Pharmacoepidemiology and Drug Safety最新文献

{"title":"Resumption of Antiplatelet Therapy After Burr-Hole Surgery and Recurrence in Patients With Chronic Subdural Hematoma: A Target Trial Emulation.","authors":"Takayuki Anno, Toshiki Fukasawa, Koji Kawakami","doi":"10.1002/pds.70394","DOIUrl":"10.1002/pds.70394","url":null,"abstract":"<p><strong>Purpose: </strong>Clinicians are often concerned that early resumption of antiplatelet therapy may increase the risk of recurrence after burr-hole surgery for chronic subdural hematoma (CSDH), yet studies on this issue remain limited. We evaluated whether early resumption of antiplatelet therapy increases CSDH recurrence using a target trial emulation framework.</p><p><strong>Methods: </strong>We identified patients who had received antiplatelet therapy preoperatively and undergone initial burr-hole surgery for CSDH from two hospital-based administrative databases (2016-2024). To estimate CSDH recurrence risk with early resumption, we compared two treatment strategies: strategy 1, resumption of antiplatelet therapy within 4 days after the initial burr-hole surgery; and strategy 2, no resumption within 30 days after the initial burr-hole surgery. We employed the clone-censor-weight method to address immortal time and time-varying confounders. Using a stabilized weighted pooled logistic regression model, we then calculated the 30-, 60-, and 90-day risk of CSDH recurrence.</p><p><strong>Results: </strong>Among 1552 eligible patients, 217 (14.0%) experienced CSDH recurrence within 90 days. Risk of CSDH recurrence at 30, 60, and 90 days was 8.1%, 13.7%, and 14.2% for strategy 1 versus 7.2%, 12.5%, and 13.9% for strategy 2. The respective risk ratios were 1.13 (95% CI, 0.76-1.56), 1.10 (0.75-1.51), and 1.02 (0.71-1.40), and the risk differences were 0.9% (-2.2 to 3.4), 1.2% (-3.7 to 5.2), and 0.3% (-4.8 to 4.6).</p><p><strong>Conclusions: </strong>This study suggests that early resumption of antiplatelet therapy may not increase CSDH recurrence risk. These findings may inform clinical decision-making regarding postoperative antiplatelet management.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70394"},"PeriodicalIF":2.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147974480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Pharmacovigilance Database in Identifying Antibiotic Resistance and Inappropriate Use: An Analysis of VigiBase Reports From Lower-Middle-Income Countries.","authors":"Hager Saleh, Joseph Mitchell, Cecilia Stålsby Lundborg, Megha Sharma","doi":"10.1002/pds.70404","DOIUrl":"10.1002/pds.70404","url":null,"abstract":"<p><strong>Background: </strong>Digital databases such as pharmacovigilance (PV) databases could provide unique opportunities to monitor trends in suspected antibiotic resistance, ineffectiveness, and misuse, extending beyond their traditional role of tracking adverse drug reactions (ADRs). This approach is potentially valuable globally but particularly advantageous in lower-middle-income countries (LMICs) where formal resistance surveillance systems are often insufficiently developed. Leveraging PV data could help generate early signals of resistance and inappropriate antibiotic use and support antimicrobial stewardship in resource-constrained settings.</p><p><strong>Objectives: </strong>To explore the potential use of PV databases in monitoring suspected antibiotic resistance trends and inappropriate use in LMICs.</p><p><strong>Methods: </strong>A retrospective cross-sectional study was conducted using VigiBase. Data were extracted in October 2024 from inception to January 1, 2024. Reports involving antibacterials for systemic use, Anatomical Therapeutic Chemical (ATC) codes J01 and J04 from LMICs were included. Selected Medical Dictionary for Regulatory Activities (MedDRA) preferred terms were mapped according to RIOLE classification to the \"resistance,\" \"ineffectiveness,\" \"off-label use,\" and \"error\" categories to identify reporting patterns. Descriptive statistics were used to summarize reports' characteristics, and associations between categorical variables were examined using chi-squared tests.</p><p><strong>Results: </strong>A total of 1570 ICSRs from 37 LMICs were identified, yielding 2958 drug-adverse event pairs, with reporting increasing markedly after 2016. The \"off-label use\" (38.6%) and \"ineffectiveness\" (37.0%) were the dominant RIOLE categories, driven mainly by the preferred terms (PTs) of Off-label use (795; 26.4%) and Drug ineffective (751; 25.4%). Resistance-related PTs accounted for 12.7% of pairs, most frequently Drug resistance (210; 7.0%) and Pathogen resistance (132; 4.5%), while \"error\" category (11.7%) was led by Product use issue (60; 2.0%) and Medication error (44; 1.5%). Watch antibiotics predominated, especially azithromycin, ceftriaxone, and meropenem, with significant associations observed between RIOLE categories and age, reporter type, ATC class, reaction outcome, AWaRe category, and WHO region.