1. Quality of antimalarials in Kinshasa peri-urban areas with regard to local pharmaceutical legislation and regulation.
- Author
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Mavungu Landu DJ, Frédérich M, Manzambi Kuwekita J, Bongo-Pasi Nswe C, Mbinze JK, Liégeois S, Kalenda Tshilombo N, Kwete Minga M, Ciza Hamuli P, Hubert P, and Marini Djang'eing'a R
- Subjects
- Antimalarials therapeutic use, Democratic Republic of the Congo, Drug Industry legislation & jurisprudence, Family Characteristics, Government Regulation, Humans, Malaria epidemiology, Pharmaceutical Preparations standards, Prospective Studies, Antimalarials standards, Drug Industry standards, Malaria drug therapy
- Abstract
Background: In the context of old pharmaceutical legislation and regulations not adapted to current realities, the aim of the present study was to evaluate the existing pharmaceutical system in peri-urban areas of Kinshasa., Methods: A prospective study was carried out during the period 2016-2018. The most used antimalarial medicines were identified through household and pharmaceutical establishment surveys. The samples of the obtained medicines were assayed with generic separation methods using the high-performance liquid chromatography technique coupled to a diode array detector. The registration status was checked for 126 antimalarial brand names. A characterization was carried out in 196 pharmaceutical establishments on the basis of standards set out by the Ministry of Health., Results: Of the 75 samples assayed, 19% (14/75) were non-compliant. Of the 124 brand names, 46.0% (57/124) were unlicensed and 14.5% (18/124) had an expired licence. Of the 196 pharmaceutical establishments, only 2 (1.0%) had an authorization to practice, none met all the Ministry of Health minimum standards and 24.5% (48/196) met the World Health Organization Guidelines for the Storage of Essential Medicines and Other Health Commodities., Conclusions: More resources should be mobilized to apply regulator sanctions., (© The Author(s) 2019. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.)
- Published
- 2020
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