Antimalarial drug quality: Methods to detect suspect drugs

Therapy

Volumn 7, Issue 1, 2010, Pages 49-57

  Kaur, Harparkash ^a   Green, Michael D ^b   Hostetler, Dana M ^c   Fernández, Facundo M ^c   Newton, Paul N ^d,e  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^b CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^c GEORGIA INSTITUTE OF TECHNOLOGY   (United States)

^d UNIVERSITY OF OXFORD   (United Kingdom)

^e MAHOSOT HOSPITAL   (Laos)

Author keywords

Antimalarials; Artemisinin; Counterfeit; Degraded; Derivatives; Drug quality; HPLC; Mass spectrometry; Substandard; Thin layer chromatography

Indexed keywords

AMODIAQUINE; ANTIMALARIAL AGENT; ARTEETHER; ARTEMETHER; ARTEMETHER PLUS BENFLUMETOL; ARTEMISININ DERIVATIVE; ARTESUNATE; BENFLUMETOL; CHLOROQUINE; DIHYDROARTEMISININ; FANSIDAR; ILLICIT DRUG; MEFLOQUINE; METAKELFIN; PIPERAQUINE; QUININE;

ANTIMALARIAL DRUG RESISTANCE; BIOEQUIVALENCE; DRUG BIOAVAILABILITY; DRUG CONTROL; DRUG EFFICACY; DRUG LEGISLATION; DRUG PACKAGING; DRUG QUALITY; DRUG SOLUBILITY; DRUG TREATMENT FAILURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIQUID CHROMATOGRAPHY; MALARIA; MALARIA FALCIPARUM; MASS SPECTROMETRY; QUALITY CONTROL; REVIEW; THIN LAYER CHROMATOGRAPHY;

EID: 75449113683     PISSN: 14750708     EISSN: 1744831X     Source Type: Journal    
DOI: 10.2217/thy.09.84     Document Type: Review

References (46)

