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Content
March 2025, Volume 48, Issue 3
- 279-286 Post-licensure Safety Surveillance of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) Among US Adults in the Vaccine Adverse Event Reporting System (VAERS)
by Mayra Oliveira & Paige Marquez & Carol Ennulat & Phillip Blanc & Kerry Welsh & Narayan Nair & Monica Taminato & Pedro L. Moro - 287-303 Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments
by Jürgen Dietrich & André Hollstein - 305-309 Advances in Drug Safety: Highlights from the 23rd Annual Meeting of the International Society of Pharmacovigilance
by Omar Aimer & Maribel Salas & Tarek A Hammad & Rania Mouchantaf & Katarina Ilic & Maxine Gossell-Williams & Ushma Mehta & Robert W. Platt & Bruce Carleton - 311-314 Principles and Practice of Pharmacovigilance and Drug Safety
by Ian W. Boyd
February 2025, Volume 48, Issue 2
- 107-117 Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation
by Almut G. Winterstein & Celeste L. Y. Ewig & Yanning Wang & Nicole E. Smolinski & Gita A. Toyserkani & Cynthia LaCivita & Leila Lackey & Sara Eggers & Esther H. Zhou & Vakaramoko Diaby & Amir Sarayani & Thuy Thai & Judith C. Maro & Sonja A. Rasmussen - 119-127 Safeguarding Patients in the AI Era: Ethics at the Forefront of Pharmacovigilance
by Ashish Jain & Maribel Salas & Omar Aimer & Zahabia Adenwala - 129-142 Drug-Induced Hypouricemia
by Chaker Ben Salem & Myriam Agrebi & Dhouha Sahnoun & Neila Fathallah & Houssem Hmouda - 143-150 Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury
by Dina Halegoua-DeMarzio & Victor J. Navarro & Ashley Davis & Jawad Ahmad & Bharathi Avula & Huiman Barnhart & A. Sidney Barritt & Herbert L. Bonkovsky & Vincent L. Chen & Gina Choi & Robert J. Fontana & Marwan S. Ghabril & Ikhlas Khan & Christopher Koh & Joseph Odin & Don C. Rockey & Hoss Rostami & Jose Serrano & Averell H. Sherker & Andrew Stolz & Hans L. Tillmann & Raj Vuppalanchi - 151-160 Incidence of Idiosyncratic Drug-Induced Liver Injury Caused by Prescription Drugs
by Vincent L. Chen & Don C. Rockey & Einar S. Bjornsson & Huiman Barnhart & Jay H. Hoofnagle - 161-177 Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study
by Mathias Møllebæk & Helga Gardarsdottir & Alexia-Georgia Bikou & Ana Kodrič & Ana Marta Silva & Armin Andersen & Christos Kontogiorgis & Elita Poplavska & Fariba Ahmadizar & Foteini Dermiki-Gkana & Ieva Rutkovska & Inês Ribeiro Vaz & Mitja Kos & Paula Barão & Renske Grupstra & Teresa Leonardo Alves & Anna Birna Almarsdóttir - 179-190 Views on the Development and Use of a New Digital Adverse Drug Event Reporting Platform in Australia: A Qualitative Study
by Eyob Alemayehu Gebreyohannes & Christopher Thornton & Myra Thiessen & Sieta T. Vries & Gretchen Coombs & Indae Hwang & Renly Lim - 191-201 Fracture-Related Safety Reporting of JAK Inhibitors: An Analysis from the WHO Global VigiBase
by Adrian Martinez de la Torre & Andreas Bech Clausen & Andrea M. Burden & Stefan Weiler
January 2025, Volume 48, Issue 1
- 1-5 Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices
by Yoshihiro Noguchi & Tomoya Tachi & Tomoaki Yoshimura - 7-23 Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials
by Shih-Hao Cheng & William Chu & Wen-Hsiang Chou & Woei-Chyn Chu & Yi-No Kang - 25-42 Comparative Effectiveness and Safety of Off-Label Underdosed Direct Oral Anticoagulants in Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis
by Pajaree Mongkhon & Noppaket Singkham & Kunyarat Ponok & Natpatsorn Liamsrijan & Wipada Phoosa & Sirayut Phattanasobhon & Laura Fanning & Vichai Senthong & Surasak Saokaew - 43-58 An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury
by Daniel Fernández-Llaneza & Romy M. P. Vos & Joris E. Lieverse & Helen R. Gosselt & Sandra L. Kane-Gill & Teun Gelder & Joanna E. Klopotowska - 59-74 Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups
by Victor Pera & Jan A. Kors & Erik M. Mulligen & Marcel Wilde & Peter R. Rijnbeek & Katia M. C. Verhamme - 75-86 Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide
by Corine Ekhart & Sjoerd H. P. Wiarda & Sonja Koppel & Souad Skalli & Waad Alghamdi & Francesca Menniti-Ippolito & Kunwarang Tangchitkhachon & John Samson Mponda & Herman J. Woerdenbag & Florence Hunsel - 87-97 The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore Potential Risks and Complications
by Yitayeh Belsti & Aya Mousa & Hannah Jackson & Lisa J. Moran & Kirsten R. Palmer & Raja Ram Dhungana & Emily Callander & Daniel Lorber Rolnik & Helena Teede & Joanne Enticott - 99-105 Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products
by Matthew R. Allen & Gwenyth Portillo Wightman & Zechariah Zhu & Adam Poliak & Davey M. Smith & Mark Dredze & John W. Ayers
December 2024, Volume 47, Issue 12
- 1193-1202 Short-Term Training, a Useful Approach for Sustainable Pharmacovigilance Knowledge Development in Tanzania, Kenya, Ethiopia and Rwanda
by Eugène Puijenbroek & Abbie Barry & Christabel Khaemba & Lazare Ntirenganya & Tigist Dires Gebreyesus & Adam Fimbo & Omary Minzi & Eyasu Makonnen & Margaret Oluka & Anastasia Guantai & Eleni Aklillu - 1203-1224 A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review
by Renato Ferreira-da-Silva & Joana Reis-Pardal & Manuela Pinto & Matilde Monteiro-Soares & Bernardo Sousa-Pinto & Manuela Morato & Jorge Junqueira Polónia & Inês Ribeiro-Vaz - 1225-1234 Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure
by Martin F. Casey & Joy Hallmark & Patricia P. Chang & Jo E. Rodgers & Aakash Mehta & Srihari V. Chari & Preston Skersick & Thomas Bohrmann & Parag Goyal & Michelle L. Meyer - 1235-1243 A Calculated Risk: Evaluation of QTc Drug–Drug Interaction (DDI) Clinical Decision Support (CDS) Alerts and Performance of the Tisdale Risk Score Calculator
