Richard Hough casts his expert legal eye on the government’s proposed changes to supervision…

On December 7, the Department of Health and Social Care (DHSC) published its long-awaited consultation on pharmacy supervision which it hopes will pave the way for new legislation that will encourage pharmacists to spend less time on activities that can be safely delegated and which will enable more effective utilisation of every member of the pharmacy team.

The DHSC’s proposals look to put in place a legal framework for delegation within a pharmacy with the intention of allowing pharmacists to spend more time with patients. The proposals will enable pharmacists to ‘authorise’ pharmacy technicians to undertake tasks that would otherwise need to be performed by, or under the supervision of, a pharmacist and for pharmacy technicians to supervise other members of the pharmacy team.

As pharmacy technicians are not currently a registered health profession in Northern Ireland, the proposals mainly apply to Great Britain only (at least until statutory registration and regulation of pharmacy technicians is adopted in NI).

DHSC is keen to stress that its proposals are not a move towards allowing pharmacists to remotely supervise a community pharmacy. Physical presence of the responsible pharmacist in a retail pharmacy as the default (as inferred under section 70(2) of the Medicines Act 1968 (MA)) will remain enshrined in primary legislation, and this position is unlikely to be changed as part of the proposed reforms.

Regulation 220 Human Medicines Regulations 2012 and Section 10(1) MA together require that the preparation, assembly, dispensing, and the final sale and supply of pharmacy and prescription-only medicines must be undertaken by or under the supervision of a pharmacist. But what does ‘under the supervision of a pharmacist’ actually mean?

Unhelpfully, supervision is not currently defined in legislation and pharmacy professionals have had to refer to case law, and more latterly professional guidance, to assist them in practice. The most recent significant cited case on supervision concluded that supervision was a ‘matter of degree’ and would vary depending as to what the profession deems best practice.

RPSGB (the RPS’s predecessor) guidance from 2005 added flesh to the bones of that judgment and we can expect both the RPS to update its guidance and the GPhC to update its rules and standards further to the conclusion of the consultation, which should hopefully provide greater clarity to pharmacy professionals on what constitutes supervisory best practice.

Under the proposals, a new, additional method of delegation termed ‘authorisation’ would be introduced into pharmacy practice. If adopted, pharmacists would be able to ‘authorise’ (without directly supervising) pharmacy technicians to perform tasks that would otherwise need to be performed by or under the supervision of pharmacists.

The proposals are designed to allow pharmacists to spend less time on tasks that can be safely delegated to pharmacy technicians, capable of working more autonomously, referring to a pharmacist only where necessary.

Pre-checked and bagged prescriptions would also be allowed be handed out by any member of the pharmacy team (not restricted to pharmacy technicians) in a retail pharmacy in the absence of a pharmacist - where the pharmacist has ‘authorised’ this. The proposals are designed to enable a broader range of pharmaceutical services to continue safely while pharmacists are engaged delivering clinical services or temporarily absent from the premises.

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. Perversely, the law currently allows pharmacy staff to give a delivery driver medicines to take to the patient, or to place a medicine in an automated collection locker for collection by the patient or their representative, but a pharmacist needs to be in a position to ‘supervise’ a member of staff if they were to pass out the same medicine on a registered pharmacy premises.

This proposal is therefore put forward in order to bring arrangements within community pharmacies into line with existing arrangements for automated lockers, collection points and home deliveries. Authorisation may be general or specific and oral or written, may be subject to conditions or varied or withdrawn by the pharmacist. 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 professional misconduct.

The NHS terms of service require medicines to be supplied ‘either by or under the direct supervision of a registered pharmacist’. If the law is changed in accordance with DHSC’s proposals, the NHS terms of service will also need to be changed to reflect the new delegated arrangements.

The proposed legislative changes will not redefine ‘supervision’ - and supervision by a pharmacist will continue as before, to be one route to lawful preparation, assembly, dispensing and final sale or supply of medicines. ‘Authorisation’ will provide a new route to lawfully undertaking these activities, but supply by or under the ‘supervision’ of a pharmacist will remain an option open to pharmacies, for example, where a pharmacy does not employ a pharmacy technician.

The consultation is open until February 29.

Richard Hough is a partner at law firm Brabners and a former pharmacist.