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Scientific title: Development of standardized methods for efficient representative sampling of drugs for laboratory analysis to obtain robust estimates of the frequency of counterfeit, substandard and degraded artemisinin containing drugs in countries.
What did we know before this research?
The World Health Organization recommends artemisinin-based combination therapy (ACT) as the first-line treatment for malaria. This consists of combining two drugs: artemisinin (which derives from the artemisia plant) and a partner drug (one of existing antimalarials). If taken alone rather than combined, they are considered monotherapies and are less effective.
Governments have purchased millions of these expensive drugs over the past decade. However, some evidence from South East Asia in 2002 suggests that there are cases of fake antimalarials. This is often reported in the news and spreads alarm.
The quality of drugs is extremely important, as poor quality drugs (which contain the wrong amounts of artemisinin) may contribute to the development of drug resistance and patients who are not treated properly are at risk of dying.
What does this study add?
With this project we aim to understand whether there are reasons to be concerned about the quality and authenticity of ACT drugs in Africa.
The study assesses the quality of drugs deriving from artemisinin in six countries. This is done through surveilling the frequency of poor quality malaria drugs as well as laboratory and field based studies.
Our aim is to maximise the efforts of malaria control globally by analysing samples from several countries and working closely with national health ministries.
The research team has used and assessed methodologies to understand how to best collect drug samples. This will enable an accurate assessment of the prevalence of poor quality drugs in a country.
The research team
Dr Harparkash Kaur, London School of Hygiene & Tropical Medicine
Dr Facundo M. Fernandez, Georgia Institute of Technology, Atlanta, USA. (Drug Forensics)
Dr Paul Newton, Centre for Clinical, Tropical Medicine, Churchill Hospital, Oxford University, Oxford UK and LSHTM, UK.
Dr Michael D. Green, Centre for Disease Control and Prevention, Atlanta, USA
Dr Sian Clarke, London School of Hygiene & Tropical Medicine, UK
Dr Obinna Onwujekwe, College of Medicine, University of Nigeria
Dr Catherine Goodman, London School of Hygiene & Tropical Medicine, UK
Dr Shunmay Yeung, London School of Hygiene & Tropical Medicine, UK
Dr. Seth Owusu-Agyei, Kintampo Health Research Centre, Kintampo
Matthew Chico, London School of Hygiene & Tropical Medicine, UK
Latest on this research
We purchased over 10,000 artemisinin containing combination antimalarials (ACCAs) in total from 6 countries - Cambodia, Ghana (Kintampo), Tanzania, Nigeria (Enugu and Ilorin), Rwanda and Equatorial Guinea (Bioko Island) following varying sample collection approaches (convenience, mystery client and overt) to provide effective surveillance of ACCAs available in a given geographical region.
Qualitative (mass spectrometry) and quantitative (high performance liquid chromatography or HPLC) content analyses to measure the amount of active pharmaceutical ingredients (APIs) were carried out in 3 independent laboratories. Results were expressed as percentage of APIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified.
Of the 10,322 samples (142 brands) substandard drugs were found in all 6 countries, while falsified formulations that did not contained the stated APIs were only found in 2 of the 6 countries.
Randomised sampling identified fewer falsified ACCAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling approach used if representative information on drug quality is to be obtained. The results were disseminated to the country-specific ministries of health, as well as relevant manufacturers.