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Content
May 2023, Volume 46, Issue 5
- 501-507 Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data
by Katarina Kralova & Carol-Ann Wilson & Nicolas Richebourg & Joan D’souza - 509-512 Comment on "Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data"
by Oliver Kuss & Wolfgang Rathmann - 513-514 Author’s Reply to Kuss and Rathmann’s Comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data”
by John-Michael Gamble & Wajd Alkabbani - 515-515 Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes
by Andrea K. Chomistek & Kelesitse Phiri & Michael C. Doherty & Jenna F. Calderbank & Stephanie E. Chiuve & Brenda Hinman McIlroy & Michael C. Snabes & Cheryl Enger & John D. Seeger
April 2023, Volume 46, Issue 4
- 327-333 Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities
by Vincent Bauchau & Kourtney Davis & Sarah Frise & Corinne Jouquelet-Royer & Jamie Wilkins - 335-342 Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22
by Harrison S. France & Jeffrey K. Aronson & Carl Heneghan & Robin E. Ferner & Anthony R. Cox & Georgia C. Richards - 343-355 Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System
by Salvatore Crisafulli & Paola Maria Cutroneo & Nicoletta Luxi & Andrea Fontana & Carmen Ferrajolo & Pasquale Marchione & Laura Sottosanti & Giovanna Zanoni & Ugo Moretti & Silvia Franzè & Paola Minghetti & Gianluca Trifirò - 357-370 Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study
by Comfort K. Ogar & Jonathan Quick & Hannah N. Gilbert & Rick A. Vreman & Aukje K. Mantel-Teeuwisse & Jean Claude Mugunga - 371-389 Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data
by Hiroki Yamamoto & Gen Kayanuma & Takuya Nagashima & Chihiro Toda & Kazuki Nagayasu & Shuji Kaneko - 391-404 Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose
by Monika Raethke & Florence Hunsel & Nicolas H. Thurin & Caroline Dureau-Pournin & Dirk Mentzer & Barbara Kovačić & Nikica Mirošević Skvrce & Evelien Clercq & Martine Sabbe & Gianluca Trifirò & Nicoletta Luxi & Alexia Giovanazzi & Saad Shakir & Olaf H. Klungel & Sandor Schmikli & Miriam Sturkenboom - 405-416 Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends
by Nelly F. Ly & Clare Flach & Thom S. Lysen & Emanuil Markov & Hanne Ballegooijen & Peter Rijnbeek & Talita Duarte-Salles & Carlen Reyes & Luis H. John & Leila Karimi & Christian Reich & Sam Salek & Deborah Layton - 417-418 The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products
by Rhiannon Braund - 433-433 Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review
by Benjamin Kompa & Joe B. Hakim & Anil Palepu & Kathryn Grace Kompa & Michael Smith & Paul A. Bain & Stephen Woloszynek & Jeffery L. Painter & Andrew Bate & Andrew L. Beam
March 2023, Volume 46, Issue 3
- 223-242 Colchicine Drug Interaction Errors and Misunderstandings: Recommendations for Improved Evidence-Based Management
by Philip D. Hansten & Malinda S. Tan & John R. Horn & Ainhoa Gomez-Lumbreras & Lorenzo Villa-Zapata & Richard D. Boyce & Vignesh Subbian & Andrew Romero & Sheila Gephart & Daniel C. Malone - 243-255 What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study
by Sonia Roldan Munoz & Douwe Postmus & Sieta T. Vries & Liana Gross-Martirosyan & Priya Bahri & Hans Hillege & Peter G. M. Mol - 257-271 Comparative Safety Analysis of Opioid Agonist Treatment in Pregnant Women with Opioid Use Disorder: A Population-Based Study
by Shuang Wang & Kimford J. Meador & Jayne Pawasauskas & Adam K. Lewkowitz & Kristina E. Ward & Todd N. Brothers & Abraham Hartzema & Brian J. Quilliam & Xuerong Wen - 273-281 Effect of Previous Anticoagulant Treatment on Risk of COVID-19
by Maruxa Zapata-Cachafeiro & Ángela Prieto-Campo & Manuel Portela-Romero & Eduardo Carracedo-Martínez & Martina Lema-Oreiro & María Piñeiro-Lamas & Somnath Chaudhuri & Ángel Salgado-Barreira & Adolfo Figueiras - 283-295 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 & Chiara Pugliese & Mattia Bartolucci & Elena Narmine Necibi & Emanuel Raschi & Fabrizio Ponti & Susi Pelotti & Elisabetta Poluzzi - 297-308 The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations
by Diego F. Wyszynski & Mondira Bhattacharya & Oscar Martínez-Pérez & Anthony R. Scialli & Melissa Tassinari & Naor Bar-Zeev & Cheryl Renz & Sonia Hernández-Díaz - 309-318 Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion
by Jillian H. Hurst & Amanda Brucker & Congwen Zhao & Hannah Driscoll & Haley P. Hostetler & Michael Phillips & Bari Rosenberg & Marc D. Samsky & Isaac Smith & Megan E. Reller & John J. Strouse & Cindy Ke Zhou & Graça M. Dores & Hui-Lee Wong & Benjamin A. Goldstein - 319-321 Optimizing Safety Surveillance for COVID-19 Vaccines at the Swedish Medical Products Agency
by Karl Mikael Kälkner & Anders Sundström & Marja-Leena Nurminen & Maria Larsson & Rickard Ljung & Veronica Arthurson - 323-323 Correction: Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
by Khristina Fauvelle & Jean Joel Bigna - 325-325 Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
by John Stekelenborg & Vijay Kara & Roman Haack & Ulrich Vogel & Anju Garg & Markus Krupp & Kate Gofman & Brian Dreyfus & Manfred Hauben & Andrew Bate
February 2023, Volume 46, Issue 2
- 109-120 Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature
by Daniele Sartori & Jeffrey K. Aronson & G. Niklas Norén & Igho J. Onakpoya - 121-128 Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
by Khristina Fauvelle & Jean Joel Bigna - 129-143 Assessment of the Frequency, Phenotypes, and Outcomes of Acute Liver Injury Associated with Amoxicillin/Clavulanate in 1.4 Million Patients in the Veterans Health Administration
by Ayako Suzuki & Hans Tillmann & James Williams & Ronald G. Hauser & Julie Frund & Mizuki Suzuki & Fred Prior & Guruprasad P. Aithal & M. Isabel Lucena & Raúl J. Andrade & Weida Tong & Christine M. Hunt - 145-155 The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic
by Ida-Lina Diak & Kimberley Swank & Kate McCartan & Maya Beganovic & James Kidd & Neha Gada & Rachna Kapoor & Lisa Wolf & Laura Kangas & Jo Wyeth & Toni Salvatore & Melina Fanari & Andrew A. LeBoeuf & Poonam Mishra & Michael D. Blum & Gerald Dal Pan - 157-174 Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting
by Catherine B. Johannes & Daniel C. Beachler & J. Bradley Layton & Heather E. Danysh & Ryan Ziemiecki & Alejandro Arana & Jade Dinh & Ling Li & Brian Calingaert & Manel Pladevall-Vila & Phillip R. Hunt & Hungta Chen & Cecilia Karlsson & Kristina Johnsson & Alicia Gilsenan - 175-193 Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting
by Heather E. Danysh & Catherine B. Johannes & Daniel C. Beachler & J. Bradley Layton & Ryan Ziemiecki & Alejandro Arana & Jade Dinh & Ling Li & Brian Calingaert & Manel Pladevall-Vila & Phillip R. Hunt & Hungta Chen & Cecilia Karlsson & Kristina Johnsson & Alicia Gilsenan - 195-208 Mortality in Patients with Parkinson’s Disease-Related Psychosis Treated with Pimavanserin Compared with Other Atypical Antipsychotics: A Cohort Study
by J. Bradley Layton & Joan Forns & Lisa J. McQuay & Heather E. Danysh & Colleen Dempsey & Mary S. Anthony & Mary Ellen Turner - 209-222 Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes
by Andrea K. Chomistek & Kelesitse Phiri & Michael C. Doherty & Jenna F. Calderbank & Stephanie E. Chiuve & Brenda Hinman McIlroy & Michael C. Snabes & Cheryl Enger & John D. Seeger
January 2023, Volume 46, Issue 1
- 1-17 Should Antidepressants be Avoided in Pregnancy?