</p><p><strong>Conclusions: </strong>These findings demonstrate that PV databases can provide valuable insights into suspected antibiotic resistance and inappropriate use patterns in LMICs, supporting their potential role as additional data sources in antimicrobial stewardship.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70404"},"PeriodicalIF":2.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13247192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148205641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Documented Adverse Reactions to Different Intravenous Iron Formulations in the Veterans Health Administration: A 10-Year Retrospective Study.","authors":"Ali Khalaf, Matthew Lane, Jennifer Meyer Reid","doi":"10.1002/pds.70411","DOIUrl":"https://doi.org/10.1002/pds.70411","url":null,"abstract":"<p><strong>Background: </strong>Intravenous (IV) iron is associated with a low risk of adverse drug reactions (ADR); however, the risk varies by formulation.</p><p><strong>Methods: </strong>A 10-year retrospective cohort study of Veterans Health Administration data was conducted to detect the cumulative incidence of any documented ADR, potentially serious ADR, and anaphylaxis to five IV iron formulations. Patients with any exposure to each of the five IV iron formulations were identified and assessed for subsequent ADR documentation listed to the same IV iron formulation.</p><p><strong>Results: </strong>A total of 133 588 patients were exposed to 162 457 unique IV iron formulations. The overall documented IV iron ADR cumulative incidence was 79 events per 10 000 (0.79%; 95% CI: 0.75%-0.84%). The potentially serious documented IV iron ADR cumulative incidence was 63 events per 10 000 (0.63%; 95% CI: 0.60%- 0.67%). The lowest cumulative incidence of documented ADR was associated with ferric carboxymaltose with 24 events per 10 000 (0.24%; 95% CI: 0.15%- 0.4%). Iron dextran was associated with the highest cumulative incidence of documented ADR with 189 events per 10 000 (1.89%; 95% CI: 1.74%- 2.05%). Iron dextran was also associated with the highest cumulative incidence of potentially serious ADR with 153 events per 10 000 (1.53%; 95% CI: 1.39%- 1.68%) and the highest cumulative incidence of documented anaphylaxis with 36 events per 10 000 (0.36%; 95% CI: 0.3%- 0.43%).</p><p><strong>Conclusions: </strong>The present study finds varying risk of documented potentially serious ADR and anaphylaxis between available IV iron formulations and aligns with previous data suggesting iron dextran is associated with a higher risk of serious ADR.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70411"},"PeriodicalIF":2.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148252666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Longer-Term Impact of Biosimilar Switching Policies in Patients With Inflammatory Bowel Disease in British Columbia, Canada: A Retrospective, Population-Based Study.","authors":"Mark Harrison, Sandra Blitz, Michael Law, Mina Tadrous, Tara Gomes, Fiona Clement, Greg Rosenfeld, Aslam Anis, Nick Bansback","doi":"10.1002/pds.70395","DOIUrl":"10.1002/pds.70395","url":null,"abstract":"<p><strong>Background and aims: </strong>In 2019, British Columbia (BC) became the first jurisdiction in North America to introduce a mandatory non-medical switching (NMS) policy requiring patients with Crohn's disease (CD) and ulcerative colitis (UC) to be switched from originator biologics to biosimilar equivalents. This study examines the influence of the BC Biosimilars Initiative NMS policy on the longer-term infliximab and adalimumab biosimilar utilization and patterns of continuation/discontinuation of biosimilars.</p><p><strong>Methods: </strong>We used health administrative data from BC to study drug utilization trends between 2015 and 2022. We used an interrupted time series design with segmented regression analysis to evaluate the impact of the Biosimilars Initiative on the utilization of biosimilars for infliximab and adalimumab and marginal Cox regression models to explore predictors of discontinuation of biosimilars post NMS.</p><p><strong>Results: </strong>The Biosimilars Initiative was associated with an increase in the proportion of biosimilars within the anti-TNF market of 29.3% (95% CI: 28.6%, 29.9%) in Phase 1 (infliximab) and 49.5% (95% CI: 48.4%, 50.7%) in the adalimumab phase; thereafter, biosimilar use increased by 1.5% per year (95% CI: 0.3%, 2.7%). After the NMS, by the end of 2022, 13.5% (n = 4648) had switched from a biosimilar to an originator or a biologic in a different class. Female patients and biologic-naive patients starting on a biosimilar were more likely to switch from a biosimilar to another drug.</p><p><strong>Conclusions: </strong>Our results suggest that the Biosimilars Initiative NMS in BC was successful in switching patients to biosimilars and that most patients remained on biosimilar versions.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70395"},"PeriodicalIF":2.