Drug Safety最新文献

{"title":"Ponatinib Safety Profile: An Analysis of 10 Years of Real-World Experience.","authors":"Elias Jabbour, Fausto Castagnetti, Mouna Bardey-Kanaan, Romuald Soichez, Nhan Thanh Nguyen, Deborah Kelly, Federica Rizzo, Petros Patos, Valentín García-Gutiérrez","doi":"10.1007/s40264-026-01695-1","DOIUrl":"10.1007/s40264-026-01695-1","url":null,"abstract":"<p><strong>Introduction: </strong>Ponatinib is a third-generation BCR::ABL1 tyrosine kinase inhibitor indicated for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Following its initial commercial availability in the USA on 14 December 2012, safety concerns, notably vascular occlusive events, led to the implementation of post-approval risk-management measures (RMMs).</p><p><strong>Objective: </strong>This retrospective study assessed the impact of these measures on adverse event (AE) reporting rates for ponatinib's important identified risks (IIRs).</p><p><strong>Methods: </strong>AEs related to ponatinib's IIRs were identified from the Incyte Global Safety Database for the period 14 December 2012 to 13 December 2022, using a Medical Dictionary for Regulatory Activities-based search of postmarketing reports. Reporting rates were calculated as the ratio of reported AEs to estimated postmarketing exposure.</p><p><strong>Results: </strong>During the first year of commercialization, the most frequently reported AEs for ponatinib pertained to the IIRs of myelosuppression, skin reactions, infections, and arterial occlusive events, with reporting rates of 0.505, 0.362, 0.330, and 0.291, respectively. Following implementation of post-approval RMMs in December 2013, reporting rates of these IIRs decreased considerably during the first 2 years of commercialization. By the end of year 10, reporting rates of these IIRs further decreased to 0.043, 0.030, 0.045, and 0.038, respectively. Notably, reporting rates for each IIR across the 10-year period were considerably lower than the reporting rates observed during the first year of ponatinib commercialization.</p><p><strong>Conclusion: </strong>This study shows declining AE reporting rates for ponatinib's IIRs since it first became commercially available, potentially because of the implementation of RMMs and increased clinicians' awareness.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1525-1533"},"PeriodicalIF":5.9,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13668898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148497311","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":"When does Follow-up on Adverse Events Improve the Understanding of Medicine and Vaccine Safety? Insights from Global Expert Perspectives.","authors":"Vijay Kara, Florence Van Hunsel, Manal Younus, Manfred Hauben, Andrew Bate, Eugène van Puijenbroek","doi":"10.1007/s40264-026-01691-5","DOIUrl":"10.1007/s40264-026-01691-5","url":null,"abstract":"<p><strong>Introduction and objective: </strong>Adverse events (AEs) reported with medicines and vaccines form the foundation of pharmacovigilance (PV), enabling the detection, assessment, and prevention of drug-related risks. Initial AE reports often lack relevant clinical detail, limiting their utility. Follow-up is used to obtain additional information but is resource-intensive. Spontaneous reporting systems receive large volumes of reports and follow-up yields additional information in only a proportion of cases. Given these volumes and variable yield, it is important to define when follow-up is most likely to add value and when it is likely to be low-yield or futile. This study aimed to identify scenarios where follow-up on AEs meaningfully improves the understanding of medicine and vaccine safety, and to delineate circumstances when it may be less beneficial or futile.</p><p><strong>Methods: </strong>A Delphi based methodology was used to systematically gather expert consensus on scenarios in which follow-up of AE reports enhances the understanding of medicine and vaccine safety.</p><p><strong>Results: </strong>Data saturation was achieved after ten interviews. Panel members identified three primary scenarios in which follow-up adds value in PV: supporting causality assessment, strengthening signal detection and monitoring, and informing risk management and public health actions. They saw questionable or no value in follow up of well-characterised labelled events, cases in which the reporter cannot be contacted or did not consent to further contact, and settings where additional data were unlikely to alter benefit-risk.</p><p><strong>Conclusion: </strong>This study characterises expert perspectives on when follow-up activities are most likely to provide actionable value. Our results indicate that follow-up improves understanding when it resolves clinical uncertainty, but is inefficient when pursued without regard to impact, supporting a shift to proportionate, purpose-driven follow-up strategies for consistent and efficient use of resources including criteria for prioritisation and de-prioritisation.