Migraines: Drugs
The question
To ask the Secretary of State for Health and Social Care, what mechanism exists for psychiatric adverse drug reaction signals, including Yellow Card reports and Prevention of Future Deaths reports, to be considered in national migraine prescribing guidance, pathway design and medicines safety assurance.
Answered by Mrs Sharon Hodgson
The safety of medicines is closely monitored through the Medicines and Healthcare products Regulatory Agency’s (MHRA) pharmacovigilance system. Reports submitted through the Yellow Card Scheme are used by the MHRA to identify and investigate potential adverse drug reaction signals, including psychiatric adverse effects. Where a safety concern is identified, the MHRA can take regulatory action and communicate new safety information to healthcare professionals and patients.
National clinical guidance and care pathways are informed by the best available evidence, including emerging medicines safety information. The National Institute for Health and Care Excellence keeps its guidance under review and considers new evidence and safety information when determining whether recommendations should be updated. Medicines safety concerns may also be considered through National Health Service medicines governance and patient safety processes.
Coroners’ Prevention of Future Deaths (PFD) reports provide an important source of patient safety learning. NHS England has established processes to review, analyse, and identify themes arising from PFD reports and to escalate issues where further action is required. Learning from PFD reports can, therefore, inform wider patient safety improvement work, including service design and clinical practice where relevant.
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