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Published in: Malaria Journal 1/2008

Open Access 01-12-2008 | Research

Substandard anti-malarial drugs in Burkina Faso

Authors: Maike Tipke, Salou Diallo, Boubacar Coulibaly, Dominic Störzinger, Torsten Hoppe-Tichy, Ali Sie, Olaf Müller

Published in: Malaria Journal | Issue 1/2008

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Abstract

Background

There is concern about an increasing infiltration of markets by substandard and fake medications against life-threatening diseases in developing countries. This is particularly worrying with regard to the increasing resistance development of Plasmodium falciparum against affordable anti-malarial medications, which has led to a change to more expensive drugs in most endemic countries.

Methods

A representative sample of modern anti-malarial medications from licensed (public and private pharmacies, community health workers) and illicit (market and street vendors, shops) sources has been collected in the Nouna Health District in north-western Burkina Faso in 2006. All drugs were tested for their quality with the standard procedures of the German Pharma Health Fund-Minilab. Detected low standard drugs were re-tested with European Pharmacopoeia 2.9.1 standards for disintegration and ultraviolet-visible spectroscopy at the laboratory of the Heidelberg University for confirmation.

Results

Overall, 86 anti-malarial drug samples were collected, of which 77 samples have been included in the final analysis. The sample consisted of 39/77 (50%) chloroquine, 10/77 (13%) pyrimethamine-sulphadoxine, 9/77 (12%) quinine, 6/77 (8%) amodiaquine, 9/77 (12%) artesunate, and 4/77 (5%) artemether-lumefantrine. 32/77 (42%) drug samples were found to be of poor quality, of which 28 samples failed the visual inspection, nine samples had substandard concentrations of the active ingredient, four samples showed poor disintegration, and one sample contained non of the stated active ingredient. The licensed and the illicit market contributed 5/47 (10.6%) and 27/30 (90.0%) samples of substandard drugs respectively.

