Pharmacoepidemiology and Drug Safety最新文献

{"title":"The Contribution to the Assignment of Defined Daily Dose (DDD) to Antineoplastic Drugs of the Italian Working Group on DDD.","authors":"Angela Boccia, Giulia Hyeraci, Anna Girardi, Rosa Gini, Gianluca Trifirò, Ylenia Ingrasciotta, Andrea Spini, Valentina Ientile, Elisabetta Poluzzi, Giampiero Mazzaglia, Ippazio Cosimo Antonazzo, Casula Manuela, Elena Tragni, Olivia Leoni, Arianna Mazzone, Michele Ercolanoni, Martina Zanforlini, Ursula Kirchmayer, Belleudi Valeria, Marco Finocchietti, Francesco Barone-Adesi, Giuseppe Roberto","doi":"10.1002/pds.70379","DOIUrl":"https://doi.org/10.1002/pds.70379","url":null,"abstract":"<p><strong>Purpose: </strong>To report the experience of the Italian Working Group on DDD (Ita-DDD-wg) in assigning DDDs to a list of antineoplastic agents.</p><p><strong>Methods: </strong>Active substances from the ATC L01 group with no assigned DDD and reimbursed at least once during 2021 by the Italian Healthcare Service were identified. A DDD-assignment reporting template was developed, including the following fields: ATC fifth-level code, active substance, route of administration, reference indication of use, reference posology, assignment criteria, DDD calculation formula, DDD value, and DDD unit of measure. Information from national and international Summaries of Product Characteristics of medicines containing the active substance of interest, along with evidence from literature and input from Ita-DDD-wg experts, were considered. DDD assignment criteria were based on ATC/DDD guidelines and, whenever necessary, complemented by ad hoc criteria.</p><p><strong>Results: </strong>Forty-three ATC 5th-level codes were evaluated, resulting in a total of 44 DDDs assigned (2 distinct DDDs were assigned respectively to topical and oral aminolaevulinic acid formulations). For 35 out of 44 DDDs, adaptations of general WHO assignment criteria or newly defined approaches were adopted, that is, calculations based on reference body surface area (BSA = 1.82 m²), treatment cycle duration, and average daily amounts of topical product.</p><p><strong>Conclusion: </strong>This work demonstrated that assigning DDDs to antineoplastic agents is feasible based on few additional assumptions and criteria with respect to those from ATC/DDD guidelines. In fact, based on this work, WHO decided to establish an ad hoc working group for evaluation and assignment of DDDs to antineoplastic agents.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70379"},"PeriodicalIF":2.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13139508/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147841326","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":"Ultrasound Procedure Codes Enable Timely Surveillance of Ongoing Pregnancies: A Nationwide Population-Based Register Study.","authors":"Margrethe Greve-Isdahl, Melanie Stecher, Jesper Dahl, Evy Dvergsdal, Suzanne Campbell, Inger Johanne Bakken, Hinta Meijerink, Hilde Marie Engjom","doi":"10.1002/pds.70361","DOIUrl":"10.1002/pds.70361","url":null,"abstract":"<p><strong>Purpose: </strong>Pregnant women in Norway are offered routine ultrasound examinations in the first and second trimester during gestational weeks 11-13 and 17-19, but attendance rates are unknown. With the introduction of maternal pertussis vaccination, we sought to investigate whether ultrasound attendance during pregnancy could identify the target population for maternal vaccination. Our study aims to investigate if pregnancy-related ultrasound codes alone can provide reliable estimates of ongoing pregnancies before data is available in birth records.</p><p><strong>Methods: </strong>In this nationwide population-based register study, we linked individual-level data from women with births in the Medical Birth Registry of Norway (MBRN) and first or second trimester ultrasound codes in the Norwegian Patient Registry (NPR) during 2018-2023. We calculated the proportion of pregnancies with pregnancy-related ultrasound examination codes, with trimester-specific codes from 2022, and median gestational age at ultrasound stratified by code.