Pharmacovigilance in emerging economies: modeling interaction among barriers

Abstract

PurposeThe main purpose of this paper is to identify and rank various barriers to pharmacovigilance (PV) in context of emerging economies and examine their interrelationships using the interpretive structural modeling (ISM) approach. The result is a model that offers insights about how to achieve rational and safe use of medicines and ensure patient safety as realized through robust national PV systems.Design/methodology/approachThe paper develops a model to analyze the interactions among PV barriers using the ISM approach. Based on input from clinical and medical product development experts, PV barriers in emerging economies were identified and reviewed. The hierarchical interrelationships among these PV barriers were analyzed in context of their driving/dependence powers.FindingsFindings of the study identify key PV barriers—lack of resources/infrastructure, weak legislation, unfair burden of disease, lack of PV capacity, training, and enforcement authority—that drive, or strongly influence, other barriers and thwart implementation of robust national PV systems in emerging economies. Pharmaceutical industry factors were PV barriers that were identified as autonomous, implying their relative disconnection from other barriers, and patient PV practices barrier was strongly dependent on other barriers.Research limitations/implicationsThe paper offers policy- and decision-makers alike with a framework to support further research into interdependencies among key PV barriers in emerging economies. It can serve as an impetus for further research with potential to broadening the understanding of how and why PV systems may be rendered ineffective. Future studies can be planned to apply the ISM approach to study PV barriers in the context of developed economies and draw lessons and implications for policy- and decision-makers by contrasting results from these studies.Practical implicationsThis paper contributes to the understanding of the multifaceted nature of PV and its barriers. The proposed approach gives public health decision-makers a better comprehension of driver PV barriers that have most influence on others versus dependent PV barriers, which are most influenced by others. Also, knowledge, attitude and practices of patients and caregivers can also be critical PV barriers in emerging economies. This information can be instrumental for public health policymakers, government entities, and health/PV practitioners to identify the PV barriers that they should prioritize for improvement and how to manage trade-offs between these barriers.Social implicationsPV barriers in emerging economies, as compared to developed economies, are inherently different and need to be examined in their specific context. The hierarchical ISM model suggests that resources and regulation initiatives by governments in emerging economies lead to through informed/enabled pharmaceutical supply chain players and eventually drive PV-specific knowledge, attitude, and practice outcomes improvements across their populace.Originality/valueThis paper highlights the deployment of ISM approach as a health policy decision support tool in the identifying and ranking barriers to effective PV systems in emerging economies, in terms of their contextual relationships, to achieve a better understanding as to how these interrelationships can affect national PV system outcomes.