FOI release

CORONIAL EVIDENCE, MEDICATION-RELATED DEATHS AND PHARMACOVIGILANCE

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/01032

Received 10 September 2026

Published 28 October 2026

Request

Under the Freedom of Information Act 2000, I request the following recorded information concerning how MHRA receives, records, assesses and uses evidence arising from coroners and inquests concerning deaths involving medicinal products. The period of this request is 1 January 2018 to the date of this request. This request is limited to existing centrally held policies, procedures, datasets, aggregate information, audits, reports and governance records. I am not requesting individual patient records, individual Yellow Card reports, a manual review of individual inquests or the creation of new statistics. Sources of coronial information Please provide copies of any policies, procedures, standard operating procedures, guidance or other recorded arrangements governing MHRA's receipt or acquisition of information from: a) Prevention of Future Death reports issued under Regulation 28; b) coroners or coroners' offices outside the Regulation 28 process; c) inquest conclusions or narrative conclusions; d) post-mortem or toxicology findings supplied following an inquest; e) the Chief Coroner or Office of the Chief Coroner; f) Ministry of Justice; g) Medical Examiner offices or NHS England; h) police or other public bodies following medication-related deaths. Deaths where no Regulation 28 report is issued Please provide any recorded policy, procedure or guidance addressing how MHRA can become aware of, or obtain information from, an inquest involving a medicinal product where the coroner does not issue a Regulation 28 Prevention of Future Death report to MHRA. Please include any recorded consideration of whether reliance on Regulation 28 reports alone would fail to identify medication-related deaths relevant to pharmacovigilance. 1. Systematic data feeds or information-sharing arrangements Please provide copies or descriptions of any existing: a) information-sharing agreements; b) memoranda of understanding; c) routine data feeds; d) notification arrangements; e) database links; f) periodic reports; between MHRA and any of the following concerning medication-related deaths: * coroners; * the Chief Coroner; * Ministry of Justice; * Office for National Statistics; * NHS England; * Medical Examiner offices; * toxicology services. Recording and Coding Please provide any existing data dictionary, coding guidance or list of database fields used by MHRA to identify that safety information originated from: a) a coroner; b) an inquest; c) a Regulation 28 report; d) a post-mortem; e) toxicology; f) a Medical Examiner; g) a death involving suspected overdose or poisoning. Please also indicate through disclosure of the relevant recorded material whether such information can be searched or retrieved according to medicinal product. Aggregate information Where already centrally held, please provide for each calendar year from 2018 onwards: a) the number of Regulation 28 reports received by MHRA concerning medicinal products; b) the number of other coronial or inquest notifications received which were not Regulation 28 reports; c) the number of safety reports or pharmacovigilance cases identified as having originated from coronial or inquest information; d) the number of cases where post-mortem or toxicology findings supplied by a coroner contributed to a pharmacovigilance assessment; e) the number of Yellow Card reports, if separately identifiable, generated from or linked to coronial information. I am requesting these figures only where they already exist. I am not requesting MHRA to perform a retrospective review of individual records to create them. Signal detection and regulatory assessment Please provide any policy, procedure, guidance or governance document describing how information arising from coroners, inquests, post-mortems or toxicology is incorporated into: a) signal detection; b) signal validation; c) signal assessment; d) periodic safety review; e) benefit-risk assessment; f) regulatory action concerning a medicinal product. Audits and gap analyses Please provide copies of any audits, reviews, reports, committee papers, risk assessments or gap analyses since 1 January 2018 considering: a) whether MHRA receives sufficient information from coroners concerning medication-related deaths; b) possible under-reporting of medication-related deaths identified at inquest; c) limitations arising where no Regulation 28 report is issued; d) barriers to linking coronial, toxicological or mortality information with pharmacovigilance data; e) proposals to improve such information flows. Suicide, poisoning and medication-related deaths Please provide any national policy, guidance or governance record specifically concerning the use of coronial or toxicological information in MHRA surveillance where death involves: a) suicide; b) intentional or suspected intentional overdose; c) accidental poisoning; d) prescribed-drug toxicity; e) a combination of prescribed medicinal products. For avoidance of doubt, I am seeking the systems by which MHRA learns from these deaths, not details of individual deceased persons. If any part would exceed the appropriate cost limit, please provide the information which can be supplied within the limit and provide section 16 advice and assistance concerning any part requiring refinement. Please provide the information electronically.

Response

See attached

Documents

• BRE 004-04 Responding to requests from Coroners and the Police (names reacted for FOI response) (redacted).pdf (6.5 MB)
• FOI2026_01032 (redacted).pdf (3.2 MB)

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

You can browse our other responses or make a new FOI request.