Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study Y. Joseph HwangHsien-Yen ChangHemalkumar B. Mehta Original Research Article 23 December 2023 Pages: 251 - 260
International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries Toshihiro KoyamaShunya IinumaHideharu Hagiya Original Research Article 22 December 2023 Pages: 237 - 249
Appeal for Increasing the Impact of Pharmacovigilance Agnes C. Kant Editorial 20 December 2023 Pages: 113 - 116
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 Guillaume FavreJonathan L. RichardsonUrsula Winterfeld Original Research Article Open access 19 December 2023 Pages: 227 - 236
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments Wen-Wen YangYi-Chen JuanRaoh-Fang Pwu Leading Article 19 December 2023 Pages: 289 - 299
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies Astrid CosteAngel YS WongIan J. Douglas Original Research Article Open access 13 December 2023 Pages: 183 - 192
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study Simon Xiwen QinFranco Wing Tak ChengEsther Wai Yin Chan Original Research Article Open access 12 December 2023 Pages: 135 - 146
Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making Yoong Khean KhooJohn C. W. LimAi Ling Sim-Devadas Leading Article 11 December 2023 Pages: 217 - 225
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes Fengge WangMichael HendryxJuhua Luo Original Research Article 09 December 2023 Pages: 125 - 133
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 Guojun DongAndrew BateMaurizio Sessa Original Research Article Open access 07 December 2023 Pages: 173 - 182
The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness Harriet DickinsonDana Y. Teltschthe Actionable AI group Current Opinion 29 November 2023 Pages: 117 - 123
An Overview of Regression Models for Adverse Events Analysis Elsa CozMathieu FauvernierDelphine Maucort-Boulch Review Article Open access 25 November 2023 Pages: 205 - 216
Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media Cristina MicaleSu GolderGraciela Gonzalez-Hernandez Original Research Article 23 November 2023 Pages: 81 - 91
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry Yasmina HachemYola MorideAntonio Vigano Original Research Article 23 November 2023 Pages: 161 - 171
Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis Jack L. JanetzkiMatthew J. SykesNicole L. Pratt Original Research Article 23 November 2023 Pages: 59 - 70
Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers Patrick ChristDiana DubrallBernhardt Sachs Original Research Article Open access 21 November 2023 Pages: 1363 - 1379
Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols Arne ReimersHanna Ljung Original Research Article Open access 16 November 2023 Pages: 23 - 28
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations Diego F. WyszynskiAris T. PapageorghiouSonia Hernández-Díaz Protocol 16 November 2023 Pages: 195 - 204
The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance) Souad Skalli Research Letter 15 November 2023 Pages: 285 - 286
Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region Yolanda Guerra MendozaViviane JusotMamadou Kamagaté Original Research Article Open access 15 November 2023 Pages: 147 - 159
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance Jiyoon ParkMalek DjelassiNoel Southall Original Research Article 08 November 2023 Pages: 71 - 80
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults Yi ShiChien-Wei ChiangPengyue Zhang Original Research Article 07 November 2023 Pages: 93 - 102
Pulmonary Toxicity Associated with Immune Checkpoint Inhibitors-Based Therapy: Current Perspectives and Future Directions Baohui HongJiabing ZhengJing Yang Systematic Review 07 November 2023 Pages: 1313 - 1322
Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France Sibylle de GermayAllison Singieron behalf of the French Pharmacovigilance Network Original Research Article 05 November 2023 Pages: 1381 - 1389
22nd ISoP Annual Meeting “Putting Patients First in Pharmacovigilance: International Perspectives from Global South” 6–9 November 2023 Bali, Indonesia ABSTRACTS 03 November 2023 Pages: 1173 - 1295
Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023 G. Caleb AlexanderDaniel BudnitzTobias Dreischulte Meeting Report 02 November 2023 Pages: 103 - 111
Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases Johnmary T. ArinzeMaria A. J. de RidderKatia M. C. Verhamme Original Research Article Open access 31 October 2023 Pages: 1353 - 1362
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 Bruce StroberLaura C. CoatesProton Rahman Original Research Article Open access 31 October 2023 Pages: 39 - 57
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 Sreedhar SagiPradeep AnjaneyaHillel P. Cohen Original Research Article Open access 30 October 2023 Pages: 1391 - 1404
Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study Kumiko O. SchnockSara E. RostasPatricia C. Dykes Original Research Article 27 October 2023 Pages: 29 - 38
The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands P. SlingerlandFlorence P. A. M. van HunselJ. W. Duijster Original Research Article 26 October 2023 Pages: 1323 - 1334
The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs) Mohamed A. ElhawaryComfort K. OgarHadir Rostom FROM THE ISoP 24 October 2023 Pages: 1307 - 1312
Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use Loreta MarquezRitu RahejaPaul Beninger Review Article 24 October 2023 Pages: 1 - 22
Sodium-Glucose Cotransporter 2 Inhibitor-Associated “Ketoacidosis” Versus “Diabetic Ketoacidosis”: The Importance of Accurate Terminology Tamara Y. MilderDavid A. MilderRichard O. Day Editorial 17 October 2023 Pages: 1303 - 1305
Levothyroxine Treatment Among Pregnant Women and Risk of Seizure in Children: A Population-Based Cohort Study Grace Mengqin GeKenneth K. C. ManIan C. K. Wong Original Research Article 16 October 2023 Pages: 1149 - 1159
Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database Moa GustafssonCristiano MatosFlorence van Hunsel Original Research Article 12 October 2023 Pages: 1133 - 1148
A Multi-method Exploratory Evaluation of a Service Designed to Improve Medication Safety for Patients with Monitored Dosage Systems Following Hospital Discharge Fatema A. AlqenaeDouglas SteinkeRichard N. Keers Original Research Article Open access 11 October 2023 Pages: 1021 - 1037
Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study Oskar GauffinJudith S. BrandG. Niklas Norén Original Research Article Open access 07 October 2023 Pages: 1335 - 1352
Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes Amber CraggSerena S. SmallCorinne M. Hohl Original Research Article Open access 02 October 2023 Pages: 1161 - 1172
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? Victoria OdeleyeOmar MasarwehIshak A. Mansi Original Research Article 02 October 2023 Pages: 1105 - 1116
Automated Classification of Quality Defect Issues Relating to Substandard Medicines Using a Hybrid Machine Learning and Rule-Based Approach Desmond Chun Hwee TeoYiting HuangPei San Ang Original Research Article 30 September 2023 Pages: 975 - 989
Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics Joshua T. WildeStacy SpringsRetsef Levi Original Research Article 29 September 2023 Pages: 1117 - 1131
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance Benjamin MicallefJean-Michel DognéJohn-Joseph Borg Original Research Article 14 September 2023 Pages: 1089 - 1103
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies Tsutomu TakeuchiKiyohiro NishikawaToshifumi Hibi Original Research Article Open access 12 September 2023 Pages: 991 - 1005
Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020) Gita A. ToyserkaniSamuel B. EwusieElaine H. Morrato Original Research Article 12 September 2023 Pages: 1073 - 1087
Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021 Sharon C. M. EssinkInge M. ZomerdijkMarie L. De Bruin Original Research Article Open access 02 September 2023 Pages: 1007 - 1020
Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective Jette A. van LintMarlieke SonnenbergNaomi T. Jessurun Original Research Article Open access 31 August 2023 Pages: 1039 - 1047
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 Eun-Yeong ChoJung-Eun ChoKi-Eun Hwang Original Research Article 31 August 2023 Pages: 951 - 960
Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach Valentina GiunchiMichele FusaroliElisabetta Poluzzi Editorial 31 August 2023 Pages: 921 - 926