Identifying safety indicators of new drug Safety Monitoring Programme (SMP) in Thailand

Abstract

The Safety Monitoring Programme (SMP), Thailand's new drug safety monitoring system, aims to perform new drug safety profiles for the country. There have been an increasing number of new drugs in Thailand, and only a few studies have explored this particular issue. This study was a part of a situational analysis of the new drug Safety Monitoring Programme in Thailand. The objective was to identify safety indicators of the SMP system through the structure, process, and outcome model. A three-round modified Delphi method, including semistructured interviews, mailed questionnaire, telephone recall, and in-person contact, was used. Forty-five persons, representing various stakeholders dealing with the SMP, were asked by telephone or in-person contact to join the expert panel. Thirteen individuals declined to participate, resulting in a panel of 32 experts. Seventy-one indicators were identified in the first round, 40 indicators in the second, and 36 indicators in the final round, and then the indicators were regrouped by similar concepts into 19 safety indicators. The assessment of the SMP through the 19 core safety indicators will be used to assess elements in the SMP system. These indicators should be further developed and continuously used and improved. All rights reserved. Copyright © 2007 Drug Information Association, Inc.