Drug SafetyPub Date : 2025-07-01Epub Date: 2025-03-15DOI: 10.1007/s40264-025-01526-9
Mona Gerentes, Mohamed Lajnef, Andrei Szöke, Bruno Aouizerate, Fabrice Berna, Maud Cléry, Isabelle Chéreau, Nathalie Coulon, Julia Clauss-Kobayashi, Eric Fakra, Jean-Michel Dorey, Caroline Dubertret, Guillaume Fond, Ophélia Godin, Tudi Goze, Christophe Lançon, Marion Leboyer, Sylvain Leignier, Pierre-Michel Llorca, Jasmina Mallet, David Misdrahi, Nicolas Oriol, Romain Rey, Paul Roux, Benoit Schorr, Mathieu Urbach, Etienne Véry, Franck Schürhoff, Baptiste Pignon
{"title":"QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ.","authors":"Mona Gerentes, Mohamed Lajnef, Andrei Szöke, Bruno Aouizerate, Fabrice Berna, Maud Cléry, Isabelle Chéreau, Nathalie Coulon, Julia Clauss-Kobayashi, Eric Fakra, Jean-Michel Dorey, Caroline Dubertret, Guillaume Fond, Ophélia Godin, Tudi Goze, Christophe Lançon, Marion Leboyer, Sylvain Leignier, Pierre-Michel Llorca, Jasmina Mallet, David Misdrahi, Nicolas Oriol, Romain Rey, Paul Roux, Benoit Schorr, Mathieu Urbach, Etienne Véry, Franck Schürhoff, Baptiste Pignon","doi":"10.1007/s40264-025-01526-9","DOIUrl":"10.1007/s40264-025-01526-9","url":null,"abstract":"<p><strong>Background: </strong>The life expectancy of patients with schizophrenia is reduced, partly due to cardiovascular diseases. Antipsychotics are associated with QT interval prolongation, which is a risk factor for arrhythmia and cardiac arrest. The differences between antipsychotic with regard to QT interval prolongation are not well understood.</p><p><strong>Objective: </strong>The aim was to compare the QT values associated with different antipsychotics within a real-world population of subjects with clinically stable forms of schizophrenia.</p><p><strong>Methods: </strong>The FACE-SZ cohort comprises subjects with psychotic disorders, referred to schizophrenia expert cents. QT interval was measured, as well as all treatments (psychotropic and others). The following maintenance treatment for schizophrenia was analysed cross-sectionally: aripiprazole, clozapine, haloperidol, amisulpride, olanzapine, quetiapine, risperidone. Age, sex, smoking status, body mass index, blood potassium levels, and the co-prescription of another QT-prolonging treatment were used as adjustment factors in multivariable linear regression analyses.</p><p><strong>Results: </strong>Among 792 patients, the mean corrected QT (QTc) interval in the sample of patients under monotherapy was 407 ms. The mean age was 31.7 years, and the majority were male (73.3 %). In comparison to the rest of the sample, clozapine was associated with a longer QTc interval (β = 0.012, 95% CI [0.006-0.018]), while aripiprazole was significantly associated with a shorter QTc interval (β = - 0.010, 95% CI [- 0.016 to - 0.005]). Other antipsychotics were not associated with significant variations of the QTc.</p><p><strong>Conclusions: </strong>The prescription of antipsychotics should always be accompanied by close monitoring of the QTc interval to prevent the risk of severe cardiac arrhythmia, particularly concerning clozapine.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"739-752"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633824","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}
Drug SafetyPub Date : 2025-07-01Epub Date: 2025-02-23DOI: 10.1007/s40264-025-01528-7
Fabian Windfuhr, Sieta T de Vries, Maria Melinder, Tanja Dahlqvist, Diogo Almeida, Bruno Sepodes, Carla Torre, Björn Wettermark, Peter G M Mol
{"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":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 > 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).</p><p><strong>Conclusions: </strong>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}
Drug SafetyPub Date : 2025-07-01Epub Date: 2025-03-12DOI: 10.1007/s40264-025-01531-y
Andrea Abate, Elisa Poncato, Maria Antonietta Barbieri, Greg Powell, Andrea Rossi, Simay Peker, Anders Hviid, Andrew Bate, Maurizio Sessa
