Preventable deaths involving opioids in England and Wales, 2013-2022: a systematic case series of coroners' reports.

BACKGROUND: Opioid deaths have increased in England and Wales. Coroners' Prevention of Future Deaths reports (PFDs) provide important insights that may enable safer use and avert harms, yet reports implicating opioids have not been synthesized. We aimed to identify opioid-related PFDs and explore coroners' concerns to prevent future deaths. METHODS: In this systematic case series, we screened 3897 coronial PFDs dated between 01 July 2013 and 23 February 2022, obtained by web scraping the UK's Courts and Tribunals Judiciary website. PFDs were included when an opioid was implicated in the death. Included PFDs were descriptively analysed, and content analysis was used to assess concerns reported by coroners. RESULTS: Opioids were involved in 219 deaths reported in PFDs (5·6% of PFDs), equating to 4418 years of life lost (median 33 years/person). Morphine (29%), methadone (23%) and diamorphine (16%) were the most common implicated opioids. Coroners most frequently raised concerns regarding systems and protocols (52%) or safety issues (15%). These concerns were most often addressed to National Health Service (NHS) organizations (51%), but response rates were low overall (47%). CONCLUSIONS: Opioids could be used more safely if coroners' concerns in PFDs were addressed by national organizations such as NHS bodies, government agencies and policymakers, as well as individual prescribing clinicians.

Identifying and managing adverse drug reactions: Qualitative analysis of patient reports to the UK yellow card scheme.

INTRODUCTION: Adverse drug reactions (ADRs) can have significant negative impact on peoples' daily lives, with physical, economic, social and/or psychological effects. Patient reporting of ADRs has been facilitated by pharmacovigilance systems across Europe. However, capturing data on patients' experiences of ADRs has proved challenging. Existing patient reports to the UK Yellow Card Scheme contain free-text comments which could be useful sources of information. OBJECTIVES: To investigate patients' experiences of ADRs and their impact on patients as described in free-text data within patient Yellow Card (YC) reports submitted to the Medicines and Healthcare products Regulatory Agency. METHODS: A qualitative review of narrative texts was conducted on free-text data from 2255 patient YC reports from July to December 2015. RESULTS: Three key narrative themes emerged from analysis of the free-text data in 2255 reports: (1) identification of ADRs, (2) severity and impact of ADRs, and (3) management of ADRs. Temporal associations were the most common method of identification followed by differential diagnoses and confirmation with information sources such as healthcare professionals (HCPs). A combination of explicit and implicit impacts were described: physical, psychological, economic and social effects often persisted and caused serious disruption to many patients' lives. A range of strategies were used to manage ADRs, including consultation with HCPs, stopping/reducing the medicine or taking medicines to alleviate symptoms. CONCLUSION: Free-text data from YC reports has been an underutilised resource to date, but this research has confirmed its potential value to pharmacovigilance and medication safety research.

Identification of different side effects between PARP inhibitors and their polypharmacological multi-target rationale.

AIMS: The aim of this study was to determine the differences and potential mechanistic rationale for observed adverse drug reactions (ADRs) between four approved PARP inhibitors (PARPi). METHODS: The Medicines and Healthcare products Regulatory Authority (MHRA) Yellow Card drug analysis profiles and NHS secondary care medicines database enabled the identification of suspected ADRs associated with the PARPi in the UK from launch to 2020. The polypharmacology of the PARPi were data-mined from several public data sources. RESULTS: The overall ADRs per 100 000 Rx identified across the four PARPi are statistically significant (χ2 test, P < .001). Rucaparib has the greatest relative suspected ADRs, which can be explained by its least clean kinome and physicochemical properties. The suspected gastrointestinal ADRs of rucaparib and niraparib can be ascribed to their kinase polypharmacology. Suspected blood and lymphatic system ADRs of PARPi can be linked to their high volume of distribution (Vd ). The thrombocytopenia rate of niraparib > rucaparib > olaparib tracked with the Vd trend. Hypertension is only associated with niraparib and could be explained by the therapeutically achievable inhibition of DYRK1A and/or transporters. Arrhythmia cases are potentially linked to the structural features of hERG ion-channel inhibition found in rucaparib and niraparib. Enhanced psychiatric/nervous disorders associated with niraparib can be interpreted from the diverse neurotransporter off-targets reported. CONCLUSIONS: Despite their similar mode of action, the differential polypharmacology of PARP inhibitors influences their ADR profile.

