Hospital Pharmacology (Jan 2018)
The role of a pharmacist in pharmacovigilance system
Abstract
Introduction: Although they represent an important mediator between patients and National Pharmacovigilance Centre, pharmacists still don't participate enough in system of reporting adverse drug reactions (ADR). By reporting ADR both quality of therapy and quality of patient's life are improving, and pharmaceutical industry is also encouraged to invent and produce new formulations which will be better beared and whose use will significantly improve risk-benefi t ratio. Aim: The aim of this work is that by collecting information about ADRs, based on direct contact of a pharmacist and patients, explain and improve the role of a pharmacist in pharmacovigilance system. Subjects and Methods: Information about adverse reactions were being collected in three private pharmacies in Inđija and in one private pharmacy in Sombor. In period from 20.12.2017.-10.01.2018. pharmacists collected data about adverse reactions of medicines. In period from 11.01.-01.02.2018. patients were additionally informed about unexpected and adverse drug reactions. The standard form for reporting an adverse reaction, which was taken from the site of Medicines and Medical Devices Agency of Serbia (ALIMS), was fi lled for each reported case and sent to National Pharmacovigilance Center (NPC). Suspect drugs were classified in categories according to Anatomical-Therapeutic-Chemical classification (ATC). Results: In first period, there were 19 reported reactions. After additional information given to patients, there were 33 reported adverse reactions. The most numerous adverse drug reactions were reported for the group of cardiovascular drugs (32.7%), the group of anti-infective drugs with systemic effects (15.4%) and for group of drugs which affect nervous system (13.5%). After analyzing reported reactions, according to NPC all of reactions were expected (52), but 3 of them fulfilled criteria of seriousness. Conclusions: Thanks to additional information and direct communication between a pharmacist and patients, reporting unexpected and adverse drug reactions is significantly improving.