Will the Cabinet Secretary detail the number and nature of recorded adverse events linked to prescribed medicines as recorded with and without the Yellow Card scheme a) in care homes; and b) leading to hospital admission, and what assurances are available that all such events have been recorded?
Pharmacovigilance in the UK is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA operates the internationally leading yellow card scheme which in common with other pharmacovigilance schemes, relies on spontaneous reporting of adverse events by healthcare professionals and patients. The submission of a yellow card provides an important safety signal but does not imply a causal association between a medicine and a particular health outcome.
Healthcare professionals have a professional responsibility to report serious adverse drug reactions to the MHRA who use this and other information to determine what if any regulatory action is required to improve the safe use of medicines.
The Yellow Card Centre Wales is one of six regional centres operating on behalf of the MHRA to collect information on yellow cards submitted in their respective regions. In 2022/23, 4,024 yellow card reports were made in Wales an increase of 93% on 2022/23 with the number of reports by GPs, hospital doctors, pharmacists, nurses, other healthcare professionals, and patients and the public all increasing on the previous year.
Detail of adverse drug reactions reported using yellow cards, or other reporting systems to health boards and trusts, are not held by the Welsh Government. Further information on adverse drug reactions in Wales including yellow cards submitted by primary care practitioners, can be found in the YCC Wales annual report.