The General Pharmaceutical Council (GPhC) proposed making inspections “unannounced as a general rule” – a potential shift from the current policy of giving pharmacies between four and six weeks’ notice – in a consultation that closed in August.
The GPhC received 812 written responses from individuals and organisations to its 12-week consultation. Of the 684 individuals who responded, 62% said unannounced inspections would “provide more assurance that pharmacies are meeting [GPhC] standards every day”, while 31% said they would not, and 7% said they did not know, according to documents released ahead of a council meeting held last week (November 8).
Half of the 123 organisations who responded said that unannounced inspections would provide more assurance that standards were being met, while 40% said the opposite, and 10% said they did not know.
The GPhC said “a number of respondents, mainly pharmacy professionals, were in favour of unannounced inspections due to their potential to uncover potentially poor practices – [such as] low staffing levels or unfollowed standard operating procedures”.
However, “a lot” of respondents “disagreed” with the unannounced inspections because they were “seen as unfair to pharmacists and [would give] the impression they were not trusted to do the right job”.
“Respondents often said that unannounced inspections would be disruptive and stressful for the pharmacy team, adding to the existing burden in community pharmacy,” the GPhC said.
“A common argument was that there might be an emergency or an isolated incident of poor performance on the particular day of the inspection, which might not show the pharmacy in its true light,” the regulator continued.
“There were a few mentions of a disproportionate impact of unannounced inspections on small independents, compared to big multiples,” the GPhC noted.
Patient care “would not benefit”
“Some” respondents said unannounced inspections would mean the pharmacy team would be “unprepared” and not know what to expect during visits, the GPhC said.
Others said that “patient care would not benefit” from unannounced inspections “in the long-term, as the pharmacy team would be ‘inspection focused’ all the time”.
“A regressive step”
There were also respondents who were “sceptical” that surprise inspections would prevent poor practice, “as those who were breaking the rules would do so regardless”, the GPhC heard.
“A few” respondents perceived the move “as a regressive step, as this used to be the norm at the time of the GPhC’s predecessor”.
“A group” of respondents shared the view that inspections are currently “pretty much unannounced”, as the window of four to six weeks gives “little notice of when the inspection would actually take place”.
Would unannounced inspections be possible?
Some respondents were also concerned that key staff or evidence may be unavailable in the pharmacy at the time, which could hinder unannounced inspections, the GPhC said.
For example, respondents wrote that “a locum working on the day might have limited knowledge of the services provided by the pharmacy or the whereabouts of key documentation”.
Premises that respondents said might be difficult to access unannounced included internet pharmacies, as well as pharmacies in airports, the GPhC noted.
In the consultation document, the GPhC acknowledged that “there may be situations when it is not possible for us to inspect a pharmacy unannounced”, such as prison pharmacies and those in “other secure environments”.
But respondents also flagged “exceptionally” busy periods – such as Christmas and Eid, during stock-taking, and in newly opened pharmacies – when “unannounced inspections might not be possible” or could “have an adverse impact on patient safety”.
Read the summary of responses to the consultation in full here.