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Pharmacy Regulation Update – February and March 2022

Every month I send our clients a note of the most interesting or important regulatory developments in community pharmacy over the preceding month.

During February and March 2022, we found ourselves talking about the following:

The Pharmaceutical Services Negotiating Committee, or PSNC, has appointed a new Chief Executive, Janet Morrison OBE, who took up her post on 1 March 2022.

The General Pharmaceutical Council, or GPhC, has appointed a new Chair, Gisela Abbam, who took up her post on 14 March 2022.

The Professional Standards Authority for Health and Social Care (PSA) has published its annual review of the GPhC and found that the GPhC is meeting 15 out of the 18 Standards of Good Regulation. Although the GPhC was found to meet all standards in the categories of General Standards, Guidance and Standards, Education and Training and Registration, it failed to meet a majority of the Standards of Good Regulation in Fitness To Practise. The specific standards which the GPhC did not meet are:

  • Standard 15: The regulator’s process for examining and investigating cases is fair, proportionate, deals with cases as quickly as is consistent with a fair resolution of the case and ensures that appropriate evidence is available to support decision-makers to reach a fair decision that protects the public at each stage of the process.
  • Standard 16: The regulator ensures 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.
  • Standard 18: All parties to a complaint are supported to participate effectively in the process.

In response to the PSA report, the GPhC has stated that “it is a key priority for us to make improvements in our fitness to practise processes”.

Further on the subject of fitness to practise, Andrea James of Brabners was recently interviewed on the Baines Law podcast, questioned about her views on subjects including the length of time it takes for fitness to practise cases to progress, inequality of arms between regulators and regulated professionals, virtual hearings and regulators who take advantage of registrants’ lack of legal knowledge. The podcast can be heard here (Spotify) or here (Player.FM – where a transcript is also available).

The Department of Health has decided both not to proceed with mandatory COVID-19 vaccination for all NHS staff, and also to repeal the existing legislation requiring COVID vaccination in all CQC-regulated care homes in England. Sajid Javid instructed all of the health and care regulators in England to issue an urgent statement about professional responsibilities regarding vaccination immediately after he announced this news. Whilst the regulators have all issued statements strongly encouraging vaccination, all those who have been specifically questioned about vaccination refusal and fitness to practise have made clear that they do not consider that refusing vaccination would, in itself, amount to a fitness to practise concern. Andrea James of Brabners was featured in Health Service Journal discussing this point on 17 February and the article can be read here.

The GPhC has updated its guidance on providing pharmacy services at a distance. The new guidance can be viewed here. It does not include any entirely new requirements but does include further guidance and examples around types of collection and delivery services, identity-checking of people using remote pharmacy services and, in particular, best practice in prescribing. A development of note is that the attention of Pharmacist Independent Prescribers is now specifically drawn to the General Medical Council’s guidance on good practice in prescribing and managing medicines and devices.

Both pharmacists and pharmacy technicians will need to resume meeting full GPhC revalidation requirements with effect from 1 October 2022. These were temporarily relaxed at the outset of the COVID-19 pandemic in 2020.

Fewer than 200 pharmacies in England provide services that require them to maintain Care Quality Commission registration. However, CQC has issued a press release regarding its recent inspection of the Lloyds Pharmacy Clinical Homecare service, which it rated ‘Inadequate’. As a result, the pharmacy has been served with a Warning Notice. This requires the pharmacy to make immediate improvements and a re-inspection will take place within six months. CQC has also shared its findings with the GPhC. The inspection report setting out the issues can be viewed here.

By 31 March 2023, all NHS and social care organisations, including community pharmacies, will need to be complaint with NHS Digital’s new Information Standard ‘DAPB4013’. The aim of the Information Standard is to help reduce medication errors and improve patient safety by standardising medication message content, enabling transfer of prescription information across health and care settings in England. The full standard is available here.

Although free COVID-19 lateral flow testing ended for most of the public on 1 April 2022, the tests remain available for all patient-facing NHS staff, including community pharmacy staff, who should continue to test twice weekly when asymptomatic according to the latest update from NHSE&I. Tests can be ordered through the portal.

Around £13 million worth of COVID-19 costs claimed by pharmacy contractors were not initially reimbursed by the BHS Business Services Authority, or NHSBSA, and a number of contractors have since been involved in a circuitous and frustrating process called PPV, or pre/post payment verification. We are now acting for a number of contractors who have commenced the formal appeal process. This is a two-stage process, which involves an independent internal review within NHSBSA, followed by an appeal to NHS Resolution (formerly known as the FHSAU).

If you would like to find out more about any of the issues featured in this update, please contact me.

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