Falsified and substandard medicines: A global pandemic

The proliferation of falsified medicines - estimated to be a $75 billion a year criminal enterprise - is the focus of a special supplement of The American Journal of Tropical Medicine and Hygiene (AJTMH). This supplement features 17 articles on falsified medicines.

The development and distribution of falsified or substandard medicines is a serious concern for international public health - it threatens the lives of millions. Poor quality medicines can cause avoidable morbidity, mortality, loss of faith within health systems, and facilitate emergence of drug resistance. This problem has been particularly studied with respect to antimalarials but examples of all the different types of medicines have been found.

“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 the WorldWide Antimalarial Research Network, Oxford. This study explores the changes over time of the quality of antimalarial medicines in Laos over the past decade.

The team found that since the implementation of many strategies to counteract the threat of falsified medicines since 2003, there has been a significant decrease in the sale and distribution of these harmful drugs in Laos.

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. 

The research also showed that patients are exposed to ineffective drugs such as chloroquine, and that there is a need for greater cooperation in obtaining authentic medicines from manufacturers.

“Falsified and substandard medicines are a huge international issue,” says Prof Philippe Guérin, Director of the WorldWide Antimalarial Research Network. “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.

“We need to work in partnership with governments, health care professionals, the private sector, research institutes, the donors and NGOs to determine the true scale of the problem, and develop realistic strategies to put an end to falsified and substandard medicines. This supplement intends to grab the attention of policy makers and leaders for this important issue.”

The supplement will be released at a panel discussion on Monday 20 April during a science event at The University of North Carolina Gillings School of Global Public Health. The event, which will be webcast live, will feature a presentation by Patricia Tabernero, and remarks by several authors of the 17 articles on falsified and substandard medicines that will appear in the journal.

Media enquiries: please contact Andrea Stewart, Centre for Tropical Medicine & Global Health, University of Oxford by email andrea.stewart@wwarn.org or tel. + 44 1865 857 412.

Details of the event and supplement:

ONLINE: Watch live streaming and join the conversation on Twitter @UNCpublichealth using the hashtag #BadMedsKill

RSVP & QUESTIONS: Reporters are invited to RSVP their intention to participate and to send questions via email to Poor-Quality-Meds@UNC.edu

WWARN speaker: Patricia Tabernero, MSc, MPh, Worldwide Antimalarial Resistance Network, Oxford University

The following experts will also deliver remarks and presentations:

• Amir Attaran, DPhil, LLB, Faculties of Law and Medicine, University of Ottawa
• Robert A. “Bob” Blouin, PhD, Dean, UNC Eshelman School of Pharmacy
• Joel Breman, MD, DTPH, AJTMH Supplement co-editor, Senior Scientist Emeritus from NIH’s Fogarty International Center
• Harparkash Kaur, PhD, London School of Hygiene and Tropical Medicine
• Professor Steve Meshnick, MD, Department of Epidemiology, Gillings School of Global Public Health
• Gaurvika ML Nayyar, MBA/MPH, AJTMH Supplement co-editor, Program Manager, United States Pharmacopeial Convention
• Barbara K. Rimer, PhD, Dean, UNC Gillings School of Global Public Health.