Drug Safety最新文献

{"title":"Understanding the Work of the Pharmacovigilance Risk Assessment Committee (PRAC): A Quantitative Review of the Post-Authorisation Safety Evaluation of Antidiabetic Drugs from 2012 to 2022.","authors":"Haoxin Le, Per Sindahl, Morten Andersen, Christine E Hallgreen","doi":"10.1007/s40264-025-01536-7","DOIUrl":"10.1007/s40264-025-01536-7","url":null,"abstract":"<p><strong>Background: </strong>The Pharmacovigilance Risk Assessment Committee (PRAC) plays a central role in the European Union's pharmacovigilance system, evaluating drug safety through several procedures and activities. Despite its central role, few studies have quantitatively investigated the PRAC's activities from a system's perspective.</p><p><strong>Objective: </strong>This study aims to map PRAC's evaluation of safety signals and concerns using antidiabetic products as a case. It characterises the drugs and adverse events involved, analyses the PRAC-led regulatory procedures where the safety signals and concerns were evaluated, and provides a comprehensive review of PRAC meeting minutes.</p><p><strong>Methods: </strong>From PRAC meeting minutes, we retrieved information on all antidiabetic drug-related adverse events discussed from 2012 to 2022. We identified drug-adverse event evaluations based on the discussion content. These were described by drug classes, System Organ Classes, PRAC procedures, and the evaluation outcomes corresponding to recommendations for regulatory actions. We also analysed the sequence of PRAC-led procedures and activities addressing drug-adverse event pairs across meeting minutes.</p><p><strong>Results: </strong>A total of 321 drug-adverse event pairs were identified, with 14 pairs associated with drug classes. Second-generation antidiabetic agents, including sodium-glucose transport protein-2 inhibitors, glucagon-like peptide-1 receptor agonists, and dipeptidyl peptidase 4 inhibitors, were the most frequently discussed. Of these, 62 pairs underwent multiple evaluations, resulting in a total of 413 evaluations. In 48% of evaluations, no regulatory action was required. Most evaluations (97%) were concluded in a single procedure, and 66% were concluded in one meeting. Periodic safety update reports accounted for 54% of drug-adverse event evaluations and updates to product information were the most frequent outcome. Signal assessment and prioritisation procedures, while less common, resulted in more diverse recommendations for regulatory action. Referrals were infrequent (N = 5) and were often triggered by the signal assessment and prioritisation procedure.</p><p><strong>Conclusions: </strong>Periodic safety update reports are the primary source for PRAC evaluations of safety signals although they are not intended for notification of new urgent safety information. Compared with periodic safety update reports, the signal assessment and prioritisation procedure evaluates fewer signals but leads to a wider range of regulatory actions, from risk minimisation measures to referrals. This difference may be attributed to the fact that signals detected in periodic safety update reports are not intended for urgent safety issues, these should be assessed through the signal assessment and prioritisation procedure, as the latter involves real-time signal management, whereas the periodic safety update reports are conducted at pr","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"781-794"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536898","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":"Identifying New Candidate Predictors of Mortality in Japanese Patients with Severe Drug Eruptions.","authors":"Shiho Sato, Tadao Ooka, Yoshito Zamami, Hirofumi Hamano, Fumikazu Hayashi, Eri Eguchi, Narumi Funakubo, Tetsuya Ohira","doi":"10.1007/s40264-025-01572-3","DOIUrl":"https://doi.org/10.1007/s40264-025-01572-3","url":null,"abstract":"<p><p>BACKGROUND AND OBJECTIVES: SCORe of Toxic Epidermal Necrolysis (SCORTEN) and ABCD-10 have been developed as scoring systems for predicting mortality associated with Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). These scores were developed based on a small number of patients; hence, their generalizability requires further exploration. The present study used three algorithms, including a machine learning method, to construct a mortality prediction model for SJS/TEN and to identify new candidate predictors of mortality from severe drug eruptions.</p><p><strong>Methods: </strong>Data from 5966 patients with SJS or TEN were extracted from the Japanese Adverse Drug Event Report Database. A mortality prediction model was then constructed using stepwise regression, L1 regularized-logistic regression, and random forests based on the patient characteristics (e.g., age, sex, primary disease, adverse events, drug classification, route of administration) and outcomes (death).</p><p><strong>Results and discussion: </strong>The mortality prediction models for SJS/TEN identified sex (men), primary disease (hyperlipidemia, diabetes mellitus, renal dysfunction, and malignant tumors), adverse events (renal dysfunction, liver dysfunction, respiratory dysfunction, bacteremia/sepsis, disseminated intravascular coagulation syndrome, shock, and multiple organ failure), number of concomitant drugs, and route of administration (injection) as common factors associated with mortality.