Development and preliminary validation of an instrument to enable laypersons to assess suspected side effects from medicines.

PURPOSE: Research into causality assessment tools enabling patients to assess suspected adverse drug reactions (ADRs) is limited. Supporting patients with tools could improve their confidence in discussions with health professionals and encourage reporting of suspected ADRs to regulators. This study describes development and preliminary validation of an instrument: Side Effect Patient ASsessment Tool (SE-PAST). METHODS: SE-PAST was developed from survey and interview data involving patients experiencing suspected ADRs. It included 10 statements enabling causality assessment, covering timing, additional information sources, and experiences, with four options: yes/no/don't know/not applicable. Scoring and weighting resulted in four categories of causal association: highly probable, probable, possible, unlikely. Validation involved obtaining feedback from 31 individuals experiencing an ADR. Further validation involved online distribution through patient support groups and comparison of reported symptoms to known ADRs. RESULTS: Validators found SE-PAST easy to read (31), to understand (27), and to complete (29). A total of 294 respondents completed SE-PAST online, with 98% completing eight or more causality assessment statements. Symptoms were categorised as highly probable (46; 16%), probable (80; 62%), possible (44; 15%), and unlikely (21; 7%). A total of 221 respondents identified one suspected medicine, with 95% of these reporting at least one symptom known to be an ADR. Of 227 providing feedback, 139 (61%) found SE-PAST useful, 160 (71%) felt motivated to discuss their experience with a health professional, and 136 (60%) were encouraged to report to the regulator. CONCLUSION: SE-PAST was easily completed and understood by people experiencing suspected ADRs and could be useful in encouraging patient reporting to health professionals and agencies.

Herpes Zoster Chorioretinopathy: A Case Series.

PURPOSE: To report two patients with herpetic zoster panuveitis and chorioretinopathy with choroidal hypopigmentation. METHODS: Retrospective chart review of two patients. RESULTS: We report a series of two patients with a history of HZO with orbital inflammation and panuveitis, who developed patchy choroidal depigmentation consistent with a choroidopathy. The lesions were extensive and involved the posterior pole and mid-periphery in both cases. Both cases demonstrated scattered areas of ellipsoid zone loss, and fluorescein angiography showed corresponding late hyperfluorescence. OCTA in one case demonstrated flow voids at the level of choriocapillaris. CONCLUSIONS: Our series suggests that herpetic chorioretinopathy may be a relatively benign process that presents late and may involve large areas of the posterior choroid.

Severity and Management of Adverse Drug Reactions Reported by Patients and Healthcare Professionals: A Cross-Sectional Survey.

Adverse drug reaction (ADR) severity levels are mainly rated by healthcare professionals (HCPs), but patient ratings are limited. This study aimed to compare patient-rated and pharmacist-rated ADR severity levels and determined methods employed for ADR management and prevention by patients and HCPs. A cross-sectional survey was conducted in outpatients visiting two hospitals. Patients were asked about ADR experiences using a self-administered questionnaire, and additional information was retrieved from the medical records. In total, 617 out of 5594 patients had experienced ADRs (11.0%), but 419 patients were valid (68.0%). Patients commonly reported that their ADR severity level was moderate (39.4%), whereas pharmacists rated the ADRs as mild (52.5%). There was little agreement between patient-rated and pharmacist-rated ADR severity levels (κ = 0.144; p < 0.001). The major method of ADR management by physicians was drug withdrawal (84.7%), while for patients, it was physician consultation (67.5%). The main methods for ADR prevention by patients and HCPs were carrying an allergy card (37.2%) and recording drug allergy history (51.1%), respectively. A higher level of ADR bothersomeness was associated with higher ADR severity levels (p < 0.001). Patients and HCPs rated ADR severity and used ADR management and prevention methods differently. However, patient rating of ADR severity is a potential signal for severe ADR detection of HCPs.

