Pharmacoepidemiology and Drug Safety最新文献

{"title":"Curriculum in Pharmacoepidemiology Training Programs: A Cross-Sectional Study to Assess Educational Needs and Alignment With Core Competencies.","authors":"Amie Goodin, Deborah Layton, Ryan Chung, Vicki Osborne, Chioma Ejekam, Xiaojuan Li, Xuerong Wen, Kristian B Filion, Luciane Cruz Lopes, Daniela C Moga","doi":"10.1002/pds.70351","DOIUrl":"10.1002/pds.70351","url":null,"abstract":"<p><strong>Purpose: </strong>Pharmacoepidemiology is a key discipline for evidence-based decision-making, yet its educational programs have not been systematically assessed for alignment with international core competencies. Our objectives were to evaluate curricula alignment of pharmacoepidemiology training programs with ISPE-recommended core competency themes and identify key curriculum content development areas.</p><p><strong>Methods: </strong>The ISPE Core Competencies Workgroup and ISPE leadership developed a curriculum and needs assessment survey, incorporating feedback from global members. The survey was electronically distributed to leaders of pharmacoepidemiology training programs (e.g., department chairs and program directors) using the ISPE contact database, followed by snowball sampling to enhance representation. Institutional respondent characteristics were categorized by sector and geographic region. Competency mapping identified the most and least represented competency categories within curricula. Needs assessment responses were reported as proportions, and free-text responses were thematically analyzed, allowing for multiple themes per response.</p><p><strong>Results: </strong>Sixty-four institutions participated (73.4% academic programs, 18.8% industry/consulting, and 7.8% government/regulatory). Representation by global region was: 35.9% Europe, 29.7% North America, 23.4% Latin America, 7.8% Asia, 1.6% Africa, and 1.6% Gulf Region. Respondents prioritized developing standards in pharmacoepidemiology training curriculum in two areas-45.5% \"Epidemiology\" and 36.4% \"Statistics, Analysis, and Data Science\"-with few endorsements of other areas. The most represented competencies covered in curricula were \"Statistics\" (100%, 45/45) and \"Study Design\" (100%, 43/43). The least represented were \"Advanced Modeling\" (54%, 25/46) and \"Professional Practice\" (66%, 31/47). Key needs in pharmacoepidemiology curriculum centered around four themes: 33.3% (8/24) \"Methods (generally)\", 33.3% (8/24) \"Analytical Skills,\" 16.7% (4/24) \"Communication (writing, teaching),\" and 25.0% \"(6/24) Other (applications, new therapies).\" Content type that would best support curriculum development, as ranked by 42 respondents, was: \"Learning objectives with pre-packaged activities\" 45.2% (19/42), \"Recorded webinars/lectures\" 28.6% (12/42), \"Example syllabi\" 21.4% (9/42), and \"Reading lists\" 4.8% (2/42).</p><p><strong>Conclusions: </strong>This global assessment highlights critical gaps in pharmacoepidemiology training, particularly in advanced analytical methods and professional practice. ISPE has a unique opportunity to address these gaps by developing targeted educational activities and resources that enhance methodological rigor and practical skills.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70351"},"PeriodicalIF":2.6,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13021568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147521666","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":"Legal Basis and Regulatory Requirements for Utilizing Real-World Evidence in Medical Product Regulatory Decision-Making.","authors":"Sungmin Park, Euna Han","doi":"10.1002/pds.70373","DOIUrl":"10.1002/pds.70373","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70373"},"PeriodicalIF":2.6,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13086517/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147699457","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":"Strategies to Enhance Satisfaction and Success in an Academic Career in Pharmacoepidemiology.","authors":"Vincent Lo Re, Greta Bushnell, Luciane Cruz Lopes, Anton Pottegård","doi":"10.1002/pds.70374","DOIUrl":"10.1002/pds.70374","url":null,"abstract":"<p><strong>Background: </strong>Building an academic career in pharmacoepidemiology requires intentional planning but can be challenging, particularly for new learners, trainees, and early faculty members who may lack awareness of the skills and benchmarks expected at each career stage. This paper provides reflections on designing a purposeful and sustainable academic career.