PCA(P)(2021)18 - Test Kit Distribution Service - Regarding Batch Recalls

Published: 25/11/21

Circular PCA(P)(2021)08 set out arrangements for a pharmacy distribution service for members of the public to access lateral flow test kits. Following the successful launch of the service, this circular informs community pharmacy contractors of changes made to the Standard Operating Procedure (SOP) regarding recall mitigations.

Detail

Following discussions with the Department for Health and Social Care and the wholesaler Alliance Healthcare, instructions have been added to the SOP for the LFD collection service in order to meet Medicines and Healthcare products Regulatory Agency (MHRA) batch traceability requirements for the distribution of LFD Self Tests.

In the event of a recall, Alliance will communicate with community pharmacies in up to four different ways and pharmacy teams are required to acknowledge these communications, check stock to identify if they have a recalled batch, isolate any recalled stock and act on all return/destruction instructions that follow.

To comply with these requirements, contractors must continue to adhere to the MHRA recording instructions as set out in the SOP, including retention of this data for six months from the date on which the stock was delivered:

• LOT Number (e.g. A1234567)

• Quantity of cartons (xx Cartons)

• Supplying wholesaler (variable)

• Date of receipt (DD/MM/YY)

Community contractors must ensure that members of the pharmacy team review the updated SOP for the Pharmacy Collect offer