Recognition of Coroners' Concerns to Prevent Future Deaths from Medicines: A Systematic Review.

BACKGROUND: Coroners, who hold inquests to determine the causes of unnatural deaths in England and Wales, having recognised factors that could cause other deaths, are legally obliged to signal concerns by sending 'Reports to Prevent Future Deaths' (PFDs) to interested persons. We aimed to establish whether Coroners' concerns about medications are widely recognised. METHODS: We searched MEDLINE, Embase and Web of Science up to 30 November, 2022 for publications linking PFDs and medications using a combination of search terms "coroner*", "inquest*", "medicine*", "medication*" and "prevent*". We also searched the BMJ, a UK journal that carries news items; and the databases Nexis Advance and News On the Web for reports in national newspapers between 2013 and 2022, using the search terms ("regulation 28" OR "prevent future deaths" OR "prevention of future deaths") AND "coroner". We recorded the number of publications, as well as their citations in Google Scholar at 23 May, 2023. RESULTS: Only 11 published papers on medicines referenced UK PFDs, nine of which were from our group. The BMJ carried 23 articles mentioning PFDs, five related to medicines. Of 139 PFDs (out of over 4000) mentioned in national newspapers, only nine related to medicines. CONCLUSIONS: The PFDs related to medicines are not widely referred to in medical journals or UK national newspapers. By contrast, the Australian and New Zealand National Coronial Information System has contributed cases to 206 publications cited in PubMed, of which 139 are related to medicines. Our search suggests that information from English and Welsh Coroners' PFDs is under-recognised, even though it should inform public health. 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.

Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners' Reports 2013-22.

INTRODUCTION: Medicines cause over 1700 preventable deaths annually in England. Coroners' Prevention of Future Death reports (PFDs) are produced in response to preventable deaths to facilitate change. The information in PFDs may help reduce medicine-related preventable deaths. OBJECTIVES: We aimed to identify medicine-related deaths in coroners' reports and to explore concerns to prevent future deaths. METHODS: We carried out a retrospective case series of PFDs across England and Wales, dated between 1 July, 2013 and 23 February, 2022, collected from the UK's Courts and Tribunals Judiciary website using web scraping, generating an openly available database: https://preventabledeathstracker.net/ . We used descriptive techniques and content analysis to assess the main outcome criteria: the proportion of PFDs in which coroners reported that a therapeutic medicine or drug of abuse had caused or contributed to a death; the characteristics of included PFDs; coroners' concerns; the recipients of PFDs; and the timeliness of their responses. RESULTS: There were 704 PFDs (18%; 716 deaths) that 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 around the major themes of patient safety (29%) and communication (26%), including minor themes of failures of monitoring (10%) and poor communication between organizations (7.5%). Most expected responses to PFDs (51%; 630/1245) were not reported on the UK's Courts and Tribunals Judiciary website. CONCLUSIONS: One in five coroner-reported preventable deaths involved medicines. Addressing coroners' concerns, including problems with patient safety and communication, should reduce harms from medicines. Despite concerns being raised repeatedly, half of the 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. CLINICAL TRIAL REGISTRATION: https://doi.org/10.17605/OSF.IO/TX3CS .

Fixed High Energy Versus Standard Titrated Energy Settings for Selective Laser Trabeculoplasty.