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1477-1491"},"PeriodicalIF":5.9,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13668932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148758489","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":"Phloroglucinol Exposure During Early Pregnancy and Risk of Major Congenital Malformations: A Nationwide Cohort Study in France.","authors":"Antoine Meyer, Alain Weill, Antoine Rachas, Perrine Capmas, Rosemary Dray-Spira","doi":"10.1007/s40264-026-01689-z","DOIUrl":"10.1007/s40264-026-01689-z","url":null,"abstract":"<p><strong>Background and aims: </strong>Phloroglucinol is a spasmolytic drug widely prescribed in France for gastrointestinal or pelvic pain, and frequently used during pregnancy despite limited evidence regarding its safety. We aimed to evaluate the association between first-trimester phloroglucinol exposure and the risk of major congenital malformations (MCMs) in a nationwide cohort.</p><p><strong>Methods: </strong>Using data from the French EPI-MERES cohort based on the national health data system (SNDS), we identified all pregnancies ending after 22 weeks between 2010 and 2022, excluding women with phloroglucinol use in the year before pregnancy. We compared the risks of 68 MCM subtypes according to exposure during gestational weeks 3-12. Adjusted odds ratios (aORs) were estimated using logistic regression controlling for maternal sociodemographic, medical and pregnancy characteristics. Interpretation relied on effect size (aOR > 1.30) and consistency across sensitivity analyses.</p><p><strong>Results: </strong>Among 6,233,539 pregnancies, 1,024,369 (16.4%) were exposed to phloroglucinol. There were 19,635 MCM cases among children exposed to phloroglucinol and 91,693 among those unexposed (overall aOR 1.05, 95% CI 1.04-1.07). Six rare malformations showed isolated elevated risk estimates: tricuspid stenosis (aOR 1.37, 95% CI 0.96-1.94), Ebstein anomaly (aOR 1.43, 95% CI 0.99-2.06), double outlet left ventricle (aOR 1.60, 95% CI 0.83-3.09), indeterminate sex and pseudohermaphroditism (aOR 1.32, 95% CI 1.05-1.66), anencephaly and similar malformations (aOR 1.55, 95% CI 0.95-2.52), and arhinencephaly/holoprosencephaly (aOR 1.90, 95% CI: 0.97-3.72). However, these findings were not consistent across sensitivity analyses.</p><p><strong>Conclusions: </strong>In this large nationwide cohort, first-trimester exposure to phloroglucinol was not associated with a clinically meaningful increase in the risk of major congenital malformations.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1493-1504"},"PeriodicalIF":5.9,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13668959/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148758214","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":"Availability and Communication of Risk Management Strategies for Pregnancy Category X Medicines across Australian Medicine Information Sources.","authors":"Helen Mayer, Jacquelina Stasinopoulos, Bronni Simpson, Jessica Gehlert, Luke E Grzeskowiak","doi":"10.1007/s40264-026-01692-4","DOIUrl":"10.1007/s40264-026-01692-4","url":null,"abstract":"<p><strong>Background: </strong>Category X medicines are those which have such a high risk of causing foetal harm that they are contraindicated in pregnancy. When used in reproductive age women, risk management strategies are warranted to reduce unintended pregnancy exposure.</p><p><strong>Objective: </strong>To identify documentation of pregnancy risk management strategies for Category X medicines across Australian medicine information sources.</p><p><strong>Method: </strong>The TGA Prescribing Medicines in Pregnancy Database (PMPD) was searched to identify Category X medicines licensed for indications relevant to reproductive age women. For each Category X medicine included in this evaluation, regulatory documents (Product Information [PI] and Consumer Medicine Information [CMI]) and corresponding monographs/chapters in clinical resources (Australian Medicines Handbook [AMH] and Therapeutic Guidelines [TG]) were reviewed for boxed warnings relating to pregnancy risks, pregnancy testing and contraception recommendations, and formal pregnancy prevention programs.</p><p><strong>Results: </strong>Thirty-nine Category X medicines were retrieved through the TGA PMPD, 19 of which met the inclusion criteria. Boxed warnings documenting pregnancy risks were present for 47% (9/19) of medicines. Pregnancy testing and contraception recommendations appeared in most PIs and CMIs (89%, 17/19), as well as in 15 of 17 (88%) medicines listed in the AMH, but were only present for one of 12 (8%) medicines listed in the TG. Structured pregnancy prevention programs exist for only 16% (3/19) of medicines.