Pharmacovigilance practices for new drugs in Thailand: A situation analysis in tertiary and university hospitals

Background: In 2017, Thailand’s Food and Drug Administration introduced a risk-based safety monitoring program (SMP) aimed at strengthening pharmacovigilance (PV) for new drugs, including new chemical entities and biologics. Despite this policy shift, drug safety monitoring continues to rely primarily on spontaneous adverse drug reaction (ADR) reporting. This study aimed to explore the implementation of PV practices for drugs with SMP status in selected tertiary and university hospitals in Thailand. Materials and Methods: A qualitative study was conducted using in-depth interviews. Pharmacists and physicians involved in drug safety monitoring were invited. Eight hospitals (five university and three tertiary care hospitals) were purposively selected. Key informants were identified through professional roles, followed by snowball sampling to include multidisciplinary perspectives. Interviews were conducted between March and September 2021, transcribed verbatim, and thematically analyzed using content analysis. The study was guided by the Consolidated Criteria for Reporting Qualitative Research. Results: Two key themes emerged. (I) PV structure: The presence and clarity of hospital-level SMP policies varied significantly. Awareness of SMP was generally higher among pharmacists than physicians; however, even pharmacists often lacked a full understanding of core policy components. Although PV focal points were designated in most hospitals, they frequently lacked the authority or integration required to coordinate effective system-wide monitoring. (II) PV process: SMP implementation was inconsistent across hospitals. Variability was observed in how hospitals identified SMP drugs, selected cases for monitoring, and reported ADRs. Key challenges included the absence of centralized guidance, limited risk communication tools, and information systems that were poorly aligned with clinical workflows. These gaps created operational challenges and undermined the effectiveness of PV efforts. Conclusion: To strengthen Thailand’s PV system and support future transition toward a risk management plan framework, national guidance, interoperable digital infrastructure, and integrated multidisciplinary approaches are urgently needed.