Evaluation on risk control Measures for Medicinal Products in Thailand

Abstract

The study aimed to evaluate the risk control measures for medicinal products in determinants of operational results. The relevant impact and factors of those were assessed to develop regulatory policy recommendation. Methods: This was a mixed-methods study by quanti-qualitative sequential approach. The study period was during year 2011-2018. A quantitative study was collected information in 2011 by a survey for opinion and operation performance at selected hospitals and private drug stores. In the qualitative phase, a literatures review, academic medical studies documents and minutes were gathered during year 2012-2018. Relevant database was also searched. The evaluated measures were the 7 nimesulide risk control directed by the Drug committee which were classified as three groups: 1) legal enforcement, 2) implement of study research and its surveillance 3) drug risk communications of responsible organizations.Results: The study was found that all risk control measures had been done by all responsible institutions in various formats or tools. Thai Food and Drug Administration had directed all decided regulatory measures to be implemented. The drug risk communication was concreted distributed. The Market Authorization Holders had complied with the legal enforcement in developing the clinical study research but it cannot be performed due to the Ethical Review Committee for Research in Human Subjects’ unapproval. Although 81.30 % of hospitals and private drug stores had acknowledged the risk but they had managed to undertake selected regulatory measures with following to their work operation guidelines in the organizations. 70.00 % of them agreed that the directed risk control measures can reduce the drug’s risk. However, during year 2006-2011, 77 hospitals (45.00%) determined to withdraw it from the hospitals’ drug list or stop using nimesulide after realizing its risk. The decided regulatory measures resulted in decreased nimesulide usage, less number of drug registration and reporting rate of nimesulide-ADRs. In conclusions: All risk control measures were made to operation except the implement of study research and its surveillance.