PRCIS: Fixed high-energy selective laser trabeculoplasty (SLT) is associated with a greater reduction in intraocular pressure (IOP) compared with the standard titrated approach at up to 36 months postprocedure. PURPOSE: There is no consensus on ideal SLT procedural laser energy settings. This study aims to compare fixed high-energy SLT to the standard titrated-energy approach within the setting of a residency training program. PATIENTS: Patients over the age of 18 years received SLT between 2011 and 2017, a total of 354 eyes. Patients with a prior history of SLT were excluded. METHODS: Retrospective review of clinical data from 354 eyes that underwent SLT. Eyes that underwent SLT using fixed high energy (1.2 mJ/spot) were compared with those with the standard titrated approach starting at 0.8 mJ/spot and titrating to "champagne" bubbles. The entirety of the angle was treated using a Lumenis laser set to the SLT setting (532 nm). No repeat treatments were included. MAIN OUTCOME MEASURE: IOP and glaucoma medications. RESULTS: In our residency training program, fixed high-energy SLT was associated with a reduction in IOP compared with a baseline of -4.65 (±4.49, n = 120), -3.79 (±4.49, n = 109), and -4.40 (±5.01, n =119) while standard titrated-energy was associated with IOP reduction of -2.07 (±5.06, n = 133), -2.67 (±5.28, n = 107), and -1.88 (±4.96, n = 115) at each respective postprocedural time point (12, 24, and 36 months). The fixed high-energy SLT group had significantly greater IOP reduction at 12 months and 36 months. The same comparison was performed for medication naïve individuals. For these individuals, fixed high-energy SLT resulted in IOP reductions of -6.88 (±3.72, n = 47), -6.01 (±3.80, n = 41), and -6.52 (±4.10, n = 46) while standard titrated-energy had IOP reductions of -3.82 (±4.51, n = 25), -1.85 (±4.88, n = 20), and -0.65 (±4.64, n = 27). For medication naïve individuals, fixed high-energy SLT resulted in a significantly greater reduction in IOP at each respective time point. Complication rates (IOP spike, iritis, and macular edema) were similar between the two groups. The study is limited by overall poor response to standard-energy treatments, whereas high-energy treatments showed similar efficacy to those in literature. CONCLUSION: This study demonstrates that fixed-energy SLT produces at least equivalent results compared with the standard-energy approach, without an increase in adverse outcomes. Particularly in the medication naïve subpopulation, fixed-energy SLT was associated with a significantly greater IOP reduction at each respective time point. The study is limited by overall poor response to standard-energy treatments, with our results showing decreased IOP reduction compared with those of previous studies. These poor outcomes of the standard SLT group may be responsible for our conclusion that fixed high-energy SLT results in a greater reduction in IOP. These results may be useful when considering optimal SLT procedural energy in future studies for validation.

Exploring Healthcare Professionals' Practices and Attitudes towards Monitoring and Reporting of Severe Adverse Drug Reactions.

Healthcare professionals (HCPs) play a key role in the monitoring of severe adverse drug reactions (ADRs). The present study aims to explore practices and barriers of HCPs in severe ADR monitoring and reporting, to evaluate their attitudes towards the monitoring and to assess the related factors. Self-administered questionnaires produced in hard copy and Google form were sent to 510 HCPs by stratified random sampling. Of the 350 HCPs that responded (68.6%), 44.9% had ever monitored ADRs. The most common practices were the observation of abnormal symptoms for ADR identification (88.5%), discontinuation of the suspected drug for ADR management (88.5%) and advice on recurrent drug allergy for ADR prevention (88.5%). Most HCPs (93.0%) obtained further patient history to identify severe ADRs. The uncertainty of the causal relationship was a major barrier to ADR reporting (60.0%). Pharmacists were more involved with practices in ADR monitoring and reporting (OR 20.405; p < 0.001), whereas longer work experience (>20 years) was negatively related to the practices (OR 0.271; p = 0.024). Over one-third (37.6%) of HCPs had a positive attitude towards severe ADR monitoring. In conclusion, the practices in severe ADR monitoring varied among different professions. However, the barriers to the reporting of ADRs still exist; hence, improving knowledge and cooperation among HCPs should be promoted.

Giant Retinal Pigment Epithelium Tear Resulting in Neurosensory Retinal Detachment: An Atypical Case.

