IMPLEMENTASI KEBIJAKAN FARMAKOVIGILANS SEBAGAI UPAYA PERLINDUNGAN HAK KESEHATAN MASYARAKAT DI INDONESIA

• Dara Ainun

  Universitas Muhammadiyah Bandung

  Author

• Astri Hanipah

  Universitas Muhammadiyah Bandung

  Author

• Alya Nur Latifah

  Universitas Muhammadiyah Bandung

  Author

• Arno Alam

  Universitas Muhammadiyah Bandung

  Author

• Alfiana Zahra

  Universitas Muhammadiyah Bandung

  Author

Pharmacovigilance is a drug monitoring system that plays a role in detecting, disseminating, understanding, and preventing drug side effects to ensure the safety of drug use in the community. From a constitutional rights perspective, pharmacovigilance is part of the state's obligation to protect citizens' health rights as mandated by the 1945 Constitution, and is related to consumer protection regarding drug safety. This study aims to review the implementation of agricultural policies in Indonesia in providing citizens' health rights using a qualitative descriptive-analytical approach based on literature studies through narrative and retrospective literature reviews. The results of the study indicate that although the pharmacovigilance regulatory framework is in place and the BPOM has the authority to monitor drugs, its implementation still faces various obstacles, such as low reporting of Adverse Drug Reactions (ADRs) by healthcare workers, limited reporting systems, a weak patient safety culture, and suboptimal post-marketing surveillance. The 2022 case of acute kidney failure in children due to syrup medication demonstrates that the pharmacovigilance system is not functioning optimally as an early warning mechanism. Therefore, strengthening the reporting system, increasing the capacity of healthcare workers, optimizing BPOM supervision, and cross-sectoral coordination are needed to ensure pharmacovigilance can effectively protect the public's right to health.

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