</p><p><strong>Conclusions: </strong>Pregnancy risk management strategies for Category X medicines are inconsistently employed across Australian medicine information sources. Improving the quality and consistency of pregnancy risk management strategies is necessary to avoid harms from inadvertent exposure during pregnancy.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1465-1475"},"PeriodicalIF":5.9,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13669030/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148359984","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":"Sexual Dysfunction Among Males Living with HIV Receiving Dolutegravir-Based Antiretroviral Therapy in Uganda: A Cross-sectional Study.","authors":"Ronald Kiguba, Mishael Ssesanga, Eva Agnes Laker Odongpiny, Munir Pirmohamed","doi":"10.1007/s40264-026-01694-2","DOIUrl":"10.1007/s40264-026-01694-2","url":null,"abstract":"<p><strong>Background: </strong>Dolutegravir, the anchor drug of combination antiretroviral therapy (cART), has been associated with sexual dysfunction. We have evaluated the burden, correlates and nature of sexual dysfunction among Ugandan males living with HIV receiving dolutegravir-based antiretroviral therapy.</p><p><strong>Methods: </strong>In a cross-sectional study in one health centre, we collected sociodemographic and clinical data via structured interviews, undertook clinical examinations and performed data abstraction from electronic medical records. Sexual function was evaluated using the International Index of Erectile Function and the Changes in Sexual Functioning Questionnaire. Modified Poisson regression was utilised to estimate prevalence ratios (PRs), modelling dolutegravir exposure as the primary independent variable while adjusting for sociodemographic and clinical factors as secondary covariates.</p><p><strong>Results: </strong>The prevalence of erectile dysfunction among males receiving dolutegravir-based cART for >  1 day to 6 months was twice that of cART-naive males (59% vs 26%) and plateaued thereafter. Dolutegravir exposure was associated with erectile dysfunction with adjusted PRs >  2 at all timepoints (> 1 day to >  2 years) compared with cART-naïve males. Older age, living with a partner, self-reported adherence, and moderate-to-severe depression were also associated with sexual dysfunction. Sexual desire frequency dysfunction was associated with dolutegravir exposure among males receiving dolutegravir for >  1 day to 6 months (PR 1.15, 95% CI 1.05-1.26) versus >  2 years.</p><p><strong>Conclusions: </strong>Dolutegravir is associated with transient central sexual desire suppression and persistent peripheral erectile dysfunction. This has the potential to lead to non-adherence and virological rebound, which needs to be monitored to safeguard the long-term success of cART.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1505-1514"},"PeriodicalIF":5.9,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13668911/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148430082","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":"Safety of Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: A Longitudinal Analysis.","authors":"Kuan Peng, Vincent K C Yan, Shirley C W Chan, Ju-Young Shin, Edward Chia-Cheng Lai, Nicole L Pratt, Esther W Y Chan, Chak-Sing Lau, Xue Li","doi":"10.1007/s40264-026-01687-1","DOIUrl":"10.1007/s40264-026-01687-1","url":null,"abstract":"<p><strong>Background: </strong>Biologic and targeted synthetic disease-modifying antirheumatic drugs effectively manage rheumatoid arthritis but are associated with varying risks of adverse events.</p><p><strong>Objective: </strong>Comparing the risk of key clinical events across biologic and targeted synthetic disease-modifying antirheumatic drugs to guide safer prescribing behavior.</p><p><strong>Methods: </strong>A population-based cohort study analysed patients with rheumatoid arthritis initiated on one of 12 biologic and targeted synthetic disease-modifying antirheumatic drugs (2009-22) in Hong Kong, with adverse events assessed over 5 years, including major adverse cardiovascular events, infections, malignancies, diabetes mellitus, depression, hospitalisation and all-cause mortality. Marginal structural models with inverse probability weighting addressed time-varying confounding and selection bias. Death was treated as a competing risk, and Bonferroni correction accounted for multiple comparisons.