</p><p><strong>Perspectives: </strong>The first part of the article focuses on four foundational elements: (1) setting aside time for regular reflection to clarify values and priorities; (2) developing a clear vision and defining missions for each professional and personal role; (3) prioritizing activities systematically to maintain alignment with one's vision, missions, and goals; (4) seeking and maintaining mentorship throughout one's career to obtain feedback and guide decision-making. We describe concrete strategies, tools, and authors' personal approaches for implementing these elements. The second part of the article outlines key skills to acquire and benchmarks to achieve during key career stages, including competencies such as time management, team-building, project management, research dissemination, research grant writing, mentorship, and leadership. In the final part, we note that structural, institutional, and life-course factors (e.g., gender, race/ethnicity, resource access, and major life events) may shape the feasibility and impact of these strategies, underscoring the importance of supportive environments, inclusive mentorship, and flexibility for sustainable careers.</p><p><strong>Implications: </strong>Our goal is not to prescribe a single pathway but to offer a reference that promotes individual reflection and catalyzes open discussion among peers, mentors, and colleagues to enhance satisfaction and success in an academic career in pharmacoepidemiology.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70374"},"PeriodicalIF":2.6,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13080759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147691504","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":"Development and Validation of Claims-Based Algorithms for Non-Melanoma Skin Cancer in Patients With Psoriasis Using Optum Market Clarity.","authors":"Huifang Liang, Shu Huang, Qiujie Jiang, Dongmu Zhang, Dianlin Guo, Simone P Pinheiro","doi":"10.1002/pds.70345","DOIUrl":"10.1002/pds.70345","url":null,"abstract":"<p><strong>Purpose: </strong>Accurate identification of non-melanoma skin cancer (NMSC) using ICD-10 claims-based algorithms is largely uncharacterized. This study aimed to develop and validate claim-based algorithms for NMSC.</p><p><strong>Methods: </strong>Adult patients with psoriasis were identified in Optum Market Clarity between Oct 2015 and Dec 2020. Eligible patients had at least 1 year of claim enrollment prior to cohort entry, linked claims-EHRs, overlapping follow-up periods, and no prior malignancy. Data were randomly split into the development and validation datasets. Broad NMSC encompassed narrow NMSC (basal cell carcinoma, squamous cell carcinoma, sebaceous cell carcinoma, and malignant neoplasms of the sweat glands), Merkel cell carcinoma, carcinoma in situ, Kaposi sarcoma of skin, and cutaneous T-cell or B-cell lymphoma. The five developed claims-based algorithms consisted of 1+ diagnosis code (1) at any position; (2) at the primary position; (3) by a dermatologist; (4) at any position plus treatment procedure code; (5) at primary position plus treatment procedure code. NMSC cases and non-cases were adjudicated using EHR records. Algorithms performance measures were estimated.</p><p><strong>Results: </strong>Of 25 647 patients (mean age 51.4 ± 15.2 years, female 53.6%), 321 broad and 281 narrow NMSC patients were identified in the development dataset (n = 12 824). Algorithm sensitivity was 89.9% (algorithm 1) and 81.9% (algorithm 2) but under 65% for algorithms 3-5 for broad NMSC. PPV ranged from 98.2% to 99.1%. Results were consistent in the validation dataset.</p><p><strong>Conclusion: </strong>This study developed and validated high-performing ICD10-based algorithms for NMSC to facilitate future dermatology research using health data.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 3","pages":"e70345"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147434720","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 Effect of COVID-19 Pandemic Restrictions on Laboratory Monitoring of Lithium Treated Outpatients in the Netherlands: A Controlled Interrupted Time Series Analysis.","authors":"Merel Tonn, Tim Bognàr, Ralph Kupka, Ingeborg Wilting, Mariette Nederlof, Toine Egberts, Arief Lalmohamed","doi":"10.1002/pds.70349","DOIUrl":"10.1002/pds.70349","url":null,"abstract":"<p><strong>Introduction: </strong>The COVID-19 pandemic restricted healthcare access. Mental illness in combination with isolation and fear of the virus possibly decreased routine monitoring for lithium using patients during the lockdown. Our aim was to study if monitoring frequencies and serum level values for lithium, TSH (thyroid stimulating hormone), and renal function changed during the COVID-19 pandemic.