Skip to content

Insights

12 September 2017

No one really knows what pharmacy 'supervision' means

Jeremy Hunt’s statement last month that the government has "no plans to allow pharmacy technicians to supervise pharmacies" would have been more helpful if he had announced there were "no plans for technicians to supervise medicines supply".

The question of who supervises what is a major issue. Another key issue is: what does 'supervision' mean?

My understanding is that the Department of Health programme board responsible for “rebalancing” pharmacy legislation has not looked at the meaning of supervision, and my initial reaction was that this is a missed opportunity.

The Royal Pharmaceutical Society says that supplies should be clinically checked. Xrayser recently wrote about a “final check”. Supervision could mean either of these things – or something different altogether. The trouble is that medicines legislation does not define “supervision”, and the wording of the legislation hasn’t changed since 1933.

In the 1940s and 1950s, when self-service was in its infancy and the internet wasn’t even a gleam in Sir Tim Berners-Lee’s eye, the High Court decided in successive cases that supervision meant a pharmacist had to be aware of what was going on, and in a position to intervene to prevent a supply that would be inappropriate.

The requirement for supervision is now in the Human Medicines Regulations. This says that except in the case of general sale list items, it is unlawful to supply medicines unless the supply is from registered premises and the “transaction” is carried out by a pharmacist, or someone acting under a pharmacist’s supervision.

Today, in the absence of a definition, pharmacy owners and pharmacists have to work out for themselves what and how to supervise.

Can a pharmacist supervise from a location that is remote from the pharmacy, perhaps by means of a video link? There seems no legal reason why not.

The General Pharmaceutical Council's guidance on internet supplies draws a distinction between a clinical check and supervision. But what does supervision involve when large numbers of monitored dosage trays are being filled by technicians or by a robot?

A pharmacist may be present permanently or intermittently. He or she may check that standard operating procedures are being followed, but I doubt whether it is always possible for a pharmacist to be aware of every item in every tray and be in a position to intervene.

On reflection, perhaps the very uncertainty surrounding the requirement to supervise a “transaction” is a good thing after all, giving pharmacy owners and pharmacists flexibility to adapt the requirement to modern pharmacy practice.


This article was written by David Reissner and published by Chemist+Druggist on 12 September 2017. For further information, please contact David on +44 (0)20 7203 5065 or at david.reissner@crsblaw.com.

TOP