Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 2 November (HL2355), what are the internationally understood definitions of (1) "suspected adverse event", and (2)"‘serious adverse event", following the administration of a drug.

My previous answer of 2 November referred specifically to reports from clinical trials. In the context of clinical trials, an adverse event (AE) is defined as: ‘Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.’ A serious adverse event (SAE) is defined as: ‘Any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect’.

The term ‘suspected’ is not used in the context of AEs and SAEs.

The definition of an adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended. Through the Yellow Card Scheme, the Medicines and Healthcare products Regulatory Agency encourages anyone to report a suspected ADR. For suspected ADRs, there is not necessarily a causal relationship with the medicine, but a suspicion by the reporter that the medicine may have been responsible. Suspected ADRs are continuously reviewed to detect possible new risks.