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Vol 272 No 7298 p570
8 May 2004

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NHS pharmaceutical regulations: change as well as consolidation needed

By Stephen Axon

Stephen Axon, of Amersham, Buckinghamshire is former secretary of the Pharmaceutical Services Negotiating Committee

It is now over 12 years since the NHS (Pharmaceutical Services) Regulations were last consolidated and the hundreds of changes spread across 20 or so statutory instruments show that a revision is long overdue. The recent changes in the GP contract have led to new medical services regulations and I am led to wonder whether the new contract will spawn revised NHS pharmaceutical regulations. If so, now is the time when we should be looking at what we would like to see in them — after all, for the community pharmacy sector these are the terms under which services are provided to our biggest and most powerful customer.

Due to the hundreds of amendments the current regulations are practically impossible for a busy pharmacist (or should I say chemist?) to comprehend. In addition to this they are out of date and in some ways resemble standard operating procedures, and certainly do not reflect the professional nature of the NHS pharmaceutical service. Most worrying in my view, however, is an inherent acceptance within recent drafting of the regulations of a movement towards an employee profession — all without any prospect of a representational body for employee community pharmacists. One part of the regulations provides an interesting example of this.

The definition of a “chemist” within the regulations has changed little since the foundation of the NHS. If we cut away the legal jargon the term is currently defined as a person who is included on a primary care trust or local health board list (in England and Wales) as: a registered pharmacist, a person lawfully conducting a retail pharmacy business or as a supplier of appliances. Put more simply this is a pharmacy or appliance company owner.

The regulations then define a “pharmacist” as a registered pharmacist (other than a supplier of appliances only) whose name is included on a PCT or LHB list or who is employed by someone or a body corporate who is so included — again, put more simply, this is a pharmacist owner or employee pharmacist.

It is when these two definitions come together that the regulations appear muddled. I use the word “appear” out of my genuine respect for the legal draftsmen who could probably marry all the amendments together and come up with clarification. I believe, however, that one of the most important aspects in any changes to the regulations is to separate the pharmacist who can provide pharmaceutical services to patients from the pharmacy that can only sell those services.

The definition of the “repeat dispensing chemist” further illustrates this point. The draftsman cleverly attempts to get around the difficulty by “construing” rather than defining. The regulations say that the term shall be “construed in accordance with Regulation 16B(1)”. ‘Chambers everyday dictionary’ defines the word “construe” as “to elucidate grammatically or to translate literally or to interpret” — so that will certainly open the doors for lawyers of both the barrack room kind and their more expensive cousins. In this respect we could do worse than to remember that some of the old health authorities interpreted the current regulations in such a way as to enable them to attempt to refuse a “professional allowance” where a pharmacist in charge had not completed the patient medication records course.

In fact, Regulation 16(B)(1) is not helpful since, in essence, it says that a chemist may provide repeat dispensing services if he is not a supplier of appliances only, and (in England) is included in an approved PCT or LHB list. Of course, that applies to the chemist not to the pharmacist. The detailed requirements relating to the additional qualifications required of the pharmacist are contained in the terms of service for chemists where the chemist must employ a pharmacist with the required qualification. If the public is to have continuity of service, unless the majority of pharmacists are “qualified” for all the future roles, there could be difficulties ahead.

When I registered, more years ago than I like to remember, my qualification enabled me to provide a full pharmaceutical service. It seems that today, despite five years’ training to master’s degree level, the highly qualified pharmacist still needs to obtain additional certification to keep PMRs, to give advice to owners of nursing homes, to undertake medicines management, to dispense repeat prescriptions, to prescribe and probably for every other role that emerges. I suppose that after 20 or so years of continuing professional development a pharmacist might be able to do what I was permitted to on first registration. There must be a happy medium somewhere but I am not sure that we all have the will to find it.

To take a leaf from the CPD manual, what lessons do we learn from this?

· As one of the two principals in the arrangements, pharmacy owners should take the lead and proactively look at the revision of the NHS (Pharmaceutical Services) Regulations from the contractor standpoint rather than just waiting for consolidation by the Department of Health

· Employees should be fully involved in any discussions

· Consultation, when it takes place, should be with the Department of Health negotiators (pharmacy has had no input into others’ regulations)

· Pharmacists do not need additional training for all the new roles so the requirements should be revisited

· Opportunities to take additional role qualifications should be provided in the preregistration year

· There might be merit in splitting the regulations into two parts, one for the contractor’s obligations, and the other a menu of pharmacist skills (possibly linking to the new contract)

· Creeping (or piecemeal) change has not improved the position of pharmacists over the years

· When revision takes place, IT should be used to keep the regulations up to date

· Community pharmacists should decide whether they wish to be owners of pharmacies, employees paid on the basis of time, or whether they would be better selling their skills on a sessional basis

· Avoid being “bounced” by the Department of Health negotiators into changing the terms of service into little more than standard operating procedures for pharmacist employees

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