OBJECTIVES To document the knowledge of, attitudes toward, and practices of adverse drug reaction (ADR) reporting and pharmacovigilance systems among healthcare professionals. Methods: This descriptive cross-sectional study was conducted using a questionnaire. This study took place at King Fahd Hospital of the University (KFHU), Khobar, Kingdom of Saudi Arabia,  between  April 2015 and  April 2...

Regional Pharmacovigilance Centre of Lombardy, via Taramelli 26, Milano 20124, Italy Regional Pharmacovigilance Centre of Veneto, P.le L.A. Scuro 10, Verona 37100, Italy Section of Psychiatry, Department of Public Health and Community Medicine, University of Verona, Policlinico GB Rossi, Piazzale Scuro 10, Verona 37134, Italy Correspondence to: Valentino Conti. Regional Pharmacovigilance Centre...

This paper shows that pharmaceutical companies and CRO often fail to respond to the recommendations of Good Pharmacovigilance Practices (GVP) by highlighting the lack of efficiency of the quality control (QC) process applied to the pharmacovigilance cases processing. The paper summarized the sampling acceptance statistical theory behind the good statistical practices regarding QC of lots and sh...

Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a no...

BACKGROUND This scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigilance system. The purpose is to investigate opportunities for effective pharmacovigilance. METHODS Si...

The Monitoring Medicines project (MM), funded by the FP-7 EU framework, was carried out between 2009 and 2013 by a consortium of 11 partners. The objectives were to support and strengthen consumer reporting of adverse drug reactions (ADRs); expand the role and scope of national pharmacovigilance centres concerning medication errors; promote improved use of pharmacovigilance data; and develop me...

Pharmacovigilance centres monitor the safety of drugs, based on adverse drug reactions (ADRs) reported by doctors, pharmacists and pharmaceutical companies. However, the under-reporting of ADRs remains a major problem. Our aim was to investigate preparedness of future doctors for their role in pharmacovigilance, by assessing their pharmacovigilance awareness, skills and knowledge. The study was...

This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assess...

UNLABELLED Pharmacovigilance has not progressed well in India and the concept is still in its infancy. India rates below 1% in pharmacovigilance as against the world rate of 5%. OBJECTIVE The aim of our study was to evaluate the knowledge, perception and practice of pharmacovigilance among registered community pharmacists in Hyderabad, India. METHODS This was a prospective study to find out...

Objective: This study was conducted among the dental students to evaluate the knowledge and attitude towards pharmacovigilance and adverse drug reactions reporting among the dental students in a private university, Malaysia. Methods: The survey was carried out among the pre-final and final year dental students using a pre-validated questionnaire that included the demographics details and survey...