DHSC's proposed supervision changes pass the buck to the GPhC

David Reissner examines the history of pharmacy supervision and highlights the problems in proposed changes to supervision laws  

Supervision has been a feature of pharmacy law since the Pharmacy and Poisons Act was passed in 1933. This Act made it unlawful to sell a poison unless the sale was made by a pharmacist or under the supervision of a pharmacist. The 1933 Act also gave the Pharmaceutical Society, which regulated the pharmacy profession, the power to appoint inspectors to investigate and enforce the law.

The meaning of “supervision” was clarified by the courts in two cases. In 1943, a Pharmaceutical Society inspector bought a bottle of strychnine over the counter in a pharmacy owned by Littlewoods Mail Order Stores. A pharmacist was on the premises, but was upstairs in a stockroom. The company was convicted of an unlawful sale. On the meaning of “supervision”, the Lord Chief Justice said:

“I do not think that, while he was upstairs and therefore absent, [the pharmacist] could be a person who was supervising a particular sale…he must be aware of what is going on at the counter and be in a position to supervise or superintend the activities of the young woman by whom each individual is effected.”

Ten years later, in a branch of Boots, a customer was observed by a Pharmaceutical Society inspector putting into a wire basket a bottle of syrup that contained codeine. The company was prosecuted. Boots was acquitted because there was a pharmacist at the counter, and the court ruled that a sale did not take place until the customer brought the bottle to the counter to pay for it. A different Lord Chief Justice said:

“I think that the sale is effected under [a pharmacist’s] supervision if he is in a position to say ‘You must not have that; that contains poison’.”

When the Pharmacy and Poisons Act was passed in 1933:

• a pharmacist’s function mainly involved making up and selling medicines;
• pharmacists did not provide clinical services as we know them today;
• home deliveries would have been rare;
• pharmacists would not normally have seen patients in consultation areas;
• there were no pharmacy technicians; and
• the NHS had not been created.

The Pharmacy and Poisons Act 1933 was replaced by the Medicines Act 1968, and the Medicines Act 1968 was replaced by the Human Medicines Regulations 2012 which is now in force, there. However, the High Court has never given a ruling on the meaning of supervision either under the 1968 Act or the 2012 Regulations.

Although there have been no High Court rulings since 1953, the meaning of “supervision” has been considered in a healthcare setting by VAT Tribunals. Those Tribunals have rejected the idea that supervising someone requires that person to be watched. For example, in a 2003 case, Allergy Testing Limited arranged for allergy testing to be carried out in pharmacies, clinics and health food shops. In deciding whether the service was directly supervised by a qualified person, the Tribunal said:

“In our judgment, supervision involves some degree of oversight of  another person’s work, and implies that the supervisor has some kind  of authority to ensure that the work is being carried out properly at all  times …”

Proposed changes to supervision laws

In late 2023, the Department launched a consultation on proposals to change the law on supervision. It wants to introduce greater skill-mix in pharmacies, deploying the skills of pharmacy technicians, and potentially freeing up pharmacists to spend more time on clinical services. The proposals do not include a definition of “supervision”. Instead, they extend the scope of the requirement for supervision by allowing pharmacists to authorise pharmacy technicians to sell or supply Pharmacy Medicines and Prescription Only Medicines.

Pharmacy technicians would be able to supervise others who sell or supply medicines. Under the proposed law, medicines previously dispensed under the supervision of a pharmacist could be handed out to patients in the absence of a pharmacist. There is room for uncertainty here, because “dispensing can have a number of different meanings”. Authorisations to pharmacy technicians may be verbal or written. This seems like a recipe for problems, because the existence and extent of any authorisation are only likely to be investigated when something has gone wrong. If an authorisation is alleged to have been verbal, it may be hard to prove.

Although the proposed changes in the law do not say what “supervision” means, the General Pharmaceutical Council will be expected to make rules for pharmacy owners, pharmacists, and pharmacy technicians to follow. When the GPhC does so, an approach that reflects twenty-first century rulings by VAT Tribunals will probably be more compatible with modern pharmacy practice than court decisions made in the very different world of the 1930s.

David Reissner is Honorary Professor of Pharmacy and Medicines Law at the University of Nottingham, and Chair of the Pharmacy Law & Ethics Association