References of "Marini Djang'Eing'A, Roland"
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See detailLes risques toxicologiques liés aux médicaments de qualité inférieure
Marini Djang'Eing'A, Roland ULg; Kalenda Tshilombo, Nicodème ULg; Ciza Hamuli, Patient ULg et al

Conference (2017, October 19)

Objective: Poor quality medicines regrouping counterfeit/falsified, sub-standards and degraded are a scourge for developing countries (1). Their public health consequences are often observed for cases of ... [more ▼]

Objective: Poor quality medicines regrouping counterfeit/falsified, sub-standards and degraded are a scourge for developing countries (1). Their public health consequences are often observed for cases of low dosage of active ingredients and sometimes for the absence of these. On the basis of the observed facts as well as suspected reported cases, we were interested in deepening the information through laboratory tests. Methods: Liquid chromatography (LC), thin layer chromatography (TLC), nuclear magnetic resonance (NMR), mass spectrometry (MS), Raman imagery (Rim) and near infrared spectroscopy (NIR) were used as targeted analytical techniques in this study, associated with the principal component analysis (PCA), while the suspect samples were obtained via the public health authorities of the DR Congo, Benin and Rwanda after their seizure. Results: The observed cases are presented by therapeutic class, namely: - analgesics: (1) cases of tablets supposed to contain paracetamol and which have caused abnormal adverse effects in patients who have consumed it, namely sedative effects, polyuria and hypotension. Using LC and complementary surveys by people interview, we were able to demonstrate the presence of a benzodiazepine and at very high doses. (2) Cases of paracetamol syrup whose excipient (glycerol) was substituted by diethylene glycol and which had caused the death of a hundred babies. Using the NIR and the PCA, we were able to elucidate this substitution. - antimalarials: (case 1) cases of arthemether-lumefantrine tablets which had no therapeutic effect. By means of TLC and LC, the absence of these two active ingredients was clearly demonstrated, but the presence of starch was revealed by Rim. (Case 2) case of quinine tablets that had no expected pharmacological effect. The use of several combined techniques (TLC, LC-MS, NMR and Rim) made it possible to demonstrate the presence of a substance with an imidazole structure (antamoeba). - antibiotics: (1) amoxicillin powder which after reconstitution in hospital caused poisoning of the babies until death for some. The reconstitution of the suspension had revealed the misuse of hydrogen peroxide instead of distilled water. (2) Finally a large-scale study (80 samples of amoxicillin powder) showed that 8% of the samples were above the claimed dosage. Conclusion: The cases presented indicate that there are effectively poor quality medicines and that they are responsible of public health problems and in particular of toxicity. Appropriate measures should be taken to protect users. [less ▲]

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See detailThe quality of artemether-lumefantrine combination and characteristics of pharmacies in the periurban areas of kinshasa
Mavungu Landu, Don Jethro ULg; Liégeois, Sophie; Manzambi Kuwekita, Joseph ULg et al

Conference (2017, October 18)

QUALITÉ DE LA COMBINAISON THERAPEUTIQUE ARTEMETHER-LUMEFANTRINE ET CARACTÉRISTIQUES DES PHARMACIES EN TERRITOIRES PÉRIURBAINS DE KINSHASA Mavungu Landu DJ.1,2, Liégeois S., Manzambi Kuwekita J.3,4, Mbinze ... [more ▼]

