The Public Health Issue of Falsified and Substandard Medicines in Resource-Limited Settings

Poor-quality medicines are a major global issue, sometimes described as a pandemic. Threatening millions of people, they risk increasing morbidity, mortality, economic losses, and diminishing trust in medical products and health systems. The issue seems to be much more important in limited-resource countries where pharmaceutical legislation and regulation are limited. Since 2017, the terms ‘substandard’ (including degraded) and ‘falsified’ are increasingly used often abbreviated as ‘SF’ medicines. Little scientific objective evidence on their prevalence is available, but surveys suggest that a substantial proportion of anti-infectives in particular, in many low-resource settings, are of poor quality. The use of SF medicines that contain suboptimal concentrations of the active pharmaceutical ingredient(s) or the incorrect active ingredient(s) are likely to favour the emergence and spread of antimicrobial resistant pathogens, putting affordable treatments at risk. Medicines with higher than recommended amounts of active pharmaceutical ingredient(s) or containing wrong harmful active ingredient(s) may induce unexpected and potentially severe adverse drug reactions. To identify poor-quality medicines after they are put on the market, at different levels of the pharmaceutical supply chain, many technologies and devices exist, each with advantages and limits. However, the breadth and depth of evidence that they perform well for that purpose for formulated medicines is limited. This chapter describes the different aspects of SF medicines, from a public health standpoint, and also discusses the available research regarding their drivers and the factors that are likely to impede action to ensure that patients receive good-quality medicines. The role of pharmacovigilance in detecting SF medicines is also discussed.