Drug Safety最新文献

{"title":"Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm.","authors":"Lovisa Sandberg, Sara Hedfors Vidlin, Levente K-Pápai, Ruth Savage, Boukje C Raemaekers, Henric Taavola-Gustafsson, Annette Rudolph, Lucy Quirant, Tomas Bergvall, Magnus Wallberg, Johan Ellenius","doi":"10.1007/s40264-025-01559-0","DOIUrl":"10.1007/s40264-025-01559-0","url":null,"abstract":"<p><strong>Background: </strong>Information on the safety of medicine use during pregnancy is limited at the time of marketing, making post-marketing surveillance essential. However, the lack of a specific indicator for pregnancy-related case reports within the international standard for transmission of individual case safety reports complicates the retrieval of such reports in pharmacovigilance databases. To address this, an algorithm to identify reports of exposures during pregnancy was developed in VigiBase, the World Health Organization global database of adverse event reports.</p><p><strong>Objective: </strong>We aimed to evaluate and characterise the VigiBase pregnancy algorithm.</p><p><strong>Methods: </strong>The rule-based algorithm uses multiple structured data elements in the International Council of Harmonisation (ICH) E2B transmission format that could potentially hold pregnancy-related information, to determine if a case report qualifies as a pregnancy case. Free text information is not considered. Three datasets were used for the evaluation. The \"Full dataset\" comprised deduplicated VigiBase data up to January 2023. The \"Downsampled dataset\" was a subsample of the Full dataset, adjusted to increase the prevalence of pregnancy reports by excluding individuals aged 45 years or older and male individuals aged 18 years or older, used to evaluate recall (i.e. sensitivity). The \"Random dataset\" was a straight random sample of the Full dataset, used to evaluate precision (i.e. positive predictive value). As a baseline for comparison, the Standardised Medical Dictionary for Regulatory Activities (MedDRA<sup>®</sup>) Query (SMQ) \"Pregnancy and neonatal topics (narrow)\" was used. To provide a gold standard for the evaluation, case reports were manually annotated as either \"pregnancy case\" or \"non-pregnancy case\", for all reports in the Downsampled dataset, and for the reports flagged as pregnancy cases by the algorithm or the SMQ baseline in the Random dataset.</p><p><strong>Results: </strong>In the Downsampled dataset with 7874 annotated reports, 253 reports were annotated as pregnancy cases. Of those, the algorithm recalled 75% (95% confidence interval [CI] 69-80), increasing to 91% (95% CI 86-95) when restricting the analysis to reports adhering to the ICH E2B format. Preprocessing obstacles of incomplete mapping of specific pregnancy terms to MedDRA<sup>®</sup> led to most false negatives followed by pregnancy information confined to free text information. The SMQ baseline had a lower recall of 62% (95% CI 56-68). In the Random dataset with 30,000 reports, the algorithm flagged 344 reports, among which 316 were annotated as pregnancy cases, leading to a precision of 92% (95% CI 88-95). The main reasons for false positives were postpartum indications, non-pregnancy-specific events or information miscoded as pregnancy related. The SMQ baseline had a lower precision of 74% (95% CI 69-78).</p><p><strong>Conclusions: </strong>The VigiBase pre","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1103-1118"},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12423168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statistical Methods for Multi-jurisdictional Australian Vaccine Safety Investigations of Rare Adverse Events.","authors":"Hannah J Morgan, Lauren Bloomfield, Hazel J Clothier, Sera Ngeh, Gemma Cadby, Dale Carcione, James H Boyd, Gonzalo Sepulveda Kattan, Jim P Buttery, Paul Effler","doi":"10.1007/s40264-025-01615-9","DOIUrl":"https://doi.org/10.1007/s40264-025-01615-9","url":null,"abstract":"<p><strong>Background: </strong>In Australia, surveillance of adverse events following immunisation is primarily conducted by states and territories, with each jurisdiction only able to view and analyse reports originating from their own population. Distributed data models (aka federated data models) are a form of decentralised collaboration, with each site maintaining ownership of its data from end-to-end including data collection, storage and analysis. The primary benefit of this model is that it maintains independence and autonomy while enabling interdependence, collaboration and scalability.</p><p><strong>Objective: </strong>We aimed to investigate statistical methods for a multi-jurisdictional collaboration when conducting a rigorous assessment of rare adverse events following immunisation at a national level.