Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase®

Journal article

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

Authors: Ampadu, HH; Hoekman, J; de Bruin, ML; Pal, SN; Olsson, S

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Springer
• Journal: Drug Safety: The Official Journal of the International Society of Pharmacovigilance
• Volume: 39
• Issue: 4
• Pages: 335-345
• Publication date: 2016-01-11
• DOI: 10.1007/s40264-015-0387-4
• EISSN: 1179-1942
• ISSN: 0114-5916
• Language: English
• Keywords: Medicine; Internal medicine; Pharmacovigilance; MedDRA; Adverse effect