Abstract
The use of medicines is unavoidable. The use of in vivo and in vitro
techniques in drug development is not sufficient for medicine approval.
In the development of drugs there are clinical stages that are carried
out to ensure the safety and efficacy of medicines. Medicines in
preproduction elicit different effects and reactions from those elicited
in the post production, as those are influenced by longer treatment
exposure, polypharmacy, bioavailability and metabolism. The post
marketing surveillance stage ensures the detection of adverse drug
reactions (ADRs) which were not detected during clinical stages. The
establishment of pharmacovigilance (PV) systems was prompted by the
thalidomide disaster, the death of Hannah Greener due to use of
chloroform, the Biologics Control Act, the Food and Drug Act,
Durham-Humphrey Amendment and the Kefauver-Harris amendments. For a good
and efficient PV system it is imperative that ADRs are reported,
quantified and documented. Since the inception of PV in South Africa in
1992, the system has progressed from passive regulatory reporting to
active surveillance activities. Studies have shown many barriers to
passive reporting of ADRs in the health care sector such as poor
knowledge by health care providers to completing the reporting form,
reporting is time consuming, and when reporting is done, there is no
acknowledgement of the submitted forms by the PV authorities. ADRs bring
about a financial burden in health budgets, therefore the management of
ADRs and more over of preventable ADRs is essential.