Abstract
This meeting report presents the key findings and discussion points of a 1-day meeting entitled ‘Fake anti-malarials: start with the facts’ held on 28th May 2015, in Geneva, Switzerland, to disseminate the findings of the artemisinin combination therapy consortium’s drug quality programme. The teams purchased over 10,000 samples, using representative sampling approaches, from six malaria endemic countries: Equatorial Guinea (Bioko Island), Cambodia, Ghana, Nigeria, Rwanda and Tanzania. Laboratory analyses of these samples showed that falsified anti-malarials (<8 %) were found in just two of the countries, whilst substandard artemisinin-based combinations were present in all six countries and, artemisinin-based monotherapy tablets are still available in some places despite the fact that the WHO has urged regulatory authorities in malaria-endemic countries to take measures to halt the production and marketing of these oral monotherapies since 2007. This report summarizes the presentations that reviewed the public health impact of falsified and substandard drugs, sampling strategies, techniques for drug quality analysis, approaches to strengthen health systems capacity for the surveillance of drug quality, and the ensuing discussion points from the dissemination meeting.
Highlights
Artemisinin-based combination therapy (ACT) is recommended as first line treatment for malaria treatment by the World Health Organization (WHO) and effective malaria treatment requires the use of good quality medication [1]
Artemisinin monotherapies [20] were more readily detected through mystery clients than through overt sampling
The findings demonstrate that the threat of substandard drugs is in some instances greater than that of falsified drugs and merit more attention than they have received so far
Summary
Artemisinin-based combination therapy (ACT) is recommended as first line treatment for malaria treatment by the World Health Organization (WHO) and effective malaria treatment requires the use of good quality medication [1]. David Schellenberg, director of the ACT Consortium, opened the meeting, citing earlier reports that as many as a third of anti-malarials are ‘fake’ [12,13,14] Such reports formed the rationale for the ACT Consortium drug quality programme to investigate the quality of artemisininbased combinations at a larger scale than in previous studies; using a representative sampling approach and standardized methodology to assess the prevalence of fake and substandard artemisinin-based combinations across a range of countries in sub-Saharan Africa. A further public health concern is the potential indirect impact, through the promulgation of drug resistance due to substandard anti-malarials To counter this threat requires routine surveillance systems and technical capacity to monitor drug quality on an ongoing basis, supported by effective regulatory action at national and international level.
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