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Letters to the Editor
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Personal control
Further clarification needed regarding GSL medicines
From Mr S. Vohra, MRPharmS
The article “Statutory Committee clarification on meaning of ‘personal
control’” (PJ, 7 August, p203) does not mention how staff
are to manage general sale list medicines, only giving advice to close
the dispensary and not sell any pharmacy medicines. I have been told
by my local pharmaceutical inspector that GSL medicines and items such
as corn plasters should also not be sold since the customer is purchasing
these from a pharmacy and appropriate questions should be asked about
the purchase, eg, in the case of customers buying items to treat foot
conditions they may have unknown diabetes. The Statutory Committee needs
to further clarify this point and the accountability or responsibility
of staff in selling such items whenever the pharmacist is not present.
Samir Vohra
Clinical Governance Facilitator
Chorley & South Ribble Primary Care Trust
Clarification has muddied the waters
From Dr G. E. Applebe, FRPharmS
I applaud the courage of the chairman of the Statutory Committee, Lord
Fraser of Carmyllie, for his attempt to clarify the concept of personal
control reported in The Journal (PJ, 7 August, p203). I must first however
correct your editorial on the topic, which states that the concept had
not been tested in the courts. The High Court did deal with the topic
(Hygienic Stores Ltd v Coombes) in 1937. Although this case was based
on the earlier legislation the wording of the 1933 Act was similar to
that in the current Medicines Act.
In the case Lord Fraser was considering the pharmacist had believed that
it was in order for the pharmacy to be open without a pharmacist provided
POM or P medicines were not handed out or sold. Indeed the pharmacist
was following the guidelines in the ‘Medicines, ethics and practice’ guide,
subject to the caveat that the absence of the pharmacist should be a
temporary one, eg, during lunch break, going to the bank, etc. This “policy” was
that followed by the inspectorate, at least during the period that I
was in the Society’s law department (1964–91). It was also
the principle followed by the Statutory Committee over those years. Lord
Fraser appears to advocate the same principle except that he puts no
limit on the pharmacist’s absence: an hour, a week, a month, etc?
I believe that Lord Fraser’s “clarification” tends
to muddy the waters in that he introduces several terms which do not
appear in the Medicines Act. His main thrust introduces phrases such
as “items not requiring the agreement or approval of a pharmacist” and “items
that require the presence of a pharmacist”. The crunch words in
the Medicines Act are “supervision” of POM and P medicines
and “personal control” of all medicines. The Act is silent
on the words “agreement”, “approval” and “presence”.
Throughout his decision, Lord Fraser does not mention even once the sale
of general sale list medicines. These are the medicines which have caused
problems with personal control over the years. It is impractical in a
modern pharmacy to separate or lock away the dispensary and all medicines.
The Act requires that, in order that a person shall be a person lawfully
conducting a retail pharmacy business, the business, so far as it concerns
the retail sale at those premises of medicinal products (whether they
are medicinal products on a general sale list or not), or the supply
at those premises of such products, is under the personal control of
a pharmacist.
Lord Fraser uses the phrase: “I understand that Parliament intended
the premises can be opened or remain open provided nothing requiring
the presence of the pharmacist is handed over in his absence.” The
concept of the presence of the pharmacist is not in the statute. It was
my understanding when the
Medicines Bill was going through the House of Commons in 1967 that medicines
should only be available from pharmacies and
sold under the supervision of a pharmacist. An exemption, the general
sale list, was created for products which could safely be
sold other than through a pharmacy but in a pharmacy they remain under
the personal
control of a pharmacist.
Lord Fraser’s words seem to widen the door permitting pharmacists
to be absent from the pharmacy provided there is no
sale of POM or P medicines, a principle followed by the Society over
the years but always with important caveats limiting that absence. The
Society, and its Council, have also stated on numerous occasions that
when a pharmacy is open, the public expect a pharmacist to be present.
That is the added value that a pharmacist brings to the public, otherwise
why have a pharmacist at all?
One eminent chairman of the Statutory Committee, while I was his secretary,
in dealing with a personal control issue said that he would not attempt
to define the term and tread where angels feared to go other than to
say it all depended on individual cases and individual circumstances.
I commend Lord Fraser in raising this thorny issue once again but sadly
I do not believe his decision has resolved the matter.
Perhaps it is time to change the law and look at a new Medicines Act.
Surely this is overdue bearing in mind the changes in outlook and policies
over the past 35 years. After all we are seeking legislative changes
for pharmacy so why not legislative changes for those products which
pharmacists supply?
Gordon Appelbe
London SE19
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A Law and Ethics Bulletin clarifying personal control is published
in this week’s issue (p298).
— EDITOR
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The
Pharmaceutical Journal