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1.
Nayyar GM, Breman JG, Newton PN, Herrington J, 2012. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12: 488–496.
-
2.
Newton PN et al.., 2006. Manslaughter by fake artesunate in Asia–will Africa be next? PLoS Med 3: e197.
-
3.
Newton PN, Caillet C, Guerin PJ, 2016. A link between poor quality antimalarials and malaria drug resistance? Expert Rev Anti Infect Ther 14: 531–533.
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4.
Newton PN et al.., 2008. A collaborative epidemiological investigation into the criminal fake artesunate trade in southeast Asia. PLoS Med 5: e32.
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5.
Dondorp AM et al.., 2004. Fake antimalarials in southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials. Trop Med Int Health 9: 1241–1246.
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6.
Newton P et al.., 2001. Fake artesunate in southeast Asia. Lancet 357: 1948–1950.
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7.
Sengaloundeth S et al.., 2009. 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.
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8.
Phanalasy S, 2017. The malaria testing and treatment landscape in the southern Lao People’s Democratic Republic (PDR). Malar J 16: 169.
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9.
Tabernero P et al.., 2015. A repeat random survey of the prevalence of falsified and substandard antimalarials in the Lao PDR: a change for the better. Am J Trop Med Hyg 92: 95–104.
-
10.
Khin HS, Aung T, Aung M, Thi A, Boxshall M, White C, 2016. Using supply side evidence to inform oral artemisinin monotherapy replacement in Myanmar: a case study. Malar J 15: 418.
-
11.
Khin HS, Aung T, Thi A, White C, 2016. Oral artemisinin monotherapy removal from the private sector in eastern Myanmar between 2012 and 2014. Malar J 15: 286.
-
12.
Thein ST, Khin HSS, Thi A, 2017. Anti-malarial landscape in Myanmar: results from a nationally representative survey among community health workers and the private sector outlets in 2015/2016. Malar J 16: 129.
-
13.
Thein ST, Khin HSS, Thi A, 2017. Insights into the availability and distribution of oral artemisinin monotherapy in Myanmar: evidence from a nationally representative outlet survey. Malar J 16: 170.
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14.
WHO, 2007. World Health Assembly Resolution WHA60.18. Available at: http://www.who.int/tdr/about/governance/documents/WHA60.18.pdf. Accessed July 16, 2017.
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15.
Fairhurst RM, Dondorp AM, 2016. Artemisinin-resistant Plasmodium falciparum malaria. Microbiol Spectr 4: EI10-0013-2016.
-
16.
Cui L et al.., 2012. Malaria in the greater Mekong subregion: heterogeneity and complexity. Acta Trop 121: 227–239.
-
17.
Hewitt S, Delacollette C, Poirot E, 2013. Malaria control in the greater Mekong subregion: an overview of the current response and its limitations. Southeast Asian J Trop Med Public Health 44 (Suppl 1 ):249–305, discussion 306–307.
-
18.
Guo S, Cui Y, He L, Zhang L, Cao Z, Zhang W, Zhang R, Tan G, Wang B, Cui L, 2013. Development of a specific monoclonal antibody-based ELISA to measure the artemether content of antimalarial drugs. PLoS One 8: e79154.
-
19.
He L, Nan T, Cui Y, Guo S, Zhang W, Zhang R, Tan G, Wang B, Cui L, 2014. Development of a colloidal gold-based lateral flow dipstick immunoassay for rapid qualitative and semi-quantitative analysis of artesunate and dihydroartemisinin. Malar J 13: 127.
-
20.
Guo S, Cui Y, Wang K, Zhang W, Tan G, Wang B, Cui L, 2016. Development of a specific monoclonal antibody for the quantification of artemisinin in Artemisia annua and rat serum. Anal Chem 88: 2701–2706.
-
21.
Guo S, He L, Tisch DJ, Kazura J, Mharakurwa S, Mahanta J, Herrera S, Wang B, Cui L, 2016. Pilot testing of dipsticks as point-of-care assays for rapid diagnosis of poor-quality artemisinin drugs in endemic settings. Trop Med Health 44: 15.
-
22.
Guo S, Zhang W, He L, Tan G, Min M, Kyaw MP, Wang B, Cui L, 2016. Rapid evaluation of artesunate quality with a specific monoclonal antibody-based lateral flow dipstick. Anal Bioanal Chem 408: 6003–6008.
-
23.
Newton PN et al.., 2009. Guidelines for field surveys of the quality of medicines: a proposal. PLoS Med 6: e52.
-
24.
Guo S, Zhang W, He L, Tan G, Min M, Kyaw MP, Wang B, Cui L, 2016. Rapid evaluation of artesunate quality with a specific monoclonal antibody-based lateral flow dipstick. Anal Bioanal Chem 408: 6003–6008.
-
25.
Batty KT, Davis TM, Thu LT, Binh TQ, Anh TK, Ilett KF, 1996. Selective high-performance liquid chromatographic determination of artesunate and alpha- and beta-dihydroartemisinin in patients with falciparum malaria. J Chromatogr B Biomed Appl 677: 345–350.
