Pharmacoepidemiology and Drug Safety最新文献

{"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}

{"title":"Drug Safety: Being Vigilant… or Proactive?","authors":"Alain Braillon","doi":"10.1002/pds.70385","DOIUrl":"https://doi.org/10.1002/pds.70385","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70385"},"PeriodicalIF":2.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778049","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":"Analysis of Mandatory Post-Marketing Surveillance Studies Supports Revised Regulatory Requirements in Korea.","authors":"Kevin Wolter, Seung-Hee Jeong, Ju-Won Woo, Eunsol Kim, Yoosun Lee, Sera Cha, Evelyn Moy, Rod Junor","doi":"10.1002/pds.70382","DOIUrl":"10.1002/pds.70382","url":null,"abstract":"<p><strong>Purpose: </strong>The objective of this analysis was to determine the contribution to the understanding of product benefit/risk made by non-randomized, observational post-marketing surveillance (PMS) studies previously required by the Ministry of Food and Drug Safety (MFDS) re-examination system and conducted by Pfizer in Korea over 2000-2024.</p><p><strong>Methods: </strong>A retrospective analysis of all Pfizer Korea PMS studies during 2000-2024 was performed, covering a wide range of therapy areas. Available Pfizer clinical study reports and re-examination reports were reviewed for sample sizes, study periods, and key safety and effectiveness findings.</p><p><strong>Results: </strong>Twenty-four studies that enrolled 21 179 Korean participants were identified. Original sample sizes assigned by MFDS were typically either 600 or 3000 participants, but enrollment challenges were common and approximately half of the PMS studies were permitted to reduce sample size. Mean study duration (FSFV-LSLV) was 3.8 years. Safety findings were consistent with existing global safety data, with no clinically significant new safety information being generated from the PMS studies.</p><p><strong>Conclusions: </strong>PMS conducted by Pfizer in Korea were often challenging to recruit and generated data that were consistent with prior global data, with no evidence of clinically meaningful differences in Korean patients. These findings support MFDS's recent transition to a risk management plan (RMP) framework, with PMS only as needed, reducing mandatory requirements for newly approved drug products. Furthermore, when a PMS study is necessary to address a specific scientific uncertainty, MFDS allows individual determination of the sample size, which will improve the feasibility of conducting the study.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70382"},"PeriodicalIF":2.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13121920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778029","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":"Beta Blocker Use and Total Knee Arthroplasty Among United States Medicare Beneficiaries.","authors":"Shailina Keshwani, Haesuk Park, Wei-Hsuan Lo-Ciganic, Roger B Fillingim, Steven M Smith","doi":"10.1002/pds.70387","DOIUrl":"10.1002/pds.70387","url":null,"abstract":"<p><strong>Background/objectives: </strong>Preclinical evidence suggests beta blockers may reduce cartilage degradation and delay knee osteoarthritis (OA) progression. While beta blockers are widely used in patients with hypertension, their potential role in preventing total knee arthroplasty (TKA) is unclear. Therefore, we assessed the association between beta blocker use and TKA in knee OA patients with hypertension.</p><p><strong>Methods: </strong>We conducted a nested case-control study using a nationally representative sample of Medicare beneficiaries with newly diagnosed knee OA and prevalent hypertension from 2011 to 2020. Beneficiaries who underwent TKA were defined as cases, while those without TKA were defined as controls. Cases and controls were matched at a 1:4 ratio based on pre-specified criteria using incident density sampling. We measured binary (exposed/unexposed) and cumulative exposure of beta blockers during 6 months before TKA using total standardized daily doses (TSDD) for each patient, categorized as unexposed (0), < 1-200, 201-400, 401-600, 601-900, > 900. Confounding was addressed using propensity score adjustment and stratification for the binary exposure and direct covariate adjustment for cumulative exposure in conditional logistic regression models.</p><p><strong>Results: </strong>We included 30 338 beneficiaries with TKA and 106 145 matched controls. The mean age (SD) was 74.4 (5.5) years, and 67.1% were women in both groups. There was no significant association between beta blocker use and odds of TKA (adjusted OR [aOR] 1.01; 95% CI, 0.97-1.02) compared with unexposed individuals. Smilarly, no cumulative exposure category was associated with TKA risk (TSDD: < 1-200 [aOR, 1.01; 95% CI,0.97-1.04]; TSDD: 201-400 [aOR 1.00; 95% CI, 0.96-1.05]; TSDD: 401-600 [aOR, 1.02; 95% CI, 0.96-1.08]; TSDD: 601-900 [aOR 0.94; 95% CI, 0.87-1.00]; and, TSDD: > 900 [aOR 0.99; 95% CI, 0.91-1.08]), compared with the unexposed group.</p><p><strong>Conclusion: </strong>We found no evidence to support that beta blocker exposure reduces the likelihood of TKA.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 5","pages":"e70387"},"PeriodicalIF":2.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147841284","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 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":"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":2.6,"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":2.6,"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":"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":2.6,"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":"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":2.6,"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":2.6,"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":2.6,"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}