Abstract:
The Safety Monitoring Programme (SMP), Thailand’s new drug safety monitoring system, aims to perform new drug safety profiles for Thailand. There has been an increasing number of new drugs in Thailand and only a few studies have explored this particular issue. This study was therefore aimed to perform situational analysis of new drug Safety Monitoring Programme in Thailand and identify safety indicators of the SMP system through the structure, process and outcome model. Various methods including documentation analysis, modified Delphi method, semi-structure interviews, and a case study strategy were used for analyzing the SMP system. Coxibs and Statins were the case study drugs to explain how structure, process affected the safety of new drug in the SMP. The results revealed that there were essential elements in the SMP influencing the qualify of safety profile of new drug. Policy, law, regulation and guideline were critical to safety profiles which affecting structure and process components such as information system, organization and ADR management system at both national and local level. The safety indicators of the SMP were identified by the 3-round Modified Delphi method. Seventy-one indicators were identified in the first round, 40 indicators in the second and 19 indicators in the final round. The assessment of the SMP through the 19 core safety indicators found that there were 6 existent elements of 9 structure indicators, 1 existent element of 6 process indicators and 2 of 4 outcome indicators. From these findings, the amendment of law, regulation and national policy should be strengthened to better the effectiveness of the SMP system. The safety indicators should be further developed and continuing used and improved.
