Infection and Drug Resistance (Oct 2022)
Quality of Antimalarial Drugs in East Africa: A Systematic Review
Abstract
Million Girma,1 Belachew Umeta,2 Gemmechu Hasen,2 Sultan Suleman2,3 1School of Pharmacy, College of Medicine and Health Sciences, Wolaita Sodo University, Wolaita Sodo, Ethiopia; 2School of Pharmacy, Institute of Health, Jimma University, Jimma, Ethiopia; 3Jimma University Laboratory of Drug Quality (JuLaDQ), Jimma University, Jimma, EthiopiaCorrespondence: Belachew Umeta, School of Pharmacy, Institute of Health, Jimma University, Po. Box: 378, Jimma, Oromia, Ethiopia, Email [email protected]: The use of poor quality drugs will have multiple consequences with an extended hazard of growing drug-resistant strains.Purpose: The review aimed to provide the quality status of antimalarial drugs in East Africa.Data Source: PubMed, Scopus, Web of Science, and Google Scholar were searched from September 5 to September 12, 2021.Study Selection: The review included articles available as original research targeted at evaluating the quality of antimalarial drugs. For inclusion, data on at least one of the following quality control parameters were required: packaging and labeling, hardness, friability, weight variation/uniformity of weight, disintegration, dissolution, and assay/percentage purity. Mendeley citation manager version 1.19.4 was used to avoid duplication and organize references, and titles and abstracts were primarily used for screening.Data Extraction: The sample collection site, drug name, and the quality control parameters tested were retrieved from the selected studies.Data synthesis: Totally, 300 antimalarial drug samples from Ethiopia, Kenya and Tanzania were included in this review. No antimalarial drug tested failed the identification and disintegration test. However, 15.93% (36/226), 5.00% (15/300), and 1.90% (3/158) of antimalarial samples failed the dissolution, assay and mass uniformity test, respectively. Moreover, amodiaquine and sulfadoxine/pyrimethamine samples failed dissolution and assay tests. In addition, amodiaquine samples failed the mass uniformity test. However, artemether/lumefantrine and quinine passed all quality control parameters tested. Overall, 19.67% (59/300) of antimalarial drug samples did not meet at least one quality control parameter. And the higher faller rate was reported for sulfadoxine/pyrimethamine accounting for 52.86% (37/70).Conclusions: An unneglected amount of antimalarial drug failed to meet at least one quality control parameter. Strengthening pharmaceutical management systems, including post-marketing surveillance, and providing the resources required for medication quality assurance, are recommended.Keywords: antimalarial drugs, quality control, coartem, artemether/lumefantrine, assay, dissolution, East Africa
