing is that it does not initiate the object of its work, the prescription. It involves itself in only part of the process, that of supply, and has little knowledge of the outcome of treatment.(1) Within Europe, pharmacists in the UK, comprising England, Scotland, Wales and Northern Ireland, are arguably pre-eminent in providing a clinical underpinning for therapeutic prescribing decisions, yet have had to accept the incongruous position as simple advisors in medicine management. Arguably, the disparity between knowing what to do and not being responsible for doing it is at its greatest in the UK. This is about to change with the advent of prescribing rights being effectively and rapidly redefined for specific nonmedical healthcare professionals. This article brings readers up-to-date with progress towards the aspiration of independent prescribing by pharmacists.
Changes in medicines prescribing in the UK
In the UK, prescribing of medicines is restricted by classification. Only medically and dentally registered practitioners are able to prescribe prescription-only medicines (POMs), which encompass the majority of therapeutically active medicines with a product authorisation. A pragmatic solution for “prescribing” by nonmedical, qualified, registered healthcare practitioners (HCP) such as pharmacists, midwives, nurses and ambulance paramedics has been the use of time-limited written instructions. These are usually sanctioned by a consultant medical practitioner, a responsible nonmedical healthcare professional and, often, a senior manager of the responsible organisation or trust. Historically, these have been standing orders, where the HCP can provide a POM without a prescription, but where there is no flexibility. Driven by the so-called first Crown Report,(2) legislative changes introduced in 2000 defined the use of an alternative, patient group directions (PGDs), which are written instructions for the supply or administration of medicines to groups of patients who, critically, may not be individually identified before presentation for treatment. A common example would be the supply of emergency hormonal contraception in a clinic. The use of PGDs for a hospital clinic where patients are invited to attend would contravene the act. PGDs are further restricted, as they do not extend to independent and public sector care homes or to those independent sector schools that provide healthcare entirely outside the NHS.(3) Although items are made available to individuals, costs are reimbursed for bulk activity. The scope for decisions is predetermined and restricted; thus, there is little “art” or individualisation to therapy.
Recognising the limitations of PGDs, the desire to make better use of healthcare resources and also, principally, to improve access for patients to a wider expertise, initiated further policy-driven changes for alternative prescribing models. It must be appreciated that the focus of the supplementary prescribing model in the UK recognises the needs of an increasing elderly population by meeting the demands of chronic disease management in community, not hospital, settings. The proposition is that, over time, empowerment of frontline staff as supplementary prescribing increases capacity and enables general medical practitioners to concentrate on patients with more complicated conditions and more complex treatments. These policy drivers allowed the door on prescribing to be unlocked.
The key was turned with the 1989 Cumberlege Report on community nursing. Legislation was passed that allowed district nurses and health visitors limited prescribing rights as “extended prescribers” funded by the Health Service for items such as dressings. Pilot projects were set up and, in 1994, it was rolled out nationwide. Having placed nonmedical prescribing on the agenda, the government opened the door slightly by constituting an advisory group on nurse prescribing, led by Dr June Crown. The second Crown Report(4) initiated the legislative changes permitting a range of nonmedical professionals to prescribe. Under Section 63 of the Health and Social Care Act 2001, powers were given to ministers, by Order, to designate new categories of prescribers, set conditions for their prescribing, change NHS regulations and amend the Prescriptions Only Medicines Order.
Two types of prescribers, independent and dependent, were recognised, the former being responsible for assessment of patients with undiagnosed conditions and for making decisions about the clinical management required for the patient. The latter are responsible for the continuing care of patients who have been clinically assessed by the independent prescriber. The concept of the dependent prescriber was refined to the process of supplementary prescribing and defined as: “A voluntary partnership between an independent prescriber (a doctor or dentist) and a supplementary prescriber (eg, pharmacist), to implement an agreed patient-specific clinical management plan (CMP) with the patient’s agreement.”(4)
The process of supplementary prescribing can only be undertaken by specifically trained and uniquely registered pharmacists. Programmes of study are accredited by the Royal Pharmaceutical Society of Great Britain (RPSGB) to provide an educational experience against specified learning outcomes with an indicative content. The training comprises a postgraduate programme of 25 days, plus a period of learning in practice under the supervision of a medical practitioner of 12 days, to enable the pharmacist to acquire the skills of supplementary prescribing practice. Developing the pharmacist’s clinical knowledge and skills in the therapeutic area for which they intend to prescribe is not considered part of the prescribing course; clinical competence is to some extent a prerequisite for entry to a supplementary prescribing programme. Most programmes also map National Prescribing Centre competencies(5) against preparation for prescribing. Critically, pharmacy practitioners are required to self-evaluate and remain within their area of clinical competency as prescribers. No legal restrictions are currently in place limiting the clinical conditions for which supplementary prescribers can prescribe. So long as it is identified in the CMP, they are able to prescribe at the NHS expense as if they were an independent prescriber, which includes controlled drugs and off-licence medicines.
