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Final word: Supervision ship may have sailed

Has pharmacy managed to miss the boat when it comes to changes to supervision, asks David Reissner

Since at least 2019, the Department of Health and Social Care has been talking about changing the law that requires pharmacists to supervise the supply of Pharmacy medicines and Prescription Only Medicines (POMs).

Underlying the DHSC’s plan to change the law is the view that legal precedents created by High Court cases in 1943 and 1953 require the pharmacist who supervises to be watching while every Pharmacy medicine and POM is handed out even, in the case of a POM, if it has been dispensed under supervision and then put on a shelf until a patient collects it. 

If this view of the law is correct, the law may be being broken on a daily basis, as pharmacists spend time with patients in consulting rooms or are engaged in providing other clinical services when P medicines and POMs are supplied.

In 2019, when the DHSC announced its five-year pharmacy funding plan for England, it said that a requirement for a pharmacist to watch medicines being handed out by others “restrict[s] full use of the skills of registered pharmacists and registered pharmacy technicians, impede[s] the deployment of modern technologies and put[s] disproportionate or unnecessary obstacles in the way of new models of service delivery by and/or involving pharmacy…”. 

The DHSC made it clear that it intended to change the law on supervision to overcome these obstacles. 

Recent legal changes

Pending a change to the law on supervision, the DHSC has already made recent changes to the law governing the respective roles of responsible pharmacists (RPs) and the superintendent pharmacists (SPs) of corporate owners. Since 2008, regulations required the presence of an RP on pharmacy premises but allowed the RP to be absent for up to two hours in a day. 

The legal duties of RPs were changed on December 1, 2022 after a consultation on recommendations made by the Medicines Rebalancing Board. The RP regulations do not mention supervision. 

In April 2022, when the DHSC reached its conclusions following a consultation on proposals by the Medicines Rebalancing Board, it explained: “The proposals on which we have consulted concern the RP. The role of the RP is a distinct and different role from the supervising pharmacist, albeit that they may be undertaken by the same pharmacist at the same time. The RP role is concerned with the organisational governance of the pharmacy, whereas supervision by a pharmacist concerns individual transactions.” 

The recent changes that have already been made to the law governing RPs, and the consultation that preceded them, are an important backdrop to some of the Pharmacy Supervision Practice Group’s recent recommendations.

The Group’s report included the following:

  • “Supervision” should no longer be interpreted to mean observing individual transactions
  • “Supervision” requires a pharmacist to be present in the pharmacy
  • The two-hour time absence limit should remain
  • When a pharmacy is closed to the public, “preparation and assembly could be undertaken without an RP being signed in, but instead under the supervision of an absent superintendent pharmacist (SP)”. 

The first and second of these recommendations directly address the objectives of the DHSC. However, requiring a pharmacist to be on the premises when supervision is exercised may mean that if a medicine has been dispensed under a pharmacist’s supervision and then bagged and put on a shelf awaiting collection, the medicine cannot be handed out if there is no pharmacist on the premises. I am not sure this is what the Supervision Practice Group intended.

RP regulations revoked

As for the recommendation that RPs should be allowed to be absent for up to two hours in a day, the Group may have missed the boat. When the law governing RPs and SPs was changed in December 2022, the Responsible Pharmacist Regulations were revoked. Instead, the GPhC has been given the power to make rules about RPs, including whether and for how long they can be absent from a pharmacy where they are signed in. 

Until the GPhC makes rules, the old RP regulations will be treated as remaining in force. However, there seems little point in lobbying the DHSC for a requirement about allowing RPs to be absent for up to two hours when ministers have handed responsibility for any decision about this to the GPhC.

What about assembly?

For many years, a manufacturer’s licence has been required for anyone who assembles medicines. Assembly includes things like labelling and changing packaging, such as putting medicines into a monitored dosage tray. However, there is an exemption from the need for a licence when medicines are assembled in a pharmacy under the supervision of a pharmacist. 

The Supervision Practice Group recommended that medicines could be assembled in a pharmacy when the premises are closed to the public without requiring an RP on the premises (with a SP supervising remotely). 

This is another boat that may have been missed because DHSC looked at this suggestion before it changed the law on December 1, 2022. All the pharmacy organisations responded to the consultation on the proposals by the Medicines Rebalancing Board. After considering all the consultation responses, the DHSC rejected the idea that a RP could be absent when medicines are assembled, saying: 

“The proposal to require there to be an RP in charge of a pharmacy premises when medicines are being…assembled, prepared or dispensed with a view to sale or supply, stems from the need to ensure that these processes are safely managed and governed – with the safety of patients being the top priority.” 

The DHSC will welcome the consensus reached by the pharmacy organisations, but it must be far from certain whether this consensus will be enough to cause it to perform a U-turn on changes to the law it made less than a year ago.

  • David Reissner is honorary professor of pharmacy and medicines law at the University of Nottingham, and chair of the Pharmacy Law and Ethics Association.
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