</p><p><strong>Methods: </strong>Victoria and Western Australia have independently established routine data linkage for vaccine safety surveillance. A data collaboration model is proposed, whereby each jurisdiction can generate de-identified population-level data for adverse events following immunisation, using agreed case definitions and analytical methods. To demonstrate its utility, Victoria and Western Australia combined data from a self-controlled case series via a meta-analysis approach using aggregate data and a pooled approach using individual-level data to investigate the association between coronavirus disease 2019 vaccines and Guillain-Barré syndrome.</p><p><strong>Results: </strong>There were 519 and 176 new Guillain-Barré syndrome International Classification of Diseases, Tenth Revision, Australian Modification coded admissions in Victoria and Western Australia, respectively, between 01/01/2020 and 31/12/2023. Combining data using a fixed-effect meta-analysis method (relative incidence: 2.64, 95% confidence interval 1.90, 3.66) and a pooled method (relative incidence: 2.45, 95% confidence interval 1.76, 3.41) confirmed the known increased incidence in the 42 days following a coronavirus disease 2019 Vaxzevria^® vaccination. Both methods resulted in a decreased standard error when compared with either state alone.</p><p><strong>Conclusions: </strong>This project represents an ongoing successful collaboration between two Australian jurisdictions using data linkage to investigate rare adverse events following immunisation and inform accurate benefit-risk analyses. The decision to use meta-analysis and pooled analysis methods should be considered on a case-by-case basis and may depend on data-sharing agreements, the ease of pooling potentially discordant data variables and underlying population characteristics.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Adverse Events in Pregnant Persons Receiving COVID-19 and Influenza Vaccines: A Disproportionality Analysis Using Combined Data from US VAERS and EudraVigilance Spontaneous Report Databases.","authors":"Leonardo Roque-Pereira, Malede Mequanent Sisay, Comfort K Ogar, Carlos E Durán, Eugene van Puijenbroek, Daniel Weibel, Katia Verhamme, Miriam Sturkenboom","doi":"10.1007/s40264-025-01561-6","DOIUrl":"10.1007/s40264-025-01561-6","url":null,"abstract":"<p><strong>Background: </strong>Although multiple post-licensure studies demonstrated that coronavirus disease-2019 (COVID-19) vaccines are safe for use during pregnancy, none of them have identified a signal of disproportionate reporting.</p><p><strong>Aim: </strong>To assess the disproportionality in reported adverse events among pregnant persons receiving COVID-19 vaccination compared with influenza vaccines in spontaneous reporting databases.</p><p><strong>Methods: </strong>Individual case safety reports (ICSRs) with COVID-19 vaccines (Pfizer, AstraZeneca, Moderna and Johnson & Johnson) and influenza vaccines were retrieved from spontaneous reporting databases in the Vaccine Adverse Event Report System (VAERS) and the EudraVigilance (EV) system between 1 December 2020 and 31 October 2023. Both datasets were combined through a common data model. Pregnancy-associated ICSRs were identified using adaptations to the European Medicines Agency (EMA) algorithm based on age groups and key medical conditions. We compared the disproportionate reporting of High-Level Terms (HLT) after COVID-19 vaccines of interest (e.g. mRNA vaccine) with another COVID-19 viral vector-based/protein subunit and influenza vaccines during pregnancy. The proportional reporting ratio (PRR) with 95% confidence intervals (CIs) was calculated using a combined dataset. PRR met the predefined criteria (PRR ≥ 2, lower 95% CI ≥ 2 and N ≥ 3), confirming a potential signal of disproportionate reporting (SDR).</p><p><strong>Results: </strong>A total of 22,383 pregnancy-related ICSRs were included. Five associations met the PRR threshold: inborn errors of steroid synthesis 35.1 (95% CI 7.8-158.3); non-site-specific embolism and thrombosis 15.9 (95% CI 3.1-82.2); general signs and symptoms not elsewhere classified (NEC) 11.17 (95% CI 3.3-38.1); peripheral nervous system disorders congenital NEC 4.2 (95% CI 2.3-7.7); and vascular anomalies congenital NEC 3.7 (95% CI 2.4-5.6), all associated with viral vector-based/protein subunit.</p><p><strong>Conclusions: </strong>Despite this analysis, several statistical disproportionalities were identified during pregnancy; the case-by-case analysis shows that embolism and thrombosis require prioritized investigation through proper causal inference studies.