Evolution and simulation of drug safety regulations: construction of a game model for capture event

Abstract

PurposeThe study focuses on drug safety regulation capture, reveals the inner mechanism and evolutionary characteristics of drug safety regulation capture and provides suggestions for effective regulation by pharmacovigilance.Design/methodology/approachThe article introduces prospect theory into the game strategy analysis of drug safety events, constructs a benefit perception matrix based on psychological perception and analyzes the risk selection strategies and constraints on stable outcomes for both drug companies and drug regulatory authorities. Moreover, simulation was used to analyze the choice of results of different parameters on the game strategy.FindingsThe results found that the system does not have a stable equilibrium strategy under the role of cognitive psychology. The risk transfer coefficient, penalty cost, risk loss, regulatory benefit, regulatory success probability and risk discount coefficient directly acted in the direction of system evolution toward the system stable strategy. There is a critical effect on the behavioral strategies of drug manufacturers and drug supervisors, which exceeds a certain intensity before the behavioral strategies in repeated games tend to stabilize.Originality/valueIn this article, the authors constructed the perceived benefit matrix through the prospect value function to analyze the behavioral evolution game strategies of drug companies and FDA in the regulatory process, and to evaluate the evolution law of each factor.