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Supervision of individual transactions ‘no longer’ needed, cross-sector group finds

A cross-sector group has developed legislative recommendations to tighten up the concept of supervision in community pharmacy.

Pharmacy “supervision” should not mean supervising individual transactions, according to the Supervision Practice Group – a cross-sectoral working group formed to provide recommendations to the government regarding the nature of supervision in pharmacy.

In a report published today (August 1), the group agreed that while the “physical presence” of a pharmacist on the premises was the “defining element” of community pharmacy, directly supervising every transaction was “no longer suitable for modern practice”.

Read more: ‘Daft bureaucracy’: Shadow health secretary questions supervision rule

The group is a cross-sectoral gathering comprising the Association Independent Multiple Pharmacies (AIMp), the Association of Pharmacy Technicians UK (APTUK), the Company Chemists’ Association (CCA), the National Pharmacy Association (NPA), the Pharmacists’ Defence Association (PDA), the Pharmacy Forum Northern Ireland (PFNI), and the Royal Pharmaceutical Society (RPS).

It hopes its recommendations will “provide a framework” for the government and regulators to “draft specifically worded revisions to legislation and regulatory rules and standards”, which would then be “subject to a full consultation process”.

Read more: Pharmacy supervision: The DH seems committed to changing the law; we must set the terms

According the to the report, the “current interpretation” of case law demands that pharmacists must directly observe individual transactions, which includes the preparation, assembly, sale and supply of all pharmacy-only (P) medicines and prescription-only medicines (POMs).

But the current regulatory framework states that pharmacists should be physically present in the pharmacy, but need not be involved in every individual transaction, it said.

 

Changing with the times

 

However, the group acknowledged that the pharmacy profession is changing – pharmacists are being positioned to take on more patient-facing roles, pharmacy technicians are capable of assuming some responsibility for medicine assembly, and the profession no longer routinely compounds medicines in the pharmacy.

Despite some areas of disagreement between the bodies, particularly regarding the level at which definitional changes to “supervision” should occur in law, the group achieved consensus on a number of points, including clarity on delegation of responsibilities in the absence of a responsible pharmacist (RP) in various scenarios, from temporary absences to out-of-hours medicines assembly.

Read more: The ‘poisoned chalice’ of supervision: where are we today?

Among other recommendations, the group said that legislative changes were needed to allow medicine to be prepared and assembled outside of opening hours without an RP present, with accountability lying with a superintendent pharmacist, who may not be on site in person.  

The group’s report sets out the discussions it has had around pharmacy supervision since December 2022, with the Department of Health and Social Care (DH), General Pharmaceutical Council (GPhC) and the Pharmaceutical Society of Northern Ireland (PSNI) “present as observers for all discussions”.

 

A "major step forward"

 

Members of the group set out their individual organisation's view on the report, and welcomed the prospect of responding to the government's formal consultation process on pharmacy supervision.

The group's chair Dr Michael Twigg lauded the report as a "major step forward for community pharmacy [that] will enable the sector to work in new ways to support their patients and communities".

Read more: Sector bodies resume talks to ‘refresh’ parts of pharmacy supervision

Meanwhile, AIMp chief executive Dr Leyla Hannbeck said that while "consensus" had been reached by the group on "many areas", "the reality is that there remain areas where organisations continue to differ in opinion". 

She continued: "We have been a big advocate for seeking a level playing field for community pharmacists in line with our GP colleagues and this applies to the rules of supervision, too."

CCA chief executive Malcolm Harrison noted that "all participants agreed on the need for change, which is crucial to realising the increasingly clinical future expected of the sector." "These changes provide the basis for the greatest evolution in pharmacy practice for 70 years," he added.

And NPA chair Nick Kaye stressed that the group achieved consensus that a "defining principle" of community pharmacy is the "physical presence of a pharmacist in the pharmacy". 

Catch up on C+D's Big Debate on pharmacy supervision 

PDA chairman Mark Koziol said the report "clearly puts forward a view that the physical presence of a pharmacist in a community pharmacy is essential in providing safe and effective patient care". "While there were differing views on the need for this to be specified in primary legislation, the general point about physical presence was agreed by all," he said.

In 2021, AIMp, the CCA and the NPA launched a working group to “refresh” discussions around changes to supervision in pharmacy, to which other sectoral bodies were invited.

While the bodies told C+D at the time that discussions would not focus on remote supervision, they said the group would analyse “some elements of supervision that may need refreshing” following “current and emergency pharmacy practice”.

Read the full report here 

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