by Frank M. C. Besag & Michael J. Vasey - 19-37 Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review
by Fatima Q. Alshaikhmubarak & Richard N. Keers & Penny J. Lewis - 39-52 Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
by John Stekelenborg & Vijay Kara & Roman Haack & Ulrich Vogel & Anju Garg & Markus Krupp & Kate Gofman & Brian Dreyfus & Manfred Hauben & Andrew Bate - 53-64 A Population-Based Study of SGLT2 Inhibitor-Associated Postoperative Diabetic Ketoacidosis in Patients with Type 2 Diabetes
by David Tak Wai Lui & Tingting Wu & Ivan Chi Ho Au & Xiaodong Liu & Matrix Man Him Fung & Chi Ho Lee & Carol Ho Yi Fong & Yu Cho Woo & Brian Hung Hin Lang & Kathryn Choon Beng Tan & Carlos King Ho Wong - 65-75 Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience
by Ingrid Oosterhuis & Joep Scholl & Eugène Puijenbroek & Agnes Kant & Florence Hunsel - 77-85 Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase®
by Florentia Kaguelidou & Zaba Valtuille & Geneviève Durrieu & Richard Delorme & Hugo Peyre & Jean-Marc Treluyer & François Montastruc & Laurent Chouchana - 87-97 Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms’ Fit for Purpose for Safety Outcomes
by Sonal Singh & Julie Beyrer & Xiaofeng Zhou & Joel Swerdel & Raymond A. Harvey & Kenneth Hornbuckle & Leo Russo & Kanwal Ghauri & Ivan H. Abi-Elias & John S. Cox & Carla Rodriguez-Watson - 99-108 Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis
by Puneet Vir Singh & Paola Tiberi & Gabriele Filippo Di Domenico & Valerio Romolini & Thembile Mzolo & Marco Costantini & Tauseefullah Akhund & Venere Basile & Maria Lattanzi & Michele Pellegrini
December 2022, Volume 45, Issue 12
- 1449-1456 Gastrointestinal Bleeding on Oral Anticoagulation: What is Currently Known
by Arnar B. Ingason & Johann P. Hreinsson & Einar S. Björnsson - 1457-1476 Prevalence, Causes and Severity of Medication Administration Errors in the Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis
by Josephine Henry Basil & Chandini Menon Premakumar & Adliah Mhd Ali & Nurul Ain Mohd Tahir & Noraida Mohamed Shah - 1477-1490 mRNA (BNT162b2) and Inactivated (CoronaVac) COVID-19 Vaccination and Risk of Adverse Events and Acute Diabetic Complications in Patients with Type 2 Diabetes Mellitus: A Population-Based Study
by Eric Yuk Fai Wan & Celine Sze Ling Chui & Anna Hoi Ying Mok & Wanchun Xu & Vincent Ka Chun Yan & Francisco Tsz Tsun Lai & Xue Li & Carlos King Ho Wong & Esther Wai Yin Chan & David Tak Wai Lui & Kathryn Choon Beng Tan & Ivan Fan Ngai Hung & Cindy Lo Kuen Lam & Gabriel Matthew Leung & Ian Chi Kei Wong - 1491-1499 Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies
by Giulio Barteselli & Grant R. Goodman & Yogesh Patel & Ivor Caro & Cloris Xue & Samuel McCallum - 1501-1516 Detectability of Medication Errors With a STOPP/START-Based Medication Review in Older People Prior to a Potentially Preventable Drug-Related Hospital Admission
by Bastiaan T. G. M. Sallevelt & Toine C. G. Egberts & Corlina J. A. Huibers & Jimmy Ietswaart & A. Clara Drenth-van Maanen & Emma Jennings & Cian O’Mahony & Katharina Tabea Jungo & Martin Feller & Nicolas Rodondi & François-Xavier Sibille & Anne Spinewine & Eugène P. Puijenbroek & Ingeborg Wilting & Wilma Knol - 1517-1527 Topiramate Utilization After Phentermine/Topiramate Approval for Obesity Management: Risk Minimization in the Era of Drug Repurposing
by Amir Sarayani & Christian Hampp & Joshua D. Brown & William Troy Donahoo & Almut G. Winterstein - 1529-1538 Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard
by Shaun M. Comfort & Bruce Donzanti & Darren Dorrell & Sunita Dhar & Chris Eden & Francis Donaldson - 1539-1549 Withdrawal Syndrome Following Discontinuation of 28 Antidepressants: Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous Reporting Database
by Chiara Gastaldon & Georgios Schoretsanitis & Elena Arzenton & Emanuel Raschi & Davide Papola & Giovanni Ostuzzi & Ugo Moretti & Erich Seifritz & John M. Kane & Gianluca Trifirò & Corrado Barbui - 1551-1552 Comment on: "A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)"
by Yoshihiro Noguchi - 1553-1555 Authors’ Response to Yoshihiro Noguchi’s Comment on: “A Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)”
by Daniel C. Malone & Lorenzo Villa-Zapata & Ainhoa Gómez-Lumbreras & John Horn & Malinda S. Tan & Richard D. Boyce
November 2022, Volume 45, Issue 11
- 1329-1348 Therapeutic Management of Idiosyncratic Drug-Induced Liver Injury and Acetaminophen Hepatotoxicity in the Paediatric Population: A Systematic Review
by Hao Niu & Edmond Atallah & Ismael Alvarez-Alvarez & Inmaculada Medina-Caliz & Guruprasad P. Aithal & Cigdem Arikan & Raul J. Andrade & M. Isabel Lucena - 1349-1362 Efficacy and Safety of Anticoagulants in Patients with Atrial Fibrillation and History of Falls or Risk of Falls: A Systematic Review and Multilevel Meta-Analysis
