Performance indicator development for pharmacovigilance system in Thailand

Abstract

The goal of this study was to develop a set of indicators to assess the performance of the national center for pharmacovigilance in Thailand. The study was initiated to respond to the need of systematic evaluation of phamacovigilance system, but the lack of comprehensive tools. The indicators were designed based on the theory of organizational performance assessment and pharmacovigilance functioning framework. This is an evaluative analysis study based on cross sectional research design. The indicators were developed based on three-stage model: 1) applying logic model and identifying indicator domains, 2) formulating the candidate indicators, and 3) validating the selected indicators through expert opinions. 21 indicators were developed and judged against two validation criteria: relevance and practicability. The set of validated indicators consisted of four domains: 1) policy, law, plan, and structural support, this domain comprised 9 indicators, which could be used to identify the existence of and the relevance of legal provisions, policy, and plans, and to examine the organizational structure. They reflected the enabling factors to enhance the successful towards the organizational goals. 2) safety surveillance, comprised 5 indicators. The indicators reflected the capability of the organization to participate and build partnerships, and bring multiple stakeholders together for successful information exchange. They referred to the coordination and collation of data between data providers and the national center, timely and effective data flow, as well as the quality of data obtained from secondary sources. 3) signal detection and decision making for risk management, comprised 4 indicators: data preparation to be analyzed, data quality, automated signal detection and decision making for risk management. This domain referred to the function of the NPVC to collect, summarize, and transform of ADR information; to identify, estimate, and evaluate the volume and seriousness of risks that associated with a pharmaceutical product; and to propose the corrective measures to minimize risks. They reflected the capability of the organization to manage large dataset and make decisions for risk management. 4) communication of safety information, comprised 3 indicators. The indicators reflected the capability of the organization to organize timely and effective dissemination of safety information, and its responsiveness to any related queries either in domestic or international level so as to facilitate safety surveillance. The developed indicators could be divided into 3 types: 10 structure indicators, 5 process indicators, and 6 outcome indicators. Most of the indicators were yes/no questions or percentage/rate measurements, subsequent qualitative data from the respondents were needed for better interpretation of the results. It could be concluded that the developed assessment tool should be tested and refined in order to be routinely used for the organizational performance assessment in the future.