POST MARKETING DRUG RISK MANAGEMENT SYSTEM IN THAILAND:SITUATION ANALYSIS AND DEVELOPMENT OF RISK ASSESSMENT CRITERIA

Abstract

Safe use of drug does not mean zero risk, so benefit and risk must be balanced throughout the drug life cycle by using drug risk management (DRM) activities. In Thailand, DRM activities are implemented via different regulatory actions, tools or laws. These activities are responsible by the Drug Safety Advisory subcommittee, under the Drug Committee of the Thai Food and Drug Administration (Thai FDA). The objectives of this research are to identify strengths, weaknesses, threats and gaps of the post-marketing DRM in Thailand and develop risk assessment criteria for decision making of the Drug Safety Advisory subcommittee. The methods used to identify strengths, weaknesses and gaps in the current system were 1) literature review,2) in-depth interview with committee members and 3) validate the result by questionnaires with Likert scale. Study results showed that the three major strengths were 1) suitable composition of the subcommittee members, 2) clear role and responsibilities of the Drug Safety Advisory subcommittee, and 3) using scientific evidences for DRM decision. The two weaknesses were 1) no process for urgent regulatory decision and 2) no guideline or criteria for committee's decision making. Two threats were 1) accusation of released legal measures and 2) challenge of increasing workload with limited resource. The two gaps were 1) lack of cooperation among the Thai FDA and academic/research institutes and 2) the weak signal detection system. The methodology used to develop risk assessment criteria for decision making were 1) literature review to find the initial framework, 2) case review to analyze the previous regulatory recommendations and modified Delphi method to validate the criteria for decision making. The risk assessment criteria were constructed from four different categories, which were in public health implications, regulatory obligations, strength of evidences and public perceptions. Our study revealed that 13 criteria should be used in the DRM decision making and proposed the regulatory recommendations. They mainly include drug or vaccine exposure, frequency of ADRs, health consequence, strength of evidences, and factors likely to cause public anxiety. This research can result in criteria used for DRM decision making for manage drug’s risk in regulatory perspective.