Drug Safety最新文献

{"title":"Assessing Natural Health Product-Drug Interactions and Coding Feasibility: Analysis of a New Zealand General Population Dataset from an Online Market Research Panel.","authors":"E Lyn Lee, Fraser Ogle, Jyadeep Nagra, Sofia Su Ye, Jeff Harrison, Joanne Barnes","doi":"10.1007/s40264-026-01667-5","DOIUrl":"10.1007/s40264-026-01667-5","url":null,"abstract":"<p><strong>Introduction: </strong>Natural health products (NHPs) include complementary/alternative medicines, dietary supplements, nutraceuticals, and traditional medicines. Natural health products are often self-prescribed and used alongside conventional medicines, raising safety concerns.</p><p><strong>Aims: </strong>This study aims to explore NHP-conventional medicine (NHP-drug) combinations used by respondents in New Zealand (NZ), identify those with the potential to cause NHP-drug interactions, and assesses the feasibility of coding NHPs using the WHODrug dictionary.</p><p><strong>Methods: </strong>A dataset from a pilot study on NHP use in NZ was analysed. Data on NHP and conventional medicine use were descriptively analysed. Where possible, specific product ingredient lists were verified. Two coders independently assigned WHODrug Global codes to each NHP and conventional medicine. Fleiss' Kappa measured inter-coder agreement.</p><p><strong>Results: </strong>Of 992 participants, 381 (38.4%) were current NHP users, reporting 1-18 NHPs. Among them, 271 (71.1%) used conventional medicines concurrently. Natural health product-drug combinations with potential interactions were found with fish oil, coenzyme Q10, turmeric, and glucosamine. An interaction involving fish oil and warfarin was rated as 'may result in significant hazard.' One-third (33.1%) of NHPs could not be coded using WHODrug. Codability agreement was higher for conventional medicines (93.7%) than for NHPs (63.5%). Fleiss' Kappa indicated moderate agreement for NHPs (κ = 0.576) and very good agreement for conventional medicines (κ = 0.911).</p><p><strong>Conclusion: </strong>Substantial concurrent NHP-drug use was identified, including combinations with potential adverse reactions. A larger, nationally representative dataset on NHP exposures in NZ is needed. Current challenges in coding NHPs highlight the need for standardised, comprehensive coding tools in future research for comprehensive analysis.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"955-967"},"PeriodicalIF":5.9,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13354645/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Educational Interventions Affecting Medication Error Reporting by Healthcare Professionals in Secondary and Tertiary Care: A Systematic Review and Narrative Synthesis.","authors":"Manahil M Monshi, Zahraa Jalal, Jeff Aston, Sarah K Pontefract, Anthony R Cox","doi":"10.1007/s40264-026-01668-4","DOIUrl":"10.1007/s40264-026-01668-4","url":null,"abstract":"<p><strong>Background: </strong>Many healthcare systems are striving to improve patient safety, as medication errors are a significant cause of avoidable morbidity and mortality. This systematic review aims to quantitatively and qualitatively assess the impact of educational interventions on medication error reporting.</p><p><strong>Methods: </strong>A systematic review of the literature was conducted from database inception to December 2024 across EMBASE (Ovid), MEDLINE (Ovid) and PsycINFO (Ovid). Any study examining educational strategies affecting medication error reporting in secondary and tertiary care settings in the English language was included, except for cross-sectional studies. Search terms included healthcare professionals, educational interventions, medication error reporting, and secondary and tertiary healthcare. Two independent reviewers screened titles, abstracts, full-text studies, extracted the data and undertook quality assessment using the Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool to assess the risk of bias in the included studies. Finally, data were synthesised as a narrative review to summarise all educational interventions.</p><p><strong>Results: </strong>The systematic search led to 3649 titles. Fourteen studies were eligible for inclusion. Most of the studies were non-randomised experimental studies and assessed the medication error reporting quantitatively, but not qualitatively. The studies reported improvements in medication error reporting rates, nurses' overall reporting competence, and healthcare professionals' form completion skills following educational interventions.</p><p><strong>Conclusion: </strong>A better understanding of educational intervention methods, rationales, time frames, frequency, and effective co-interventions may improve medication error reporting. Combining education with other interventions had positive outcomes related to medication error reporting compared with education alone. Educational interventions improved the quantity and some quality measures of medication error reporting.