Conclusion

These findings provide further evidence for the wide-spread existence of substandard anti-malarial medications in Africa and call for strengthening of the regulatory and quality control capacity of affected countries, particularly in view of the now wider available and substantially more costly artemisinin-based combination therapies.
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Literature
1.
go back to reference Greenwood BM, Bojang K, Whitty CJM, Targett GA: Malaria. Lancet. 2005, 365: 1487-1498. 10.1016/S0140-6736(05)66420-3.CrossRef Greenwood BM, Bojang K, Whitty CJM, Targett GA: Malaria. Lancet. 2005, 365: 1487-1498. 10.1016/S0140-6736(05)66420-3.CrossRef
2.
go back to reference Kouyaté B, Sie A, Yé M, De Allegri M, Müller O: The great failure of malaria control in Africa: A district perspective from Burkina Faso. PLoS Med. 2007, 4: e127-10.1371/journal.pmed.0040127. doi:10.1371/journal.pmed.0040127PubMedCentralCrossRefPubMed Kouyaté B, Sie A, Yé M, De Allegri M, Müller O: The great failure of malaria control in Africa: A district perspective from Burkina Faso. PLoS Med. 2007, 4: e127-10.1371/journal.pmed.0040127. doi:10.1371/journal.pmed.0040127PubMedCentralCrossRefPubMed
3.
go back to reference Müller O, Traoré C, Becher H, Kouyaté B: Malaria morbidity, treatment-seeking behaviour, and mortality in a cohort of young children in rural Burkina Faso. Trop Med Int Health. 2003, 8: 290-296. 10.1046/j.1365-3156.2003.01030.x.CrossRefPubMed Müller O, Traoré C, Becher H, Kouyaté B: Malaria morbidity, treatment-seeking behaviour, and mortality in a cohort of young children in rural Burkina Faso. Trop Med Int Health. 2003, 8: 290-296. 10.1046/j.1365-3156.2003.01030.x.CrossRefPubMed
7.
go back to reference Cockburn R, Newton PN, Agyarko KE, Akunyili D, Withe NJ: The global threat of counterfeit drugs: why industry and government must communicate the danger. PLoS Med. 2005, 2: e100-10.1371/journal.pmed.0020100.PubMedCentralCrossRefPubMed Cockburn R, Newton PN, Agyarko KE, Akunyili D, Withe NJ: The global threat of counterfeit drugs: why industry and government must communicate the danger. PLoS Med. 2005, 2: e100-10.1371/journal.pmed.0020100.PubMedCentralCrossRefPubMed
8.
go back to reference The World Bank: Pharmaceuticals: Counterfeits, Substandard Drugs and Drug Diversion. HNP brief no 2 Report number 32192. 2005 The World Bank: Pharmaceuticals: Counterfeits, Substandard Drugs and Drug Diversion. HNP brief no 2 Report number 32192. 2005
9.
go back to reference Basco LK: Molecular epidemiology of malaria in Cameroon. XIX. Quality of antimalarial drugs used for self-medication. Am J Trop Med Hyg. 2004, 70: 245-250.PubMed Basco LK: Molecular epidemiology of malaria in Cameroon. XIX. Quality of antimalarial drugs used for self-medication. Am J Trop Med Hyg. 2004, 70: 245-250.PubMed
10.
go back to reference Ahmad K: WHO fights fake pharmaceuticals. Lancet Infect Dis. 2006, 6: 195-10.1016/S1473-3099(06)70427-3.CrossRef Ahmad K: WHO fights fake pharmaceuticals. Lancet Infect Dis. 2006, 6: 195-10.1016/S1473-3099(06)70427-3.CrossRef
11.
go back to reference Newton PN, Green MD, Fernández FM, Day NPJ, White NJ: Counterfeit anti-infective drugs. Lancet Infect Dis. 2006, 6: 602-613. 10.1016/S1473-3099(06)70581-3.CrossRefPubMed Newton PN, Green MD, Fernández FM, Day NPJ, White NJ: Counterfeit anti-infective drugs. Lancet Infect Dis. 2006, 6: 602-613. 10.1016/S1473-3099(06)70581-3.CrossRefPubMed
12.
go back to reference Hall KA, Newton PN, Green MD, De Veij M, Vandenabeele P, Pizzanelli D, Mayxay M, Dondorp A, Fernandez F: Characterization of counterfeit artesunate antimalarial tablets from southeast Asia. Am J Trop Med Hyg. 2006, 75: 804-811.PubMed Hall KA, Newton PN, Green MD, De Veij M, Vandenabeele P, Pizzanelli D, Mayxay M, Dondorp A, Fernandez F: Characterization of counterfeit artesunate antimalarial tablets from southeast Asia. Am J Trop Med Hyg. 2006, 75: 804-811.PubMed
13.
go back to reference Rozendaal J: Fake antimalaria drugs in Cambodia. Lancet. 2001, 357: 890-10.1016/S0140-6736(05)71830-4.CrossRefPubMed Rozendaal J: Fake antimalaria drugs in Cambodia. Lancet. 2001, 357: 890-10.1016/S0140-6736(05)71830-4.CrossRefPubMed
15.
go back to reference Green MD: Antimalarial drug resistance and the importance of drug quality monitoring. J Postgrad Med. 2006, 52: 288-290.PubMed Green MD: Antimalarial drug resistance and the importance of drug quality monitoring. J Postgrad Med. 2006, 52: 288-290.PubMed
16.
