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Pharmacy Regulation Update – January 2022

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

In January 2022, this included the following:

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

The regulations changed on both 22 December 2021 and 1 January 2022.  Many of the changes arise from learning during the pandemic.  The key amendments can be summarised as:

  • Introduction of a new type of enhanced service, the National Enhanced Service (NES), for use when NHSE&I commissions an enhanced service with standard conditions that apply nationally.
  • Revised Terms of Service to allow NHSE&I to introduce a pandemic response programme which includes requirements on contractors to e.g. implement appropriate infection control measures.
  • Introduction of a Listed Prescription Item Voucher (LPIV) scheme, to permit supply of medicines without charge to patients.
  • Powers for NHSE&I to issue a Pandemic Treatment Protocol or Pandemic Treatment Patient Group Direction, permitting contractors to supply POMs without prescription.
  • A new market entry power for NHSE&I to refuse certain new routine applications if granting the application would result  in  an  “undesirable  increase  in  the availability of essential services” in the area.  The affected applications are those (a) to meet a need, or secure improvements or better access, identified in the PNA (whether current or future gaps in provision) and (b) to amend the days or times when essential services are provided in the area.
Integrated Care Systems

All 42 Integrated Care Systems are still expected to become operational by April 2022 but, within its 2022/23 priorities and operational planning guidance published on 14 January, NHSE&I confirmed that ICSs will now not proceed to a statutory footing until 1 July 2022 (a three-month delay).

Pharmaceutical Needs Assessments

Further on the subject of delays, the deadline for publication of revised Pharmaceutical Needs Assessments has been pushed back to October 2022 (from an original date of April 2022).


A new Chief Pharmaceutical Officer for England, David Webb, will replace Keith Ridge during February 2022.  Mr Webb comes from a secondary rather than primary care background and is currently Chief Pharmacist and Clinical Director for Pharmacy and Medicines Optimisation at Guy’s and St Thomas’ NHS Foundation Trust.


Free personal protective equipment (PPE) for community pharmacy teams has been extended to 31 March 2023 and can continue to be accessed via the government’s PPE portal.

Independent prescribers

I’ve previously written about the imminent changes for Pharmacist Independent Prescribers.  Health Education England has now announced funding for no-cost independent prescriber training to commence between 16 February and early March 2022.  For those not ready to apply immediately, further funded places will be available in Autumn 2022.


The Chairs for both of the forthcoming COVID-19 Public Inquiries were announced during December. Those are Baroness Heather Hallett for the UK-wide Inquiry and Lady Poole for the Scotland-only Inquiry.  My team is already assisting a number of healthcare sector clients in relation to both Inquiries. The Scotland-only Inquiry is at a more advanced stage and draft terms of reference were issued on 14 December.

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