QUALITÉ DE LA COMBINAISON THERAPEUTIQUE ARTEMETHER-LUMEFANTRINE ET CARACTÉRISTIQUES DES PHARMACIES EN TERRITOIRES PÉRIURBAINS DE KINSHASA Mavungu Landu DJ.1,2, Liégeois S., Manzambi Kuwekita J.3,4, Mbinze J.5, Mavungu Nsiona J.6,Hubert P.1, Michel B.2,7, Gretry L.8, Minga Kwete M.9, Reginster J-Y.3, Frédérich M.1, Marini Djang'Eing'A R.1 1 Département de Pharmacie, Université de Liège, Liège, Belgique; 2 Ecole Régionale Postuniversitaire d’Aménagement et de Gestion intégrés des Forêts et Territoires tropicaux, Kinshasa, RDC; 3 Département des Sciences de la Santé Publique, Université de Liège, Liège, Belgique; 4 Section de Santé Communautaire, Institut Supérieur des Techniques Médicales de Kinshasa, Kinshasa, RDC; 5 Département de Galénique et d’Analyse des Médicaments, Université de Kinshasa, Kinshasa, RDC; 6 Division Provinciale de la Santé, Kinshasa, RDC; 7 Faculté Universitaire des Sciences Agronomiques de Gembloux, Université de Liège, Gembloux, Belgique; 8 Plateforme Afrique Centrale, PACODEL, Kinshasa, RDC; 9 Secure drug, Kinshasa, RDC. Introduction: Le paludisme causé par le Plasmodium falciparum demeure un problème majeur de santé publique. Le traitement avec des antipaludiques de bonne qualité est une composante importante dans le contrôle de cette maladie. Cependant en Afrique centrale, plus de 25% des médicaments serait contrefaits ou de qualité inférieure, situation qui serait encore plus dramatique dans les territoires périurbains. Objectif: Afin de permettre une sensibilisation des populations vivant dans ces milieux, une étude a été menée dans le but d’évaluer l’existant au niveau sanitaire pharmaceutique. Méthodes: Dans le contexte ci-mentionné, une étude préliminaire et prospective a été menée dans la zone de santé de Mont Ngafula 1 située dans les territoires périurbains de la Ville de Kinshasa durant la période allant du 22 février au 10 décembre 2016. Trente échantillons de poudre pour suspension d’artéméther et de luméfantrine ont été collectés. L’analyse de la qualité de ces médicaments a été réalisée au moyen de méthodes séparatives génériques utilisant la technique de chromatographie liquide à haute performance couplé à un détecteur à barrettes de diodes. Une caractérisation a été également effectuée dans 127 établissements pharmaceutiques sur base des normes édictées par le Ministère de la Santé Publique congolais. Résultats: Le résultat des analyses des échantillons d’antimalariques (ou antipaludéens) montre qu’une poudre pour suspension d’artéméther et de luméfantrine sur trois (33,3%) ne contenait pas la concentration prévue en artéméther et/ou en luméfantrine. Par ailleurs, le résultat des observations évoque qu’aucun établissement pharmaceutique ne respectait l’ensemble des normes du Ministère de la Santé Publique. Conclusion: Cette étude nous apprend qu’en territoires périurbains de Kinshasa, un échantillon sur trois (33,3%) de la combinaison Artéméther-Luméfantrine est non conforme, les suspensions sont sous-dosées. Quant aux pharmacies existantes, aucune d’entre elles ne respecte l’ensemble des normes minimales édictées par le Ministère de la Santé Publique de la RDC. [less ▲]

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See detailInvestigation of content of Panda oleosa (Pierre), a plant used in Kisangani areas for its antihyperglycemic activity
Katemo Muhoya, Frédéric; Kadima Ntokamunda, Justin; Njakarinala Ranarivelo et al

Conference (2017, October 05)

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See detailPoor quality medicines in Africa: how to combat this real scourge
Marini Djang'Eing'A, Roland ULg; Sacre, Pierre-Yves ULg; Ziemons, Eric ULg et al

Conference (2017, October 04)

Poor (or low) quality medicines remain a crucial problem of public health around the world. They encompass falsified /counterfeit, substandard or degraded drugs. If proportion of 1% is estimated in ... [more ▼]

