Drug Safety最新文献

{"title":"Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis.","authors":"Christopher A Gravel, William Bai, Antonios Douros","doi":"10.1007/s40264-024-01433-5","DOIUrl":"10.1007/s40264-024-01433-5","url":null,"abstract":"<p><strong>Background and objective: </strong>It is unclear which comparator is the most appropriate for bias reduction in disproportionality analyses based on spontaneous reports. We conducted a quasi-quantitative bias analysis using two well-studied drug-event combinations to assess how different comparators influence the directionality of bias in pharmacovigilance.</p><p><strong>Methods: </strong>We used the US Food and Drug Administration Adverse Event Reporting System focusing on two drug-event combinations with a propensity for stimulated reporting: rivaroxaban and hepatotoxicity, and canagliflozin and acute kidney injury. We assessed the directionality of three disproportionality analysis estimates (reporting odds ratio, proportional reporting ratio, information component) using one unrestricted comparator (full data) and two restricted comparators (active comparator, active comparator with class exclusion). Analyses were conducted within two calendar time periods, defined based on external events (approval of direct oral anticoagulants, Food and Drug Administration safety warning on acute kidney injury with sodium-glucose cotransporter 2 inhibitors) hypothesized to alter reporting rates.</p><p><strong>Results: </strong>There were no false-positive signals for rivaroxaban and hepatotoxicity irrespective of the comparator. Restricting to the initial post-approval period led to false-positive signals, with restricted comparators performing worse. There were false-positive signals for canagliflozin and acute kidney injury, with restricted comparators performing better. Restricting to the period before the Food and Drug Administration warning weakened the false-positive signal for canagliflozin and acute kidney injury across comparators.</p><p><strong>Conclusions: </strong>We could not identify a consistent and predictable pattern to the directionality of disproportionality analysis estimates with specific comparators. Calendar time-based restrictions anchored on relevant external events had a considerable impact.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11286628/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140848208","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":"Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling.","authors":"George A Neyarapally, Leihong Wu, Joshua Xu, Esther H Zhou, Oanh Dang, Joann Lee, Dharmang Mehta, Rochelle D Vaughn, Ellen Pinnow, Hong Fang","doi":"10.1007/s40264-024-01468-8","DOIUrl":"https://doi.org/10.1007/s40264-024-01468-8","url":null,"abstract":"<p><strong>Introduction: </strong>The accurate identification and timely updating of adverse reactions in drug labeling are crucial for patient safety and effective drug use. Postmarketing surveillance plays a pivotal role in identifying previously undetected adverse events (AEs) that emerge when a drug is used in broader and more diverse patient populations. However, traditional methods of updating drug labeling with new AE information have been manual, time consuming, and error prone. This paper introduces the LabelComp tool, an innovative artificial intelligence (AI) tool designed to enhance the efficiency and accuracy of postmarketing drug safety surveillance. Utilizing a combination of text analytics and a trained Bidirectional Encoder Representations from Transformers (BERT) model, the LabelComp tool automatically identifies changes in AE terms from updated drug labeling documents.</p><p><strong>Objective: </strong>Our objective was to create and validate an AI tool with high accuracy that could enable researchers and FDA reviewers to efficiently identify safety-related drug labeling changes.</p><p><strong>Results: </strong>Our validation study of 87 drug labeling PDF pairs demonstrates the tool's high accuracy, with F1 scores of overall performance ranging from 0.795 to 0.936 across different evaluation tiers and a recall of at least 0.997 with only one missed AE out of 483 total AEs detected, indicating the tool's efficacy in identifying new AEs.</p><p><strong>Conclusion: </strong>The LabelComp tool can support drug safety surveillance and inform regulatory decision-making. The publication of this tool also aims to encourage further community-driven enhancements, aligning with broader interests in applying AI to advance regulatory science and public health.