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A review of safety incidents in England and Wales for vascular endothelial growth factor inhibitor medications.

ABSTRACT: PURPOSE: To learn from patient safety incidents (PSIs) following recent introduction of vascular endothelial growth factor inhibitor medications (anti-VEGF) in ophthalmic care, as reported via a national incident reporting database. METHODS: Thematic retrospective review of anti-VEGF medications PSIs as reported via clinical incident reporting methods in NHS care in England and Wales from 2003 to 2010, ascertained from database mining at the National Patient Safety Agency (NPSA). RESULTS: In all, 166 relevant anti-VEGF incidents were reported. Reports have increased year on year from 2006. Incident severity as reported: 10 were reported as 'severe harm' and 23 as 'moderate harm'. The remainder were 'low' or 'no harm' events. The incident themes and/or causes found and by order of severity included: intra-ocular inflammation/endophthalmitis (n=16); treatment or follow-up delays (n=45); wrong medication (n=26); wrong eye/patient injection (n=17); missing records (n=12). Other problems included medication availability and refrigeration failures. We reflect on potential solutions for addressing the matters found. Systemic safety matters, stroke, subdural hemorrhage, and myocardial infarction (total n=3) followed anti-VEGF treatments. CONCLUSION: Although infrequent, anti-VEGF medication PSIs or errors do occur and are thus a threat to quality. This review also provides supporting evidence to existing concerns and challenges surrounding age-related macular degeneration service pressures and provision. Lessons for improvement of care from a national incident reporting database for a frequently undertaken and recently introduced ophthalmic procedure were found. Suggestions are proposed for improving quality by reducing such problems based on analysis of such reports. Endophthalmitis reports following intra-vitreal injections suggest rigorous infection control measures are required.

SUBMITTER: Kelly SP

PROVIDER: S-EPMC3178143 | biostudies-other | 2011 Jun

REPOSITORIES: biostudies-other

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Project description:BackgroundThe UK performs poorly relative to other economically developed countries on numerous indicators of care quality for children. The contribution of iatrogenic harm to these outcomes is unclear. As primary care is the first point of healthcare contact for most children, we sought to investigate the safety of care provided to children in this setting.Methods and findingsWe undertook a mixed methods investigation of reports of primary care patient safety incidents involving sick children from England and Wales' National Reporting and Learning System between 1 January 2005 and 1 December 2013. Two reviewers independently selected relevant incident reports meeting prespecified criteria, and then descriptively analyzed these reports to identify the most frequent and harmful incident types. This was followed by an in-depth thematic analysis of a purposive sample of reports to understand the reasons underpinning incidents. Key candidate areas for strengthening primary care provision and reducing the risks of systems failures were then identified through multidisciplinary discussions. Of 2,191 safety incidents identified from 2,178 reports, 30% (n = 658) were harmful, including 12 deaths and 41 cases of severe harm. The children involved in these incidents had respiratory conditions (n = 387; 18%), injuries (n = 289; 13%), nonspecific signs and symptoms, e.g., fever (n = 281; 13%), and gastrointestinal or genitourinary conditions (n = 268; 12%), among others. Priority areas for improvement included safer systems for medication provision in community pharmacies; triage processes to enable effective and timely assessment, diagnosis, and referral of acutely sick children attending out-of-hours services; and enhanced communication for robust safety netting between professionals and parents. The main limitations of this study result from underreporting of safety incidents and variable data quality. Our findings therefore require further exploration in longitudinal studies utilizing case review methods.ConclusionsThis study highlights opportunities to reduce iatrogenic harm and avoidable child deaths. Globally, healthcare systems with primary-care-led models of delivery must now examine their existing practices to determine the prevalence and burden of these priority safety issues, and utilize improvement methods to achieve sustainable improvements in care quality.

Project description:ObjectivesPrisoners use healthcare services three times more frequently than the general population with poorer health outcomes. Their distinct healthcare needs often pose challenges to safe healthcare provision. This study aimed to characterise patient safety incidents reported in prisons to guide practice improvement and identify health policy priorities.Design: We carried out an exploratory multi-method analysis of anonymised safety incidents from prisons.SettingSafety incidents had been reported to the National Reporting and Learning System by prisons in England between April 2018 and March 2019.ParticipantsReports were reviewed to identify any unintended or unexpected incident(s) which could have, or did, lead to harm for prisoners receiving healthcare.Main outcome measuresFree-text descriptions were examined to identify the type and nature of safety incidents, their outcomes and harm severity. Analysis was contextualised with subject experts through structured workshops to explain relationships between the most common incidents and contributory factors.ResultsOf 4112 reports, the most frequently observed incidents were medication-related (n = 1167, 33%), specifically whilst administering medications (n = 626, 54%). Next, were access-related (n = 559,15%), inclusive of delays in patients accessing healthcare professionals (n = 236, 42%) and managing medical appointments (n = 171, 31%). The workshops contextualised incidents involving contributing factors (n = 1529, 28%) into three key themes, namely healthcare access, continuity of care and the balance between prison and healthcare priorities.ConclusionsThis study highlights the importance of improving medication safety and access to healthcare services for prisoners. We recommend staffing level reviews to ensure healthcare appointments are attended, and to review procedures for handling missed appointments, communication during patient transfers and medication prescribing.

Project description:Vascular endothelial growth factor pathway inhibitors (VEGFi), used as anti-angiogenic drugs to treat cancer are associated with cardiovascular toxicities through unknown molecular mechanisms. Endothelial cell-derived microparticles (ECMPs) are biomarkers of endothelial injury and are also functionally active since they influence downstream target cell signalling and function. We questioned whether microparticle (MP) status is altered in cancer patients treated with VEGFi and whether they influence endothelial cell function associated with vascular dysfunction. Plasma MPs were isolated from cancer patients before and after treatment with VEGFi (pazopanib, sunitinib, or sorafenib). Human aortic endothelial cells (HAECs) were stimulated with isolated MPs (106 MPs/mL). Microparticle characterization was assessed by flow cytometry. Patients treated with VEGFi had significantly increased levels of plasma ECMP. Endothelial cells exposed to post-VEGFi treatment ECMPs induced an increase in pre-pro-ET-1 mRNA expression, corroborating the increase in endothelin-1 (ET-1) production in HAEC stimulated with vatalanib (VEGFi). Post-VEGFi treatment MPs increased generation of reactive oxygen species in HAEC, effects attenuated by ETA (BQ123) and ETB (BQ788) receptor blockers. VEGFi post-treatment MPs also increased phosphorylation of the inhibitory site of endothelial nitric oxide synthase (eNOS), decreased nitric oxide (NO), and increased ONOO- levels in HAEC, responses inhibited by ETB receptor blockade. Additionally, gene expression of proinflammatory mediators was increased in HAEC exposed to post-treatment MPs, effects inhibited by BQ123 and BQ788. Our findings define novel molecular mechanism involving interplay between microparticles, the ET-1 system and endothelial cell pro-inflammatory and redox signalling, which may be important in cardiovascular toxicity and hypertension associated with VEGFi anti-cancer treatment. New and noteworthy: our novel data identify MPs as biomarkers of VEGFi-induced endothelial injury and important mediators of ET-1-sensitive redox-regulated pro-inflammatory signalling in effector endothelial cells, processes that may contribute to cardiovascular toxicity in VEGFi-treated cancer patients.

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A review of safety incidents in England and Wales for vascular endothelial growth factor inhibitor medications.

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