Drug Safety最新文献

{"title":"A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore.","authors":"Pei San Ang, Michelle Sau Yuen Ng, Desmond Chun Hwee Teo, Sreemanee Raaj Dorajoo, Filina Meixuan Tan, Alice Qunyuan Mai, Wayne Guo Wei Ng, Jalene Wang Woon Poh, Chih Tzer Choong","doi":"10.1007/s40264-025-01544-7","DOIUrl":"10.1007/s40264-025-01544-7","url":null,"abstract":"<p><strong>Introduction: </strong>Health product defects are complex issues affecting the quality standards of health products and indirectly impact public health outcomes. It is crucial for the pharmaceutical industry to be clear of the reporting and case management requirements for such issues. The Health Sciences Authority of Singapore used a mixed-methods evaluation strategy, combining an online questionnaire and face-to-face focus group discussions to identify areas for knowledge enhancement and challenges faced by the industry regarding product defect reporting and recall procedures. These findings were used to plan training workshops.</p><p><strong>Methods: </strong>A self-administered online survey was emailed to representatives of all pharmaceutical companies with registered medicines and/or vaccines, or cell, tissue and gene therapy products (CTGTPs) in Singapore. The aim was to find out the challenges faced with product defect reporting and recall procedures. Two face-to-face focus group discussions were conducted with selected companies, specifically those that conducted product recalls between September 2022 and August 2024. A two-day online industry training workshop was held in October 2024. Pre- and post-workshop quizzes, including self-rating questions, were conducted to quantify the participants' baseline knowledge and what they gained from the workshop.</p><p><strong>Results: </strong>In total, 136 out of 463 individuals (29.4%) completed the online survey questionnaire for medicines and vaccines, while 24 out of 42 individuals (57.1%) completed the survey for CTGTPs. Seventeen industry professionals were invited for two focus group discussions. Participants provided feedback on existing processes, and requested clearer guidelines and examples on reportable defects, to aid their internal decision-making. The training workshop saw 318 and 271 industry professionals in attendance over two days, respectively, with 160 participating in both pre- and post-workshop quizzes. There was an improvement in average quiz scores ranging from 4.5% to 25.0% post-workshop. Participants' self-ratings also improved from a median of 3 (out of 5) to median of 4 from pre- to post-workshop.</p><p><strong>Conclusions: </strong>The series of evaluations revealed an enhanced understanding of regulatory requirements in industry professionals through a combination of surveys, focus group discussions and tailored training workshops. These initiatives can equip the industry with knowledge to make informed decisions and enhance overall compliance with product defect reporting and recall procedures. The findings would be used to streamline our processes related to defect and recall.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"875-892"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958839","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":"A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection.","authors":"Yi Shi, Yuedi Yang, Ruoqi Liu, Anna Sun, Xueqiao Peng, Lang Li, Ping Zhang, Pengyue Zhang","doi":"10.1007/s40264-025-01545-6","DOIUrl":"10.1007/s40264-025-01545-6","url":null,"abstract":"<p><strong>Introduction: </strong>Biochemical drug similarity-based methods demonstrate successes in predicting adverse drug events (ADEs) in preclinical settings and enhancing signals of ADEs in real-world data mining. Despite these successes, drug similarity-based ADE detection shall be expanded with false-positive control and evaluated under a time-to-detection setting.</p><p><strong>Methods: </strong>We tested a drug similarity-based Bayesian method for early ADE detection with false-positive control. Under the tested method, prior distribution of ADE probability of a less frequent drug could be derived from frequent drugs with a high biochemical similarity, and posterior probability of null hypothesis could be used for signal detection and false-positive control. We evaluated the tested and reference methods by mining relatively newer drugs in real-world data (e.g., the US Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS) data) and conducting a simulation study.</p><p><strong>Results: </strong>In FAERS analysis, the times to achieve a same probability of detection for drug-labeled ADEs following initial drug reporting were 5 years and ≥ 7 years for the tested method and reference methods, respectively. Additionally, the tested method compared with reference methods had higher AUC values (0.57-0.79 vs. 0.32-0.71), especially within 3 years following initial drug reporting. In a simulation study, the tested method demonstrated proper false-positive control, and had higher probabilities of detection (0.31-0.60 vs. 0.11-0.41) and AUC values (0.88-0.95 vs. 0.69-0.86) compared with reference methods. Additionally, we identified different types of drug similarities had a comparable performance in high-throughput ADE mining.</p><p><strong>Conclusion: </strong>The drug similarity-based Bayesian ADE detection method might be able to accelerate ADE detection while controlling the false-positive rate.