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859274","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":"Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study","authors":"Cristina Morciano, Marco Massari, Maria Cutillo, Valeria Belleudi, Gianluca Trifirò, Nadia Mores, Ester Sapigni, Aurora Puccini, Giovanna Zanoni, Manuel Zorzi, Giuseppe Monaco, Olivia Leoni, Stefania Del Zotto, Sarah Samez, Flavia Mayer, Giuseppe Marano, Francesca Menniti Ippolito, Roberto Da Cas, Giuseppe Traversa, Stefania Spila Alegiani","doi":"10.1007/s40264-024-01462-0","DOIUrl":"https://doi.org/10.1007/s40264-024-01462-0","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background and Objective</h3><p>Cases of appendicitis were identified in the pivotal randomized clinical trial on BNT162b2 mRNA vaccine and reported from coronavirus disease 2019 (COVID-19) vaccine pharmacovigilance systems. Three cohort studies and two self-controlled case series (SCCS) studies evaluating the association between mRNA vaccines and appendicitis reported discordant results. To address this uncertainty, the present study examines in a large population, with a SCCS design, the association between mRNA (BNT162b2 and mRNA-1273) and, for the first time, viral vector (ChAdOx1-S and Ad26.COV2-S) COVID-19 vaccines and acute appendicitis.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>The SCCS study design was used to evaluate the association between COVID-19 vaccination and subsequent onset of acute appendicitis. The study was based on record linkage of health archives through TheShinISS application, a statistical tool that locally processes data from regional health care databases according to ad hoc, study-tailored and common data model. The study population included all vaccinated subjects ≥ 12 years old between 27 December 2020 and 30 September 2021. The acute appendicitis was identified through discharge diagnoses of hospital admissions or emergency department visits. Incident cases were defined as those who experienced a first event of acute appendicitis in the study period, excluding subjects with a diagnosis of appendicitis in the previous 5 years. Exposure was defined as the first or second dose of BNT162b2, mRNA-1273 and ChAdOx1-S and the single dose of Ad26.COV2-S. The risk interval was defined as 42 days from the first or second vaccination dose and divided into pre-specified risk subperiods; the reference period was the observation time outside the risk interval. Relative incidences (RI) and 95% confidence intervals (95% CI) were estimated with the SCCS method ‘modified for event-dependent exposures’, through unbiased estimating equations. The seasonal component was considered as a time-dependent covariate.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>In the 42-day risk interval 1285 incident cases of acute appendicitis occurred: 727 cases after the first dose and 558 cases after the second dose. In the main analysis, no increased risks of acute appendicitis were observed in subjects vaccinated with BNT162b, mRNA-1273, ChAdOx1-S and Ad26.COV2-S. The subgroup analyses by sex showed an increased risk in the 14–27 day risk interval, in males after the first dose of mRNA-1273 (RI of 1.71; 95% CI 1.08–2.70, <i>p</i> = 0.02) and in females after the single dose of Ad26.COV2-S (RI of 4.40; 95% CI 1.29–15.01, <i>p</i> = 0.02).</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>There was no evidence of association of BNT162b, ChAdOx1-S, mRNA-1273 and Ad26.COV2-S with acute appendicitis in the general population. The results of the subgroup analyses by sex needs to be consid","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141772418","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 Calculated Risk: Evaluation of QTc Drug-Drug Interaction (DDI) Clinical Decision Support (CDS) Alerts and Performance of the Tisdale Risk Score Calculator.","authors":"Rachel L Wasserman, Diane L Seger, Mary G Amato, Andrew Y Hwang, Julie Fiskio, David W Bates","doi":"10.1007/s40264-024-01466-w","DOIUrl":"https://doi.org/10.1007/s40264-024-01466-w","url":null,"abstract":"<p><strong>Introduction: </strong>A risk factor for a potentially fatal ventricular arrhythmia Torsade de Pointes is a prolongation in the heart rate-corrected QT interval (QTc) ≥ 500 milliseconds (ms) or an increase of ≥ 60 ms from a patient's baseline value, which can cause sudden cardiac death. The Tisdale risk score calculator uses clinical variables to predict which hospitalized patients are at the highest risk for QTc prolongation.