Drug Safety最新文献

{"title":"Development and Validation of a Two-Stage NLP System Combining Rule-Based Extraction and LLM-Based Classification for Deprescribing Recommendations in Discharge Summaries.","authors":"Kenji Fujita, Marion Matheson, Bhavya Valecha, Sarah N Hilmer","doi":"10.1007/s40264-026-01716-z","DOIUrl":"https://doi.org/10.1007/s40264-026-01716-z","url":null,"abstract":"<p><strong>Introduction: </strong>Polypharmacy in older adults is associated with increased risks of adverse drug events and functional decline. Discharge summaries often contain deprescribing recommendations, but these are frequently overlooked due to documentation complexity.</p><p><strong>Objective: </strong>The aim of this study was to develop and validate a two-stage hybrid natural language processing (NLP) system combining rule-based extraction and large language model (LLM)-based classification for automated identification of deprescribing recommendations from discharge summaries.</p><p><strong>Methods: </strong>This retrospective cohort study included 850 discharge summaries from patients aged ≥ 65 years with hospitalisation for ≥ 48 h across six public hospitals in New South Wales, Australia. Model 1 (rule-based extraction) identified discharge medications and candidate sentences containing pre-defined deprescribing keywords. Model 2 (LLM-based classification) categorised candidate sentences into five categories, from which a binary outcome (deprescribing recommendation present versus absent) was derived using a pre-specified mapping. Data were split into training (80%) and test (20%) sets. Gold standard classifications were established by independent reviews, followed by adjudication of discrepancies.</p><p><strong>Results: </strong>Model 1 extracted 9631 discharge medications (median 11 per patient) and 1061 candidate sentences from 850 patients (median age 82.8 years). Model 2 achieved an F1 score of 0.91 and accuracy of 0.90 for the binary outcome in the test set (144 medications). Inter-rater reliability showed substantial agreement (Cohen's kappa 0.70). The most frequently identified medications recommended for deprescribing were antibiotics and opioids. The most common misclassification was incorrectly identifying actions completed during hospitalisation as post-discharge recommendations. The combined processing time averaged 12.6 seconds per discharge summary.</p><p><strong>Conclusions: </strong>A two-stage hybrid approach combining rule-based extraction and open-source LLM-based classification could identify deprescribing recommendations from discharge summaries, enabling cost-efficient, privacy-compliant local deployment.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":5.9,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148886263","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":"Communicating Drug Safety and Safe Use Conditions in Risk Evaluation and Mitigation Strategy Materials.","authors":"Ameet Sarpatwari, Frazer A Tessema, Mayookha Mitra-Majumdar, Su Been Lee, Heidi Zakoul, Beatrice L Brown, Gita A Toyserkani, Kate Heinrich Oswell, Cynthia LaCivita, Gerald J Dal Pan, Steven Woloshin, Jerry Avorn, Aaron S Kesselheim","doi":"10.1007/s40264-026-01721-2","DOIUrl":"https://doi.org/10.1007/s40264-026-01721-2","url":null,"abstract":"<p><strong>Introduction: </strong>The FDA requires Risk Evaluation and Mitigation Strategy (REMS) programs for certain drugs with serious safety risks.</p><p><strong>Objective: </strong>The aim of this study was to analyze the structure, readability, and informational content of educational materials used in REMS programs to assess their potential to communicate drug-related risks and support safe use for 13 drugs with active REMS programs as of 2021.</p><p><strong>Methods: </strong>Materials were collected from manufacturers' REMS websites between July 2021 and February 2022. From patient-, prescriber-, and pharmacist-facing documents-including fact sheets, guides, training materials, enrollment forms, and knowledge assessments-we extracted audience targeting; Flesch-Kincaid readability scores; estimated reading time; inclusion of REMS goals, drug indications, risks, and benefits; presence of comprehension assessments and reporting mechanisms. Results REMS packages contained a median of 14 documents (range 4-23) and 69 pages (range 8-414). All programs targeted prescribers and pharmacists, while 12 targeted patients. The median Flesch-Kincaid reading level was 10.5 for patient materials, 12.7 for prescriber materials, and 12.5 for