2023-12-13 17:10:23
Since the Pharmacy and Poisons Act 1933, the law has required Prescription Only Medicines and Pharmacy medicines to be sold personally by a pharmacist or for a pharmacist to supervise.
The current requirement for pharmacist supervision is found both in regulation 220 of the Human Medicines Regulations 2012 in relation to the sale or supply of Prescription Only Medicines and Pharmacy medicines; and in section 10 of the Medicines Act 1968, exempting pharmacies, care homes and hospitals from the need for a manufacturer’s licence for the preparation, dispensing or assembly of medicines.
The meaning of supervision was considered in cases heard in 1943 and 1953. In the context of retailing from shops 90, 80 and 70 years ago, the courts held that supervision required a pharmacist to know what was being sold or supplied and to be in a position to intervene to prevent a sale or supply that would be inappropriate.
In the decades that have passed, there has been a good deal of debate about what supervision requires. Retailing has changed and so has pharmacy practice. The requirement for supervision, which is now in the Human Medicines Regulations 2012, has different wording to the wording of the Pharmacy and Poisons Act 1933.
The Department of Health and Social Care has just launched a long-awaited consultation on supervision https://www.gov.uk/government/consultations/pharmacy-supervision#:~:text=This%20consultation%20sets%20out%20proposals,sale%20and%20supply%20of%20medicines
The Department recognises that there is “a need for greater clarity about how and when the current requirements apply”.
Supervision – no proposed change in the law
The Department does not, in fact, propose to make any change to the law on supervision. Wisely, the Department has avoided any attempt to define “supervision”, because it would be difficult to arrive at a definition that would stand the test of time. The Department concedes that there are different views about what the requirement for supervision entails. The Department, referring to what it calls “layers of governance”, sees its role as providing a legal framework, and intends to leave the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland to make relevant Rules and Standards, and the Royal Pharmaceutical Society to provide professional guidance on supervision.
The Department’s emphasis is on “professional regulation, rather than the criminal law”, which will be welcome to everyone within the profession. However, having acknowledged that there are different views of what “supervision” means and that there is a need for greater clarity, failing to address supervision in legislation will not provide greater clarity as to what supervision involves.
Proposed changes in the law
Rather than addressing supervision in legislation, the Department instead proposes:
Aseptic dispensing in hospitals
Pharmacy technicians will be able to supervise aseptic dispensing in hospitals that have a Chief Pharmacist.
Community pharmacies
As an alternative to selling or supplying Prescription Only Medicines and Pharmacy medicines under a pharmacist’s supervision, these medicines may be sold or supplied
- by a Pharmacy Technician if a pharmacist has authorised the Pharmacy Technician to do this; or
- by a person who acts under the supervision of a Pharmacy Technician who has been authorised by a pharmacist.
Authorisation may be general or specific and oral or written.
In giving an authorisation, a pharmacist “must have due regard to patient safety”. Failure to do this will not invalidate the authorisation, but may be regarded as misconduct.
Absent pharmacists
If a pharmacist is absent from the pharmacy and a medicine that has been dispensed under a pharmacist’s supervision is ready for sale or supply, the pharmacist can authorise another person (who need not be a Pharmacy Technician) to sell or supply in the pharmacist’s absence.
Unlike the case of pharmacists who are not absent, a Pharmacy Technician cannot authorise another person to make a sale or supply in the absence of a pharmacist.
For the purpose of this provision, the pharmacist will be treated as absent from the premises if they are at the pharmacy but not available to intervene in, or not in a position to intervene in, the transaction in question.
Again, in giving an authorisation, a pharmacist “must have due regard to patient safety”. Failure to do this will not invalidate the authorisation, but may be regarded as misconduct.
Legitimising home deliveries, etc
Regulation 220 of the Human Medicines Regulations requires Prescription Only Medicines and Pharmacy medicines to be sold or supplied on registered pharmacy premises. It could be argued that this means that, strictly speaking, home deliveries are not lawful (not that anyone would wish to take the point). The Department proposes to change the word “on” to “at or from”. This will not only put home deliveries on a lawful footing, but will also provide a sound legal basis for the use of collection points, including automated collection kiosks and lockers.
Next steps
The Parliamentary process to make changes to the law is quite involved and the timing may, of course, be affected by a General Election. There are other factors that mean the law will not be changed quicly.
Controlled drugs are outside the scope of the consultation and the Home Office will have to be involved in any changes concerning these.
The NHS terms of service in England, Northern Ireland, Scotland and Wales all require prescribed medicines to be supplied under the “direct supervision” of a pharmacist. By the time the law is changed, the terms of service will need to have been brought into alignment.
The changes in the law may not immediately apply in Northern Ireland because Northern Ireland does not have Pharmacy Technicians, although there is a current proposal to change this.
The GPhC and Pharmaceutical Society of Northern Ireland will have to consult and make Rules and Standards, but supervision is not the top of their agendas: Rules and Standards for Responsible Pharmacists, Superintendent Pharmacists and Chief Pharmacists need to be addressed first.
Consultation response
The consultation ends on 29 February 2023. The PLEA Executive intends to submit a response. Members who wish to express any views are invited to email davidreissner1@gmail.com by 5 February 2024.