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"921-939"},"PeriodicalIF":5.9,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147812198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strengthening Pharmacovigilance in Latin America: Multidisciplinary Insights from Two ISoP Latin American Chapter Symposia.","authors":"Jessica Liliana Vargas-Neri, Angela Caro-Rojas, Gilberto Castañeda-Hernández, Christian Camilo Cuello-Meza, Betty Duarte, Daniela Fontana, Cinthya Galicia-Quintanar, Victoria Hall-Ramírez, Diego Salas, Maribel Salas, Julia Jeanett Segura-Uribe, Mónica Tarapues, Heyde Patricia Zuluaga-Arias, Carlos Aceves-González, Josué Bautista-Arteaga, William Carreño-Quintero, Daniela Daza-Paz, Diana María González-Achury, Rosana Angélica Ramírez-Pedreros, Diego Armando Galvis-Sánchez, Luz Dary Terán-Mercado","doi":"10.1007/s40264-026-01662-w","DOIUrl":"10.1007/s40264-026-01662-w","url":null,"abstract":"<p><p>Pharmacovigilance in Latin America has witnessed notable progress in recent years, marked by advancements in regulatory frameworks, regional cooperation, and increased academic involvement. However, heterogeneity among countries, uneven institutional development, and limited resources still hinder its full impact on public health. In this context, the Latin American Chapter of the International Society of Pharmacovigilance (ISoP LATAM) has played a key role in organizing two regional symposia: Cartagena, Colombia (2023), and Merida, Mexico (2025). Through multidisciplinary roundtables and open forums, ISoP LATAM has brought together regulators, academia, healthcare professionals, researchers, patient organizations, and industry representatives to promote dialogue, identify opportunities, and propose measures to improve pharmacovigilance in the region. Discussion included regulatory harmonization and convergence, the adoption of international standards for risk management and safety reporting, and the integration of artificial intelligence and real-world evidence into pharmacovigilance systems. Participants emphasized the importance of addressing medication errors through a Human Factors/Ergonomics approach, strengthening the monitoring and regulation of biosimilars, and creating differentiated frameworks for recognizing therapeutic failures. The expansion of pharmaceutical care and the systematic inclusion of pharmacovigilance education across the health sciences' curriculum were highlighted as priorities. The reflections from these symposia emphasize the crucial role of ISoP LATAM in providing a platform for open and multidisciplinary discussions. Shifting the focus from solely regulatory topics to a broader public health perspective and expanding the agenda to include emerging fields such as pharmacogenomics, ecopharmacovigilance, and patient engagement-while ensuring fair access to technological innovations-will be vital for enhancing drug safety in Latin America.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"871-882"},"PeriodicalIF":5.9,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13354678/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147493768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Estimating the Prevalence of Prescribed Medication Use in Pregnancy with a Systematic Review and Meta-analysis.","authors":"Clare Sullivan, Aisling Kerr, Marie Cahill, Angela C Flynn, Fergal O'Shaughnessy, Brian Cleary, Kathleen Bennett","doi":"10.1007/s40264-026-01664-8","DOIUrl":"10.1007/s40264-026-01664-8","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Medication use in pregnancy is common, but decisions balancing the needs of maternal and fetal health can be complex. Ongoing monitoring of medication use in pregnancy is essential to ensure their continued safe and appropriate use in this population.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this review is to estimate the prevalence of prescribed medication use in pregnancy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This review was carried out in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was registered in the PROSPERO database (CRD42024533866). PubMed, Medline, Cinahl (EBSCO), APA PsychINFO (EBSCO), Embase (Ovid), Scopus, and Web of Science databases were systematically searched for relevant articles published from January 2010 to May 2025. Inclusion criteria specified that studies provided a value for prescribed medication use in the general population of pregnant women during part or all of the gestational period. Articles were independently dual screened, and relevant data were extracted and validated from included studies. Quality and bias of the studies were assessed using the Joanna Briggs Institute critical appraisal tool for prevalence studies. A narrative synthesis was conducted for all studies. A random-effects meta-analysis with logit transformation was used to pool prevalence