pharmacist materials. Reading time varied, with patient-directed materials requiring a median of 18:08 min per drug. REMS-specific risks were discussed in a median 80% of documents, while drug indications were noted in a median of 33%, and efficacy or other safety concerns were often not included. Ten (77%) programs included comprehension assessments, and 10 (77%) provided patient enrollment forms. Adverse event reporting instructions were inconsistent. Conclusions REMS educational materials varied in length, complexity, and content, often exceeding recommended readability levels for patient-directed materials. Streamlining content and enhancing clarity and completeness may improve comprehension and support safe use of REMS-covered drugs.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":5.9,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148879581","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":"Esketamine Use and Attempted Suicide or Intentional Self-Harm Among Individuals with Treatment-Resistant Depression: A Retrospective Cohort Study.","authors":"You Wang, Alexandra S Storaci, G Caleb Alexander, Jason B Gibbons","doi":"10.1007/s40264-026-01722-1","DOIUrl":"https://doi.org/10.1007/s40264-026-01722-1","url":null,"abstract":"<p><strong>Background: </strong>Treatment-resistant depression (TRD) is associated with elevated suicide risk, but real-world evidence on whether esketamine reduces suicide attempts and intentional self-harm remains limited.</p><p><strong>Objective: </strong>The aim was to estimate whether current esketamine exposure was associated with a higher or lower risk of recorded nonfatal, medically attended suicide attempt or intentional self-harm among adults with TRD using a large, real-world administrative claims database.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using a nationwide, multipayer administrative claims database from January 2015 through June 2025. Among 1,574,657 adults eligible for matching, patients initiating esketamine after TRD were matched to up to three controls using risk-set propensity score matching. A marginal structural model combined a baseline esketamine treatment probability weight accrued from TRD to index with longitudinal inverse probability of treatment weights. Follow-up continued through month 18.</p><p><strong>Results: </strong>The final cohort of complete 3:1 matched sets included 23,140 patients, comprising 5785 treated patients and 17,355 controls, who contributed 295,137 patient-months. Current esketamine exposure was not associated with a statistically distinguishable difference in recorded nonfatal, medically attended suicide attempt or intentional self-harm. The hazard ratio (HR) was 1.017, the 95% confidence interval (CI) was 0.670-1.544, and p = 0.938. In the within-treated analysis, the pooled current-exposure HR was 0.718 (95% CI 0.456-1.130; p = 0.152). In the secondary full-cohort analysis, the estimate per additional cumulative exposed calendar month was 1.039 (95% CI 0.999-1.081; p = 0.057) and the carryover joint test was nonsignificant (p = 0.893).</p><p><strong>Conclusions: </strong>Current esketamine exposure was not associated with a statistically distinguishable difference in recorded nonfatal, medically attended suicide attempt or intentional self-harm. The CI remained compatible with clinically meaningful benefit and harm.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":5.9,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148879600","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":"Current Challenges in Monitoring the Safety and Utilisation of the Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs): A UK Perspective.","authors":"Miranda Davies, Linda Härmark","doi":"10.1007/s40264-026-01676-4","DOIUrl":"10.1007/s40264-026-01676-4","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1005-1008"},"PeriodicalIF":5.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147835171","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":"Pharmacovigilance Regulatory Requirements for the Natural Health Products (NHPs) Industry in World Health Organization-Defined High Health Expenditure Countries (2020): A Scoping Review.","authors":"Xin Yi Lim, Sanyogita Ram, Shane Scahill, Joanne Barnes","doi":"10.1007/s40264-026-01674-6","DOIUrl":"10.1007/s40264-026-01674-6","url":null,"abstract":"<p><strong>Background: </strong>Pharmacovigilance is the science and practice of safety monitoring for medicines-related problems; it is also applicable to a broader scope of health products, including natural health products (NHPs). The NHPs industry is a key stakeholder in pharmacovigilance for NHPs, but academic review of regulatory requirements concerning pharmacovigilance for the NHPs industry is limited.