The Superintendent Pharmacist must be satisfied that overall governance, systems and processes for handling COVID-19 vaccines are:
- appropriate and robust
- include adherence to the nationally developed Standard Operating Procedures
The Superintendent Pharmacist should be available to the Responsible Pharmacist, where applicable, to offer support and advice in a timely way.
The Responsible Pharmacist’s role is to secure the safe and effective running of the vaccination site and all pharmaceutical services provided at it. The Responsible Pharmacist will:
- be accountable for ensuring that the individual registered premises or associated premises are fit to receive, store and use vaccine
- that they and all involved staff are working to the SOPs
- that staff involved are competent
Any pharmacist supervising management of vaccine stocks and administration of COVID-19 vaccination under the terms of a National Immunisation Protocol or administering vaccinations under the terms of a Patient Group Direction must be trained and fully competent to do so.
An appropriate governance framework should be in place between any pharmacist supervising administration or administering COVID-19 vaccine, the Responsible Pharmacist of the pharmacy from which the service is provided, and the Superintendent Pharmacist or Pharmacist Owner.
The framework must:
- detail the respective professional and legal accountabilities of the pharmacy professionals involved in governing and delivering the service
- detail the risks to patient safety and the steps and measures in place to mitigate those risks
The framework should include the names of accountable individuals, who will:
- put steps and measures in place to mitigate risk
- operate those measures
- provide assurance that they are operating as intended
- scrutinise and report such assurance
Commissioning, supply and safe delivery
NHS England commission the provision of a COVID-19 vaccination service directly from community pharmacy through a local enhanced service.
Vaccines will be centrally supplied, with the vaccine supply chain managed jointly by the Department for Business, Energy and Industrial Strategy (BEIS), UK Health Security Agency (UKHSA – formerly known as PHE) logistics, NHS England and Regions. Vaccines supplied to community pharmacy will usually be in the refrigerated state.
Other consumables and items required to allow for vaccinations to take place will be supplied in line with the NHSE Supply Inventory List.
NHS England has produced a Standard Operating Procedure that describes the operating model and design requirements for safe delivery of COVID-19 vaccines in the community.
Adapting advice for temporary vaccination sites
Superintendent Pharmacists may wish to adapt the daily COVID-19 vaccine management checklist produced for temporary vaccination sites.
Differences between the vaccines
A UK Health Security Agency (UKHSA) guide summarises the key differences.
Further advice on multiple vaccines
Maintaining the cold chain
Storage of vaccines at the correct temperature is critical to ensure their safety, quality, and efficacy. The correct selection, setup and monitoring of the pharmacy refrigerator will reduce the risk of temperature excursions. Monitoring of fridges with an independent data logger is an important requirement, and provides a detailed record of storage temperatures in the event of a temperature excursion or fridge failure.
In the event of a temperature excursion outside of the recommended storage conditions, a careful assessment must be made of the potential impact on the vaccine to ensure it remains effective and safe for use.
Further advice on maintaining the cold chain
Sites will need to ensure that vaccines are stored securely at all points between receipt and use or disposal.
All waste must be handled in such a way as to prevent theft and mis-use both on site and after removal from the site.
Waste vaccines and empty vials must be placed into the clinical or medicinal waste stream according to normal local clinical waste management procedures.
Outer cartons must be defaced using permanent black marker pens, and must be disposed of via the confidential waste stream.
Further advice is included in NHS England’s COVID-19 Waste Management Standard Operating Procedure.