Preventable deaths involving medicines in England and Wales, 2013-22: a systematic case series of coroners’ reports

Objectives To identify medicines-related deaths in coroners’ reports and to explore concerns to prevent future deaths. Design Retrospective case series of coroners’ Prevention of Future Deaths reports (PFDs). Setting England and Wales. Participants Individuals identified in 3897 PFDs dated between 1 July 2013 and 23 February 2022, collected from the UK’s Courts and Tribunals Judiciary website using web scraping, and populated into an openly available database: Main outcome measures Proportion of PFDs in which coroners reported that a therapeutic medicine or drug of abuse caused or contributed to a death; characteristics of the included PFDs; coroners’ concerns; recipients of PFDs and the timeliness of their responses. Results 704 PFDs (18%; 716 deaths) involved medicines, representing an estimated 19,740 years of life lost (average of 50 years lost per death). Opioids (22%), antidepressants (9.7%), and hypnotics (9.2%) were the most common drugs involved. Coroners expressed 1249 concerns, primarily related to patient safety (29%) and communication (26%), including failures of monitoring (10%) and poor communication between organisations (7.5%). NHS England (6%), the Department of Health and Social Care (5%) and the Medicines and Healthcare products Regulatory Agency (2%) received the most medicines-related PFDs. However, most expected responses to PFDs (51%; 615/1245) were not reported on the UK’s Courts and Tribunals Judiciary website. Conclusions One in five deaths deemed preventable by coroners involved medicines. Taking actions to address coroners’ concerns, including improving patient safety and poor communication, should increase the safety of medicines. Many concerns were raised repeatedly, but half of PFD recipients failed to respond, suggesting that lessons are not generally learned. The rich information in PFDs should be used to foster a learning environment in clinical practice that may help reduce preventable deaths. Trial registration What is already known on this topic? Medicines are essential to the provision of healthcare, but if used inappropriately, have the potential to cause significant harms, including death. When an unnatural death occurs, these deaths are often reported to the coroner, which can result in a report to highlight concerns to prevent future deaths. Samples of coroners’ reports have been analysed to identify concerns relating to preventable deaths involving medicines, which found that anticoagulants contributed the most. However, an investigation of all available reports has not been conducted to determine the overall impact of medicines. What this study adds? One in five preventable deaths in England and Wales involved a medicine or drug of misuse, costing nearly 20,000 years of life lost. Opioids, antidepressants, and hypnotics were the most common medicines involved in preventable deaths. Coroners repeatedly raised similar concerns, primarily relating to patient safety and communication. However, it is unclear whether these reports are being used in clinical practice to guide actions to prevent similar deaths. ### Competing Interest Statement All authors have completed the ICMJE uniform disclosure form at and declare no support from any organisation for the submitted work. HSF has received scholarships (2020-22) from Brasenose College, University of Oxford and Fidelity National Information Services for undergraduate study, from the British Pharmacological Society (2022) for meritorious performance in a research competition and received payments (2022) from Brasenose College, University of Oxford for undergraduate teaching. JKA has published papers in bioscience journals and edited textbooks on adverse drug reactions; he has often acted as an expert witness in civil actions relating to suspected adverse drug reactions and in coroners courts. CH holds grant funding from the NIHR, the NIHR School of Primary Care Research. CH has received expenses and fees for his media work, for teaching EBM and is also paid for his GP work in NHS out of hours (contract Oxford Health NHS Foundation Trust). CH is the Director of the Centre for Evidence-based Medicine (CEBM). REF has undertaken research and published on adverse drug reactions and medication errors. REF has acted as an expert witness in coronial and other legal cases related to these. ARC holds grant funding from Cancer Alliance. ARC has received fees for media work, a scientific advisory committee at IQVIA, and external examining at UK Universities. ARC is the Head of the School of Pharmacy at the University of Birmingham and is an honorary pharmacovigilance pharmacist at the West Midlands Centre for Adverse Drug Reaction Reporting. GCR is the Director of a limited company that is independently contracted to work as an Epidemiologist and teach at the University of Oxford. GCR received scholarships (2017-2020) from the NHS National Institute of Health Research (NIHR) School for Primary Care Research (SPCR), the Naji Foundation, and the Rotary Foundation to study for a DPhil at the University of Oxford. The study guarantor (HSF) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and registered have been explained. ### Clinical Protocols ### Funding Statement No funding was obtained for this study. An Engagement and Dissemination grant (2020) and Seedcorn funding (2021) was obtained from the National Institute of Health Research (NIHR) School for Primary Care Research (SPCR) to develop the Preventable Deaths Tracker website: ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study used (or will use) ONLY openly available human data that were originally located at: I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All study materials, data, and statistical code is openly available via online repositories. The study protocol was preregistered on the Open Science Framework (OSF; ); the code to generate the database and the Preventable Deaths Tracker is openly available via GitHub (); individual Prevention of Future Deaths reports are available on the Courts and Tribunals Judiciary website (); all other study materials are openly available via the OSF project page (). All study materials, data, and statistical code is openly available via online repositories. The study protocol was preregistered on the Open Science Framework (OSF; ); the code to generate the database and the Preventable Deaths Tracker is openly available via GitHub (); individual Prevention of Future Deaths reports are available on the Courts and Tribunals Judiciary website (); all other study materials are openly available via the OSF project page ().