by Rachel L. Wasserman & Diane L. Seger & Mary G. Amato & Andrew Y. Hwang & Julie Fiskio & David W. Bates - 1245-1263 Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations
by Gerd Rippin & Héctor Sanz & Wilhelmina E. Hoogendoorn & Nicolás M. Ballarini & Joan A. Largent & Eleni Demas & Douwe Postmus & Theodor Framke & Lukas M. Aguirre Dávila & Chantal Quinten & Francesco Pignatti - 1265-1274 Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling
by George A. Neyarapally & Leihong Wu & Joshua Xu & Esther H. Zhou & Oanh Dang & Joann Lee & Dharmang Mehta & Rochelle D. Vaughn & Ellen Pinnow & Hong Fang - 1275-1292 Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System
by Michele Fusaroli & Stefano Polizzi & Luca Menestrina & Valentina Giunchi & Luca Pellegrini & Emanuel Raschi & Daniel Weintraub & Maurizio Recanatini & Gastone Castellani & Fabrizio Ponti & Elisabetta Poluzzi - 1293-1306 Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre
by Annabelle S. Chidiac & Nicholas A. Buckley & Firouzeh Noghrehchi & Rose Cairns - 1441-1441 RETRACTED ARTICLE: Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India
by Upinder Kaur & Aakanksha Jaiswal & Ayushi Jaiswal & Kunal Singh & Aditi Pandey & Mayank Chauhan & Mahek Rai & Sangeeta Kansal & Kishor Patwardhan & Vaibhav Jaisawal & Sankha Shubhra Chakrabarti
November 2024, Volume 47, Issue 11
- 1061-1074 Adopting STOPP/START Criteria Version 3 in Clinical Practice: A Q&A Guide for Healthcare Professionals
by Carlotta Lunghi & Marco Domenicali & Stefano Vertullo & Emanuel Raschi & Fabrizio De Ponti & Graziano Onder & Elisabetta Poluzzi - 1075-1093 A Systematic Overview of Contraindications and Special Warnings for Biologic and Targeted Synthetic Disease Modifying Antirheumatic Drugs: Establishing a Framework to Create a “Safety Checklist”
by Lykke Skaarup & Elvina Ingrid & Alexandre Sepriano & Elena Nikiphorou & René Østgård & Kim Lauper & Ilona Grosse-Michaelis & Margreet Kloppenburg & Bente Glintborg & David F. L. Liew & Tue W. Kragstrup - 1095-1126 Tardive Dyskinesia with Antipsychotic Medication in Children and Adolescents: A Systematic Literature Review
by Frank M. C. Besag & Michael J. Vasey & Iffah Salim & Chris Hollis - 1127-1136 Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance
by Cosimo Zaccaria & Loris Piccolo & María Gordillo-Marañón & Gilles Touraille & Corinne Vries - 1137-1148 Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
by Ignacio Salamanca Cueva & Jennifer E. Gerber & Andrew Hastie & Carlos Brotons & Falko Panzer & Jean-Yves Pirçon & Paul Talsma & Tamara Eckermann & Vanja Nikic & Xavier Martinez Gomez & Hannah Alsdurf - 1149-1156 Optimal Significance Levels and Sample Sizes for Signal Detection Methods Based on Non-constant Hazards
by Odile Sauzet & Julia Dyck & Victoria Cornelius - 1157-1169 Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study
by 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 - 1171-1188 The Methodological Quality of Observational Studies Examining the Risk of Pregnancy Drug Use on Congenital Malformations Needs Substantial Improvement: A Cross-Sectional Survey
by Yulong Jia & Jing Wang & Chunrong Liu & Peng Zhao & Yan Ren & Yiquan Xiong & GuoWei Li & Meng Chen & Xin Sun & Jing Tan
October 2024, Volume 47, Issue 10
- 931-940 Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy
by Jennifer G. Lyons & Mayura U. Shinde & Judith C. Maro & Andrew Petrone & Austin Cosgrove & Maria E. Kempner & Susan E. Andrade & Jamila Mwidau & Danijela Stojanovic & José J. Hernández-Muñoz & Sengwee Toh - 941-956 The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System
by Priya Bahri & Georgy Genov & Peter Arlett & Viola Macolić Šarinić & Evdokia Korakianiti & Alexis Nolte & Martin Huber & Sabine M. J. M. Straus - 957-990 Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review
by Jenine Shafi & Maneet K. Virk & Emma Kalk & James G. Carlucci & Audrey Chepkemoi & Caitlin Bernard & Megan S. McHenry & Edwin Were & John Humphrey & Mary-Ann Davies & Ushma C. Mehta & Rena C. Patel - 991-1010 Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis
by Agustín Ciapponi & Mabel Berrueta & Fernando J. Argento & Jamile Ballivian & Ariel Bardach & Martin E. Brizuela & Noelia Castellana & Daniel Comandé & Sami Gottlieb & Beate Kampmann & Agustina Mazzoni & Edward P. K. Parker & Juan M. Sambade & Katharina Stegelmann & Xu Xiong & Andy Stergachis & Pierre Buekens - 1011-1023 What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study
by Chiara Bellitto & Nicoletta Luxi & Francesco Ciccimarra & Luca L’Abbate & Monika Raethke & Florence Hunsel & Thomas Lieber & Erik Mulder & Fabio Riefolo & Felipe Villalobos & Nicolas H. Thurin & Francisco B. Marques & Kathryn Morton & Fergal O’Shaughnessy & Simona Sonderlichová & Andreea Farcas & Giele-Eshuis Janneke & Miriam C. Sturkenboom & Gianluca Trifirò - 1025-1037 Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study
by Vincent Ka Chun Yan & Yu Yang & Eric Yuk Fai Wan & Francisco Tsz Tsun Lai & Celine Sze Ling Chui & Xue Li & Carlos King Ho Wong & Ivan Fan Ngai Hung & Chak Sing Lau & Ian Chi Kei Wong & Esther Wai Yin Chan - 1039-1049 Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports
by Uma Mahadevan & Gweneth Levy & Lianne Gensler & Mira Ali & Ana P. Lacerda & Lani Wegrzyn & Hannah Palac & Tina Bhutani-Jacques & Millie Long & Megan E. B. Clowse & Alexa B. Kimball & Christina Chambers & Anthony R. Scialli - 1051-1059 The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions
