Background: There is growing concern in sub-Saharan Africa that poor-quality antimicrobial medicines may negate management of infectious diseases of public health importance should they fail to meet the set criteria of quality, safety and efficacy.
Objectives: The objective was to ascertain the quality of antiretroviral, antimalarial and antituberculosis medicines supplied and available in the public health sector in Zambia.
Design: A descriptive cross-sectional study was conducted involving the analysis of data from the continuous routine in-country post-marketing surveillance programme in Zambia that assessed the quality of antiretroviral, antimalarial and antituberculosis medicines supplied to public healthcare facilities between January 2018 and June 2023.
Methods: Data were extracted from laboratory quality analysis results from samples collected as part of routine post-marketing surveillance by the Zambia Medicines Regulatory Authority between January 2018 and June 2023. The samples were collected from various levels of the pharmaceutical supply chain across Zambia. Samples were analysed according to their respective pharmacopoeia standards at the Medicines Control Authority of Zimbabwe Quality Control Laboratory, a World Health Organization prequalified laboratory. Data were extracted using a structured Excel database and analysed using Microsoft Excel, and GraphPad Prism Software was used for visualizations.
Results: Of the 198 samples, 86 (43.43%) were antiretrovirals, 54 (27.27%) antimalarials and 58 (29.29%) antituberculosis medicines. Of these 198 samples, 171 (86.36%) originated from Asia, 19 (9.60%) Africa and 8 (4.04%) Europe. All sampled medicines met their respective quality specifications with respect to tests, which included appearance, identification, assay, uniformity of mass, weight variation, disintegration, dissolution, pH and specific gravity, giving a compliance rate of 100%.
Conclusion: Antiretrovirals, antimalarials and antituberculosis medicines obtained from public healthcare facilities in Zambia through routine post-marketing surveillance met their quality standards. This might positively impact treatment outcomes for HIV/AIDS, malaria and tuberculosis. There is a need for large-scale continuous monitoring of the quality of medicines in order to ensure quality is maintained and substandard products removed from the pharmaceutical supply chain.
Keywords: Antimicrobial medicines; Zambia; falsified; post-marketing surveillance; quality; substandard.
Outcomes from testing of antiretroviral, antimalarial and antituberculosis medicines in the Zambian public health facilities to establish if they are of good quality, safe and effective for treatment of HIV, malaria and tuberculosis Why was the study done? Management of diseases require the medicines used are able to treat specific ailments for them to be beneficial to the patient. Bad quality medicines may not be able to treat infections and sometimes may be harmful to the patient taking them. Reports of infections that are resistant to treatment are increasing, partly due to poor-quality medicines. This increasing trend disturbs programmes that aim at eradication of these diseases, and frustrates governments. This study aimed to understand the quality of medicines for diseases that cause a lot of hospital admissions and deaths in Zambia. What did the researchers do? The authors studied results of antiretrovirals, antimalarials and antituberculosis medicines collected across Zambia over a five-and-a-half-year period and tested in a quality control laboratory to understand the quality of these products. Quality of these products can affect treatment outcomes of HIV, malaria and tuberculosis. Knowing the quality of medicines in circulation helps generate evidence for decision-making by medicine regulatory bodies as they protect public health. What did the researchers find? Of the 198 results, the majority (n = 86) were antiretrovirals, followed by antituberculosis medicine (n = 58) and antimalarials (n = 54). All medicines that were tested passed with respect to the tests, giving a compliance rate of 100%. This should give confidence to the public pharmaceutical supply chain, with respect to how they procure their pharmaceuticals and how they are distributed and stored. What do the findings mean? The results show that medicines procured for the public sector in Zambia largely meet their quality requirements. This might positively impact treatment outcomes for HIV/AIDS, malaria and tuberculosis. More similar studies are required to establish a true picture of the quality of these medicines.
© The Author(s) 2024.