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GPhC to conduct unannounced pharmacy inspections by 2020

Pharmacies could be subject to unannounced inspections as soon as April 2019 and the results published online and in-store, the General Pharmaceutical Council (GPhC) has said.

The move to unannounced inspections – due to come into effect between April 2019 and April 2020 – is a shift from the current policy of giving advance notice of between four and six weeks, and was confirmed at a council meeting last week (December 6), the GPhC said.

The proposal was “strongly supported” by the majority of pharmacy professionals who responded to a consultation on the GPhC’s plans to overhaul its inspections process, the regulator said.

Pharmacies with restricted access, such as those in prisons and airports, will not receive unannounced inspections, the GPhC said.

As is the case now, inspections will halt if the inspector feels the inspection presents “an additional risk to public safety”, the regulator added.

C+D reported in November that “a number” of respondents to the GPhC’s consultation believed unannounced inspections could help uncover poor practice, such as low staffing. But “a lot” of respondents disagreed with the proposal, because it was “seen as unfair to pharmacists” and would give “the impression they were not trusted to do the right job”.

The Pharmaceutical Services Negotiating Committee (PSNC) said in August that unannounced inspections were “unnecessary and undesirable”.

Displaying inspection results in the pharmacy

Inspection results and any resulting action plans will be published on a forthcoming website with a “short narrative explaining the key judgments made”, and a link to a more detailed report that includes supporting evidence, the GPhC said.

The public site will be “easy to search and analyse”, the regulator promised.

Pharmacies are expected to display their inspection outcome in-store, using a GPhC-branded sign, the regulator added.

“We will consider making the display of inspection outcomes a requirement…in absence of legal powers to enforce,” it said.

Outcome change to “met or not-met”

As part of its new approach, inspection ratings will narrow from “excellent”, “good”, “satisfactory” or “poor” to just two possible outcomes: the pharmacy has “met” or “not met” the standards, the GPhC said.

There were a “range of comments” in the consultation on this proposal, with a majority in support, the GPhC said. “As a regulator for the public, it is important that the outcome of an inspection works for the public first and foremost.”

However, for each of the five principles within the 26 standards, pharmacies would receive one of four ratings: “standards not met”; “standards met”; “good practice”; or “excellent practice”.

Meeting every standard to pass

The GPhC said pharmacies will have to meet every standard in order to pass an inspection, to ensure they are meeting them “every day”.

This was the “most controversial” of the proposals with the “majority” of pharmacy professionals responding to the consultation disagreeing with it, although there were also “many” in support, the GPhC continued.

Some suggested the requirement would be “unfair, and should depend upon the nature of the unmet standard and its potential impact on patient safety”, the GPhC said.

However, the six-year-old standards need to “reinforce the need for standards to be met every day”, the GPhC stressed.

The GPhC will also introduce three new types of inspections: “routine”, “intelligence-led” and “themed”, it said (see below).

GPhC chief executive Duncan Rudkin said: “These changes will help us to provide greater assurance to the public that pharmacy services are safe and effective, and to drive continuous improvement in the quality of care.”

The GPhC plans to begin to publish its inspection reports from April 2019, while the other changes will come into effect between April 2019 and April 2020, it said.

The three types of inspection

Routine inspections

“We will continue to carry out routine inspections of every pharmacy so the public are assured that a pharmacy is continuing to meet our standards and to help the pharmacy identify how it can further improve the services it provides to patients.

“We will improve our approach by moving to a programme increasingly informed by risk indicators to identify which pharmacies we should inspect first. We will use a pharmacy’s previous inspection rating as a proxy indicator of risk along with other relevant information we may hold, such as scale and complexity of services provided or change of ownership.”

Intelligence-led inspections

“We will ring-fence some of our existing resources to conduct inspections that are quickly initiated in response to intelligence that we have received from others, to make sure we are able to rapidly address risks or concerns raised with us.”

Themed inspections

“We plan to take forward a programme of themed inspections which will involve visiting a selection of pharmacies to focus on specific themes or issues, enabling us to better understand the underlying issues, their causes and effects. Composite reports will be published to inform the sector on the issues and risks that have been found, and to inform discussions on how to continually improve pharmacy services in these areas.”

Source: GPhC council documents, April 12

Would you be happy to display your inspection outcome in your pharmacy?

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