by Pantelis Natsiavas & George Nikolaidis & Jenny Pliatsika & Achilles Chytas & George Giannios & Haralampos Karanikas & Margarita Grammatikopoulou & Martha Zachariadou & Vlasios Dimitriadis & Spiros Nikolopoulos & Ioannis Kompatsiaris
September 2024, Volume 47, Issue 9
- 829-839 Proceedings of the Canadian Medication Appropriateness and Deprescribing Network’s 2023 National Meeting
by Tiphaine Pierson & Verna Arcand & Barbara Farrell & Camille L. Gagnon & Larry Leung & Lisa M. McCarthy & Andrea L. Murphy & Nav Persaud & Lalitha Raman-Wilms & James L. Silvius & Michael A. Steinman & Cara Tannenbaum & Wade Thompson & Johanna Trimble & Cheryl A. Sadowski & Emily G. McDonald - 841-842 Bridging the Evidence Gap: Sotrovimab Use in Pregnancy and the Need for Comprehensive Drug Safety Data
by Ursula Winterfeld - 843-851 Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry
by Diego F. Wyszynski & Lydia Demetriou & Cheryl Renz & Shirin Aliabadi & Dragutin Rafailovic & Lee P. Shulman & Myriam Drysdale & Keele E. Wurst - 853-868 Key Opinion Leaders’ Interviews to Inform the Future of Benefit–Risk Planning in the Medical Total Product Life Cycle of Global Pharmaceutical and Medical Device Organizations
by Arianna Simonetti & Susan Colilla & Brian Edwards & Jürgen Kübler & Leila Lackey & Lisa Rodriguez & Susan Talbot & Hong Yang & William Wang & Danae Williams & James Matthew Higginson - 869-881 Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies
by Adi Mor & Scott Friedman & Sharon Hashmueli & Amnon Peled & Massimo Pinzani & Matthew Frankel & Rifaat Safadi - 883-894 Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study
by Rebeccah Nehard & Catherine Vauzelle & Delphine Beghin & Mathilde Latour & Elisabeth Elefant & Bénédicte Coulm & Benoît Marin - 895-907 Timing Matters: A Machine Learning Method for the Prioritization of Drug–Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exposure
by Vera Battini & Marianna Cocco & Maria Antonietta Barbieri & Greg Powell & Carla Carnovale & Emilio Clementi & Andrew Bate & Maurizio Sessa - 909-919 Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020
by Mufaddal Mahesri & Ameet Sarpatwari & Krista F. Huybrechts & Joyce Lii & Su Been Lee & Gita A. Toyserkani & Cynthia LaCivita & Esther H. Zhou & Gerald J. Dal Pan & Aaron S. Kesselheim & Katsiaryna Bykov - 921-923 Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers
by Antoine Pariente & Francesco Salvo & Virginie Bres & Jean-Luc Faillie - 925-930 Correction to: Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes
by Amber Cragg & Serena S. Small & Erica Lau & Adrianna Rowe & Anthony Lau & Katherine Butcher & Corinne M. Hohl
August 2024, Volume 47, Issue 8
- 721-731 Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics
by Robin E. Ferner & Jeffrey K. Aronson - 733-743 Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies
by Joanne Treacy & Elaine H. Morrato & Robert Horne & Michael S. Wolf & Ameet Bakhai & Marie-Claire Wilson & Mark Lightowler & Sibel Guerler & Jeremy Jokinen - 745-757 Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database
by Renato de Filippis & John M. Kane & Elena Arzenton & Ugo Moretti & Emanuel Raschi & Gianluca Trifirò & Corrado Barbui & Pasquale De Fazio & Chiara Gastaldon & Georgios Schoretsanitis - 759-769 Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
by Samantha B. Shapiro & Hui Yin & Oriana H. Y. Yu & Laurent Azoulay - 771-781 Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study
by Anum Saqib Zaidi & Gregory M. Peterson & Colin M. Curtain & Mohammed S. Salahudeen - 783-798 COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance
by María Gordillo-Marañón & Agnieszka Szmigiel & Vladimíra Yalmanová & Irina Caplanusi & Georgy Genov & David Benee Olsen & Sabine Straus - 799-807 Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults
by Carina D’Aiuto & Carlotta Lunghi & Line Guénette & Djamal Berbiche & Karine Bertrand & Helen-Maria Vasiliadis - 809-819 Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis
by Christopher A. Gravel & William Bai & Antonios Douros - 821-822 Comment on: “Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: A Swedish Population-Based Cohort Study”
by Rita Avó-Baião & Raquel Vareda & Andreia Lopes - 823-825 Author’s Reply to Avó-Baião et al.’s Comment on “Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: A Swedish Population-Based Cohort Study”
by Nele Brusselaers - 827-827 Correction to: Using Social Media as a Source of Real‑World Data for Pharmaceutical Drug Development and Regulatory Decision Making
by Didrik Wessel & Nicolai Pogrebnyakov
July 2024, Volume 47, Issue 7
- 601-605 Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis
by Emanuel Raschi & Francesco Salvo & Andrew Bate & Fabrizio De Ponti & Elisabetta Poluzzi & Marco Tuccori & Eugène Puijenbroek & Nitin Joshi & Charles Khouri - 607-615 Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination
by María Gordillo-Marañón & Gianmario Candore & Karin Hedenmalm & Kate Browne & Robert Flynn & Loris Piccolo & Aniello Santoro & Cosimo Zaccaria & Xavier Kurz - 617-641 Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy
by Brandon W. Lennep & Jesse Mack & Srinivasu Poondru & Elizabeth Hood & Brooke D. Looney & Monique Williams & Judeth J. Bianco & Alicia K. Morgans - 643-653 The Role of Mitochondria in Statin-Induced Myopathy
by Gavin Bell & Anastasia Thoma & Iain P. Hargreaves & Adam P. Lightfoot - 655-671 The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)
by Meredith Y. Smith & Elaine H. Morrato & Nallely Mora & Viviana Nguyen & Hilary Pinnock & Almut G. Winterstein - 673-686 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
by 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 - 687-697 Fatal Intoxications with Zopiclone—A Cause for Concern?
