Журнал фармаконадзора

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The Beginning of Pharmacovigilance in Bosnia and Herzegovina

Kondza Martin, Tubic, Biljana, Muhovic, Dinka

Aims: The aims of this article are to present the impact of the pharmacovigilance performance improvement in Bosnia and Herzegovina on the reporting results gathered at the national pharmacovigilance database. Subjects and methods: Bosnia and Herzegovina is a country in Europe with a complicated political structure, the highest rate of unemployment and a low Gross Domestic Product. Although the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina was established in 2009, with the Main Office for Pharmacovigilance as the national pharmacovigilance center, there were no activities and work in the field of pharmacovigilance. In 2017 several changes were made in the work of the Main Office such as: employment of an external expert for the work of pharmacovigilance, holding lectures and workshops, collecting and analyzing adverse drug reactions, signing various co-operations with professional chambers and health institutions forwarding reports to the World Health Organization and writing annual reports. Results: These changes showed an increase in the collected adverse drug reactions by 130% and 28% on an annual level for 2017 and 2018, respectively. Bosnia and Herzegovina became a full member of the Uppsala Monitoring Center, a global office for drug monitoring by the World Health Organization. Conclusion: Bosnia and Herzegovina can be used as an example for developing a sustainable pharmacovigilance system in countries with low economical standards.