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Pharmacy Regulation Monthly – September 2022

Each month I prepare a note of the most interesting or important regulatory developments in community pharmacy over the preceding month.  During September 2022, these were:

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 have been laid before Parliament and mean that, with effect from 1 October 2022, it will form part of the NHS pharmacy terms of service for contractors to undertake “an approved workforce survey annually, in an approved manner”.  This change has been agreed between NHSE and PSNC to try and obtain a fuller picture of the community pharmacy workforce, in particular the number of vacancies and regions where these are particularly hard to fill.  In recognition of the work involved in completing the annual workforce survey, from 1 October 2022 contractors will no longer be required to complete an annual patient satisfaction survey.   Although patient satisfaction surveys will no longer form part of the NHS pharmacy terms of service, in our experience these surveys can provide very helpful data both for GPhC inspection and fitness to practise purposes and also when responding to NHS market entry applications, in particular unforeseen benefits applications.

The Professional Standards Authority, or PSA (the body which sets standards for and oversees the 10 UK health and care regulators), has published a new report ‘Safer Care For All – Solutions From Professional Regulation & Beyond’.  The report can be accessed here.

Interestingly, the report has quite a focus on pharmacy and, specifically, the larger multiples.  Key comments include:

“We are seeing large corporate chains accused of ‘hard sell’ tactics, and other questionable practices, that seem to prioritise profit over the best interests of both patients and registrants. However, the regulation of ‘high street’ providers of healthcare is complex and piecemeal, and may not be fit for purpose”.

“Technology is transforming both how we deliver care, and the techniques and services on offer…people can now access a whole range of healthcare online, including pharmaceutical, optical and dental service…Evidence suggests that online healthcare businesses are underperforming against their ‘physical’ competitors in terms of quality of care and sometimes engage in risky practices”.

There is a “relative power imbalance between the regulator [GPhC] and some large corporations. Not only are regulators outstripped financially by large businesses, there is also the question of how feasible it would be, in practice, for regulators to impose the most serious sanction of erasure on a large chain. Boots for example has over 2,200 UK stores, Lloyds Pharmacy over 1,500…These businesses play an integral role in the delivery of healthcare in the community. Were regulators to take the most extreme action of removing these businesses from the register it would leave a large number of people – in the short term at least – without a healthcare provider they can rely on. These businesses may, in effect, come close to being too big to fail”.

“The inherent tension between profit and patient best interest should be monitored”.

The most interesting of the PSA’s recommendations is that “the UK Governments should consider extending business regulation powers to all regulators whose registrants work in ‘high street’ practices”.

Details of the Community Pharmacy Contractual Framework for 2022/23 and 2023/24 have been confirmed by PSNC and appear here.  Although, as agreed at the outset of the five-year deal, the overall funding envelope remains unchanged, PSNC has secured some improvements for contractors, including the write-off of £100 million excess margin, an independent economic review prior to the next contract negotiation and amendments to some service specifications to allow the services to be delivered by Pharmacy Technicians.

The PSA also published its 2021/22 review of the General Pharmaceutical Council.  The full report can be reviewed here. Although the GPhC performed well in most areas of its work, it failed to meet 60% of the Standards of Good Regulation in relation to fitness to practise.  Standards not met by the GPhC include Standard 15: having a fair and proportionate process for examining and investigating cases, dealing with cases reasonably quickly and ensuring that appropriate evidence is available to support decision-makers to reach fair decisions, Standard 16: ensuring that all decisions are made in accordance with its processes, are proportionate, consistent and fair, take account of the statutory objectives, the regulator’s standards and the relevant case law and prioritise patient and service user safety and Standard 18: ensuring all parties to a complaint are supported to participate effectively in the process.

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