Background
Malaria, in the world's 104 endemic countries, occurs predominantly among intertwined poverty and lack of access to efficacious medicines. A grossly neglected aspect of malaria control is the importance that patients should not just have access to medicines, but should have access to good quality-assured medicines. This was recently emphasized in the resolution adopted by the United Nations Human Rights Council "Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, to medicines that are affordable, safe, efficacious and of quality".
In the last decade many studies have highlighted deficiencies in medicine quality afflicting all classes of medicines, with no country immune. The problem is not new, with reports of falsified cinchona bark from the 1600s and falsified quinine from the 1800s.
There has been considerable confusion over definitions of different types of poor quality medicines. The terms falsified (i.e. produced by criminals fraudulently), substandard (i.e. unintentional but negligent errors in factory processes) and degraded (i.e. degradation through inadequate storage after leaving the factory or interaction with inadequate excipients) were used to define medicine quality. With increasing use of the term 'counterfeit' to refer to intellectual property (IP) concerns, the term falsified was used to avoid IP associations. Public health should be the prime consideration in defining and combating poor quality medicines. Nonetheless, there remains a lack of worldwide consensus on what constitutes a falsified medicine and no international treaty to criminalize the manufacturer or distributor of falsified medicines.
Falsified medicines may usually be identified by their fake packaging but both packaging and chemical analysis are required to be sure of a sample's regulatory status and public health impact. Such investigations are difficult as instrumental and chemical analysis with sophisticated and expensive equipment, reagents and technical capacity are essential. For packaging analysis, genuine examples of products, direct from the manufacturer, are needed as comparators but are difficult to obtain. Recently, portable instruments to determine the quality of anti-malarials, such as Raman spectrometers and the Global Pharma Health Fund GPHF-Minilab®, have become available and are being used to screen medicine chemical quality. For forensic investigations, innovative chemical fingerprinting and palynology techniques can provide clues as to the origin of medicines through analysis of their mineral and pollen composition, respectively.
The consequences of using poor quality medicines range from prolonged sickness, treatment failure, side effects, loss of income, increased healthcare costs and death. In addition, societies may lose confidence in otherwise effective medicines, in healthcare systems and suffer major economic losses. Of particular current relevance, falsified or substandard anti-malarials containing subtherapeutic amounts of artemisinin derivatives or only one of the two active ingredients in artemisinin combination therapy (ACT), the primary treatment recommended for uncomplicated falciparum malaria, are very likely to contribute to disastrous anti-malarial artemisinin resistance, increasing mortality and morbidity and risking the loss of these vital medicines for malaria control.
Nevertheless, objective data on the geography and epidemiology of poor quality medicines are sparse. Estimates of anti-malarial quality vary widely depending on the sampling methodology used, with most reports not employing rigorous scientific techniques, potentially biasing results. In order to understand the shortcomings of the data and how the existing data may help inform policy to improve anti-malarial quality, an openly accessible databank of all the published reports of the quality of anti-malarials was developed: the WWARN Antimalarial Quality Surveyor. Here, the Surveyor is described, the database analysed and the implications for public health and potential interventions discussed.