Supervision

DHSC undertook a consultation process to update relevant legislation around the supervision of activities by a pharmacist in a pharmacy. DHSC has issued its response to the consultation, and draft legislation has been published; see here.

The legislation, once it comes into force, will allow:

• pharmacists to authorise any member of the pharmacy team to hand out checked and bagged prescriptions in the absence of a pharmacist. (Expected late 2025, when the legislation comes into force)
• pharmacists to authorise registered pharmacy technicians to carry out, or supervise others to carry out, the preparation, assembly, dispensing, sale and supply of medicines. (Expected to take effect only once supporting regulatory rules, standards and professional guidance have been developed)

Rules, standards and professional guidance

The GPhC is expected to develop and introduce new regulatory standards for Superintendent Pharmacists and Responsible Pharmacists, and Rules for Responsible Pharmacists, to support the implementation of the new legislation.

They have explained that they will hold a public consultation on our proposed new standards and rules, once the final legislation comes into effect. The date for the consultation is still to be confirmed.

The Royal Pharmaceutical Society will also develop guidance to support the implementation of the new standards and rules.

The current meaning of Supervision

The process of …

• preparing, assembling or dispensing a medicine and
• supplying or handing it over to the patient

… must both be carried out or supervised by a pharmacist, but in practice, the two supervision requirements are merged into one.

Currently, pharmacists assess whether a prescription is clinically appropriate for the patient (a clinical check). They or an appropriate pharmacy team member will also perform an accuracy check of the dispensed medicine. This may be carried out by an Accuracy Checking Technician (ACT). With robust procedures or protocols, the final supply of the dispensed medicine can go ahead (and be supervised) when the pharmacist is in the pharmacy’s consultation room, so long as the pharmacist is interruptible (and interrupted if further intervention is required of them).

Resources

New Pharmacy Regs: What you need to know – Supervision is one of several important regulatory changes currently underway to help make dispensing more efficient and support capacity for the provision of clinical services, these are explained in this briefing.

Supervision in Community Pharmacy Guidance – This RPS guidance on supervision is likely to be updated after planned GPhC standards/rules for responsible pharmacists and standards for superintendent pharmacists have been issued.

RPS Strengthening Pharmacy Governance (Supervision)

At the end of 2023, the Department of Health and Social Care (DHSC) opened a consultation on proposals to update legislation, Medicines Act 1968 and Human Medicines Regulations 2012, around the supervision of activities by a pharmacist in a pharmacy.

Within the consultation, the two proposals concerning community pharmacy, both subject to appropriate pharmacist authorisation, are:

1. Pharmacy technicians dispensing and supplying medicines, or supervising others doing so – primarily to give pharmacists more time to do other clinical work; and
2. Pharmacy team members handing out (i.e. supplying) bagged and dispensed medicines to patients or their representatives at the pharmacy premises, in the absence of a pharmacist – for example, to allow collection of dispensed medicines when the supervising pharmacist is on a lunch break.

These proposals, if implemented, will bring significant changes to pharmacist supervision of the dispensing process.

Our Response

Community Pharmacy England, which includes representatives of the CCA and NPA and those with AIM membership, considered the proposals and submitted a full response to the consultation.

Broadly, our response supports the proposals, seeking amendments to the drafting of the proposed legislation to ensure the new provisions, if implemented, can be used in practice.

Perhaps unusually for a consultation on supervision, there is no proposal to change the interpretation of supervision. However, the consultation provides helpful clarification of its current interpretation, based on 2005 professional guidance which includes:

• in the case of a POM or P supply of a dispensed medicine:
  • as regards the ‘awareness’ requirement, the pharmacist will be aware of the supply (having done the earlier checks), but will not be aware of the actual supply at the moment to supply
  • the ‘in a position to intervene’ requirement is met by the pharmacist being on the premises and interruptible, and procedures or protocols ensuring that the supply will not ahead if the threshold for a pharmacist’s intervention is met but the pharmacist was not interrupted

In addition, the DHSC consultation document indicates that professional guidance can develop the interpretation of supervision, within the limits of the existing court decisions, and the Royal Pharmaceutical Society has committed to reviewing its guidance. There is, therefore, scope for new guidance to develop the interpretation of supervision further and recognise current good dispensing practice involving the use of, for example, robotic and automated dispensing systems.

In relation to proposal 2, we have said this should enable automated locker boxes to be located on pharmacy premises, which would mean safe storage of medicines on pharmacy premises, greater in person accessibility of pharmacist advice and less potential for the market entry controls to be undermined.

The Pharmacy Supervision Practice Group has published a report that makes recommendations to reframe legislation, regulation and professional standards and guidance around the future of supervision in community pharmacy.

The group includes organisations from across the community pharmacy sector, with members from the Company Chemists’ Association (CCA), the National Pharmacy Association (NPA), the Association of Independent Multiple Pharmacies (AIM), the Pharmacists’ Defence Association (PDA), the Association of Pharmacy Technicians UK (APTUK), the Pharmacy Forum Northern Ireland (PFNI) and the Royal Pharmaceutical Society (RPS).

The report informed the General Pharmaceutical Council’s (GPhC’s) consideration of the rules and/or standards for responsible pharmacists and standards for superintendent pharmacists that will follow this consultation.

Our news article provides more information about the report.