Poor (or low) quality medicines remain a crucial problem of public health around the world. They encompass falsified /counterfeit, substandard or degraded drugs. If proportion of 1% is estimated in developed countries, they are globally about 10 % of counterfeit drugs according to Food and Drug Administration, with 30% in low income countries and astonishing values (80 %) reported in some African countries. The consequences and dangers of such medicines are therapeutic failure, drug poisoning, microbial resistance or even death. For the pharmaceutical industries, there are loss of image, loss of financial income and employment. There is need to combat this scourge, but most of the time, means are very limited and even lacking. In this context, several means or tools are developed by the ULg Pharmacy Department including the simple ones including organoleptic tests, simple analytical tests such as analytical balance, pHmeter, thin layer chromatography (TLC), UV-visible spectrophotometry to the more complex including liquid chromatography (LC) coupled to UV-Vis detector, or to mass spectrometry, nuclear magnetic resonance, Raman imagery (RIM) and near infrared (NIR) spectroscopy associated with the principal component analysis (PCA). In this way, we have analyzed several suspected samples obtained via the public health authorities of the D.R. Congo, Benin and Rwanda after their seizure or through collaborations. The results are presented by therapeutic class, namely: analgesics: - by using LC and complementary information from victim patients, we were able to discover an abnormal presence of a benzodiazepine at very high doses in paracetamol tablets which was the cause of unusual adverse effects (sedative effects, polyuria and hypotension) in patients who have consumed it; - by using the NIR-PCA, we were able to elucidate the substitution of an excipient (glycerol) by diethylene glycol in paracetamol syrup which caused the death of a hundred babies. antimalarials: - we faced cases of arthemether-lumefantrine tablets which had no therapeutic effect. By means of TLC and LC, the absence of these two active ingredients was clearly demonstrated, but the presence of starch was revealed by RIM; - another case of quinine tablets that had no expected pharmacological effect was faced. The use of several combined techniques (TLC, LC-MS, NMR and RIM) allowed to detect the presence of a substance with an imidazole structure (antamoeba). antibiotics: - the case of amoxicillin powder which after reconstitution in hospital caused poisoning of the babies until death for some was investigated. The reconstitution of the suspension in the laboratory had revealed the misuse of hydrogen peroxide instead of distilled water; - we participated to a large-scale study (80 samples of amoxicillin powder) that showed 8% of overdose. The cases presented indicate that there are effectively poor quality medicines and there is need to sustain strong collaborations while reinforcing appropriate measures to protect users. [less ▲]

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See detailPreliminary Phytochemical Content and Antidiabetic Potential Investigations of Panda oleosa (Pierre) Used in Kisangani Areas
Katemo Muhoya, Frédéric; Kadima Ntokamunda, Justin; Njakarinala Ranarivelo et al

in American Journal of Analytical Chemistry (2017), 8

Panda oleosa Pierre (POP), a tropical plant tree, has been used in traditional medicine in Kisangani city and around to treat various diseases including diabètes and HIV/AIDs. This study aims to evaluate ... [more ▼]

Panda oleosa Pierre (POP), a tropical plant tree, has been used in traditional medicine in Kisangani city and around to treat various diseases including diabètes and HIV/AIDs. This study aims to evaluate the chemical composition of POP extracts while setting up chromatographic fingerprints for their quality control, and the anti-hyperglycemic potential of trunk bark aqueous extracts of POP. Common chemical reactions were used for identification of main secondary metabolic groups. Thin layer chromatography was used to set up several chromatographic fingerprints of water and alcoholic extracts while evaluating chemical composition. Oral glucose tolerance test served to induce hyperglycemia in a rabbit model. The extracts were given as 25 mg/kg, 50 mg/kg, and 100 mg/kg body weight, 30 minutes before loading animals with glucose 4 g/kg. Blood samples were collected at various times: just before extracts (T-30), before (T0) and after glucose load (T30, T60, T120, and T180). Blood glucose levels were measured with One Touch Glucometer. The identification tests revealed the presence of saponins (3.58%), tannins (5%); alkaloids, quinones, flavonoids, and terpenes sterols could not be formerly detected by the reagents used. Interesting chromatographic spots were observed whose behaviors are of catechic tannin proanthocyanes. The extract significantly reduced glucose levels in dose dependent manner as compared to control and glibenclamide reference groups. The average of mean percentage of reduction in glucose level at T120 with the extract 100 mg/kg was close to that of glibenclamide 0.25 mg/kg (49% and 40.2%). These findings back the traditional use of the plant to treat diabetic patients and constitute a foundation for an extensive study to find a new antidiabetic phythomedicine. [less ▲]

