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 interms 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 ARVs dispensed in health facilities of Lusaka.ACross Section Survey was conducted in nine health facilities of Lusaka District, using 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 was 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 labeled. 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 monographsReferences
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4. CSO (2009) HIV/AIDS projections report 2008 version 5.
5. WHO (2003) Counterfeit triple antiretroviral combination product (Ginovir 3D) detected in Cote d'Ivoire. WHO QSM/MC/IEA.110, Bulletin d”Analyse N°
2003/U/NX/20391/M/ NC, Direction des Laboratoires et des Controles, (date de notification juillet 2003) AFSSAPS.
6. UNAIDS (2008), Uniting the World against AIDS: Sub-SaharanAfrica.
7. WHO (2006) Programmes and Projects, Bulletin of the World Health Organization, Past Issues, 84(9):685-764.
8. WHO (2008) Geneva: World Health Organization; 2008. [Updated 2008 Feb, cited 2009 Aug 22]. Available from: http://www.who.int/mediacentre/factsheets/fs275/en/.
9. WHO (2007) General information on counterfeit medicines, [http://www.who.int/medicines/services/counterfeit/] webcite, Accessed Aug 2009.
10. WHO (2009) AIDS Epidemic, Geneva: World Health Organization; 2007 Dec. [cited 2009 Aug 26]. Available from:http://www.who.int/hiv/epiupdates/en/index.htm
11. Ahmed Abdo-Rabbo, Amal Bassili and Hoda Atta (2005) The quality of antimalarials available in Yemen, Malaria Journal,4:28.
12. Kelesidis T, Kelesidis I, Rafailidis P.I and Falagas M.E (2007) Counterfeit or substandard antimalarial drugs, a review of the scientific evidence, Journal of Antimicrobial Chemotherapy, 60(3):214-236.
13. Siringi S (2004) AIDS drugs being sold illegally on market stalls in Kenya, Lancet; 363: 377. South China Business Journal,June/July/August(2008).
14. Bate R and Boateng K (2007) Bad Medicine in Market: Short Publications, American Enterprise Institute for Public Policy Research, Accessed online on 05/08/2009.
15. Ahmad K (2004) Antidepressants are sold as antiretrovirals in DR Congo, The Lancet, 363:713.
16. Kaisernetwork.org. Daily HIV/AIDS Report (2003) Drug Access/Ethiopian Health Officials Warn Public Against Counterfeit Antiretroviral, http://www.kaisernetwork.org/dailyDR_ID=20261.
17. Hanif M, Mobarak M, RonanA, Rahman D, Donovan J. et al. (2008) Fatal renal failure caused by diethylene glycol in paracetamol exlixir, The Bangladesh epidemic, British MedicalJournal, 311:88–91.
18. Quick JD, Rankin JR, Laing RO, O'Connor RW, Hogerzeil HV, Dukes MN, Garnett A (1997) Managing Drug Supply, The Selection, Procurement, Distribution and Use of Pharmaceuticals, 2nd Ed. West Hartford, Connecticut: Management Sciences for Health, Inc; 1997:275.
19. Apoola A, Sriskandabalan PS, Wade AAH (2001) Selfmedication with zidovudine that was not. Lancet; 357:1370.
20. Layloff T (2006) Drug manufacture, industrial pharmacy considerations, quality assurance and regulation. Management Sciences for Health, Baltimore.
21. Ravinetto R (2004) Counterfeit ARVs in DRC, EDRUG, Available from:http://www.essentialdrugs.org/edrug.
22. Severe P. and Leger P. (2008)ART in a Thousand Patients with AIDS in Haiti:N EnglJ. Med:353, 2325-2334.
23. Shakoor O, Taylor RB and Behrens RH (1997) Assessment of the incidence of sub-standard drugs in developing countries. Tropical Medicine and International Health,2(9):839-845.
24. Zarina Geloo (2005) Growing resistance to life-prolonging AIDs drugs in Zambia,Third World Network.
25. Fiddian Paul (2007) Pharmaceutical International African Correspondent, Pharmaceutical Regulatory Authority checks Zambian Viracept Supply.
26. Zambian Government Announces That Reported HIV/AIDS Cure Found to Be Pesticide (2000) Medical News Today [http://www.medicalnewstoday.com/articles/73084.php] webcite.
27. Wood G.L and Haber J. (2002).Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice.6th Edition, Mosby Elsevier,USA .
Published
2014-03-31
How to Cite
1.
Munkombwe D, Nzala S, Muungo T. Quality Analysis of Some First-line Antiretroviral Drugs Dispensed in Lusaka District Health Facilities of Zambia. Journal of Agricultural and Biomedical Sciences [Internet]. 31Mar.2014 [cited 14Jul.2025];2(1):11-7. Available from: https://journals.unza.zm/index.php/JABS/article/view/343
Section
Biomedical Sciences
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