estimates (95% confidence interval, CI) where sufficient studies defined medication use in a similar way. Cochran's Q, I&lt;sup&gt;2&lt;/sup&gt;, and τ&lt;sup&gt;2&lt;/sup&gt; were used to measure heterogeneity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 13,416 unique articles were identified and screened. Seventy studies were included. The pooled prevalence for prescribed medication alone during pregnancy was 56% (CI 44-67%, p &lt; 0.01, I&lt;sup&gt;2&lt;/sup&gt; = 100%, τ&lt;sup&gt;2&lt;/sup&gt; = 1.30), based on 23 studies and a population of 7.3 million. The pooled prevalence for prescribed medications alone for the first, second, and third trimesters was 31% (CI 22-40%, p &lt; 0.01, I&lt;sup&gt;2&lt;/sup&gt; = 100%, τ&lt;sup&gt;2&lt;/sup&gt; = 0.65) from 14 studies, 30% (CI 21-42%, p &lt; 0.01, I&lt;sup&gt;2&lt;/sup&gt; = 100%, τ&lt;sup&gt;2&lt;/sup&gt; = 0.56) from 9 studies, and 34% (CI 22-49%, p &lt; 0.01, I&lt;sup&gt;2&lt;/sup&gt; = 100%, τ&lt;sup&gt;2&lt;/sup&gt; = 0.77) from 8 studies, respectively. The pooled prevalence for prescribed medications including prescribed vitamins and minerals was 83% (CI 75-89%, p &lt; 0.01, I&lt;sup&gt;2&lt;/sup&gt; = 100%, τ&lt;sup&gt;2&lt;/sup&gt; = 1.66) based on 26 studies and a population of 4.9 million. For this more inclusive group, the pooled prevalence for the first, second, and third trimesters was 52% (CI 44-61%, p &lt; 0.01, I&lt;sup&gt;2&lt;/sup&gt; = 100%, τ&lt;sup&gt;2&lt;/sup&gt; = 0.46) from 14 studies, 56% (CI 42-70%, p &lt; 0.01, I&lt;sup&gt;2&lt;/sup&gt; = 100%, τ&lt;sup&gt;2&lt;/sup&gt; = 0.88), and 59% (CI 42-74%, p &lt; 0.01, I&lt;sup&gt;2&lt;/sup&gt; = 100%, τ&lt;sup&gt;2&lt;/sup&gt; = 1.25) both from 10 studies, respectively. Methods used to estimate prevalence varied greatly owing to differences in the definition of prescribed medi","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"899-920"},"PeriodicalIF":5.9,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13354688/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147590672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer's Disease: Timing and Duration of Adverse Events.","authors":"Anton P Porsteinsson, Sanjeda R Chumki, David Wang, Pedro Such, Anton M Palma, Zhen Zhang, Alpesh Shah, Uwa Kalu, C Brendan Montano","doi":"10.1007/s40264-026-01670-w","DOIUrl":"10.1007/s40264-026-01670-w","url":null,"abstract":"<p><strong>Introduction: </strong>Agitation symptoms are a common and burdensome aspect of Alzheimer's dementia. Historically, agitation has been managed using off-label treatments such as atypical antipsychotics, but this approach is associated with safety concerns in older, more vulnerable patients. Brexpiprazole is an atypical antipsychotic that has been recently approved in several countries for the treatment of agitation associated with dementia due to Alzheimer's disease. Previous analyses show that brexpiprazole was efficacious and generally well tolerated for up to 24 weeks. Building upon previous work, this post hoc analysis aimed to evaluate the timing and duration of treatment-emergent adverse events (TEAEs) during brexpiprazole treatment.</p><p><strong>Methods: </strong>In a 12-week analysis, data were pooled from three phase 3, randomized, double-blind, placebo-controlled trials of brexpiprazole in participants with agitation associated with dementia due to Alzheimer's disease. In a separate 24-week analysis, brexpiprazole data were combined from a 12-week randomized trial and a 12-week active-treatment extension trial. The median time from starting treatment to first reporting a TEAE and the median duration of all TEAEs were determined.</p><p><strong>Results: </strong>A total of 1043 participants received at least one dose of trial medication. Over 12 weeks, brexpiprazole 2 or 3 mg/day (the approved therapeutic dosages in the United States, N = 366) compared to placebo (N = 388) had similar time to first TEAE (32 days and 28 days, respectively), similar duration of all TEAEs (6 days and 4 days), and longer time to discontinuation due to adverse events (47 days and 30 days). Over 24 weeks (N = 163), the time to first TEAE on brexpiprazole 2 or 3 mg/day was 52 days, and the duration of all TEAEs was 3 days. Among participants who did not report a TEAE in the 12-week parent trial, TEAEs were rare throughout the 12-week extension trial.</p><p><strong>Conclusions: </strong>These exploratory analyses reinforce that brexpiprazole is generally well tolerated over 12 weeks, and also over 24 weeks among patients who tolerated the first 12 weeks of treatment. The results provide a practical clinical insight into the safety of brexpiprazole over time in patients with agitation associated with dementia due to Alzheimer's disease.</p><p><strong>Trial registration: </strong>Post hoc analysis of NCT01862640, NCT01922258, NCT03548584, NCT03594123 (ClinicalTrials.gov).