</p><p><strong>Methods: </strong>Using the PHARMO database (laboratory, pharmacy, and hospitalization data), we identified lithium users in The Netherlands over 2 years (14 October 2018-14 October 2020). The first year served as the control period; the second year was divided into pre-COVID, lockdown, and post-lockdown segments. A time series analysis with a linear regression model was performed to test for differences in monitoring frequency and aberrant serum levels at the beginning of the lockdown (immediate effect) and during the lockdown (post-lockdown trend, effect over 12 weeks).</p><p><strong>Results: </strong>We identified 2835 patients using lithium. Monitoring measurements declined by 52% (7.74% vs. 4.01%) for lithium serum levels, 28% (5.56% vs. 4.20%) for TSH, and 26% (17.7% vs. 13.2%) for renal function in the first week of lockdown. These reductions were statistically significant compared to the control period. Monitoring for all measurements gradually recovered during lockdown. Changes in aberrant serum levels were not statistically different during the exposure and control periods.</p><p><strong>Conclusion: </strong>Monitoring for lithium, TSH and renal function declined at the beginning of lockdown. However, it is unlikely that postponed laboratory measurements had clinically relevant negative treatment effects since no differences in aberrant serum levels were identified.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 3","pages":"e70349"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12982162/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147444606","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":"Assessment of Off-Label Psychotropic Drug Use in Children and Adolescents: A Multi-Center Cross-Sectional Study in China.","authors":"Yue-Peng Teng, Cai-Dong Li, Wen-Juan Lei, Jun Wu, Ya-Ya Wang, Min Meng, Liu-Cheng Li, Cui-Li Yue","doi":"10.1002/pds.70340","DOIUrl":"10.1002/pds.70340","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to assess the use of psychotropic drugs in children and adolescents and their off-label use in clinical settings across multiple hospitals in China, as well as to further analyze the influencing factors of off-label use and evidence-based medical evidence.</p><p><strong>Methods: </strong>A multi-center retrospective cross-sectional investigation was conducted in secondary and tertiary public hospitals. The study collected prescriptions for patients under 18 years old, which contained psychotropic drugs, including antidepressants, antianxiety drugs, antipsychotics, mood stabilizers, and psychostimulants. Evidence for the prescription was determined by the clinical practice guidelines and Thomson Grades in the Micromedex. Logistic regression analysis was used to explore the influencing factors of off-label use of psychotropic drugs.</p><p><strong>Results: </strong>A total of 1261 medical records involving 34 kinds of psychotropic drugs for 813 children and adolescent patients were identified. Among them, off-label medical records accounted for 74.2% (936 medical orders), and the three most-used off-label drugs include fluvoxamine, tandospirone, and sertraline. Among patients with off-label drug use, the incidence was significantly higher in females than in males, while the incidence in adolescents (12-17 years old) was significantly higher than that in children (2-11 years old) (p < 0.05). The types of off-label drug use among all the included psychotropic drugs were mainly over-age (45.9%) and unapproved indication use (36.2%). Multiple logistic regression revealed that female (OR = 1.134, 95% CI [1.027, 1.749], p = 0.031) and adolescent (OR = 2.520, 95% CI [1.181, 5.374], p = 0.017) were related to a higher risk of off-label use of psychotropic drugs when compared to male and children, respectively. Twenty-one kinds (61.8%) of off-label drug types were identified, among which 15 kinds of psychotropic drug use were not supported by evidence-based medical evidence.</p><p><strong>Conclusion: </strong>Off-label use of psychotropic drugs is highly prevalent in children and adolescents. The use of psychotropic drugs should be based on instructions and evidence-based medical evidence to ensure their rational use in these patient populations. The drug administration should standardize the practice of pediatric prescription in the future.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 3","pages":"e70340"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147284793","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":"Real-World Dynamic Patterns and Predictors of Antiretroviral Therapy Adherence Among Adults Living With HIV in Belgium: Evidence From Group-Based Trajectory Modeling.","authors":"Dieudonné Ilboudo, Sékou Samadoulougou, Jean Cyr Yombi, Anouk Neven, Fati Kirakoya-Samadoulougou","doi":"10.1002/pds.70347","DOIUrl":"10.1002/pds.70347","url":null,"abstract":"<p><strong>Purpose: </strong>People living with HIV (PLWH) face many challenges in adhering to antiretroviral therapy (ART). Measuring individual changes in adherence is essential to assess quality of care and to manage healthcare costs. This study aimed to identify patterns of ART adherence among adult PLWH in Belgium over a 24-month follow-up period.