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Quality of antimalarials in Kinshasa peri-urban areas with regard to local pharmaceutical legislation and regulation.


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.

SUBMITTER: Mavungu Landu DJ 

PROVIDER: S-EPMC7322209 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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<h4>Background</h4>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.<h4>Methods</h4>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 m  ...[more]

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