Preventing Future Deaths from Medicines: Responses to Coroners’ Concerns in England and Wales
Coroners inquire into sudden, unexpected, or unnatural deaths. We have previously established 99 cases (100 deaths) in England and Wales in which medicines or part of the medication process or both were mentioned in coroners’ ‘Regulation 28 Reports to Prevent Future Deaths’ (coroners’ reports).
We wished to see what responses were made by National Health Service (NHS) organizations and others to these 99 coroners’ reports.
Where possible, we identified the party or parties to whom these reports were addressed (names were occasionally redacted). We then sought responses, either from the UK judiciary website or by making requests to the addressee directly or, for NHS and government entities, under the Freedom of Information Act 2000. Responses were analysed by theme to indicate the steps taken to prevent future deaths.
We were able to analyse one or more responses to 69/99 cases from 106 organizations. We analysed 201 separate actions proposed or taken to address the 160 concerns expressed by coroners. Staff education or training was the most common form of action taken (44/201). Some organisations made changes in process (24/201) or policy (17/201), and some felt existing policies were sufficient to address some concerns (22/201).
Coroners’ concerns are often of national importance but are not currently shared nationally. Only a minority of responses to coroners’ reports concerning medicines are in the public domain. Processes for auditing responses and assessing their effectiveness are opaque. Few of the responses appear to provide robust and generally applicable ways to prevent future deaths.
Compliance with Ethical Standards
The West Midlands Centre for Adverse Drug Reactions receives funding from the Medicines and Healthcare products Regulatory Agency (MHRA).
Conflict of interest
Robin Ferner has provided medicolegal reports for coroners and others. Tohfa Ahmad, Zainab Babatunde and Anthony R. Cox have no conflicts of interest directly relevant to the content of this study.
This study was an analysis of publicly available data. No approval was sought.
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