LAUSR

The global burden of substandard and falsified (SF) medicines is only beginning to be better understood. A 2017 literature review by WHO estimated a 10.5% observed failure rate of the analysed medical product samples in low-income and middle-income countries.1 The report also estimated that between 72 430 and 169 271 deaths in children under 5 with pneumonia could be attributed to the use of SF antibiotics and between 31 000 and 116 000 estimated deaths from malaria in sub-Saharan Africa could be due to SF antimalarials.1 Further, the economic impact due to reduced effectiveness of SF antimalarial products was estimated at about US$38.5 million in sub-Saharan Africa.1 Another literature review and meta-analysis estimated the overall prevalence of SF medicines at 13.6% in low-income and middle-income countries with economic burden ranging from US$10 billion to US$200 billion.2 Further, SF antibiotic medicines containing inferior amount of active ingredient can promote antimicrobial resistance.3 While more limited evidence is available on the prevalence of SF medicines in high-income countries,1 and the extent to which SF medicines affect countries at various stages of health system development is different, the problem is really global.4 5 The true prevalence of SF medicines is unknown due to methodological limitations affecting a number of published studies (eg, inadequate sampling techniques and inadequate analytical procedures), varying or unclear definition of what constitutes a substandard or falsified medicine, uneven coverage of geographical and therapeutic areas and limited availability of up-to-date data.6 7 Even so, the available evidence illustrates the fact that SF medicines are a threat to individual and public health, can undermine trust in the healthcare system and waste resources.1 5 Substandard medicines are defined by WHO as “authorized medical products that fail to meet either their quality standards or specifications, …