The General Pharmaceutical Council (GPhC) proposed that its inspectors “may choose to defer the first inspection” of relocated pharmacies for “up to two years” or “conduct a visual inspection of the premises remotely…by video call” in December council papers published last week (December 6).
“Under the current system, a full on-site first inspection must be conducted” six months after a pharmacy moves premise – but “this takes significant time and resource”, it said.
Read more: ‘Watch this space’: GPhC to ‘review and refresh’ inspections approach
A spokesperson today (December 9) told C+D that “for a new registration consisting of a change of address only, and where no other risk factors are identified, [the GPhC is] proposing to take this approach as a starting point for all visits going forwards”.
“The inspector would still retain the ability to conduct an on-site visit should this be necessary,” they stressed.
“Risk profile”
The council papers also laid out plans to “take a risk-based approach to determine when the first inspection of a pharmacy takes place”.
The spokesperson told C+D that GPhC inspectors currently conduct a “site visit before registration is granted”, with a pharmacy’s first “full on-site inspection at six months from the date of registration”.
“We are proposing that where no other risk indicators are present, the first inspection may take place at any time up to 12 months for a ‘bricks-and-mortar’ pharmacy, and this would be at the inspector’s discretion,” they added.
“We will prioritise first inspections within 12 months, and within six months for online pharmacies because of the observed difference in compliance rates,” the papers said.
Read more: PDA demands axe for GPhC after inspection numbers collapse
The GPhC said that this decision would be “based on a pharmacy’s risk profile”.
This profile might be affected by “issues identified as part of the registration process, any fitness to practise (FtP) determinations, anticipated changes to or developments in services being offered, and nature of the business – for example providing any specialist or prescribing services”, it added.
The proposals come amid attempts to employ “shorter, targeted inspection methodology for some routine inspections, which will focus on areas of higher risk”, the papers said.
Read more: ‘Gross incompetence’: High Court orders GPhC to reconsider FtP case
The GPhC added that some “pharmacy types [are] known to present greater risk, for example online pharmacies” – with “85% meeting standards compared to 91% for other pharmacy types”.
“Our approach to inspection methodology will remain iterative and under continued review” with the next formal review scheduled for the first quarter of 2025/26, it said, adding that the changes “are scheduled to be implemented by the end of January 2025”.
GPhC chief pharmacy officer and deputy registrar Roz Gittens revealed plans to “review and refresh what [it is] doing in terms of [its] methodology” at the Pharmacy Show in Birmingham in October.
Read more: CQC to ‘pick up’ regulation of pharmacists prescribing from home
In June, the Pharmacists’ Defence Association (PDA) repeated its call for the GPhC to be stripped of its role as the pharmacy premises regulator amid a sharp drop in inspections.
According to the PDA’s calculations at the time, the regulator’s rate of inspections has declined so dramatically that a pharmacy would only expect to have a routine inspection “once every 15-17 years”, despite there being 1,000 fewer pharmacies than in 2019.
Meanwhile, the High Court of Justice has called out the “gross incompetence and unfairness” of the GPhC’s handling of a pharmacist’s alleged role in “fraudulent” medication sales overseas, ordering the regulator to “undertake the whole process again”.
