For a robust Pharmacovigilance system in a country, training of healthcare professionals is of utmost importance. The training is the integral part of continual improvement in any quality management system. The present article describes the different training modules and experience from the Pharmacovigilance Programme of India (PvPI) and emphasizes that if training and education elements with special reference to pharmacovigilance are implemented for all concerned stakeholders in a healthcare system, the efficiency of deliverables will be improved and objectives of the organization can easily be achieved. The PvPI has been putting its best efforts to train healthcare professionals in pharmacovigilance and it has achieved new heights in establishing best practices for the other countries to follow for the development of pharmacovigilance system in their respective countries or regions. The aim of this article is to suggest how capacity building in a pharmacovigilance system can help low- and middle-income countries in area of pharmacovigilance. The authors tried to conceptualize the process and implementation of the training program under PvPI.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698288 | PMC |
| http://dx.doi.org/10.4103/ijp.ijp_638_22 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
A retrospective analysis of medications associated with pityriasis rosea reported in the FDA adverse events reporting system.
Arch Dermatol Res
January 2025
Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 1150 NW 14th Street, Miami, FL, 33136, USA.
Pityriasis rosea (PR) is an acute exanthematous disease with an uncertain physiopathology, increasingly recognized as potentially drug induced. This study aims to investigate medication triggers associated with PR by analyzing cases reported in the FDA Adverse Event Reporting System (FAERS) database. A retrospective review of 343 PR cases reported in the FAERS database from January 1, 1998, to March 31, 2024, was conducted.
View Article and Find Full Text PDFDrug use and acute kidney injury: a Drug-Wide Association Study (DWAS) in Denmark and Sweden.
Clin Kidney J
January 2025
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
Background: Knowledge of which medications may lead to acute kidney injury (AKI) is limited, relying mostly on spontaneous reporting in pharmacovigilance systems. We here conducted an exploratory drug-wide association study (DWAS) to screen for associations between dispensed drugs and AKI risk.
Methods: Using two large Danish and Swedish data linkages, we identified AKI hospitalizations occurring between April 1997 and December 2021 in Denmark and between March 2007 and December 2021 in Sweden.
Unveiling unexpected adverse events: post-marketing safety surveillance of gilteritinib and midostaurin from the FDA Adverse Event Reporting database.
Ther Adv Drug Saf
January 2025
Department of Pharmacy, Daping Hospital, Army Medical University, No. 10 Changjiang Branch Road, Yuzhong District, Chongqing 400042, China.
Background: Gilteritinib and midostaurin are FLT3 inhibitors that have made significant progress in the treatment of acute myeloid leukemia. However, their real-world safety profile in a large sample population is incomplete.
Objectives: We aimed to provide a pharmacovigilance study of the adverse events (AEs) associated with gilteritinib and midostaurin through the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.
Unveiling the safety profile of lecanemab: A comprehensive analysis of adverse events using FDA adverse event reporting system data.
J Alzheimers Dis
January 2025
Department of Pharmacy, Women and Children's Hospital of Ningbo University, Ningbo, China.
Background: Lecanemab, a novel monoclonal antibody targeting amyloid-β, has shown promise in treating Alzheimer's disease. Comprehensive post-marketing safety data analysis is crucial to understand its real-world risk profile.
Objective: This study aimed to evaluate the safety profile of lecanemab using data from the FDA Adverse Event Reporting System (FAERS), with a focus on nervous system disorders and amyloid-related imaging abnormalities.
Purpose: Heart failure (HF) is a disease that leads to approximately 300,000 fatalities annually in Europe and 250,000 deaths each year in the United States. Type 2 Diabetes Mellitus (T2DM) is a significant risk factor for HF, and testing for N-terminal (NT)-pro hormone BNP (NT-proBNP) can aid in early detection of HF in T2DM patients. We therefore developed and validated the HFriskT2DM-HScore, an algorithm to predict the risk of HF in T2DM patients, so guiding NT-proBNP investigation in a primary care setting.
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!