</p><p><strong>Objective: </strong>To determine the rate of overridden QTc drug-drug interaction (DDI)-related clinical decision support (CDS) alerts per patient admission and the prevalence by Tisdale risk score category of these overridden alerts. Secondary outcome was to determine the rate of drug-induced QTc prolongation (diQTP) associated with overrides.</p><p><strong>Methods: </strong>Our organization's enterprise data warehouse was used to retrospectively access QTc DDI alerts presented for patients aged ≥ 18 years who were admitted to Brigham and Women's Hospital during 2022. The QTc DDI CDS alerts were included if shown to a physician, fellow, resident, physician assistant, or nurse practitioner when entering the order in inpatient areas for patients with a length of stay of at least 2 days. Variables collected for the Tisdale calculator included age, sex, whether patient was on a loop diuretic, potassium level, admission QTc value, admitting diagnosis of acute myocardial infarction, sepsis, or heart failure, and number of QTc-prolonging drugs given to the patient.</p><p><strong>Results: </strong>A total of 2649 patients with 3033 patient admissions had 18,432 QTc DDI alerts presented that were overridden. An average of 3 unique QTc DDI alerts were presented per patient admission and the alerts were overridden an average of 6 times per patient admission. Overall, 6% of patient admissions were low risk (score ≤ 6), 64% moderate risk (score 7-10), and 30% high risk (score ≥ 11) of QTc prolongation. The most common QTc DDI alerts overridden resulting in an diQTP were quetiapine and propofol (11%) and amiodarone and haloperidol (7%). The diQTP occurred in 883 of patient admissions (29%) and was more frequent in those with higher risk score, with 46% of patient admissions with diQTP in high risk, 23% in moderate risk, and 8% in low risk.</p><p><strong>Conclusion: </strong>Use of the Tisdale calculator to assess patient-specific risk of QT prolongation combined with CDS may improve overall alert quality and acceptance rate, which may decrease the diQTP rate.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141562982","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":"Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea.","authors":"Hyunjoo Kim, Nayeong Son, Dahee Jeong, Myungsik Yoo, In Young Choi, Wona Choi, Yeon Woong Chung, Sung Woo Ko, Seonjeong Byun, Sun Im, Da Woon Sim, Jewon Seo, Min-Gyu Kang, Jun Kyu Lee, Young-Gyun Seo, Hye-Ji An, Yeesuk Kim, Sungeu Chae, Dae Won Jun, Dong-Jin Chang, Seong Geun Kim, Siyeon Yi, Hyeon-Jong Yang, Inho Lee, Hye Jung Park, Jae-Hyun Lee, Bonggi Kim, Eunkyung Euni Lee","doi":"10.1007/s40264-024-01418-4","DOIUrl":"10.1007/s40264-024-01418-4","url":null,"abstract":"<p><strong>Introduction: </strong>Angiotensin receptor blockers are widely used antihypertensive drugs in South Korea. In 2021, the Korea Ministry of Food and Drug Safety acknowledged the need for national compensation for a drug-induced liver injury (DILI) after azilsartan use. However, little is known regarding the association between angiotensin receptor blockers and DILI.</p><p><strong>Objective: </strong>We conducted a retrospective cohort study in incident users of angiotensin receptor blockers from a common data model database (1 January, 2017-31 December, 2021) to compare the risk of DILI among specific angiotensin receptor blockers against valsartan.</p><p><strong>Methods: </strong>Patients were assigned to treatment groups at cohort entry based on prescribed angiotensin receptor blockers. Drug-induced liver injury was operationally defined using the International DILI Expert Working Group criteria. Cox regression analyses were conducted to derive hazard ratios and the inverse probability of treatment weighting method was applied. All analyses were performed using R.</p><p><strong>Results: </strong>In total, 229,881 angiotensin receptor blocker users from 20 university hospitals were included. Crude DILI incidence ranged from 15.6 to 82.8 per 1000 person-years in treatment groups, most were cholestatic and of mild severity. Overall, the risk of DILI was significantly lower in olmesartan users than in valsartan users (hazard ratio: 0.73 [95% confidence interval 0.55-0.96]). In monotherapy patients, the risk was significantly higher in azilsartan users than in valsartan users (hazard ratio: 6.55 [95% confidence interval 5.28-8.12]).</p><p><strong>Conclusions: </strong>We found a significantly higher risk of suspected DILI in patients receiving azilsartan monotherapy compared with valsartan monotherapy. Our findings emphasize the utility of real-world evidence in advancing our understanding of adverse drug reactions in clinical practice.