The General Pharmaceutical Council (GPhC) has revamped how it inspects and regulates pharmacies, and there is the real risk that some might not have adequately prepared for these changes.
The expectation is unannounced inspections will quickly become the norm, replicating the approach of other healthcare regulators. There is no letter with notice of the visit date, which would otherwise give an opportunity to make any required adjustments to systems and services. With advance warning any documentation could also be meticulously scrutinised, before being submitted to the GPhC.
For many pharmacy owners, the first sign their premises are about to be inspected is when the inspector is stood across the counter. This may come as a significant culture shock, especially factoring in the raised bar for achieving a “pass” in meeting every standard.
Pharmacies inspected from April are expected to have their reports published on the new pharmacy inspections website [launching this summer]. The GPhC has admitted in a document about inspections that all areas flagged for improvement, regardless of how minor, will be published online in these reports, warts and all.
Another concern, acknowledged by the GPhC in this document, is it may not always be “clear cut” whether a standard has been failed or not. While inspections should be evidence-based, inspectors are expected to use their professional judgement, the GPhC said.
A pharmacy might fail an inspection should the inspector deem relatively minor issues to have the cumulative potential of not meeting a standard. The inspector will be expected to consider the “scale” and “impact” of any areas of weakness or required improvement. The greater the concern for public safety, the greater the likelihood of a standard not being met.
Pharmacy owners should be wary of the potential impact a negative report could have. It is unlikely there will be a lawful basis for preventing the publication of a potentially damaging report on the GPhC website. Even where required evidence is provided and an improvement action plan completed, this might come too late. The commercial and reputational harm might have already been done.
The GPhC has set out a number of areas where a standard might not be met. These are wide-ranging and not always obvious, such as:
- Are standard operating procedures fully up to date and can it be evidenced that they are being followed? Are they reflective of current practice? Are responsibilities clearly defined?
- Are pharmacy records complete, clear and accurate? For example, are records within the private prescription record book fully complete, including dates, prescriber address and quantity of medicines?
- Is the controlled drug cabinet compliant with the regulations and is there evidence that access to the cabinet is being safely managed with systems in place, such as overnight safe custody of the key?
This should not be cause for sleepless nights for those well-versed with the changes. However, it is strongly recommended that pharmacy owners should be confident their pharmacy would meet all of the standards, were it to be inspected tomorrow.
Andrew Andrews is a senior associate within the regulatory compliance team at the law firm VWV