Original scientific paper

https://doi.org/10.20471/acc.2023.62.03.11

Pharmacovigilance in Serbia: a Ten-Year Pharmacoepidemiologic Analysis

Dejan Živanović ; Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia; Department of Psychology, College of Social Work, Belgrade, Serbia *
Vesna Mijatović Jovin ; Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia
Jovan Javorac ; Institute for Pulmonary Diseases of Vojvodina, Sremska Kamenica, Serbia; Department of Internal Medicine, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia
Isidora Samojlik ; Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia
Aleksandar Rašković ; Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia
Marija Jevtić ; Insitute for Public Health of Vojvodina, Novi Sad, Serbia; Department of Hygiene, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia; Centre de Recherche sur la Santé Environnementale et Professionnelle, École de Santé Publique, Université Libre de Bruxelles, Brussels, Belgium
Svetlana Stojkov ; Faculty of Pharmacy, University of Business Academy, Novi Sad, Serbia; Department of Biomedical Sciences, College of Vocational Studies for the Education of Preschool Teachers and Sports Trainers, Subotica, Serbia
Nataša Jovanović Lješković ; Faculty of Pharmacy, University of Business Academy, Novi Sad, Serbia
Nataša Perković Vukčević ; Military Medical Academy, Belgrade, Serbia; Department of Pharmacological Sciences, Faculty of Medicine, National University of Defense, Belgrade, Serbia

* Corresponding author.

Abstract

Pharmacovigilance as a science and group of activities related to detection, collection,
analysis, understanding and prevention of adverse drug reactions (ADRs) is an essential activity
in the regulatory system of drugs of any country. Defining increased patient safety as the main
purpose of ADR reporting, a well-designed national pharmacovigilance system achieves its ultimate
goal, i.e., protection of public health. In organizational and technical terms, the Republic of Serbia
has a well-developed system of pharmacovigilance, created on the basis of a proven reliable system
of the former SFR Yugoslavia, and carried out by the National Agency for Medicines and Medical
Devices of Serbia (ALIMS), which conducts all organized activities aimed at strengthening the national
system of ADR monitoring and reporting. Unlike the neighboring Croatia and Montenegro
with similar pharmacovigilance systems, Serbia has only recently approached the WHO standard
of 200 reports per million inhabitants despite a significant increase of 180 ADR reports per million
inhabitants in 2019 (1251 in total). Considering this, our study aimed to provide a critical insight
into the practice of pharmacovigilance in Serbia by pharmacoepidemiologic analysis of a ten-year
period of ADR monitoring and reporting activities.

Keywords

Adverse drug reactions; Adverse drug reaction monitoring and reporting; Suspected drug; Adverse events following immunization

Hrčak ID:

315076

URI

https://hrcak.srce.hr/315076

Publication date:

1.11.2023.

Article data in other languages: croatian

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