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147974422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Plasmode Simulation-Based Bias Analysis for Residual Confounding by Unmeasured Variables Leveraging Information-Rich Subsets.","authors":"Rishi J Desai, Shirley V Wang, Haritha S Pillai, Mufaddal Mahesri, Bowen Gu, Joyce Lii, Sarah Dutcher, Chanelle Jones, Fatma M Shebl, Marie C Bradley, Wei Hua, Hana Lee, Gerald J Dal Pan, Sebastian Schneeweiss, Robert Ball","doi":"10.1002/pds.70383","DOIUrl":"10.1002/pds.70383","url":null,"abstract":"<p><strong>Aim: </strong>To develop a quantitative bias analysis approach based on realistic assumptions reflective of the complexities of healthcare data.</p><p><strong>Methods: </strong>We describe a 'plasmode' simulation-based bias analysis for residual confounding from unmeasured variables by leveraging granular information from a subset of cohort members. We generated 500 simulated cohorts based on individual-level claims and linked electronic health record (EHR) data identifying new users of varenicline and bupropion from the Mass General Brigham site of the FDA Sentinel Real World Evidence Data Enterprise. Two adverse outcomes were simulated: (1) neuropsychiatric hospitalizations and (2) major adverse cardiovascular events (MACE), and measured confounding factors, identified from information available in claims including demographics, comorbid conditions, and comedications, were tailored to each outcome. Residual confounding was simulated using potential confounders measured in EHRs but unmeasured in claims including suicidal ideation for the neuropsychiatric outcomes and body mass index (BMI), blood pressure (BP), and smoking pack-years for the MACE outcome. These simulations retained the correlation between claims and EHR-based confounders observed in empirical data for realistic reflection of proxy adjustment of unmeasured confounders. Analyses were conducted in simulated data with and without adjustment for the EHR-based covariates to evaluate the extent of residual confounding in claims-only analyses.</p><p><strong>Results: </strong>After 500 simulations, the median absolute standardized mean difference (ASMD) between treatment groups in the unadjusted sample was 0.16 for suicidal ideation; while < 0.1 for BMI, BP, and smoking pack-years. For both outcomes, adjustment using claims-based variables provided relative bias close to 0, leading to the conclusion that EHR-measured confounders that were unmeasured in claims were unlikely to result in strong residual confounding within realistic simulations informed by empirical data.</p><p><strong>Conclusion: </strong>The proposed approach provides a method for quantifying bias in non-randomized studies threatened by the unavailability of potentially important confounding variables.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70383"},"PeriodicalIF":2.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147841294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methodological Characteristics in Economic Evaluations of Health Technology Assessment Reports Submitted for Drug Reimbursement in Brazilian Public Health.","authors":"Gilson Pires Dorneles, Cintia Pereira de Araujo, Suena Parahiba, Bruna Marmett, Ana Paula Blankenheim, Marina Guahnon, Cinara Stein, Maicon Falavigna","doi":"10.1002/pds.70371","DOIUrl":"10.1002/pds.70371","url":null,"abstract":"<p><strong>Objectives: </strong>To characterize methodological aspects and the quality reporting of economic evaluation in HTA reports of drugs submitted to the Brazilian public health system.</p><p><strong>Methods: </strong>An electronic search for HTA reports focusing on drug incorporation into the public health system published between 2020 and June 2024 was conducted in the Conitec database. The study selection and data extraction were performed to obtain bibliographic data, base case characteristics, and methodological features. Furthermore, the quality reporting of economic evaluation was verified by the Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022). Descriptive statistics summarize the data extracted from the documents.</p><p><strong>Results: </strong>We included 188 economic evaluations of HTA reports about drug reimbursement; the great majority submitted to private companies or public institutions. Most economic evaluations adopted cost-utility or cost-effectiveness analysis using a comparator in the public system. Economic evaluation studies presented frequent inconsistent reports of cost and health outcomes and in the deterministic and probabilistic sensitivity analyses. Markov, decision tree, and partitioned survival model were the main mathematical models applied. Cost-effectiveness analysis mainly adopted QALY or QALY plus life-years gained as health outcomes, but there was a lack of clarity in the methods to incorporate health utilities in the cost-utility analysis. Finally, we identified that the quality reporting of economic evaluation needs to be improved.</p><p><strong>Conclusion: </strong>The methods and reporting quality of economic evaluations submitted to Conitec exhibit heterogeneity characteristics. Strengthening and standardizing guidance for preparing health economic evaluations is needed to ensure greater consistency, transparency, and decision-making reliability.