Journal of Pharmacovigilance

Survey on counterfeiting of amoxicillin and amoxicillin + clavulanic acid marketed in Lubumbashi

6^th Pharmacovigilance Congress

September 28-30, 2016 Toronto, Canada

Pierrot Mwamba T

University of Lubumbashi, Congo

Scientific Tracks Abstracts: J Pharmacovigil

Abstract:

Counterfeit medicines represent a major health risk in the treatment of various pathologies. They are responsible for resistance emergence in the treatment of infectious diseases. This study was conducted in order to identify illegal and legal drugs marketed in the city of Lubumbashi and assess the quality of all samples concerned by this study. The study included amoxicillin and amoxicillin + clavulanic acid for oral administration. Visual inspection of medicines, investigation of authenticity of drugs from pharmaceutical regulatory authorities, and determination of content were used as study parameters. A total of 48 samples were collected including 34 of amoxicillin and 14 of combination amoxicillin + clavulanic acid. 16 (33%) samples are not permitted to be marketed. 23 (33%) samples were substandard according to the US Pharmacopeia in terms of dosage of active ingredient. Out of 23, in 21 (91%) samples, the active ingredient was in lower amount (under-dosing) and 2 samples (9%) had both under-dosing and overdosing. The proportion of non-compliance is highest among medicines non permitted to be marketed (81.25% vs 31.25%; p�?0,005). It is obvious that strengthening the capacity of the drug regulatory authority of the DRC reduces the influx of counterfeit drug and substandard.

Biography :

Pierrot Mwamba T is Associate Researcher in Drug Analysis and Industrial Pharmacy. He has completed his Post-graduation in University of Lubumbashi. He has published one paper in The Pan African Medical Journal. Currently, he is being trained by Professor Jean Baptiste Kalonji and Professor Pierre Duez on research theme: Counterfeiting drugs in D R Congo.

Email: pierrotmwamba@gmail.com