by Lova Tralla & Sara Gustavsson & Carl Söderberg & Anna K. Jönsson & Fredrik C. Kugelberg - 699-710 Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values
by Bereket Tesfaldet & Tejas Patel & Minjun Chen & Frank Pucino & Lilliam Rosario & Paul Hayashi & Eileen Navarro Almario - 711-719 The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study
by Ying Li & Lin Dang & Chengzhi Lv & Bingjiang Lin & Juan Tao & Nan Yu & Ya Deng & Huiping Wang & Xiaojing Kang & Hui Qin & Rong Chen & Jinnan Li & Yunsheng Liang & Yanhua Liang & Yuling Shi
June 2024, Volume 47, Issue 6
- 515-520 A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines
by Souad Skalli & Angela Caro-Rojas & Hadir Rostom & Mohamed A. Elhawary - 521-528 The Role of Pharmacogenomics in Rare Diseases
by Alice Man & Gabriella S. S. Groeneweg & Colin J. D. Ross & Bruce C. Carleton - 529-533 The Problems with Online Health Product Sales: How can Regulations be Improved?
by Yi Jing Sng & Daryl Kwok & Eugene Goh & Annie Tan & Jessica Teo & Cheng Leng Chan - 535-543 Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems
by Yoshihiro Noguchi & Tomoaki Yoshimura - 545-556 Risk Factors Associated with Medication Administration Errors in Children: A Prospective Direct Observational Study of Paediatric Inpatients
by Johanna I. Westbrook & Ling Li & Amanda Woods & Tim Badgery-Parker & Virginia Mumford & Alison Merchant & Erin Fitzpatrick & Magdalena Z. Raban - 557-569 Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation
by Ling Li & Jannah Baker & Renee Quirk & Danielle Deidun & Maria Moran & Ahmed Abo Salem & Nanda Aryal & Bethany A. Dort & Wu Yi Zheng & Andrew Hargreaves & Paula Doherty & Sarah N. Hilmer & Richard O. Day & Johanna I. Westbrook & Melissa T. Baysari - 571-573 Not Just Another Reporting Guideline? Here’s Why READUS-PV is a Major Step Forward
by Yoon K. Loke - 575-584 The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement
by 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 Hunsel & Eugène Puijenbroek & Emanuel Raschi & Charles Khouri - 585-599 The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration
by 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 Hunsel & Eugène Puijenbroek & Emanuel Raschi & Charles Khouri
May 2024, Volume 47, Issue 5
- 405-418 The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally
by Irina Caplanusi & Agnieszka Szmigiel & Menno van der Elst & Marie Louise Schougaard Christiansen & Steffen Thirstrup & Cosimo Zaccaria & Bénédicte Cappelli & Georgy Genov & Sabine Straus - 419-438 Tacrolimus-Induced Neurotoxicity After Transplant: A Literature Review
by Paige Verona & Jocelyn Edwards & Kassidy Hubert & Federica Avorio & Vincenzina Lo Re & Roberta Stefano & Anna Carollo & Heather Johnson & Alessio Provenzani - 439-451 Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review
by Bronya Calvarysky & Idit Dotan & Daniel Shepshelovich & Avi Leader & Talia Diker Cohen - 453-464 In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life
by Mylène Tisseyre & Mathis Collier & Nathanaël Beeker & Florentia Kaguelidou & Jean-Marc Treluyer & Laurent Chouchana - 465-474 Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study
by Jingping Hu & Chaojin Chen & Xiaoyue Li & Xiangyang Zang & Jie Ke & Shaoli Zhou & Haiyan Mai & Chulian Gong - 475-485 A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review
by Daniele Sartori & Jeffrey K. Aronson & Nils Erlanson & G. Niklas Norén & Igho J. Onakpoya - 487-493 Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS)
by Pedro L. Moro & Carol Ennulat & Hannah Brown & Gina Woody & Bicheng Zhang & Paige Marquez & Emily Jane Woo & John R. Su - 495-511 Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making
by Didrik Wessel & Nicolai Pogrebnyakov - 513-513 Correction to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
by Eric B. Cohen & Meenal Patwardhan & Ritu Raheja & David H. Alpers & Raul J. Andrade & Mark I. Avigan & James H. Lewis & Don C. Rockey & Francis Chui & Alexandru M. Iacob & Camila C. Linardi & Arie Regev & Jesse Shick & M. Isabel Lucena
April 2024, Volume 47, Issue 4
- 289-299 The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
by Wen-Wen Yang & Yi-Chen Juan & Grace Hui-Min Wu & Raoh-Fang Pwu - 301-319 Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
by Eric B. Cohen & Meenal Patwardhan & Ritu Raheja & David H. Alpers & Raul J. Andrade & Mark I. Avigan & James H. Lewis & Don C. Rockey & Francis Chui & Alexandru M. Iacob & Camila C. Linardi & Arie Regev & Jesse Shick & M Isabel Lucena - 321-332 Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy
by Eric B. Cohen & Arie Regev & Anju Garg & Adrian M. Bisceglie & James H. Lewis & John M. Vierling & Judith Hey-Hadavi & Klaudia Steplewski & Anna Fettiplace & Chunlin L. Chen & Nonko Pehlivanov & Stuart Kendrick & Mark I. Avigan - 333-354 Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis
by Lorenzo Vittorio Rindi & Drieda Zaçe & Neva Braccialarghe & Barbara Massa & Virginia Barchi & Roberta Iannazzo & Ilenia Fato & Francesco Maria & Dimitra Kontogiannis & Vincenzo Malagnino & Loredana Sarmati & Marco Iannetta - 355-363 Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease
by Marjolein Drent & Petal A. Wijnen & Naomi T. Jessurun & Ankie M. Harmsze & Otto Bekers & Aalt Bast - 365-375 An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older
by Gaël Santos & Raghavendra Devadiga & Chun Soo Kim & Joon Bang - 377-387 Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
by Monica A. Muñoz & Gerald J. Dal Pan & Yu-Jung Jenny Wei & Hong Xiao & Chris Delcher & Andrew Giffin & Nabila Sadiq & Almut G. Winterstein - 389-400 Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data
