Pharmacovigilance System In Indonesia: A Narrative Review Of Regulations, Healthcare Professional Practices And Reporting Challenges
DOI:
https://doi.org/10.31941/benzena.v5i01.7969Keywords:
Pharmacovigilance, BPOM Regulation, Healthcare Professionals, Underreporting, e-MESOAbstract
Background: Pharmacovigilance is an essential instrument for protecting public health after drugs are marketed. However, the implementation of this system in Indonesia was still hampered because the periodic adverse drug reactions (ADR) reporting rate was recorded as very low.
Objective: This review was aimed to evaluate the regulatory changes in Indonesian pharmacovigilance. Additionally, this study reviewed the competency levels, psychological conditions of healthcare professionals, operational barriers on the national reporting platform, and compared systems across Southeast Asia.
Method: This study was conducted using a narrative review method. Literature sources were collected from BPOM regulations and recent original articles regarding ADR reporting practices by healthcare professionals. Evaluations were also conducted on the challenges of using the e-MESO application in various healthcare facilities across Indonesia, alongside a comparative study of pharmacovigilance governance in Southeast Asia.
Results: Indonesia was found to have strengthened its legal framework for pharmacovigilance progressively to achieve WHO Listed Authority (WLA) status. Nevertheless, knowledge-practice gaps and the phenomenon of low ADR reporting were identified to be still widely found in the field. These barriers were triggered by a blame culture, a lack of local guidelines, the absence of an autosave feature, and the administrative burden on the e-MESO system. The comparative study demonstrated that Indonesia needs to implement proactive methods, such as trigger tools, and optimize the role of structured consumer reporting by the public.
Conclusion: This narrative review concluded that strengthening of pharmacovigilance in Indonesia was supported by new regulations, but was hindered by systemic underreporting and psychosocial challenges that also occurred in Southeast Asia. Therefore, system improvements could not rely solely on e-MESO 2.0, but instead demanded a no blame culture reform in healthcare facilities, the establishment of local Standard Operating Procedures, the application of proactive methods, early education in pharmacy institutions, and active community involvement.
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