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1127-1139"},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12423122/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Epidemiology of Thrombotic Thrombocytopenia Syndrome 2011 to 2022: English Sentinel Network Cohort Studies.","authors":"José M Ordóñez-Mena, Debasish Kar, Xuejuan Fan, Filipa Ferreira, Sneha N Anand, Deborah Layton, David Clifton, Mark Joy, Anshul Thakur, Anu Alessi, Andrew Lee, Lisa Mather, Simon de Lusignan","doi":"10.1007/s40264-025-01566-1","DOIUrl":"10.1007/s40264-025-01566-1","url":null,"abstract":"<p><strong>Background and objective: </strong>Thrombotic thrombocytopenia syndrome (TTS) is a rare condition following vaccination with adenovirus-vectored coronavirus disease 2019 (COVID-19) vaccines. This retrospective analysis of England primary care data aimed to estimate TTS event rates before, during, and after the COVID-19 pandemic, and following AZD1222 (ChAdOx1-nCoV-19) vaccination.</p><p><strong>Methods: </strong>Primary care data on TTS events were collected using the Oxford-Royal College of General Practitioners Research and Surveillance Centre sentinel network. TTS events were defined as thromboembolism with coincident (± 7 days) thrombocytopenia events using Systematized Nomenclature of Medicine clinical terms (the current Brighton Collaboration definition could not be used in the study as data related to specific parameters [e.g., D-dimer or PF4 antibodies] were not available in the primary care database). Multivariable logistic regression analyses were performed to assess the association between covariates and TTS.</p><p><strong>Results: </strong>Incident TTS rates per 100,000 person-years were: 0.42 in a pre-COVID-19 cohort (1 January, 2011-31 December, 2019; 9,062,313 individuals); 0 in 39,448 individuals with confirmed COVID-19 (1 July-31 December, 2020); 0.48 and 0.47 during the pre-vaccination pandemic period spanning 1 January-14 August, 2020 (13,245,710 individuals) and 15 August-31 December, 2020 (13,347,462 individuals); 2.41 in an AZD1222-vaccinated cohort (5,544,761 individuals; 1 January, 2021-4 July, 2022). Multivariable logistic regression analysis of TTS events (- 7/+ 42 days event-window; pre-COVID-19 cohort) showed greater odds in older individuals and high-risk groups as defined by the Joint Committee on Vaccination and Immunization. Thrombotic thrombocytopenia syndrome was rare in all cohorts. Differential covariate distributions precluded comparisons of TTS rates across cohorts. Covariate distributions within thromboembolism and thrombocytopenia cases were comparable to those of TTS cases.</p><p><strong>Conclusions: </strong>Our study, using a previous definition of TTS, reinforces the very rare nature of TTS before and during the pandemic, and before and after the introduction of the AZD1222 vaccine; it also confirms the established very low incident event rate in individuals vaccinated with AZD1222.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1161-1175"},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12423223/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Evaluation of Duplicate Adverse Event Reports Characteristics in the Food and Drug Administration Adverse Event Reporting System.","authors":"Scott Janiczak, Sarah Tanveer, Karen Tom, Rongmei Zhang, Yong Ma, Lisa Wolf, Monica A Muñoz","doi":"10.1007/s40264-025-01560-7","DOIUrl":"10.1007/s40264-025-01560-7","url":null,"abstract":"<p><strong>Introduction: </strong>The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) receives duplicate reports of adverse events associated with drug and therapeutic biological products. Duplicate reports, defined as multiple reports of the same adverse event(s) related to the administration of the same marketed product(s) to the same individual patient at a particular point in time, may be received in FAERS for many reasons. The presence of duplicate reports can negatively impact public health surveillance efforts by impeding both safety signal identification and signal evaluation.</p><p><strong>Objectives: </strong>To characterize the features and contributing factors associated with duplicate reports in FAERS.</p><p><strong>Methods: </strong>We manually assessed a convenience sample of individual case safety reports (ICSRs) for duplication, resulting in two data sets: one consisting of non-duplicate reports and one with duplicate reports. We then compared key features of these two datasets, including both structured and unstructured data fields. Key comparison features included: report and reporter type, country of report origin, data source for report, and outcome. In addition, we evaluated information similarity of reports for seven data elements (e.g., age, sex, suspect products) within sets of duplicates using both structured and unstructured fields. We used pairwise sentence bidirectional encoder representations from transformers (SBERT) cosine similarity scores to examine free-text narrative similarity.