Quality Analysis of some First-line Antiretroviral Drugs Dispensed in Lusaka District Health Facilities of Zambia
Derick Munkombwe
The University of Zambia
Abstract
In the last few years, governments around the world have
pledged to massively scale up the delivery of antiretroviral
drugs (ARVs) to achieve universal access for all. However,
recent reports of generic medicine including ARVs that they
contain little or no active pharmaceutical ingredients are
disturbing.
In Zambia anecdotal data show that there is an increase in
morbidity and mortality in people living with HIV/AIDS. For
instance, a physician at the University Teaching Hospital
(UTH) reported that his eight patients did not respond to any
combination after developing resistance to first-line ARVs.
Currently, in Zambia, there is insufficient publicly available data
describing the ARV drug quality in terms of active
pharmaceutical ingredients (API), and labelling standards
according to official monographs. The purpose of this study
was to determine the quality of some first-line ARVs dispensed
in health facilities of Lusaka.
A Cross-sectional survey was conducted in nine health facilities
of Lusaka District, using a convenience sampling technique.
Eleven sample units containing twenty active ingredients were
analyzed. Each sample unit was sealed in a tin of either 30 or 60
tablets. A protocol of the Ministry of Health adapted from
German Pharm Health Fund (GPHF-minilab) that employs
Thin Layer Chromatography (TLC) techniques were used.
It was found that over 94% of the first-line ARV medicines
sampled contained the active pharmaceutical ingredients in the
right amounts as per label claim on the packages and that on
average over 90% of these drugs were correctly labelled. It can
therefore be concluded that first-line ARVs dispensed in
Lusaka District of Zambia are of good quality and meet the
requirements as stipulated in the official monographs.