Pharmacoepidemiology and Drug Safety最新文献

{"title":"Uncovering Medication Errors Leading to Hospital Admissions in the Emergency Department: An External, Prospective Validation of Clinical Decision Rules.","authors":"Nadjia Amini, Sabrina De Winter, Sanne Nijs, Ann-Sophie Jacob, Sandra Verelst, Peter Vanbrabant, Lorenz Van der Linden, Isabel Spriet","doi":"10.1002/pds.70265","DOIUrl":"10.1002/pds.70265","url":null,"abstract":"<p><strong>Purpose: </strong>Drug-related admissions (DRAs) remain highly prevalent and are linked with increased morbidity and mortality. Rapid and accurate identification is key to both their acute management and secondary prevention. To this end, two clinical decision rules (CDRs) were recently developed to identify the causal adverse drug event (ADE-CDR) or the underlying adverse drug reaction (ADR-CDR). The aim of this study was to assess the diagnostic accuracy of both CDRs in a new patient cohort.</p><p><strong>Methods: </strong>A prospective, cross-sectional study was conducted at the emergency department (ED) of the University Hospitals Leuven in Belgium. Adult patients were included if admitted to the hospital via the ED. DRA was adjudicated by team consensus and compared to both ADE-CDR and ADR-CDR. Diagnostic accuracy was determined, and multivariable logistic regression was used to explore risk factors for DRAs.</p><p><strong>Results: </strong>From 1 October 2018 to 26 September 2019, 438 patients were included, 58 (13.2%) of whom incurred a DRA. ADE-CDR had a sensitivity of 89.7% and a specificity of 22.4%. The sensitivity and specificity of ADR-CDR were 46.6% and 60.8%, respectively. Two risk factors were found for DRA: the presence of ≥ 1 comorbidity (odds ratio (OR) 4.71, 95% confidence interval (CI): 1.42-15.49) and ambulance transport (OR 2.16, 95% CI: 1.21-3.82).</p><p><strong>Conclusion: </strong>ADE-CDR showed a high sensitivity. In terms of specificity, both CDRs were unable to rule in DRAs in our setting. Conversely, the ADE-CDR showcased the potential to rule out DRAs.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70265"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145496251","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":"Titel: Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Among Patients Treated With Immune Checkpoint Inhibitors Compared to Other Antineoplastic Medications: A Nationwide Study.","authors":"Ida M Heerfordt, Magnus Middelboe, Christian Kjer Heerfordt, Henrik Horwitz, Rasmus Huan Olsen","doi":"10.1002/pds.70272","DOIUrl":"https://doi.org/10.1002/pds.70272","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to assess the risk of Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) among patients treated with immune checkpoint inhibitors (ICIs), compared to those receiving molecularly targeted therapies or conventional chemotherapy, using real-world data.</p><p><strong>Methods: </strong>We conducted a nationwide study involving all patients treated with antineoplastic agents in Denmark from May 2018 to December 2024, identified through the Danish National Hospital Medication Registry. SJS/TEN cases were identified within 3 months of each administration using the International Classification of Diseases, 10th Revision codes L51.1 and L51.2, as recorded in the Danish National Patient Register. Incidence rates of SJS/TEN were calculated per 10 000 patients treated, and incidence rate ratios (IRRs) were estimated to compare treatment modalities.</p><p><strong>Results: </strong>Among 91 424 patients treated with antineoplastic agents, 19 developed SJS/TEN. The incidence rates per 10 000 patients treated were 6.89 for ICIs, 1.79 for molecularly targeted therapies, and 1.51 for conventional chemotherapy. Patients receiving ICIs had a higher risk of developing SJS/TEN compared with those receiving molecularly targeted therapies (IRR 3.84, 95% CI 1.39-10.60, p = 0.009) or conventional chemotherapy (IRR 4.57, 95% CI 1.52-11.57, p = 0.001).</p><p><strong>Conclusion: </strong>While the risk of SJS/TEN is higher among patients treated with ICIs compared to those receiving other types of antineoplastic agents, the overall incidence in the real-world setting remains low.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70272"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145541838","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 Reporting and Methodological Recommendations for Observational Studies Estimating the Effects of Deprescribing Medications (REMROSE-D) ISPE-Endorsed Guidance.","authors":"Kaleen N Hayes, Joshua D Niznik, Danijela Gnjidic, Frank Moriarty, Dimitri Bennett, Marie-Laure Laroche, Denis Talbot, Matthew Alcusky, Maurizio Sessa, Antoinette B Coe, Caroline Sirois, Andrew R Zullo, Xiaojuan Li, Sri Harsha Chalasani, Jehath Syed, Mouna Sawan, Daniela C Moga","doi":"10.1002/pds.70255","DOIUrl":"10.1002/pds.70255","url":null,"abstract":"<p><strong>Purpose: </strong>Pharmacoepidemiologic studies on deprescribing are challenging to implement, yet little guidance exists on methods to avoid bias and minimum reporting for replicability and appraisal. We developed consensus recommendations for the methods and reporting of observational studies that aim to examine the effects of deprescribing.