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70371"},"PeriodicalIF":2.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147819271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Time Windows Used When Identifying Current Drug Use and Polypharmacy.","authors":"Sabrina Giometto, Mette Reilev, Martin Thomsen Ernst, Henrik Støvring, Anton Pottegård","doi":"10.1002/pds.70384","DOIUrl":"10.1002/pds.70384","url":null,"abstract":"<p><strong>Purpose: </strong>The length of the time window used to assess \"current drug use\" or \"number of medications used\" will influence the estimates hereof; however, no consensus exists on the optimal width of such time windows. We aimed to explore how the estimated prevalence of drug use in general, and of polypharmacy in particular, is affected by definitions used.</p><p><strong>Methods: </strong>We conducted a drug-utilization study divided into two parts. In the first part, we focused on current drug use. Using population-based registries from Denmark, we identified adults (i.e., individuals aged ≥ 18) during 2020-2022, and among them, current use of different drugs, including those with typically chronic or episodic patterns of use. The second part of the study focused on polypharmacy. We estimated its prevalence, based on different definitions, using population-based registries from Denmark in a cohort of older adults (i.e., individuals aged ≥ 65) in 2022. We also evaluated the accuracy of different criteria for predicting polypharmacy using simulations.</p><p><strong>Results: </strong>Evaluating current drug use, the proportion of individuals classified as exposed increased with the length of the time window for all drugs, reaching a plateau considering a 120-150-day window for statins, glucose-lowering drugs, and selective serotonin reuptake inhibitors, and a 180-300-day window for opioids, whereas no plateau was reached for non-steroidal anti-inflammatory drugs within 360 days. The prevalence of polypharmacy ranged from 21% (10 different 4th level Anatomical Therapeutic Chemical (ATC) groups in 1 year) to 92% (two different 4th level ATC groups in 1 year) depending on the applied definition. In the simulation, the best criterion for identifying polypharmacy required at least two dispensations during the one-year study period for each of at least five drugs, with sensitivity ranging between 0.93 and 1.0, and specificity between 0.72 and 1.0.</p><p><strong>Conclusions: </strong>Time windows up to 120 days are too short to identify baseline drug use in the Danish setting. How polypharmacy is defined significantly influences its estimate, suggesting a need to use multiple definitions in each study.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70384"},"PeriodicalIF":2.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13156664/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying the Initiation of a New Line of Therapy for Metastatic Lung, Breast, and Colorectal Cancer in Real-World Data: A Scoping Review.","authors":"Oluwadamilola Onasanya, Seyed Hamidreza Mahmoudpour, Benjamin Bates, Irene M Shui, Geoffrey Liu, Eng Hooi Tan, Yi-Hsin Yang, Maribel Salas, Joseph Fadare, Dimitri Bennett, Paula Lana de M Drummond, Judy Ju-Young Shin, Sonia Guleria, Jocelyn R Wang, Manila Hada, Helene Denis, Soko Setoguchi, Ilse Truter, Luciane C Lopes, Ruth Wangia Dixon","doi":"10.1002/pds.70370","DOIUrl":"10.1002/pds.70370","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to identify and synthesize published algorithms for identifying the initiation of a new line of therapy (LOT) for metastatic lung, breast, and colorectal cancer in real-world data (RWD).</p><p><strong>Methods: </strong>We conducted a scoping review of published, English-language studies describing algorithms for identifying any LOTs with systemic anti-cancer therapy (SACT) for either non-metastatic or metastatic lung, breast, or colorectal cancer in RWD between January 1, 2014, and April 29, 2024. Dual reviewers independently screened titles, abstracts, and full-text articles, with disagreements resolved by a third reviewer. Data were extracted, categorized, synthesized, and summarized in narrative and tabular formats.</p><p><strong>Results: </strong>The review identified 25 studies, mainly (64%) from the United States. Electronic health/medical records (EHRs) were the most frequently utilized (72%) RWD source. Twenty-four studies (96%) described RWD algorithms for identifying the initiation of a new LOT for metastatic lung, breast, or colorectal cancer. In 23 studies, algorithms required observing a new, adjuvant, SACT after an \"incident\" metastatic diagnosis code, which had been preceded by a metastasis-free lookback period of varied duration. Three studies' algorithms required observation of the completion of non-metastatic LOTs before initiation of a new LOT for metastatic cancer. Three studies validated their algorithms.