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The beginning of pharmacovigilance in Bosnia and Herzegovina
AUTORI:
MARTIN KONDŽA;
Tubić Biljana;
Muhović Dinka;
ZNANSTVENA PODRUČJA
BIOMEDICINA I ZDRAVSTVO
FARMACIJA
BIOMEDICINA
SADRŽAJ
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.
SADRŽAJ (eng)
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.
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