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Use of Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) Checklist in Risk Minimisation/Mitigation Studies: A Review and Survey
Use of Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) Checklist in Risk Minimisation/Mitigation Studies: A Review and Survey
The Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) checklist is endorse...
Prenatal and Early Childhood Exposure to Proton Pump Inhibitors and Antibiotics and the Risk of Childhood Cancer: A Nationwide Population-Based Cohort Study
Prenatal and Early Childhood Exposure to Proton Pump Inhibitors and Antibiotics and the Risk of Childhood Cancer: A Nationwide Population-Based Cohort Study
Our microbiome is established during infancy, a time important for later health and long-term effects. Proton pump inhibit...
Trends in Proton Pump Inhibitor Use in Sweden by Sex and Age: A Drug Utilisation Study
Trends in Proton Pump Inhibitor Use in Sweden by Sex and Age: A Drug Utilisation Study
Proton pump inhibitors (PPIs) are among the most popular drugs worldwide. Yet, there are concerns on long-term safety and ...
Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health
Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health
The Global Use of Medicines [Internet]. 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/...
Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments
Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments
Recent artificial intelligence (AI) advances can generate human-like responses to a wide range of queries, making them a u...
Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database
Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database
Improving adverse events following immunisation (AEFI) detection is vital for vaccine safety surveillance, as an early saf...
Prenatal Exposure to Proton Pump Inhibitors and Risk of Serious Infections in Offspring During the First Year of Life: A Nationwide Cohort Study
Prenatal Exposure to Proton Pump Inhibitors and Risk of Serious Infections in Offspring During the First Year of Life: A Nationwide Cohort Study
Proton pump inhibitor (PPI) use in children increases the risk of infections, prompting inquiry into the impact of prenata...
Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study
Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study
Adverse drug events (ADEs) are understudied in the ambulatory care setting. We aim to estimate the prevalence and characte...
Fracture-Related Safety Reporting of JAK Inhibitors: An Analysis from the WHO Global VigiBase
Fracture-Related Safety Reporting of JAK Inhibitors: An Analysis from the WHO Global VigiBase
The Janus kinase (JAK) inhibitors are treatment options for autoimmune diseases. Numerous safety concerns have been raised...
Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study
Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study
Risk minimisation measures (RMMs) aim to ensure safe use of medicines, but their implementation in clinical practice is co...
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...
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