</p><p><strong>Conclusions: </strong>Different algorithms are being used to identify LOT initiation for metastatic cancer. Most algorithms require an incident diagnosis of metastasis before considering subsequent SACT as newly initiated LOT for metastatic cancer. However, definitions of metastasis onset and gap duration to therapy initiation vary.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70370"},"PeriodicalIF":2.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13121922/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Analysis of Potential Side Effects of Targeted Oral Hypoglycemic Agents Using Spontaneous Adverse Event Reports and Social Media Data.","authors":"Se-Hoon Oh, Dong-Young Park, Yun-Kyoung Song","doi":"10.1002/pds.70386","DOIUrl":"10.1002/pds.70386","url":null,"abstract":"<p><strong>Aim: </strong>Adverse events (AEs) detected in tweets and in the FDA Adverse Event Reporting System (FAERS) provide valuable insights into patient experiences with oral hypoglycemic agents including sodium-glucose transporter 2 (SGLT2) and dipeptidyl peptidase-4 (DPP4) inhibitors. This study compared the side effects identified from tweets with those in the FAERS to identify the AEs associated with each drug.</p><p><strong>Materials and methods: </strong>We collected AE data through tweet and the FAERS during 2017-2021. Relevant sentences in the tweets were annotated and manually labeled to identify AE terms. The data obtained from both sources were categorized according to the System Organ Class (SOC) of the Medical Dictionary for Regulatory Activities. Renal and urinary disorders were defined as the index comparator with a value of 1.0. The relative frequency of a side effect compared with the index comparator was obtained.</p><p><strong>Results: </strong>Both drugs showed similarities in high-frequency SOCs. The largest difference between the two datasets for DPP4 inhibitors was observed for the Cardiac disorders category. It ranked 12th in FAERS but 1st in tweets data, showing a marked difference in index values (FAERS 0.75, Tweet 10.80). For the SGLT2 inhibitor, the most evident difference was in the Surgical and medical procedures category. In this category, the index from FAERS was 0.26, while that from tweets was 3.49, ranking 12th and 1st, respectively.</p><p><strong>Conclusions: </strong>Despite the differences in the quantity and types of side effects between the two sources, we were able to identify which clinically significant side effects patients were concerned about and worried about.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70386"},"PeriodicalIF":2.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13138893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147841270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy.","authors":"Helen Dolk, Christine Damase-Michel, Joan Morris, Amanda Neville, Ester Garne, Sue Jordan, Anke Rissmann, Alessio Coi, Deirdre Folan, Dieuwke Broekstra, Jennifer M Broughan, Lea Bruneau, Clara Cavero-Carbonell, Elly den Hond, Miriam Gatt, Mika Gissler, Babak Khoshnood, Anna Latos Bielenska, Hedvig Nordeng, Ljubica Odak, Mary O'Mahony, Isabelle Perthus, J Luke Richardson, Florence Rouget, Joanna Sichitiu, David Tucker, Natalya Zymak-Zakutnya, Maria Loane","doi":"10.1002/pds.70360","DOIUrl":"10.1002/pds.70360","url":null,"abstract":"<p><strong>Background: </strong>The evidence gap relating to the risk of congenital anomalies (CA) associated with first trimester medication exposure in pregnancy is well recognized.</p><p><strong>Aims: </strong>We describe the EUROmediCAT network and databases, and the methodological approach to pregnancy pharmacovigilance.</p><p><strong>Material and methods: </strong>Multidisciplinary expertise includes CA diagnosis and epidemiology, pharmacoepidemiology, pharmacology and teratology. The EUROmediCAT central database comprises standardized data from 19 EUROCAT CA registries in 14 countries, including more than 40 000 CA cases 1995-2021 with first trimester medication exposure data recorded, and a population coverage of 14.6 million births, growing by more than 650 000 births per year. The distributed database enables federated data analysis across eight countries which can link data from CA registries to electronic healthcare data, with population coverage of up to 900 000 births per year for linkage to maternal prescriptions, of which 300 000 births per year for linkage also to data on all births.</p><p><strong>Results: </strong>The databases have enabled a variety of study designs: case-malformed control studies, cohort studies, disease cohort studies, signal detection studies, prevalence and ecological studies, and medication utilization studies.</p><p><strong>Discussion: </strong>A key strength is that studies of CA risk can address accurately the specificity of risk by type of CA.</p><p><strong>Conclusion: </strong>EUROmediCAT presents a unique data and expert resource for tackling the enormous evidence gap regarding the safety of medication during pregnancy.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70360"},"PeriodicalIF":2.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}