Pharmacoepidemiology and Drug Safety最新文献

{"title":"Utilisation Trends of Lisdexamfetamine: Insights From Recent Medicine Shortages in Australia.","authors":"Jack Janetzki, Lisa Kalisch, Kelly Hall, Nicole Pratt","doi":"10.1002/pds.70113","DOIUrl":"10.1002/pds.70113","url":null,"abstract":"<p><strong>Purpose: </strong>Investigate the impact of recent notified medicine shortages on dispensing patterns of 30, 40, 50, and 60 mg strengths of lisdexamfetamine for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Australia.</p><p><strong>Methods: </strong>Pharmaceutical Benefits Scheme (PBS) aggregate dispensing data for 2022-2024 were analysed. Monthly dispensings and Defined Daily Doses (DDDs) for lisdexamfetamine were calculated overall and by product strength.</p><p><strong>Results: </strong>From January 2022 to August 2023, there was a constant increase in overall dispensing and volume of lisdexamfetamine likely due to expansion of PBS prescribing restrictions allowing subsidy of this medicine for patients 18 years and older in February 2021. Dispensings of the 30 mg strength decreased from August 2023 corresponding with shortages of this product. Dispensings of the 50 mg peaked in October 2023 then decreased. During the shortage of the 30 and 50 mg strengths, dispensings of the 40 and 60 mg strengths increased, however, by December 2023 dispensings of these strengths were also decreasing. Dispensings of 70 mg strengths grew steadily throughout 2024. DDDs changed substantially during the shortage period suggesting that people likely transitioned to different strengths of lisdexamfetamine to maintain their dose.</p><p><strong>Conclusion: </strong>Dispensing patterns of lisdexamfetamine, by strength, changed significantly during the medicines shortages periods revealing potential changes in prescriber and patient behaviours, such as switching to higher strength products or using medicines intermittently, to maintain continuity of care. To facilitate quality use of medicines during shortages, dispensing patterns must be monitored so that inequities of access can be identified and addressed.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70113"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143391334","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":"Adapting the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) Guide 1.5 for Use in Post-Authorisation Safety Studies Using US Data.","authors":"Sarah Ruth Hoffman, Geetika Kalloo, Stephan Lanes, Aziza Jamal-Allial, Todd Sponholtz, Corinne Brooks, Maria Guzman, Maria I Van Rompay, Oluwadamilola Onasanya, Vincent J Willey, Erica Foster, Nadia Messeh, Jill Layton, Dawn Ponist, Maryline L E Noan-Lainé, Krista Schroeder","doi":"10.1002/pds.70109","DOIUrl":"10.1002/pds.70109","url":null,"abstract":"<p><strong>Purpose: </strong>Many post-authorization safety studies focus on congenital malformations and rely on diagnosis codes found in US data sources. However, no authoritative standards exist for identifying and classifying malformations in these data. To address this, we translated an existing public health surveillance guide, the European Concerted Action on Congenital Anomalies and Twins (EUROCAT), into an ICD-10-CM code list for use in studies using US administrative healthcare data. The EUROCAT guide was selected for its decisive major or minor classification of each code. However, translation was required for use in US data sources since EUROCAT utilizes ICD-10-BPA which differs from ICD-10-CM (the coding system commonly encountered in US data sources).</p><p><strong>Methods: </strong>We mapped EUROCAT to ICD-10-CM. For each code, manual review was conducted by two or more researchers, and major/minor classification was based on code descriptions since some codes differed between coding systems.</p><p><strong>Results: </strong>A final code list was created, containing 916 ICD-10-CM codes for 744 major and 172 minor malformations. The code list contains ICD-10-CM codes, their corresponding descriptions, their major or minor classification and disease category according to EUROCAT, and variables indicating anomalies caused by genetic or infectious diseases unlikely attributable to a medication.</p><p><strong>Conclusions: </strong>We adapted the EUROCAT Guide 1.5 into an ICD-10-CM code list for use in pregnancy studies using US data sources. This list includes new ICD-10-CM codes available in 2024. As new ICD-10-CM codes become available, or as the EUROCAT Guide is updated, further updates to this list will be needed.