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26.
Karbwang J, Na-Bangchang K, Molunto P, Banmairuroi V, Congpuong K, 1997. Determination of artemether and its major metabolite, dihydroartemisinin, in plasma using high-performance liquid chromatography with electrochemical detection. J Chromatogr B Biomed Sci Appl 690: 259–265.
-
27.
Dondorp A, Nosten F, Stepniewska K, Day N, White N, 2005. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet 366: 717–725.
-
28.
Dondorp AM et al.., 2010. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. Lancet 376: 1647–1657.
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WHO, 2015. Guidelines for the Treatment of Malaria. 3rd edition. Geneva, Switzerland: World Health Organization, 316.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 62 | 62 | 15 |
| Full Text Views | 784 | 138 | 2 |
| PDF Downloads | 224 | 34 | 3 |
Quality Testing of Artemisinin-Based Antimalarial Drugs in Myanmar
Suqin Guo
Suqin Guo
College of Agronomy and Biotechnology, China Agricultural University, Beijing, China;
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Myat Phone Kyaw
Myat Phone Kyaw
Myanmar Medical Association, Yangon, Myanmar;
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Lishan He
Lishan He
College of Agriculture, Guangxi University, Nanning, Guangxi, China;
Breeding Base of Guangxi Key Laboratory of Agri-Environment and Agri-Products Safety, Nanning, Guangxi, China;
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Breeding Base of Guangxi Key Laboratory of Agri-Environment and Agri-Products Safety, Nanning, Guangxi, China;
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Myo Min
Myo Min
Myanmar Medical Association, Yangon, Myanmar;
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Xiangxue Ning
Xiangxue Ning
College of Agronomy and Biotechnology, China Agricultural University, Beijing, China;
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Wei Zhang
Wei Zhang
College of Agronomy and Biotechnology, China Agricultural University, Beijing, China;
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Baomin Wang
Baomin Wang
College of Agronomy and Biotechnology, China Agricultural University, Beijing, China;
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Liwang Cui
Liwang Cui
Department of Entomology, Pennsylvania State University, University Park, Pennsylvania
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Artemisinin-based combination therapies are the frontline treatment of Plasmodium falciparum malaria. The circulation of falsified and substandard artemisinin-based antimalarials in Southeast Asia has been a major predicament for the malaria elimination campaign. To provide an update of this situation, we purchased 153 artemisinin-containing antimalarials, as convenience samples, in private drug stores from different regions of Myanmar. The quality of these drugs in terms of their artemisinin derivative content was tested using specific dipsticks for these artemisinin derivatives, as point-of-care devices. A subset of these samples was further tested by high-performance liquid chromatography (HPLC). This survey identified that > 35% of the collected drugs were oral artesunate and artemether monotherapies. When tested with the dipsticks, all but one sample passed the assays, indicating that the detected artemisinin derivative content corresponded approximately to the labeled contents. However, one artesunate injection sample was found to contain no active ingredient at all by the dipstick assay and subsequent HPLC analysis. The continued circulation of oral monotherapies and the description, for the first time, of falsified parenteral artesunate provides a worrisome picture of the antimalarial drug quality in Myanmar during the malaria elimination phase, a situation that deserves more oversight from regulatory authorities.
Author Notes
These authors contributed equally to this work.
Financial support: This research was supported by National Institute of Allergy and Infectious Diseases, National Institutes of Health (U19AI089672).
Authors’ addresses: Suqin Guo, Xiangxue Ning, Wei Zhang, and Baomin Wang, China Agricultural University, College of Agronomy and Biotechnology, Beijing, China, E-mails: guosuqin074910@163.com, gainknight@gmail.com, zhangwei12@cau.edu.cn, and wbaomin@263.net. Myat Phone Kyaw and Myo Min, Myanmar Medical Association, Malaria Control, Yangon, Yangon Region, Myanmar, E-mails: kyaw606@gmail.com and myomin27@gmail.com. Lishan He, Guangxi University, College of Agriculture, Nanning, China, E-mail: hls0305@163.com. Liwang Cui, Penn State University, Entomology, University Park, Pennsylvania, E-mail: luc2@psu.edu.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Nayyar GM, Breman JG, Newton PN, Herrington J, 2012. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12: 488–496.
-
2.
Newton PN et al.., 2006. Manslaughter by fake artesunate in Asia–will Africa be next? PLoS Med 3: e197.
-
3.
Newton PN, Caillet C, Guerin PJ, 2016. A link between poor quality antimalarials and malaria drug resistance? Expert Rev Anti Infect Ther 14: 531–533.
-
4.
Newton PN et al.., 2008. A collaborative epidemiological investigation into the criminal fake artesunate trade in southeast Asia. PLoS Med 5: e32.
-
5.
Dondorp AM et al.., 2004. Fake antimalarials in southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials. Trop Med Int Health 9: 1241–1246.
-
6.
Newton P et al.., 2001. Fake artesunate in southeast Asia. Lancet 357: 1948–1950.
-
7.