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11182788/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140184040","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":"Fatal Intoxications with Zopiclone-A Cause for Concern?","authors":"Lova Tralla, Sara Gustavsson, Carl Söderberg, Anna K Jönsson, Fredrik C Kugelberg","doi":"10.1007/s40264-024-01424-6","DOIUrl":"10.1007/s40264-024-01424-6","url":null,"abstract":"<p><strong>Introduction: </strong>Zopiclone, a controlled substance prescribed for insomnia, has become a common toxicological finding in forensic autopsy cases. This study investigated the role and extent of zopiclone use in fatal intoxications in Sweden.</p><p><strong>Methods: </strong>All forensic autopsy cases positive for zopiclone in femoral blood during 2012-2020 were selected. Among these cases, fatalities caused by intoxication according to the cause of death certificates issued by the forensic pathologist were identified. Intoxications where zopiclone contributed to the cause of death were included in the study. The Swedish Prescribed Drug Register was utilized to examine whether the included cases were prescribed zopiclone or not.</p><p><strong>Results: </strong>In total 7320 fatal intoxications underwent a forensic autopsy during the study period, 573 of them were caused by zopiclone. Among the zopiclone fatalities, 87% (n = 494) had a prescription for zopiclone, and 8% (n = 43) were monointoxications. Most fatalities, 62% (n = 354) were suicides, and zopiclone was involved in about 17% (n = 354) of all intoxication suicides in Sweden. Women were significantly (p < 0.01) overrepresented in suicides with zopiclone, comprising 56% (n = 291) of fatalities. The median age was 55 years among zopiclone intoxications compared with 44 years amongst all fatal intoxications.</p><p><strong>Conclusion: </strong>This study demonstrates that the toxicity of zopiclone can be lethal both in combination with other substances and on its own. Most individuals dying in fatal zopiclone intoxications were prescribed zopiclone, which potentially indicates that a more restrictive prescribing rate could prevent future intoxication deaths, especially when caring for patients with an increased suicide risk.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11182790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140305172","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":"The Role of Mitochondria in Statin-Induced Myopathy.","authors":"Gavin Bell, Anastasia Thoma, Iain P Hargreaves, Adam P Lightfoot","doi":"10.1007/s40264-024-01413-9","DOIUrl":"10.1007/s40264-024-01413-9","url":null,"abstract":"<p><p>Statins represent the primary therapy for combatting hypercholesterolemia and reducing mortality from cardiovascular events. Despite their pleiotropic effects in lowering cholesterol synthesis, circulating cholesterol, as well as reducing the risk of other systemic diseases, statins have adverse events in a small, but significant, population of treated patients. The most prominent of these adverse effects is statin-induced myopathy, which lacks precise definition but is characterised by elevations in the muscle enzyme creatine kinase alongside musculoskeletal complaints, including pain, weakness and fatigue. The exact aetiology of statin-induced myopathy remains to be elucidated, although impaired mitochondrial function is thought to be an important underlying cause. This may result from or be the consequence of several factors including statin-induced inhibition of coenzyme Q₁₀ (CoQ₁₀) biosynthesis, impaired Ca²⁺ signalling and modified reactive oxygen species (ROS) generation. The purpose of this review article is to provide an update on the information available linking statin therapy with mitochondrial dysfunction and to outline any mechanistic insights, which may be beneficial in the future treatment of myopathic adverse events.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140140089","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":"The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE).","authors":"Meredith Y Smith, Elaine H Morrato, Nallely Mora, Viviana Nguyen, Hilary Pinnock, Almut G Winterstein","doi":"10.1007/s40264-024-01417-5","DOIUrl":"10.1007/s40264-024-01417-5","url":null,"abstract":"<p><strong>Introduction: </strong>The Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) was developed to improve the quality of reporting of risk minimization program evaluations. In light of continued inadequacies in study reporting, and high-profile program implementation failures, we updated the RIMES Checklist to incorporate additional concepts from the Standards for Reporting of Implementation studies (StaRI).