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70109"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11829207/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425954","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":"Validation of Clinical Practice Research Datalink (CPRD) Aurum Mother-Baby Link.","authors":"Catherine Vasilakis-Scaramozza, Rebecca Persson, George Kafatos, David Neasham, Katrina Wilcox Hagberg, Susan Jick","doi":"10.1002/pds.5860","DOIUrl":"10.1002/pds.5860","url":null,"abstract":"<p><strong>Purpose: </strong>Assess the validity of the Clinical Practice Research Datalink (CPRD) Aurum Mother-Baby Link (MBL).</p><p><strong>Methods: </strong>We assessed the validity of CPRD Aurum MBL pairs using several strategies. Our study population was based on all available MBL pairs in a 100-practice sample of CPRD Aurum. We sent a questionnaire to the general practitioner of a sample of MBL patients asking if linkage was correct and whether delivery date was correct within 14 days. We also compared MBL delivery date to the matched child's birth date in CPRD Aurum. Finally, in the Hospital Episode Statistics (HES) eligible population, we compared MBL delivery date to birthing parent's HES delivery date.</p><p><strong>Results: </strong>The study population included 124 962 MBL pairs: 124 962 livebirths, 91 218 birthing parents, and 123 562 deliveries. Based on 361 questionnaire responses standardized to the MBL population, 85% (95% CI 74%-96%) of pairs were confirmed as correctly matched, <1% (0.04%-1.4%) were incorrectly matched, and 13% (10%-18%) could not be confirmed. For 71% (61%-82%) of the sample, delivery date was correct within 14 days. Among the entire population of 124 962 MBL pairs, 73% of MBL pairs had MBL delivery date within the baby's birth month recorded in CPRD Aurum. Among 79 834 patients with HES linkage, 94% of 107 080 MBL deliveries in CPRD Aurum were confirmed in HES.</p><p><strong>Conclusions: </strong>Our various assessments of CPRD Aurum MBL found the great majority of pairs were correctly matched and most delivery dates were correct within 14 days. Further refinement of delivery dates may be necessary for some studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e5860"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440477","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":"Advancing Research Transparency and Reproducibility in Pharmacoepidemiology.","authors":"Shirley V Wang, Anton Pottegård","doi":"10.1002/pds.70096","DOIUrl":"https://doi.org/10.1002/pds.70096","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70096"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414778","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":"Geographic and Temporal Patterns in Biologic Prescriptions for Inflammatory Bowel Diseases in the Public Healthcare System in Brazil: An Ecological Study.","authors":"Caroline Tianeze de Castro, Marcio Dos Santos Natividade, Marcos Pereira, Samilly Silva Miranda, Erika Aragão, Carlos Antonio de Souza Teles Santos, Djanilson Barbosa Dos Santos","doi":"10.1002/pds.70114","DOIUrl":"10.1002/pds.70114","url":null,"abstract":"<p><strong>Purpose: </strong>To analyze the geographic and temporal patterns of biologic prescriptions for inflammatory bowel disease (IBD) in Brazil's public national unified health system (SUS).</p><p><strong>Methods: </strong>This ecological study used data from patients with IBD in the SUS Outpatient Information System between 2008 and 2022. Prais-Winsten regression was used to estimate the trends in prescription rate of biologics. For geographic analysis, average prescription rate of biologics was calculated by state for three periods: 2008-2012, 2013-2017, and 2018-2022. Global Moran's index (GMI) and local indicators of spatial autocorrelation (LISA) were used to assess spatial autocorrelation and identify spatial clusters of biologic prescriptions, respectively.</p><p><strong>Results: </strong>The prescription rate of biologics increased from 3.0% to 16.7%. Infliximab was the most prescribed drug from 2008 to 2012 (3.0%-4.2%), and adalimumab was the most widely prescribed drug from 2013 to 2022 (4.3%-9.1%). Higher prescription rates of biologics were observed in patients with Crohn's disease than in those with ulcerative colitis (40.5% vs. 3.2%). Biologics were primarily prescribed in the Southeast and South; however, the central-western and northern regions showed greater changes in prescription rates over time. There were increased clusters of high biologic prescriptions across the three evaluated periods.