</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"969-983"},"PeriodicalIF":5.9,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13354622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147644528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Scoping Review of Case-Level Causality Assessment Tools Developed Between 2008 and 2023; Strengths, Weaknesses and Potential Future Improvements.","authors":"Dawn Cooper, Mohammed Toseef Ansari, Taylor Aurelius, Amy Bobbins, Sandeep Dhanda, Christopher A Gravel, Manfred Hauben, Denise Morris, Kathryn Morton, Robert Platt, Eugene Van Puijenbroek, Alison Yeomans, Miranda Davies","doi":"10.1007/s40264-026-01665-7","DOIUrl":"10.1007/s40264-026-01665-7","url":null,"abstract":"<p><strong>Background: </strong>Various approaches to causality assessment have been developed that generally fall into the following three categories; expert judgement/global introspection, algorithms or probabilistic/Bayesian methods (or a combination of these). Causality assessment tools (CATs) are designed to assess the likelihood that a medicine has caused an adverse event in a specific individual.</p><p><strong>Objective: </strong>To provide an up-to-date assessment of existing CATs, the International Working Group on New Developments in Pharmacovigilance conducted a scoping review to identify CATs developed or updated between 2008 and 2023. The objective was to describe key components and strengths and weaknesses and to categorise CATs based on therapeutic area, clinical setting or patient population to support selection of the most appropriate tool within a specific context. We also discuss additional considerations for the assessment of adverse drug reactions seen with biologics.</p><p><strong>Methods: </strong>Searches were conducted in Embase and MEDLINE and to identify relevant grey literature. Review articles that described CATs developed between 1 January, 2008 until 31 December, 2023 (including updates to pre-existing CATs) were included. The key components of each CAT identified were extracted in addition to its strengths, weaknesses and other performance characteristics.</p><p><strong>Results: </strong>In total, 48 articles and 7 grey literature sources were eligible for inclusion; 18 CATs were identified, categorised as: global introspection (n = 1, 6%), algorithmic (n = 12, 67 %), hybrid (n = 4, 22%) and probabilistic (n = 1, 6 %). Algorithmic CATs included those for use in specific outcomes (severe cutaneous adverse reaction n = 1, drug-induced liver injury n = 4), or in specific populations/settings (paediatric n = 1, neonatal intensive care units n = 1). One CAT (World Health Organization tool for assessing adverse events following immunization, WHO-AEFI) was designed for use with vaccines.</p><p><strong>Conclusions: </strong>Causality assessment tools designed to assess certain outcomes, such as drug-induced liver injury and severe cutaneous adverse reaction, may benefit from the future inclusion of biomarkers as predictors of risk. For specific biologics, such as immune checkpoint inhibitors where there is a heightened risk of immune-mediated AEs, there may be a role for biomarkers to help identify immune checkpoint inhibitor-induced toxicity. Additional considerations for causality may include drug quality, potential for medication error and assessment of adherence to risk minimisation measures.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"883-897"},"PeriodicalIF":5.9,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147572783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incident Neutropenia in New Users of Different Non-opioid Analgesics: An Observational Propensity Score-Controlled Cohort Study.","authors":"Stephan Gut, Marlene Rauch, Jan Gaertner, Susan S Jick, Christoph R Meier, Julia Spoendlin","doi":"10.1007/s40264-026-01697-z","DOIUrl":"https://doi.org/10.1007/s40264-026-01697-z","url":null,"abstract":"<p><strong>Background: </strong>Nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol have been associated with neutropenia and agranulocytosis with inconsistent results.</p><p><strong>Objective: </strong>To investigate the risk of neutropenia in association with frequently used NSAIDs compared to paracetamol.</p><p><strong>Methods: </strong>We conducted a cohort study using the UK-based Clinical Practice Research Datalink (CPRD) GOLD. In three pairwise comparisons, we compared the risk of neutropenia including agranulocytosis (defined by Read codes) between new NSAID users (diclofenac, ibuprofen, and naproxen) and new paracetamol users (active comparator) during a maximum follow up of 60 days. Secondary and tertiary outcomes additionally included (1) in-patient diagnosed agranulocytosis and (2) laboratory values indicating neutropenia. Both were additionally restricted to only agranulocytosis. We applied propensity score-fine stratification to control for measured confounding and quantified incidence rates (IRs) as well as hazard ratios (HRs) with 95% confidence intervals (CIs).