{"title":"Off-the-Shelf Large Language Models for Causality Assessment of Individual Case Safety Reports: A Proof-of-Concept with COVID-19 Vaccines.","authors":"Andrea Abate, Elisa Poncato, Maria Antonietta Barbieri, Greg Powell, Andrea Rossi, Simay Peker, Anders Hviid, Andrew Bate, Maurizio Sessa","doi":"10.1007/s40264-025-01531-y","DOIUrl":"10.1007/s40264-025-01531-y","url":null,"abstract":"<p><strong>Background: </strong>This study evaluated the feasibility of ChatGPT and Gemini, two off-the-shelf large language models (LLMs), to automate causality assessments, focusing on Adverse Events Following Immunizations (AEFIs) of myocarditis and pericarditis related to COVID-19 vaccines.</p><p><strong>Methods: </strong>We assessed 150 COVID-19-related cases of myocarditis and pericarditis reported to the Vaccine Adverse Event Reporting System (VAERS) in the United States of America (USA). Both LLMs and human experts conducted the World Health Organization (WHO) algorithm for vaccine causality assessments, and inter-rater agreement was measured using percentage agreement. Adherence to the WHO algorithm was evaluated by comparing LLM responses to the expected sequence of the algorithm. Statistical analyses, including descriptive statistics and Random Forest modeling, explored case complexity (e.g., string length measurements) and factors affecting LLM performance and adherence.</p><p><strong>Results: </strong>ChatGPT showed higher adherence to the WHO algorithm (34%) compared to Gemini (7%) and had moderate agreement (71%) with human experts, whereas Gemini had fair agreement (53%). Both LLMs often failed to recognize listed AEFIs, with ChatGPT and Gemini incorrectly identifying 6.7% and 13.3% of AEFIs, respectively. ChatGPT showed inconsistencies in 8.0% of cases and Gemini in 46.7%. For ChatGPT, adherence to the algorithm was associated with lower string complexity in prompt sections. The random forest analysis achieved an accuracy of 55% (95% confidence interval: 35.7-73.5) for predicting adherence to the WHO algorithm for ChatGPT.</p><p><strong>Conclusion: </strong>Notable limitations of ChatGPT and Gemini have been identified in their use for aiding causality assessments in vaccine safety. ChatGPT performed better, with higher adherence and agreement with human experts. In the investigated scenario, both models are better suited as complementary tools to human expertise.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"805-820"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613979","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}
Drug SafetyPub Date : 2025-07-01Epub Date: 2025-03-19DOI: 10.1007/s40264-025-01538-5
Jonathan Renninger, Lisa Kurz, Heather Stein
{"title":"Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients.","authors":"Jonathan Renninger, Lisa Kurz, Heather Stein","doi":"10.1007/s40264-025-01538-5","DOIUrl":"10.1007/s40264-025-01538-5","url":null,"abstract":"<p><p>Chimeric antigen receptor T-cell (CAR-T) therapies are one of the main approaches among targeted cellular therapies. Despite the potential benefit and durable responses observed in some patients receiving CAR-T therapies, serious and potentially fatal toxicities remain a major challenge. The most common CAR-T-associated toxicities include cytokine release syndrome (CRS), neurotoxicity, cytopenias, and infections. While CRS and neurotoxicity are generally managed with tocilizumab and corticosteroids, respectively, high-grade toxicities can be life-threatening. Close postinfusion monitoring and assessment of clinical laboratory parameters, patient-related and clinical risk factors (e.g., age, tumor burden, comorbidities, baseline laboratory parameters, and underlying abnormalities), and therapy-related risk factors (e.g., CAR-T type, dose, and CAR-T-induced toxicity) are effective strategies to mitigate the toxicities. Clinical laboratory parameters, including various cytokines, have been identified for CRS (interleukin [IL]-1, IL-2, IL-5, IL-6, IL-8, IL-10, C-reactive protein [CRP], interferon [IFN]-γ, ferritin, granulocyte-macrophage colony-stimulating factor [GM-CSF], and monocyte chemoattractant protein-1), neurotoxicity (IL-1, IL-2, IL-6, IL-15, tumor necrosis factor [TNF]-α, GM-CSF, and IFN-γ), cytopenias (IL-2, IL-4, IL-6, IL-10, IFN-γ, ferritin, and CRP), and infections (IL-8, IL-1β, CRP, IFN-γ, and procalcitonin). CAR-T-associated toxicities can be monitored and treated to mitigate the risk to patients. Assessment of alterations in clinical laboratory parameter values that are correlated with CAR-T-associated toxicities may predict development and/or severity of a given toxicity, which can improve patient management strategies and ultimately enable the patients to better tolerate these therapies.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"719-737"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174263/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662865","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}
Drug SafetyPub Date : 2025-07-01Epub Date: 2025-03-12DOI: 10.1007/s40264-025-01533-w
Meredith Y Smith, Rachel Davis, Priya Bahri, Delphine Saragoussi, Viviana Nguyen, Gita A Toyserkani, Alison Hamilton