</p><p><strong>Results: </strong>Among 2697 patients with rheumatoid arthritis (4276 treatment episodes), the estimated 5-year cumulative probability of adverse events were broadly comparable across biologic and targeted synthetic disease-modifying antirheumatic drugs: with hospitalisation that ranged from 0.48 (95% confidence interval 0.271, 0.636) for baricitinib to 0.726 (0.665, 0.785) for tocilizumab; mortality from 0.028 (0.002, 0.049) for adalimumab to 0.07 (0.03, 0.118) for abatacept; major adverse cardiovascular events from 0.025 (0.004, 0.046) for golimumab and 0.025 (0.007, 0.046) for adalimumab to 0.072 (0.035, 0.107) for abatacept; infection from 0.213 (0.15, 0.265) for etanercept to 0.389 (0.17, 0.664) for rituximab; malignancy from 0.012 (0, 0.028) for abatacept to 0.116 (0, 0.309) for baricitinib; diabetes from 0.018 (0.003, 0.03) for etanercept to 0.079 (0.015, 0.152) for golimumab; depression from 0 (no events recorded) for baricitinib to 0.029 (0, 0.09) for rituximab; and gastritis from 0.041 (0, 0.078) for baricitinib to 0.114 (0.075, 0.157) for tofacitinib. Risks were compared with etanercept to estimate risk differences, which is the most frequently prescribed agent in Hong Kong with a well-documented safety profile. Tocilizumab was associated with a higher hospitalisation risk (risk difference 0.205; 95% confidence interval 0.104, 0.299) and tofacitinib was associated with a higher gastritis risk (risk difference 0.055; 95% confidence interval 0.001, 0.105).</p><p><strong>Conclusions: </strong>This study demonstrates broadly similar safety profiles among Biologic and targeted synthetic disease-modifying antirheumatic drugs after rigorous adjustment, alleviating concerns about severe adverse events. These findings provide clinicians with evidence to make informed treatment decisions for patients with rheumatoid arthritis.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1435-1451"},"PeriodicalIF":5.9,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13668902/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148338391","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":"The Bidirectionality of Lawyer Reporting Bias in Disproportionality Analysis.","authors":"Manfred Hauben, Rave Harpaz","doi":"10.1007/s40264-026-01690-6","DOIUrl":"10.1007/s40264-026-01690-6","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1429-1433"},"PeriodicalIF":5.9,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148360015","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":"Transient Oral Corticosteroid Use and Acute Upper Gastrointestinal Bleeding in Mild-to-Moderate Asthma: A Case-Crossover Study.","authors":"Jiaying Li, Pierre Ernst, Samy Suissa","doi":"10.1007/s40264-026-01699-x","DOIUrl":"10.1007/s40264-026-01699-x","url":null,"abstract":"<p><strong>Background: </strong>Sustained exposure to oral corticosteroids (OCS) increases the risk of upper gastrointestinal bleeding (UGIB). It is uncertain whether short-term OCS treatment of asthma exacerbations increases this risk. This study aims to estimate the risk of acute UGIB after transient OCS use in patients with mild-to-moderate asthma.</p><p><strong>Methods: </strong>We used a case-crossover design within a cohort of patients with mild-to-moderate asthma, aged 18-40 years during 2000-2023, from the UK's Clinical Practice Research Datalink. Subjects who experienced a first severe UGIB formed the case series. Short-term OCS was defined by a prescription for ≤ 14 days, with a 30-day residual effect period. For each case, the UGIB event date and 6 control dates, selected at 45-day intervals in the prior year, were considered exposed if the prescription spanned the date. The odds ratio (OR) of UGIB was estimated using conditional logistic regression, adjusted for time-varying use of asthma inhalers and medications related to bleeding risks. Findings The cohort involved 655,217 patients with mild-to-moderate asthma, with 743 experiencing a first UGIB who received 1160 OCS prescriptions in the past year. The crude and adjusted ORs of UGIB after OCS use versus non-use was 1.12 (95% confidence interval [CI]: 0.92-1.37), and 1.12 (95% CI: 0.91-1.36), respectively. Higher OCS-related UGIB risk was observed during periods of no inhaled corticosteroid (ICS) use, but not during periods of regular ICS use.</p><p><strong>Conclusion: </strong>Short-term OCS use does not increase UGIB risk in patients with mild-to-moderate asthma. There may be interaction between OCS and ICS in affecting UGIB risk in this patient population.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1515-1523"},"PeriodicalIF":5.9,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148561202","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 Aspects of a Medicines Shortage Policy Tool: Evidence from Australia's Serious Scarcity Substitution Instruments.","authors":"Jack Janetzki, Lisa Kalisch-Ellett, Nicole Pratt, Anna Kemp-Casey","doi":"10.1007/s40264-026-01693-3","DOIUrl":"10.1007/s40264-026-01693-3","url":null,"abstract":"<p><strong>Background: </strong>Medication shortages are a considerable and ongoing issue in healthcare, disrupting consumer access to medicines. Since 2021, Australia's national medicines regulator has issued Serious Scarcity Substitution Instruments (SSSIs), allowing pharmacists to substitute a specific therapeutically equivalent strength and/or formulation of a medicine without prior approval from a prescriber. The impact of SSSIs on utilisation of medicines has not been investigated.