</p><p><strong>Methods: </strong>We formed candidate recommendations based on our prior systematic review that methodologically appraised observational studies on deprescribing. We then conducted a two-round modified Delphi process with researchers working in deprescribing pharmacoepidemiology to refine, select, and reach consensus on recommendations for a checklist based on > 70% agreement of their importance. We termed this list the REMROSE-D (Reporting and Methodological Recommendations for Observational Studies estimating the Effects of Deprescribing medications) guidance.</p><p><strong>Results: </strong>Twenty-three candidate recommendations were presented to the Delphi panel. The round 1 survey was completed by 55 participants, and 18 of the 23 candidate recommendations were selected for inclusion. Five candidate recommendations without consensus plus two additional items suggested by participants were included in a round 2 survey of 25 deprescribing researchers. Five of these seven items garnered consensus for inclusion, and two were excluded. The final REMROSE-D guidance contains 23 recommendations for the methods and reporting of observational research on deprescribing.</p><p><strong>Conclusion: </strong>To ensure rigor and reproducibility in observational studies of the effects of deprescribing, the REMROSE-D guidance provides recommendations for important reporting and methods considerations, including time zero, precise definitions of deprescribing, addressing confounding by indication, and careful consideration of follow-up to avoid immortal time bias.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70255"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12617387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145513436","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":"Age- and Sex-Related Trends in Psychotropic Prescribing Among Youths in Denmark and the United States: 2010-2020.","authors":"Phuong Tran, Lotte Rasmussen, Alejandro Amill-Rosario, Mette Bliddal, Susan dosReis, Rikke Wesselhoeft","doi":"10.1002/pds.70256","DOIUrl":"10.1002/pds.70256","url":null,"abstract":"<p><strong>Objectives: </strong>To compare age- and sex-specific trends of psychotropic prescribing between Danish and US 3-17-year-old youths.</p><p><strong>Methods: </strong>A consecutive annual cross-sectional study of trends in psychotropic prescribing from 2010 to 2020. Data sources included the Danish National Prescription Registry data and, for the US, a 25% random sample of the IQVIA PharMetrics Plus for Academics database. Psychotropic prescribing (i.e., ADHD medications, antidepressants, and antipsychotics), measured as annual prevalence, was estimated for each therapeutic class, by age group and sex, separately by country. We used Joinpoint models to calculate the average annual percentage change (AAPC).</p><p><strong>Results: </strong>ADHD medication prescribing decreased for 5-9 year-olds in both countries from 2010 to 2020, while prescribing among 10-17 year-olds was stable in the US and increased in Denmark, particularly among females (AAPC = 4.2% versus 1.4% among males). Antidepressant prescribing increased in older US youths, especially among 14-17 year-olds (AAPC = 6.5%), and females (AAPC = 7.2%). In Denmark, however, prescribing was low and decreased over time, especially among females (AAPC = -4.2%). Antipsychotic prescribing decreased in both countries for all age groups, with the largest decrease among males (Denmark: AAPC = -5.2% and US: AAPC = -6.1%).</p><p><strong>Conclusion: </strong>Pediatric antipsychotic prescribing generally decreased, whereas ADHD medication and antidepressant prescribing presented opposing patterns in the two countries. ADHD medication prescribing increased among Danish females and adolescents, but was stable in the US. Antidepressant prescribing decreased in Denmark, particularly among females, which opposed the marked rise for this group in the US. Future cross-national studies should examine the rationale underpinning variation in antidepressant prescribing.