{"title":"Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint.","authors":"Meredith Y Smith, Rachel Davis, Priya Bahri, Delphine Saragoussi, Viviana Nguyen, Gita A Toyserkani, Alison Hamilton","doi":"10.1007/s40264-025-01533-w","DOIUrl":"10.1007/s40264-025-01533-w","url":null,"abstract":"<p><strong>Background: </strong>Significant methodological shortcomings have been documented to date in risk minimisation program evaluations for medicinal products, including overreliance on survey methods alone. Recently updated guidances from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recommend the use of frameworks and mixed methods designs to improve the rigor of these assessments.</p><p><strong>Objective: </strong>The purpose of this paper was to exemplify how a mixed methods approach, guided by an implementation science framework, can be used to design the evaluation of a risk minimisation program.</p><p><strong>Methods: </strong>We selected the Practical, Robust, Implementation and Sustainability Model (PRISM) as the implementation science framework to guide our mixed methods approach. PRISM provides a comprehensive and systematic approach to measuring the key domains relevant to the implementation and outcomes of a risk minimisation program. We mapped the PRISM domains to the evaluation dimensions described in the EMA and FDA guidances. We then specified a mixed methods evaluation design and data collection methods using a fictitious risk minimisation program as a case study for illustrative purposes.</p><p><strong>Results: </strong>On the basis of our case study, we developed quantitative and qualitative measures, including specific items for surveys and interviews, for both formative and summative evaluations. For both the formative and summative evaluations, measures focussed on assessing (1) contextual factors that could affect program implementation and impact and (2) outcomes including implementability and acceptability as well as degree of program reach, adoption, implementation, effectiveness and maintenance.</p><p><strong>Conclusions: </strong>Mixed methods, guided by a well-established implementation science framework, can be applied to ensure comprehensive formative and summative evaluations that provide fit-for-purpose information that may inform regulatory decision-making.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"821-838"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613981","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}
Drug SafetyPub Date : 2025-07-01Epub Date: 2025-03-12DOI: 10.1007/s40264-025-01541-w
Robert A Björnsson, Sigurdur Sölvi Sigurdsson, Dagur Tjörvi Arnarson, Egill Logason, Einar Stefan Björnsson
{"title":"The Frequency of Drug-Induced Liver Injury Due to Antibiotics Among Hospitalised Patients.","authors":"Robert A Björnsson, Sigurdur Sölvi Sigurdsson, Dagur Tjörvi Arnarson, Egill Logason, Einar Stefan Björnsson","doi":"10.1007/s40264-025-01541-w","DOIUrl":"10.1007/s40264-025-01541-w","url":null,"abstract":"<p><strong>Introduction: </strong>Most epidemiological studies have found antibiotics to be the most common cause of drug-induced liver injury (DILI). It is unclear what the risk of DILI is associated with different antibiotics.</p><p><strong>Objective: </strong>The aim of the study was to assess the frequency of DILI due to the most commonly used antibiotics among inpatients, in a population-based setting.</p><p><strong>Methods: </strong>Patients who were treated with the 14 most-used antibiotics at Landspitali University Hospital Iceland 2012-2023, with concomitant: > 5 × upper limit of normal (ULN) of alanine aminotransferase (ALT) and/or > 2 × ULN of alkaline phosphatase (ALP), were identified. If DILI was a potential cause, the Revised Electronic Causality Assessment Method (RECAM) method was used to determine likelihood of DILI.</p><p><strong>Results: </strong>Overall 2292 patients fulfilled the inclusion criteria, 52 of whom were found to have DILI, median age 67 (range 21-93) years, 58% females, 17 (33%) with jaundice and three (5.8%) died of liver failure. The most commonly implicated agent was amoxicillin/clavulanate (n = 23) in 1:1327 users (0.075%), ceftriaxone (n = 8) 1:3779 (0.02%), cefazolin (n = 7) 1: 6363 (0.016%), cloxacillin 1:6024 (n = 4) (0.017%), piperacillin/tazobactam (n = 2) 1:1551 (0.097%), vancomycin (n = 2) 1:1966 (0.076%), trimethoprim-sulfamethoxazole (TMP/SMX) (n = 3) 1:1096 (0.091%) and ciprofloxacin (n = 1) 1:10,938 (0.009%). In two cases, more than one antibiotic was considered likely.</p><p><strong>Conclusions: </strong>Drug-induced liver injury was found to be a rare adverse effect of antibiotics in a population-based setting. Overall, 33% presented with jaundice but three died of liver failure, all due to amoxicillin/clavulanate, which was the most common cause occurring in around 1 in 1300 users. However, TMP/SMX was associated with the highest proportional risk of DILI.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"795-804"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613980","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}