</p><p><strong>Results: </strong>Among the 2297 reports in the sample, 901 (39%) were classified as duplicates, consisting of 237 unique duplicate sets. Compared to non-duplicate reports, duplicates were more likely to be foreign reports (82% versus 37%), reported by healthcare professionals (89% versus 68%), mention other regulatory authority databases (42% versus 11%), describe published case reports (34% versus 11%), or have a serious outcome (97% versus 83%) (p < 0.0001). Within sets of duplicates (n = 237), coded information was frequently different, with only 16% (n = 39) having concordance of all 7 data elements. The narrative was highly similar among most sets of duplicates; we found that the median similarity score for the duplicate pairs was 0.87 compared to 0.48 for non-duplicate pairs.</p><p><strong>Conclusions: </strong>We observed differences in the attributes of and potential contributors to duplicate reports in FAERS that may inform duplicate prevention, detection, and management strategies. However, further studies are needed to better understand the implications of these findings and how potential regulatory changes and technological advances can be leveraged to further address duplicate reporting in adverse event reporting systems.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1119-1126"},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12423208/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Temporal Trends of Anticholinergic Drug Exposure Among Older Adults: A 25-Year Population-Based Study.","authors":"Amanda Evelo, Silvan Licher, Bruno H Stricker, Loes E Visser, Rikje Ruiter","doi":"10.1007/s40264-025-01562-5","DOIUrl":"10.1007/s40264-025-01562-5","url":null,"abstract":"<p><strong>Background: </strong>Exposure to anticholinergic drugs is associated with adverse outcomes, particularly among older adults. Limiting the anticholinergic burden (ACB) among older patients has been advocated for decades, but reliable population-level data on temporal trends are lacking. Here, we estimated the cumulative incidence and incidence rates (IRs) of a cumulative ACB score of three or more (cACB ≥ 3) among older adults in a community-dwelling population and described the changes in IR over the past 25 years.</p><p><strong>Methods: </strong>Within the population-based Rotterdam Study, pharmacy dispensing records were obtained from 11,038 individuals aged 65+ years from 1996 to 2020. The cACB score was calculated with the Anticholinergic Cognitive Burden Scale and supplemented with drugs on the ACB scale by the Expertisecentre PHarmacotherapy in OldeR people (EPHOR). Age- and sex-specific IRs were calculated, and non-overlapping 5-year episodes were defined to determine time trends in IRs.</p><p><strong>Results: </strong>The cumulative incidence of a cACB ≥ 3 was 25.3% between 1996 and 2020. Compared with 1996-2000, the IR of cACB ≥ 3 had declined by 54% between the 2016-2022 episode (IR ratio: 0.46, 95% confidence interval (CI): 0.41-0.52). Participants aged 86-90 years had more than 1.5 times the rate of a cACB ≥ 3 compared with participants aged 66-70 years (IR ratio: 1.67, 95% CI 1.46-1.91).</p><p><strong>Conclusions: </strong>Exposure to anticholinergic drugs has decreased by over 50% between 1996 and 2020 in this population of community-dwelling adults. However, the oldest old had and remained to have the highest risk of a cACB ≥ 3 during our study period. Thus, prescribers and pharmacists should continue to regularly review the prescription of drugs with an ACB, especially among those vulnerable to adverse outcomes.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1141-1147"},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12423137/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144511685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Choosing an Index Date for Untreated Patients in External Comparator Studies.","authors":"Luis Antunes, Gerd Rippin, Eleanor Ralphs, Artis Luguzis, Kellyn Arnold, Hopin Lee","doi":"10.1007/s40264-025-01613-x","DOIUrl":"https://doi.org/10.1007/s40264-025-01613-x","url":null,"abstract":"<p><strong>Background and objective: </strong>Selecting an index date (also called time zero or baseline) can be challenging for External Comparator (EC) studies when comparing against untreated patients. Existing literature addresses methods for defining an index date for untreated patients in observational studies generally, but not for EC studies specifically, which are likely to benefit from customized approaches.