A Framework for Assessing the Economic Value of Pharmacovigilance in Low- and Middle-Income Countries

Abstract

Pharmacovigilance (PV) programs are an essential component of national healthcare systems. Wellfunctioning 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. Key pointsPharmacovigilance is a key but underfunded component of national healthcare programs in lowand middle-income countries.A framework is proposed for assessing the economic value of pharmacovigilance programs.Evidence generated using this framework could assist stakeholders in evaluating investments to increase the capacity and efficiency of pharmacovigilance and contribute to improving population health.

Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems

“…NRA financial and human resources should not be divided equally among all regulated products and regulatory processes [ 11 , 13 ]. In LMICs, where available resources are rarely close to commensurate with the needs and expectations of the NRA, adoption of a risk-based approach for resource allocation is crucial [ 11 , 30 ]. A risk-based approach seeks to channel available resources to regulatory functions and activities that are most likely to facilitate access to quality-assured products and identify and address high-risk quality problems (e.g., a falsified anti-tuberculosis medicine), thereby maximizing the impact of regulatory investments [ 30 , 31 ].…”

“…In LMICs, where available resources are rarely close to commensurate with the needs and expectations of the NRA, adoption of a risk-based approach for resource allocation is crucial [ 11 , 30 ]. A risk-based approach seeks to channel available resources to regulatory functions and activities that are most likely to facilitate access to quality-assured products and identify and address high-risk quality problems (e.g., a falsified anti-tuberculosis medicine), thereby maximizing the impact of regulatory investments [ 30 , 31 ]. Generally, such activities include oversight of country clinical trials and manufacturing, country post-marketing pharmacovigilance and quality surveillance, and supply chain security.…”

“…It includes analyzing the pharmaceutical market, specific country characteristics and the regulatory environment, and it seeks to ascertain attributes that increase (risk triggers) or decrease (risk-mitigating factors) the probability of risk occurrence (Fig. 3 ) [ 30 , 32 ]. Risk estimation then calculates the probability and magnitude of each identified risk and ranks them commensurately with available resources.…”

Pharmacovigilance in resource-limited countries

“…Hopefully, the fee-based model for PV that has been introduced in the EU can be adapted elsewhere. However, it is important that governments also allocate dedicated funds for PV to ensure steady and sustainable support to PV in the country [33,34].…”

Utilisation Analysis of Antihypertensive Drugs in Bosnia and Herzegovina for the Time-period 2013-2015

“…This is the most complex database in the healthcare system based on which all participants in this system (health funds and ministries, pharmaceutical companies, hospitals, pharmacies) can plan their business policy. This base provides data on use of all drugs at both global as country level, through all segments of the system, based on individual products and doses for all drug forms ( 8 ).…”