Purpose: We report a rare case of neurosensory retinal detachment (RD) in the setting of a giant retinal pigment epithelium (RPE) tear. Methods: A 58-year-old man presented with a macula-involving RD in the left eye. Exam revealed a neurosensory detachment inferiorly and RPE abnormalities temporally. Optical coherence tomography showed a large RPE tear and detachment in the temporal macula contiguous with a neurosensory RD. Results: No clear etiology was identified and failure of conservative management led to vitrectomy with RD repair. Follow-up intravenous fluorescein angiography 3 months postoperatively showed a large RPE window defect. Conclusions: RPE tears are common; however, concomitant neurosensory RD is rare. A thorough workup to determine treatable causative factors is necessary; in the event of idiopathic diagnosis, close follow-up is necessary to determine the need for surgery. Pars plana vitrectomy, external drainage of subretinal fluid, endolaser, and 5000-centistoke silicone oil placement were successful in this patient.

A qualitative study of prescribing errors among multi-professional prescribers within an e-prescribing system.

Background Computerised Physician Order Entry (CPOE) is considered to enhance the safety of prescribing. However, it can have unintended consequences and new forms of prescribing error have been reported. Objective The aim of this study was to explore the causes and contributing factors associated with prescribing errors reported by multidisciplinary prescribers working within a CPOE system. Main Outcome Measure Multidisciplinary prescribers experience of prescribing errors in an CPOE system. Method This qualitative study was conducted in a hospital with a well-established CPOE system. Semi-structured qualitative interviews were conducted with prescribers from the professions of pharmacy, nursing, and medicine. Interviews analysed using a mixed inductive and deductive approach to develop a framework for the causes of error. Results Twenty-three prescribers were interviewed. Six main themes influencing prescribing were found: the system, the prescriber, the patient, the team, the task of prescribing and the work environment. Prominent issues related to CPOE included, incorrect drug name picking, default auto-population of dosages, alert fatigue and remote prescribing. These interacted within a complex prescribing environment. No substantial differences in the experience of CPOE were found between the professions. Conclusion Medical and non-medical prescribers have similar experiences of prescribing errors when using CPOE, aligned with existing published literature about medical prescribing. Causes of electronic prescribing errors are multifactorial in nature and prescribers describe how factors interact to create the conditions errors. While interventions should focus on direct CPOE issues, such as training and design, socio-technical, and environmental aspects of practice remain important.

Drug-Related Problems in Hospitalised Patients with Chronic Kidney Disease: A Systematic Review.

INTRODUCTION: Globally, chronic kidney disease (CKD) is one of the leading causes of mortality. Impaired renal function makes CKD patients vulnerable to drug-related problems (DRPs). AIM: The aim of this systematic review was to investigate the prevalence and nature of DRPs among hospital in-patients with CKD. METHODS: A systematic review of the literature was conducted using Medline, EMBASE, PsycINFO, Web of Science (Core Collection), CINAHL plus (EBSCO), Cochrane Library (Wiley), Scopus (ELSEVIER) and PubMed (U.S.NLM) from index inception to January 2020. Studies investigating DRPs in hospitalised CKD patients published in the English language were included. Two independent reviewers extracted the data and undertook quality assessment using the Joanna Briggs Institute (JBI) tool. RESULTS: A total of 2895 unique titles were identified; with 20 meeting the inclusion criteria. DRPs prevalence in CKD was reported between 12 and 87%. The most common DRPs included ineffective treatment, inappropriate drug choice and dosing problems. Antibiotics, H2-antihistamines and oral antidiabetics (metformin) were common drug classes involved in DRPs. Factors associated with DRPs included severity of CKD, the number of medications taken, age, length of hospital stay, and gender. CONCLUSION: This systematic review provides evidence that DRPs are a frequent occurrence and burden for hospitalised patients with stage 1-4 CKD. Heterogeneity in study design, case detection and definitions are common, and future studies should use clearer definitions and study designs. Protocol Registration: PROSPERO: CRD42018096364.

The Association Between Obstructive Sleep Apnea and Cotton-Wool Spots in Nonproliferative Diabetic Retinopathy.