</p><p><strong>Conclusions: </strong>The increase in biologic prescriptions over time may be attributed to their enhanced efficacy in inducing and maintaining IBD remission. Biologic prescriptions in Brazil are experiencing temporal and geographical changes, indicating that disparities in drug prescriptions may decrease with universal, equitable healthcare access, despite administrative challenges in obtaining these medications through SUS.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70114"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414785","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 Healthcare Integrated Research Database (HIRD) as a Real-World Data Source for Pharmacoepidemiologic Research.","authors":"John J Barron, Vincent J Willey, Brett T Doherty, Ozgur Tunceli, Craig R Waltz, Michael Grabner, Daniel C Beachler, Stephan Lanes, Mark J Cziraky","doi":"10.1002/pds.70110","DOIUrl":"10.1002/pds.70110","url":null,"abstract":"<p><strong>Background and methods: </strong>The Healthcare Integrated Research Database (HIRD) is a large, comprehensive real-world data (RWD) source for health-related research. Demographic and healthcare-related characteristics of individuals are sourced from routinely updated RWD. The HIRD includes health insurance claims and other health-related information for individuals enrolled in health insurance plans offered or managed by Elevance Health and has been utilized for research for almost two decades. Individuals in the HIRD reside throughout the United States. Data in the HIRD have been available since January 2006, and are updated monthly.</p><p><strong>Results: </strong>As of July 2024, the researchable population of the HIRD included over 91 million individuals with medical benefits, and over 24 million individuals were actively enrolled. The median age of individuals in the HIRD is 36 years (interquartile range [IQR]: 22, 54), and 50% of individuals in the HIRD are female. The median duration of continuous enrollment in the HIRD is 2.0 years (IQR: 0.8, 4.7). For those actively enrolled, the median duration of continuous enrollment is 3.8 years (IQR: 1.7, 8.3). Other important characteristics of the HIRD include the ability to trace data back to their source, support both deterministic and probabilistic linkage with external data sources, and link family members within health plans.</p><p><strong>Conclusions: </strong>The HIRD has been a trusted resource to generate real-world evidence for a variety of health-related research, including regulatory-required safety studies, comparative effectiveness studies, and health economics and outcomes research.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70110"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11798679/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143256021","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":"Impact of Pharmacovigilance Interventions Targeting Fluoroquinolones on Antibiotic Use in the Netherlands and the United Kingdom.","authors":"Tomas Lasys, Yared Santa-Ana-Tellez, Satu J Siiskonen, Rolf H H Groenwold, Helga Gardarsdottir","doi":"10.1002/pds.70081","DOIUrl":"10.1002/pds.70081","url":null,"abstract":"<p><strong>Purpose: </strong>Fluoroquinolones are antibiotics associated with adverse events that prompted the European Medicines Agency to implement risk minimization measures (RMMs) in 2018/19 and 2020. Our aim is to assess the RMMs' impact on antibiotic prescriptions in primary care during 2014-2023.</p><p><strong>Methods: </strong>We assessed antibiotic prescriptions using CPRD GOLD (the United Kingdom, UK) and PHARMO (the Netherlands, NL). Prescriptions were assessed for fluoroquinolones and alternative antibiotics. The impact of RMMs on prescribing was assessed with interrupted time series (ITS) using monthly prescription rates per 10 000 person-years (MPTPY).