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Vol 279 No 7479 p582
24 November 2007

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News feature

Pharmacists could be responsible for more than one pharmacy in future

This final article in our series on the responsible pharmacist consultation looks at the circumstances in which a pharmacist can be responsible for more than one pharmacy, the role of guidance to support the changes and the time needed to prepare for them. Dawn Connelly (on the staff of The Journal) reports

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The “one responsible pharmacist per pharmacy” rule caused considerable debate among the profession when the Health Bill was going through Parliament last year. The Government’s consultation on the responsible pharmacist regulations (PJ, 3 November 2007, p494) says that the Government recognises there may be exceptions to this rule in the future and seeks views on the circumstances of these exceptions.

The Government proposes two possible examples of exceptional circumstances. The first is where a temporary pharmacy is in operation, for example at a festival or agricultural show.

“Trained pharmacy staff would be available at the pharmacy with the pharmacist responsible for the main pharmacy in a nearby town or village also becoming responsible for the safe running of the temporary pharmacy,” says the consultation. In this case the responsible pharmacist would set out temporary procedures and decide which staff can undertake various activities.

The second scenario proposed is where a pharmacist is responsible for separate registered premises in which a pharmacist-operated dispensing machine is located (remote supervision).

“The Government does not believe it is sensible or appropriate to require [the responsible pharmacist] to be responsible for a registered pharmacy where he or she only stands guard over a machine operated by a pharmacist from another pharmacy,” the consultation document explains.

Both of these proposals were floated at the informal consultation stage. Most people thought that the temporary pharmacy scenario should not be considered as an exception and no consensus was reached on the second scenario. The consultation, therefore, seeks views on these and other possible scenarios which may constitute exceptional circumstances.

The consultation makes it clear that the Government does not consider holidays, accidents, problems at home and travel disruption to be cases where exceptional circumstances might apply.

In addition to these exceptional circumstances, the Government proposes that, as an extra safeguard, there will be specific conditions with which a responsible pharmacist must comply before he or she can be responsible for more than one pharmacy. Six possible conditions are proposed. These are that:

• The responsible pharmacist must have the capacity to ensure the safe running of each pharmacy for which he or she is responsible

• Certain pharmacy staff must be employed

• A limit is set on the period for which the pharmacist can be responsible for more than one pharmacy

• The relevant regulatory body is notified (to enable inspectors to plan their visits to check compliance with the conditions)

• Each pharmacy concerned is owned or managed by the same company or individual

• The responsible pharmacist is responsible for a maximum of two pharmacies at the same time

A further chapter in the consultation document concerns conditions that must be fulfilled before a responsible pharmacist may supervise activities in a pharmacy where he or she is not the responsible pharmacist.

This, it says, may be necessary, for example, when responsible pharmacist A needs to be absent from the pharmacy but has no second pharmacist (or, when the new supervision requirements are introduced, a registered technician) to supervise transactions.

If the responsible pharmacist in pharmacy B can meet both the conditions for absence and the supervision regulations, he or she may leave pharmacy B and supervise transactions in pharmacy A. In this scenario, pharmacist A would remain responsible for pharmacy A and pharmacist B would remain responsible for pharmacy B.

The Government is seeking views on whether it is necessary for regulations to specify conditions — in addition to those for absence from the pharmacy and any future supervision regulations — that must be met before responsible pharmacists can supervise transactions in another pharmacy. It proposes that both pharmacies should have the same owner and that each must have adequate suitably trained staff.

Introduction of the regulations

The Government proposes that most of the responsible pharmacist regulations are introduced at the same time, including those that relate to the pharmacy procedures and record, the ability of the responsible pharmacist to be absent and the requirement related to recent experience in the relevant pharmacy sector.

Views are sought on what might be a reasonable time to allow pharmacists, the professional regulatory bodies and others to prepare (see Panel below).

Implementation timetable

The Government says that it is aiming to lay most of the responsible pharmacist regulations before Parliament by spring 2008 and introduce them in early 2009 but that this timetable is by no means certain.

A spokeswoman for the Department of Health told The Journal: “The majority view emerging from informal consultation earlier this year was that the preparation period should not be prolonged and nine months was felt to be about the right time allowed for this. However, another view might emerge from this much wider, formal, consultation. We will need to take that into account.”

Consultation on the supervision regulations will follow the same process as for the responsible pharmacist regulations. Depending on the outcome of the responsible pharmacist consultation, the Government hopes to begin the process of informal consultation by autumn 2008.

However, it asks for views on whether the introduction of regulations that are more closely linked with supervision requirements should be part of the later consultation on supervision.

These would be those related to the exceptional circumstances in which a pharmacist can be responsible for more than one pharmacy and the responsible pharmacist’s ability to supervise transactions in a pharmacy where he or she is not the responsible pharmacist.

Some of the regulations relating to the qualifications and experience required to become a responsible pharmacist may also need to be introduced either following or at the same time as the supervision regulations, the Government suggests. It is seeking views on this.

During informal consultation, some people thought that guidance may be helpful to support implementation of the regulations. However, the Government’s view is that pharmacists and pharmacy owners should continue to use best practice and current guidance available from professional regulatory bodies, other pharmacy organisations and pharmacy owners.

However, it is happy to hear views on the need for further guidance, what should be included and who might produce it, the consultation states.

This is the final article in our series, which we hope has made the consultation document more accessible. The consultation closes on 20 January 2008.

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