Purpose: This work reports the association of obstructive sleep apnea (OSA) and cotton-wool spots (CWS) seen in patients with nonproliferative diabetic retinopathy (DR). Methods: A random sample of patients diagnosed with DR between January 1, 2015 and December 31, 2018, were selected from medical-billing codes. Dilated funduscopic examination findings and medical history were analyzed by reviewing medical records. Results: CWS were present in 12 of 118 patients without OSA, compared with 11 of 32 patients with OSA (10.2% vs 34.4%, respectively; P = .002). OSA was more common in men (68.8%, P = .03) and associated with a higher body mass index (30.0 ± 5.0 without OSA vs 33.6 ± 5.5 with OSA, P < .001). When comparing those with and without OSA, there was no association with age; glycated hemoglobin A1c; stage of DR; insulin dependence; presence of diabetic macular edema; smoking status; or a history of hypertension, hyperlipidemia, cardiovascular disease, or other breathing disorder. Conclusions: The presence of OSA is associated with CWS in patients with DR, as well as male sex and a higher body mass index. Further research is needed to determine the ophthalmologist's role in the timely referral of patients with CWS for OSA evaluation.

Correlates of spontaneous reporting of adverse drug reactions within primary care: the paradox of low prescribers who are high reporters.

AIM(S): To examine Primary Care Trust (PCT) demographics influencing general practitioner (GP) involvement in pharmacovigilance. METHODS: PCT adverse drug reaction (ADR) reports to the Yellow Card scheme between April 2004 and March 2006 were obtained for the UK West Midlands region. Reports were analysed by all drugs, and most commonly reported drugs ('top drugs'). PCT data, adjusted for population size, were aggregated. Prescribing statistics and other characteristics were obtained for each PCT, and associations between these characteristics and ADR reporting rates were examined. RESULTS: During 2004-06, 1175 reports were received from PCTs. Two hundred and eighty (24%) of these reports were for 14 'top drugs'. The mean rate of reporting for PCTs was 213 reports per million population. A total of 153 million items were prescribed during 2004-06, of which 33% were 'top drugs'. Reports for all drugs and 'top drugs' were inversely correlated with the number of prescriptions issued per thousand population (r(s)=-0.413, 95% CI -0.673, -0.062, P < 0.05, and r=-0.420, 95% CI -0.678, -0.071, P < 0.05, respectively). Reporting was significantly negatively correlated with the percentages of male GPs within a PCT, GPs over 55 years of age, single-handed GPs within a PCT, the average list size of a GP within a PCT, the overall deprivation scores and average QOF total points. ADR reports did not correlate significantly with the proportion of the population over 65 years old. CONCLUSIONS: Some PCT characteristics appear to be associated with low levels of ADR reporting. The association of low prescribing areas with high ADR reporting rates replicates previous findings.

Assessment of Corneal Haze After PRK and the Effect of Sutureless Amniotic Membrane Graft by Corneal Densitometry.

PURPOSE: To assess whether densitometry analysis appropriately monitors the development of haze in myopic patients after photorefractive keratectomy (PRK) when compared to subjective slit-lamp haze grade examinations, and whether sutureless cryo-preserved amniotic membrane reduced postoperative haze development when compared to the standard bandage contact lens. METHODS: In this retrospective cohort at the Center for Refractive Surgery, Walter Reed National Military Medical Center, a secondary analysis of prospectively collected data was performed. In the prospective study, participants underwent PRK for myopia. Postoperatively, a standard bandage contact lens was applied to the dominant eye and a sutureless cryo-preserved amniotic membrane graft to the nondominant eye. Participants were evaluated at 1, 3, and 6 months postoperatively for haze formation and corneal densitometry using slit-lamp biomicroscopy and Scheimpflug imaging, respectively. RESULTS: Densitometry measurements at 6 months postoperatively were positively and significantly associated with the presence or absence of haze as assessed by slit-lamp examination in 39 patients (78 eyes; age range: 21 to 44 years). Eyes with increased densitometry measurements had 2.3 to 3.4 times the odds (P ⩽ .014) of having clinical haze on slit-lamp examination. Eyes with the amniotic membrane graft showed a positive correlation with increased corneal densitometry throughout most layers of the cornea. CONCLUSIONS: Densitometry analysis appears to be a useful tool to supplement slit-lamp examination in monitoring haze development after PRK. The amniotic membrane failed to show a reduction in corneal densitometry in myopic eyes after PRK. [J Refract Surg. 2020;36(5):293-299.].