by Thibaut Galvain & Ruaraidh Hill & Sarah Donegan & Paulo Lisboa & Gregory Y. H. Lip & Gabriela Czanner - 1363-1368 Lost in Translation: A Multilingual Survey of Interlinguistic Variations in Terms Used in Pharmacovigilance
by Jeffrey K. Aronson - 1369-1380 Factors Influencing Preferences and Responses Towards Drug Safety Communications: A Conjoint Experiment Among Hospital-Based Healthcare Professionals in the Netherlands
by Esther Vries & Elisabeth Bakker & Taco B. M. Monster & Petra Denig & Peter G. M. Mol - 1381-1402 Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy
by Christian Leporini & Caterina Sarro & Caterina Palleria & Iolanda Caccavo & Brunella Piro & Rita Citraro & Giovambattista Sarro - 1403-1411 Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink
by Rebecca Persson & Myriam Cordey & Maria Paris & Susan Jick - 1413-1421 Medicine-Induced Acute Kidney Injury Findings from Spontaneous Reporting Systems, Sequence Symmetry Analysis and a Case–Control Study with a Focus on Medicines Used in Primary Care
by Elizabeth E. Roughead & Mhairi Kerr & Anna Moffat & Gizat M. Kassie & Nicole Pratt - 1423-1438 Network Analysis for Signal Detection in Spontaneous Adverse Event Reporting Database: Application of Network Weighting Normalization to Characterize Cardiovascular Drug Safety
by Mátyás Pétervári & Bettina Benczik & Olivér M. Balogh & Balázs Petrovich & Bence Ágg & Péter Ferdinandy - 1439-1440 Correction to: Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data
by Samantha Lane & Saad Shakir
October 2022, Volume 45, Issue 10
- 1011-1014 Conundrum of Clinical QTc Monitoring
by Marek Malik - 1015-1018 How Important is Gender in Leadership in Pharmacovigilance? Personal Reflections from the First Female President of the International Society of Pharmacovigilance
by Mira Harrison-Woolrych - 1019-1036 High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment
by Johannes M. M. Boots & Rogier A. M. Quax - 1037-1048 Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis
by Marijana Putnikovic & Zoe Jordan & Zachary Munn & Corey Borg & Michael Ward - 1049-1056 Impact of Vaccine Hesitancy on Onset, Severity and Type of Self-reported Adverse Events: A French Cross-Sectional Survey
by Charles Khouri & Ayoub Larabi & Pierre Verger & Fatima Gauna & Jean-Luc Cracowski & Jeremy Ward - 1057-1067 Analytical Approaches to Reduce Selection Bias in As-Treated Analyses with Missing In-Hospital Drug Information
by Yeon-Hee Baek & Yunha Noh & In-Sun Oh & Han Eol Jeong & Kristian B. Filion & Hyesung Lee & Ju-Young Shin - 1069-1081 Prescribing Patterns of Codeine and Alternative Medicines in Children in Europe
by Kelly Plueschke & Robert Flynn & Karin Hedenmalm & Aikaterini-Christina Deli & Miguel-Angel Maciá-Martinez & Patricia García-Poza & David Olsen & Pierre Nguyen & Chantal Quinten - 1083-1098 Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis
by Monica Hoof & Katherine Chinchilla & Linda Härmark & Cristiano Matos & Pedro Inácio & Florence Hunsel - 1099-1109 A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis
by Upinder Kaur & Anju K.L & Mayank Chauhan & Aditi Joshi & Agniva Das & Sangeeta Kansal & Vaibhav Jaisawal & Kishor Patwardhan & Sankha Shubhra Chakrabarti
September 2022, Volume 45, Issue 9
- 929-939 Pancreas and Adverse Drug Reactions: A Literature Review
by Konrad Sosnowski & Piotr Nehring & Adam Przybyłkowski - 941-949 Impact of Policy Interventions on Oxycodone Prescribing in Queensland, Australia: An Uncontrolled Interrupted Time Series Study
by William Tumusiime & Caitlin Hardman & Elizabeth McCourt - 951-959 Anti-tumor Necrosis Factor-Alpha Therapy and Hypoglycemia: A Real-World Pharmacovigilance Analysis
by Yu Zhou & Wenhuo Xie & Linyao Wang & Xinyan Zhu & Jianbin Li & Libin Liu & Shuaijun Zhu & Lijing Wang - 961-970 BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA®-Coded Adverse Events in Randomized Controlled Trials
by Alma Revers & Michel H. Hof & Aeilko H. Zwinderman - 971-981 Patient-Reported Reasons for Switching or Discontinuing Statin Therapy: A Mixed Methods Study Using Social Media
by Su Golder & Davy Weissenbacher & Karen O’Connor & Sean Hennessy & Robert Gross & Graciela Gonzalez Hernandez - 983-994 Cardiovascular Risks of Diclofenac Versus Other Older COX-2 Inhibitors (Meloxicam and Etodolac) and Newer COX-2 Inhibitors (Celecoxib and Etoricoxib): A Series of Nationwide Emulated Trials
by Morten Schmidt & Henrik Toft Sørensen & Lars Pedersen - 995-1002 Differences in the Recurrence Rate of Immediate Adverse Drug Reactions According to the Components of Alternative Contrast Media: Analysis of Repetitive Computed Tomography Cases in a Single Tertiary Hospital
by Sung-Ryeol Kim & Nak-Hoon Son & Hye Jung Park & Kyung Hee Park & Jung-Won Park & Jae-Hyun Lee - 1003-1008 Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data
