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FormalPara Key Points

Coroners write Reports to Prevent Future Deaths.

Reports to Prevent Future Deaths can identify important concerns related to medicines.

However, those related to deaths from medicines are rarely the subject of articles in the medical or lay press.

1 Introduction

Adverse drug reactions, medication errors and non-therapeutic uses of drugs lead to potentially avoidable harms that sometimes have fatal outcomes. Responsibility for determining the causes of unnatural deaths in England and Wales rests with Coroners, independent judicial officers who must identify who died and determine how the person came to die, when, and where [1]

The Coroner's Office in England probably dates back to the end of the twelfth century [2]. Current legislation in England and Wales is contained in the Coroners and Justice Act 2009 and subsequent amendments [3]. The Coroners and Justice Act 2009 (Commencement No. 15, Consequential and Transitory Provisions) Order 2013 brought into force on 25 July, 2013 a provision contained in Schedule 5 paragraph 7 of the 2009 Act regarding ‘action to prevent other deaths’ [4]. When facts that come to light during an inquest ‘give rise to a concern that circumstances creating a risk of other deaths will occur or will continue to exist, in the future, and … in the Coroner’s opinion, action should be taken to prevent the occurrence or continuation of such circumstances, or to eliminate or reduce the risk of death created by such circumstances, the Coroner must report the matter to a person who the Coroner believes may have the power to take such action.’ Reports to Prevent Future Deaths (PFDs) are published on the website of the Ministry of Justice [5].

We have previously examined PFDs to find those relevant to harm from medicines. For example, a manual survey of 500 PFDs found 99 related to medication [6], and an automated search using a web-scraper compiled a list of over 4000 PFDs, more than 250 of which are related to alcohol, drugs, or some aspect of medication, for example, drug delivery or administration [7, 8].

Based on findings at a formal judicial inquiry, Coroners’ concerns are set out in PFDs that require responses from those to whom they are addressed. These are usually organisations that are directly involved in the event, but they can include organisations (such as regulatory bodies) with national responsibilities. They should also help to inform national and international strategies for reducing harms from medicines, but are only likely to do so if they are noticed in medical journals or by the wider public. We have previously suggested that addressees, including Government organisations, may not respond adequately to PFDs [9]. We hypothesised that the concerns of Coroners relating to medicines expressed in PFDs are not widely disseminated, either to the public or in medical journals. We aimed to establish whether such concerns are widely recognised.

2 Methods

We searched MEDLINE, Embase and Web of Science from inception to November 2022, using a combination of search terms “coroner*”, “inquest*”, “medicine*”, “medication*”, and “prevent*”, and selected papers in the medical literature referring to Coroners’ PFDs. We retrieved full-text versions of each relevant paper and also established how often it had been cited using Google Scholar. We analysed the full-text papers to determine the subject of the paper.

We also searched the BMJ, which is a UK general medical journal that carries news reports, and the databases Nexis Advance and News On the Web for reports mentioning PFDs in British newspapers, The Guardian, Times, Daily Telegraph and Independent, and the Daily Mail, Daily Record, Daily Star, Mirror and Sun, 2013–22, using the search terms (“regulation 28” OR “prevent future deaths” OR “prevention of future deaths”) AND “coroner”. In Nexis Advance, we then chose the option ‘Duplicates of high similarity grouped’ to amalgamate articles with (near-) identical titles from, for example, different editions of the same newspaper. From these, we selected articles mentioning PFDs related to medication, according to a previously published algorithm [6]. When articles relating to medicines referred to inquests on specified individuals, we established that a PFD on the individual could be found on the Judiciary website [5].

The number of publications was recorded, as well as their citations in Google Scholar at 23 May, 2023.

3 Results

3.1 Medical Journals

Our searches in Embase, MEDLINE and World of Science identified 92 non-duplicate entries for published papers, of which 16 appeared to be relevant by title and abstract (see Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] diagram, Fig. 1). The 16 full papers were retrieved; of these, ten referred to PFDs issued after inquests in which medication was determined to have caused or contributed to the death. One additional paper was identified from reference lists. One or more authors from our research group contributed to nine of the 11 full papers identified, and one was an editorial comment on a paper from the group. Two further papers from our group are in press [10, 26]. The subjects of the papers are shown in Table 1.

Fig. 1
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Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart. PFD Coroner’s Regulation 28 Letter for the Prevention of Future Deaths

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Table 1 Full papers indexed in Embase, MEDLINE or Web of Science concerning Coroners in PFDs (Regulation 28 letters) related to medicines
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3.2 Newspapers

We identified 341 articles in national British daily newspapers, of which 84 were automatically removed because they were of ‘high similarity’ (see the PRISMA diagram, Fig. 1). Removing further duplicates reduced the number of relevant articles to 139, of which 11 referred to one or more unique PFDs related to medicines (Table 2).