by Matthew D. Jones & Shaojun Liu & Freyja Powell & Asma Samsor & Felicity Chao Ru Ting & Nikolaos Veliotis & Yin Mei Wong & Bryony Dean Franklin & Sara Garfield - 401-402 Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”
by Wan-Ting Huang & Robert T. Chen & Caroline Cassard - 403-404 Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”
by Fan Bu & Faaizah Arshad & George Hripcsak & Patrick B. Ryan & Martijn J. Schuemie & Marc A. Suchard
March 2024, Volume 47, Issue 3
- 195-204 The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
by Diego F. Wyszynski & Aris T. Papageorghiou & Cheryl Renz & Torri D. Metz & Sonia Hernández-Díaz - 205-216 An Overview of Regression Models for Adverse Events Analysis
by Elsa Coz & Mathieu Fauvernier & Delphine Maucort-Boulch - 217-225 Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
by Yoong Khean Khoo & John C. W. Lim & Wei Chuen Tan-Koi & Nokuthula Sikhethiwe Kitikiti & Ai Ling Sim-Devadas - 227-236 Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project
by Guillaume Favre & Jonathan L. Richardson & Alan Moore & Yvonne Geissbühler & Valentine Jehl & Alison Oliver & Svetlana Shechtman & Orna Diav-Citrin & Maya Berlin & Tal Haan & David Baud & Alice Panchaud & Anil Mor & Meritxell Sabidó & Sabrina Souza & Christina Chambers & Yrea R. J. Rijt-Weetink & Eugène P. Puijenbroek & Laura M. Yates & François Girardin & Michael Stellfeld & Ursula Winterfeld - 237-249 International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries
by Toshihiro Koyama & Shunya Iinuma & Michio Yamamoto & Takahiro Niimura & Yuka Osaki & Sayoko Nishimura & Ko Harada & Yoshito Zamami & Hideharu Hagiya - 251-260 Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
by Y. Joseph Hwang & Hsien-Yen Chang & Thomas Metkus & Kathleen M. Andersen & Sonal Singh & G. Caleb Alexander & Hemalkumar B. Mehta - 261-270 Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project
by Yrea R. J. Rijt-Weetink & Toine C. G. Egberts & Florence P. A. M. Hunsel & David J. Lewis & Laura M. Yates & Ursula Winterfeld & Eugène P. Puijenbroek - 271-284 Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS
by Michele Fusaroli & Valentina Giunchi & Vera Battini & Stefano Puligheddu & Charles Khouri & Carla Carnovale & Emanuel Raschi & Elisabetta Poluzzi - 285-286 The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)
by Souad Skalli - 287-288 Correction to: The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)
by Souad Skalli
February 2024, Volume 47, Issue 2
- 113-116 Appeal for Increasing the Impact of Pharmacovigilance
by Agnes C. Kant - 117-123 The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
by Harriet Dickinson & Dana Y. Teltsch & Jan Feifel & Philip Hunt & Enriqueta Vallejo-Yagüe & Arti V. Virkud & Katoo M. Muylle & Taichi Ochi & Macarius Donneyong & Joseph Zabinski & Victoria Y. Strauss & Juan M. Hincapie-Castillo - 125-133 SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes
by Fengge Wang & Michael Hendryx & Nianjun Liu & Aurelian Bidulescu & Anirban K. Mitra & Juhua Luo - 135-146 Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study
by Simon Xiwen Qin & Franco Wing Tak Cheng & Wang Chun Kwok & Lydia W. Y. Fung & Tian Tian Ma & Hei Hang Edmund Yiu & Chloe Bloom & Christine F. McDonald & Ching-Lung Cheung & Francisco Tsz Tsun Lai & Celine Sze Ling Chui & Xue Li & Carlos King Ho Wong & Eric Yuk Fai Wan & Ian Chi Kei Wong & Esther Wai Yin Chan - 147-159 Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region
by Yolanda Guerra Mendoza & Viviane Jusot & Félix Adou & Martin Ota & Diego Mpia Elenge & Tasim Begum & Nkululeko Mdladla & Olga Menang & Jean Claude Yavo & Mamadou Kamagaté - 161-171 A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
by Yasmina Hachem & Yola Moride & Anne-Marie Castilloux & Genaro Castillon & Maja Kalaba & Andrée Néron & Rihab Gamaoun & Marc O. Martel & Pierre Beaulieu & Mark Ware & Antonio Vigano - 173-182 Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing
by Guojun Dong & Andrew Bate & François Haguinet & Gabriel Westman & Luise Dürlich & Anders Hviid & Maurizio Sessa - 183-192 Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
by Astrid Coste & Angel YS Wong & Charlotte Warren-Gash & Julian Matthewman & Andrew Bate & Ian J. Douglas - 193-193 Correction to: Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media
by Cristina Micale & Su Golder & Karen O’Connor & Davy Weissenbacher & Robert Gross & Sean Hennessy & Graciela Gonzalez-Hernandez
January 2024, Volume 47, Issue 1
- 1-22 Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use
by Loreta Marquez & Ritu Raheja & May Chan-Liston & John Marcinak & Alvin Estilo & Liliam Pineda Salgado & Jason Jiang & Curtis Chang & Paul Beninger - 23-28 Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols
by Arne Reimers & Hanna Ljung - 29-38 Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study
by Kumiko O. Schnock & Sara E. Rostas & Catherine S. Yoon & Stuart Lipsitz & David W. Bates & Patricia C. Dykes - 39-57 Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
by Bruce Strober & Laura C. Coates & Mark G. Lebwohl & Atul Deodhar & Evan Leibowitz & Katelyn Rowland & Alexa P. Kollmeier & Megan Miller & Yanli Wang & Shu Li & Soumya D. Chakravarty & Daphne Chan & May Shawi & Ya-Wen Yang & Diamant Thaҫi & Proton Rahman - 59-70 Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis
by Jack L. Janetzki & Matthew J. Sykes & Michael B. Ward & Nicole L. Pratt - 71-80 Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance
