A framework for assessing the economic value of pharmacovigilance in low- and middle-income countries.

Pharmacovigilance (PV) programs are an essential component of national healthcare systems. Well-functioning PV programs can improve population health by identifying and reducing medicines-related problems (MRPs). Many low- and middle-income countries lack functional PV systems, but this deficiency has not been described in terms of the potential economic value of strengthening PV systems. The assessment of economic value for PV can support rational decision making at the country level. We propose a framework for assessing the economic value of PV. We divide national PV systems into four levels: (1) no PV, (2) basic PV, (3) semi-functional PV, and (4) functional PV. These categories represent increasing levels of investment in PV capacity at the national or health facility level for all available medicines, including vaccines. The proposed framework can be used to estimate the costs of PV (including the value of investments to increase PV capacity and the costs of managing MRPs) and outcomes associated with PV (including improvements in morbidity, mortality, and quality of life as a result of the reduction in MRPs). The quantitative approach proposed for assessing costs and benefits uses a decision-analytic modeling framework that would estimate the value of the consequences of MRPs adjusted for their probability of occurrence. This allows the quantification of value using monetary outcomes (cost-benefit analysis), natural units (cost-effectiveness analysis), or mortality adjusted for quality of life or disability (cost-utility analysis). Evidence generated using this framework could assist policy makers, program managers, and donors in evaluating investments that aim to increase the capacity and efficiency of national and facility-level PV programs in low- and middle-income countries.