Introduction: In France since 2011, report of adverse drug reactions (ADRs) has been extended to patients (and patients' associations) who can declare directly ADRs to their regional pharmacovigilance centre. In pharmacovigilance, informativeness of ADRs reports is important to improve signal's detection. The present study was performed to compare the quality of patients', physicians and community pharmacists' reports.
Methods: We performed a retrospective study investigating the quality of patients', physicians and community pharmacies' ADRs reported to Toulouse University PharmacoVigilance Centre (TUPVC) from January 2014 to June 2017. We used mandatory and non-mandatory criteria, as defined by European Medicines Agency. Reports' quality was defined as "satisfactory" when more than 90% of items were completed. We also compared reports' quality according to ADRs seriousness and the used reporting tools (email or the mobile app VigiBip).
Results: The number of reports to TUPVC increased between 2014 and 2016 (+51%) for patients and remained stable for pharmacists and physicians. According to the mandatory criteria, quality of the investigated reports was "satisfactory" (more than 90% of the items filled) whatever the reporter and without significant differences between reporters. For the non-mandatory criteria, clinical description of ADRs and ADRs' outcome were only filled over 90%. Significant differences were observed between the different reporters: community pharmacists informed better clinical description, ADR outcome and concomitant drugs versus both patients and physicians. Physicians informed better medical history and biological data whereas patients informed medical history and other aetiologies better than pharmacists and clinical description of ADRs better than physicians.
Conclusion: The present study failed to show differences between pharmacies', physicians' and patients' ADRs reports, for the mandatory criteria. However, significant differences were found for non-mandatory criteria with drug data more filled by pharmacists and medical ones more by physicians and patients.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.therap.2019.01.008 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Editorial: Biologic drugs in immune-mediated inflammatory diseases, validation, drug-utilization, effectiveness, regulation, costs, and safety in the real-world.
Front Pharmacol
January 2025
Department of Diagnostic and Public Health, Section of Pharmacology, University of Verona, Verona, Italy.
Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system.
Front Pharmacol
January 2025
Fengxian Hospital, Southern Medical University, Shanghai, China.
Background: In the past few decades, selective serotonin reuptake inhibitors (SSRIs) became widely used antidepressants worldwide. Therefore, the adverse reactions of patients after SSRI administration became a public and clinical concern. In this study, we conducted a pharmacovigilance study using the Adverse Event Reporting System (FAERS) database of the US Food and Drug Administration.
View Article and Find Full Text PDFProbiotics in the Management of Chronic Bacterial Prostatitis Patients: A Randomized, Double-Blind Trial to Evaluate a Possible Link Between Gut Microbiota Restoring and Symptom Relief.
Microorganisms
January 2025
Operative Unit of Clinical Pharmacology and Pharmacovigilance, Department of Health Science, AOU Dulbecco, University Magna Graecia of Catanzaro, 88100 Catanzaro, Italy.
Several studies have suggested that probiotics could play a role in the management of patients with chronic bacterial prostatitis (CBP). In this randomized, placebo-controlled clinical study, we evaluated the efficacy and safety of consumption of probiotics containing human DG as an add-on treatment in patients with clinical recurrences of CBP, through gut microbiota modification analysis. Enrolled patients with CBP were randomized to receive for 3 months probiotics containing human DG or placebo following 1 month treatment with ciprofloxacin.
View Article and Find Full Text PDFMachine-Learning Parsimonious Prediction Model for Diagnostic Screening of Severe Hematological Adverse Events in Cancer Patients Treated with PD-1/PD-L1 Inhibitors: Retrospective Observational Study by Using the Common Data Model.
Diagnostics (Basel)
January 2025
Department of Regulatory Science, College of Pharmacy, Graduate School, Kyung Hee University, Seoul 02447, Republic of Korea.
: Earlier detection of severe immune-related hematological adverse events (irHAEs) in cancer patients treated with a PD-1 or PD-L1 inhibitor is critical to improving treatment outcomes. The study aimed to develop a simple machine learning (ML) model for predicting irHAEs associated with PD-1/PD-L1 inhibitors. : We utilized the Observational Medical Outcomes Partnership-Common Data Model based on electronic medical records from a tertiary (KHMC) and a secondary (KHNMC) hospital in South Korea.
View Article and Find Full Text PDFDuration of Time Intervals for Risk Minimization Measure Effectiveness Studies.
Clin Pharmacol Ther
January 2025
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Insights into the time needed for evaluation of risk minimization measures' (RMMs) effectiveness might identify areas for improvement. We assessed the duration of time intervals between regulatory milestones for RMM effectiveness studies assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). We included completed RMM effectiveness post-authorization safety studies (PASSs) assessed by PRAC between 2016 and 2022.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!