by Samantha Lane & Saad Shakir - 1009-1010 Correction to: Impact of Policy Interventions on Oxycodone Prescribing in Queensland, Australia: An Uncontrolled Interrupted Time Series Study
by William Tumusiime & Caitlin Hardman & Elizabeth McCourt
August 2022, Volume 45, Issue 8
- 815-837 A Review of Causal Inference for External Comparator Arm Studies
by Gerd Rippin & Nicolás Ballarini & Héctor Sanz & Joan Largent & Chantal Quinten & Francesco Pignatti - 839-852 Kidney Damage and Stress Biomarkers for Early Identification of Drug-Induced Kidney Injury: A Systematic Review
by Ravi J. Desai & Christina L. Kazarov & Adrian Wong & Sandra L. Kane-Gill - 853-862 Combining Machine Learning with a Rule-Based Algorithm to Detect and Identify Related Entities of Documented Adverse Drug Reactions on Hospital Discharge Summaries
by Hui Xing Tan & Chun Hwee Desmond Teo & Pei San Ang & Wei Ping Celine Loke & Mun Yee Tham & Siew Har Tan & Bee Leng Sally Soh & Pei Qin Belinda Foo & Zheng Jye Ling & Wei Luen James Yip & Yixuan Tang & Jisong Yang & Kum Hoe Anthony Tung & Sreemanee Raaj Dorajoo - 863-871 A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)
by Lorenzo Villa-Zapata & Ainhoa Gómez-Lumbreras & John Horn & Malinda S. Tan & Richard D. Boyce & Daniel C. Malone - 873-880 Short-Term Risk of Unintentional Poisoning After New Initiation of Central Nervous System Medications in Swedish Older Adults: A Register-Based Case-Crossover Study
by Yang Zhao & Yajun Liang & Lucie Laflamme & Christian Rausch & Kristina Johnell & Jette Möller - 881-889 Developing Strategic Recommendations for Implementing Smart Pumps in Advanced Healthcare Systems to Improve Intravenous Medication Safety
by Adam Sutherland & Matthew D. Jones & Moninne Howlett & Sara Arenas-Lopez & Arif Patel & Bryony Dean Franklin - 891-908 Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database
by Michele Fusaroli & Valentina Isgrò & Paola Maria Cutroneo & Carmen Ferrajolo & Valentina Cirillo & Francesca Del Bufalo & Emanuel Raschi & Elisabetta Poluzzi & Gianluca Trifirò - 909-922 Safety of Praziquantel and Albendazole Coadministration for the Control and Elimination of Schistosomiasis and Soil-Transmitted Helminths Among Children in Rwanda: An Active Surveillance Study
by Joseph Kabatende & Abbie Barry & Michael Mugisha & Lazare Ntirenganya & Ulf Bergman & Emile Bienvenu & Eleni Aklillu - 923-923 Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands”
by Rujittika Mungmunpuntipantip & Viroj Wiwanitkit - 925-926 Authors’ Reply to Mungmunpuntipantip et al.’s Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands”
by Agnes Kant & Florence Hunsel - 927-927 Correction to: Machine Learning in Causal Inference: Application in Pharmacovigilance
by Yiqing Zhao & Yue Yu & Hanyin Wang & Yikuan Li & Yu Deng & Guoqian Jiang & Yuan Luo
July 2022, Volume 45, Issue 7
- 699-702 An Update on the International Society of Pharmacovigilance China Chapter
by Yalu Wen & Tianyi Yang & Li Zhang & Brian Edwards & Honghui Wu & Jukai Huang & Xiaohui Yang - 703-712 Incidence, Pathogenesis, and Management of Proton Pump Inhibitor-Induced Nephrotoxicity
by Xiao Wei & Jun Yu & Zhengkun Xu & Chun Wang & Yonggui Wu - 713-735 Prevalence of Use of Traditional, Complementary and Alternative Medicine by the General Population: A Systematic Review of National Studies Published from 2010 to 2019
by E Lyn Lee & Noni Richards & Jeff Harrison & Joanne Barnes - 737-745 Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis
by Yanrong Li & Yang Jiang & Haixue Wang & Li Zhang & Yue Yang - 747-754 Collection of Data on Adverse Events Related to Medicinal Products: A Survey Among Registries in the ENCePP Resources Database
by Kelly Plueschke & Carla Jonker & Valerie Strassmann & Xavier Kurz - 755-764 Quantitative Prediction of Adverse Event Probability Due to Pharmacokinetic Interactions
by Michel Tod & Thomas Rodier & Marine Auffret - 765-780 Signaling COVID-19 Vaccine Adverse Events
by Rave Harpaz & William DuMouchel & Robbert Manen & Alexander Nip & Steve Bright & Ana Szarfman & Joseph Tonning & Magnus Lerch - 781-790 Incidence of Acute Renal Failure in Patients Using Levetiracetam Versus Other Antiseizure Medications: A Voluntary Post-Authorization Safety Study
by Raphaelle Beau-Lejdstrom & Lai San Hong & Xabier Garcia de Albeniz & Florin Floricel & Johan Lorenzen & Francois Bonfitto & Linda Kalilani & Christian Loesch & Graham Luscombe & Susana Perez-Gutthann & Isabelle Mottet & Nadia Foskett - 791-807 Hip Fracture Risk After Treatment with Tramadol or Codeine: An Observational Study
by Erica A. Voss & Saberi Rana Ali & Arun Singh & Peter R. Rijnbeek & Martijn J. Schuemie & Daniel Fife - 809-811 Comment on: "Drug–Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data"
by Yoshihiro Noguchi - 813-814 Authors’ Reply to Noguchi’s comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data.”