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70256"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12587754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145445233","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":"Causal Forests Versus Inverse Probability of Treatment Weighting to Adjust for Cluster-Level Confounding: A Parametric and Plasmode Simulation Study Based on US Hospital Electronic Health Record Data.","authors":"Mike Du, Stephen Johnston, Paul M Coplan, Victoria Y Strauss, Sara Khalid, Daniel Prieto-Alhambra","doi":"10.1002/pds.70257","DOIUrl":"10.1002/pds.70257","url":null,"abstract":"<p><strong>Background: </strong>Rapid innovation and new regulations increase the need for post-marketing surveillance of implantable devices. However, complex multi-level confounding related to patient-level and surgeon or hospital covariates hampers observational studies of risks and benefits. We conducted two simulation studies to compare the performance of Causal Forests (CF) versus Inverse Probability of Treatment Weighting (IPTW) to reduce confounding bias in the presence of strong surgeon impact on treatment allocation.</p><p><strong>Methods: </strong>Two Monte Carlo simulation studies were carried out: (1) Parametric simulations with patients nested in clusters (ratio 10:1, 50:1, 100:1, 200:1, 500:1) and sample size n = 10 000 were conducted with patient and cluster level confounders; (2) Plasmode simulations generated from a cohort of 9981 patients admitted for pancreatectomy between 2015 and 2019 from the US PINC AT hospital research database. Different CF algorithms and IPTW were used to estimate binary treatment effects.</p><p><strong>Results: </strong>Performance varied with the strength of cluster-level confounding. Under weak to moderate surgeon influence, CF and IPTW performed similarly. When confounding was strong (OR = 2.5), CF reduced bias compared with IPTW: in parametric simulations, relative bias averaged 11.2% for CF versus 19.9% for IPTW, with similar advantages observed in plasmode simulations.</p><p><strong>Conclusions: </strong>CF shows promise as a method for estimating treatment effects in scenarios where cluster-level confounding strongly impacts treatment allocation. More research is needed to guide its use.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70257"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12583492/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145438857","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":"Perinatal Outcomes After the Use of Kampo Medicines Containing Ephedra During Pregnancy.","authors":"Aoi Noda, Ryutaro Arita, Taku Obara, Minoru Ohsawa, Satoko Suzuki, Ken Haneda, Ryo Obara, Kei Morishita, Genki Shinoda, Keiko Murakami, Masatsugu Orui, Mami Ishikuro, Akiko Kikuchi, Shin Takayama, Tadashi Ishii, Shinichi Kuriyama","doi":"10.1002/pds.70251","DOIUrl":"10.1002/pds.70251","url":null,"abstract":"<p><strong>Purpose: </strong>Japanese traditional (Kampo) medicines containing ephedra are used to relieve symptoms of the common cold during pregnancy. The risks associated with perinatal outcomes, however, remain unclear. Thus, we evaluated the risk of adverse perinatal outcomes associated with the use of Kampo medicines containing ephedra during pregnancy using data from the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study (TMM BirThree Cohort Study).</p><p><strong>Methods: </strong>Questionnaires were distributed to pregnant women who participated in the TMM BirThree Cohort Study at approximately weeks 12 and 26 of pregnancy. Adverse perinatal outcomes in women who used Kampo medicines containing ephedra or acetaminophen during pregnancy were assessed. Odds ratios (ORs) were estimated using weighted logistic regression analyses.</p><p><strong>Results: </strong>Among 20 083 pregnant women, acetaminophen and Kampo medicines containing ephedra were used by 5.3% and 3.5% of women, respectively. The OR for caesarean section was 0.95 (95% confidence interval [CI], 0.75-1.20), for preterm birth (PTB) was0.99 (95% CI, 0.63-1.55), for low birth weight (LBW) was 1.04 (95% CI, 0.72-1.49), for small for gestational age (SGA) was 0.98 (95% CI, 0.58-1.65), and for low Apgar scores at 5 min was 0.85 (95% CI, 0.25-2.93) in the women who used Kampo medicines containing ephedra during pregnancy.</p><p><strong>Conclusions: </strong>No statistically significant association was seen between the use of Kampo medicines containing ephedra during pregnancy and an increased risk of needing a caesarean section, PTB, LBW, SGA, or low Apgar scores. Although further research is needed, this study may assist in clinical decision-making.