Pharmacy regulator may only be reviewed fully every five years

A proposal for “a more targeted approach” to performance reviews means that reviews of the General Pharmaceutical Council could move from once per year to once every five years.

Full regulatory reviews of the General Pharmaceutical Council (GPhC) could move from once per year to once every five years under proposals put forward by the body that oversees it.

The Professional Standards Authority (PSA) — which regulates the ten healthcare regulatory bodies, including the GPhC — consulted on the proposals as part of changes to the way it conducts performance reviews.

This comes after the PSA found that the GPhC met just two out of five standards of good regulation relating to fitness to practise during its 2019–2020 review. In the previous year, the GPhC met six out of ten standards in the same area.

Pharmacist representatives have warned that conducting a full review of PSA standards only once every five years creates “a real risk” of regulatory failure.

But in its response to the consultation, seen by The Pharmaceutical Journal, the GPhC said that under the proposed “targeted” approach, scheduling regular reviews of all standards “would seem unnecessary”.

Under the current system, the PSA reviews all 10 regulatory bodies against 18 standards each year.

However, in the consultation document, the PSA said initial feedback requested ahead of the consultation, which closed on 4 March 2021, found that “a number of stakeholders questioned the need for annual reviews”.

As a result, the PSA proposed “a more targeted approach” to performance reviews, which could see the PSA use available material to assess regulators against a set of seven factors that provide “confidence in the performance of a regulator in respect of some or all of the standards and indicate a lower level of review”.

These include “evidence that the regulator is aware of and addressing emerging risks in respect of the profession”, and that “the regulator has not made any significant changes to processes or policies”.

The regulator would also be assessed against a set of six factors that might indicate the need for a closer review, including “evidence that the regulator was not meeting appropriate key performance indicators” or “concerns identified in previous performance reviews”.

A standard would be reviewed if some of the six factors applied, “or we had not reviewed the standard within the last five years”.

The GPhC said that if “the proposed targeted and risk-based approach works properly in the way described, and includes the appropriate safeguards as discussed above, then it would seem unnecessary to build in a regular review of all standards”.

“However, we accept that it may be helpful to schedule in a full review as a safety mechanism, at least until the new model becomes more established,” it added.

The GPhC said it “would still expect to see some review and assessment of the ‘lower risk’ areas year on year, to maintain a balanced picture of our overall performance”.

In its response to the consultation, the Pharmacists’ Defence Association said: “We have serious concerns about the twice a decade full review of the regulators and were this to go ahead there is a real risk that regulatory failure would not be identified in a timely manner.”

The PDA added that it would “recommend a maximum two-year interval between these ‘all standards reviews’”.

“We engage with the GPhC … formally and informally but this still does not give us the level of insight or information that the annual performance review does,” the PDA said.

“For example, the revelation in the PSA 2018–2019 annual performance review that the PSA had significant concern about the fairness and transparency of the GPhC fitness to practise process would never have been identified without the PSA performance review.”

The PSA said in its report that it found “multiple” examples where fitness-to-practise documents, decisions or the reasons for decisions were not recorded on case notes, with decisions also inconsistent in some cases.

Reform of the Professional Standards Authority

The Professional Standards Authority (PSA) is itself currently subject to proposals from the UK governments to change the way it works in the future.

A consultation on the governments’ proposals ends in June 2021, but the PSA has already expressed concern about the suggested introduction of “accepted outcomes”.

This would mean that fitness-to-practise cases could be closed at the examination stage if the practitioner accepts the regulator’s findings and any proposed sanctions.

The PSA has said it is worried that the changes would also mean that there would be no independent body responsible for challenging unsafe accepted outcomes, and that it would be up to the regulator involved, and not the courts, to make the final decision on whether any accepted outcomes should be altered.

Last updated
The Pharmaceutical Journal, PJ, April 2021, Vol 306, No 7948;306(7948)::DOI:10.1211/PJ.2021.1.77488

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