by John-Michael Gamble & Wajd Alkabbani
June 2022, Volume 45, Issue 6
- 597-599 The International Society of Pharmacovigilance Vaccines Special Interest Group: Challenges and Opportunities
by Rebecca E. Chandler - 601-621 Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions
by Giovana R. Onzi & Nathalia D’Agustini & Solange C. Garcia & Silvia S. Guterres & Paula R. Pohlmann & Daniela D. Rosa & Adriana R. Pohlmann - 623-638 Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study
by Richard L. Morrow & Barbara Mintzes & Patrick C. Souverein & Christine E. Hallgreen & Bilal Ahmed & Elizabeth E. Roughead & Marie L. Bruin & Sarah Brøgger Kristiansen & Joel Lexchin & Anna Kemp-Casey & Ingrid Sketris & Dee Mangin & Sallie-Anne Pearson & Lorri Puil & Ruth Lopert & Lisa Bero & Danijela Gnjidic & Ameet Sarpatwari & Colin R. Dormuth - 639-650 Drug-Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database
by Carolina Valeiro & Cristiano Matos & Joep Scholl & Florence Hunsel - 651-661 Analysis of Reports on Adverse Drug Reactions Related to Herbal Medicinal Products and Herbal Supplements in the Netherlands Received by the National Pharmacovigilance Centre Lareb
by Florence P. A. M. Hunsel & Djurre Kooi & Sonja Koppel & Burt H. Kroes & Herman J. Woerdenbag - 663-673 Amyotrophic Lateral Sclerosis as an Adverse Drug Reaction: A Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System
by Anna Gaimari & Michele Fusaroli & Emanuel Raschi & Elisa Baldin & Luca Vignatelli & Francesco Nonino & Fabrizio Ponti & Jessica Mandrioli & Elisabetta Poluzzi - 675-684 Montelukast and Nightmares: Further Characterisation Using Data from VigiBase
by Sarah Watson & Elenor Kaminsky & Henric Taavola & Marian Attalla & Qun-Ying Yue - 685-698 Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data: A Multinational Network Cohort Study
by Azza Shoaibi & Gowtham A. Rao & Erica A. Voss & Anna Ostropolets & Miguel Angel Mayer & Juan Manuel Ramírez-Anguita & Filip Maljković & Biljana Carević & Scott Horban & Daniel R. Morales & Talita Duarte-Salles & Clement Fraboulet & Tanguy Carrour & Spiros Denaxas & Vaclav Papez & Luis H. John & Peter R. Rijneek & Evan Minty & Thamir M. Alshammari & Rupa Makadia & Clair Blacketer & Frank DeFalco & Anthony G. Sena & Marc A. Suchard & Daniel Prieto-Alhambra & Patrick B. Ryan
May 2022, Volume 45, Issue 5
- 403-405 Artificial Intelligence and Machine Learning for Safe Medicines
by Andrew Bate & Yuan Luo - 407-418 Artificial Intelligence in Pharmacovigilance: An Introduction to Terms, Concepts, Applications, and Limitations
by Jeffrey K. Aronson - 419-427 Black Swan Events and Intelligent Automation for Routine Safety Surveillance
by Oeystein Kjoersvik & Andrew Bate - 429-438 “Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time?
by Robert Ball & Gerald Dal Pan - 439-448 Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance
by Raymond Kassekert & Neal Grabowski & Denny Lorenz & Claudia Schaffer & Dieter Kempf & Promit Roy & Oeystein Kjoersvik & Griselda Saldana & Sarah ElShal - 449-458 Intelligent Telehealth in Pharmacovigilance: A Future Perspective
by Heba Edrees & Wenyu Song & Ania Syrowatka & Aurélien Simona & Mary G. Amato & David W. Bates - 459-476 Machine Learning in Causal Inference: Application in Pharmacovigilance
by Yiqing Zhao & Yue Yu & Hanyin Wang & Yikuan Li & Yu Deng & Guoqian Jiang & Yuan Luo - 477-491 Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review
by Benjamin Kompa & Joe B. Hakim & Anil Palepu & Kathryn Grace Kompa & Michael Smith & Paul A. Bain & Stephen Woloszynek & Jeffery L. Painter & Andrew Bate & Andrew L. Beam - 493-510 Applying Machine Learning in Distributed Data Networks for Pharmacoepidemiologic and Pharmacovigilance Studies: Opportunities, Challenges, and Considerations
by Jenna Wong & Daniel Prieto-Alhambra & Peter R. Rijnbeek & Rishi J. Desai & Jenna M. Reps & Sengwee Toh - 511-519 Artificial Intelligence-Based Pharmacovigilance in the Setting of Limited Resources
by Likeng Liang & Jifa Hu & Gang Sun & Na Hong & Ge Wu & Yuejun He & Yong Li & Tianyong Hao & Li Liu & Mengchun Gong - 521-533 Identifying and Mitigating Potential Biases in Predicting Drug Approvals
by Qingyang Xu & Elaheh Ahmadi & Alexander Amini & Daniela Rus & Andrew W. Lo - 535-548 Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data
by Guillaume L. Martin & Julien Jouganous & Romain Savidan & Axel Bellec & Clément Goehrs & Mehdi Benkebil & Ghada Miremont & Joëlle Micallef & Francesco Salvo & Antoine Pariente & Louis Létinier - 549-561 Automated Drug Coding Using Artificial Intelligence: An Evaluation of WHODrug Koda on Adverse Event Reports
by Eva-Lisa Meldau & Shachi Bista & Emma Rofors & Lucie M. Gattepaille - 563-570 Using Iterative Pairwise External Validation to Contextualize Prediction Model Performance: A Use Case Predicting 1-Year Heart Failure Risk in Patients with Diabetes Across Five Data Sources
by Ross D. Williams & Jenna M. Reps & Jan A. Kors & Patrick B. Ryan & Ewout Steyerberg & Katia M. Verhamme & Peter R. Rijnbeek - 571-582 Leveraging Machine Learning to Facilitate Individual Case Causality Assessment of Adverse Drug Reactions
by Yauheniya Cherkas & Joshua Ide & John Stekelenborg - 583-596 Supervised Machine Learning-Based Decision Support for Signal Validation Classification
by Muhammad Imran & Aasia Bhatti & David M. King & Magnus Lerch & Jürgen Dietrich & Guy Doron & Katrin Manlik
April 2022, Volume 45, Issue 4
- 305-318 New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence
by Osman Moneer & Beatrice L. Brown & Jerry Avorn & Jonathan J. Darrow & Mayookha Mitra-Majumdar & Krysten W. Joyce & Murray Ross & Catherine Pham & Aaron S. Kesselheim - 319-331 Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands
