{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T20:51:31Z","timestamp":1791233491250,"version":"4.1.0"},"reference-count":32,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"6","license":[{"start":{"date-parts":[[2024,12,4]],"date-time":"2024-12-04T00:00:00Z","timestamp":1733270400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,4]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n<jats:p>Sustainable access to high-quality antimalarial medicines is pivotal to achieving universal and effective malaria control. Poor-quality antimalarial medicines are prevalent in sub-Saharan Africa, impeding malaria control initiatives and claiming the lives of many children. Regular monitoring of the quality of antimalarial medicines is crucial to ensure the quality of service to the community. A cross-sectional study using a postmarket surveillance (PMS) approach was conducted from 2019 to 2023. Samples were collected from the port of entry, local manufacturers, and various distribution outlets in 15 regions of mainland Tanzania. The samples were subjected to tier 1 evaluation, comprising a product information review (PIR) and identification using the Global Pharma Health Fund-Minilab<jats:sup>\u00ae<\/jats:sup> techniques. Samples that failed the identification tests and 10% of the samples from distribution outlets that passed the tests were subjected to confirmatory testing (tier 2), which included assays, related substances, dissolution, and sterility per the pharmacopeial monographs. During five annual PMSs, 2,032 antimalarial samples were collected and subjected to quality tests. All samples complied with the standard specifications for identity, dissolution, related substances, sterility, physical evaluation, disintegration, and assay. A total of 292 (55.5%) tested samples failed the PIR evaluation, with incomplete package information in leaflets contributing to 64.7% of all deviations. Antimalarial medicines circulating in the mainland Tanzanian market meet expected quality standards. Continuous monitoring of the quality of antimalarial medicines is recommended.<\/jats:p>","DOI":"10.4269\/ajtmh.24-0145","type":"journal-article","created":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T14:54:42Z","timestamp":1727794482000},"page":"1215-1222","source":"Crossref","is-referenced-by-count":2,"title":["A Comprehensive Assessment of Quality of Antimalarial Medicines in Mainland Tanzania: Insights from Five Years of Postmarket Surveillance"],"prefix":"10.4269","volume":"111","author":[{"given":"Eulambius M.","family":"Mlugu","sequence":"first","affiliation":[{"name":"Department of Pharmaceutics and Pharmacy Practice, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob","family":"Mhagama","sequence":"additional","affiliation":[{"name":"Tanzania Medicines and Medical Devices Authority, Dodoma, Tanzania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Damas","family":"Matiko","sequence":"additional","affiliation":[{"name":"Tanzania Medicines and Medical Devices Authority, Dodoma, Tanzania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siya","family":"Agustine","sequence":"additional","affiliation":[{"name":"Tanzania Medicines and Medical Devices Authority, Dodoma, Tanzania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moses","family":"Nandonde","sequence":"additional","affiliation":[{"name":"Tanzania Medicines and Medical Devices Authority, Dodoma, Tanzania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Masunga","sequence":"additional","affiliation":[{"name":"Tanzania Medicines and Medical Devices Authority, Dodoma, Tanzania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter P.","family":"Kunambi","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raphael Zozimus","family":"Sangeda","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Microbiology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yonah H.","family":"Mwalwisi","sequence":"additional","affiliation":[{"name":"Tanzania Medicines and Medical Devices Authority, Dodoma, Tanzania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Fimbo","sequence":"additional","affiliation":[{"name":"Tanzania Medicines and Medical Devices Authority, Dodoma, Tanzania;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"b1","series-title":"World Malaria Report 2023","year":"2023"},{"key":"b2","series-title":"Tanzania Demographic and Health Survey and Malaria Indicator Survey 2022: Key Indicators Report","year":"2023"},{"key":"b3","series-title":"Global Sustainable Development Goals","year":"2022"},{"key":"b4","series-title":"National Malaria Strategic Plan 2021\u20132025: Transitioning to Malaria Elimination in Phases","year":"2021"},{"key":"b5","series-title":"Am J Trop Med Hyg","first-page":"119","article-title":"Estimated under-five deaths associated with poor-quality anti-malarials in sub-Saharan Africa","volume":"92","author":"Renschler","year":"2015"},{"key":"b6","series-title":"BMJ Open","first-page":"e021825","article-title":"Economic cost of substandard and falsified human medicines and cosmetics with banned ingredients in Tanzania from 2005 to 2015: A retrospective review of data from the regulatory authority","volume":"8","author":"Mori","year":"2018"},{"key":"b7","series-title":"A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products","year":"2020"},{"key":"b8","series-title":"Trans R Soc Trop Med Hyg","first-page":"1019","article-title":"Counterfeit and substandard antimalarial drugs in Cambodia","volume":"100","author":"Lon","year":"2006"},{"key":"b9","series-title":"Expert Rev Anti Infect Ther","first-page":"531","article-title":"A link between poor quality anti-malarials and malaria drug resistance?","volume":"14","author":"Newton","year":"2016"},{"key":"b10","series-title":"Lancet Infect Dis","first-page":"488","article-title":"Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa","volume":"12","author":"Nayyar","year":"2012"},{"key":"b11","series-title":"JAMA Netw Open","first-page":"e181662","article-title":"Prevalence and estimated economic burden of substandard and falsified medicines in low- and middle-income countries: A systematic review and meta-analysis","volume":"1","author":"Ozawa","year":"2018"},{"key":"b12","series-title":"Malar Res Treat","first-page":"12","article-title":"Evaluation of the quality of artemisinin-based antimalarial medicines distributed in Ghana and Togo","volume":"806416","author":"Osei-Safo","year":"2014"},{"key":"b13","series-title":"Malar J","first-page":"127","article-title":"Postmarketing surveillance of antimalarial medicines used in Malawi","volume":"14","author":"Chikowe","year":"2015"},{"key":"b14","series-title":"Am J Trop Med Hyg","first-page":"51","article-title":"Substandard anti-malarials available in Afghanistan: A case for assessing the quality of drugs in resource poor settings","volume":"92","author":"Lalani","year":"2015"},{"key":"b15","series-title":"Futur J Pharm Sci","first-page":"131","article-title":"Pharmaceutical quality of antimalarial drugs: Quinine sulfate and Artemether\/Lumefantrine tablets sold on Bukavu 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