by Jiyoon Park & Malek Djelassi & Daniel Chima & Robert Hernandez & Vladimir Poroshin & Ana-Maria Iliescu & Douglas Domalik & Noel Southall - 81-91 Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media
by Cristina Micale & Su Golder & Karen O’Connor & Davy Weissenbacher & Robert Gross & Sean Hennessy & Graciela Gonzalez-Hernandez - 93-102 Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults
by Yi Shi & Chien-Wei Chiang & Kathleen T. Unroe & Ximena Oyarzun-Gonzalez & Anna Sun & Yuedi Yang & Katherine M. Hunold & Jeffrey Caterino & Lang Li & Macarius Donneyong & Pengyue Zhang - 103-111 Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023
by G. Caleb Alexander & Daniel Budnitz & Carmel Hughes & Renke Maas & Alpana Mair & Emily G. McDonald & Andreas D. Meid & Rupert Payne & Hanna M. Seidling & Saad Shakir & Samy Suissa & Cara Tannenbaum & Sebastian Schneeweiss & Tobias Dreischulte
December 2023, Volume 46, Issue 12
- 1303-1305 Sodium-Glucose Cotransporter 2 Inhibitor-Associated “Ketoacidosis” Versus “Diabetic Ketoacidosis”: The Importance of Accurate Terminology
by Tamara Y. Milder & David A. Milder & Jerry R. Greenfield & Richard O. Day - 1307-1312 The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
by Mohamed A. Elhawary & Comfort K. Ogar & Mónica Tarapués & Angela Caro & Helen Byomire Ndagije & Ghita Benabdallah & Houda Sefiani & Hadir Rostom - 1313-1322 Pulmonary Toxicity Associated with Immune Checkpoint Inhibitors-Based Therapy: Current Perspectives and Future Directions
by Baohui Hong & Jiabing Zheng & Rong Chen & Caiyun Zheng & Bin Du & Ruping Ni & Jing Yang - 1323-1334 The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands
by P. Slingerland & Florence P. A. M. Hunsel & T. Lieber & L. Balveren & J. W. Duijster - 1335-1352 Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study
by Oskar Gauffin & Judith S. Brand & Sara Hedfors Vidlin & Daniele Sartori & Suvi Asikainen & Martí Català & Etir Chalabi & Daniel Dedman & Ana Danilovic & Talita Duarte-Salles & Maria Teresa García Morales & Saara Hiltunen & Annika M. Jödicke & Milan Lazarevic & Miguel A. Mayer & Jelena Miladinovic & Joseph Mitchell & Andrea Pistillo & Juan Manuel Ramírez-Anguita & Carlen Reyes & Annette Rudolph & Lovisa Sandberg & Ruth Savage & Martijn Schuemie & Dimitrije Spasic & Nhung T. H. Trinh & Nevena Veljkovic & Ankica Vujovic & Marcel Wilde & Alem Zekarias & Peter Rijnbeek & Patrick Ryan & Daniel Prieto-Alhambra & G. Niklas Norén - 1353-1362 Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases
by Johnmary T. Arinze & Maria A. J. Ridder & Dina Vojinovic & Hanne Ballegooijen & Emanuil Markov & Talita Duarte-Salles & Peter Rijnbeek & Katia M. C. Verhamme - 1363-1379 Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
by Patrick Christ & Diana Dubrall & Matthias Schmid & Bernhardt Sachs - 1381-1389 Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France
by Sibylle Germay & Allison Singier & Francesco Salvo & Antoine Pariente - 1391-1404 Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch
by Sreedhar Sagi & Pradeep Anjaneya & Sameer Kalsekar & Andrea Kottke & Hillel P. Cohen
November 2023, Volume 46, Issue 11
- 1049-1071 Managing Cardiovascular and Cancer Risk Associated with JAK Inhibitors
by Victor Yang & Tue W. Kragstrup & Christopher McMaster & Pankti Reid & Namrata Singh & Stine R. Haysen & Philip C. Robinson & David F. L. Liew - 1073-1087 Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)
by Gita A. Toyserkani & Samuel B. Ewusie & Philip Turk & Janifer Quick & Elaine H. Morrato - 1089-1103 An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance
by Benjamin Micallef & Jean-Michel Dogné & Janet Sultana & Sabine M. J. M. Straus & Robert Nisticò & Anthony Serracino-Inglott & John-Joseph Borg - 1105-1116 Association of Strict Versus Lenient Cholesterol Lowering with Cardiac Outcomes, Diabetes Progression and Complications, and Mortality in Patients with Diabetes Treated with Statins: Is Less More?
by Victoria Odeleye & Omar Masarweh & Jorge Restrepo & Carlos A Alvarez & Ishak A. Mansi - 1117-1131 Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics
by Joshua T. Wilde & Stacy Springs & Jacqueline M. Wolfrum & Retsef Levi - 1133-1148 Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database
by Moa Gustafsson & Cristiano Matos & João Joaquim & Joep Scholl & Florence Hunsel - 1149-1159 Levothyroxine Treatment Among Pregnant Women and Risk of Seizure in Children: A Population-Based Cohort Study
by Grace Mengqin Ge & Kenneth K. C. Man & Edmund C. L. Cheung & Patrick Ip & Wing Cheong Leung & Annie W. C. Kung & Ching-Lung Cheung & Ian C. K. Wong - 1161-1172 Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes
by Amber Cragg & Serena S. Small & Erica Lau & Adrianna Rowe & Anthony Lau & Katherine Butcher & Corinne M. Hohl
October 2023, Volume 46, Issue 10
- 921-926 Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach
by Valentina Giunchi & Michele Fusaroli & Manfred Hauben & Emanuel Raschi & Elisabetta Poluzzi - 927-949 Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel
by Joanne Wing Yan Chiu & Soo Chin Lee & James Chung-man Ho & Yeon Hee Park & Ta-Chung Chao & Sung-Bae Kim & Elgene Lim & Ching-Hung Lin & Sherene Loi & Su Ying Low & Lynette Li San Teo & Winnie Yeo & Rebecca Dent - 951-960 Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea
by Eun-Yeong Cho & Jung-Eun Cho & Seung Hun Jang & Ki-Eun Hwang - 961-974 Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study
by Christabel Khaemba & Abbie Barry & Wyckliff P. Omondi & Elvis Kirui & Margaret Oluka & Gurumurthy Parthasarathi & Sammy M. Njenga & Anastacia Guantai & Eleni Aklillu - 975-989 Automated Classification of Quality Defect Issues Relating to Substandard Medicines Using a Hybrid Machine Learning and Rule-Based Approach
