The global pandemic of falsified medicines: laboratory and field innovations and policy perspectives.

Abstract

This supplement to the American Journal of Tropical Medicine and Hygiene, entitled “The pandemic of falsified medicines: laboratory and field innovations and policy perspectives,” showcases 17 articles on detection technologies and methods, field surveillance data, multisectorial perspectives, and policy interventions and recommendations needed to create a coordinated and effective response to curb the pandemic of poor-quality medicines. The goal of this special issue is to alert scientists, public health authorities, and decision makers to the problem of poor-quality drugs and to take prompt actions to mitigate and resolve the growing peril. Poor-quality medicines are a real and urgent threat to decades of success in global public health, particularly for programs combating human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis, and malaria where mortality rates have seen dramatic declines worldwide.1–3 Safe, effective, high-quality, and affordable medical products are essential to positive and equitable health outcomes for all, as noted by the U.S. Food and Drug Administration (FDA) Commissioner, Margaret Hamburg, in her Foreword to this supplement.4 Although previously thought to be limited to low-income countries with weak pharmaceutical regulatory systems and problems with antimalarials (Figure 1 ), increasing reports of a large variety of poor-quality medicines and medicinal products, such as vitamin supplements, in high- and middle-income economies are illustrative of the pandemic nature of this problem.5–7 It is estimated that falsified medicines result in $75 billion in illegal annual revenues to criminals and have caused prolonged, severe illness and deaths worldwide; this figure needs more precision.8 The increasing number of countries reporting breaches of the supply chain, and products being falsified, along with the recent doubling of articles published on “fake drugs” every 5 years in PubMed indicate the problem is of pandemic proportions and growing. This may be an underestimate of the problem. Incidents regarding the distribution and use of poor-quality pharmaceuticals often go unreported due to poor surveillance systems and are kept from the public record by governments and pharmaceutical companies.9 Further clouding the problem is an ongoing debate and confusion over terms related to poor-quality medicines.10,11 In this summary, we use the term falsified as a synonym for counterfeit, devoid of considerations of intellectual property. We classify poor-quality drugs into three main types: falsified (intentional fraudulent manufacturing), substandard (unintentional errors caused in manufacturing), and degraded (medicines that become poor quality after manufacturing because of poor storage environments or handling). Figure 1. Increasing reports of poor-quality antimalarials, 1976–2012, Worldwide Antimalarial Resistance Network (WWARN), Antimalarial Quality Surveyor.5 In 2013, an estimated 122,350 deaths in children under 5 years of age in 39 sub-Saharan African countries were associated with the consumption of poor-quality antimalarials, representing 4% of all under-five deaths, as reported by Renschler and others.12 The impact of falsified and substandard medicines goes beyond the morbidity and mortality affecting vulnerable patients and extends to increased microbial resistance, when active drug is in low amounts in the product; existing drug-resistant microbes in patients can be spread by mosquitoes and other vectors when no active ingredient is present. In addition, socioeconomic losses and loss of public trust are associated with poor-quality medicines, all of which jeopardize years of global public health success and investments.13 Over the last decade, many new stakeholders have joined the cause to combat poor-quality medicines, yet little tangible progress has been made. Moreover, the problem continues to spread globally, creating an even greater challenge to cooperation among stakeholders, many with limited resources.8,10,13 The need is urgent for collaboration among those with expertise in policy, technology, surveillance, and logistics to secure global medicine supply chains.