title: Monitoring the quality of medicines: results from Africa, Asia, and South America.
abstract: Monitoring the quality of medicines plays a crucial role in an integrated medicines quality assurance system. In a publicly available medicines quality database (MQDB), the U.S. Pharmacopeial Convention (USP) reports results of data collected from medicines quality monitoring (MQM) activities spanning the period of 2003-2013 in 17 countries of Africa, Asia, and South America. The MQDB contains information on 15,063 samples collected and tested using Minilab® screening methods and/or pharmacopeial methods. Approximately 71% of the samples reported came from Asia, 23% from Africa, and 6% from South America. The samples collected and tested include mainly antibiotic, antimalarial, and antituberculosis medicines. A total of 848 samples, representing 5.6% of total samples, failed the quality test. The failure proportion per region was 11.5%, 10.4%, and 2.9% for South America, Africa, and Asia, respectively. Eighty-one counterfeit medicines were reported, 86.4% of which were found in Asia and 13.6% in Africa. Additional analysis of the data shows the distribution of poor-quality medicines per region and by therapeutic indication as well as possible trends of counterfeit medicines.
authors.forename: Mustapha
authors.initials: M
authors.lastname: Hajjou
authors.forename: Laura
authors.initials: L
authors.lastname: Krech
authors.forename: Christi
authors.initials: C
authors.lastname: Lane-Barlow
authors.forename: Lukas
authors.initials: L
authors.lastname: Roth
authors.forename: Victor S
authors.initials: VS
authors.lastname: Pribluda
authors.forename: Souly
authors.initials: S
authors.lastname: Phanouvong
authors.forename: Latifa
authors.initials: L
authors.lastname: El-Hadri
authors.forename: Lawrence
authors.initials: L
authors.lastname: Evans
authors.forename: Christopher
authors.initials: C
authors.lastname: Raymond
authors.forename: Elaine
authors.initials: E
authors.lastname: Yuan
authors.forename: Lang
authors.initials: L
authors.lastname: Siv
authors.forename: Tuan-Anh
authors.initials: TA
authors.lastname: Vuong
authors.forename: Kwasi Poku
authors.initials: KP
authors.lastname: Boateng
authors.forename: Regina
authors.initials: R
authors.lastname: Okafor
authors.forename: Kennedy M
authors.initials: KM
authors.lastname: Chibwe
authors.forename: Patrick H
authors.initials: PH
authors.lastname: Lukulay
mesh_terms: D000349:Africa; D000900:Anti-Bacterial Agents / Q000592:standards*; D000962:Antimalarials / Q000737:chemistry / Q000592:standards*; D000995:Antitubercular Agents / Q000737:chemistry / Q000592:standards*; D001208:Asia; D058110:Counterfeit Drugs; D016208:Databases, Factual; D004364:Pharmaceutical Preparations / Q000592:standards*; D013020:South America; D013997:Time Factors
chemical_list: D000900:Anti-Bacterial Agents; D000962:Antimalarials; D000995:Antitubercular Agents; D058110:Counterfeit Drugs; D004364:Pharmaceutical Preparations