Classification: Official
Publication reference: C1697

A policy for use by healthcare professionals and senior managers responsible for the transfer and safe handling of COVID-19 vaccines

29 September 2022, Version 1

(Replaces mutual aid and transfer of COVID-19 vaccines between NHS vaccination sites version 2)

1. Policy scope

For use by healthcare professionals and senior managers across the NHS who are responsible for the safe handling and transfer of COVID-19 vaccines.

This policy applies across all vaccine delivery models currently operational within the NHS England (NHSE) COVID-19 vaccination programme and applies to unpunctured vials of all COVID-19 vaccines in use at any point within the NHS COVID-19 vaccination programme.

2. Policy intent

To provide clear information on the safe transfer of COVID-19 vaccines, namely the transfer of vaccine from one organisation or provider of NHS COVID-19 vaccination services to another, sometimes across legal entities. This policy has been informed by operational experience and feedback from the system.

NHSE has systems and processes in place to ensure that the right amount of vaccine is delivered to the right place, at the right time. Designated administration sites should therefore always seek to use all the vaccines that have been allocated to them. However, it is recognised that it may be necessary to transfer vaccines to other sites in limited circumstances. Where these circumstances arise, this policy outlines how a transfer should occur within the permitted regulations.

Approval to transfer vaccine must be completed by an appropriate registered healthcare professional with responsibility for medicines management at both the requesting and donating sites (this may be the same individual if both sites sit within the same legal entity e.g. an NHS Trust with several hospitals). It is expected that this individual will have comprehensive knowledge of safe handling of medicines and be aware of the regulations governing medicines and the permitted movements. It is recommended that this individual is a pharmacist or pharmacy technician wherever possible.

Systems must ensure that their process for oversight and approval of transfers is authorised by an appropriate registered healthcare professional and delegated tasks are assigned to agreed, named individuals within system vaccine operations centres (SVOC) or regional vaccine operations centres (RVOC) as appropriate.

Policy Statements

• Transfers of COVID-19 vaccines within legal entities or between GP practices comprising a primary care network (PCN) collaboration are permitted under current medicines regulation, and are not ‘mutual aid’, rather these are ‘permitted movement’. Such permitted movement must be recorded to maintain accurate perpetual inventory oversight.
• There should be no routine transfers between separate legal entities (e.g. general practice to community pharmacy), such transfers are classed as ‘mutual aid’. Such mutual aid should only take place in exceptional circumstances; and
• Transfers of vaccine will be monitored within systems, regionally and nationally.

Rationale for policy

From a regulatory and product integrity perspective, it is critical that transfer of these COVID -19 vaccines (either as mutual aid or as a permitted movement) beyond the designated delivery sites is strictly limited in line with the product characteristics outlined in the marketing authorisations to maintain patient safety and product viability.

It is important that each region has fair and equitable access to the supply of COVID-19 vaccines. Perpetual inventory allows NHSE to oversee distribution of stock including COVID-19 vaccine transfer requests. This provides optimal access to vaccine supplies whilst minimising risk of waste.

3 Background

COVID-19 vaccines are owned by UK Health Security Agency (UKHSA) until the point of administration. The vaccines are never owned by NHS vaccination sites.

Vaccinating teams and organisations are responsible for the safe handling of vaccine in their possession in line with the manufacturer’s specifications and the regulations set out by the MHRA. The NHS Specialist Pharmacy Service has developed guidance and template Standard operating procedures (SOPs). Providers should also ensure they are working to the relevant requirements within their respective contracts in relation to management and administration of the vaccine, including reporting actual stock use and vaccine waste.

Deliveries of COVID-19 vaccine are made to NHS designated COVID-19 vaccination sites based on nationally and locally determined allocation principles, ensuring equity in access across England. Sites are expected to deliver their vaccination services using their allocated vaccine, however there may be instances when transfer of vaccine from one site to another is necessary to avoid waste or missed opportunities to vaccinate.

SVOCs and RVOCs can oversee and manage vaccine transfers via the Vaccine Transfer Application in Foundry. Individual sites can manage vaccine transfers via the Site Stock Manager on Foundry.

Dependant on the type of vaccine transfer, each instance of appropriate and authorised COVID-19 vaccine transfer must be recorded either by the system or region via the Vaccine Transfer Application, or by site via Site Stock Manager. This information may be made available to third parties such as the NHS Business Services Authority to inform post payment verification processes.