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See detailIs supercritical fluid chromatography hyphenated to massspectrometry suitable for the quality control of vitamin D3 oilyformulations?
Andri, Bertyl ULg; Dispas, Amandine ULg; Klinkenberg, Régis et al

in Journal of Chromatography. A (2017), 1515

Nowadays, many efforts are devoted to improve analytical methods regarding efficiency, analysis timeand greenness. In this context, Supercritical Fluid Chromatography (SFC) is often regarded as a ... [more ▼]

Nowadays, many efforts are devoted to improve analytical methods regarding efficiency, analysis timeand greenness. In this context, Supercritical Fluid Chromatography (SFC) is often regarded as a goodalternative over Normal Phase Liquid Chromatography (NPLC). Indeed, modern SFC separations arefast, efficient with suitable quantitative performances. Moreover, the hyphenation of SFC to mass spec-trometry (MS) provides additional gains in specificity and sensitivity. The present work aims at thedetermination of vitamin D3 by SFC-MS for routine Quality Control (QC) of medicines specifically. Basedon the chromatographic parameters previously defined in SFC-UV by Design of Experiments (DoE) andDesign Space methodology, the method was adapted to work under isopycnic conditions ensuring a base-line separation of the compounds. Afterwards, the response provided by the MS detector was optimizedby means of DoE methodology associated to desirability functions. Using these optimal MS parameters,quantitative performances of the SFC-MS method were challenged by means of total error approachmethod validation. The resulting accuracy profile demonstrated the full validity of the SFC-MS method. It was indeed possible to meet the specification established by the European Medicines Agency (EMA) (i.e. 95.0 − 105.0% of the API content) for a dosing range corresponding to at least 70.0-130.0% of theAPI content. These results highlight the possibility to use SFC-MS for the QC of medicine and obviouslysupport the switch to greener analytical methods. [less ▲]

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See detailComparative Phytochemical Composition and Hypoglycemic Activity of Some Plants Used by Traditional Healers to Treat Diabetes in Kisangani
KATEMO MUHOYA, Frédéric; Kadima Ntokamunda, Justin-Léonard; Marini Djang'Eing'A, Roland ULg

in International Journal of Pharmacy & Pharmaceutical REsearch (2017), Vol. 9(Issue 4), 312-321

Background: Phytochemical and Biological studies are always needed to define chemical composition, bioactivity and toxicity of plants from folk medicines before integrating them into conventional ... [more ▼]

Background: Phytochemical and Biological studies are always needed to define chemical composition, bioactivity and toxicity of plants from folk medicines before integrating them into conventional medicines. Here we compared phytochemical composition and antihyperglycemic activity of some plants used in Kisangani to treat diabetes. Methods: The plants tested are Aloe vera (AV), Bidens pilosa (BP), Cassia alata (CA), Cassia occidentalis (CO), Catharanthus roseus pink flower (CRp), Catharanthus roseus white flower or alba (CRw), Mangifera indica (MI), Morinda lucida (ML), Morinda morindoides (MM), Panda oleosa (PO), Terminalia catappa (TC), and Vernonia amygdalina (VA). Their content in polyphenols, saponins, alkaloids and mineral ash were compared. Hyperglycemia was induced in rabbits by oral glucose tolerance test with glibenclamide 0.2 mg/kg as reference. Blood glucose level was assayed by Folin-Wu photometric method. The mean percentage in glucose level reduction (MPR) was calculated from control untreated animals. The relative potency of each extract (RP) was calculated from glibenclamide MPR taken as 100%. Results: Flavonoids, tannins and saponins, were the main components; alkaloids were found only in CRp, CRw, ML and MM. The water content varied from 67% to 88%; Total ashes content was lower in roots (9%) than other parts (11-16%). Glibenclamide gave MPR=56.8% and RP=100%. MPR and RP for plant extracts were, ML(29.8%; 52.4%), CA(31.9%; 56.2%), MI(46.6%; 81.9%), MM(46.6%; 81.9%), TC(47.2%; 83.1%), VA(49.4%; 86.9%), CO(54.4%; 95.8%), CRw(57.4%; 101.0%), BP(60.8%; 107.0%), CRp(63.2%; 111.1%), AV(64.5%; 113.4%), PO(83.2%;146.3%). Conclusion: All plants but Panda oleosa have been studied by others; the main phytochemical groups reported have been confirmed in the local species. All plants exhibited some antihyperglycemic activity, differing however by their relative potency. [less ▲]