by Desmond Chun Hwee Teo & Yiting Huang & Sreemanee Raaj Dorajoo & Michelle Sau Yuen Ng & Chih Tzer Choong & Doris Sock Tin Phuah & Dorothy Hooi Myn Tan & Filina Meixuan Tan & Huilin Huang & Maggie Siok Hwee Tan & Suan Tian Koh & Jalene Wang Woon Poh & Pei San Ang - 991-1005 Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies
by Tsutomu Takeuchi & Kiyohiro Nishikawa & Fumika Yamada & Akimichi Morita & Mamitaro Ohtsuki & Yasuo Suzuki & Mamoru Watanabe & Hisashi Yamanaka & Toshifumi Hibi - 1007-1020 Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021
by Sharon C. M. Essink & Inge M. Zomerdijk & Sabine M. J. M. Straus & Helga Gardarsdottir & Marie L. Bruin - 1021-1037 A Multi-method Exploratory Evaluation of a Service Designed to Improve Medication Safety for Patients with Monitored Dosage Systems Following Hospital Discharge
by Fatema A. Alqenae & Douglas Steinke & Hilary Belither & Peter Robertson & Jennifer Bartlett & Jack Wilkinson & Steven D. Williams & Lawrence Brad & Mark Jeffries & Darren M. Ashcroft & Richard N. Keers - 1039-1047 Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective
by Jette A. Lint & Marlieke Sonnenberg & Harald E. Vonkeman & Bart J. F. Bemt & Eugene P. Puijenbroek & Naomi T. Jessurun
September 2023, Volume 46, Issue 9
- 819-833 Cardiovascular Toxicity of Immune Checkpoint Inhibitors: A Guide for Clinicians
by Emanuel Raschi & Simone Rossi & Andrea Giglio & Michele Fusaroli & Flavio Burgazzi & Rita Rinaldi & Luciano Potena - 835-845 Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study
by David R. Cornblath & Pieter A. van Doorn & Hans-Peter Hartung & Ingemar S. J. Merkies & Hans D. Katzberg & Doris Hinterberger & Elisabeth Clodi - 847-855 Finding Needles in the Haystack: Clinical Utility Score for Prioritisation (CUSP), an Automated Approach for Identifying Spontaneous Reports with the Highest Clinical Utility
by Vijay Kara & Greg Powell & Olivia Mahaux & Aparna Jayachandra & Naashika Nyako & Christopher Golds & Andrew Bate - 857-866 Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study
by Michele Fusaroli & Francesco Salvo & Claire Bernardeau & Maryam Idris & Charles Dolladille & Antoine Pariente & Elisabetta Poluzzi & Emanuel Raschi & Charles Khouri - 867-879 Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand
by Muireann Walton & Vadim Pletzer & Thomas Teunissen & Thomas Lumley & Timothy Hanlon - 881-895 Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment
by Yamin Shu & Lei Wang & Yiling Ding & Qilin Zhang - 897-904 The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
by Jill Vanthienen & Marine Vassilev Petrov & Thuy Mai Luu & Anik Cloutier & Anke Raaijmakers & Jan A. Staessen & Zhenyu Zhang & Thomas Salaets & Annouschka Laenen & Anne Smits & Anne-Monique Nuyt & Adrien Flahault & Karel Allegaert - 905-916 Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database
by Clément Jambon-Barbara & Claire Bernardeau & Julien Bezin & Matthieu Roustit & Sophie Blaise & Jean-Luc Cracowski & Charles Khouri - 917-918 Comment on: “Deliberate Self-Poisoning: Real-Time Characterisation of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System”
by Emiliano Cappello & Giulia Valdiserra & Marco Bonaso & Sara Ferraro & Irma Convertino & Marco Tuccori - 919-920 Authors’ Reply to Cappello et al. Comment on: “Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System”
by Michele Fusaroli & Guido Pelletti & Valentina Giunchi & Emanuel Raschi & Fabrizio De Ponti & Susi Pelotti & Elisabetta Poluzzi
August 2023, Volume 46, Issue 8
- 711-713 Future of ChatGPT in Pharmacovigilance
by Hanyin Wang & Yanyi Jenny Ding & Yuan Luo - 715-724 Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review
by Anne-Sophie Garnier & Guillaume Drablier & Marie Briet & Jean-François Augusto - 725-742 Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review
by Sharon E. Davis & Luke Zabotka & Rishi J. Desai & Shirley V. Wang & Judith C. Maro & Kevin Coughlin & José J. Hernández-Muñoz & Danijela Stojanovic & Nigam H. Shah & Joshua C. Smith - 743-751 Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data
by Fahed Al-Azzawi & Israa Mahmoud & François Haguinet & Andrew Bate & Maurizio Sessa - 753-763 Hospitalisations Related to Adverse Drug Reactions in Switzerland in 2012–2019: Characteristics, In-Hospital Mortality, and Spontaneous Reporting Rate
by Patrick E. Beeler & Thomas Stammschulte & Holger Dressel - 765-779 Provision and Characterization of a Corpus for Pharmaceutical, Biomedical Named Entity Recognition for Pharmacovigilance: Evaluation of Language Registers and Training Data Sufficiency
by Jürgen Dietrich & Philipp Kazzer - 781-795 Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques
by Siun Kim & Taegwan Kang & Tae Kyu Chung & Yoona Choi & YeSol Hong & Kyomin Jung & Howard Lee - 797-807 Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance
by Faaizah Arshad & Martijn J. Schuemie & Fan Bu & Evan P. Minty & Thamir M. Alshammari & Lana Y. H. Lai & Talita Duarte-Salles & Stephen Fortin & Fredrik Nyberg & Patrick B. Ryan & George Hripcsak & Daniel Prieto-Alhambra & Marc A. Suchard - 809-811 Comment on “Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
by Jürgen O. Kirchner - 813-815 Authors’ Reply to Juergen O Kirchner’s Comment on “Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
by Corinne Willame & Daniel Weibel & Miriam C. J. M. Sturkenboom - 817-817 Correction to: Comment on: “Should Antidepressants be Avoided in Pregnancy?”