by Agnes Kant & Jurriaan Jansen & Leontine Balveren & Florence Hunsel - 333-344 A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project
by Leonardo Roque Pereira & Carlos E. Durán & Deborah Layton & Georgios Poulentzas & Panagiotis-Nikolaos Lalagkas & Christos Kontogiorgis & Miriam Sturkenboom - 345-357 Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding
by Sigal Kaplan & Mikhail Zeygarnik & Tal Stern - 359-367 Postoperative Respiratory Events in Surgical Patients Exposed to Opioid Analgesic Shortages Compared to Fully Matched Patients Non-exposed to Shortages
by Rosa Rodriguez-Monguio & Zhixin Lun & Tasce Bongiovanni & Catherine L. Chen & Enrique Seoane-Vazquez - 369-378 Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach
by Esther Vries & Elisabeth Bakker & Remy D. C. Francisca & Stijn Croonen & Petra Denig & Peter G. M. Mol - 379-388 Intracranial Hemorrhage Following Anticoagulant Treatment in Denmark: Spontaneous Adverse Drug Reaction Reports Versus Real-World Data
by Benedikte Irene Osmanski & Astrid Blicher Schelde & Espen Jimenez-Solem & Martin Erik Nyeland & Henrik Horwitz - 389-398 Consensus Obtained for the Nephrotoxic Potential of 167 Drugs in Adult Critically Ill Patients Using a Modified Delphi Method
by Matthew P. Gray & Erin F. Barreto & Diana J. Schreier & John A. Kellum & Kangho Suh & Kianoush B. Kashani & Andrew D. Rule & Sandra L. Kane-Gill - 399-399 Correction to: A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project
by Leonardo Roque Pereira & Carlos E. Durán & Deborah Layton & Georgios Poulentzas & Panagiotis-Nikolaos Lalagkas & Christos Kontogiorgis & Miriam Sturkenboom - 401-401 Correction to: Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception
by Tina Singh & Frédérique Delannois & François Haguinet & Lifeter Yenwo Molo
March 2022, Volume 45, Issue 3
- 193-213 A Review on Application of DNA Barcoding Technology for Rapid Molecular Diagnostics of Adulterants in Herbal Medicine
by Alok Senapati & Supriyo Basak & Latha Rangan - 215-235 Cannabinoid-Related Acute Pancreatitis: An Update from International Literature and Individual Case Safety Reports
by Camille Azam & Louis Buscail & Adrian Culetto & Maryse Lapeyre-Mestre - 237-247 Sales of Over-the-Counter Products Containing Codeine in 31 Countries, 2013–2019: A Retrospective Observational Study
by Georgia C. Richards & Jeffrey K. Aronson & Brian MacKenna & Ben Goldacre & F. D. Richard Hobbs & Carl Heneghan - 249-257 The Extent of Medication-Related Hospital Admissions in Australia: A Review from 1988 to 2021
by Renly Lim & Lisa M. Kalisch Ellett & Susan Semple & Elizabeth E. Roughead - 259-274 Improving the Safety of Medicines via Digital Technology: An Assessment of the Scope and Quality of Risk Minimization Websites in the United States and United Kingdom
by Meredith Y. Smith & Sarah Frise & Jane Feron & Ryan Marshall - 275-285 High-Dimensional Propensity Score-Adjusted Case-Crossover for Discovering Adverse Drug Reactions from Computerized Administrative Healthcare Databases
by Etienne Volatier & Francesco Salvo & Antoine Pariente & Émeline Courtois & Sylvie Escolano & Pascale Tubert-Bitter & Ismaïl Ahmed - 287-295 Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data
by Wajd Alkabbani & Ryan Pelletier & Michael A. Beazely & Youssef Labib & Breanna Quan & John-Michael Gamble - 297-304 Impact of Preventive Strategies on Gastrointestinal Complications in Elderly Patients on Concomitant Use of Oral Anticoagulants and Nonsteroidal Anti-Inflammatory Drugs: A Nationwide Cohort Study
by Suhyun Lee & Kyu-Nam Heo & Mee Yeon Lee & Woo‑Youn Kim & Young-Mi Ah & Jaekyu Shin & Ju‑Yeun Lee
February 2022, Volume 45, Issue 2
- 97-99 Medication Errors Special Interest Group of the International Society of Pharmacovigilance and the Trends in International Collaboration for Patient Safety
by Mohamed A. Elhawary & Hadir Rostom & Brian Edwards & Angela Caro - 101-126 Cancer Chemotherapy-Induced Sinus Bradycardia: A Narrative Review of a Forgotten Adverse Effect of Cardiotoxicity
by Juan Tamargo & Ricardo Caballero & Eva Delpón - 127-136 Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database
by So-Fai Tsang & Shirali Pandya & Kristina Barakov & Joan Keutzer & Grace Lewis & Leorah Ross & Selena Freisens - 137-144 Spontaneous Reporting to Regulatory Authorities of Suspected Adverse Drug Reactions to COVID-19 Vaccines Over Time: The Effect of Publicity
by Robin E. Ferner & Richard J. Stevens & Christopher Anton & Jeffrey K. Aronson - 145-153 Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports
by Corine Ekhart & Florence Hunsel & Eugène Puijenbroek & Rebecca Chandler & Eva-Lisa Meldau & Henric Taavola & G. Niklas Norén - 155-168 Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception
by Tina Singh & Frédérique Delannois & François Haguinet & Lifeter Yenwo Molo - 169-180 Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration
by David Croteau & Ellen Pinnow & Eileen Wu & Monica Muñoz & Ilynn Bulatao & Gerald Dal Pan - 181-189 β-Blockers and the Risk of Depression: A Matched Case–Control Study
by Delia Bornand & Daphne Reinau & Susan S. Jick & Christoph R. Meier - 191-192 Correction to: Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy
by John W. Day & Jerry R. Mendell & Eugenio Mercuri & Richard S. Finkel & Kevin A. Strauss & Aaron Kleyn & Sitra Tauscher-Wisniewski & Francis Fonyuy Tukov & Sandra P. Reyna & Deepa H. Chand
January 2022, Volume 45, Issue 1
- 1-18 Patient Safety Incidents Related to the Use of Parenteral Nutrition in All Patient Groups: A Systematic Scoping Review