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See detailEtude comparative des profils de dissolution in vitro de quinine sulfate générique et princeps en utilisant la Chromatographie Liquide Haute Performance
Mbinze Kindenge, Jérémie ULg; Diallo, Tediane; Yemoa, Loconon ULg et al

in Médecine d'Afrique Noire (2017), 64

Introduction : La quinine est une molécule préconisée pour le traitement du paludisme dans les régions où les souches de P. falciparum sont polyrésistantes. Face à l’importante utilisation de ses ... [more ▼]

Introduction : La quinine est une molécule préconisée pour le traitement du paludisme dans les régions où les souches de P. falciparum sont polyrésistantes. Face à l’importante utilisation de ses médicaments génériques d’une part, et au fléau des médicaments de qualité inférieure d’autre part, il devient plus que nécessaire d’appuyer les données des tests physico-chimiques par celles de dissolution in vitro dont l’évaluation et la comparaison des cinétiques permettra de prédire le comportement in vivo du principe actif et par conséquent l’efficacité du médicament générique. L’objectif de la présente étude est de réaliser une étude comparative de la cinétique de dissolution d’un princeps et d’un générique à base de quinine comprimé 300 mg commercialisés à Kinshasa. Matériels et méthodes : L’étude a été réalisée en utilisant trois milieux de pH différents (1,2 - 4,5 - 6,8) tels que recommandés par l’Agence Européenne de Médicament et en se servant d’un appareil de dissolution, tandis que l’équipement de chromatographie liquide à haute performance couplée à un détecteur à barrette de diodes a été utilisé pour la quantification. La méthode statistique fit factor a été appliquée pour comparer les résultats de dosage de la quinine dans les trois milieux tout en ayant évalué le biais à différents temps de dissolution. Résultats : Les différents échantillons de médicaments générique et princeps ont été conformes quant à l’identification et au dosage de la quinine, par contre leurs cinétiques de dissolution étaient non similaires. Discussion : Ceci pourrait avoir une influence sur l’efficacité du produit générique et la sécurité des consommateurs, dénotant l’importance d’examiner les profils de dissolution des génériques avant toute autorisation de mise sur le marché plus particulièrement dans les pays en voie de développement. [less ▲]

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See detailLe fléau des faux médicaments
Marini Djang'Eing'A, Roland ULg; Ziemons, Eric ULg; Sacre, Pierre-Yves ULg et al

Conference given outside the academic context (2017)

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See detailINVESTIGATION DE LA QUALITE D’ANTIBIOTIQUES A BASE D'AMOXICILLINE DANS LE CADRE DE LA SURVEILLANCE DU MARCHE OFFICIEL ET PERIPHERIQUE DE QUELQUES VILLES DE LA R.D. CONGO
Kalenda Tshilombo, Nicodème ULg; Ciza Hamuli, Patient ULg; Mavungu Landu, Don Jethro ULg et al

Poster (2017, March)

Drug counterfeiting is a sad and worrisome reality, especially in developing countries where quality control is not effective and sometimes not existing at all despite political will of governments. The ... [more ▼]

