Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study

Abstract

Background: Since 2012, in compliance with the changes in the European legislation, the Bulgarian Drug Agency (BDA) has been receiving adverse drug reaction (ADR) reports directly from patients as well as from healthcare professionals and marketing authorization holders (MAH). Adverse reaction reports from patients and consumers have different characteristics from those sent by healthcare professionals. Moreover, they may require specific algorithm and assessment methods in order to be informative and beneficial to the pharmacovigilance system.

Keywords

• adverse drug reaction reports
• patients and consumers
• reporting level
• seriousness criteria
• pharmacovigilance