What changes are being proposed to supervision legislation and guidance?

A cross-sector working group has set out proposed changes to supervision legislation and guidance, to enable the pharmacy workforce to maximise their skills and professional roles, to promote integration within the wider NHS, and to free up pharmacists to be available for patients and to deliver clinical services.

The group included representatives from the Association of Independent Multiple Pharmacies, Association of Pharmacy Technicians, Company Chemists’ Association, the National Pharmacy Association, the Pharmacists’ Defence Association, Pharmacy Forum Northern Ireland and The Royal Pharmaceutical Society of Great Britain.

It is still important for a pharmacist to be physically present in the pharmacy

The group was in agreement that the physical presence of a pharmacist was ‘an important and defining element of community pharmacy to ensure the safe and effective operation of the pharmacy’.

But members disagreed about whether this should be defined in primary legislation, or in secondary legislation or other guidance.

‘Supervision’ does not mean supervising every individual transaction

Previous legal cases have suggested that a pharmacist must directly observe the preparation, assembly, sale and supply of all pharmacy-only (P) and prescription-only (POM) medicines, although this is not explicitly spelled out in current regulatory framework.

Since the 1968 Medicines Act and 2012 Regulations were put in place, dispensing has evolved so that communities now supply original packs rather than compounding on site, registered pharmacy technicians have been introduced, pharmacy teams rely increasingly on technology and the volume of dispensing workload has increased significantly.

The group proposed that the definition of supervision should be clarified, to enable community pharmacists to play a ‘much more ambitious and necessary role’, in ‘a wider range of clinical and patient facing services related to pharmaceutical care and their unique skills around medicines’.

Some activities can continue while the RP is absent, in specific circumstances and for no more than two hours

The group set out some questions to define whether the responsible pharmacist’s (RP) absence was necessary for a defined and limited period of time, whether the risk of absence was less than the risk of presence (such as if a rest break was required), if the absence was temporary and if there were appropriate risk management processes in place ensuring the continued provision of patient care and access to a pharmacist.

In these circumstances, the group agreed that checked and bagged prescriptions that had already been checked as professionally and clinically appropriate, and did not require further pharmacist intervention, could be supplied to patients while the RP was absent.

But they said that those requiring further pharmacist intervention would have to wait until the RP returned.

And further work was needed in consultation with the Medicines and Healthcare Products Regulatory Authority (MHRA) around the sale of P medicines in the absence of the RP, the group said.

Pharmacists can delegate some tasks and responsibility to pharmacy technicians, but retain accountability when delegating to non-registered members of the pharmacy team

As well as freeing up pharmacist time, the group was keen that community pharmacy should offer both pharmacists and pharmacy technicians job satisfaction and fulfilment and be a ‘rewarding and interesting career for other members of the pharmacy team’.

There was consensus around the need to make changes to supervision to enable pharmacy technicians and other team members to play a greater role in the assembly, sale and supply of medicines.

Pharmacists should therefore be able to delegate aspects of the assembly, sale and supply of medicines to other members of the team, if a two-way conversation with clear accountability takes place, the group said.

And it clarified that if the RP delegates to another registered professional – either a pharmacy technician or a pharmacist – then that professional would be accountable for that task.

But if tasks were delegated to non-registered professionals, the RP would retain accountability for the task.

The group also stressed that the person accepting the delegation must be confident, competent and willing to do so, and the task should not be imposed on them.

Medicines can be prepared and assembled out-of-hours when the RP is not signed in, with responsibility resting with the SP

The group suggested that there are fewer risks to patient safety when the pharmacy is closed than when it is open.

It proposed that the preparation and assembly of medicines could take place while the pharmacy is closed and without the RP being signed in.

This would allow suitable pharmacy team members to carry out this task, or for the preparation and assembly of medicines to be delivered through automation.

In this situation, the responsibility and accountability for the accuracy of preparation and assembly would lie with the superintendent pharmacist (SP), who could put suitable structures in place – such as deciding correct staffing levels, training and competency of the staff required and the quality of the dispensing robot.

And when the RP was signed in and the pharmacy open to the public, the responsibility and accountability would revert to the RP.

When the RP assesses the professional and clinical appropriateness of medicines prepared and assembled under the SP’s oversight, they would assume responsibility only for the clinical safety of those medicines.

The group highlighted that the proposal relies on ‘a robust process’ to be able to identify which medicines had been assembled under the SP’s oversight and under the RP’s oversight, so that the right individual could be held accountable in the case of a dispensing error.