</p><p><strong>Results: </strong>For the entire study period (2018-2023), we retrieved data on 323 549 pregnancies for 249 915 women. Of the 59 739 pregnancies identified through MBRN in 2022-2023, 57 416 (96.1%) had at least one recorded routine trimester-specific ultrasound. The second trimester ultrasound was recorded in 92.9% (55 503/59 739) of pregnancies, with 87.7% (48 672/55 503) at the recommended time. The first trimester ultrasound code was recorded in 61.6% (36 799/59 739) of pregnancies, and 58.4% (34 886/59 739) had both codes.</p><p><strong>Conclusions: </strong>The high attendance rate of at least one routine ultrasound examination during pregnancy (96.1%) in 2022-2023 confirms the reliability of trimester-specific ultrasound codes as an indicator for ongoing pregnancies. This provides valuable data for timely assessment of interventions targeting pregnant women, before information is available in birth registries.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70361"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13031883/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147531612","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":"Longitudinal and Seasonal Trends in Reimbursed and Non-Reimbursed Methylphenidate Dispense and Its Most Common Alternatives in Belgium.","authors":"Natan Van Wichelen, Tim Boogaerts, Arzo Raeime, Laurinda Sa Ferreira, Celine Gys, Adrian Covaci, Alexander L N van Nuijs, Hans De Loof","doi":"10.1002/pds.70380","DOIUrl":"https://doi.org/10.1002/pds.70380","url":null,"abstract":"<p><strong>Purpose: </strong>The dispense of methylphenidate (MPH) for attention-deficit hyperactivity disorder (ADHD) treatment often raises concerns about overdiagnosis, over-, mis-, and abuse. However, in-depth temporal analyses on dispensing and reimbursement data are lacking in Belgium and globally.</p><p><strong>Methods: </strong>Longitudinal trends in the dispensing of MPH and its alternatives, including atomoxetine (ATO), modafinil (MOD), and guanfacine (GUA), were analyzed from 2011 to 2022 in Belgium using data from IFSTAT and IQVIA databanks. The dataset uniquely separates MPH and MOD into reimbursed and non-reimbursed categories across age groups (6-17 and > 17 years). These trends were further examined in the context of international literature to provide a comprehensive framework for comparison.</p><p><strong>Results: </strong>MPH is the most prescribed ADHD medication. Over the 12-year study period, all included drugs showed an increasing trend. For MPH and MOD, this rise is driven by non-reimbursed dispensing, while reimbursed dispensing remained stable. During summer months, a seasonal drop in MPH dispensing for the 6-17Y age group suggests an annual 'MPH drug holiday' to evaluate the necessity of continued use. While comprehensive pharmacovigilance is currently limited by insufficient demographic data and specific prescription indications, addressing these gaps presents an opportunity to better understand the underlying causes of observed dispensing trends.</p><p><strong>Conclusion: </strong>Differentiating between reimbursed and non-reimbursed dispensing is crucial to accurately describe the increasing use of this group of ADHD medication. More granular data is needed to assess whether changes to prescribing practices are necessary and to inform future development of guidelines.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70380"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147723321","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":"Comparative Cardiovascular Safety of Prescription Amphetamine and Methylphenidate Initiation Among Older Adult Medicare Beneficiaries.","authors":"Noah Smith, Daniel Manion, Emily Slade, Chris Delcher, Karen Blumenschein, Daniela C Moga","doi":"10.1002/pds.70381","DOIUrl":"https://doi.org/10.1002/pds.70381","url":null,"abstract":"<p><strong>Background: </strong>Prescription stimulant use among the United States' (US) older adult population is increasing, yet little is known about the cardiovascular safety profiles of the two major prescription stimulant classes, methylphenidate (MPD) and amphetamine (AMP).</p><p><strong>Objective: </strong>To compare the hazard of major adverse cardiovascular (CV) events between new users of prescription MPD and AMP products in US older adults.