The Pharmaceutical Journal
Vol 269 No 7206 pp49-50
13 July 2002

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Big response to prescribing proposals

The Government’s consultation document on supplementary prescribing (MLX 284) was sent to 168 interested organisations as well as being made available on the Medicines Control Agency website in April. Lin-Nam Wang (on the staff of The Journal) looks at some of the responses to the proposals for creating this new role for pharmacists

Consultation on supplementary prescribing by pharmacists, nurses and possibly others, ended on 9 July. Anne Ryan, policy manager at the Medicines Control Agency, told The Journal that there had been a "big response" to the consultation and one day before the deadline, the number of responses had reached 622. The Royal Pharmaceutical Society's response was approved at its Council meeting last month (PJ, 29 June, p927) and is now available on the policy pages of the website.

Like the Society, most of the other organisations involved in pharmacy support the principle of supplementary prescribing by pharmacists in general, but there are slightly different views on the workings of the proposed arrangements.

Three main areas of concern are the absence of satisfactory means to allow dual access to patient records, the requirement that dispensing and prescribing should be kept separate, and what training might be required. Also, considering that the formal document MLX 284 followed initial informal consultations, between November 2001 and February 2002, with organisations such as the Society, the National Pharmaceutical Association and the Pharmaceutical Services Negotiating Committee, there is a consensus that it lacks useful suggestions for how predictable practical problems could be tackled.

Digby Emson, chairman of the Company Chemists Association, comments: "Supplementary prescribing will enable community pharmacists to use their clinical skills for the benefit of patients. It's too early to say how it will work, and there are still a lot of questions to be answered. Some of the issues still need to be explored, such as access to the patient's record and how the relationship between doctor, pharmacist and patient will work."

Proposed working definition

MLX 284 proposes a working definition of supplementary prescribing that requires a partnership between the independent prescriber, supplementary prescriber and the patient and an agreed clinical management plan for each patient.

The Government does not expect all pharmacists to undertake the new role, but the Society says that every pharmacist should be seen as a potential supplementary prescriber. The NPA sees community pharmacists rather than primary care pharmacists taking on the role, first because primary care pharmacists have full-time commitments. It says that it would not be economical to recruit more primary care pharmacists to prescribe when the resources already exist in the form of community pharmacists. Secondly, for most patients, using community pharmacists would mean that the present arrangement whereby patients are inconvenienced by having to make a trip to the surgery for their medicines to be prescribed then another to the pharmacy for them to be dispensed would be eliminated.

In contrast, Malcolm Ward, chairman of the Dispensing Doctors Association told The Journal: "We in primary care are not ready for supplementary prescribing as envisaged. I think that it might work well in the hospital setting or in large practices where nurses and pharmacists work alongside doctors in the same premises." The DDA's response to MLX 284 highlights numerous concerns, including the opinion that for the independent prescriber, producing a written clinical management plan for each and every patient would be "an awesome task" and that it was "hard to envisage how this will save time".

Access to patient records

The consultation document lists seven proposed principles of supplementary prescribing. These include, for example, that patient safety should be paramount and that there should be benefit to patients and the National Health Service. It is also clear that the sharing of patient records will be key to the new arrangements. That said, we are faced with the problem of how and when this will materialise.

The Association of the British Pharmaceutical Industry's response says that essential contemporaneous access to patient records will be difficult unless the supplementary prescriber and independent prescriber share the same premises, and recommends that supplementary prescribing without such access should not be permitted, even with retrospective recording.

The DDA goes further, saying that until electronic systems enabling sharing and updating of patient records are in place, supplementary prescribing may "put patients at risk because of failure to maintain adequate updating of ... records regarding changes in treatment, formulation or dose made by the supplementary prescriber." But the NPA says that in terms of patient care, pharmacy cannot afford to put supplementary prescribing on hold until technology catches up and points out that even when a pharmacy and the GP practice are co-located and access is relatively easy, patients' notes are not always comprehensive, meaningful or legible. Also, a single unified health care record does not currently exist anyway, with some patients having records held for them in many places, for example, hospital records, GP records and patient medication records in pharmacies. The NPA endorses a patient-held smart card as an ideal solution but suggests that in the meantime, patient-held notes such as those used in antenatal care should be introduced and that the Department of Health should implement a national template for them.

Medicines to be included

Patients with specific non-acute conditions (eg, asthma, diabetes) or health needs (eg, anticoagulation treatment) are expected to benefit most from supplementary prescribing. However, supplementary prescribing will not be restricted to these situations and any patient should be able to take advantage of the arrangements as long as the supplementary and independent prescribers agree.

With the exception of Controlled Drugs and unlicensed medicines outside paediatric care, the Government has provisionally concluded that all medicines should be prescribable (including black triangle drugs and drugs suggested by the British National Formulary as "less suitable for prescribing") so as not to be "unnecessarily restrictive". However, the NPA and the Association of Independent Multiple Pharmacies agree with the Society that, eventually, Controlled Drugs should be deemed suitable for supplementary prescribing so that terminally ill patients have improved access to expert palliative care.

The ABPI is concerned that supplementary prescribing might compromise patient access to innovative medicines. It says that cost minimisation should not be a driving factor in determining what is prescribable and calls for audit measures to be put in place to ensure this, as well as to safeguard high quality clinical care.

