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Letters to the Editor
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.
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?
A Law and Ethics Bulletin clarifying personal control is published in this week’s issue (p298).