Since 2019 and its public consultation, the General Pharmaceutical Council has been working towards implementing the agreed principles of a revised inspection process. Key amongst these principles is that its 'inspections should 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'.
Under the existing regime, inspections can either be routine, intelligence-led or themed. However, the GPhC has paused its programme of routine inspections during the pandemic. Since April this year physical inspections have only partially resumed. The focus has been on pharmacies with previously failed inspections and re-inspection due, and on newly registered pharmacies not previously subject to inspection.
The GPhC had already ring-fenced resources for intelligence-led inspections and has continued to immediately respond to intelligence and specific concerns raised about a pharmacy during the pandemic.
The previous ratings system has been overhauled in favour of a binary outcome of 'standards met' or 'standards not all met'. Pharmacies are currently inspected under the five principles of governance, staff, premises, services (including medicines management), and equipment and facilities.
A failure to meet all standards in a single one of these will equate to an overall rating of 'not all met'. The GPhC will then require that the pharmacy owner and superintendent pharmacist of such pharmacies complete an Improvement Action Plan. These need to be completed within a specified timeframe, with progress monitored by the GPhC.
Where a pharmacy is unable to complete an Improvement Action Plan and execute any required changes or there is a perceived serious risk to patient safety, the GPhC has a range of statutory enforcement powers available to it. It is strongly recommended that pharmacy owners seek legal advice at the earliest opportunity should they become subject to any enforcement action.
Both the full report and summary findings are published on the GPhC's specially designated inspections portal, which is accessible to the public. Any improvement or regulatory enforcement action is also published, and pharmacies are required to display the inspection outcome instore.
Inspection reports can only be challenged on factual inaccuracies and, where upheld, cannot be subject to appeal. There is, therefore, significant commercial and reputational risk for businesses resting on inspections.
The GPhC recently announced: "We are currently reviewing what a more risk-based and proportionate routine inspection programme would look like, which will start later in the year."
Neither the nature of this review nor any timescale have been disclosed. The announcement might be an indication that the GPhC is giving serious consideration to moving further away from the old-style practice of advance notice of routine inspections. Unannounced inspections could well become the norm.
The GPhC will likely continue to prioritise inspecting newly registered pharmacies and those that have previously failed inspections and been subject to enforcement action, over those who have consistently met the standards.
The regulator has become more adept at gathering and monitoring data and intelligence and will undoubtedly continue to prioritise intelligence-led inspections. It need not be a substantiated concern and each case is dealt with in accordance with its specific facts and circumstances. An intelligence-led inspection is triggered whenever the GPhC interprets the data or a concern reported to them as suggestive of a potential risk to patient safety.
Particularly for pharmacy owners faced with an unannounced inspection, it is strongly recommended that they sufficiently scrutinise the basis for any inspection and where possible, seek immediate advice and support. Responsibility for meeting the standards will always rest upon the owner. However, the issue with an unannounced inspection is that it may just happen on a day when neither the owner and/or the superintendent are present.
The GPhC would rarely suspend an inspection, even in circumstances where the responsible pharmacist that day might be a locum. The inspection team would continue and speak with those working at the pharmacy that day, as the expectation is that the pharmacy team as whole must be meeting the standards.
Pharmacy owners need to be prepared that an inspection could take place at any time between 9am and 5pm when they may not necessarily be on the premises. This necessitates being satisfied that all members of staff have received all necessary training and are adequately prepared for an unannounced inspection, were one to take place.
It is important, therefore, to ensure that staff have immediate access to information and documentation and that they are in a position to explain all of the processes and requirements relevant to their role, in the event that they are required to do so.
Both continuously reviewing all aspects of your service for compliance and adequately preparing the entire pharmacy team is key to ensuring that the pharmacy is not only meeting the GPhC’s standards but would be in a position to demonstrate that when the inspector calls.
This article was first published in Independent Community Pharmacist.
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