</p><p><strong>Results: </strong>Our weighted cohorts included 1,003,314 (paracetamol) to 2,207,612 (diclofenac) patients. Weighted IRs of neutropenia (primary outcome) were between 2.1/10,000 person years (PYs) and 2.3/10,000 PYs. HRs for the primary outcome ranged between 1.00 (95% CI 0.51-1.94) and 1.12 (95% CI 0.57-2.23) for NSAIDs versus paracetamol. The secondary and tertiary outcome yielded reduced HRs between 0.53 and 1.03, and even lower HRs when restricted to agranulocytosis (HR between 0.19 and 0.51).</p><p><strong>Conclusion: </strong>Our results indicate no risk of neutropenia for NSAIDs when compared to paracetamol. An increased risk of agranulocytosis in association with paracetamol is possible, but residual confounding by frailty may at least partially explain this association.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":5.9,"publicationDate":"2026-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148629713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation Science for Effective Risk Management of Medicines: A Call for Global Action.","authors":"Meredith Y Smith, Priya Bahri, Delese Mimi Darko, Alex N O Dodoo, Adrien Inoubli, Elaine H Morrato, Christine Perera, Shanti Pal","doi":"10.1007/s40264-026-01702-5","DOIUrl":"https://doi.org/10.1007/s40264-026-01702-5","url":null,"abstract":"<p><p>Pharmaceutical risk minimization, as an essential element of pharmacovigilance, aims to reduce medicinal product risks in order to improve a product's benefit-risk profile. However, to date the practical application of risk minimization has proved challenging. In particular, risk minimization standards developed by and for high-income countries have been shown to have limited suitability in low and middle income countries (LMICs) and high-income countries have struggled to deliver these programs with consistently high quality and demonstrable long-term impact. The World Health Organization's new 2025 framework for pharmacovigilance-'The Global Smart Pharmacovigilance Strategy'-calls for developing comprehensive and sustainable safety monitoring and risk management practices as integral components of healthcare and regulatory systems in all member countries globally. The field of implementation science offers a robust set of approaches to address current gaps and challenges in risk minimization, one that can help meet the needs of twenty-first century pharmacovigilance. We call for the convening of an internationally representative expert forum to develop a pragmatic framework and set of recommendations regarding the application of implementation science good practices to advance risk minimization for medicinal products globally. The framework and recommendations should be practical, sustainable and equally applicable for use in LMIC and high-income countries. In addition, the framework and recommendations should be accompanied by a blueprint for implementation science capacity building as well as a dissemination plan for promoting uptake of the framework and recommendations by industry and regulatory authorities worldwide.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":5.9,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148629694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges and Opportunities for Signal Detection During Public Health Emergencies: An Historical Re-evaluation of the Disproportionality Analysis of the ADR Reporting of Anti-COVID-19 Monoclonal Antibodies in Vigibase.","authors":"Nicoletta Luxi, Chiara Bellitto, Francesco Ciccimarra, Fabio Scapini, Elena Arzenton, Francesco Maccarrone, Ugo Moretti, Emanuel Raschi, Elisabetta Poluzzi, Daniele Focosi, Jacopo Angelini, Pasquale De Nardo, Alessia Savoldi, Evelina Tacconelli, Gianluca Trifirò, Marco Tuccori","doi":"10.1007/s40264-026-01705-2","DOIUrl":"https://doi.org/10.1007/s40264-026-01705-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Anti-spike monoclonal antibodies (mAbs) for early treatment of COVID-19 represented a significant improvement in the pharmacological management of the SARS-COV-2 pandemic, especially in early phases, but the continuous emergence of novel virus variants of concern (VoC) required a rapid and continuous benefit-risk assessment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To identify possible unexplored safety signals of anti-SARS-CoV-2 mAbs through disproportionality analysis using VigiBase, the World Health Organization (WHO) global pharmacovigilance database.