</p><p><strong>Methods: </strong>We employed a new user comparative safety study from a 5% random sample of fee-for-service Medicare beneficiaries. Continuously enrolled beneficiaries (Parts A/B/D) aged ≥ 66 years who initiated MPD or AMP (1/1/17-12/31/21) were included. We required a 1-year washout before the first prescription claim (index date) and excluded those with contraindications based on diagnosis codes. The primary outcome was incident modified 4-Point Major Adverse Cardiovascular Event (4-P MACE), including acute myocardial infarction, stroke or transient ischemic attack, ventricular arrhythmia, or all-cause mortality; secondary outcomes included all-cause mortality and CV events (all MACE excluding death). We used a 1-year follow up after index date that was censored at change in insurance coverage, therapeutic switch, addition of the comparator drug, or end of the study (12/31/21). Confounders included demographics, healthcare utilization indicators, comorbidities, and other medications. We used trimmed propensity scores (PS) to create stabilized inverse probability of treatment weights (IPTW) and Cox proportional hazard regression to estimate the effect of MPD vs. AMP initiation on the first occurrence of 4-P MACE.</p><p><strong>Results: </strong>We identified 2526 Medicare beneficiaries initiating MPD (N = 1340, mean [SD] age = 76.7 [7.4] years, 54.3% female sex) or AMP (N = 1186, mean [SD] age = 72.3 [5.4] years, 60.6% female sex). After PS trimming and applying IPTW, the groups were well-balanced based on absolute standardized mean differences. During 2021.6 person-years follow up (MPD [1009.9 years] vs. AMP [1011.8 years]), 339 4-P MACE events occurred (MPD [N = 280] vs. AMP [N = 59]), of which 225 were deaths (MPD [N = 192] vs. AMP [N = 33]), and 114 were CV events (MPD [N = 88] vs. AMP [N = 26]). In the primary analysis, MPD vs. AMP initiation was associated with an increased risk of 4-P MACE (HR = 1.73, 95% CI [1.36, 2.19]). The secondary analysis showed a statistically significant increased risk of all-cause mortality (HR = 2.20, 95% CI [1.62, 3.00]), but not adverse CV events (HR = 1.14, 95% CI [0.77, 1.67]).</p><p><strong>Conclusions: </strong>Initiation of MPD vs. AMP among older adults was associated with an increase in the hazard of 4-P MACE. Secondary analysis suggested that this increase was driven by all-cause mortality as opposed to adverse CV events.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70381"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147723345","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":"Effectiveness of the Local Additional Risk Minimisation Measures for Yellow Fever Vaccine in the United Kingdom: A Survey of Healthcare Professionals and Vaccinees.","authors":"Leila Karimi, Artis Luguzis, Neha Pawar, Marine Dufournet, Fernando Morelli, Yael Thollot, Marie-Caroline Guichard, Guillemette Petti, Lin Li","doi":"10.1002/pds.70359","DOIUrl":"10.1002/pds.70359","url":null,"abstract":"<p><strong>Purpose: </strong>Following two fatal adverse reactions after yellow fever (YF) vaccination in the United Kingdom (UK) between 2018 and 2019, both involving unapproved use, the UK Medicines and Healthcare products Regulatory Agency (MHRA) mandated that the Marketing Authorisation Holder incorporate a checklist into the YF vaccine (STAMARIL) Risk Management Plan. This checklist was implemented as part of the local additional risk minimisation measures (aRMMs) in 2021, along with an updated patient information leaflet (PIL), to assist UK healthcare professionals (HCPs) in conducting risk-benefit evaluations during YF vaccination consultations. We evaluated the effectiveness of these interventions among HCPs at authorised YF vaccination centres and vaccinees across the UK.</p><p><strong>Methods: </strong>Using a cross-sectional online survey among eligible UK HCPs and YF vaccinees in 2023, we assessed five effectiveness indicators: four for HCPs (aRMMs YF pre-vaccination checklist awareness, standardised YF pre-vaccination checklist utilisation, PIL distribution and knowledge and understanding of checklist's key safety messages) and one for vaccinees (PIL receipt). Each indicator was successful if achieved by ≥ 80% of the respondents. The proportion of desirable answers provided for each indicator with 95% confidence interval (CI) was calculated.