</p><p><strong>Conclusions: </strong>Our findings showed that sex, hyperlipidemia as the primary disease, number of concomitant drugs, use of antipyretic analgesics, and route of administration may be considered as predictors of mortality in patients with SJS/TEN. The external validity of these factors needs to be examined in the future.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144324733","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":"Reporting Adverse Drug Events: A Comparison of an Online Patient Tool Versus Telephone-Based Monitoring in Community Pharmacy Patients in the Netherlands.","authors":"Henok D Habtemariam, Henk-Jan Guchelaar, Lisanne E N Manson, Jesse J Swen, Agnes C Kant, Stefan Böhringer","doi":"10.1007/s40264-025-01571-4","DOIUrl":"https://doi.org/10.1007/s40264-025-01571-4","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug events (ADEs) are events occurring after the administration of a drug. Several authorities are involved in capturing these ADEs to improve pharmacovigilance. These ADEs are reported directly to healthcare professionals or via the telephone, online, or e-mail and are crucial for maintaining drug safety.</p><p><strong>Objective: </strong>Patient-reported adverse drug events (ADEs) are collected using various tools, though not much is known with regard to the comparability of these different methodologies. It is known that telephone-based surveys result in a higher report rate, although it is not known if this has an effect on the type of ADEs that are reported. In this prospective study, we aimed to investigate if there are differences in the number, type, and severity of ADEs reported via telephone and online in an event monitoring setting.</p><p><strong>Methods: </strong>Patients included in Dutch community pharmacies were asked whether they experienced any ADEs via telephone and online (Lareb Intensive Monitoring) surveys as part of the PREPARE study. The PREPARE study was a multicenter study, researching the effect of genotype-guided dosing on the incidence of clinically relevant adverse drug reactions. With the paired data acquired in the PREPARE study, we investigated differences in the number, type, and severity of the reported ADEs.</p><p><strong>Results: </strong>Patients (N = 525) completed both the telephone and online surveys. Of the 525 patients who completed both surveys, 326 reported ADEs via telephone and 239 online. A visual comparison showed a similar distribution in the type of ADEs among the methods except for less commonly reported types of ADEs and cardiac disorders. The perceived severity of ADEs were proportionally reported as more severe during the telephone survey versus the online survey.</p><p><strong>Conclusions: </strong>Our study showed a clear difference in the number of ADEs reported during telephone and online monitoring. Additionally, the differences in the type of ADEs and the severity distribution of both tools shows that the tools are not exchangeable (CT.gov identifier: NCT03093818).</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293526","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":"Identifying Maternal Conditions Leading to Gabapentinoid Prescriptions in Pregnancy Using Electronic Health Records from Six European Countries: A Contribution from the IMI ConcePTION Project.","authors":"Anna-Belle Beau, Olga Paoletti, Justine Bénévent, Marie Beslay, Xavier Moisset, Elisa Ballardini, Laia Barrachina-Bonet, Clara Cavero-Carbonell, Alex Coldea, Laura García-Villodre, Anja Geldhof, Rosa Gini, Mika Gissler, Sue Jordan, Maarit K Leinonen, Marco Manfrini, Visa Martikainen, Vera R Mitter, Joan K Morris, Amanda J Neville, Hedvig Nordeng, Aurora Puccini, Jingping Mo, Christine Damase-Michel","doi":"10.1007/s40264-025-01565-2","DOIUrl":"https://doi.org/10.1007/s40264-025-01565-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction and objective: &lt;/strong&gt;Given the recent increase in the prescription and dispensation of gabapentinoids (gabapentin and pregabalin) and the importance of controlling for underlying maternal illnesses in drug safety studies, we aimed to develop algorithms for identifying maternal conditions leading to gabapentinoid prescribing among pregnant women using data from six electronic healthcare data sources across Europe.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study was conducted in Finland, France (Haute-Garonne), Italy (Emilia Romagna), Norway, Spain (Valencian region), and Wales (UK), covering three million pregnancies from 2006 to 2020. Algorithms were developed to detect epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) (approved indications for gabapentinoids by the European Medicines Agency, with the exception of gabapentin for GAD) using data ± 1 year around the gabapentinoid prescription date. Data included prescriber specialty, primary and specialized health care diagnoses, and co-prescription/dispensation data. Additional analyses investigated potential unlicensed indications (such as fibromyalgia, restless legs syndrome, bipolar disorder) and potential for abuse (using codes for substance use disorders and alcohol withdrawal).