The Pharmaceutical Journal Vol 267 No 7158 p121-123
28 July 2001

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Supervision

Legal position different for sale and dispensing

From Mr J. Ferguson, FRPharmS

The article by Anthony Harrison “Competence is the key to safe supervision and delegation” (PJ, 21 July, p89) is interesting, but it does not seem to me to take the position forward for community pharmacy. The evidence suggests that the Royal Pharmaceutical Society’s Council has recognised for at least the past 15 years that, as Mr Harrison says, “there are strong positive arguments for reviewing the nature of supervision”. That is obvious from the statements relating to the Council’s interpretation of supervision given in the current edition of “Medicines, ethics and practice” (July 2001). The definition of supervision that Mr Harrison quotes from the July 2000 edition is not repeated in the new issue, as far as I can ascertain. What is the present interpretation and on what is it based?

There are two separate aspects to consider — the sale of pharmacy medicines and the dispensing of National Health Service prescriptions. Both are covered by legislation, so the final definition would be for the courts if the Society’s interpretation was challenged or a case hinged on whether or not a sale or supply had, in fact, been supervised. It is not clear whether that is the case for the other professions featured in Mr Harrison’s article or whether the examples he gives are, instead, of regulatory/professional body guidance unrelated to specific legislation.

As the MEP makes clear at Section 1.2.2, pharmacy medicines can only be sold in a pharmacy and by a pharmacist “or a person who acts under the supervision of a pharmacist” (Medicines Act 1968). The same section of MEP makes it clear that there cannot be supervision unless a pharmacist is present in the pharmacy and highlights Service Specification 10 in the Code of Ethics which includes a requirement that “all staff whose work regularly includes the sale of pharmacy medicines must be competent and that assistants must be trained to know when the pharmacist should be consulted”. So there is provision for delegation of tasks to trained members of staff whom the accountable pharmacist considers to be “competent to perform them” within the pharmacy protocol (Code of Ethics Part 2A1[f]).

The legal position relating to the dispensing of NHS prescriptions is, in my view, different. NHS dispensing does not constitute a sale but is “supply in circumstances corresponding to retail sale” and is therefore covered by the Medicines Act. In addition, however, it is covered for England and Wales by the provision in the NHS Act 1977 that except as provided in regulations (they cover dispensing by doctors), no arrangements shall be made for dispensing of medicines with anyone other than registered pharmacists or persons lawfully conducting a retail pharmacy business who undertake “that all medicines supplied by them ... are to be dispensed either by or under the direct supervision of a registered pharmacist”. The inclusion of the word “direct” has never been considered by the Society to impose any additional requirement. However. here the requirement is to supervise directly the dispensing of each medicine. This mirrors the requirement in the law that preceded the Medicines Act (Pharmacy and Poisons Act 1933) that each sale or supply of the equivalent nowadays of a pharmacy medicine had to be by a pharmacist or be under the supervision of a pharmacist. It was under that legislation that the Court of Appeal defined supervision as existing when the pharmacist was bodily present, aware of the transaction and in a position to intervene if considered necessary. Thus every dispensing of a medicine against an NHS prescription has to be supervised directly.

The new Code of Ethics (Part 3 4.1[b]) states that “every prescription must be professionally assessed by a pharmacist ... ” who may then delegate subsequent tasks to persons considered by the accountable pharmacist to be competent to perform them. This seems to parallel Mr Harrison’s description of the position in dentistry where tasks can be delegated to competent dental therapists provided that is done by a dentist who has examined the patient. The role of the professional in both cases appears to be to recognise the exceptional.

So the current Code interprets the legal requirement for supervision as being met in the case of a sale of a pharmacy medicine, if sales are made, within the pharmacy protocol by appropriately trained assistants, considered to be competent by the pharmacist professionally accountable for the decision to supply the medicine (Code of Ethics Part 2A1); and in the case of the supply of a medicine against an NHS prescription, if a pharmacist professionally assesses every prescription and presumably then decides if he or she needs to see it again or the dispensing can be completed by a technician the pharmacist considers to be competent to do so, the pharmacist accepting that he or she remains accountable for the supply.

As the first sentence of the introduction to the new Code of Ethics states: “The public places great trust in the knowledge, skills and professional judgement of pharmacists.” Supervision, as currently interpreted, would appear to be the minimum exercise of knowledge and professional judgement, in these areas of service, that people have the right to expect in assurance of the quality of the pharmaceutical service provided to them.

John Ferguson
Haywards Heath,
West Sussex

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