</p><p><strong>Results: </strong>Among the 153 HCPs who responded, 73.9% (95% CI: 66.4%-80.2%) were aware of the aRMMs checklist, 89.5% (95% CI: 83.7%-93.5%) utilised any standardised checklist(s), 92.2% (95% CI: 86.8%-95.5%) distributed the PIL to vaccinees and 46.4% (95% CI: 38.7%-54.3%) provided desirable answers to ≥ 80% of the questions on knowledge and understanding of key safety messages. Among 125 vaccinees who responded, 87.2% (95% CI: 80.2%-92.0%) confirmed PIL receipt.</p><p><strong>Conclusion: </strong>Three of the five effectiveness indicators were successful. Importantly, no YF vaccination errors were reported in the UK National Travel Health Network and Centre Annual Return reports (2021-2024) following aRMM implementation. Therefore, these findings suggest that the local aRMMs provide an effective framework for the safe administration of YF vaccine.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70359"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13034499/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147574528","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":"Assessing Research Impact With Bibliometrics and Altmetrics: The Case of the Canadian Network for Observational Drug Effect Studies (CNODES).","authors":"Alexandra M Yip, Ingrid S Sketris, Samuel A Stewart, Pauline Reynier, Philippe Mongeon, Kristian B Filion","doi":"10.1002/pds.70350","DOIUrl":"10.1002/pds.70350","url":null,"abstract":"<p><strong>Purpose: </strong>Our purpose was to measure the research output and impact of the Canadian Network for Observational Drug Effect Studies (CNODES).</p><p><strong>Methods: </strong>We used OpenAlex to collect metadata on citation counts for all 115 CNODES articles published between January 2011 and March 2022. We obtained the altmetric scores from Altmetric.com. We examined mean citation counts and altmetric scores overall and by publication venue, study type, and author characteristics. We used general linear and mixed effects modeling to examine the association of citation counts/altmetric scores with the following characteristics: author's gender, trainee status and institution, study design, journal venue, article type, and jurisdiction(s) of data.</p><p><strong>Results: </strong>In total, 232 authors co-authored at least one publication. While about half of authors were women, men accounted for two-thirds of authorships. Trainees accounted for 28% of first authorships. The median citation count was 19.0 (interquartile range: 9.0-52.0), and the median altmetrics score was 4.0 (interquartile range: 1.0-22.0). Compared with original, observational research, methodologic research was associated with a lower altmetric score (adjusted difference: -57.4, 95% CI: -87.7; -27.1) but not citation counts (adjusted difference: 40.5, 95% CI: -26.2; 107.1). Publication in a \"top 10\" medical journal was associated with higher citation counts (adjusted difference: 89.8, 95% CI: 42.1, 137.5) and altmetric scores (adjusted difference: 168.3, 95% CI: 91.1, 245.5) scores.</p><p><strong>Conclusions: </strong>The patterns identified using bibliometrics and altmetrics demonstrated CNODES's author and institutional networks and their publications' mobilization and use by the academic community and broader publics.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70350"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13013095/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147513891","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":"Factors Associated With Concurrent Benzodiazepine and Opioid Use Following Total Hip and Knee Arthroplasty: A Nationwide Cohort Study.","authors":"Manuela Yepes-Calderón, Rob G H H Nelissen, Marcel L Bouvy, Liza N van Steenbergen, Albert Dahan, Frits R Rosendaal, Maaike G J Gademan","doi":"10.1002/pds.70368","DOIUrl":"10.1002/pds.70368","url":null,"abstract":"<p><strong>Purpose: </strong>Concurrent use of benzodiazepines and opioids is discouraged due to synergistic adverse effects. However, patients undergoing total hip or knee arthroplasty (THA/TKA) often receive them, particularly in the first 3 postoperative months. We identified factors associated with new outpatient concurrent benzodiazepine-opioid dispensation following THA/TKA.