</p><p><strong>Objectives: </strong>To map, describe and compare regulatory requirements for the NHPs industry regarding pharmacovigilance for NHPs in selected international jurisdictions.</p><p><strong>Methods: </strong>The top 30 countries/regions from the World Health Organization's (WHO) list of nations with the highest Current Health Expenditure in 2020 were identified. For these countries/regions, publicly accessible regulatory instruments describing pharmacovigilance requirements for the NHPs industry, available in English on official governmental websites and selected secondary resources, were sought.</p><p><strong>Results: </strong>Regulatory documents from 12 countries/regions (Australia, Brazil, Canada, China, India, Japan, Republic of Korea, South Africa, Switzerland, UK, USA and the EU) were included. Definitions of NHPs vary across jurisdictions, while regulatory frameworks most clearly diverge between single medicine-based systems that include NHPs, and those that apply separate medicine- and food-based primary legislation to different NHP categories. Most included jurisdictions require the NHPs industry (i.e., product sponsors, market authorisation holders, registration/license holders, manufacturers) to report serious adverse drug reactions (ADRs) within 15 days of becoming aware of such reports. However, requirements for submitting foreign ADR reports, periodic safety update reports, conducting literature screening, and employing a Qualified Person for Pharmacovigilance differ. In jurisdictions that apply separate medicine- and food-based primary legislation to different NHP categories, pharmacovigilance requirements for the industry correspondingly vary. There are usually fewer (or no) requirements for products regulated as food compared with those included under medicine-based regulations.</p><p><strong>Conclusions: </strong>Pharmacovigilance regulatory requirements for the NHPs industry vary between and within countries/regions, primarily focusing on reporting serious ADRs. To support effective benefit-risk assessment of NHPs and safeguard public health, future policy-oriented research should assess the impact of these regulatory differences on industry practice and for pharmacovigilance for NHPs, examine requirements in countries not included here, and explore pathways towards international regulatory harmonisation.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1023-1043"},"PeriodicalIF":5.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13498520/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147765693","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":"Gabapentin and Pregabalin Use in First Trimester of Pregnancy and Risk of Specific Congenital Anomalies: An IMI ConcePTION European Case-Malformed Control Study.","authors":"Anna-Belle Beau, Erika Cifuentes Castro, Justine Benevent, Marie Beslay, Laia Barrachina-Bonet, Jorieke E H Bergman, Clara Cavero-Carbonell, Alessio Coi, Helen Dolk, Ester Garne, Miriam Gatt, Jonathan Hoareau, Elly Den Hond, Anna Latos-Bielenska, Nathalie Lelong, Mary O'Mahony, Xavier Moisset, Joan Morris, Amanda J Neville, Joanna Sichitiu, Maria Loane, Christine Damase-Michel","doi":"10.1007/s40264-026-01672-8","DOIUrl":"10.1007/s40264-026-01672-8","url":null,"abstract":"<p><strong>Introduction and objective: </strong>Given the increasing use of gabapentinoids and ongoing safety concerns, we assessed the association between first-trimester exposure to gabapentin and pregabalin and the risk of specific congenital anomalies (CAs) in the offspring.</p><p><strong>Methods: </strong>Using EUROmediCAT data, we conducted a case-malformed control study based on 170,126 registrants with major CAs from livebirths, fetal deaths (≥20 weeks), and terminations of pregnancy for fetal anomaly in nine European countries (2000-2020), covering 10.6 million births. We compared gabapentinoid use in registrants with a specific CA with those among other registrants with non-genetic CA (main control group) and among registrants with a genetic condition (secondary control group). We estimated odds ratios (OR) and 95% confidence intervals (CI), adjusting for registry, birth year, and maternal age. Analyses included specific subgroups of CA with ≥3 exposed registrants.