Health and Economic Burden of Substandard and Falsified Medicines

Abstract

One in 10 medical products in low- and middle-income countries (LMICs) are reportedly substandard or falsified (SF). Poor quality medicines burden health systems and individuals by diverting resources to harmful or ineffective products, prolonging illnesses and increasing risks of complications and mortality. While several models have been developed to estimate the health and economic impact of SF medicines, they have been applied solely to specific medicines (i.e., antimalarials and antibiotics) in a small number of settings. In order to address this gap and advance the field, this dissertation aimed to develop tools to help countries assess their health and economic burden from SF medicines more broadly. First, we developed a conceptual framework as a guide for the estimation of the health and economic burden of SF medicines by identifying high priority medicines and evaluating data availability, gaps and modeling approaches. Second, we developed an adaptable model as a tool that can be used to estimate the health and economic burden of any medicine in any country. Third, we applied it oxytocin in Kenya as a case study. Finally, we developed a comprehensive disease-specific model for oxytocin that captures all relevant aspects of disease progression and specifications to generate more accurate estimates and to compare its findings to those generated by an adaptable model. The adaptable model estimated that among 1.2 million pregnant patients delivering in healthcare facilities in Kenya yearly, the burden of SF oxytocin (assuming a prevalence of 7%) is estimated be responsible for 2,493 additional cases of postpartum bleeding, 25 hysterectomies, 26 deaths and over 420 years of life lost. The economic burden was estimated to be approximately $1,240,000 from a societal perspective, reflecting approximately $300,000 due to early death and lost productivity and approximately $940,000 in direct medical costs annually. For the same population, the oxytocin-specific model estimated that 7% SF oxytocin is responsible for 2,067 additional cases of postpartum bleeding, 15 hysterectomies, 32 deaths, over 600 years of life lost, 560 QALYs lost and 2,187 DALYs accrued every year. The economic burden was estimated to be approximately $1,970,000 from a societal perspective, reflecting approximately $740,000 due to early death and lost productivity and approximately $1,220,000 in direct medical costs. The magnitude of the burden generated by the oxytocin-specific model was comparable to the adaptable model. but the results yielded were more accurate. These findings demonstrate that SF oxytocin is an urgent issue to be addressed and Kenya and that the adaptable model can be leveraged by relevant stakeholders as a tool to generate high-level estimates on the health and economic burden of any medicine in their country. The significance of this study lies in its ability to provide policymakers in Kenya with crucial information that will assist them in making informed decisions about the issue of SF oxytocin and in its potential to provide other key stakeholders tools to generate locally specific and policy-relevant evidence on the burden of other SF medicines.