The Chief Pharmaceutical Officer’s letter (8 December 2020) sets out the principles and expectations necessary to maintain integrity, and therefore safety, quality and effectiveness, of the COVID-19 vaccines by GP led Local Vaccination Centres (PCN Designated Sites).
These principles are essential to ensure the delivery of a successful national vaccination programme. Maintaining the safety of individuals for these novel vaccines, with handling characteristics different to other established vaccines, while minimising wastage is paramount.
The deployment of the AstraZeneca COVID-19 vaccine is covered in a further Chief Pharmaceutical Officer’s letter (31 December 2020).
The purpose of this page is to outline the key areas where pharmaceutical expertise should be focussed in these sites.
The expectation is that the Primary Care Lead Pharmacist for a locality in primary care, as agreed by the Regional Chief Pharmacist and often being the CCG lead pharmacist, will be responsible for securing the necessary pharmaceutical support.
This page is to aid conversations between the Lead GP at the PCN Designated Site and the Primary Care Lead Pharmacist responsible for pharmaceutical support.
It provides the guiding principles to deliver safe vaccination processes with particular emphasis on the correct storage and handling of these COVID-19 vaccines (especially those developed using mRNA technology with specific handling requirements – temperature, dilution or limited movements).
It is presented as a series of principles so that PCN Designated Sites can be assured that individuals receive a safe and effective vaccine that has been handled according to the manufacturer’s recommendations. It is complemented by suites of Standard Operating Procedures for Primary Care (Pfizer-BioNTech) and Standard Operating Procedures for Primary Care (AstraZeneca), plus other resources which relate to the various tasks covered (see Underpinning policies below). They are designed to assure patient safety and maximum possible consistency of practice between PCN Designated Sites. They will ensure that tasks are undertaken, risks identified and managed, nationally mandated outcomes achieved, and that professional responsibilities and accountabilities are recognised and fulfilled. They may be used as templates or may be used to check that existing local procedures are robust and comprehensive.
This guidance is intended to be used by the Lead GP at PCN Designated sites with the support of the Primary Care Lead Pharmacist.
The following principles outline the overarching areas where pharmaceutical expertise is required
- Product Integrity
- Medicines Governance
- Risk Management
The activities to be undertaken, the rationale behind them together with examples of assurance are detailed below. Assurance is built from three elements – training & competency, procedures, and audit of performance against these.