All medicinal products authorized in the European Union are subjects of constant drug-
safety monitoring processes. It is organized in a pharmacovigilance system that is designed …

Patients who report suspected adverse drug reactions (ADRs) help minimize drug safety
risks and bolster the pharmacovigilance system. The aim of this study was to examine the …

Patients are recognized as important players in the pharmacovigilance system. This study
aims to describe and compare the characteristics of patient reporting systems, reporting …

Background: Patients are important stakeholders in pharmacovigilance; however, little
formal evaluation has been undertaken of existing patient reporting schemes within and …

The direct reporting of adverse drug reactions by patients is becoming an increasingly
important topic for discussion in the world of pharmacovigilance. At this time, few countries …

The analysis of safety data from spontaneous reporting systems has a proven value for the
detection and analysis of the risks of medicines following their placement on the market and …

Abstract Introduction: Adverse drug reactions (ADRs) are threat to the patient's safety and
the quality of life, and they increase the cost of health care. Spontaneous ADR reporting …

Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients,
but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug …

Introduction New pharmacovigilance legislation was adopted in the EU in 2010 and became
operational in July 2012. The legislation placed an obligation on all national competent …

Objective To give an overview of the views of different types of reporters (patients and
healthcare professionals (HCPs)) and assessors of adverse drug reactions (ADRs) on what …