The Poor-quality medical products in the Democratic Republic of Congo: A ten-year retrospective study in Kinshasa (2012–2021)
Introduction Substandard and falsified (SF) medical products continue to threaten public health worldwide, particularly in developing countries. Unfortunately, the available literature primarily focuses on anti-infective drugs. Purpose The aim of this study is to review data on the quali...
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Orapuh, Inc.
2025-05-01
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| Online Access: | https://www.orapuh.org/ojs/ojs-3.1.2-4/index.php/orapj/article/view/356 |
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| author | Dadit Ive Kitenge Jocelyn Mankulu Kakumba Aristide Onoloke Onoloke Guislain Onya Lohaka Walter Ndjibu Kiungu Didi Mana Kialengila Patient Ciza Hamuli Jérémie Mbinze Kindenge Jean-Pierre Mufusama Koy Sita |
| author_facet | Dadit Ive Kitenge Jocelyn Mankulu Kakumba Aristide Onoloke Onoloke Guislain Onya Lohaka Walter Ndjibu Kiungu Didi Mana Kialengila Patient Ciza Hamuli Jérémie Mbinze Kindenge Jean-Pierre Mufusama Koy Sita |
| author_sort | Dadit Ive Kitenge |
| collection | DOAJ |
| description |
Introduction
Substandard and falsified (SF) medical products continue to threaten public health worldwide, particularly in developing countries. Unfortunately, the available literature primarily focuses on anti-infective drugs.
Purpose
The aim of this study is to review data on the quality of medical products to contribute to the development of future field studies.
Methods
A ten-year retrospective study in Kinshasa, DRC, analyzed data on poor-quality medical products from 2012 to 2021. The study identified international non-proprietary names, pharmaceutical forms, countries of origin, causes of non-compliance, therapeutic classes, batch numbers, and labeling.
Results
Although the descriptive statistics derived from these data show a rate of non-compliance ranging from 0.45% to 1.34%, well below recent World Health Organization estimates, the current study reveals that quality problems with medical products also affect therapeutic classes other than antimalarials and antibiotics.
Conclusion
This study aimed to analyze data on the quality of medical products in Kinshasa to contribute to future studies. The study involved 59,961 samples analyzed over a decade, with 258 non-compliant samples in the first laboratory, 670 in the second laboratory, and 7,681 in the third laboratory. Factors such as the country and continent of manufacture, therapeutic classes, non-compliant drugs, and pharmacological forms were considered. These results highlight the need for regulatory authorities to implement effective surveillance and monitoring policies for all establishments involved in the quality control of medicines and health products. Such efforts are essential for ensuring consumer safety and reflecting the quality of regulatory activities, which must encompass all parameters that contribute to the development of an exemplary quality model.
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| format | Article |
| id | doaj-art-a84f3aed27f34341bbec333f3caf8d00 |
| institution | OA Journals |
| issn | 2644-3740 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Orapuh, Inc. |
| record_format | Article |
| series | Orapuh Journal |
| spelling | doaj-art-a84f3aed27f34341bbec333f3caf8d002025-08-20T01:51:16ZengOrapuh, Inc.Orapuh Journal2644-37402025-05-016410.4314/orapj.v6i4.39The Poor-quality medical products in the Democratic Republic of Congo: A ten-year retrospective study in Kinshasa (2012–2021)Dadit Ive Kitenge0Jocelyn Mankulu Kakumba1Aristide Onoloke Onoloke2Guislain Onya Lohaka3Walter Ndjibu Kiungu4Didi Mana Kialengila5Patient Ciza Hamuli6Jérémie Mbinze Kindenge7Jean-Pierre Mufusama Koy Sita8University of Kinshasa, Kinshasa, Democratic Republic of the CongoUniversity of Kinshasa, Kinshasa, Democratic Republic of the CongoUniversity of Kinshasa, Kinshasa, Democratic Republic of the CongoUniversity of Kinshasa, Kinshasa, Democratic Republic of the CongoUniversity of Kinshasa, Kinshasa, Democratic Republic of the CongoUniversity of Kinshasa, Kinshasa, Democratic Republic of the CongoUniversity of Kinshasa, Kinshasa, Democratic Republic of the CongoUniversity of Kinshasa, Kinshasa, Democratic Republic of the CongoUniversity of Kinshasa, Kinshasa, Democratic Republic of the Congo Introduction Substandard and falsified (SF) medical products continue to threaten public health worldwide, particularly in developing countries. Unfortunately, the available literature primarily focuses on anti-infective drugs. Purpose The aim of this study is to review data on the quality of medical products to contribute to the development of future field studies. Methods A ten-year retrospective study in Kinshasa, DRC, analyzed data on poor-quality medical products from 2012 to 2021. The study identified international non-proprietary names, pharmaceutical forms, countries of origin, causes of non-compliance, therapeutic classes, batch numbers, and labeling. Results Although the descriptive statistics derived from these data show a rate of non-compliance ranging from 0.45% to 1.34%, well below recent World Health Organization estimates, the current study reveals that quality problems with medical products also affect therapeutic classes other than antimalarials and antibiotics. Conclusion This study aimed to analyze data on the quality of medical products in Kinshasa to contribute to future studies. The study involved 59,961 samples analyzed over a decade, with 258 non-compliant samples in the first laboratory, 670 in the second laboratory, and 7,681 in the third laboratory. Factors such as the country and continent of manufacture, therapeutic classes, non-compliant drugs, and pharmacological forms were considered. These results highlight the need for regulatory authorities to implement effective surveillance and monitoring policies for all establishments involved in the quality control of medicines and health products. Such efforts are essential for ensuring consumer safety and reflecting the quality of regulatory activities, which must encompass all parameters that contribute to the development of an exemplary quality model. https://www.orapuh.org/ojs/ojs-3.1.2-4/index.php/orapj/article/view/356Poor-quality medicinessubstandard and falsified medical productsKinshasaDemocratic Republic of the Congodocumentary quality survey |
| spellingShingle | Dadit Ive Kitenge Jocelyn Mankulu Kakumba Aristide Onoloke Onoloke Guislain Onya Lohaka Walter Ndjibu Kiungu Didi Mana Kialengila Patient Ciza Hamuli Jérémie Mbinze Kindenge Jean-Pierre Mufusama Koy Sita The Poor-quality medical products in the Democratic Republic of Congo: A ten-year retrospective study in Kinshasa (2012–2021) Orapuh Journal Poor-quality medicines substandard and falsified medical products Kinshasa Democratic Republic of the Congo documentary quality survey |
| title | The Poor-quality medical products in the Democratic Republic of Congo: A ten-year retrospective study in Kinshasa (2012–2021) |
| title_full | The Poor-quality medical products in the Democratic Republic of Congo: A ten-year retrospective study in Kinshasa (2012–2021) |
| title_fullStr | The Poor-quality medical products in the Democratic Republic of Congo: A ten-year retrospective study in Kinshasa (2012–2021) |
| title_full_unstemmed | The Poor-quality medical products in the Democratic Republic of Congo: A ten-year retrospective study in Kinshasa (2012–2021) |
| title_short | The Poor-quality medical products in the Democratic Republic of Congo: A ten-year retrospective study in Kinshasa (2012–2021) |
| title_sort | poor quality medical products in the democratic republic of congo a ten year retrospective study in kinshasa 2012 2021 |
| topic | Poor-quality medicines substandard and falsified medical products Kinshasa Democratic Republic of the Congo documentary quality survey |
| url | https://www.orapuh.org/ojs/ojs-3.1.2-4/index.php/orapj/article/view/356 |
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