Changes to patient therapy are recorded in the Common Patient Record within 48 hours. The flexibility of prescribing by pharmacists in the UK is currently defined by the CMP, which must be reassessed and reinitiated on at least a yearly basis. This is a legal document, so any case brought is heard in the potentially more penalising criminal, not civil, court. The exact requirements are specified in a Statutory Instrument (SI)(6) and include:
– Suspected or known adverse reactions to any medicinal product which may be prescribed or administered under the plan.
– Suspected or known adverse reactions to any other medicinal product taken at the same time as any medicinal product prescribed or administered under the plan.
Table 1 presents a typical CMP for essential hypertension. Careful consideration of the form and the nature of supplementary prescribing as described prophesises problems for hospital pharmacy. First, the CMP is a patient-specific agreement with a single individual independent prescriber, when hospital medical practice is generally a team approach with at best one consultant but with peripatetic medical staff. Secondly, patients attend secondary care in hospitals when primary care solutions in the community are deemed inappropriate. This predisposes complex drug therapies and the need to act rapidly. CMPs are not designed to allow such prescribing freedom and speed of response. Thirdly, guidelines and protocols, often in conflict with each other, are used as a surrogate for defining the scope of practice. They do not, however, substitute in the UK for the legal requirement to demonstrate a body of knowledge and common practice under the Bolam test(7) or to defend the practice itself as required by the Bolitho refinement.(8) Even though it has been recognised that medical practitioners should normally follow guidelines(9) when managing the care of the patient, in hospitals drug therapy is necessarily more open and even less likely to be defendable. Further practical teething problems with supplementary prescribing have been identified,(10) and parallel the experience of nurse supplementary, independent and extended prescribers. The storing of patient information, confidentiality, negligence, duty of care, vicarious liability, informed consent, fraud, professional ethics and professionalism are additional issues complicating this development.
Such problems have been tentatively overcome in hospital secondary care, with supplementary pharmacy prescribers working in highly specialised clinic situations where patients return over a period of time before being discharged back into the community, such as managing medicines for chronic obstructive pulmonary disease, renal disease and specialist coronary care. Perhaps surprisingly, pharmacists providing total parenteral nutrition services are also able to prescribe using patient-specific CMPs, as patients receive a tailored service for a defined period and the majority fall into a narrow range of feeding requirements.
There is a paradox created in practice with the activities of a supplementary pharmacy prescriber being reviewed by clinical pharmacists. In relation to other prescribing professions, the RPSGB requires, as part of its service specifications, for every prescription to be professionally assessed by a pharmacist to determine suitability for the patient. Yet, in the UK, there is no absolute requirement for a second pharmacist to assess the prescriptions issued by a prescribing pharmacist before they are dispensed. Currently, no guidance exists to address this clinical governance issue. The original government target of 1,000 supplementary pharmacy prescribers by the end of 2004 has not been realised, despite payment of fees. From the first registration on 18 March 2004 up to 8 August 2005, only 614 pharmacists have subsequently completed the educational requirements. Reasons for a lack of engagement may be the identified difficulties in utilising a CMP within the hospital environment or hesitancy awaiting the outcome of the consultation document MLX321(11) on pharmacist independent prescribing. The outcome may persuade the UK government to open the door for pharmacy independent prescribing for any condition from the full British National Formulary (BNF). Then a new era for the profession will be initiated. Key positions of hospital admissions and discharge can then be taken by clinical pharmacy practitioners.
To place UK developments in perspective, legislation has been passed allowing nurses full independent prescribing from a growing list of POMs, which includes controlled drugs. The government target was for half of all nurses to be prescribers by 2004. Currently, the number of registered nurse supplementary, extended and independent prescribers outweighs pharmacists by 8.47:1. The consultation document MLX320 proposing the extension for independent nurse prescribing to any condition from the full BNF closed for consultation months before its pharmacy equivalent. The UK is re-engineering health services. Whatever model emerges in the UK, it is clear that neither pharmacy nor nursing will be the same again.
It is clear that, in the UK, pharmacists have been allowed to put a foot through the prescribing door and ultimately may be able to step through, and that the nursing profession is considerably more advanced in attaining full independent prescribing rights. Timescales have been protracted despite clear and weighty policy drivers. This supports the argument for an EU directive paving the way for a consistent approach across Europe to nonmedical pharmacy prescribing.(12) The original concept of providing patient access to support for chronic disease management underpinned the design of the CMP. This instrument does not lend itself readily to hospital practice. While supplementary pharmacy prescribing provides a greater level of flexibility than standing orders or PGDs, it is bound by the need to identify a companion medical practitioner. With short-stay patients and teamworking, it is difficult to envisage supplementary prescribing creating a huge paradigm shift in hospital practice. Independent pharmacy prescribing would provide a solution to many of the problems identified and would arguably legitimise “common” clinical practice and give pharmacy the opportunity to achieve its vocational aspirations.