Special supplement highlights global threat of falsified and substandard medicines

Today, the American Journal of Hygiene and Tropical Medicine releases a special supplement focussing on the proliferation of falsified medicines - estimated to be a $75 billion a year criminal enterprise. The supplement is made up of 17 research papers.

The supplement was released at a panel discussion during a science event at The University of North Carolina Gillings School of Global Public Health which featured a presentation by Patricia Tabernero, former Scientific Co-ordinator of WWARN’s Drug Quality group and first author of one of the publications.

Poor quality medicines - both falsified and substandard - of commonly used antimalarials and other medicines are frequently found. The consequences include prolonged sickness, treatment failure, side effects, loss of income, increased healthcare costs and death. These medicines may contain sub-therapeutic amounts of artemisinin derivatives, such as artesunate, but usually contain no malaria medication at all. Inadequate dosing has serious implications for worsening antimalarial resistance.

“Although attempts have been made, there is still no globally recognized consensus on the definitions of what substandard or falsified medicines actually are,” says Prof Paul Newton, senior author of two of the papers included in the supplement, Director of the Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, and Head of Drug Quality at the WorldWide Antimalarial Resistance Network (WWARN). “Overall, there is a lack of evidence-based research within this field which perpetuates a lack of global will and accountability to tackle this scourge.”

The supplement features a study from the Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit and WWARN. This study explores the changes over time of the quality of antimalarial medicines in Laos over the past decade.

In 2003, a random survey of antimalarial medicines found that 84 per cent of artesunate tablet samples tested - a then commonly used antimalarial - did not contain the correct pharmaceutical ingredients. This same survey was repeated in 2012 and all of the antimalarials contained the correct pharmaceutical ingredients, a triumph in Laos’ battle against falsified antimalarials.

“In this nine year period, major changes have occurred in Laos that have allowed people in remote regions of the country better access to healthcare services and safer antimalarial treatments” says Patricia Tabernero, first author of the study from WWARN. “The implementation of malaria control and surveillance strategies, the development of quality assurance systems, and better awareness and education on falsified medicines, have all played a significant role in the decrease of the trade of these dangerous medicines.”

Although, none of the antimalarial samples analysed in the 2012 survey were falsified, over one quarter of samples were either substandard or had begun to degrade over time. Degradation may be caused by storage of medicines in hot conditions. Substandard medicines are a hazard to patients’ health and increase the risk of drug resistance by exposing organisms to sub-therapeutic levels of active ingredients. 

This research shows that Laos has had success in responding to this threat over the past decade, but there is much more work to be done globally. Some attention has been given by policy makers to the issue of falsified medicines, but very little on the problem of substandard medicines, a growing concern. This supplement intends to grab the attention of policy makers and leaders for this important issue.

Publication details:

Patricia Tabernero et al. 'A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better' American Journal of Tropical Medicine and Hygiene 15-0057 Published online April 20, 2015 , doi:10.4269/ajtmh.15-0057