</p><p><strong>Results: </strong>First-trimester gabapentinoid exposure was identified in 37 registrants, with most registered in the Valencian region (Spain) (37.8%), EFEMERIS (France) (13.5%) and three other registries (8.1% each). Over 60% of the exposures were observed during 2015-2020. Seven out of 91 EUROCAT subgroups had ≥3 exposed registrants: congenital heart defects, ventricular septal defects, severe congenital heart defects, limb anomalies, urinary anomalies, genital anomalies, and hypospadias. A significantly higher proportion of exposure (0.4‰, 12 exposed cases) was observed among cases with ventricular septal defect compared with registrants in the non-genetic control group (0.2‰, 17 exposed cases), with an adjusted OR of 2.5 (95% CI 1.1-5.3); and the adjusted OR was elevated but non-significant compared with the registrants in the genetic group (2.3; 95% CI 0.8-6.9).</p><p><strong>Conclusions: </strong>We observed an association between first trimester exposure to gabapentinoids and ventricular septal defect, the most common cardiac anomaly, although this finding is based on only 37 exposed registrants. While our findings align with some previous studies suggesting teratogenic risks associated with gabapentinoids, they also reveal the challenges of studying rare exposures and rare outcomes.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1085-1097"},"PeriodicalIF":5.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13498513/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148148951","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":"Incidence of Naloxone-Use Before and After Implementing Opioid Safety Measures for Patients Hospitalised on General Wards in a Swiss University Hospital.","authors":"Anja Jungo, Kanchan Dongre, Delia Halbeisen, Tobias Schneider, Sibylle Chettata, Niklaus Gygli, Murat Bilici, Christoph R Meier, Anne B Leuppi-Taegtmeyer","doi":"10.1007/s40264-026-01679-1","DOIUrl":"10.1007/s40264-026-01679-1","url":null,"abstract":"<p><strong>Background: </strong>Opioids are high-risk medications that in overdose can lead to severe life-threatening or fatal adverse drug events. Inadvertent overdose is often the cause of opioid intoxication in hospitals. We introduced digital weight-based as-needed morphine and hydromorphone order sets at our hospital in November 2020 to prevent such adverse events. Naloxone given to reverse life-threatening opioid intoxication (LTOI) is a marker for these events in patient records.</p><p><strong>Aim: </strong>The main aim was to ascertain the incidence of opioid-treated patients requiring naloxone for the management of LTOI on general wards before and after implementation of the order sets.</p><p><strong>Methods: </strong>This investigator-driven, retrospective, observational, single-centre cohort study investigated naloxone administrations for LTOIs per 1000 opioid-treated patients, and per 1000 inpatients on general wards between 2019 and 2024 at the University Hospital Basel (USB). Prescription data and electronic hospital records were reviewed.</p><p><strong>Results: </strong>During the study period, a total of 78,438 patient cases received prescription opioids, of which 149 required naloxone for LTOIs. The incidence of naloxone-treated LTOIs per 1000 opioid treated patients was 3.21 prior to the introduction of the order sets and declined to 1.46 four years later (55% reduction, p = 0.002). There were 181,314 inpatients during the study period. The incidence of naloxone per 1000 inpatients was 1.14 before and 0.64 four years after the introduction of the order sets (44% reduction, p = 0.023).</p><p><strong>Conclusion: </strong>We observed a significant reduction in the incidence of naloxone use for LTOI following the introduction of digital order sets for as-required morphine and hydromorphone indicating their effect to help promote safe opioid use and to improve patient safety in our hospital.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1045-1055"},"PeriodicalIF":5.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148143128","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":"Sexual Dysfunction with Antipsychotics: Emerging Clues from a Disproportionality Analysis of the World Health Organization VigiBase.","authors":"Efstathios Pavlidis, Spyridon Siafis, Elena Arzenton, Salvatore Crisafulli, Emanuel Raschi, Ugo Moretti, Andrea M Isidori, Emmanuele A Jannini, Gianluca Trifirò, Erich Seifritz, Corrado Barbui, Chiara Gastaldon, Georgios Schoretsanitis","doi":"10.1007/s40264-026-01673-7","DOIUrl":"10.1007/s40264-026-01673-7","url":null,"abstract":"<p><strong>Introduction: </strong>Antipsychotic-associated sexual adverse drug reactions (ADRs) are well known in clinical practice, although efforts to understand differences between antipsychotics and distinct types of sexual ADRs are limited.