</p><p><strong>Methods: </strong>A retrospective analysis of longitudinal data related to PLWH in Belgium was conducted using the Pharmanet database from 2019 to 2022. Adherence was assessed monthly and reported as the proportion of days covered. Group-based trajectory modeling was used to identify adherence patterns, with changes within each trajectory described using chi-square tests. Unordered multinomial logistic regression was used to identify predictors.</p><p><strong>Results: </strong>We included 15 128 prevalent ART users, 2076 of whom were incident ART users living with HIV, 65.3% were male, 40.4% were aged between 35 and 49 years, and 44.9% lived in the Flanders region. During follow-up period, 61.0% of prevalent users and 52.1% of incident users maintained optimal adherence. Three groups (\"consistently high\" (61.0%), \"moderately decreasing\" (28.6%), and \"highly decreasing\" (10.4%)); and four groups adherence trajectories (\"consistently high\" (52.1%), \"moderately decreasing\" (24.3%), \"early decrease\" (12.9%), and \"late decrease\" (10.8%)) were identified respectively among prevalent and incident ART users. Female sex, younger age, living in the Brussels-Capital Region, and treatment initiation during the COVID-19 pandemic were significantly associated with suboptimal adherence.</p><p><strong>Conclusions: </strong>ART adherence during the 24 months of follow-up among PLWH in Belgium was suboptimal. Interventions targeting at-risk groups during periods of declining adherence are needed among PLWH.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 3","pages":"e70347"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147444612","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":"Early Identification of Cardiovascular Adverse Events Associated With Rofecoxib Using Real-World Data From the UK: A Nested Case-Control and Case-Crossover Study.","authors":"Donya Moslemzadeh, Patrick C Souverein, Svetlana V Belitser, Eibert R Heerdink, Olaf H Klungel, Shahab Abtahi","doi":"10.1002/pds.70343","DOIUrl":"10.1002/pds.70343","url":null,"abstract":"<p><strong>Background: </strong>Traditional pharmacovigilance systems have limitations in detecting common adverse drug reactions. We investigated whether real-world data (RWD) could have detected rofecoxib's cardiovascular adverse effects earlier using nested case-control (NCC) and case-crossover (CCO) designs.</p><p><strong>Methods: </strong>We included adult rofecoxib users from the UK CPRD GOLD (1999-2004). In NCC design, cases of a first major adverse cardiovascular event (MACE) were matched with four controls on age, sex, practice and calendar time. Rofecoxib exposure was categorised as current (≤ 3 months), recent (3-6), or past use (> 6) in NCC, and assessed at the start of each 3-month interval in CCO design. Exposure odds in CCO were compared between a 3-month risk with four reference windows. Conditional logistic regression models estimated adjusted intensity ratio (aIR). To identify the shortest time necessary to detect the association, analyses were conducted in 1-, 2-, 3-, 4- and 5-years after the drug's market uptake.</p><p><strong>Results: </strong>Three thousand two hundred and eighteen cases were matched to 10 745 controls (mean age 73.8 years, 66% female). In NCC, current rofecoxib use (42% of cases) was associated with an 18% higher risk of MACE (aIR 1.18, 95% CI 1.08-1.29) versus past use. The CCO (3210 risk and 12 737 reference windows) showed an 83% increased risk of MACE (aIR 1.83, 95% CI 1.53-2.18). First signal emerged after 2 years with CCO (aIR 3.94, 95% CI 1.88-8.25), and after 3 years with NCC design (aIR 1.46, 95% CI 1.18-1.81).</p><p><strong>Conclusion: </strong>Using RWD, cardiovascular adverse effects of rofecoxib could have been detected within 2 years of the market entry in the UK, well before traditional pharmacovigilance methods. This supports incorporating RWD analysis into routine drug safety monitoring.