by Priya Mistry & Rebecca Heather Smith & Andy Fox - 19-26 Safety of Intravenous Push Levetiracetam Compared to Intravenous Piggyback at a Tertiary Academic Medical Center: A Retrospective Analysis
by Afrah Alkazemi & Kevin C. McLaughlin & Michael G. Chan & Michael J. Schontz & Kevin E. Anger & Paul M. Szumita - 27-35 Hybrid Method Incorporating a Rule-Based Approach and Deep Learning for Prescription Error Prediction
by Seunghee Lee & Jeongwon Shin & Hyeon Seong Kim & Min Je Lee & Jung Min Yoon & Sohee Lee & Yongsuk Kim & Jong-Yeup Kim & Suehyun Lee - 37-44 A 13-Year National Monitoring Study to Assess Narcotic Prescriptions and Indications (2007–2019)
by Joelle Perri-Plandé & Ghada Miremont-Salamé & Joëlle Micallef & Cameron Herman & Marie Baumevieille & Frédéric Abriat & Maryse Lapeyre-Mestre & Françoise Haramburu & Amélie Daveluy - 45-64 RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability
by Ernest Nadal & Hidehito Horinouchi & Jin-Yuan Shih & Kazuhiko Nakagawa & Martin Reck & Edward B. Garon & Yu-Feng Wei & Jens Kollmeier & Bente Frimodt-Moller & Emily Barrett & Olga Lipkovich & Carla Visseren-Grul & Silvia Novello - 65-74 Renin–Angiotensin–Aldosterone System Inhibitors and Risk of Acute Pancreatitis: A Population-Based Cohort Study
by Julie Rouette & Hui Yin & Emily G. McDonald & Alan Barkun & Laurent Azoulay - 75-82 The Risk of Preoperative Central Nervous System-Acting Medications on Delirium Following Hip or Knee Surgery: A Matched Case-Control Study
by Gizat M. Kassie & Elizabeth E. Roughead & Tuan A. Nguyen & Nicole L. Pratt & Lisa M. Kalisch Ellett - 83-95 The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions
by Gianmario Candore & Sebastian Monzon & Jim Slattery & Loris Piccolo & Rodrigo Postigo & Xavier Xurz & Sabine Strauss & Peter Arlett
December 2021, Volume 44, Issue 12
- 1247-1269 COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety
by Nicoletta Luxi & Alexia Giovanazzi & Annalisa Capuano & Salvatore Crisafulli & Paola Maria Cutroneo & Maria Pia Fantini & Carmen Ferrajolo & Ugo Moretti & Elisabetta Poluzzi & Emanuel Raschi & Claudia Ravaldi & Chiara Reno & Marco Tuccori & Alfredo Vannacci & Giovanna Zanoni & Gianluca Trifirò - 1271-1281 Mechanisms, Management and Prevention of Pemetrexed-Related Toxicity
by Nikki Rouw & Berber Piet & Hieronymus J. Derijks & Michel M. den Heuvel & Rob Heine - 1283-1295 The Effectiveness and Value of Written Medicine Information Across Asia and Africa: Systematic Review
by Pitchaya Nualdaisri & Sarah A. Corlett & Janet Krska - 1297-1309 Maternal Complications and Prescription Opioid Exposure During Pregnancy: Using Marginal Structural Models
by Xuerong Wen & Shuang Wang & Adam K. Lewkowitz & Kristina E. Ward & Erin Christine Brousseau & Kimford J. Meador - 1311-1321 Renal Safety of Hydroxyethyl starch 130/0.42 After Cardiac Surgery: A Retrospective Cohort Analysis
by Benedict Morath & Andreas D. Meid & Johannes Rickmann & Jasmin Soethoff & Markus Verch & Matthias Karck & Marcin Zaradzki - 1323-1339 Dispensing of Potentially Harmful Prescription Drugs in 1.8 Million Pregnant Women in France: A Nationwide Study Based on Two Risk Classification Systems
by Pierre-Olivier Blotière & Christine Damase-Michel & Alain Weill & Géric Maura - 1341-1353 An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine
by Paola Pirrotta & Fernanda Tavares-Da-Silva & Maribel Co & Nicolas Lecrenier & Caroline Hervé & Jens-Ulrich Stegmann - 1355-1364 Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study
by Fumihiko Sakai & Norihiro Suzuki & Xiaoping Ning & Miki Ishida & Chiharu Usuki & Katsuhiro Iba & Yuki Isogai & Nobuyuki Koga - 1365-1374 Repeated or Continuous Medically Supervised Ketamine Administration Associated with Hepatobiliary Adverse Events: A Retrospective Case Series
by Samantha Cotter & Jennie Wong & Neha Gada & Rajdeep Gill & S. Christopher Jones & Grace Chai & Daniel Foster & Mark Avigan & Mallika Mundkur - 1375-1390 Safety Profile of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season
by Ignacio Salamanca de la Cueva & Elisa Cinconze & Tamara Eckermann & Ugo Nwoji & Lode Godderis & Emily Lu & Xavier Martínez-Gómez & Huajun Wang & Emad Yanni
November 2021, Volume 44, Issue 11
- 1121-1123 Inconsistent Safety Outcome Reporting in Randomized Clinical Trials of COVID-19 Vaccines Complicates Informed Medical Decisions
by Joseph E. Blais & Yue Wei & Celine S. L. Chui & Esther W. Chan & Ian C. K. Wong - 1125-1149 Drug-Induced Liver Injury: Highlights and Controversies in the Recent Literature
by Joseph William Clinton & Sara Kiparizoska & Soorya Aggarwal & Stephanie Woo & William Davis & James H. Lewis - 1151-1164 Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database
by Keran Moll & Hui Lee Wong & Kathryn Fingar & Shayan Hobbi & Minya Sheng & Timothy A. Burrell & Linda O. Eckert & Flor M. Munoz & Bethany Baer & Azadeh Shoaibi & Steven Anderson - 1165-1178 Identifying Actionability as a Key Factor for the Adoption of ‘Intelligent’ Systems for Drug Safety: Lessons Learned from a User-Centred Design Approach
by George I. Gavriilidis & Vlasios K. Dimitriadis & Marie-Christine Jaulent & Pantelis Natsiavas - 1179-1191 Role of Drug–Gene Interactions and Pharmacogenetics in Simvastatin-Associated Pulmonary Toxicity
by Naomi T. Jessurun & Marjolein Drent & Petal A. Wijnen & Ankie M. Harmsze & Eugène P. Puijenbroek & Otto Bekers & Aalt Bast - 1193-1208 Systematising Pharmacovigilance Engagement of Patients, Healthcare Professionals and Regulators: A Practical Decision Guide Derived from the International Risk Governance Framework for Engagement Events and Discourse
by Priya Bahri & Antoine Pariente - 1209-1214 Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report