</p><p><strong>Methods: </strong>The development of the updated checklist, the RIMES-StaRI Extension (RIMES-SE), entailed developing a study protocol and drafting an initial pool of items based on a mapping of the RIMES against the StaRI checklist. A modified e-Delphi exercise was then conducted to determine the importance and understandability of items for checklist inclusion. An expert workshop and an online commentary period for additional feedback followed.</p><p><strong>Results: </strong>The RIMES-SE contains 27 items. It includes two signature features of the StaRI Checklist: 1) a dual strand of items (represented in two columns) describing the risk minimization program (the 'intervention') and the corresponding implementation strategy; and 2) applicable to an array of different research methodologies.</p><p><strong>Conclusions: </strong>The RIMES-SE Statement and Checklist extends the reporting guidelines set forth in the original RIMES Checklist via inclusion of key implementation science concepts. It is intended to improve the quality and transparency of reporting of risk minimization evaluation studies so as to advance drug safety science.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11182855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140119128","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":"Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis.","authors":"Emanuel Raschi, Francesco Salvo, Andrew Bate, Fabrizio De Ponti, Elisabetta Poluzzi, Marco Tuccori, Eugène van Puijenbroek, Nitin Joshi, Charles Khouri","doi":"10.1007/s40264-024-01419-3","DOIUrl":"10.1007/s40264-024-01419-3","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140157774","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":"The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement.","authors":"Michele Fusaroli, Francesco Salvo, Bernard Begaud, Thamir M AlShammari, Andrew Bate, Vera Battini, Andreas Brueckner, Gianmario Candore, Carla Carnovale, Salvatore Crisafulli, Paola Maria Cutroneo, Charles Dolladille, Milou-Daniel Drici, Jean-Luc Faillie, Adam Goldman, Manfred Hauben, Maria Teresa Herdeiro, Olivia Mahaux, Katrin Manlik, François Montastruc, Yoshihiro Noguchi, G Niklas Norén, Roberta Noseda, Igho J Onakpoya, Antoine Pariente, Elisabetta Poluzzi, Myriam Salem, Daniele Sartori, Nhung T H Trinh, Marco Tuccori, Florence van Hunsel, Eugène van Puijenbroek, Emanuel Raschi, Charles Khouri","doi":"10.1007/s40264-024-01421-9","DOIUrl":"10.1007/s40264-024-01421-9","url":null,"abstract":"<p><strong>Background and aim: </strong>Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and results are generally poorly reported in published articles and existing guidelines do not capture the specific features of disproportionality analyses. We here describe the development of a guideline (REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance [READUS-PV]) for reporting the results of disproportionality analyses in articles and abstracts.</p><p><strong>Methods: </strong>We established a group of 34 international experts from universities, the pharmaceutical industry, and regulatory agencies, with expertise in pharmacovigilance, disproportionality analyses, and assessment of safety signals. We followed a three-step process to develop the checklist: (1) an open-text survey to generate a first list of items; (2) an online Delphi method to select and rephrase the most important items; (3) a final online consensus meeting.</p><p><strong>Results: </strong>Among the panel members, 33 experts responded to round 1 and 30 to round 2 of the Delphi and 25 participated to the consensus meeting. Overall, 60 recommendations for the main body of the manuscript and 13 recommendations for the abstracts were retained by participants after the Delphi method. After merging of some items together and the online consensus meeting, the READUS-PV guidelines comprise a checklist of 32 recommendations, in 14 items, for the reporting of disproportionality analyses in the main body text and four items, comprising 12 recommendations, for abstracts.</p><p><strong>Conclusions: </strong>The READUS-PV guidelines will support authors, editors, peer-reviewers, and users of disproportionality analyses using individual case safety report databases. Adopting these guidelines will lead to more transparent, comprehensive, and accurate reporting and interpretation of disproportionality analyses, facilitating the integration with other sources of evidence.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11116242/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140852036","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}