</p><p><strong>Results: </strong>Between 2014 and 2023, we identified cohorts of 4.0 (UK) and 0.9 million (NL) antibiotic users. Fluoroquinolones were prescribed to initiate 1.5% (UK) to 5.8% (NL) of the treatment episodes. Fluoroquinolone prescribing before the RMMs slowly decreased in the UK and was stable in the NL. The 2018/19 RMMs were associated with a steady downward post-RMMs trend in incident use of fluoroquinolones (MPTPY -0.7 [UK] and -0.8 [NL]) and opposite changes after 2020 RMMs (MPTPY 0.6 [UK] and 1.8 [NL]). The 2018/2019 RMMs were linked with increasing trends for other antibacterials (J01XX) in both countries and other beta-lactam antibacterials in the UK, but most antibiotics had decreasing trends post-RMMs in both countries. After the 2020 RMMs, some antibiotic groups showed upward trends.</p><p><strong>Conclusion: </strong>The risk minimization measures in 2018/2019 were associated with a moderate decrease in fluoroquinolone prescribing, with no further decrease after 2020 RMMs. There was no sustained increase in other antibiotic prescribing, suggesting that overprescribing was negligible as an unintended impact of RMMs.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70081"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11739677/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143009446","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":"INSIGHT: A Tool for Fit-for-Purpose Evaluation and Quality Assessment of Standardized Observational Data Sources for Real World Evidence on Medicine and Vaccine Safety.","authors":"Vjola Hoxhaj, Constanza L Andaur Navarro, Judit Riera-Arnau, Roel J H J Elbers, Ema Alsina, Caitlin Dodd, Miriam C J M Sturkenboom","doi":"10.1002/pds.70089","DOIUrl":"10.1002/pds.70089","url":null,"abstract":"<p><strong>Purpose: </strong>To describe the development of INSIGHT, a real-world data quality tool to assess completeness, consistency, and fitness-for-purpose of observational health data sources.</p><p><strong>Methods: </strong>We designed a three-level pipeline with data quality assessments (DQAs) to be performed in ConcePTION Common Data Model (CDM) instances. The pipeline has been coded using R.</p><p><strong>Results: </strong>INSIGHT is an open-source tool that identifies potential data quality issues in CDM-standardized instances through the systematic execution and summary of over 588 configurable DQAs. Level 1 focuses on conformance to the ConcePTION CDM specifications. Level 2 evaluates the temporal plausibility of events and uniqueness of records. Level 3 provides an overview of distributions, outliers, and trends over time to facilitate fit-for-purpose evaluation. Therefore, level 1 and 2 assure a proper data standardization, while level 3 provides information regarding the study population, and potential sub-populations. The DQAs are run locally and assessed centrally by a data quality revisor together with the data access provider's representatives.</p><p><strong>Discussion: </strong>Data quality is the sum of several internal and external features of the data. While DQAs can provide reassurance about fitness-for-purpose for secondary-use data sources, improvements in data collection are essential to reduce errors and enhance overall data quality for Real World Evidence.</p><p><strong>Conclusion: </strong>INSIGHT aims to support clinical and regulatory decision-making for medicines and vaccines by evaluating the quality of observational health data sources to support fit for purpose assessment. Assessing and improving data quality will enhance the reliability and quality of the generated evidence.</p><p><strong>Study registration: </strong>This research was registered in EU PAS registration with number EU50142.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70089"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979423","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":"Masking in Active Comparator Designs in Pharmacovigilance: A Retrospective Bias Analysis on the Spontaneous Reporting of Thiazolidinediones and Cardiovascular Events.","authors":"William Bai, Antonios Douros, Christopher A Gravel","doi":"10.1002/pds.70102","DOIUrl":"10.1002/pds.70102","url":null,"abstract":"<p><strong>Introduction: </strong>Masking is a reporting bias where drug safety signals are muffled by elevated reporting of other medications in spontaneous reporting databases. While the impact of masking is often limited, its effect when using restricted designs, such as active comparators, can be consequential.