by Toyotaka Iguchi & Hikari Umeda & Michie Kojima & Yuri Kanno & Yuta Tanaka & Natsumi Kinoshita & Daisaku Sato - 1215-1230 Surveillance of Antidepressant Safety (SADS): Active Signal Detection of Serious Medical Events Following SSRI and SNRI Initiation Using Big Healthcare Data
by Mia Aakjær & Marie Louise Bruin & Murat Kulahci & Morten Andersen - 1231-1242 Desloratadine Exposure and Incidence of Seizure: A Nordic Post-authorization Safety Study Using a New-User Cohort Study Design, 2001–2015
by Annette Kjær Ersbøll & Kaushik Sengupta & Eero Pukkala & Kristian Bolin & Eline Aas & Martha Emneus & Dena Rosen Ramey & Joanne E. Brady & Daniel Mines & Kristian Aasbjerg & Christian Vestergaard & Gunnar Gislason & Alfred Peter Born & Thora Majlund Kjærulff
October 2021, Volume 44, Issue 10
- 1017-1020 A Multidisciplinary Approach in Pharmacovigilance Awareness: ISoP Egypt Chapter’s MedSafetyWeek Experience
by Hadir Rostom & Mohamed A. Elhawary & Islam N. Ali - 1021-1032 Eritrean Pharmacovigilance System: Key Strategies, Success Stories, Challenges and Lessons Learned
by Mulugeta Russom & Iyassu Bahta & Merhawi Debesai - 1033-1040 Use of Primary Care Data in Research and Pharmacovigilance: Eight Scenarios Where Prescription Data are Absent
by Grace N. Okoli & Puja Myles & Tarita Murray-Thomas & Hilary Shepherd & Ian C. K. Wong & Duncan Edwards - 1041-1058 Drug-Related Problems in Hospitalised Patients with Chronic Kidney Disease: A Systematic Review
by Wadia S. Alruqayb & Malcolm J. Price & Vibhu Paudyal & Anthony R. Cox - 1059-1072 Patient Global Impression of Benefit–Risk (PGI-BR): Incorporating Patients’ Views of Clinical Benefit–Risk into Assessment of New Medicines
by Daniel Eek & Katarina Halling & Emuella Flood & Matthew Blowfield & Oren Meyers & Meredith Venerus & Jean Paty & Richard Hermann - 1073-1083 Motives to Report Adverse Drug Reactions to the National Agency: A Survey Study among Healthcare Professionals and Patients in Croatia, The Netherlands, and the UK
by Sieta T. de Vries & Petra Denig & Adriana Andrić & Marina Dimov Di Giusti & Alicia Ptaszynska-Neophytou & Linda Härmark & Peter G. M. Mol - 1085-1098 Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles
by Noha Iessa & Viola Macolic Sarinic & Lilit Ghazaryan & Naira Romanova & Asnakech Alemu & Watcharee Rungapiromnan & Porntip Jiamsuchon & Pattreya Pokhagul & Jose Luis Castro & Diego Macias Saint-Gerons & Gayane Ghukasyan & Mengistab Teferi & Madhur Gupta & Shanthi Narayan Pal - 1099-1107 Safety of Eslicarbazepine Acetate in Elderly Versus Non-Elderly Patients with Focal Seizures: From Pooled Data of Clinical Studies to 8 Years of Post-Marketing Experience
by Luís M. Magalhães & Raquel Costa & Mariana Vieira & Joana Moreira & Helena Gama & Patrício Soares-da-Silva - 1109-1119 Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy
by John W. Day & Jerry R. Mendell & Eugenio Mercuri & Richard S. Finkel & Kevin A. Strauss & Aaron Kleyn & Sitra Tauscher-Wisniewski & Francis Fonyuy Tukov & Sandra P. Reyna & Deepa H. Chand
September 2021, Volume 44, Issue 9
- 917-928 A Scoping Review of Non-Medical and Extra-Medical Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
by Rebekah Brennan & Mayyada Wazaify & Haneen Shawabkeh & Ian Boardley & Jim McVeigh & Marie Claire Hout - 929-938 NSAIDs and COVID-19: A Systematic Review and Meta-analysis
by Nicholas Moore & Pauline Bosco-Levy & Nicolas Thurin & Patrick Blin & Cécile Droz-Perroteau - 939-948 Augmenting Product Defect Surveillance Through Web Crawling and Machine Learning in Singapore
by Pei San Ang & Desmond Chun Hwee Teo & Sreemanee Raaj Dorajoo & Mukundaram Prem Kumar & Yi Hao Chan & Chih Tzer Choong & Doris Sock Tin Phuah & Dorothy Hooi Myn Tan & Filina Meixuan Tan & Huilin Huang & Maggie Siok Hwee Tan & Michelle Sau Yuen Ng & Jalene Wang Woon Poh - 949-955 Bayesian Modeling for the Detection of Adverse Events Underreporting in Clinical Trials
by Yves Barmaz & Timothé Ménard - 957-971 Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance
by Annamaria Mascolo & Cristina Scavone & Carmen Ferrajolo & Concetta Rafaniello & Romano Danesi & Marzia Re & Antonio Russo & Enrico Coscioni & Francesco Rossi & Roberto Alfano & Annalisa Capuano - 973-985 Is There an Increased Risk of Hepatotoxicity with Metamizole? A Comparative Cohort Study in Incident Users
by Karin Hedenmalm & Alexandra Pacurariu & Jim Slattery & Xavier Kurz & Gianmario Candore & Rob Flynn - 987-998 Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020
by Elena Rocca & Oskar Gauffin & Ruth Savage & Sara Hedfors Vidlin & Birgitta Grundmark - 999-1006 Study of Natural Products Adverse Reactions (SONAR) in Adults with Mental Health Conditions: A Cross-Sectional Study
by Liliane Zorzela & Baljit Khamba & Emma Sparks & Candace Necyk & Liana Urichuk & Martin A. Katzman & David Koczerginski & Pierre Chue & Joanne Barnes & Sunita Vohra - 1007-1009 Comment on: "Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)"
by Alain Braillon & Marine Martin - 1011-1013 Authors’ Reply to Braillon and Martin’s Comment on “Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)”
by Priya Bahri & Daniel R. Morales & Adrien Inoubli & Jean-Michel Dogné & Sabine M. J. M. Straus - 1015-1015 Correction to: Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature
by Pitchaya Nualdaisri & Sarah A. Corlett & Janet Krska
August 2021, Volume 44, Issue 8
- 825-834 Monitoring and Managing Lorlatinib Adverse Events in the Portuguese Clinical Setting: A Position Paper
by Fernando Barata & Carlos Aguiar & Tiago Reis Marques & José Bravo Marques & Venceslau Hespanhol - 835-841 The Role of the Contextual Cohort to Resolve Some Challenges and Limitations of Comparisons in Pharmacoepidemiology
by Vicki Osborne & Samantha Lane & Saad A. W. Shakir