</p><p><strong>Objective: </strong>The aim of this study was to assess and prioritize the profile of each antipsychotic regarding sexual ADRs reporting, and to account for potential confounders.</p><p><strong>Methods: </strong>We used VigiBase^® to conduct a case/non-case study using a customized clinically guided search strategy of antipsychotic-related sexual ADRs. The reporting odds ratio (ROR) and Bayesian information component (IC) with relevant 95% confidence intervals (95% CIs) were used as disproportionality measures to identify signals of disproportionate reporting (SDRs). Antipsychotics were compared with all other drugs and with thiazides (positive control). Sensitivity analyses included non-serious reports, excluding patients with potentially confounding co-medication(s), excluding adolescent and elderly patients, and including cases with co-reported hyperprolactinemia. Analyses were stratified by sex. Antipsychotics were ranked in terms of clinical priority using qualitative and quantitative criteria.</p><p><strong>Results: </strong>We included 5195 cases of antipsychotic-related sexual ADRs (43.1% serious, median time to onset of 61 days, 36.1% physician-reported). Several SDRs emerged in males (erectile dysfunction [3487 reports; ROR 2.49, 95% CI 2.40-2.57]; priapism [2372 reports; ROR 15.55, 95% CI 14.82-16.32]) and females (decreased libido [373 reports; ROR 1.61, 95% CI 1.46-1.79]) for all antipsychotic classes, except for muscarinic antagonists in females (ROR 0.64, 95% CI 0.55-0.73; IC - 0.65, 95% CI - 0.86 to - 0.45). In both sexes, the highest number of reports were for risperidone, aripiprazole and olanzapine. The SDRs disappeared in the sensitivity analysis including only non-serious cases and cases with co-reported hyperprolactinemia. Sexual ADRs for all antipsychotics were classified as of moderate priority, with the exception of fluspirilene (low priority).</p><p><strong>Conclusions: </strong>Notwithstanding limitations, including inability to infer causality, these findings raise the hypothesis that sexual ADRs could be a class effect of antipsychotics, yet possibly reversible, in both women and men.</p><p><strong>Registration: </strong>The protocol is registered to the Open Science Framework: https://osf.io/96eq7 .</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1099-1110"},"PeriodicalIF":5.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147671091","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":"Health Information Exchanges (HIEs) as Novel Sources for Population-Based Post Marketing Surveillance of Medical Products: A Pilot Study from the FDA Sentinel Innovation Center.","authors":"Anjum Khurshid, David Kendrick, Haritha S Pillai, Jenny Sun, Eliel Oliveira, Alexis Jaquish, Sarah K Dutcher, Patricia Bright, Youjin Wang, Jie Li, Tiffany Austin, Patrick J Heagerty, Michael E Matheny, Sebastian Schneeweiss, Rishi J Desai","doi":"10.1007/s40264-026-01669-3","DOIUrl":"10.1007/s40264-026-01669-3","url":null,"abstract":"<p><strong>Introduction: </strong>Health information exchanges (HIEs) provide the capability to electronically move health care information among different health care information systems and store these data for downstream use cases. However, use of data from HIEs for postmarketing surveillance of medical products has not previously been explored.</p><p><strong>Objectives: </strong>To conduct a pilot descriptive study characterizing data from MyHealth Access Network, a statewide HIE for Oklahoma, to understand its utility for conducting pharmacoepidemiology studies.</p><p><strong>Materials and methods: </strong>MyHealth Access Network connects 95% of all hospital activity, 100% of federally qualified health center activity, and most community behavioral health clinics, tribal health systems, and independent providers in the state. As a use case to understand data in MyHealth Access Network, we characterized patients aged ≥18 years with type 2 diabetes mellitus (T2DM), and treated with one of two common antidiabetic drug classes: sodium-glucose co-transporter 2 inhibitors (SGLT-2i) and dipeptidyl peptidase 4 inhibitors (DPP-4i) in a new user cohort design. A cohort entry date was defined based on records of medication initiation for either of the two drug classes, using dispensing data from insurance claims (when available) or prescribing data from electronic health records (EHRs) when claims were not available. Patient characteristics including demographics, comorbidities, comedications, clinical and lifestyle-related factors, and healthcare utilization factors were summarized for the two exposure groups.