</p><p><strong>Methods: </strong>In this nationwide cohort study, we linked the Dutch Arthroplasty Register with the Dutch Foundation for Pharmaceutical Statistics, which provided medication dispensation data. We included all patients undergoing primary elective THA/TKA (2013-2022) who had no preoperative concurrent use in the 6 months pre-procedure. The primary outcome was ≥ 7 days of a new concurrent benzodiazepine-opioid dispensation within 90-day postoperative. Determinants included patient and implant characteristics, and preoperative medication use. Multivariable logistic regression analyses were performed, adjusted for age, sex, and comorbidity.</p><p><strong>Results: </strong>Among 89 139 THA and 76 710 TKA patients, 3756 (4%) and 5571 (7%), respectively, received new postoperative concurrent benzodiazepine-opioid dispensation within 90-days postoperative. The main factor associated with such dispensation was preoperative benzodiazepine use (THA: OR 23.5 [95% CI: 21.8-25.3], TKA: OR 22.8 [95% CI: 21.3-24.3]), followed by preoperative antidepressant/anxiolytic use (THA: OR 2.9 [95% CI: 2.6-3.1], TKA: OR 2.5 [95% CI: 2.3-2.7]). Other factors included female sex, current smoking, and American Society of Anesthesiologists (ASA) scale III-IV. Preoperative pain scores, preoperative opioid use, and implant characteristics showed little to no association with the outcome.</p><p><strong>Conclusions: </strong>Preoperative benzodiazepine use was the main factor associated with new outpatient concurrent benzodiazepine-opioid dispensation after THA/TKA, followed by preoperative antidepressant/anxiolytic use. These results highlighted that careful review of the patient's medication history when planning postoperative pain management could help prevent unsafe co-prescription.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70368"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13067209/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147646182","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":"Medications for Nausea and Vomiting of Pregnancy and the Risks for Adverse Birth Outcomes.","authors":"Laure Sillis, Essi Whaites Heinonen, Michael Ceulemans, Veerle Foulon, Yunjun Luo, Diana Johnson, Christina D Chambers","doi":"10.1002/pds.70367","DOIUrl":"https://doi.org/10.1002/pds.70367","url":null,"abstract":"<p><strong>Purpose: </strong>Nausea and vomiting of pregnancy (NVP) is common during pregnancy. However, evidence on the safety of its treatment is still conflicting. This study compared the risk for adverse birth outcomes between mothers exposed to NVP medications and unmedicated mothers, with and without NVP.</p><p><strong>Methods: </strong>This prospective, observational cohort study is part of the MotherToBaby Pregnancy Studies initiative, which recruits participants during pregnancy and collects data through maternal telephone interviews and medical records. The study includes live-born singleton pregnancies enrolled from 2010 to 2023, with available first-trimester NVP symptom data. Pregnant women exposed to any NVP medications were compared to pregnant women with untreated NVP and pregnant women without NVP. Statistical analysis involved calculating risk ratios (RR) for major congenital malformations, preterm delivery, small for gestational age (SGA), and admission to the neonatal intensive care unit (NICU).</p><p><strong>Results: </strong>This study included 2711 pregnant individuals, categorized into NVP treatment exposed (n = 603; mean [SD] age, 33.2 [4.3] years), untreated NVP (n = 1567; mean [SD] age, 33.3 [4.4] years), and no NVP (n = 541; mean [SD] age, 33.4 [4.4] years). Major congenital malformations occurred in 6.12% (n = 29) of the NVP treatment exposed group, 5.11% (n = 80) of the untreated NVP group, and 5.55% (n = 30) of the no NVP group, with adjusted RR for treatment exposed 1.22 (95% CI, 0.79-1.87) compared to untreated NVP and 1.05 (95% CI, 0.63-1.76) compared to no NVP. The adjusted RR of preterm birth was 1.21 (95% CI, 0.88-1.67) for treatment exposed compared to untreated NVP. The adjusted RR of infants being SGA was 1.25 (95% CI, 0.90-1.74) compared to untreated NVP. Doxylamine (n = 345 [57.21%]) and ondansetron (n = 286 [47.43%]) were the most commonly used NVP treatments. When the risks for adverse birth outcomes were evaluated separately for these medications, ondansetron exposure was associated with higher RRs for SGA compared with both untreated NVP (adjusted RR 1.80, 95% CI 1.23-2.60) and no NVP (1.99, 95% CI 1.22-3.24). The confidence intervals indicate that the estimates are relatively imprecise but suggest an increased risk in both comparisons.