4 Policy governing vaccine transfer

Although transfer of COVID-19 vaccine should be undertaken proportionally (and in the case of mutual aid, by exception), the types of COVID-19 vaccine transfer that are covered by this policy are:

Permitted within current medicines regulations:

Vaccine transfer within a PCN collaboration agreement

Where different sites within a PCN collaboration are working together and operating as a single PCN collaboration for the purposes of the COVID-19 Vaccination programme enhanced service specification, transfer of COVID-19 vaccine from one practice to another practice for use within the terms of the collaboration agreement is permitted. Where the sites have different accounts on Foundry and request or donate stock of COVID-19 vaccine to other sites, it is necessary to record any transfer on the Site Stock Manager on Foundry. Updated stock levels will be apparent within Foundry and subsequent allocations will be adjusted to account for these.

Approval mechanism: Electronic approval on Site Stock Manager within Foundry. Signed off by registered healthcare professional responsible for vaccine handling at both the donating and receiving site within the PCN grouping. System vaccine operations centres (SVOC) approval is required where movement is between sites using different ODS codes, this should be completed by the responsible individual on the Vaccine Transfer Application.

Approval Criteria: The donor and recipient site are within the same PCN grouping or collaboration agreement and both sites must have an account on Foundry. Vaccine handling requirements must be adhered to; adequate storage and cold chain must be maintained. Vaccines must be transferred in their original carton or container.

Permitted within current medicines regulations:

Vaccine transfer within a legal entity

Transfer of vaccine within a legal entity is permitted movement. Where sites within the same legal entity have different Foundry accounts, it is necessary to record any transfer of vaccine between sites on the electronic application within Foundry to ensure that updated stock levels are apparent and subsequent allocations can be adjusted to account for transfers.

Approval mechanism: Electronic approval on Site Stock Manager within Foundry. Signed off by the registered healthcare professional responsible for vaccine handling within the legal entity, or their delegated officer (e.g. pharmacist operating under the direction of the hospital chief pharmacist). No SVOC approval is required for movement within NHS legal entities; where the legal entities are part of a pharmacy multiple, SVOC approval is required.

Approval criteria: The donor and recipient site are within the same legal entity and both have separate accounts on Foundry. All vaccine handling requirements must be adhered to; adequate storage and cold chain must be maintained. Vaccines must be transferred in their original carton or container.

Permitted by exception: Vaccine transfer from one legal entity to another by mutual aid

Transfer of COVID-19 vaccines is permitted from one organisation providing NHS COVID-19 vaccination services to another in scenarios where otherwise vaccine would be wasted or appointments would be cancelled due to unforeseen circumstances e.g. equipment failure. Mutual aid must never be a substitute for good planning and appropriate stock management.

Where sites are requested to provide stock of COVID-19 vaccine to other sites, updated stock levels will be immediately apparent within Foundry and subsequent allocations will be adjusted to account for transfers.

Approval mechanism: Electronic approval on Site Stock Manager within Foundry with sign off by a registered healthcare professional at the donor and receiving sites; and the responsible person at system vaccine operations Centres (SVOC) via the Vaccine Transfer Application. SVOC must agree that the request to mutual aid is for an exceptional reason.

Approval Criteria: Both the requesting and donating sites must have accounts on Foundry. All vaccine handling requirements must be adhered to; adequate storage and cold chain must be maintained. Vaccines must be transferred in their original carton or container.

5 Process governing transfer of COVID-19 vaccine

The electronic Vaccine Transfer Application must be completed for each COVID-19 vaccine transfer.

To maintain assurance and enable operational management of COVID-19 vaccine transfers, robust governance processes must be followed to agree any transfer. Responsibility for safe and secure handling of the COVID-19 vaccine, including during transportation must be agreed between the organisations involved in the transfer. Sites should use the vaccine transfer checklist to support the safe transfer of vaccines.

Vaccine transfers will be routinely monitored at system, regional and national level for appropriateness and for quality and safety purposes. Where multiple, frequent mutual aid transfers are occurring at certain sites or systems, determination of the root cause for the transfer requests will be undertaken.

Where transfers occur between different regions, the respective regional vaccine operational centres (RVOC) must be made aware of the proposed transfer prior to the transfer taking place.

The RVOC, through delegated roles, will maintain oversight of transfers to ensure that vaccine transfers do not replace routine mechanisms of supply and any transfers are completed according to safe handling requirements for the specific vaccine being transferred.