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 3","pages":"e70343"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12971294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147390155","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":"A Systematic Process for Assessing Fitness-for-Purpose of Health Outcomes for Computable Phenotyping With Electronic Health Record Data.","authors":"Nicole M Gatto, David J Cronkite, Paige D Wartko, Robert Ball, David S Carrell, Rhoda Eniafe, Rishi Desai, James S Floyd, Terrence Lee, Jennifer C Nelson, Fatma M Shebl, Ryan Schoeplein, Sengwee Toh, Mingfeng Zhang, Sascha Dublin, José J Hernández-Muñoz","doi":"10.1002/pds.70346","DOIUrl":"10.1002/pds.70346","url":null,"abstract":"<p><strong>Purpose: </strong>Information from electronic health records (EHRs) may be incorporated into computable phenotype algorithms in efforts to overcome inaccuracies of algorithms based on administrative claims data alone. However, such efforts can be resource-intensive and unsuccessful. Assessing the feasibility of computable phenotyping for a health outcome of interest (HOI) before proceeding is therefore recommended.</p><p><strong>Methods: </strong>We developed a systematic fitness-for-purpose (FFP) assessment process to implement concepts outlined in a previously described general framework for computable phenotyping incorporating EHR data. Our process includes verifying the HOI is well-defined, reviewing clinical information about the HOI, identifying existing algorithms and their performance, evaluating HOI clinical and data complexity, and determining an overall FFP conclusion and recommendation. We applied this process to 10 HOIs lacking high-performing claims-based algorithms, selecting HOIs of public health importance that varied in clinical and data complexity, including neutropenia, pericardial effusion, and drug-induced liver injury.</p><p><strong>Results: </strong>HOIs assessed as having moderate (vs. easy) overall difficulty had characteristics such as the need for natural language processing, integration of multiple laboratory test results, or longitudinal EHR data. HOIs assessed as having high difficulty required using data from multiple EHR sources, ruling out many other potential causes, or relying on low-sensitivity diagnostic tests. Input from experts in EHR data and clinical care was crucial.</p><p><strong>Conclusion: </strong>EHR data have the potential to enhance the accuracy of defining certain HOIs for research and surveillance compared to administrative claims data. The process and tools we created will support others in assessing FFP of HOIs for computable phenotyping.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 3","pages":"e70346"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147444599","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":"Characteristics of United States Food and Drug Administration Drug Recalls Involving Opioid Medications, 2002-2025.","authors":"Julio C Nunes, Gabriel P A Costa, Joao P De Aquino","doi":"10.1002/pds.70341","DOIUrl":"10.1002/pds.70341","url":null,"abstract":"<p><strong>Purpose: </strong>To characterize the frequency, causes, and severity of opioid medication recalls using United States Food and Drug Administration (FDA) Enforcement Reports.</p><p><strong>Methods: </strong>We conducted a 2002-2025 descriptive analysis of recalls involving seven opioids. FDA free-text recall reasons were categorized into five standardized domains (wrong dose/potency, contamination, mispackaging/mislabeling, defective delivery system, and quality assurance deviations) by two independent reviewers, with agreement assessed using Cohen's κ (95% CI). Recall severity (Class I-III) was compared across drugs using the chi-square test, and temporal trends were evaluated with linear regression.</p><p><strong>Results: </strong>We identified 286 opioid-related recalls, involving over 350 million units. Fentanyl (26.2% of events; > 30 million units), hydromorphone (20.3%; > 11 million), morphine (19.6%; > 73 million), oxycodone (12.6%; > 188 million), and hydrocodone (13.9%; > 50 million) accounted for most events. Recalls of buprenorphine (7.0%; > 3 million) and methadone (3.2%; > 400 thousand) were less frequent. Quality assurance deviations accounted for most recalls (49.5%), followed by mispackaging/mislabeling (14.4%), wrong dose/potency (13.7%), defective delivery systems (12.3%), and contamination (10.1%). Inter-rater agreement for categorization was high (κ = 0.88 [0.84-0.93]). Class I recalls (risk of death) comprised 35 events (12.2%), concentrated among fentanyl (n = 10), morphine (n = 9), and hydromorphone (n = 9) (χ² = 43.1, df = 12, p < 0.001). Recall frequency increased significantly over time (r = 0.63, p = 0.001). Unit count data were missing for 34 events (11.9%), and production denominators were unavailable.</p><p><strong>Conclusions: </strong>Opioid recalls reflect manufacturing or quality assurance problems that may undermine product reliability. More complete recall reporting, including quantitative data, would support efforts to reduce risks associated with pharmaceutical quality failures.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 3","pages":"e70341"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147271346","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}