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Gabapentinoids were prescribed/dispensed in 1770 pregnancies (7.7 per 1000) in Spain, 2912 pregnancies (6.6 per 1000) in Wales, 3163 pregnancies (3.6 per 1000) in Norway, 2406 pregnancies (3.0 per 1000) in Finland, 908 pregnancies (2.2 per 1000) in Italy, and 269 pregnancies (1.9 per 1000) in France. A maternal condition related to gabapentinoid prescriptions was identified by the algorithm in 2797 (88.4%) in Norway, 2180 (74.9%) in Wales, 1269 (71.7%) in Spain, 1534 (63.8%) in Finland, 163 (60.6%) in France, and 396 (43.6%) pregnancies in Italy. Anxiety (licensed or unlicensed) was the most commonly captured condition in Wales (70.5%), Spain (51.5%), Finland (42.0%), and Italy (26.2%), whereas neuropathic pain prevailed in Norway (76.9%) and France (49.8%). Epilepsy was the least frequent maternal condition leading to gabapentinoid prescriptions across all data sources (below 15% of all pregnancies). The relative preponderance of these conditions differed between pregabalin and gabapentin. Additionally, unlicensed indications were captured in 0% to 13% of pregnancies, depending on the data source. The analyses of potential for abuse showed that records of alcohol withdrawal and/or substance use disorders (within 1 year before and after the gabapentinoids prescription/dispensation date) were present in 3% of pregnancies in Italy and up to 23% in Wales.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Our study provides valuable insights into gabapentinoid use during pregnancy, with anxiety being the most common condition among pregnant women with gabapentinoid prescriptions in Finland, Italy, Spain, and Wales, whereas neuropathic pain predominated in France and ","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293525","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":"Investigation of Ochratoxin A and Citrinin Occurrence in Medicinal Herbal Products from the Czech Market.","authors":"Jakub Toman, Darina Pickova, Karolina Brandova, Vladimir Ostry, Frantisek Malir","doi":"10.1007/s40264-025-01570-5","DOIUrl":"https://doi.org/10.1007/s40264-025-01570-5","url":null,"abstract":"<p><strong>Introduction: </strong>Medicinal plants are extensively utilized as dietary supplements to encourage disease prevention and to support the treatment of various health disorders. Unfortunately, several plants are known for mycotoxin contamination, which may overwhelm any beneficial effects the plants might have.</p><p><strong>Objective: </strong>The purpose of the study was to determine the presence of ochratoxin A (OTA) and citrinin (CIT) in medicinal herbal products (MHP).</p><p><strong>Methods: </strong>Sixty samples of different MHP types were purchased on the Czech market during 2020-2021. Both mycotoxins were determined using high-performance liquid chromatography with a fluorescence detector with immunoaffinity columns employed as a pretreatment.</p><p><strong>Results: </strong>In total, 40% and 27% of samples were above the limit of quantification with the concentrations ranging up to 826.62 ng/g and 472.79 ng/g for OTA and CIT, respectively. The co-occurrence was confirmed in six MHP types.</p><p><strong>Conclusions: </strong>MHP could be a significant source of OTA and CIT. To protect the health of MHP users, it is desirable to continue monitoring the presence of mycotoxins in MHP. During this study, new OTA regulations for herbs came into force in the EU.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144282993","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":"https://doi.org/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":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","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":"https://doi.org/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, 272 (12%) were classified as duplicates, consisting of 85 unique duplicate sets. Compared with non-duplicate reports, duplicates were more likely to be foreign reports (85% versus 51%), reported by healthcare professionals (89% versus 74%), mention other regulatory authority databases (44% versus 20%), or describe published case reports (28% versus 19%) (p = 0.01). Within sets of duplicates (n = 85), coded information was frequently different, with only 16% (n = 14) 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 0.74 compared with 0.38 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":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Large-scale Empirical Identification of Candidate Comparators for Pharmacoepidemiological Studies.","authors":"Justin Bohn, James P Gilbert, Christopher Knoll, David M Kern, Patrick B Ryan","doi":"10.1007/s40264-025-01569-y","DOIUrl":"https://doi.org/10.1007/s40264-025-01569-y","url":null,"abstract":"<p><strong>Background and objective: </strong>The new user cohort design has emerged as a best practice for the estimation of drug effects from observational data. However, despite its advantages, this design requires the selection and evaluation of comparators for appropriateness, a process that can be challenging. The objective of this work was to introduce an empirical approach to rank candidate comparators in terms of their similarity to a target drug in high-dimensional covariate space.