by Alain Braillon & Susan Bewley & Aubrey Blumsohn & Florian Naudet
July 2023, Volume 46, Issue 7
- 619-623 The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed
by Manal M. Younus & Mayada Alkhakany & Priya Bahri & Angela Caro & Hadir Rostom & Helen Byomire Ndagije & Mohamed A. Elhawary - 625-636 Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update
by Patricia García-Abeijon & Catarina Costa & Margarita Taracido & Maria Teresa Herdeiro & Carla Torre & Adolfo Figueiras - 637-646 Safety and Effectiveness of Rasagiline in Chinese Patients with Parkinson’s Disease: A Prospective, Multicenter, Non-interventional Post-marketing Study
by Wen Su & Zhanhua Liang & Wei Mao & Ming Shao & Xingyue Hu & Yuncheng Wu & Wenshi Wei & Zhenguo Liu & Kezhong Zhang & Beisha Tang & Shuai Cao & Zhuolun Song & Haibo Chen - 647-660 Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea
by Seon Choe & Suehyun Lee & Chan Hee Park & Jeong Hoon Lee & Hyo Jung Kim & Sun-ju Byeon & Jeong-Hee Choi & Hyeon-Jong Yang & Da Woon Sim & Bum-Joo Cho & Hoseok Koo & Min-Gyu Kang & Ji Bong Jeong & In Young Choi & Sae-Hoon Kim & Woo Jin Kim & Jae-Woo Jung & Sang-Hoon Lhee & Young-Jin Ko & Hye-Kyung Park & Dong Yoon Kang & Ju Han Kim - 661-675 Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries
by Elena Dudukina & Szimonetta Komjáthiné Szépligeti & Pär Karlsson & Kofi Asomaning & Anne Kjersti Daltveit & Katja Hakkarainen & Fabian Hoti & Helle Kieler & Astrid Lunde & Ingvild Odsbu & Matti Rantanen & Johan Reutfors & Laura Saarelainen & Vera Ehrenstein & Gunnar Toft - 677-687 Expert Consensus on the Nephrotoxic Potential of 195 Medications in the Non-intensive Care Setting: A Modified Delphi Method
by Britney A. Stottlemyer & Kaleab Z. Abebe & Paul M. Palevsky & Linda Fried & Ivonne H. Schulman & Chirag R. Parikh & Emilio Poggio & Edward D. Siew & Orlando M. Gutierrez & Edward Horwitz & Matthew R. Weir & F. Perry Wilson & Sandra L. Kane-Gill - 689-702 Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study
by Shahab Abtahi & Romin Pajouheshnia & Carlos E. Durán & Judit Riera-Arnau & Magdalena Gamba & Ema Alsina & Vjola Hoxhaj & Morten Andersen & Claudia Bartolini & Sarah Brøgger Kristiansen & Jeremy Brown & Christine Erikstrup Hallgreen & Patricia Garcia-Poza & Helga Gardarsdottir & Rosa Gini & Anna Girardi & Emily Holthuis & Consuelo Huerta & Luisa Ibánez & Giorgio Limoncella & Mar Martín-Pérez & Olga Paoletti & Giuseppe Roberto & Patrick Souverein & Karin M. A. Swart & Kevin Wing & Miriam Sturkenboom & Olaf Klungel - 703-710 Sustained Decline of Direct General Practitioner Reporting of Adverse Drug Reactions in Australia and Paucity in Details of Australian Reports in Safety Advisories
by Ian W. Boyd & John McEwen
June 2023, Volume 46, Issue 6
- 517-532 Communicating for the Safe Use of Medicines: Progress and Directions for the 2020s Promoted by the Special Interest Group of the International Society of Pharmacovigilance
by Priya Bahri & Geoffrey Bowring & Brian D. Edwards & Christopher Anton & Jeffrey K. Aronson & Angela Caro-Rojas & Bruce P. J. Hugman & Peter G. Mol & Gianluca Trifirò & Katarina Ilic & Riadh Daghfous & Irene Fermont & Giovanni Furlan & Wolfgang Gaissmaier & Mohammad Ishaq Geer & Kenneth Y. Hartigan-Go & François Houÿez & Hansjörg Neth & Gediminas Norgela & Yaowares Oppamayun & D. K. Theo Raynor & Mehdi Bouhlel & Federica Santoro & Janet Sultana - 533-543 Impact of Lifestyle and Socioeconomic Position on the Association Between Non-steroidal Anti-inflammatory Drug Use and Major Adverse Cardiovascular Events: A Case-Crossover Study
by Kasper Bonnesen & Lars Pedersen & Vera Ehrenstein & Marie Stjerne Grønkjær & Henrik Toft Sørensen & Jesper Hallas & Timothy Lee Lash & Morten Schmidt - 545-552 Cardiovascular Toxicities Associated with Anaplastic Lymphoma Kinase Inhibitors: A Disproportionality Analysis of the WHO Pharmacovigilance Database (VigiBase)
by Takahiro Niimura & Koji Miyata & Hirofumi Hamano & Yuuki Nounin & Hiroto Unten & Masaki Yoshino & Satoru Mitsuboshi & Fuka Aizawa & Kenta Yagi & Toshihiro Koyama & Mitsuhiro Goda & Yasunari Kanda & Yuki Izawa-Ishizawa & Yoshito Zamami & Keisuke Ishizawa - 553-563 Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India
by Upinder Kaur & Zeba Fatima & Kalika Maheshwari & Vikas Sahni & Amol Dehade & Anju KL & Ashish Kumar Yadav & Sangeeta Kansal & Vaibhav Jaisawal & Sankha Shubhra Chakrabarti - 565-574 Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study
by Ronald Kiguba & Henry Zakumumpa & Helen B. Ndagije & Norah Mwebaza & Ronald Ssenyonga & Phil Tregunno & Kendal Harrison & Munir Pirmohamed - 575-585 Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials
by Fariba Ahmadizar & Nicoletta Luxi & Monika Raethke & Sandor Schmikli & Fabio Riefolo & Putri Widi Saraswati & Camelia Bucsa & Alhadi Osman & Megan Liddiard & Francisco Batel Maques & Giuliana Petrelli & Simona Sonderlichová & Nicolas H. Thurin & Felipe Villalobos & Gianluca Trifirò & Miriam Sturkenboom - 587-599 The Effect of Metformin on Chemotherapy-Induced Toxicities in Non-diabetic Breast Cancer Patients: A Randomised Controlled Study
by Manar A. Serageldin & Amira B. Kassem & Yasser El-Kerm & Maged W. Helmy & Mahmoud M. El-Mas & Noha A. El-Bassiouny - 601-614 Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk
by Olivia Mahaux & Greg Powell & François Haguinet & Paulina Sobczak & Namrata Saini & Allen Barry & Amira Mustafa & Andrew Bate - 615-616 Comment on: "Should Antidepressants be Avoided in Pregnancy?"
by Alain Braillon & Susan Bewley & Aubrey Blumsohn & Florian Naudet - 617-618 Authors’ Reply to Braillon et al. ’s Comment on “Should Antidepressants be Avoided in Pregnancy?”
by Frank M. C. Besag & Michael J. Vasey
May 2023, Volume 46, Issue 5
- 435-437 Erice Manifesto 2022: On the Surveillance of Potential Harms Caused by Food Supplements in Europe
by Francesca Menniti-Ippolito & Eugenio Aiello & Elena Arzenton & Alessandro Assisi & Urška Blaznik & Jacqueline J. M. Castenmiller & Marta Crevani & Dominique de Clock & Silvia Di Giacomo & Silvia Emendi & Laura Augusta Gonella & Ilaria Ippoliti & Marie Lindquist & Lara Magro & Gabriela Mazzanti & Nadia Mores & Ugo Moretti & Paola Angela Moro & Budimka Novakovic & Emanuel Raschi & Inese Siksna & Maria Rosa Valetto & Annabella Vitalone & Gwenn Vo Van Regnault - 439-448 Implications of Non-Specific Effects for Testing, Approving, and Regulating Vaccines
by Christine Stabell Benn & Nelly Amenyogbe & Anders Björkman & Jorge Domínguez-Andrés & Eleanor N. Fish & Katie L. Flanagan & Sabra L. Klein & Tobias R. Kollmann & Kirsten Ohm Kyvik & Mihai G. Netea & Naja Hulvej Rod & Frederik Schaltz-Buchholzer & Frank Shann & Liisa Selin & Sanne M. Thysen & Peter Aaby