1. Guerra CA, Gikandi PW, Tatem AJ et al.: The limits and intensity of Plasmodium falciparum transmission: implications for malaria control and elimination worldwide. PLoS Med. 5, E38 (2008).
2. Lewison G, Srivastava D: Malaria research, 1980-2004, and the burden of disease. Acta Trop. 106, 96-103 (2008).
3. Greenwood BM, Bradley AK, Greenwood AM et al.: Mortality and morbidity from malaria among children in a rural area of The Gambia, West Africa. Trans. R. Soc. Trop. Med. Hyg. 81, 478-486 (1987).
4. World Health Organisation: Guidelines for the treatment of malaria. WHO, Geneva, Switzerland (2006).
5. Dondorp AM, Nosten F, Yi P et al.: Artemisinin resistance in Plasmodium falciparum malaria. N. Engl. J Med. 361, 455-467 (2009). ■■ Original article demonstrating the emergence of drug resistance to artemisinin derivatives.
6. Roper C, Pearce R, Nair S et al.: Intercontinental spread of pyrimethamine-resistant malaria. Science 305, 1124 (2004) ■■ Providing insight into the spread of Plasmodium falciparum antimalarial drug resistance from Asia into Africa.
7. Caudron JM, Ford N, Henkens M et al.: Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop. Med. Int. Health 13, 1062-1072 (2008). ■■ Review article highlighting the problem of substandard drugs, including antimalarials, in developing countries.
8. Leslie T, Kaur H, Mohammed N, Kolaczinski K, Ord R, Rowland M: An epidemic of Plasmodium falciparum malaria in Afghan refugees in the tribal areas of Pakistan fuelled by substandard antimalarial drugs. Emerg. Infect. Dis. 15, 1753-1759 (2009).
9. Breman JG: The ears of the hippopotamus: manifestations, determinations and estimates of the malaria burden. Am. J. Trop. Med. Hyg. 64, 1-11 (2001). ■ Provides the most comprehensive account of the burden of malaria in Africa.
10. Spencer H, Kaseje D, Roberts J, Huong A: Consumption of chloroquine phosphate provided for treatment of malaria by volunteer village health worker in Saradidi, Kenya. Ann. Trop. Med. Parasitol. 81, 116-123 (1987).
11. Amin AA, Snow RW: Brands, costs and registration status of antimalarial drugs in the Kenyan retail sector. Malar. J. 26, 36 (2005).
12. Kaur H, Goodman CA, Masanja MI et al.: A nationwide survey of the quality of antimalarials in retail outlets in Tanzania, PLoS ONE 3, E3403 (2008).
13. Onwujekwe O, Kaur H, Dike N et al.: Quality of anti-malarial drugs provided by public and private healthcare providers in south-east Nigeria. Malar. J. 8, 22 (2009).
14. Newton PN, Green MD, Fernandez FM, Day NJP, White NJ: Counterfeit anti-infective medicines. Lancet Infect. Dis. 6, 602-613 (2006).
15. Hall KA, Newton PN, Green MD et al.: Characterization of counterfeit artesunate antimalarial tablets from southeast Asia. Am. J. Trop. Med. Hyg. 75, 804-811 (2006).
16. Sengaloundeth S, Green MD, Fernández FM, Manolin O, Phommavong K, Insixiengmay V: A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR - implications for therapeutic failure and drug resistance. Malar. J. 8, 172 (2009).
17. Newton PN, McGready R, Fernandez F, Green MD, Sunjio M, Bruneton C: Manslaughter by fake artesunate in Asia - will Africa be next? PLoS Med. 3, E197 (2006).
18. 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 12, 68-74 (2007).
19. Bates R, Coticelli P, Tren R, Attaran A: Antimalarial drug quality in the most severely malarious parts of Africa - a six country study. PLoS ONE 3, E2132 (2008).
20. Oyeniran M: NAFDAC seizes N3M malaria drugs. Nigerian Tribune, 28 September (2006).
21. Oyeniran M: AFDAC impounds N10M substandard drugs. Nigerian Tribune, 4 April (2007).
22. Basco LK: Molecular epidemiology of malaria in Cameroon. XIX. Quality of antimalarial drugs used for self-medication. Am. J. Trop. Med. Hyg. 70, 245-250 (2004).
23. Minzi OMS, Moshi MJ, Hipolite D et al.: Evaluation of the quality of amodiaquine and sulphadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar Es Salaam Tanzania. J. Clin. Pharm. Ther. 28, 117-122 (2003).
24. Amin AA, Snow RW, Kokwaro GO: The quality of sulphadoxinepyrimethamine and amodiaquine products in the Kenyan retail sector. J. Clin. Pharm. Ther. 30, 559-565 (2005).
25. Gaudiano MC, Di Maggio A, Cocchieri E, Antoniella E, Bertocchi P, Alimonti S: Medicines informal market in Congo, Burundi and Angola: counterfeit and sub-standard antimalarials. Malar. J. 6, 22 (2007).
26. Rozendaal J: Fake antimalarials circulating in Cambodia. Bull. Mekong Malaria Forum 7, 62-68 (2000).
27. Ofori-Adjei D, Commey JO, Adjepon-Yamoah KK: Serum chloroquine levels in children before treatment for malaria. Lancet 1, 1246 (1984).
28. Newton PN, Lee SJ, Goodman C et al.: Guidelines for field surveys of the quality of medicines: a proposal. PLoS Med. 6, E52 (2009).
29. Newton PN, Fernández FM, Plançon A et al.: Collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia. PLoS Med. 5(2), E32 (2008). ■■ Provides the first report of a collaborative effort of scientists and INTERPOL in detecting and tracing the counterfeited antimalarial drug artesunate to traders in China who were prosecuted.
30. Ioset JR, Kaur H: Simple field assays to check quality of current artemisinin-based antimalarial combination formulations. PLoS ONE 4, E7270 (2009).
31. Risha PG, Msuya Z, Clark M, Johnson K, Ndomondo-Sigonda M, Layloff T: The use of MiniLab® to improve the testing of regulatory authorities in resource limited settings: Tanzanian experience. Health Policy 87, 217-222 (2008).
32. Cody RB, Laramee JA, Durst HD: Versatile new ion source for the analysis of materials in open air under ambient conditions. Anal. Chem. 77, 2297-2302 (2005).
33. Takáts Z, Wiseman JM, Gologan B, Cooks RG: Mass spectrometry sampling under ambient conditions with desorption electrospray ionization. Science 306, 471-473 (2004).
34. Green MD, Dwight LM, Wirtz RA, White NJ: A colorimetric field method to assess the authenticity of drugs sold as the antimalarial artesunate. J. Pharm. Biomed. Anal. 24, 65-70 (2000).
35. Green MD, Mount DL, Wirtz RA: Authentication of artemether, artesunate, and dihydroartemisinin antimalarial tablets using a simple colorimetric method. Trop. Med. Int. Health 6, 980-982 (2001).
36. Green MD, Nettey H, Rojas OV, Pamanivong C, Khounsaknalath L, Ortiz MG: Use of refractometry and colorimetry as field methods to rapidly assess antimalarial drug quality. J. Pharm. Biomed. Anal. 43, 105-110 (2007).
37. Newton P, Proux S, Green M, Smithuis F, Rozendaal J, Prakongpan S: Fake artesunate in Southeast Asia. Lancet 357, 1948-1950 (2001).
38. Ricci C, Nyadong L, Yang F, Fernandez FM, Brown CD, Newton PN, Kazarian SG: Assessment of hand-held Raman instrumentation for in situ screening for potentially counterfeit artesunate antimalarial tablets by FT-Raman spectroscopy and direct ionization mass spectrometry. Anal. Chim. Acta 623, 178-186 (2008).
39. Yoon WL, Jee RD, Charvill A, Lee G, Moffat AC: Application of near-infrared spectroscopy to the determination of the sites of manufacture of proprietary products. J. Pharm. Biomed. Anal. 34, 933-944 (2004).
40. WHO: Counterfeit medicines. Fact sheet No. 275 (2006)http://whqlibdoc. who.int/fact-sheet/2006/FS-275.pdf(Accessed 26 September, 2009)
41. WHO: Drug policywww.searo.who.int/EN/Section10/Section21/Section340-4040. htm(Accessed 8 October, 2009)
42. International Medical Products Anti-Counterfeiting Taskforce: IMPACTwww.who.int/impact/en/index.html (Accessed 6 September, 2009)
43. WHO: WHO and partners accelerate fight against counterfeit medicines (2006) www.who.int/mediacentre/news/releases/2006/pr69/en/(Accessed 23 September, 2009)
44. WHO: Prequalification programme. A United Nations programme managed by WHO http://apps.who.int/prequal/(Accessed 8 October, 2009)
45. Pharmacy & Poisons Boardwww.pharmacyboardkenya.org/(Accessed 8 October, 2009)
46. Global Pharma Health Fund (GPHF) - a charitable organization initiated and funded exclusively by donations from Merck (Darmstadt, Germany) and manufacturer of the MiniLabwww.gphf.org/web/en/start/index.htm (Accessed 6 October, 2009)