Dear Contractor
Canice Ward, Head of the Medicines Regulatory Group (MRG), has written to contractors detailing the method of inspection which will be deployed from mid-February 2021 (view here).
You will be aware that pharmacy inspections carried out by MRG were suspended in 2020 to allow contractors and their teams to concentrate on continuity of service in the light of additional pressures due to the COVID pandemic, and to reduce the possibility of cross-contamination. This was welcomed by CPNI Board members and contractors.
The Department’s position is that it is important that a degree of external governance is now reintroduced to protect the public and contractors, but is also agreed that a resumption of full inspections is not appropriate at this time.
Canice Ward, Head of MRG, has been working closely with CPNI to develop a self-assessment document which ensures governance activity – but with the least possible imposition on a pressurised sector in a COVID environment.
This document has been evaluated and the process trialled by representatives from the CPNI Board. It was agreed that the assessment criteria covers the statutory and professional parameters within which community pharmacy operates and that the proforma has been stripped back to the bare essentials. It appears to be a pragmatic and acceptable process for reintroducing external governance to the sector.
When the self-assessment has been completed, returned and assessed, the inspectorate will follow up, where appropriate, with a much shortened inspection visit arranged with the contractor and which is designed to check selected key areas. Inspectors will abide by COVID-related restrictions and will wear PPE during the visit.
Not all premises will be covered in the first tranche, but the process will be rolled out in line with the existing inspection schedule.
ACTION
Contractors are asked to:
- Note the content of the letter;
- Prioritise the completion of the self-assessment form if contacted by MRG, and return it as directed within the specified time frame; and
- Work with the MRG Inspectorate to facilitate a short follow-up visit as required.
Any issues should be flagged up with Canice Ward and his team in the first instance, or with me at CPNI.
Kind regards – Mike
SENT ON BEHALF OF Prof Mike Mawhinney
Head of Regulatory Affairs