At the weekend, I saw a sailing dinghy that was a class winner in the 1948 Olympics. It was a lovely thing; all varnished wood and brass fittings, but it really stood out as antiquated among the modern moulded and streamlined dinghies. It was a good illustration of where the law is with pharmacy supervision; the original case law, with a key case dating from 1943, is very old but incremental steps are heading towards a more modern legal framework.

And after much discussion, the industry is now being consulted on key proposals for change.

 

Legal changes

 

As pharmacy professionals will be aware, current medicines legislation requires that the preparation, assembly, dispensing of medicines, and the sale and supply of P and POM medicines must be undertaken by a pharmacist or under the supervision of pharmacist.

This is set out in section 10 Medicines Act 2010 and Regulation 220 Human Medicines Regulations 2012 (HMR 2012).  There is no legal definition of supervision and the 1940s decision referred to above is the case that set out the principle of direct supervision of individual transactions.

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In the 1990s, the position shifted slightly when the Court of Appeal, looking at supervision for surveyors, said supervision was a matter of degree and should follow what was regarded as good practice in the profession.

In 2005, guidance was formulated by the then regulator, Royal Pharmaceutical Society of Great Britain (RPSGB), which made it clear that a pharmacist needed to assess every prescription to meet the requirement in section 10 of the Medicines Act. It also clarified that at the point of supply, if a pharmacist was involved in a consultation, pharmacy medicines could be sold, and dispensed prescriptions that had been checked could be supplied providing an SOP was in place. This created some tension with the 1943 case.

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The pharmacist’s professional responsibility for the sales or supplies of medicines that took place was unchanged. The amendments outlined in this consultation may change the balance of professional responsibility for sales and supplies, but the degree of accountability between the pharmacist and pharmacy technician is likely to be complex and fact dependent.

 

The proposals

 

There are three core proposals in the consultation:

1. The first proposal is a new concept of “authorisation” of a pharmacy technician by a pharmacist. This would enable the preparation, assembly, dispensing, sale and supply of P and POM medicines to be carried out by or under the supervision of a pharmacy technician. This involves amendments to the Medicine Act 1968 and the HMR 2012. Importantly, the proposal is that an authorisation can be given orally or in writing, and be specific or general.

2. The second proposal is to enable pharmacies to authorise any member of the pharmacy team to hand out checked prescriptions in a pharmacist’s absence. The expectation would be that clear SOPs would be in place which govern the authorisation. (The mechanism would be a new regulation 220B inserted into the HMR (2012)).

3. Proposal three relates to hospital aseptic facilities. Here, chief pharmacists would oversee the pharmacy service as a whole but registered pharmacy technicians would supervise the preparation, assembly and dispensing of medicines in hospital aseptic facilities.

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There is an ancillary proposal that there is an amendment to the reference in regulation 220 of the HMR 2012 to a supply needing to take place “on” registered pharmacy premises to “at or from” such premises. This is to allow current practices such as deliveries by drivers to have a proper legal basis.

Importantly, the consultation says: “We continue to believe that there should be a pharmacist responsible for every pharmacy premises and a registered pharmacy professional responsible for the dispensing of medicines.” This is not quite the same as specifically confirming physical presence of a pharmacist in a retail pharmacy business, but the consultation does also say that it has taken account of the consensus from the Supervision Practice Group that the physical presence of a pharmacist within a retail pharmacy premises is crucial.

 

Comments so far

 

A number of organisations such as the RPS, The Pharmacists’ Defence Association (PDA) and the Pharmacy Law and Ethics Association (PLEA) have already submitted consultation responses and there are likely to be many more.

It appears that concerns have been raised across the board about the proposals that authorisation should be a wide concept and the authorisation can be given orally as well as in writing.  Commentators have pointed out the scope for misunderstanding, and difficulties in evidencing an authorisation if it was to be given orally.

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The least contentious change may be the “at or from registered pharmacy premises” amendment to regulation 220 HMR. However there appears to be less agreement on the proposals relating to hospital aseptic facilities with PDA strongly opposed to changes.

The consultation closes on February 29 2024.

 

What happens next?

 

There will be additional public consultations for some of the changes proposed. The Advisory Council on the Misuse of Drugs will also be consulted on the implications of the consequential changes to the Misuse of Drugs Regulations 2001. However, the government has said that it is proposing to bring in the provisions on handing out checked and bagged items in the absence of the pharmacist as soon as practically possible.

 

This is a general overview and any views or reflections are the author’s own. Independent legal advice should be sought for any specific concerns.

Susan Hunneyball is a solicitor and partner at Gordons Partnership.