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"923-931"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12259350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985825","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":"Evaluation of Mortality in Users of Pimavanserin Compared with Other Atypical Antipsychotics in Patients with Parkinson's Disease Psychosis: An Update.","authors":"Sapna Rao, Lisa J McQuay, Joan Forns, Rebecca MacKay, Heather E Danysh, Dilesh Doshi, Victor Abler, Mary S Anthony, J Bradley Layton","doi":"10.1007/s40264-025-01543-8","DOIUrl":"10.1007/s40264-025-01543-8","url":null,"abstract":"<p><strong>Introduction: </strong>Pimavanserin is the only antipsychotic medication approved in the USA to specifically treat hallucinations and delusions associated with Parkinson's disease psychosis (PDP).</p><p><strong>Objective: </strong>To compare mortality risk in patients with PDP after initiation of pimavanserin or comparator atypical antipsychotics in an overall PDP cohort and in a subcohort of patients residing in long-term care or skilled nursing facilities (LTC/SNFs).</p><p><strong>Methods: </strong>This cohort study identified patients aged ≥ 65 years with PDP initiating pimavanserin or a comparator antipsychotic in US Medicare claims (2016-2021). Cox proportional hazards models were used to estimate hazard ratios (HRs) comparing all-cause mortality in the propensity score-matched treatment groups. Cumulative incidence curves, time period-specific relative risk, and risk difference estimates evaluated risk over time.</p><p><strong>Results: </strong>In this follow-up analysis, we identified 4384 pimavanserin initiators and 28,042 comparator initiators in the overall PDP cohort, and 921 pimavanserin initiators and 7963 comparator initiators in the LTC/SNF subcohort. After matching, the overall PDP cohort had 4381 patients in each treatment group, and the LTC/SNF subcohort had 905 patients in each group. The matched HR for mortality (pimavanserin versus comparator) was 0.76 (95% CI 0.68-0.85) in the overall PDP cohort and 0.90 (95% CI 0.74-1.10) in the LTC/SNF subcohort. In the overall PDP cohort, time period-specific relative risks and risk differences showed that pimavanserin initiators had a lower risk of mortality throughout the first 365 days of follow-up.</p><p><strong>Conclusion: </strong>In the overall PDP cohort, mortality risk was lower among pimavanserin initiators than comparator antipsychotic initiators.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"893-907"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12259748/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986737","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":"Observed Versus Expected Analysis-How Does It Fit in the Pharmacovigilance Toolkit?","authors":"Lionel Van Holle","doi":"10.1007/s40264-025-01584-z","DOIUrl":"https://doi.org/10.1007/s40264-025-01584-z","url":null,"abstract":"<p><p>Observed versus expected (O/E) analyses have been used in an unprecedented scale for the safety monitoring of the COVID-19 mass vaccination. The extent of their usage changed its nature, which consisted of a mixture of medical expertise and epidemiology, into something more algorithmic and automated. By doing so, the observed versus expected analysis became closer to disproportionality analysis (DPA), which is also a type of observed versus expected analysis that differs in the way the expected is calculated. A qualitative assessment of the strengths and limitations of both methods concludes that the algorithmic O/E is more likely to underestimate under-reporting, is more likely to be sensitive to asymmetrical differences in the definition of the condition of interest, and is more dependent on a greater variety of data sources or medical knowledge that might not be accurate for emerging safety issues (exposure, background incidence rate, and risk window). Provided some adjustment (stratification and/or subgrouping) of the routine disproportionality into a targeted disproportionality occurs, which would account for the epidemiological specifics of the vaccine and event-of-interest, the targeted DPA has the potential to be promoted from a signal detection method into a signal evaluation method that could advantageously replace the algorithmic O/E analysis. Research on the setup of a sensitivity analysis framework integrating several standardized choices of disproportionality settings, along with measures (qualitative or quantitative) of the biases for each choice, could be more beneficial for the pharmacovigilance field than studies designed to estimate the background incidence rates of adverse events of special interest for the sole purpose of being used in O/E analyses.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759470","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":"Correction: 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/s40264-025-01585-y","DOIUrl":"10.1007/s40264-025-01585-y","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706825","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":"Real-World Data Insights into Antidepressant Prescription and Adherence During Pregnancy in Catalonia (Spain).","authors":"Lucía Bellas, Lina Camacho-Arteaga, Maria Giner-Soriano, Albert-Prats-Uribe, Ainhoa Gómez-Lumbreras, Cristina Aguilera, Antonia Agustí","doi":"10.1007/s40264-025-01576-z","DOIUrl":"https://doi.org/10.1007/s40264-025-01576-z","url":null,"abstract":"<p><strong>Background: </strong>Affective disorders, particularly depression, are common among women of childbearing age, and pregnancy often exacerbates symptoms. Antidepressants are often required for treatment, but adherence during pregnancy is variable. Although some studies suggest potential risks to the foetus, many cannot rule out confounding by indication. In this context, understanding real-world patterns of antidepressant prescription and adherence during pregnancy is essential to inform clinical practice and ensure adequate mental healthcare.</p><p><strong>Objective: </strong>The aim of the present study was to characterise the use of antidepressants in a cohort of pregnant women using electronic health records.