</p><p><strong>Methods: </strong>A simulation study was performed to assess different index date assignments and analytical approaches in terms of bias and other performance characteristics: The first approach took the time from a major clinical event (say, diagnosis date) to treatment start as observed in the treated cohort and randomly assigned these times to the untreated cohort to derive the index dates. This approach was applied without and with the condition that the emulated index dates in the untreated cohort needed to be before the observed event times (index date emulation [IDE] and modified index date emulation approach [mIDE]). The second approach was to start the follow-up period at the diagnosis date (early index date approach [EID]) and to perform an analysis according to a time-dependent Cox model (or its generalization, e.g., a Marginal Structural Cox Model). This model was applied both in a traditional but also in a modified manner (modified early index date approach, mEID), where the modified model coded the treatment cohorts before the true (treated patients) and emulated (untreated patients, using IDE) treatment start dates to belong to a third treatment category. This allowed the treatment comparison of interest to be restricted to the time after the true and emulated treatment start dates.</p><p><strong>Results: </strong>The IDE and mEID approaches were shown to be unbiased with identical performance, while mIDE and EID exhibited significant bias.</p><p><strong>Conclusions: </strong>We showed that our EC analysis approach based on emulated index dates for untreated patients constitutes a valid concept, which may be advantageous for many external comparator studies.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment on: Association of GLP1-Receptor Agonists with Risk of Hepatocellular Carcinoma: A Retrospective Cohort Study.","authors":"Chien-Hsiang Weng, Philip A Chan, Joseph Magagnoli, Charles L Bennett","doi":"10.1007/s40264-025-01617-7","DOIUrl":"10.1007/s40264-025-01617-7","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145148413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Authors' Response to Weng et al.'s Comment on \"Association of GLP1-Receptor Agonists with Risk of Hepatocellular Carcinoma: A Retrospective Cohort Study\".","authors":"Ishak A Mansi, Moheb Boktor","doi":"10.1007/s40264-025-01616-8","DOIUrl":"https://doi.org/10.1007/s40264-025-01616-8","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145148379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Content Analysis of Promotional Materials for Prescription Drugs Authorized Under Emergency Use Authorization.","authors":"Bridget Kelly, Kathryn J Aikin, Helen W Sullivan, Gabe Madson, Anne-Celine Jeffroy-Menard, Diamond Hawkins, Kathy Vu, Shirley Liu, Lauren McCormack, Sandra Crouse Quinn","doi":"10.1007/s40264-025-01610-0","DOIUrl":"https://doi.org/10.1007/s40264-025-01610-0","url":null,"abstract":"<p><strong>Introduction: </strong>Under Section 564 of the Federal Food, Drug and Cosmetic Act, the United States (US) Food and Drug Administration (FDA) may, pursuant to a declaration by the US Department of Health and Human Services Secretary, based on one of four types of determinations, authorize an unapproved product or unapproved uses of an approved product for emergency use. Although sponsors are not prohibited from promoting products with Emergency Use Authorizations (EUAs), little is known about how they promote these products.</p><p><strong>Objectives: </strong>The aim of this study was to investigate how EUAs are being described in promotional materials disseminated to health care providers (HCPs) and consumer audiences.</p><p><strong>Methods: </strong>A content analysis was conducted on promotional materials for drugs authorized under an EUA that were submitted to the FDA between April 2020 and April 2023. Each material was coded for the presence or absence and location of certain words, phrases, or resources relating to EUAs and product risk information. Statistical analyses include descriptive statistics and bivariate analyses comparing materials created for consumer and HCP audiences. Readability statistics were also conducted for consumer materials.</p><p><strong>Results: </strong>The sample included 423 promotional materials. Most materials included risk information; however, few included a formal definition of an EUA. Materials for HCPs were more likely to contain links to fact sheets and other information and resources related to EUAs. The reading level of consumer materials was very difficult (requiring graduate-level education).</p><p><strong>Conclusion: </strong>Although most of the materials contained risk and benefit information in promotional materials about EUAs, improvements could be made through the inclusion of a specific definition of \"EUA\" and more prominent information about limitations of use in consumer materials. Readability could also be improved for consumer materials by applying plain language principles.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145148419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}