</p><p><strong>Methods: </strong>We used data from the US Food and Drugs Administration Adverse Event Reporting System (1999Q3-2013Q3) to study masking in a real-world example. Rosiglitazone, a thiazolidinedione with elevated reporting after safety concerns over cardiovascular risks, was the masking candidate. We hypothesized that stimulated reporting masked signals for another thiazolidinedione, pioglitazone. We computed estimates of proportional reporting ratios and information components, using the Bayesian confidence propagation neural network, for pioglitazone-myocardial infarction and pioglitazone-cardiac failure under unrestricted and active comparator designs, with and without the mask, before (1999Q3-2007Q1) and after (2007Q2-2013Q3) safety concerns. Relative change-in-estimates were computed to compare results with and without rosiglitazone.</p><p><strong>Results: </strong>From 1999Q3-2007Q1, relative change-in-estimates of proportional reporting ratio for pioglitazone-myocardial infarction was 0.00 in unrestricted design and 0.10 in active comparator, and for pioglitazone-cardiac failure, the change was 0.01 and 0.62, respectively. From 2007Q2-2013Q3, relative change-in-estimates for pioglitazone-myocardial infarction was 0.41 in unrestricted design and 18.00 in active comparator; the change for pioglitazone-cardiac failure was 0.04 and 1.03, respectively. Relative changes in estimates of information component mirrored these trends.</p><p><strong>Conclusions: </strong>Masking can influence signal detection in active comparator designs where external events impact reporting rates in reference sets. Evaluating masking in related contexts is essential for drug safety monitoring and resource allocation for follow-up studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70102"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984575","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":"Using Quantitative Bias Analysis to Adjust for Misclassification of COVID-19 Outcomes: An Applied Example of Inhaled Corticosteroids and COVID-19 Outcomes.","authors":"Marleen Bokern, Christopher T Rentsch, Jennifer K Quint, Jacob Hunnicutt, Ian Douglas, Anna Schultze","doi":"10.1002/pds.70086","DOIUrl":"10.1002/pds.70086","url":null,"abstract":"<p><strong>Background: </strong>During the pandemic, there was concern that underascertainment of COVID-19 outcomes may impact treatment effect estimation in pharmacoepidemiologic studies. We assessed the impact of outcome misclassification on the association between inhaled corticosteroids (ICS) and COVID-19 hospitalisation and death in the United Kingdom during the first pandemic wave using probabilistic bias analysis (PBA).</p><p><strong>Methods: </strong>Using data from the Clinical Practice Research Datalink Aurum, we defined a cohort with chronic obstructive pulmonary disease (COPD) on 1 March 2020. We compared the risk of COVID-19 hospitalisation and death among users of ICS/long-acting β-agonist (LABA) and users of LABA/LAMA using inverse probability of treatment weighted (IPTW) logistic regression. We used PBA to assess the impact of non-differential outcome misclassification. We assigned beta distributions to sensitivity and specificity and sampled from these 100 000 times for summary-level and 10 000 times for record-level PBA. Using these values, we simulated outcomes and applied IPTW logistic regression to adjust for confounding and misclassification. Sensitivity analyses excluded ICS + LABA + LAMA (triple therapy) users.</p><p><strong>Results: </strong>Among 161 411 patients with COPD, ICS users had increased odds of COVID-19 hospitalisations and death compared with LABA/LAMA users (OR for COVID-19 hospitalisation 1.59 (95% CI 1.31-1.92); OR for COVID-19 death 1.63 (95% CI 1.26-2.11)). After IPTW and exclusion of people using triple therapy, ORs moved towards the null. All implementations of QBA, both record- and summary-level PBA, modestly shifted the ORs away from the null and increased uncertainty.</p><p><strong>Conclusions: </strong>We observed increased risks of COVID-19 hospitalisation and death among ICS users compared to LABA/LAMA users. Outcome misclassification was unlikely to change the conclusions of the study, but confounding by indication remains a concern.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70086"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706700/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952668","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}