International health · 2020
Quality of antimalarials in Kinshasa peri-urban areas with regard to local pharmaceutical legislation and regulation.
СтатьяНазвание и аннотация: Перевод в очереди
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Mavungu Landu Don Jethro, Frédérich Michel, Manzambi Kuwekita Joseph, Bongo-Pasi Nswe Christian, Mbinze J K, Liégeois Sophie, Kalenda Tshilombo Nicodème, Kwete Minga Mineze, Ciza Hamuli Patient, Hubert Philippe, Marini Djang'eing'a Roland
Аннотация
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.
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.