Drug counterfeiting is a sad and worrisome reality, especially in developing countries where quality control is not effective and sometimes not existing at all despite political will of governments. The consequences are harmful in particular for substandard medicines that pose more threats to populations in those countries due to their direct negative impact on patients such as failure of medical treatment including development of drug resistance and even death. Socio-economic consequences and negative reputation concerning the pharmaceutical industry are also observed. Unfortunately accurate detailed data on such medicines are not easy to obtain. Most of the time available data are often estimated from case reports or studies carried out in a specific area and during a defined period.Health authorities’ in the Democratic Republic of Congo are trying to identify this scourge by set up several strategies to fight against. One of them is built on the best knowledge of drugs from several horizons through the assessment of their quality to allow appropriate measurement. In this context, we have focused our study towards amoxicillin alone and/or combined with potassium clavulanate since it is one the very used medicines in pediatric medications. The formulations are powder for suspension. Two analytical methods were developed based on the USP monography, applying isocratic liquid chromatography. Prior to their application in routine, we evaluated the suitability of these methods through validation applying the accuracy profile of total error. Since it was planned to transfer the methods to DRC, several operating factors were taken into account namely operator, day and equipment. Interesting results were obtained in terms of trueness (relative biases below than 2.3%), precision (RSD of Intermediate precision below 2.8%), accuracy (beta-expectation tolerance intervals between -6.0% and 3.8%) for the concentration levels of interest. The latter were able to allow monitoring the quality of the two active ingredients here above in the 65 samples from Congolese market. They were collected in Kinshasa, Lubumbashi, Matadi and Kolwezi at official and non-official medicines distributors, in peripheral area. The dramatic results obtained confirm that substandard and counterfeit medicines remain a crucial problem on public health in low-income countries. Appropriate measures are really needed to set up the drug quality improvement. [less ▲]

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See detailUV Visible Spectrophotometric Determination of the Quality of Antiretroviral Drugs Distributed in Kinshasa
Ntambwe Kamangu, Erick; Mbinze Kindenge, Jérémie ULg; Mingu M., Arnold et al

in Open Acces Library Journal (2017)

Background: Antiretrovirals (ARVs) are the molecules used in the fight against infection by the Human Immunodeficiency Virus (HIV). Their main objective is to stop the virus from replicating and thus ... [more ▼]

Background: Antiretrovirals (ARVs) are the molecules used in the fight against infection by the Human Immunodeficiency Virus (HIV). Their main objective is to stop the virus from replicating and thus allow the immune system to recover. In 2001, the program to fight against HIV/AIDS United Nations (UNAIDS) and its partners has decided to strengthen the pharmaceutical channel and improve access to good quality care. Thus ARV quality control is recommended. Objective: The objective of this work was to monitor the quality of ARVs distributed in Kinshasa. Methodology: In this work, UV-visible spectrophotometry is used for the analysis of ARVs presented in simple form distributed in the city of Kinshasa. Results: The results of this work show that the stated and analyzed ARVs contain active ingredients; there is no placebo. Ten percent of these ARVs are non-compliant with regard to dosing of the active test. Conclusion: These results confirm the need to control these drugs to protect patients from adverse consequences related to their poor quality. [less ▲]

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See detailApplication of design space optimization strategy to the developmentof LC methods for simultaneous analysis of 18 antiretroviral medicinesand 4 major excipients used in various pharmaceutical formulations
Habyalimana, Védaste ULg; Mbinze Kindenge, Jérémie ULg; Yemoa, Loconon ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2017), 139

tAs one of the world’s most significant public health challenges in low- and middle-income countries,HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from coun ... [more ▼]

tAs one of the world’s most significant public health challenges in low- and middle-income countries,HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from coun-terfeiting. For that, we developed screening and specific HPLC methods that can analyze 18 antiretroviralmedicines (ARV) and 4 major excipients. Design of experiments and design space methodology wereinitially applied for 15 ARV and the 4 excipients with prediction thanks to Monte Carlo simulations andfocusing on rapidity and affordability thus using short column and low cost organic solvent (methanol)in gradient mode with 10 mM buffer solutions of ammonium hydrogen carbonate. Two other specificmethods dedicated to ARV in liquid and in solid dosage formulations were also predicted and opti-mized. We checked the ability of one method for the analysis of a fixed-dose combination composedby emtricitabine/tenofovir/efavirenz in tablet formulations. Satisfying validation results were obtainedby applying the total error approach taking into account the accuracy profile as decision tool. Then, thevalidated method was applied to test two samples coded A and B, and claimed to contain the tested ARV.Assay results were satisfying only for sample B. [less ▲]

