Performance assessment of the Thai National Center for Pharmacovigilance

Abstract

BACKGROUND:

The Thai National Pharmacovigilance Center (NPVC) has operated since 1983, but its performance has never been formally assessed.

OBJECTIVE:

The paper aimed to present the main findings of performance assessment of the Thai NPVC.

METHODS:

A survey was conducted. Data from January 2011-December 2013 were collected. The performance was assessed through four indicator domains.

RESULTS:

The NPVC has a clear mission to guide its roles and responsibilities. The center has a well-established structure, adequate budget, qualified personnel, and good IT infrastructure, but it has no in-house IT personnel.

Safety surveillance function was considered excellent. The Thai adverse drug reaction database accumulate a number of quality reports. Typically, new signals of traditional or herbal medicines could be generated from the database.

The risk management process was well established and carried out. The National Drug Safety Advisory Sub-Committee was composed of qualified representatives from related disciplines. Not only do these committee members make safety decisions, but they also provide key safety messages and communicate these to their member audiences.

The risk communication function was evaluated to be unsatisfactory. It was not effectively distributed to individual health care professionals.

CONCLUSIONS:

The overall performance of the Thai NPVC was considerably good. The findings suggested that risk communication should be improved. Moreover, organizational performance should be routinely evaluated. If possible, benchmarking with international pharmacovigilance centers should also be performed.