</p><p><strong>Methods: </strong>This observational cohort drug-utilisation study assessed antidepressant prescription patterns, adherence and persistence among pregnant women using data from the SIDIAP (Information System for the Development of Research in Primary Care) database in Catalonia from January 2011 to June 2020.</p><p><strong>Results: </strong>Among 99,605 pregnancies, 14.9% involved antidepressant prescriptions, but only 5.8% of these were collected from pharmacies. The median pregnancy duration was 38.4 weeks, and the median maternal age was 33.5 years. Anxiety was the most common health issue associated with an antidepressant prescription. Paroxetine was the most frequently prescribed antidepressant, although sertraline usage increased over time. Antidepressant prescriptions and adherence decreased during pregnancy, with an increase in the postpartum period. About 11.6% of pregnancies involved a concurrent prescription of another antidepressant, and 29.2% of women resumed antidepressant use after pregnancy. Women who initiated antidepressants during pregnancy were more likely to persist with treatment than those with pre-existing prescriptions.</p><p><strong>Conclusions: </strong>Our study describes antidepressant use during pregnancy in Catalonia. It is remarkable that there is a notable gap between antidepressant prescriptions and dispensations. Given the risks of untreated maternal depression, strengthening primary care with adequate resources and personalised support is essential for improving perinatal mental healthcare.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590655","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":"Temporal Changes in Reporting of Neurodevelopmental Outcomes After Maternal Exposure to Valproate: A Contribution of the ConcePTION Project.","authors":"Dimitra Gkolfi, Yrea R J van Rijt-Weetink, Henric Taavola-Gustafsson, Lovisa Sandberg, Boukje C Raemaekers, Florence P A M van Hunsel, Anneke L M Passier, Rebecca L Bromley, Laura M Yates, Eugène P van Puijenbroek","doi":"10.1007/s40264-025-01583-0","DOIUrl":"https://doi.org/10.1007/s40264-025-01583-0","url":null,"abstract":"<p><strong>Background: </strong>Understanding changes over time in the quantity and characteristics of reports submitted to pharmacovigilance centres is crucial for accurately interpreting safety signals associated with exposure during pregnancy.</p><p><strong>Objective: </strong>We aimed to assess temporal changes in the outcome measures for signal detection, specifically the number and clustering of reported adverse events concerning maternal valproate exposure and neurodevelopmental outcomes in offspring.</p><p><strong>Methods: </strong>An observational study using VigiBase analysed changes in the number of reports and event clustering related to neurodevelopmental outcomes in offspring following valproate exposure during pregnancy. Reports from the start of VigiBase till 3 April, 2023 were identified using the VigiBase pregnancy algorithm. Time trend graphs illustrated reporting behavioural changes, with particular focus on the impact of major scientific publications and regulatory decisions. Report clusters, identified by the vigiGroup method, were randomised and independently reviewed by three qualified reviewers for clinical relevance to neurodevelopmental outcomes, morphological disorders or other entities.</p><p><strong>Results: </strong>Over time, an increase in reports mentioning neurodevelopmental outcomes and a more diverse pattern of adverse events for valproate has been reported. An increase in the number of reports following key publications and international regulatory guidelines was visible.</p><p><strong>Conclusions: </strong>Our study revealed an increase over time in reporting and awareness of neurodevelopmental outcomes and valproate exposure during pregnancy, following important publications and regulatory decisions. However, the extent to which these developments contributed to the observed increase remains unclear.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144583409","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":"Obituary Ronald Meyboom: A Professional Life Devoted to Pharmacovigilance.","authors":"Toine Egberts, Eugene van Puijenbroek, Bert Leufkens","doi":"10.1007/s40264-025-01577-y","DOIUrl":"https://doi.org/10.1007/s40264-025-01577-y","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539553","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":"Signals of Adverse Reactions to Herbal Medicines: Evidence and Document Analysis Based on a Scoping Review.","authors":"Daniele Sartori, Jeffrey K Aronson, Judith S Brand, Oskar Gauffin, Sara Hedfors Vidlin, G Niklas Norén, Igho J Onakpoya","doi":"10.1007/s40264-025-01580-3","DOIUrl":"https://doi.org/10.1007/s40264-025-01580-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;To date, signals of adverse reactions to herbal medicines have not been systematically reviewed, limiting pharmacovigilance of herbal medicines because of a lack of data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;We sought to analyse the available evidence on signals involving herbal medicines and to determine to what extent they had been documented at the European Union (EU) level and in the USA.