Responsibilities

Chief or Lead Pharmacists

The Chief or Lead 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 Chief or Lead Pharmacist should be available to the Responsible Pharmacist, where applicable, to offer support and advice in a timely way.

Lead Clinician

In circumstances where a vaccination service is provided by a contracted non-NHS organisation which does not employ a pharmacist:

• the Lead Clinician must notify NHSEI of the name of a pharmacist who will fulfil the role of Chief/ Superintendent Pharmacist for vaccination sites on which that organisation operates.

Responsible Pharmacists

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

Supervising Pharmacists

In particular, the framework must detail the risks to patient safety and the steps and measures in place to mitigate those risks. It must also include the names of the individuals who are accountable for putting those steps and measures in place, for operating them, and for providing assurance that they are operating as intended.

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, with an appropriate governance framework in place.

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

Supply

The vaccine supply chain is managed jointly by the Department for Business, Energy & Industrial Strategy (BEIS), PHE logistics, NHSE and Regions.

NHS England has also published additional information about the vaccination programme.

Ordering supplies

Vaccines will be centrally supplied.

Information and guidance specific to COVID-19 Vaccine Pfizer-BioNTech provides further details of relevant SOPs.

Onward supply and on-site storage

Onward supply

For onward supply to vaccination sites and school vaccination teams:

• Bespoke quantities should be packed into coolboxes in response to pre-agreed orders/requisitions immediately before onward supply.
• There should be no packing down in the absence of an order or request from a named site or team for a specified quantity.
• Only if these requirements are met is it legally acceptable for quantities less than original packs of 195 vials to be supplied.

On-site storage

For on-site storage immediately before use, arrangements should be in place to ensure safe & secure short-term storage of vaccines at 2-8C in a dedicated fridge or coolbox until administration, which is expected to be on the day of supply.

Safe management of multiple vaccines

During September & October 2021 it is likely that both branded Comirnaty and unbranded Pfizer vaccine will be in the supply chain. We have produced guidance on handling 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 pharmacy refrigerators and coolboxes will reduce the risk of temperature excursions. Monitoring 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.

We have produced further advice on management of the cold chain.

Waste disposal

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.