</p><p><strong>Conclusions: </strong>No increased risks of major congenital malformations or other adverse birth outcomes were observed when comparing women treated with NVP medications to those with untreated NVP or no NVP, in overall comparisons, supporting the pharmacological treatment of NVP when needed. Ondansetron exposure was associated with an increased risk of SGA, which may at least partially be influenced by greater NVP severity among ondansetron-treated women rather than treatment effect itself.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70367"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147691497","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":"Correction to \"The Military Health System Data Repository: Leveraging Closed, Familial-Linked Electronic Health Record Data for a Large Generalizable US Population\".","authors":"","doi":"10.1002/pds.70375","DOIUrl":"https://doi.org/10.1002/pds.70375","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70375"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147691445","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 Challenges of Emulating a Target Trial to Assess Effectiveness of Timing of PCSK9 Inhibitor Treatment Initiation Post Myocardial Infarction.","authors":"Thomas Cars, Stefan Gustafsson, Queenie Chan, Nafeesa Dhalwani, Shia T Kent, Andrew Briggs, Chris P Gale, Anselm Gitt, J Wouter Jukema, Philippe Gabriel Steg, Johan Sundström, Stefan James, Emil Hagström, M Alan Brookhart","doi":"10.1002/pds.70354","DOIUrl":"10.1002/pds.70354","url":null,"abstract":"<p><strong>Background: </strong>Studies comparing treatment strategies based on initiation timing-such as starting PCSK9 inhibitor (PCSK9i) therapy sooner versus later after a myocardial infarction (MI)-are prone to immortal time bias. Clone-censor-weight methods can address these issues and allow the researcher to emulate a trial in which patients are assigned to protocols dictating when PCSK9i is initiated. This study aimed to evaluate the comparability of patients in a clone-censor-weight setup who initiated a PCSK9i within 12 months post-MI versus non-initiators.</p><p><strong>Methods: </strong>We included adult patients hospitalized for MI in Sweden (2015-2021) and followed them for 3 years. We considered two treatment strategies: initiating PCSK9i within 12 months versus not initiating PCSK9i during the same period. We applied the clone-censor-weight method to address immortal time bias and assessed remaining bias using covariate balance metrics and negative control outcomes.</p><p><strong>Results: </strong>The primary study sample included 38  627 episodes of MI, with 561 (1.5%) initiating PCSK9i treatment within 12 months. These patients were younger, had higher baseline LDL-C levels, and were more frequently treated with ezetimibe during their post-MI follow-up compared to non-initiators. Although clone-censor-weight estimation was free of immortal time bias, it faced challenges in achieving adequate balance of covariates due to the high rates of censoring (relatively small number of people initiating a PCSK9i in the first year) and strong association between covariates and censoring. Truncation of weights provided more stable estimates but at the expense of some covariate imbalances.</p><p><strong>Conclusions: </strong>The clone-censor-weight method is a promising approach that allows researchers to answer questions about the effect of treatment policies. But practical guidance is needed to address problems that arise from small, highly imbalanced groups, which is common with most newly introduced treatments.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70354"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13031884/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147531658","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}