Return to search

Evaluation of medicine safety reporting systems in South Africa

Pharmacovigilance is “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. To date, no comprehensive study has been performed to evaluate the pharmacovigilance system in the public health sector in South Africa. The primary aim of this study was to evaluate the current status of pharmacovigilance systems within the public healthcare sector in South Africa, and the level of functioning of these systems, in order to provide relevant recommendations, where necessary, for improvement, using the Indicator-based Pharmacogivilance Assessment Tool (IPAT). National and provincial entities were deemed compulsory (n=14), while facilities were selected via random, stratified sampling to obtain a representation at each facility level (n=101). The IPAT was amended for relevance at each level of data collection. Indicators are classified as core and supplementary and compliance with core indicators shows the level of functioning National entities obtained an IPAT score of 36 out of a maximum of 72, achieving 50% compliance. Province D and Province G obtained overall IPAT scores of 29 and 12 respectively out of a maximum of 40, achieving an overall 72.5% and 30% compliance respectively Results at provincial and facility levels were not fully representative due to a limited response rate of 22.2% and 65.3% respectively. Regional/tertiary facilities and district facilities displayed increased awareness and implementation of pharmacovigilance activity than the lower levels of Community Health Centres (CHCs) and Primary Health Centres (PHCs). South Africa”s public healthcare system possesses the infrastructure for a well functioning pharmacovigilance system. However there are gaps in level of functioning at a national, provincial and facility level. Addressing these gaps would show a marked improvement in the system and go a long way towards the contribution of medicine safety information not only locally, but to aid other developing nations.

Identiferoai:union.ndltd.org:netd.ac.za/oai:union.ndltd.org:nmmu/vital:29517
Date January 2017
CreatorsThornborrow-Geswind, Kirsten
PublisherNelson Mandela Metropolitan University, Faculty of Health Sciences
Source SetsSouth African National ETD Portal
LanguageEnglish
Detected LanguageEnglish
TypeThesis, Masters, MPharm
Formatxii, 235 leaves, pdf
RightsNelson Mandela Metropolitan University

Page generated in 0.0016 seconds