Sengaloundeth S et al.., 2009. 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.
-
8.
Phanalasy S, 2017. The malaria testing and treatment landscape in the southern Lao People’s Democratic Republic (PDR). Malar J 16: 169.
-
9.
Tabernero P et al.., 2015. A repeat random survey of the prevalence of falsified and substandard antimalarials in the Lao PDR: a change for the better. Am J Trop Med Hyg 92: 95–104.
-
10.
Khin HS, Aung T, Aung M, Thi A, Boxshall M, White C, 2016. Using supply side evidence to inform oral artemisinin monotherapy replacement in Myanmar: a case study. Malar J 15: 418.
-
11.
Khin HS, Aung T, Thi A, White C, 2016. Oral artemisinin monotherapy removal from the private sector in eastern Myanmar between 2012 and 2014. Malar J 15: 286.
-
12.
Thein ST, Khin HSS, Thi A, 2017. Anti-malarial landscape in Myanmar: results from a nationally representative survey among community health workers and the private sector outlets in 2015/2016. Malar J 16: 129.
-
13.
Thein ST, Khin HSS, Thi A, 2017. Insights into the availability and distribution of oral artemisinin monotherapy in Myanmar: evidence from a nationally representative outlet survey. Malar J 16: 170.
-
14.
WHO, 2007. World Health Assembly Resolution WHA60.18. Available at: http://www.who.int/tdr/about/governance/documents/WHA60.18.pdf. Accessed July 16, 2017.
-
15.
Fairhurst RM, Dondorp AM, 2016. Artemisinin-resistant Plasmodium falciparum malaria. Microbiol Spectr 4: EI10-0013-2016.
-
16.
Cui L et al.., 2012. Malaria in the greater Mekong subregion: heterogeneity and complexity. Acta Trop 121: 227–239.
-
17.
Hewitt S, Delacollette C, Poirot E, 2013. Malaria control in the greater Mekong subregion: an overview of the current response and its limitations. Southeast Asian J Trop Med Public Health 44 (Suppl 1 ):249–305, discussion 306–307.
-
18.
Guo S, Cui Y, He L, Zhang L, Cao Z, Zhang W, Zhang R, Tan G, Wang B, Cui L, 2013. Development of a specific monoclonal antibody-based ELISA to measure the artemether content of antimalarial drugs. PLoS One 8: e79154.
-
19.
He L, Nan T, Cui Y, Guo S, Zhang W, Zhang R, Tan G, Wang B, Cui L, 2014. Development of a colloidal gold-based lateral flow dipstick immunoassay for rapid qualitative and semi-quantitative analysis of artesunate and dihydroartemisinin. Malar J 13: 127.
-
20.
Guo S, Cui Y, Wang K, Zhang W, Tan G, Wang B, Cui L, 2016. Development of a specific monoclonal antibody for the quantification of artemisinin in Artemisia annua and rat serum. Anal Chem 88: 2701–2706.
-
21.
Guo S, He L, Tisch DJ, Kazura J, Mharakurwa S, Mahanta J, Herrera S, Wang B, Cui L, 2016. Pilot testing of dipsticks as point-of-care assays for rapid diagnosis of poor-quality artemisinin drugs in endemic settings. Trop Med Health 44: 15.
-
22.
Guo S, Zhang W, He L, Tan G, Min M, Kyaw MP, Wang B, Cui L, 2016. Rapid evaluation of artesunate quality with a specific monoclonal antibody-based lateral flow dipstick. Anal Bioanal Chem 408: 6003–6008.
-
23.
Newton PN et al.., 2009. Guidelines for field surveys of the quality of medicines: a proposal. PLoS Med 6: e52.
-
24.
Guo S, Zhang W, He L, Tan G, Min M, Kyaw MP, Wang B, Cui L, 2016. Rapid evaluation of artesunate quality with a specific monoclonal antibody-based lateral flow dipstick. Anal Bioanal Chem 408: 6003–6008.
-
25.
Batty KT, Davis TM, Thu LT, Binh TQ, Anh TK, Ilett KF, 1996. Selective high-performance liquid chromatographic determination of artesunate and alpha- and beta-dihydroartemisinin in patients with falciparum malaria. J Chromatogr B Biomed Appl 677: 345–350.
-
26.
Karbwang J, Na-Bangchang K, Molunto P, Banmairuroi V, Congpuong K, 1997. Determination of artemether and its major metabolite, dihydroartemisinin, in plasma using high-performance liquid chromatography with electrochemical detection. J Chromatogr B Biomed Sci Appl 690: 259–265.
-
27.
Dondorp A, Nosten F, Stepniewska K, Day N, White N, 2005. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet 366: 717–725.
-
28.
Dondorp AM et al.., 2010. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. Lancet 376: 1647–1657.
-
29.
WHO, 2015. Guidelines for the Treatment of Malaria. 3rd edition. Geneva, Switzerland: World Health Organization, 316.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 62 | 62 | 15 |
| Full Text Views | 784 | 138 | 2 |
| PDF Downloads | 224 | 34 | 3 |