go back to reference WHO, Malaria Control Department & Essential Drugs and Medicines Policy Department: Access to antimalarial medicines improving the affordability and financing of artemisinin-based combination therapies. WHO/CDS/MAL/2003.1095. 2003, 12-14. WHO, Malaria Control Department & Essential Drugs and Medicines Policy Department: Access to antimalarial medicines improving the affordability and financing of artemisinin-based combination therapies. WHO/CDS/MAL/2003.1095. 2003, 12-14.
18.
go back to reference Jähnke R: Couterfeit Medicines and the GPHF-Minilab for Rapid Drug Quality Verification. Pharm Ind. 2004, 66: 1187-1193. Jähnke R: Couterfeit Medicines and the GPHF-Minilab for Rapid Drug Quality Verification. Pharm Ind. 2004, 66: 1187-1193.
20.
go back to reference Jähnke R, Küsters G: Low-cost quality assurance of medicines using the GPHF-Minilab. Drug Inf J. 2001, 35: 941-945. Jähnke R, Küsters G: Low-cost quality assurance of medicines using the GPHF-Minilab. Drug Inf J. 2001, 35: 941-945.
21.
go back to reference Mukhopadhyay R: The hunt for counterfeit medicines. Anal Chem. 2007, 2623-2627. Mukhopadhyay R: The hunt for counterfeit medicines. Anal Chem. 2007, 2623-2627.
22.
go back to reference Müller O, Becher H, Baltussen van Zweeden A, Yé Y, Diallo DA, Konaté AT, Gbangou A, Kouyaté B, Garenne M: Effect of zinc supplementation on malaria morbidity among West African children: a randomized double-blind placebo-controlled trial. BMJ. 2001, 322: 1567-1572. 10.1136/bmj.322.7302.1567.PubMedCentralCrossRefPubMed Müller O, Becher H, Baltussen van Zweeden A, Yé Y, Diallo DA, Konaté AT, Gbangou A, Kouyaté B, Garenne M: Effect of zinc supplementation on malaria morbidity among West African children: a randomized double-blind placebo-controlled trial. BMJ. 2001, 322: 1567-1572. 10.1136/bmj.322.7302.1567.PubMedCentralCrossRefPubMed
23.
go back to reference Hamani AI: Les médicaments de la rue à Niamey: Modalités de vente et contrôle de qualité de quelques médicaments anti-infectieux. Université de Bamako, Faculté de Medecine de Pharmacie et d'Odonto-stomatologie Masters thesis. 2005 Hamani AI: Les médicaments de la rue à Niamey: Modalités de vente et contrôle de qualité de quelques médicaments anti-infectieux. Université de Bamako, Faculté de Medecine de Pharmacie et d'Odonto-stomatologie Masters thesis. 2005
24.
go back to reference Europäisches Arzneibuch: 2.9.1 Zerfallszeit von Tabletten und Kapseln. 2005, 1: 283-4. 5.0 Europäisches Arzneibuch: 2.9.1 Zerfallszeit von Tabletten und Kapseln. 2005, 1: 283-4. 5.0
25.
go back to reference Europäisches Arzneibuch: 2.2.25 UV-Vis-Spektroskopie. 2005, 1: 46-8. 5.0 Europäisches Arzneibuch: 2.2.25 UV-Vis-Spektroskopie. 2005, 1: 46-8. 5.0
26.
go back to reference Atemnkeng MA, Chimanuka B, Plaizier-Vercammen J: Quality evaluation of chloroquine, quinine, sulfadoxine-pyrimethamine and proguanil formulations sold on the market in East Congo DR. J Clin Pharm Ther. 2007, 32: 123-132. 10.1111/j.1365-2710.2007.00797.x.CrossRefPubMed Atemnkeng MA, Chimanuka B, Plaizier-Vercammen J: Quality evaluation of chloroquine, quinine, sulfadoxine-pyrimethamine and proguanil formulations sold on the market in East Congo DR. J Clin Pharm Ther. 2007, 32: 123-132. 10.1111/j.1365-2710.2007.00797.x.CrossRefPubMed
28.
go back to reference Ogwal-Okeng JW, Owino E, Obua C: Chloroquine in the Ugandan market fails quality test: a pharmacovigilance study. Afr Health Sci. 2003, 3: 2-6.PubMedCentralPubMed Ogwal-Okeng JW, Owino E, Obua C: Chloroquine in the Ugandan market fails quality test: a pharmacovigilance study. Afr Health Sci. 2003, 3: 2-6.PubMedCentralPubMed
29.
go back to reference Legris C: La détection des médicaments contrefaits par investigation de leur authenticité. Étude pilote sur le marché pharmaceutique illicite de Cote d'Ivoire. Université Henri Poincaré, Nancy I. 2005, France; Phd Thesis Legris C: La détection des médicaments contrefaits par investigation de leur authenticité. Étude pilote sur le marché pharmaceutique illicite de Cote d'Ivoire. Université Henri Poincaré, Nancy I. 2005, France; Phd Thesis
30.
go back to reference Gaudiano MC, Di Maggio A, Cocchieri E, Antoniella E, Bertocchi P, Alimonti S, Valvo L: Medicines informal market in Congo, Burundi and Angola: counterfeit and sub-standard antimalarials. Malar J. 2007, 6: 22-10.1186/1475-2875-6-22.PubMedCentralCrossRefPubMed Gaudiano MC, Di Maggio A, Cocchieri E, Antoniella E, Bertocchi P, Alimonti S, Valvo L: Medicines informal market in Congo, Burundi and Angola: counterfeit and sub-standard antimalarials. Malar J. 2007, 6: 22-10.1186/1475-2875-6-22.PubMedCentralCrossRefPubMed
