Quality Analysis of some First-line Antiretroviral Drugs Dispensed in Lusaka District Health Facilities 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.