Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that healthcare professionals are provided with timely guidance on prescribing alternatives when products they routinely prescribe are subject to safety recalls.

The Defective Medicines Report Centre (DMRC) is part of the Medicines and Healthcare products Regulatory Agency (MHRA). The role of the DMRC is to minimise the hazard to patients arising from the distribution of defective medicines by providing an emergency assessment and communication system between manufacturers, distributors, wholesalers, pharmacies, regulatory authorities, and users. It achieves this aim by:

• receiving and assessing reports of suspected defective medicinal products for human use;
• advising and monitoring necessary actions by the responsible Licence Holder; and
• communicating the details of this action to relevant parties as necessary.

Where a medicinal product recall is required, the decision is taken in consultation with the relevant Licence Holder. It is the Licence Holder’s responsibility to ensure that a recall is carried out effectively throughout the distribution chain to the appropriate level. If necessary, the DMRC will issue a Recall Notification to support action taken by the Licence Holder. Where possible, the DMRC will actively engage with the Department to inform us of upcoming recalls, especially where there may be limited marketed products available or critical medicines involved. The Department’s Medicines Supply Team have a range of well-established processes and tools to mitigate risks to patients, and in some circumstances, this can include the prescribing of an alternative medicine.

The Department follows a clear operating framework for managing medicines shortages and, working with National Health Service specialist clinicians, develops appropriate management plans, including comprehensive guidance for prescribers, which are ratified by the Medicines Shortage Response Group to ensure that the most appropriate communication route is used. We work collaboratively with the MHRA throughout the recall process to ensure that when prescribing an alternative medicine should be considered, that this can be communicated in the Recall Notification, or as close to the issue of the Recall Notification that could result in a supply issue.