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70251"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12583451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145438860","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":"Overlap Weights for Binary Outcomes: A Performance Assessment.","authors":"Seo Young Park, Jaeil Ahn, Jae Hoon Lee, Jaewoo Kwon, Hana Lee","doi":"10.1002/pds.70253","DOIUrl":"https://doi.org/10.1002/pds.70253","url":null,"abstract":"<p><strong>Background: </strong>Inverse probability weighting (IPW) is a widely used method to estimate the causal effect of treatment from observational data. However, it can be unstable when extreme propensity score (PS) values lead to very large weights. Overlap weights (OW), which emphasize subjects in areas of covariate overlap, reduce the influence of extreme PS without excluding participants. While the OW method has shown strong performance in simulations with continuous outcomes, its utility in binary outcome settings-common in health research-has not been thoroughly evaluated.</p><p><strong>Methods: </strong>We conducted simulation studies to evaluate the performance of OW in comparison to other PS weighting methods including IPW, trimmed IPW, and matching weights, in settings with extreme PS values and a binary outcome. Using simulated datasets with varying degrees of PS overlap and treatment prevalence, we assessed covariate balance and treatment effect estimation performance. The performance of the PS weighting methods was further illustrated through an application to data from a study on pancreatic ductal adenocarcinoma.</p><p><strong>Results: </strong>In simulation studies, IPW's performance deteriorated markedly as the overlap in the covariate distribution decreased. In contrast, OW achieved exact covariate balance and consistently showed the highest efficiency among all methods evaluated. In the application to real-world data characterized by low treatment prevalence and substantial covariate imbalance, OW also outperformed the other methods in terms of both standard error and covariate balance.</p><p><strong>Conclusion: </strong>These findings suggest superior performance of OW in terms of covariate balance and estimation efficiency in settings with extreme PS and a binary outcome.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70253"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145409688","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":"Epidemiological Profile of Exogenous Intoxications by Self-Medication in Brazil: A Decade of Trends and the Impact of the COVID-19.","authors":"Lucas Borges Pereira, Júlia Casanova Durante, Leonardo Régis Leira Pereira, Fabiana Rossi Varallo, Maria Olívia Barboza Zanetti","doi":"10.1002/pds.70269","DOIUrl":"10.1002/pds.70269","url":null,"abstract":"<p><strong>Purpose: </strong>Self-medication carries the potential for significant adverse events when practiced irresponsibly. The indiscriminate use of medicines notably intensified during the COVID-19 pandemic. This study aimed to investigate the epidemiological profile of exogenous intoxications due to self-medication among Brazilians from 2014 to 2023.</p><p><strong>Methods: </strong>This was a cross-sectional, descriptive, and exploratory study utilizing secondary data from the Brazilian Ministry of Health's Notifiable Diseases Information System. Confirmed cases of self-medication intoxication reported between 2014 and 2023 were included. Descriptive analysis, incidence and lethality rate calculations, chi-squared tests (p ≤ 0.05), and Multiple Correspondence Analysis (MCA) were performed to explore potential associations between sociodemographic and clinical variables.</p><p><strong>Results: </strong>A total of 23 859 cases were analyzed. The study observed a predominance of adults (20-59 years), women (70.8%), and individuals self-identifying as White or Brown (mixed-race). Most cases resulted from an acute-single exposure to the medication and resolved with complete recovery without sequelae. There was a national increase in incidence, particularly in 2022 and 2023, and significant variations among Brazilian Federative Units. The MCA identified associations between advanced age and the type of exposure (repeated or chronic) and the severity of outcomes. It also revealed changes in the sociodemographic profile of self-medication intoxications during the COVID-19 pandemic.</p><p><strong>Conclusions: </strong>These findings underscore the pandemic's impact on self-medication patterns and intoxication notifications. The study highlights the need for public policies focused on health education, appropriate medicine use, and strengthening the culture of reporting in Brazil.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70269"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12620163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145534577","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":"Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using Merative MarketScan Research Databases.","authors":"Astrid Coste, Angel Y S Wong, Francois Haguinet, Andrew Bate, Ian J Douglas","doi":"10.1002/pds.70250","DOIUrl":"10.1002/pds.70250","url":null,"abstract":"<p><strong>Background: </strong>Despite testing of epidemiological methods in US Claims databases for signal detection, such data sources have not become a routine capability. The Self Controlled Case Series (SCCS) is one of the most promising methods for drug safety signal detection using Real World Data, and incorporating active comparators could potentially improve its performance by addressing confounding by indication.