Preventing Future Deaths from Medicines: Responses to Coroners' Concerns in England and Wales.

INTRODUCTION: 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). OBJECTIVE: We wished to see what responses were made by National Health Service (NHS) organizations and others to these 99 coroners' reports. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Use of information sources regarding medicine side effects among the general population: a cross-sectional survey.

AIM: To determine the use and perceived value of different information sources that patients may use to support identification of medicine side effects; to explore associations between coping styles and use of information sources. BACKGROUND: Side effects from medicines can have considerable negative impact on peoples' daily lives. As a result of an ageing UK population and attendant multi-morbidity, an increasing number of medicines are being prescribed for patients, leading to increased risk of unintended side effects. METHODS: A cross-sectional survey of patients who use medicine, recruited from community pharmacies. The survey sought views on attributes of various information sources, their predicted and actual use, incorporating a shortened Side Effects Coping Questionnaire (SECope) scale and the abbreviated Miller Behavioural Style Scale (MBSS). FINDINGS: Of 935 questionnaires distributed, 230 (25.0%) were returned, 61.3% from females; 44.7% were retired and 84.6% used at least one medicine regularly. 69.6% had experienced a side effect, resulting in 57.5% of these stopping the medicine. Patient information leaflets (PILs) and GPs were both predicted and actually most widely used sources, despite GPs being judged as relatively less accessible and PILs less trustworthy, particularly by regular medicine users. Pharmacists, considered both easy to access and trustworthy, were used by few in practice, while the internet was considered easy to access, but less trustworthy and was also little used. SECope sub-scales for non-adherence and information seeking showed positive associations with stopping a medicine and seeking information from a health professional. More high monitors than low monitors stopped a medicine themselves, but there were no differences in use of information sources. Information seeking following a side effect is a common strategy, potentially predicted by the SECope, but not the MBSS. Limited GP accessibility could contribute to high internet use. Further research could determine how the trustworthiness of PILs can be improved.

Making medicines safer: analysis of patient reports to the UK's Yellow Card Scheme.

Objectives: No studies describing UK patient Yellow Card reports have been published since the evaluation of the first two years of direct patient reporting (2005-7), when 5,180 reports were analyzed.Methods: Patient Yellow Card reports submitted July-December 2015 for vaccines and other drugs were analyzed. Comparisons to the initial evaluation were made of: reporting method, number of suspect drugs, proportion classed as serious. Factors affecting seriousness of reports were examined.Results: There were 3,060 patient Yellow Card reports analyzed. Vaccine reports have increased from very few in 2005-7 to 25% of reports. The proportion of reports citing one drug (94.3%) and the proportion considered serious (70.3%) increased from the 84% and 58% respectively found in 2005-7. The main method of reporting had changed from paper (61%) to internet (88.5%). Serious reports were more common in females, for vaccines in young persons, but in adults for other drugs, and included more reaction terms than non-serious reports.Conclusion: Patient reporting, in particular to vaccines, has increased dramatically since 2005-7. Increases in the proportion of reports concerning one drug and the proportion considered serious could indicate that the usability of patient reports may have improved in comparison to early reporting.

Amateur endurance athletes' use of non-steroidal anti-inflammatory drugs: a cross-sectional survey.

OBJECTIVE: To explore amateur endurance athletes' use and views about non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: An online cross-sectional survey of amateur athletes at four athletic clubs. KEY FINDINGS: Of a sample of 129 of amateur athletes, 68% (n = 88) reported using NSAIDs in the previous 12 months (84.4% in triathletes, 70.9% in runners and 52.5% in cyclists). Overall, ibuprofen was the most popular drug (n = 48). There was a lack of knowledge of adverse drug reactions, with only 26% of use advised by a doctor or pharmacist. CONCLUSIONS: There is high usage of NSAIDs in amateur athletes, including before and during events, largely without professional health advice. Informational needs of amateur athletes are not being met.