</p><p><strong>Methods: </strong>We generated new user cohorts for each RxNorm ingredient and Anatomic Therapeutic Chemical level 4 class in five administrative claims databases then extracted aggregated pre-treatment covariate data for each cohort across five clinically oriented domains. We formed all pairs of cohorts with ≥ 1000 patients and computed a scalar similarity score, defined as the average of cosine similarities computed within each domain, for each pair. We then generated ranked lists of candidate comparators for each cohort.</p><p><strong>Results: </strong>Across up to 1350 cohorts forming 922,761 comparisons, drugs that were more similar in the Anatomic Therapeutic Chemical hierarchy had higher cohort similarity scores. The most similar candidate comparators for each of six example drugs corresponded to alternative treatments used in the target drug's indication(s), and choosing the top-ranked comparator for randomly selected drugs tended to produce balance on most covariates. This approach also ranked highly those comparators chosen in high-quality published new user cohort design studies.</p><p><strong>Conclusion: </strong>Empirical comparator recommendations may serve as a useful aid to investigators and could ultimately enable the automated generation of new user cohort design-derived evidence, a process that has previously been limited to self-controlled designs.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224742","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":"Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials.","authors":"Richard C Zink, Rebecca Lyzinski, Geoffrey Mann","doi":"10.1007/s40264-025-01518-9","DOIUrl":"10.1007/s40264-025-01518-9","url":null,"abstract":"<p><p>The Medical Dictionary for Regulatory Activities (MedDRA) was developed in the mid-to-late 1990s to address the shortcomings of other medical dictionaries used for coding adverse events. Since that time, MedDRA has become the required coding dictionary for major regulatory authorities involved with the International Council for Harmonisation. Due to the increased specificity and significant increase in terminology over time, several approaches have been developed to aggregate terms for the purposes of signal detection and labeling. We present the approaches taken and suggested to date to aggregate preferred terms into meaningful medical concepts. We discuss the pros and cons of different methods in which to group terms, and illustrate that analyses performed for MedDRA preferred terms can also be conducted using aggregated terms. However, some features of adverse events available at the preferred term level, such as severity and relationship to study therapy, require additional consideration for analysis. In the last 25 years, the pendulum for medical coding is swinging in the other direction. Faced with a deluge of preferred terms, users of MedDRA are developing new ways in which to collapse terms into medical concepts. The ability to identify safety concerns and communicate important data in drug labels effectively and consistently are at risk, particularly with the introduction of new aggregations.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"595-606"},"PeriodicalIF":4.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425185","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":"Navigating Diverging Perspectives: Reasoning, Evidence, and Decision-Making in Drug Safety.","authors":"Tarek A Hammad, Simon Davies","doi":"10.1007/s40264-025-01537-6","DOIUrl":"10.1007/s40264-025-01537-6","url":null,"abstract":"<p><p>Decision making in drug safety is a complex and iterative process that requires the integration of diverse evidence sources, scientific reasoning, and clinical judgment. Diverging opinions among stakeholders-including pharmacovigilance professionals, regulatory authorities, clinical researchers, statisticians, and epidemiologists-often stem from differences in data interpretation, methodological approaches, and thresholds for concern or action. This paper examines the key sources of these divergences and presents a structured framework to enhance alignment in drug safety decision making. The proposed framework outlines three core dimensions: evidence assessment, interpretation, and action. It distinguishes between quantitative aspects, such as effect magnitude and measurement error, and qualitative considerations, including contextual interpretation and risk thresholds. The framework also underscores the importance of multidisciplinary collaboration, as safety professionals must actively engage with other scientific and regulatory stakeholders to ensure a comprehensive evaluation of the evidence. A fundamental challenge in pharmacovigilance is the need to communicate the complexities of drug safety assessment to a broader audience, including those who may not be familiar with the nuances of safety decision making. This paper aims to serve not only as a resource for new pharmacovigilance professionals, but also as a tool to facilitate clearer communication between disciplines. By adopting a structured approach and fostering open dialogue, drug safety professionals can enhance transparency and improve regulatory and clinical decision-making processes.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"587-593"},"PeriodicalIF":4.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12098510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613978","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}