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The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey

Poor-quality medicines are a threat to public health in many low- and middle-income countries, and prospective surveys are needed to inform corrective actions. Therefore, we conducted a cross-sectional survey on a sample of products used for children and available in the private market in Kinshasa,...

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Autores principales: Schiavetti, Benedetta, Wynendaele, Evelien, De Spiegeleer, Bart, Mbinze, Geremie J., Kalenda, Nicodème, Marini, Roland, Melotte, Vera, Hasker, Epco, Meessen, Bruno, Ravinetto, Raffaella, Van der Elst, Josiane, Mutolo Ngeleka, Daniel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The American Society of Tropical Medicine and Hygiene 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5930909/
https://www.ncbi.nlm.nih.gov/pubmed/29313479
http://dx.doi.org/10.4269/ajtmh.17-0732
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author Schiavetti, Benedetta
Wynendaele, Evelien
De Spiegeleer, Bart
Mbinze, Geremie J.
Kalenda, Nicodème
Marini, Roland
Melotte, Vera
Hasker, Epco
Meessen, Bruno
Ravinetto, Raffaella
Van der Elst, Josiane
Mutolo Ngeleka, Daniel
author_facet Schiavetti, Benedetta
Wynendaele, Evelien
De Spiegeleer, Bart
Mbinze, Geremie J.
Kalenda, Nicodème
Marini, Roland
Melotte, Vera
Hasker, Epco
Meessen, Bruno
Ravinetto, Raffaella
Van der Elst, Josiane
Mutolo Ngeleka, Daniel
author_sort Schiavetti, Benedetta
collection PubMed
description Poor-quality medicines are a threat to public health in many low- and middle-income countries, and prospective surveys are needed to inform corrective actions. Therefore, we conducted a cross-sectional survey on a sample of products used for children and available in the private market in Kinshasa, Democratic Republic Congo: amoxicillin (AX) and artemether/lumefantrine (AL), powders for suspension, and paracetamol (PC) tablets 500 mg. Overall, 417 products were covertly purchased from 61 wholesalers. To obtain a representative sample, the products were weighted on their market shares and a subset of 239 samples was randomly extracted to undergo in-depth visual inspection locally, and they were chemically assessed at two accredited laboratories in Belgium. Samples were defined of “poor-quality” if they failed to comply with at least one specification of the International Pharmacopoeia (for AL) or United States Pharmacopoeia 37 (for AX and PC). Results are reported according to the Medicine Quality Assessment Reporting Guideline. The visual inspection detected nonconformities in the aspects of antimalarial powders for suspension, and poor-quality labels across all medicine types. According to chemical analysis, 27.2% samples were of poor quality and 59.5% of AL samples were underdosed in artemether. Poor quality was more frequent for locally manufactured antimalarials (83.3%, P = 0.021; 86.4%, P = 0.022) and PC (4.8%, P = 0.000). The poor quality of the surveyed products may decrease the treatment’s efficacy and favor the development of resistances to antimalarials. It is hoped that these findings may guide the corrective actions of the Democratic Republic of Congo Regulatory Authority, which was the main partner in the research.
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spelling pubmed-59309092018-05-08 The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey Schiavetti, Benedetta Wynendaele, Evelien De Spiegeleer, Bart Mbinze, Geremie J. Kalenda, Nicodème Marini, Roland Melotte, Vera Hasker, Epco Meessen, Bruno Ravinetto, Raffaella Van der Elst, Josiane Mutolo Ngeleka, Daniel Am J Trop Med Hyg Articles Poor-quality medicines are a threat to public health in many low- and middle-income countries, and prospective surveys are needed to inform corrective actions. Therefore, we conducted a cross-sectional survey on a sample of products used for children and available in the private market in Kinshasa, Democratic Republic Congo: amoxicillin (AX) and artemether/lumefantrine (AL), powders for suspension, and paracetamol (PC) tablets 500 mg. Overall, 417 products were covertly purchased from 61 wholesalers. To obtain a representative sample, the products were weighted on their market shares and a subset of 239 samples was randomly extracted to undergo in-depth visual inspection locally, and they were chemically assessed at two accredited laboratories in Belgium. Samples were defined of “poor-quality” if they failed to comply with at least one specification of the International Pharmacopoeia (for AL) or United States Pharmacopoeia 37 (for AX and PC). Results are reported according to the Medicine Quality Assessment Reporting Guideline. The visual inspection detected nonconformities in the aspects of antimalarial powders for suspension, and poor-quality labels across all medicine types. According to chemical analysis, 27.2% samples were of poor quality and 59.5% of AL samples were underdosed in artemether. Poor quality was more frequent for locally manufactured antimalarials (83.3%, P = 0.021; 86.4%, P = 0.022) and PC (4.8%, P = 0.000). The poor quality of the surveyed products may decrease the treatment’s efficacy and favor the development of resistances to antimalarials. It is hoped that these findings may guide the corrective actions of the Democratic Republic of Congo Regulatory Authority, which was the main partner in the research. The American Society of Tropical Medicine and Hygiene 2018-03 2018-01-08 /pmc/articles/PMC5930909/ /pubmed/29313479 http://dx.doi.org/10.4269/ajtmh.17-0732 Text en © The American Society of Tropical Medicine and Hygiene This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Articles
Schiavetti, Benedetta
Wynendaele, Evelien
De Spiegeleer, Bart
Mbinze, Geremie J.
Kalenda, Nicodème
Marini, Roland
Melotte, Vera
Hasker, Epco
Meessen, Bruno
Ravinetto, Raffaella
Van der Elst, Josiane
Mutolo Ngeleka, Daniel
The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey
title The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey
title_full The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey
title_fullStr The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey
title_full_unstemmed The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey
title_short The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey
title_sort quality of medicines used in children and supplied by private pharmaceutical wholesalers in kinshasa, democratic republic of congo: a prospective survey
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5930909/
https://www.ncbi.nlm.nih.gov/pubmed/29313479
http://dx.doi.org/10.4269/ajtmh.17-0732
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