Quality of Selected Anti-Retroviral Medicines: Tanzania Mainland Market As A Case Study

Abstract

Background: Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure, and prolonged illness, development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. Thus, to ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market.Methods: This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All collected samples were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and ten percent (10%) of all that complied with the screening test requirements were selected for full quality control testing in the World Health Organisation prequalified laboratory at Tanzania Medicines and Medical Devices Authority (TMDA). Samples collected from the medicine distribution outlets were also subjected to product information review. Results: A total of 2,630 samples were collected, of which 83.7% (2200/2630) were from port of entry (POEs). Of the 2200 samples screened, all conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27% (7/2630) and lamivudine/zidovudine/nevirapine 0.27% (7/2630) that failed the disintegration test. Also, of the 100 samples selected for full quality control testing, 3% of them failed to compile with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2% (2/100) and 1% (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6%) versus specification limits (90% -110%). Out of the 430 samples which were subjected to product information review, 25.6% (110/430) failed to comply with the packaging and labelling requirements. Conclusion: The quality of majority of ARVs circulating on the Tanzania Mainland market was good but, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania market.

Emerging Antimicrobial Drug Resistance in Africa and Latin America: Search for Reasons

“…52 All samples were subjected to screening using the GPHF Minilab, and samples failing the screening were transferred to a TMDA prequalified quality control laboratory for further analysis. 53 , 54 …”