Study

Types of PFDs

Findings

Anis et al. 2022 3

113 CVD-related PFDs involving anticoagulants, published between Jul 2013 and Dec 2019.

●        Warfarin, enoxaparin, and rivaroxaban were most involved in CVD-related PFDs.

●        Poor systems, communication, and failures in medical records were the most common concerns reported by coroners.

●        PFDs were often sent to NHS trusts, hospitals, and general practices, but 60% had not received responses.

●        PFDs offer lessons for prescribers and policymakers on the safety and appropriate use of therapies.

●        It is unclear whether changes are being made to incorporate lessons from PFDs; thus, acting on PFDs at a national level would help to prevent deaths.

Aronson et al. 2022 4

17 PFDs, published between Nov 2018 and Dec 2019, describing online purchase of medicines or non-medicinal chemicals, which contributed to deaths.

●        Two PFDs reported that products, which caused death, were obtained from the dark web.

●        Prescription-only medications were the most involved drugs purchased online.

●        Mental health and drug dependence/abuse were common contributory factors.

●        Concerns included ease of obtaining medicines, the regulation of supply and importation of medicines, including the regulation of the dark web, and the lack of a limit on the amount and frequency of orders.

●        90% of PFD recipients did not respond to the coroner within the legal time limit (56 days).

●        PFDs offered healthcare workers, policymakers, and the public lessons regarding purchasing medicines online.

Bilip & Richards 2021 9

One PFD relating to paraffin-based emollient creams

●        There were frequent fires involving paraffin-based creams, mostly in elderly residents;

●        There is a wide availability of paraffin-based creams and a lack of awareness of their fire risk; the risk of potential build up on clothing and the lethal outcomes of these fires.

●        The PFD was sent to several national organizations, including the DHSC, who responded by outlining actions previously taken in response to deaths involving paraffin-based emollients.

●        Of the six organizations to which the PFD was addressed, only three had responded by January 2021.

●        Further emollient deaths have occurred after this PFD; thus, lessons were not learned, and actions are still needed.

Cox & Ferner 2021 5

Two PFDs associated with tramadol

●        PFDs highlighted the dangers of repeat prescribing of tramadol, the importance of communicating its risks, and the need for evidence-based solutions to prevent future harms.

●        Actions on individual cases reported in PFDs could be used to prevent deaths more broadly if communication and adoption were more widespread.

Dernie et al. 2022 6

219 PFDs involving opioids

●        For every opioid-related PFD, a median of 33 years of life were lost.

●        Morphine, methadone, and heroin were most often involved.

●        Coroners’ concerns were frequently related to systems and protocols and maintaining accurate medical records and plans for patients taking opioids.

●        Concerns were most often addressed to NHS organizations.

●        Responses to PFDs were poor (47% overall), and their lessons were only disseminated locally.

●        Issuing PFDs depends on the working practices of individual coroners; the process is neither audited nor assessed.

Ferner et al. 2019 13

Responses to 69 of 99 PFDs relating to medicines, published between Apr 2015 and Sep 2016 from 106 organizations

●        Common actions taken by organizations were staff education or training and changes to processes or policy, although some organizations reported existing policies were sufficient.

●        The median time taken for organizations to respond to PFDs was 53 days.

●        Coroners often brought to light systemic failures of general importance that prompted actions that otherwise would not have been completed.

●        Important concerns are often shared only locally, preventing widespread learning from nationally relevant lessons.

●        Few responses to PFDs are published, and little information is provided as to why.

Ferner et al. 2017 14

99 PFDs in which medicines or the medication process was identified, published between April 2015 and September 2016

●        Anticoagulants, antidepressants, and drugs of abuse were the most mentioned medicines.

●        Adverse reactions to prescribed medications, omission of necessary treatment, failure to monitor treatment, and poor systems were the most highlighted concerns.

●        Concerns were related to issues in education or training, lack of clear guidelines or protocols, and failure to implement existing guidelines.

●        Pharmacovigilance could benefit if health organisations, professional and regulatory bodies, and market authorisation holders were more aware of PFDs.

France et al. 2022 7

704 PFDs involving medicines, published between Jul 2013 and Feb 2022

●        1 in 5 PFDs involved medicines (716 deaths)

●        19,740 years of life were lost

●        Opioids, antidepressants, and hypnotics were the most common medicines involved

●        Patient safety and communication were the most common concerns raised by coroners

●        NHS England, DHSC, and MHRA were the organizations who most often received medicines-related PFDs

●        51% of expected responses were not available

●        Addressing coroners’ concerns could feasibly improve the safety of medicines.

●        PFDs contain important information and have the potential to contribute to a learning environment in clinical practice that could prevent future deaths.

●        The current PFD system does not take steps to enforce or audit responses to PFDs, despite the legal requirement.

●        Concerns should be shared more broadly to ensure that national lessons are learnt.

Richards 2021 10

Two PFDs describing deaths from ingestion of alcohol-based hand sanitisers

●        There were eight recommendations to prevent intentional and accidental ingestion of alcohol-based hand sanitisers in healthcare and community settings.

●        PFDs provide an ‘opportunity to develop and implement mitigation strategies’ and ‘an opportunity to educate healthcare professionals and the public in harm reduction’.

●        No process is in place to confirm the implementation of actions discussed in the addressees’ responses.

●        Coroners’ concerns were not widely communicated in the NHS despite being addressed to NHS England.

Swift et al. 2022 11

23 PFDs relating to SARS-CoV-2, published between Jan 2020 and Jun 2021

●        communication problems and the failure to follow protocols were the most common coroners' concerns

●        NHS organizations, and the Government were the most common recipients of PFDs; however, response rates were poor.

●        There was significant geographical variation in the reporting of PFDs.

●        Coroners’ concerns should be considered during the UK Government’s inquiry into the handling of the pandemic so that repeated mistakes can be avoided.

●        There is no formal system by which PFDs are currently audited or analysed, so coroners’ concerns may go unreported and unrecognised.

Thomas & Richards 2021 8

One PFD attributed to a non-steroidal anti-inflammatory drug (NSAID), diclofenac

●        Adverse drug reactions from NSAIDs should be considered in children and adolescents, especially those with complex needs.

●        There were missed opportunities for further testing and observations that resulted in systematic failures in the documentation and transmission of information.

●        No response to the PFD from the NHS trust had been published (>4 years overdue).

Zhang & Richards 2022 12

A review of all available PFDs (N=4001), published between Jul 2013 and Jun 2022

●        The most common category assigned to PFDs were ‘hospital (clinical procedures and medical management)” related deaths. However, 73% of deaths on the Courts and Tribunals Judiciary website were not categorized.

●        There was significant geographical variation in PFD writing: 20 coroners were responsible for 30% of all PFDs.

●        One in three (36%) PFDs were without responses

●        The Courts and Tribunals website had significant problems with poor categorization, missing information, and formatting issues; many PFDs contained misspellings and formatting inconsistencies.

●        Poor management and standardization within the Courts and Tribunals website limit the analysis of PFDs.

●        Technology can simplify the process of auditing PFDs and ensure that changes are made to prevent future deaths.

●        PFDs hold a rich source of information that decision-makers should use to improve public health and safety.