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A Calculated Risk: Evaluation of QTc Drug–Drug Interaction (DDI) Clinical Decision Support (CDS) Alerts and Performance of the Tisdale Risk Score Calculator
A Calculated Risk: Evaluation of QTc Drug–Drug Interaction (DDI) Clinical Decision Support (CDS) Alerts and Performance of the Tisdale Risk Score Calculator
A risk factor for a potentially fatal ventricular arrhythmia Torsade de Pointes is a prolongation in the heart rate-correc...
Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation
Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation
Preventing prenatal exposure to teratogenic medications is an important goal of regulatory risk mitigation efforts. In the...
Views on the Development and Use of a New Digital Adverse Drug Event Reporting Platform in Australia: A Qualitative Study
Views on the Development and Use of a New Digital Adverse Drug Event Reporting Platform in Australia: A Qualitative Study
Reporting of adverse drug events (ADEs) to regulatory authorities remains low, particularly among consumers. To explore st...
Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are an...
Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury
Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury
 The attribution of drug-induced liver injury (DILI) to specific herbal and dietary supplements (HDS) is confound...
An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury
An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury
The recent rise in acute kidney injury (AKI) incidence, with approximately 30% attributed to potentially preventable adver...
Safeguarding Patients in the AI Era: Ethics at the Forefront of Pharmacovigilance
Safeguarding Patients in the AI Era: Ethics at the Forefront of Pharmacovigilance
Artificial intelligence is increasingly being used in pharmacovigilance. However, the use of artificial intelligence in ph...
Incidence of Idiosyncratic Drug-Induced Liver Injury Caused by Prescription Drugs
Incidence of Idiosyncratic Drug-Induced Liver Injury Caused by Prescription Drugs
The incidence of drug-induced liver injury (DILI) is not known for most prescription medications. We aimed to estimate the...
Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups
Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups
While medication errors (MEs) have been studied in the European Medicines Agency’s EudraVigilance, extensive charact...
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
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
Medication use is increasing to treat both pre-existing and pregnancy-related medical conditions or complications. This st...
Drug-Induced Hypouricemia
Drug-Induced Hypouricemia
Hypouricemia is defined as a serum uric acid concentration of ≤ 2.0 mg/dL or 119 μmol/L...
Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide
Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide
The use of herbal products globally is substantial, but varying definitions and regulatory frameworks have led to differen...
The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System
The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System
This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU). Its legislative aim of better ...
Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure
Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure
Use of heart failure-exacerbating medications (HFEMs) may lead to preventable episodes of acute decompensated heart failur...
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
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
The aim of this study was to investigate the cardiovascular safety of romosozumab in postmenopausal women with osteoporosi...
Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre
Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre
Paracetamol dosing errors can cause acute liver injury, with potentially toxic doses only slightly above the therapeutic r...
Comparative Effectiveness and Safety of Off-Label Underdosed Direct Oral Anticoagulants in Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis
Comparative Effectiveness and Safety of Off-Label Underdosed Direct Oral Anticoagulants in Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis
Off-label underdosed direct oral anticoagulants (DOACs) are commonly utilised in Asian patients with atrial fibrillation (...
A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review
A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review
The safety of antiviral agents in real-world clinical settings is crucial, as pre-marketing studies often do not capture a...
Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System
Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System
Impulsivity induced by dopaminergic agents, like pramipexole and aripiprazole, can lead to behavioral addictions that impa...
The Methodological Quality of Observational Studies Examining the Risk of Pregnancy Drug Use on Congenital Malformations Needs Substantial Improvement: A Cross-Sectional Survey
The Methodological Quality of Observational Studies Examining the Risk of Pregnancy Drug Use on Congenital Malformations Needs Substantial Improvement: A Cross-Sectional Survey
An increasing number of observational studies have investigated the risk of using drugs during pregnancy on congenital mal...
Correction to: Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes
Correction to: Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes
Funding Funding for this work was provided by the Canadian Institut...
Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations
Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations
Missing data and unmeasured confounding are key challenges for external comparator studies. This work evaluates bias and o...
Adopting STOPP/START Criteria Version 3 in Clinical Practice: A Q&A Guide for Healthcare Professionals
Adopting STOPP/START Criteria Version 3 in Clinical Practice: A Q&A Guide for Healthcare Professionals
The growing complexity of geriatric pharmacotherapy necessitates effective tools for mitigating the risks associated with ...
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis
Pregnant persons are susceptible to significant complications following COVID-19, even death. However, worldwide COVID-19 ...
Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports
Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports
Upadacitinib is indicated for diseases affecting persons of childbearing potential including rheumatoid arthritis, psoriat...
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”
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”
The purpose of this review is to provide an overview of the contraindications, special warnings, and boxed warnings with t...
The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions
The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions
Preventable medication errors have been proven to cause significant public health burden, and ePrescription is a key part ...
Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study
Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study
Cases of appendicitis were identified in the pivotal randomized clinical trial on BNT162b2 mRNA vaccine and reported from ...
Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling
Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling
The accurate identification and timely updating of adverse reactions in drug labeling are crucial for patient safety and e...
Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study
Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study
Immunocompromised individuals are at high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection a...
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