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), Standard Operating Procedures for Primary Care (AstraZeneca) and Standard Operating Procedures for Primary Care (Moderna), 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.
|Principle||Activity||Rationale||Examples of Assurance|
|Product Integrity||Product must always be handled and stored within manufacturer’s recommendations.||The product must be fit for purpose.||Temperature monitoring system
Temperature data loggers
Fridge monitoring records
Validated cool bags (for within the designated PCN site and for roving vaccinators)
Relevant SOPs in place
Cold Chain Policy/Procedure which includes escalation process
|Security of storage locations is essential to ensure the safety of the public and sustainability of the programme.||Vaccines must be securely stored and not remain overnight in non-CQC registered premises.||Relevant CQC registration for additional location(s) where medicines are stored overnight.
Relevant SOPs including transport to non-permanent sites.
|Medicines Governance||Relevant SOPs must be in place and cover every step of the process. Clear lines of responsibility are defined within them.||To ensure consistency and delivery of care.
Those delivering care understand when escalation is required.
|Up to date SOPs in place.
Trained and competent staff adhere to the SOPs and escalate where necessary.
|Records of vaccine stock management are contemporaneously maintained.||Accurate stock control is essential in delivering the programme. Supply of products is restricted, and products have limited shelf life.||Relevant SOPs in place
Stock control records (paper/electronic/blended)
|All staff must be trained, competent and understand their responsibilities.||To ensure the safety of individuals and staff.||Nationally delivered training completed.
Relevant SOPs in place, which are read, understood and signed.
|Risk Management||Deviations from recommended practice are identified, escalated and managed appropriately.||The appropriate decisions are taken by those responsible so that product integrity is maintained, safety assured and programme reputation preserved.
|Red flag events are understood known and reported in a timely manner.
Examples of red flags:
· Wastage above 5%
· Stock discrepancies
· Temperature excursions outside 2oC – 8oC
· Individuals requiring treatment for adverse events (for replenishment of anaphylaxis kits)
· Needle stick injuries
|Incidents (both errors and ADRs) are reported according to the local/national incident reporting system.||Learning from incidents can be shared and used to improve practice.||Incident record is complete.
National reporting undertaken where necessary
A number of underpinning policies should be in place in PCN designated hubs. These include:
- Cold chain policy including daily temperature monitoring of fridge(s). An example for Primary Care is available on the SPS website.
- Anaphylaxis protocol – see Resuscitation Council (UK) anaphylaxis guidance for vaccination settings
- Summary updated. Link to Moderna SOPs added.