Table 2 Articles from UK newspapers that mentioned specific inquests referred to PFDs, 2013–22; duplicates of three relevant articles in the Daily Telegraph are not included; one PFD relating to a drug-associated death reported in the Mirror could not be identified in the judiciary website)
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In addition to the articles referring to specific PFDs, The Guardian published three analyses of PFDs and The Times published one, with titles including ‘High number of prison deaths are preventable, says a damning new report’ [11] and ‘Ten women murdered after violent partners allowed gun’ [12]. In 2018, The Guardian published an account of the methods used to investigate deaths of mental health patients after National Health Service (NHS) care failures [13]. The Guardian researchers relied on PFDs stored as publicly available .pdf documents on the Chief Coroner’s website between 1 January, 2012 and 8 February, 2018, converting almost 2000 documents to machine searchable text using optical character recognition software and searching for relevant terms. Failings were assigned to one of 15 categories. The BMJ published 23 articles by the legal correspondent Clare Dyer that referred to PFDs, not all of which were indexed; five referred specifically to medicines (Table 3).

Table 3 Articles in the BMJ that mentioned PFDs related to medicines, including unindexed articles
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4 Discussion

This study shows that medical journals have published very little based on PFDs related to medicines, and that the UK’s national newspapers largely ignore Coroners’ concerns. In 2019 (the last year before the coronavirus disease 2019 pandemic), 530,841 deaths were registered in England and Wales [14]; 210,900 deaths were referred to Coroners, who ordered 82,100 post-mortem examinations and opened 30,000 inquests [15]. Coroners wrote approximately 520 PFDs that year, some of which were written to multiple addressees. However, many Coroners did not write a single PFD. Responses are published on the Judiciary.gov.uk website at the discretion of the Chief Coroner. We have noted previously that the website publishes only a minority of responses; even after Freedom of Information requests to the addressees of PFDs, only two-thirds of responses were available [9].

Our study is limited by the use of only one source to establish the number of citations of published papers. However, the source we used, Google Scholar, includes citations to electronic media, reference books and other citing works, and thus is expected to overestimate the number of citations relative to other sources. A further limitation is that more thorough searches may have uncovered further relevant publications, but failure to find articles about PFDs with simple searches suggests that they are less likely to be found or cited by those who may be able to prevent deaths more widely. We cannot eliminate the possibility that PFDs are accessed directly and used in local policy and training initiatives—and future work could include examining the extent to which Medication Safety Officers and Chief Medical Officers of NHS trusts use available PFDs. The paucity of studies based on PFDs contrasts with the substantial number of studies that have used the Australian and New Zealand National Coronial Information System [16], which has contributed to 206 publications cited in PubMed, of which 139 relate to medicines. That database contains information on every death reported by a Coroner in Australia from 2001 and New Zealand from 2007, with the express intention of helping Coroners fulfil their mandate to improve public health and safety. It contains details of the deceased and the circumstances of death, together with complete text reports relevant to the investigation. The data have informed decisions made by the Therapeutic Goods Administration in Australia and Medsafe in New Zealand on several matters related to harms from medicines. However, the National Coronial Information System is a secure database and is not publicly available.

The public interest would be served by using data from Coroners’ inquests to improve public safety. While inquests in England and Wales are judicial hearings, held (with rare exceptions) in public, their findings are not easily accessible. The only official and readily available record may be the PFD, if one is issued to express a Coroner’s concerns. If Coroners’ concerns are to be considered, and the adequacy of responses to them properly assessed, PFDs and responses must be widely disseminated (Fig. 2).

Fig. 2
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Routes to and from Regulation 28 Letters for the Prevention of Future Deaths (PFDs); numerical data are from 2019

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We have found little evidence that the concerns expressed by Coroners in PFDs are widely appreciated or used to improve medication safety. There are several possible reasons: many Coroners issue PFDs infrequently or not at all. There is no effective follow-up of requests, and addressees may not reply, despite a legal obligation to do so, or may provide inadequate responses. Furthermore, the current system of publishing PFDs does not classify findings by standard International Classification of Diseases, Tenth Revision codes, does not allow them to be easily machine searched and does not provide access to the coronial determination that led to the PFD.

The value of PFDs would be significantly increased by (i) classifying deaths according to the International Classification of Diseases codes, (ii) storing PFDs in a machine-readable form, (iii) giving access to detailed information on coronial findings that lead to PFDs and (iv) distributing notices of PFDs nationally. The results of inquiries by Coroners and medical examiners worldwide into potentially preventable deaths involving medicines should be used to strengthen the safety of medicines.

5 Conclusions

Our search suggests that, in contrast to data from the National Coronial Information System, information from UK Coroners’ PFDs is underused, even though it informs public health.