</p><p><strong>Results: </strong>A total of 65,225 DPP-4i initiators and 98,863 SGLT-2i initiators met our inclusion criteria. The mean age was around 60 years and nearly half were women in both the groups. While there was a large proportion of those with unknown race information (31% DPP-4i, 24% SGLT-2i), the majority were White (47% DPP-4i, 57% SGLT-2i). The second most reported race category was American Indian or Alaskan Natives (15% DPP-4i, 10% SGLT-2i), which is in line with their representation in the 2024 US Census for Oklahoma. Hemoglobin A1c (HbA1c) results were available for 68% and 67% of the DPP-4i and SGLT-2i groups with mean ± SD of 8.0± 2.0% and 8.1 ± 1.9%, respectively. Serum creatinine was recorded for 72% DPP-4i and 71% SGLT-2i initiators with mean ± SD of 1.2 ± 0.8 mg/dL and 1.1 ± 0.5 mg/dL, respectively.</p><p><strong>Discussion: </strong>Health information exchanges may offer a promising resource that can contribute to population-based postmarketing surveillance of medical products infrastructure owing to their longitudinal capture of information across various healthcare settings.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1057-1067"},"PeriodicalIF":5.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147671131","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":"Reliability of Self-Reported Maternal Health and Mother-Infant Outcome Data in Web-Based Questionnaires.","authors":"Laure Sillis, Laura Van Mechelen, Marleen M H J van Gelder, Sien Lenie, Karel Allegaert, Annick Bogaerts, Maarten De Vos, Titia Hompes, Anne Smits, Kristel Van Calsteren, Jan Y Verbakel, Veerle Foulon, Michael Ceulemans","doi":"10.1007/s40264-026-01671-9","DOIUrl":"10.1007/s40264-026-01671-9","url":null,"abstract":"<p><strong>Objectives: </strong>The BELpREG registry in Belgium collects self-reported real-world data on perinatal medication use and mother-infant outcomes. Given the importance of self-reported data for pregnancy safety studies, this study aims to assess the reliability of maternal health and mother-infant outcome data reported in BELpREG.</p><p><strong>Methods: </strong>We compared self-reported maternal health and mother-infant outcomes in the BELpREG registry with medical record data from gynaecologists, general practitioners, and midwives. Participants included pregnant women enrolled in BELpREG, aged 18 years or older, who delivered between November 2022 and April 2024 and had medical record data provided by at least one healthcare professional (HCP). Comparisons for continuous variables such as pre-pregnancy body mass index (BMI), gestational age at delivery, and infant metrics at birth were analysed using intraclass correlation coefficients (ICCs). For dichotomous and categorical variables, including pregnancy complications, delivery characteristics, and hospital admissions, we used Cohen's Kappa and observed proportions of positive and negative agreement.</p><p><strong>Results: </strong>This study included 175 participants with available medical record data. Medical records were mostly returned by gynaecologists (40%) and midwives (25.7%). Reliability was high for pregnancy complications, onset, and mode of delivery. Gestational age showed almost perfect concordance (ICC 0.99). Infant outcomes, including birth metrics and Apgar scores, were highly reliable (ICC > 0.90), with almost perfect categorisation into birth weight percentiles (Cohen's Kappa 0.97). Self-reported maternal BMI exhibited moderate reliability as a continuous measure (ICC 0.75), but almost perfect agreement when categorised (Cohen's Kappa 0.89). The low prevalence of hospital admissions, delivery complications, infant complications, postpartum complications, and birth defects limited the assessment of these outcomes.</p><p><strong>Conclusions: </strong>The BELpREG registry demonstrated high agreement between self-reported and HCP-reported data for most maternal health and mother-infant outcomes, supporting its use in future pregnancy safety studies.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1069-1084"},"PeriodicalIF":5.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147654004","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}