Drug SafetyPub Date : 2025-07-01Epub Date: 2025-06-07DOI: 10.1007/s40264-025-01567-0
Chaker Ben Salem
{"title":"Comment on \"Drug-Induced Cognitive Impairment\".","authors":"Chaker Ben Salem","doi":"10.1007/s40264-025-01567-0","DOIUrl":"10.1007/s40264-025-01567-0","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"839-840"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246991","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":"Narrative Search Engine for Case Series Assessment Supported by Artificial Intelligence Query Suggestions.","authors":"Alem Zekarias, Eva-Lisa Meldau, Shachi Bista, Joana Félix China, Lovisa Sandberg","doi":"10.1007/s40264-025-01529-6","DOIUrl":"10.1007/s40264-025-01529-6","url":null,"abstract":"<p><strong>Introduction: </strong>Manual identification of case narratives with specific relevant information can be challenging when working with large numbers of adverse event reports (case series). The process can be supported with a search engine, but building search queries often remains a manual task. Suggesting terms to add to the search query could support assessors in the identification of case narratives within a case series.</p><p><strong>Objective: </strong>The aim of this study is to explore the feasibility of identifying case narratives containing specific characteristics with a narrative search engine supported by artificial intelligence (AI) query suggestions.</p><p><strong>Methods: </strong>The narrative search engine uses Best Match 25 (BM25) and suggests additional query terms from two word embedding models providing English and biomedical words to a human in the loop. We calculated the percentage of relevant narratives retrieved by the system (recall) and the percentage of retrieved narratives relevant to the search (precision) on an evaluation dataset including narratives from VigiBase, the World Health Organization global database of adverse event reports for medicines and vaccines. Exact-match search and BM25 search with the Relevance Model (RM3), an alternative way to expand queries, were used as comparators.</p><p><strong>Results: </strong>The gold standard included 55/750 narratives labelled as relevant. Our narrative search engine retrieved on average 56.4% of the relevant narratives (recall), which is higher when compared with exact-match search (21.8%), without a significant drop in precision (54.5% to 43.1%). The recall is also higher as compared with RM3 (34.4%).</p><p><strong>Conclusions: </strong>Our study demonstrates that a narrative search engine supported by AI query suggestions can be a viable alternative to an exact-match search and BM25 search with RM3, since it can facilitate the retrieval of additional relevant narratives during signal assessments.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"767-779"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633822","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}
Drug SafetyPub Date : 2025-07-01Epub Date: 2025-04-09DOI: 10.1007/s40264-025-01542-9
Gita A Toyserkani, Suzanne B Robottom, Elaine H Morrato
{"title":"REMS Logic Model: A Pragmatic Framework for Incorporating Drug Safety into Clinical Practice.","authors":"Gita A Toyserkani, Suzanne B Robottom, Elaine H Morrato","doi":"10.1007/s40264-025-01542-9","DOIUrl":"10.1007/s40264-025-01542-9","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"715-718"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987240","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}
Drug SafetyPub Date : 2025-07-01Epub Date: 2025-06-07DOI: 10.1007/s40264-025-01568-z
Arne Reimers, Per Odin, Hanna Ljung
{"title":"Authors' reply to Chaker Ben Salem's comment on: \"Drug-Induced Cognitive Impairment\".","authors":"Arne Reimers, Per Odin, Hanna Ljung","doi":"10.1007/s40264-025-01568-z","DOIUrl":"10.1007/s40264-025-01568-z","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"841"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246990","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}