Pregledni rad
https://doi.org/10.3325/cmj.2018.59.124
Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study
Una Glamočlija
orcid.org/0000-0003-1206-6990
; School of Medicine, University of Mostar, Mostar, Bosnia and Herzegovina
Biljana Tubić
; Agency for Medicines and Medical Devices, Banja Luka, Bosnia and Herzegovina
Martin Kondža
; Agency for Medicines and Medical Devices, Banja Luka, Bosnia and Herzegovina
Aleksandar Zolak
; Agency for Medicines and Medical Devices, Banja Luka, Bosnia and Herzegovina
Nataša Grubiša
; Agency for Medicines and Medical Devices, Banja Luka, Bosnia and Herzegovina
Sažetak
Aim To compare individual case safety reports (ICSR) rates
and characteristics between Croatia, Serbia, Montenegro,
and Bosnia and Herzegovina (B&H).
Methods This retrospective pharmacoepidemiological
study used the data from ICSR received by the Agency for
Medicines and Medical Devices in B&H in 2011-2016. The
number, characteristics, and sources of reports, suspected
drugs, and patient characteristics were analyzed. The results
were compared with the publicly available data from
Croatia, Serbia, and Montenegro.
Results The number of reported adverse drug reactions
per one million of inhabitants was lowest in B&H and highest
in Croatia. There were significant differences in reporter
characteristics, sources of reports, and the percentage
of missing data in ICSR, while the Anatomical Therapeutic
Chemical product classes, patient’s sex, and adverse drug
reaction System Organ Classes were similar.
Conclusion Despite the historical and geographical vicinity
of B&H and its neighboring countries, there were significant
differences in indicators of pharmacovigilance development.
Ključne riječi
Hrčak ID:
237475
URI
Datum izdavanja:
15.6.2018.
Posjeta: 840 *