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a disproportionality analysis of VigiBase (February 2020-December 2023). All de-duplicated individual case safety reports (ICSRs) for bamlanivimab, bamlanivimab/etesevimab, casirivimab/imdevimab, regdanvimab, sotrovimab, and tixagevimab/cilgavimab were retrieved. Descriptive analyses of ICSRs and distribution of suspected adverse drug reactions across VoC-defined periods (Alpha, Delta, Omicron) were performed. Disproportionality analysis was conducted and reported in accordance with the READUS-PV guideline. Reporting odds ratios (RORs) with 95% confidence intervals (CI) were calculated at the MedDRA Preferred Term (PT) level, using the entire database as reference (excluding vaccines). Statistically significant drug-adverse reaction pairs included in the EMA Important Medical Event (IME) list and not described in the Summary of Product Characteristics (SmPC) were identified as potential safety signals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among 15,250 de-duplicated ICSRs, casirivimab/imdevimab accounted for the majority of reports (33.5%). Most cases involved female patients aged 45-64 years, predominantly reported from the Americas. Overall, 42,799 drug-adverse reaction pairs were identified, 33,948 (79.3%) of which were identified after filtering out, and 3047 (9.0%) were IMEs. Eighty-three unique drug-adverse reaction pairs had a statistically significant RORs, among which 56 (67.5%) were not listed in the SmPC. Bamlanivimab, as both monotherapy and in combination with etesevimab, showed increased reporting of several cardiac adverse events, including acute myocardial infarction (MI) and cardiac arrest. For tixagevimab/cilgavimab, disproportionality was found for acute MI (N = 6; ROR 12.7, 95% CI 5.7-28.4) and atrial fibrillation (N = 29; ROR 9.0, 95% CI 6.2-13.0). For regdanvimab, disproportionality emerged for hypokalemia (N = 13; ROR 5.8, 95% CI 3.4-10.1). For casirivimab/imdevimab, 5 out of 15 PTs were classified as adverse event of special interest: seizure-like phenomena (N = 8; ROR, 44.2; 95% CI 21.9-89.1), Guillain-Barré syndrome (N = 6; ROR 13.4, 95% CI 6.0-30.0), encephalopathy (N = 13; ROR 5.4, 95% CI 3.1-9.3), generalized tonic-clonic seizure (N = 9; ROR 5.0, 95% CI 2.6-9.7), and seizure (N = 57; ROR 3.1, 95% CI 2.4-4.0).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;This analysis identified potential cardiovascular and neuro","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":5.9,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148561169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Presence of Benzodiazepines in Aquatic Environments: A Systematic Review of the Literature.","authors":"Jacopo Grisotto, Irene Cristini, Salvatore Crisafulli, Francesco Ciccimarra, Francesca Patuzzi, Federica Soardo, Elisabetta Mariavittoria Giunco, Giovanna Paolone, Gianluca Trifirò","doi":"10.1007/s40264-026-01703-4","DOIUrl":"https://doi.org/10.1007/s40264-026-01703-4","url":null,"abstract":"<p><strong>Introduction: </strong>Pharmaceuticals in aquatic environments are a growing environmental concern. Because of their widespread use and poor removal by conventional wastewater treatment, benzodiazepines are frequently detected in treated effluents.</p><p><strong>Objective: </strong>To synthesise global evidence on the occurrence and distribution of benzodiazepines and their metabolites across the urban water cycle.</p><p><strong>Methods: </strong>The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed in performing this systematic review. Bibliographic databases PubMed (including PubMed Central and Medline), Embase and Scopus were searched, from the inception date to July 26th, 2024, using query terms related to benzodiazepines (BDZs) and water pollution. Titles, abstracts and full text of the articles were independently evaluated by six review authors.</p><p><strong>Results: </strong>Of 1973 records identified, 119 studies published between 2001 and 2024 met the inclusion criteria. Most research (N = 102) was conducted in European countries, followed by Asia (N = 29), America (N = 16), Africa (N = 5) and Australia (N = 2). Reported BDZ concentrations varied widely across the included studies, ranging from below analytical detection limits to several thousand ng/L, depending on the specific compound, sampling strategy, analytical technique, and environmental matrix. Most of the included studies searched BDZs in surface water (N = 61), followed by wastewater treatment plants (WWTP) effluents (N = 47) and WWTP influents (N = 40). Diazepam (N = 64 studies), oxazepam (N = 58 studies), lorazepam (N = 45 studies), temazepam (N = 31 studies) and alprazolam (N = 29 studies) were the most frequently detected compounds.</p><p><strong>Conclusion: </strong>Global data highlight the need for standardised monitoring frameworks, targeted sources mitigation, and advanced water treatment technologies capable of efficiently removing chemically stable pharmaceutical compounds. Strengthening these approaches is essential to reduce ecological risks, minimise human exposure, and safeguard the long-term integrity of aquatic ecosystems.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":5.9,"publicationDate":"2026-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148548214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}