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We used the results of a published scoping review of interventional and non-interventional studies that reported signals of adverse reactions to drugs. We assigned Anatomical Therapeutic Chemical classification to all drugs, and identified herbal medicines when they fell under the  Anatomical Therapeutic Chemical V90. We ascertained the presence of the adverse reaction, or related adverse reactions, for each signal in reference documents for healthcare professionals: the US Botanical Safety Handbook and the EU monographs and US Dietary Supplement Fact Sheets; and in those for consumers: the US Dietary Supplement Label Database. We summarised the data descriptively, treating US documents as one and comparing harms across pairs of US and EU documents by signal. Documents were deemed concordant if they both included the same or related adverse reactions, or if neither did. We also compared adverse reactions across US documents for healthcare professionals with those for consumers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 10,861 signals covered by the scoping review, 53 (0.49%) concerned herbal medicines, all based on case reports. Reference documents from both the US and EU were available for 37 signals. Most of the documents were concordant (73%), and ten (27%) were discordant: six adverse reactions were mentioned only in US documents, three only in EU monographs, and one was warned against in US documents but not in EU documents. Twenty-one signals could be followed up in the Botanical Safety Handbook and Dietary Supplement Fact Sheets. Most (68%) US documents for healthcare professionals were concordant. When the Botanical Safety Handbook and Dietary Supplement Fact Sheets did not include an adverse reaction, neither did the Dietary Supplement Label Database. However, when they did, only 20% of the labels for consumers did too. The proportion of labels mentioning adverse reactions otherwise available in documents intended for healthcare professionals ranged widely, reflecting differences across multiple labels for the same products.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Very few signals of adverse reactions from the wider scoping review concerned herbal medicines, and were all based on case reports. Information was mostly concordant across documents in the EU and USA. As manufacturers are solely responsible for the contents of the Dietary Supplement Label Database, regulatory oversight may be required to ensure that consistent and comprehensive information on the harms of herbal medicines is made avai","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539554","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":"Stakeholders' Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey.","authors":"Fabian Windfuhr, Sieta T de Vries, Maria Melinder, Tanja Dahlqvist, Diogo Almeida, Bruno Sepodes, Carla Torre, Björn Wettermark, Peter G M Mol","doi":"10.1007/s40264-025-01528-7","DOIUrl":"10.1007/s40264-025-01528-7","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The use of patient registries in regulatory, health technology assessment (HTA), and payer decision-making has gained increasing attention in recent years. Stakeholders' perspectives toward the use of registry-based real-world evidence (RWE) are unknown.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;The purpose of this study was to assess stakeholders' perspectives toward the use of RWE from patient registries in decision-making on medicines and explore factors influencing their intention to use registry data in the future.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;European regulators, HTA/payers, and other stakeholders (industry, academia, healthcare professionals, patient representatives) were invited by email to participate in a web-based survey. The survey was open between November 2023 and January 2024 and contained 24 questions including demographics and questions about perspectives toward registry-based data for decision-making purposes. The latter consisted of 5-point Likert scale items based on the theory of planned behavior (TPB), i.e., attitudes, subjective norm, perceived behavioral control, and intention. Descriptive analyses and a logistic regression analysis (outcome: intention; determinants: demographics, attitudes, subjective norm, behavioral control) were performed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Included were 191 respondents (response rate: 16%), of whom 110 were regulators (58%), 24 HTA/payers (13%), and 54 other stakeholders (28%). Most respondents were between 41 and 50 years old (32%), 65% were women, and 53% had &gt; 10 years work experience. Respondents considered registry data in the medicinal product lifecycle most informative for characterization of disease epidemiology (mean 4.4; 95% confidence interval (CI) 4.2-4.5), and least informative for comparative effectiveness (mean 3.6; 95% CI 3.4-3.7). Reaching the relevant patient population was perceived as the biggest strength (mean 3.6; 95% CI 3.4-3.8), and data quality as the largest weakness of patient registries (mean 2.4; 95% CI 2.2-2.6). Compared with regulators, HTA/payers had a similar intention to use registry data (Odds ratio (OR) 1.56; 95% CI 0.47-5.16), while other stakeholders were more frequently very open (intention) to using registry data in the future (OR 8.48; 95% CI 3.00-23.98). Respondents from organizations in Northern Europe were less often very open to using registry data in the future than respondents from multinational organizations (OR 0.19; 95% CI 0.04-0.85). Finally, respondents with a high perceived behavioral control concerning the use of registry data were more often very open to using registry data in the future than respondents with a neutral or low perceived behavioral control (OR 3.45; 95% CI 1.37-8.64).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The participants in our survey were generally open to increasing the use of registry data in the future. Nevertheless, perceived weaknesses such as data quality and accessibility will need to","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"753-765"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174299/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482529","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}