Study of the Pharmacovigilance Reporting System Based on Hospital Reporting in North Sumatra from 2019-2024 / Kajian Sistem Pelaporan Farmakovigilans Berdasarkan Pelaporan Rumah Sakit Di Sumatera Utara Pada Rentang 2019-2024

Pharmacovigilance safeguards patient safety, yet hospital ADR reporting in North Sumatra remains limited. This research to assess compliance with BPOM’s 10 completeness criteria and identify determinants that support or hinder implementation. Methods: A mixed methods approach with a sequential explanatory design was applied. descriptive analysis of 2019-2024 e-MESO reports and in-depth interviews with hospitals categorized as Complete, Incomplete, and Non-reporting. Results: Out of 210 hospitals, only 11 (5%) actively reported through e-MESO, producing 50 reports, 98% complete and 2% incomplete. About 74% were spontaneous reports, mostly skin reactions, with 40% serious cases in elderly patients. Qualitative analysis revealed seven main themes: understanding, reporting process, barriers, management support, e-MESO system, expectations, and interprofessional collaboration. Conclusion: While individual report completeness is high, system-level participation is low, so full compliance with the 10 criteria is not yet achieved. Reporting quality is largely shaped by managerial support, organizational readiness, and interprofessional collaboration. Recommended actions include expanding SOP-based reporting on the 10 criteria, appointing a clinical pharmacist as the person-in-charge, conducting cross-profession training, and coordinating e-MESO technical issues with BPOM particularly strengthening type-C hospitals.

Farmakovigilans penting untuk keselamatan pasien, namun pelaporan efek samping obat (ESO) di rumah sakit Sumatera Utara masih rendah. Tujuan: Menilai kepatuhan pelaporan terhadap 10 kriteria BPOM serta mengidentifikasi faktor pendukung/penghambat implementasinya. Metode: Penelitian ini menggunakan pendekatan mixed methods dengan desain sequential explanatory. ata kuantitatif laporan e-MESO 2019-2024 dianalisis deskriptif, data kualitatif diperoleh melalui wawancara pada RS kategori Complete, Incomplete, dan Tidak Lapor. Hasil: Dari 210 rumah sakit, hanya 11 (5%) yang aktif melapor melalui e-MESO, menghasilkan 50 laporan, dengan 98% lengkap dan 2% tidak lengkap. Sebanyak 74% laporan bersifat spontan, didominasi reaksi kulit, dan 40% kasus serius terjadi pada pasien lansia. Analisis kualitatif menghasilkan tujuh tema utama: pemahaman, proses pelaporan, kendala, dukungan manajemen, sistem e-MESO, harapan, dan kolaborasi antarprofesi. Kesimpulan: Secara berkas, kelengkapan hampir memenuhi 10 kriteria; namun pada tingkat sistem, partisipasi RS masih rendah sehingga target belum terpenuhi. Kualitas pelaporan terutama dipengaruhi dukungan manajemen, kesiapan organisasi, dan kolaborasi antarprofesi. Rekomendasi operasional: perluasan pelaporan berbasis SOP 10 kriteria, penunjukan apoteker klinis sebagai PIC, pelatihan lintas profesi, serta koordinasi teknis e-MESO dengan BPOM dengan penekanan pada RS tipe C.