</p><p><strong>Objectives: </strong>This study aims to evaluate the performance of the SCCS with and without active comparators for signal detection using US Merative MarketScan Commercial Claims and Medicare databases.</p><p><strong>Methods: </strong>We applied the SCCS to macrolide and fluoroquinolone antibiotics, using amoxicillin and cefalexin as active comparators. In total, 7 drugs and 30 outcomes from all organ classes were selected. We developed a reference set of 104 positive controls and 58 negative controls, using a taxonomy framework to ensure the selected drug outcome pairs are theoretically well suited to the SCCS design. A two-year observation period with a 30-day risk window after each dispensing was used. Diagnostic performance was measured using sensitivity and specificity with respect to the product labels.</p><p><strong>Results: </strong>The SCCS without active comparators achieved sensitivities of 0.73 and 0.72 and specificities of 0.68 and 0.62 in commercial and Medicare claims, respectively, for pairs with sufficient power. Active comparators increased specificity up to 0.84 and 0.86, respectively, in Commercial Claims and Medicare but decreased sensitivity to 0.45 and 0.36.</p><p><strong>Conclusions: </strong>MarketScan databases are potentially suitable for drug safety signal detection due to their large size and information contained. Using a carefully designed reference set of drug-outcome pairs well suited to the study design, the SCCS, while imperfect, performed comparably to optimal settings identified in previously published studies. Active comparators did not enhance overall performance but showed improved specificity by better controlling confounding by indication at the cost of reduced sensitivity.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70250"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12603968/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145489573","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":"Utilization of Oral Contraceptives and Hormone Therapy for Menopause Among Female Individuals With Migraine With Aura: A Descriptive Study.","authors":"Liza R Gibbs, Matthew P Fox, Hugo J Aparicio, Susan Jick","doi":"10.1002/pds.70266","DOIUrl":"https://doi.org/10.1002/pds.70266","url":null,"abstract":"<p><strong>Purpose: </strong>Combined oral contraceptives (COCs) are contraindicated in migraine with aura due to stroke risk, and some hormone therapy for menopause guidelines recommend caution in this population. However, this guidance is informed by sparse or older evidence reflective of higher doses than typically prescribed today. This study aimed to describe modern-day utilization of COCs and hormone therapy among female individuals with migraine with aura from 2000 to 2024.</p><p><strong>Methods: </strong>Using United Kingdom medical record data, this study evaluated the use of COCs and progestogen-only pills (POPs) among reproductive-age individuals and hormone therapy among post-reproductive age individuals, before and after migraine with aura diagnosis. Post-diagnosis medication utilization was described relative to baseline characteristics and pre-diagnosis use of each medication, overall and longitudinally.</p><p><strong>Results: </strong>Among 142 867 individuals of reproductive age, 84 374 (59%) used oral contraceptives on or after migraine with aura diagnosis, predominantly POPs (n = 75 823, 53% of those with any oral contraceptive) over COCs (n = 21 968, 15%). Most oral contraceptive users in the year pre-diagnosis used COCs (n = 36 909/56760, 66%). Among 46 913 individuals of post-reproductive age, 20 990 (45%) had a prescription for hormone therapy after migraine with aura diagnosis, with transdermal formulations used increasingly over calendar time.</p><p><strong>Conclusions: </strong>Utilization of COCs declined but did not fully cease after migraine with aura diagnosis. Post-diagnosis utilization of hormone therapy for menopause was common. Given this utilization among individuals with migraine with aura, high-quality evidence quantifying the risk of stroke associated with modern-day use of these medications in this population is needed to inform patient and provider decision making.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70266"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145513479","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}