Quality analysis of some first-line HIV/AIDS medicines dispensed in Lusaka District Health facilities of Zambia

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Date
2011-11-16
Authors
Munkombwe, Derick
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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 medicines including ARVs containing 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 due to ARV drug resistance, treatment failure and adverse drug reactions.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(Geloo 2005). It is a well known fact that poor drug quality can contribute to poor treatment outcomes of the patient. In Zambia there is currently insufficient publicly available data describing the ARV drug quality in terms of active pharmaceutical ingredients (API), and labeling standards according to official monographs. The purpose of this study was to determine the quality of some first-line HIV/AIDS medicines dispensed in health facilities and to assess the proportion of substandard ARVs in Lusaka District. A Cross Section Survey was conducted in nine health facilities of Lusaka District, using convenience sampling technique. A few ARV drug samples were selected randomly from the nine facilities. Eleven sample units were analyzed. Each sample unit was sealed in a tin of either 30 or 60 tablets. The tablets were removed from their original containers and number coded before taken for analysis after recording the names, strengths, batch numbers and expiry dates. The quality analysis of (1) Stavudine (d4T)/Lamivudine (3TC)/Nevirapine (NVP), (2) Lamivudine (3TC)/Zidovudine (AZT), (3) Nevirapine (NVP), (4) Efavirenz (EFV) and (5) Stavudine (d4T)/Lamivudine (3TC) was carried out using the protocol adapted from German Pharm Health Fund (GPHF-minilab) that employs Thin Layer Chromatography (TLC) techniques at Tejay Pharmaceutical Laboratories in Lusaka, Zambia. A total of eleven drug samples were assayed and analyzed.The analytical tests that were performed included: the identification of the API, measurement of the percentage content of API in the samples and assessment of packaging material according to prescribed monographs.The findings of the study indicated that:- In all the samples assayed, API was identified as per label claim on the container.- One (3A) of the eleven samples was found to contain less than 80% API content. Sample 3A had Nevirapine percentage content less than the recommended 80-100%.- Samples 1B and 1C did not comply with the labeling requirements on the package according to the Statutory Instrument No. 47 of 1993. They did not reflect medicine category on the package. - All the eleven samples complied with labeling information on the inserts as per standard.The meaning of the results is that over 94% of the first-line HIV/AIDS medicines sampled contained the API in the right amounts as per label claim on the packages and that on average over 90% of these drugs were correctly labeled in accordance with the Statutory Instrument No. 47 of 1993 of PRA, Ministry of Health in Zambia.Finally, from the study it can be concluded that first-line HIV/AIDS medicines dispensed in Lusaka District of Zambia are of good quality and meet the requirements as stipulated in the official monographs.
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HIV/AIDS---Drugs , Antiretroviral Drugs
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