A Quantitative Analysis of China’s Pharmacovigilance Policy Based on the PMC Index Model

Abstract

Objective To study the current situation of China’s pharmacovigilance system, and to provide some suggestions for the improvement of related policies. Methods A policy modeling consistency (PMC) index model of pharmacovigilance policy was constructed to quantitatively assess the samples of policies combining text mining. Then, the PMC surface was established to obtain the visualization results of China’s pharmacovigilance policy samples, and their shortcomings were clearly analyzed by comparison. Results and Conclusion Forty-one percent of China’s pharmacovigilance policies were rated as excellent, 54% as acceptable, and the overall evaluation was acceptable. But there is still some room for improvement. On the whole, there are problems of insufficient policy synergy, lack of policy incentives and constraints, and incomplete coverage of policy functions. It is recommended that China’s pharmacovigilance policy system should be optimized by strengthening policy coordination, increasing policy incentives and constraints, and guiding multi-subjects to participate in coordination. These findings and recommendations can provide operational ideas for the system of China’s pharmacovigilance policy.

Keywords

pharmacovigilance / PMC index model / policy evaluation / adverse drug reaction

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