31.
go back to reference Minzi OM, Moshi MJ, Hipolite D, Massele AY, Tomson G, Ericsson O, Gustafsson LL: Evaluation of the quality of amodiaquine and sulfadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar Es Salaam Tanzania. J Clin Pharm Ther. 2003, 28: 117-122. 10.1046/j.1365-2710.2003.00470.x.CrossRefPubMed Minzi OM, Moshi MJ, Hipolite D, Massele AY, Tomson G, Ericsson O, Gustafsson LL: Evaluation of the quality of amodiaquine and sulfadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar Es Salaam Tanzania. J Clin Pharm Ther. 2003, 28: 117-122. 10.1046/j.1365-2710.2003.00470.x.CrossRefPubMed
32.
go back to reference Shakoor O, Taylor RB, Behrens RH: Assessment of the incidence of substandard drugs in developing countries. Trop Med Int Health. 1997, 2: 839-884. 10.1046/j.1365-3156.1997.d01-403.x.CrossRef Shakoor O, Taylor RB, Behrens RH: Assessment of the incidence of substandard drugs in developing countries. Trop Med Int Health. 1997, 2: 839-884. 10.1046/j.1365-3156.1997.d01-403.x.CrossRef
33.
go back to reference Taylor RB, Shakoor O, Behrens RH, Everard M, Low AS, Wangboonskul J, Reid RG, Kolawole JA: Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet. 2001, 357: 1933-1936. 10.1016/S0140-6736(00)05065-0.CrossRef Taylor RB, Shakoor O, Behrens RH, Everard M, Low AS, Wangboonskul J, Reid RG, Kolawole JA: Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet. 2001, 357: 1933-1936. 10.1016/S0140-6736(00)05065-0.CrossRef
34.
go back to reference WHO: The quality of antimalarials. A study in selected African countries. Geneva: World Health Organization. 2003, 1-67. WHO: The quality of antimalarials. A study in selected African countries. Geneva: World Health Organization. 2003, 1-67.
35.
go back to reference Amin AA, Snow RW, Kokwaro GO: The quality of sulphadoxine-pyrimethamine and amodiaquine products in the Kenyan retail sector. J Clin Pharm Ther. 2005, 30: 559-65. 10.1111/j.1365-2710.2005.00685.x.PubMedCentralCrossRefPubMed Amin AA, Snow RW, Kokwaro GO: The quality of sulphadoxine-pyrimethamine and amodiaquine products in the Kenyan retail sector. J Clin Pharm Ther. 2005, 30: 559-65. 10.1111/j.1365-2710.2005.00685.x.PubMedCentralCrossRefPubMed
36.
go back to reference Kelesidis T, Kelesides I, Rafailidis PI, Falagas ME: Counterfeit and substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother. 2007, 60 (2): 214-236. 10.1093/jac/dkm109.CrossRefPubMed Kelesidis T, Kelesides I, Rafailidis PI, Falagas ME: Counterfeit and substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother. 2007, 60 (2): 214-236. 10.1093/jac/dkm109.CrossRefPubMed
37.
go back to reference Risha PG, Shewiyo D, Msami A, Masuki G, Vergote G, Vervaet C, Remon JP: In vitro evaluation of the quality of essential drugs on the Tanzanian market. Trop Med Int Health. 2002, 7: 701-707. 10.1046/j.1365-3156.2002.00937.x.CrossRef Risha PG, Shewiyo D, Msami A, Masuki G, Vergote G, Vervaet C, Remon JP: In vitro evaluation of the quality of essential drugs on the Tanzanian market. Trop Med Int Health. 2002, 7: 701-707. 10.1046/j.1365-3156.2002.00937.x.CrossRef
38.
go back to reference Newton PN, Mc Gready R, Fernandez F, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJM, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NPJ, Greenwood BM, Nosten F, White NJ: Manslaughter by fake artesunate in Asia – Will Africa be next. PLos Med. 2006, 3: e197-10.1371/journal.pmed.0030197.PubMedCentralCrossRef Newton PN, Mc Gready R, Fernandez F, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJM, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NPJ, Greenwood BM, Nosten F, White NJ: Manslaughter by fake artesunate in Asia – Will Africa be next. PLos Med. 2006, 3: e197-10.1371/journal.pmed.0030197.PubMedCentralCrossRef
39.
go back to reference Atemnkeng MA, De Cock K, Plaizier-Vercammen J: Quality control of active ingredients in artemisinin-derivative-antimalarials within Kenya and DR Congo. Trop Med Int Health. 2007, 12: 68-74.PubMed Atemnkeng MA, De Cock K, Plaizier-Vercammen J: Quality control of active ingredients in artemisinin-derivative-antimalarials within Kenya and DR Congo. Trop Med Int Health. 2007, 12: 68-74.PubMed
Metadata
Title
Substandard anti-malarial drugs in Burkina Faso
Authors
Maike Tipke
Salou Diallo
Boubacar Coulibaly
Dominic Störzinger
Torsten Hoppe-Tichy
Ali Sie
Olaf Müller
Publication date
01-12-2008
Publisher
BioMed Central
Published in
Malaria Journal / Issue 1/2008
Electronic ISSN: 1475-2875
DOI
https://doi.org/10.1186/1475-2875-7-95

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