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See detailCréation d’un Centre d’Excellence en Assurance et Contrôle de Qualité des Médicaments et Produits de Santé
Marini Djang'Eing'A, Roland ULg; Masereel, Bernard ULg; Verpoorten, Dominique ULg et al

Report (2017)

Dans la plupart des pays d’Afrique Subsaharienne, la qualité des médicaments est un problème majeur de santé publique (SP). Ce secteur souffre de la circulation et de la vente des médicaments illicites ... [more ▼]

Dans la plupart des pays d’Afrique Subsaharienne, la qualité des médicaments est un problème majeur de santé publique (SP). Ce secteur souffre de la circulation et de la vente des médicaments illicites, altérés, périmés et même falsifiés, et dont, par ailleurs, la qualité est peu voire non contrôlée. A côté des médicaments « classiques », les produis de santé ainsi que les médicaments traditionnels améliorés (MTA) à base de plantes sont aussi concernés par ces pratiques peu scrupuleuses. A ces pratiques s’additionnent le manque d’assurance sur leur innocuité et leur qualité avec, par conséquent, un déficit au niveau de la sécurité sanitaire des consommateurs qui est aggravée par la prescription, l’administration et l’usage irrationnels. Le présent projet vise à contribuer à l'amélioration de la qualité des médicaments en RDC, éléments pratiquement incontournables de nos jours pour l’amélioration de la SP. Plus spécifiquement, le projet compte renforcer les capacités locales mais aussi régionales de l’Afrique Centrale en termes de formation dans le but de répondre aux besoins quant à la disponibilité de médicaments de qualité et surtout à développer un réseau des personnes formées dans le domaine de la qualité. La mise en œuvre se focalise sur la création d’un centre de référence à l’Unikin évoluant à terme vers un centre d’excellence régional avec trois missions, la formation, la recherche et le service. Au niveau de la formation, deux cursus officiels étalés sur deux ans seront organisés en alternance : (1) Diplômes d’Etudes Supérieures Spécialisées (DESS) en Contrôle des médicaments et (2) DESS en Assurance Qualité. Ces DESS correspondent en Communauté Wallonnie-Bruxelles à un Master de spécialisation. Un Diplôme d’Etudes Supérieures en Analyse des médicaments (DEA) sera également organisé et mènera au doctorat. Enfin, des modules seront ouverts à des formations certifiantes. Celles-ci s’adressent au personnel de santé tel que celui du Ministère de la Santé (Direction du Médicament), du secteur Industriel Pharmaceutique (Laboratoires de fabrication et de contrôle, importateurs, distributeurs), des instituts étatiques de contrôle, des pharmaciens, des médecins, et des étudiants des Facultés/Départements de Pharmacie (3ème cycle). Se rapportant au service, le centre s’orientera sur la résolution des problèmes spécifiques confrontés sur terrain par le personnel cité ci-haut comme par exemple l’analyse des médicaments essentiels, des nouveaux médicaments et de nouvelles formulations médicamenteuses. Pour renforcer de manière pérenne ces formations à l’Unikin, une thèse de doctorat sera réalisée en Sciences Pharmaceutiques avec comme tronc principal le Contrôle Qualité et les implications socio-anthropologiques. La sensibilisation au problème de la qualité et de l’usage optimal des médicaments est également envisagée pour les acteurs indirects du secteur pharmaceutique tels que les autorités et les pouvoirs organisateurs locaux étant donné leur forte implication dans la prise des décisions stratégiques dans ce secteur. L’excellence sera visée afin de renforcer la collaboration scientifique existante avec les universités de la RDC (Kisangani) et de la région de l’Afrique centrale et de l’ouest (U-Douala, U-Yaoundé-1, U-Abomey Calavi, U-Ouagadougou) au travers de la dispensation de certains cours par les enseignants de ces universités et l’attribution des bourses d’excellence aux Assistants de ces universités. [less ▲]