Strengthening global action against poor quality drugs

Abstract

Medicines are supposed to treat or prevent illnesses, but falsified or substandard drugs can harm and even kill. This problem is shared by both developing and developed countries. For example, in 2012 in Pakistan, more than 120 people died and hundreds more suffered adverse reactions after taking a contaminated heart medicine. In the same year in the USA, a contaminated injectable steroid drug, compounded under grossly unhygienic conditions at the New England Compounding Center, resulted in an outbreak of fungal meningitis. As of Feb 11, 2013, the outbreak has made 704 people ill and killed 46. To respond to the global threat of falsified or substandard drugs, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to convene a consensus committee, which has gathered information and deliberated on approaches to mitigate this public health problem. Their recommendations were presented in Countering the Problem of Falsified and Substandard Drugs, released on Feb 13. The IOM report recognises that the absence of a precise and internationally agreed definition to frame the problems of poor quality drugs is the major obstacle to advancing a global discourse. The report categorises such drugs into two types: falsified drugs (a false representation of identity or source or both), and substandard drugs (not up to national specifications because of quality system failures). The once widely used but controversial term to describe falsified drugs, “counterfeit”, is not used in this report, because of concern about the conflation of enforcement of intellectual property rights and access to medicines, particularly legitimate generic drugs. Another barrier is the lack of rigorous research and robust data to accurately estimate the global burden of falsified and substandard drugs. Governments and drug companies contribute to this problem by withholding information for fear of eroding public confidence. Using available literature, which largely consists of case studies and convenience samples of pharmacies or dispensaries, the report reviews global trends of falsified and substandard drugs. At least 124 countries in 2011 were affected by illegal trade and manufacture of drugs. However, low-income and middle-income countries bore a disproportionate burden, with striking evidence of poor quality antimicrobial and antimalarial drugs. The report suggests that governments should establish and strengthen their surveillance systems to detect falsified and substandard drugs, and integrate these systems with established public health systems. This approach is especially crucial for developing countries, and greater international investment and technical support is needed to improve their surveillance systems. Global drug supply chains have grown more and more complicated, crossing continents, and governments need to catch up. The report recommends that the FDA establishes a mandatory track-and-trace system to identify and verify drug authentication. Indeed, governments and companies have talked about track-and-trace systems many times, but the absence of internationally accepted technology or standards, as well as the cost of implementing such a system, makes it hard for many countries to follow and comply. The world is badly in need of a comprehensive global strategy that unifies the efforts of all the stakeholders including governments, drug companies, health professionals, customers, civil societies, and judicial systems transnationally to combat poor quality drugs. Who will take the lead? In 2012, The Lancet called for “wise and bold leadership” from WHO. So does this report, which calls on the World Health Assembly to adopt consistent definitions for poor quality drugs, and to develop a code of practice, which includes guidelines on surveillance, regulation, and law enforcement, to respond to and prevent the problems of falsified and substandard drugs. WHO is also urged to engage with the major stakeholders, and to collaborate with other international agencies such as the UN Office on Drugs and Crime and the World Customs Organisation, which are better suited in law enforcement, criminal justice, and control of imports and exports. WHO has been struggling to define its role regarding falsified and substandard drugs on the one hand and questions of intellectual property on the other. But, as the report says: “At times, trademark infringement can become a public health problem, but it is not a public health problem in itself, even in so much as it pertains to medicines.” This IOM report provides a reference and instruction for WHO to continue to play an assertive central role in the fight against falsified and substandard drugs, within the context of public health and patient protection.