</p><p><strong>Objective: </strong>To determine whether SSSIs are effective in addressing medicine shortages and meeting patients' needs.</p><p><strong>Methods: </strong>This retrospective cohort study used aggregated pharmacy claims to examine the utilisation of 12 medicines, which had an SSSI. We calculated the percentage change in defined daily doses dispensed per 1000 population per day in the 11 months after SSSI implementation, compared with the previous 2 years. A percentage change of less than 20% was used to indicate success.</p><p><strong>Results: </strong>Following medicine shortages, utilisation fell for 10 of the 12 medicines examined. For eight of these medicines (amoxicillin, cefalexin, estradiol, fluoxetine, insulin degludec with insulin aspart, isosorbide mononitrate, vigabatrin, and warfarin) decreases in utilisation were minimised to < 20%. On average, SSSIs where all permitted substitute products were scarce (e.g., abatacept) were associated with larger decreases in use (between - 22 and - 68%) than those for which none or only some of the substitutes were in shortage (between - 45 and + 7%, respectively).</p><p><strong>Conclusions: </strong>While product shortages led to decreases in medicines consumption, SSSIs appeared to be successful in limiting decreases. However, SSSIs were less likely to be successful when many of the permitted substitute products were also scarce.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1453-1464"},"PeriodicalIF":5.9,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13668942/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148374861","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":"Strengthening Signal Detection by Proactive Adverse Event Case Identification in Electronic Health Records Using a Text-Mining Tool.","authors":"Gabriëlla von Kreijfelt, Juliëtte Zwaveling, Jette A van Lint, Loes E Visser, Agnes C Kant","doi":"10.1007/s40264-026-01739-6","DOIUrl":"https://doi.org/10.1007/s40264-026-01739-6","url":null,"abstract":"<p><strong>Background: </strong>The spontaneous reporting system is the cornerstone of pharmacovigilance but is limited by substantial underreporting, which may delay safety signal detection.</p><p><strong>Objective: </strong>The aim of this study was to evaluate the electronic health record-adverse event search method for identifying and reporting additional potential adverse drug reactions in electronic health records to strengthen routine signal detection.</p><p><strong>Methods: </strong>Between August 2022 and August 2025, targeted searches for adverse drug reactions were conducted in approximately 2,750,000 electronic health records from two Dutch hospitals using a data collection text-mining tool. Search criteria were derived from information in spontaneous reports of specific drug-adverse event associations. Structured (e.g. laboratory results, medication prescriptions) and unstructured (e.g. clinical notes, hospital discharge letters) data were used to identify potential adverse drug reactions. Identified cases were manually verified and, when relevant, reported to the Netherlands Pharmacovigilance Centre Lareb and analysed alongside spontaneous reports for signal detection.</p><p><strong>Results: </strong>A total of 147 electronic health record-derived cases were reported for 41 drug-adverse event associations. These contributed to 34 signal detection analyses, supporting the assessment of seven safety signals. In 75% of the cases, a suspected causal relationship was documented by healthcare professionals in clinical notes. Electronic health record-derived cases accounted for up to 73% of the reports included in the seven detected signals.</p><p><strong>Conclusions: </strong>This study demonstrates that electronic health records can be used as an additional source of individual case safety reports in routine pharmacovigilance practice, supporting the further assessment of selected potential safety signals. Despite limitations related to efficiency, this proactive approach has potential to address underreporting and complement the spontaneous reporting system, strengthening signal detection.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":5.9,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149227409","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}