An analysis of the trends, characteristics, scope, and performance of the Zimbabwean pharmacovigilance reporting scheme
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Date
2020
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Wiley-Blackwell
Abstract
We aimed to determine the reporting trends and characteristics of Individual Case
Safety Reports (ICSRs) from the Zimbabwean national pharmacovigilance system.
ICSRs submitted to VigiBaseTM, the World Health Organisation's ICSR database between January 1993 and December 2017 were retrospectively reviewed with respect to the suspected medicine, System Organ Class (SOC), adverse drug reaction
(ADR) type and seriousness, Anatomic Therapeutic Chemical (ATC) group, age, and
gender. In total, 4071 ICSRs were submitted to VigiBaseTM from targeted spontaneous reporting (n = 2909; 71.5%), vaccine surveillance (n = 679; 16.7%), and passive
spontaneous reporting (n = 483; 11.9%), respectively
Description
Keywords
Adverse drug reaction, Drug safety, Pharmacovigilance, Post-market surveillance, Spontaneous reporting system
Citation
4. Masuka, J. T., & Khoza, S. (2020). An analysis of the trends, characteristics, scope, and performance of the Zimbabwean pharmacovigilance reporting scheme. Pharmacology Research and Perspectives,8(5), e00657