A surveillance system and drug forensic network to monitor the quality and authenticity of artemisinin combination treatments in Africa

Multiple, across select countries in Africa

Dr. Harparkash Kaur, LSHTM

Joint-PI's

Facundo M. Fernandez, Georgia Institute of Technology, Atlanta, USA. (Drug Forensics)

Paul Newton, Centre for Clinical, Tropical Medicine, Churchill Hospital, Oxford University, Oxford UK and LSHTM, UK.

Michael D. Green, Centre for Disease Control and Prevention, Atlanta, USA

The quality of antimalarial medicines is of major concern globally as poor quality drugs undermine effective treatment and probably engender drug resistance. WHO estimates that there are up to three million deaths from malaria annually. Although the prevalence of poor quality antimalarials in Africa is yet to be determined, a large percentage of these deaths might be avoided if the medicines were effective, of good quality and used properly. Artemisinin derivatives (artesunate, artemether and dihydroartemisinin) in combination with partner medicines (ACTs) are the most effective antimalarial drugs available providing rapid cure.

Successful drugs such as ACTs are at risk of being counterfeited or produced with insufficient quality control resulting in substandard products. There is widespread distribution of fake artesunate tablets in SE Asia, resulting in fatalities amongst people who would have otherwise survived their malaria infection. Fake antimalarials containing sub-therapeutic amounts of artemisinin derivatives may engender resistance, and there are preliminary reports indicating the emergence of artemisinin derivative resistant strains (Noedl et al. 2008). Counterfeit artemisinin derivatives and ACTs have already been described from 6 sub-Saharan African countries, but no large scale objective efforts have been undertaken to assess their prevalence.

The aim of this study is to assess the quality of artemisinin derivatives and ACTs in Africa via:

• Surveillance – To obtain statistically valid estimates of the frequency of counterfeit and substandard artemisinin mono-therapies and ACTs in Africa
• Stability - Lab and field based studies to assess the degradation under different storage conditions
• Forensic and Quality Network - Establish “Counterfeit Drug Forensic Network – CODFIN” to investigate the origin of fakes, their forensic inter-relationships and compile a comprehensive record of drugs analysis

The drug quality team aims to evaluate to ensure that the quality of antimalarial drugs available to malaria patients in malaria endemic countries to determine the prevalence of good quality ACTs. Different sampling strategies and approaches have been employed to collect samples from four countries. Plans are underway to design country specific sampling strategies for the further collection of samples in 2-3 additional countries. Samples of ACTs collected from Rwanda, Cambodia, Ghana and the first round of Tanzania have been analysed. Data is being used to classify drugs as counterfeit or substandard and to determine the most sound sampling strategies and approaches. This work will ultimately contribute towards a holistic package of animalarial drug quality surveillance.