The sector is entering a new era of unannounced inspections. The landscape has been changing for some time within pharmacy regulation – the General Pharmaceutical Council’s (GPhC) August 2018 consultation, on its approach to regulating pharmacies, was a clear indication that it was serious about rewriting the inspection rulebook. Unannounced pharmacy inspections represent one of its most significant shake-ups.

The GPhC said it received strong support for unannounced inspections during its consultation, and support for the regulator working towards implementing what it identified as the key principles that underpin its new approach: ensuring “inspections reflect as closely as possible how patients and the public experience pharmacy services day to day”, and that “all standards for registered pharmacies need to be met every day”.

Some within the sector view this intervention as a necessary sea change, which will help to shed light on pharmacies with generally poor day-to-day business practices – that might otherwise only get their house in order ahead of an inspection.

How will it work?

What is clear is that the GPhC is continuing with a trend towards a more robust regulatory approach. This is happening at a time when many pharmacy owners have been subjected to challenging economic and political pressures.

The initial indication is that unannounced inspections will be implemented at some point between April this year and April 2020. From this time, inspections will either be routine, intelligence-led, or themed.

All pharmacies will be subject to routine inspections, to ensure that standards continue to be met. Under intelligence-led inspections, the GPhC plans to ringfence existing resources to ensure it can immediately respond to specific concerns raised about a pharmacy. Themed inspections will involve visits to a cross-section of pharmacies, and will focus on specific themes or issues.

The existing rating system – of ‘excellent’, ‘good’, ‘satisfactory’ and ‘poor’ – will be overhauled in favour of a binary outcome; standards will either be ‘met’ or ‘not met’. This will mean that any standard found not to have been met – even in part – will equate to the ‘standards not all met’ outcome.

In theory, it will become easier for a pharmacy to “fail” an inspection, given that the compliance bar has been raised requiring that all of the standards are met. This will be coupled with the commercial and reputational ramifications for any pharmacy affected by an adverse inspection report.

Pharmacies will only be able to challenge the factual accuracies of an inspection report. If the findings are upheld, there will be no right of appeal against an inspection report being published.

The GPhC plans to publish the inspection results – short narratives and the reports themselves – together with any action plan on a designated online platform. It plans to convey inspection outcomes in a clear and transparent way to the public, and will highlight where any improvement or regulatory enforcement action has been deemed necessary. Pharmacies will also be required to clearly display their inspection outcome in-branch, using a notice devised by the GPhC.

What can you do to prepare?

Pharmacies will need to invest the time and resources to comprehensively review all aspects of their service for compliance, and address any areas where they may be falling short. Members of staff should receive training and be sufficiently prepared for unannounced inspections, and the methods used by inspectors to gather evidence.

Forewarned is forearmed. Pharmacy owners should immediately assess their service against the standards to ensure they would be adequately met, were an inspection to be carried out tomorrow.

Are all policies and procedures compliant and kept under review? Are records such as training logs and appraisals kept up to date? Will members of staff be able to quickly direct an inspector to requested folders and information, and explain those processes and requirements relevant to their role? Is there evidence to demonstrate that customer feedback is being gathered and acted upon in continuously assessing and monitoring the quality of the service?

The new GPhC approach will require all pharmacies to be highly proactive and in constant anticipation of an inspection, but the majority of registered pharmacies should not be unduly daunted by the prospect of an unannounced inspection. Pharmacy regulation is evolving, and although this undoubtedly represents a further challenge for community pharmacy, it is by no means an insurmountable one.

Andrew Andrews is a senior associate within the regulatory compliance team at the law firm VWV