The clinical management plan

For supplementary prescribing to happen, the clinical management plan must be written, agreed and signed by both the independent and supplementary prescribers. The plan must also specify the range of medicines that may be prescribed for the patient as well as the range and circumstances within which the dose can be changed by the supplementary prescriber.

In addition to this, the consultation document proposes that, ideally, the clinical management plan should be discussed and agreed with the patient. With respect to this, the ABPI is concerned that the document does not make proposals as to how patient involvement and engagement will be ensured. It also thinks that if patients are to be involved in managing their treatment, then pharmaceutical companies should be permitted to provide "non-promotional information" about medicines to them.

The Task Force on Medicines Partnership recommends that the plan should be written in a language that the patient can understand, is signed by the patient (or the patient's parent or carer) and a copy should be given to the patient. Furthermore, the plan should reflect the reality of clinical practice in that many patients are cared for by a number of people and the number of signatories to a plan should not be restricted to two.

Accountability

MLX 284 says that the partnership between independent and supplementary prescribers is to be voluntary and both prescribers must be prepared to share responsibility. For example, the independent prescriber will have to accept responsibility for ensuring the clinical management plan is kept up to date and for resuming full responsibility for the patient's care if the supplementary prescriber requests. Examples of the supplementary prescriber's responsibilities include contributing to the clinical management plan and accepting clinical responsibility and professional accountability for decisions.

Mark Koziol, director of the Pharmacy Insurance Agency, told The Journal that the PIA had not submitted a response to the MCA, but in response to the proposals, it had already had discussions with its underwriters so that arrangements will be in place to provide cover for pharmacists who wish to undertake this "significantly more risky" role.

Training

Before undertaking supplementary prescribing, pharmacists must successfully complete any necessary training and competence to prescribe must be registered. However, the document provides little information on what that training might involve.

The AIMp says that training should be available to all pharmacists and that the training required will be fundamentally different from the training nurse prescribers will need. The NPA supports this, saying that on average pharmacy students spend 800 hours studying pharmacology compared to 500 hours spent by medical students and 20 hours by nursing students, so pharmacists would require considerably fewer hours studying the subject. In common with the Society, it also calls for training for supplementary prescribing to be incorporated into the pharmacy undergraduate curriculum in the future, with registration as a prescriber to take place after successful completion of a period of supervised practice.

The PSNC told The Journal that it wants training provisions to be flexible and it expects that much of the training can be done without a classroom element (ie, by distance learning courses). It is concerned that if attendance at a 25-day training course was required, this would, regrettably, result in a lack of uptake of the service, particularly bearing in mind the current shortage of pharmacists.

The College of Pharmacy Practice agrees that adequate training will be needed and that some of this could be met by distance learning. It suggests that the type of topics that should be covered are diagnosis, dealing with patients and working as part of a team.

Separation of supplementary prescribing and dispensing

The principle that prescribing and dispensing should be kept separate is opposed by many pharmacy organisations. For example, according to Sue Sharpe, chief executive of the PSNC, although the PSNC believes that the separation of prescribing and dispensing is an important general principle, it does not believe that it is either necessary or appropriate in the context of supplementary prescribing where there is an agreed clinical plan.

This view is echoed by the NPA, which says that supplementary prescribing introduces entirely different controls and checks (eg, specific criteria) so that patient safety and clinical governance would not be compromised. The AIMp admits that in the past many pharmacists have argued against the amalgamation of prescribing and dispensing responsibilities (as in objections to dispensing doctors) but they feel that improved data collection techniques will allow anomalous practices to be identified. In contrast, however, the ABPI maintains that there will be a conflict of interest sufficient to justify the division of responsibilities and the setting up of systems to ensure probity.

Costs and funding

Although the consultation document also sought views on the potential costs to small businesses of drawing up and implementing supplementary prescribing, not all relevant organisations felt ready to address this. Peter Cattee, chairman of the AIMp, referred to costs as a complicated area and said that his association had not yet formed a view on the cost implications.

Unsurprisingly, the consultation document omits the funding issue. Sue Sharpe told The Journal : "It is likely that the service itself would be funded by primary care trusts as an additional service under local pharmaceutical services or as an adjunctive national contract. The question of who would meet start-up costs for training (eg, course and locum fees), setting up a consultation area or the time taken to develop each plan is open to discussion." Ian Simpson, chief executive of the CPP, said that the college has "expressed hope that the NHS would fund the training, not just for NHS employees, but for community pharmacists".

What next?

Three years down the line from the Crown report in 1999, the consultation period for the creation of this new generation of prescribers has finally passed. Once the MCA has collated responses, the findings will be sent to the various committees that advise Ministers. This sounds good for pharmacy, but there are those who say that supplementary prescribing is too small a step in the right direction and call for independent prescribing from the start (PJ, 11 May, p633). The Society itself has said that it foresees pharmacists prescribing independently in the future.

The ultimate question is whether supplementary prescribing will really benefit patients. The Consumers' Association says that it will in theory, but again its response points out gaps: "The proposals as they are set out in this consultation do not adequately reassure us the public would be sufficiently protected." Patients must have confidence in the arrangements for supplementary prescribing to work. It seems that with so many issues still to be ironed out, the Government's aim to implement the necessary changes during this year may be difficult to achieve.