Peran Krusial Farmakovigilans dalam Meningkatkan Keamanan Pasien (Patient Safety)

Ana Widyaningsih

doi:10.56951/zrh11y34

Peran Krusial Farmakovigilans dalam Meningkatkan Keamanan Pasien (Patient Safety)

Penulis

Ana Widyaningsih Corporate Pharmacovigilance, Dexa Group

DOI:

https://doi.org/10.56951/zrh11y34

Kata Kunci:

farmakovigilans, keamanan pasien, keamanan obat

Abstrak

Farmakovigilans adalah ilmu atau aktivitas yang berhubungan dengan pendeteksian, penilaian, pemahaman dan pencegahan efek samping obat atau masalah lain terkait dengan penggunaan obat. Pentingnya pemantauan keamanan
obat dimulai dari adanya tragedi penggunaan thalidomide sehingga dibentuklah program internasional untuk memperkuat sistem regulasi keamanan produk. Evaluasi keamanan obat dilakukan melalui serangkaian tahapan uji sebelum obat dipasarkan. Namun, aktivitas farmakovigilans yang dilakukan pascapemasaran menjadi krusial untuk mendeteksi efek samping langka yang belum dapat dideteksi dari tahapan uji sebelum obat dipasarkan. Kolaborasi multisektor antara
berbagai pihak terkait dan pemangku kepentingan sangat menentukan keberhasilan farmakovigilans dengan tujuan untuk memastikan keamanan penggunaan obat dan keamanan pasien.

Unduhan

Baca Selengkapnya

Referensi

1. World Health Organization. WHO Pharmacovigilance Indicators: a practical manual for the assessment of pharmacovigilance system. Geneva:WHO press;2015.

2. World Health Organization. Pharmacovigilance: ensuring the safe use of medicines. Geneva:WHO;2015.

3. Uppsala Monitoring Centre. Safety monitoring of medicinal products. Guidelines for setting up and running

a pharmacovigilance centre. Uppsala: WHO Collaborating Centre for International Drug Monitoring; 2000.

4. Khoo YK, Lim JCW, Tan-Koi WC, Kitikiti NS, Sim-Devadas AL. Promoting collaboration of regulators and patients in improving drug safety and regulatory decision making. Drug Saf. 2024;47(3):217-25. doi: 10.1007/s40264-023-01385-2.

5. Waghmare R, Salve K. A review on pharmacovigilance: current trends and future directions. Int J of Pharm Sci. 2024;2(11):786-95. doi: 10.5281/zenodo.14178068.

6. Hamid A, Rahim R, Teo S. Pharmacovigilance and its importance for primary health care professionals. Korean J Fam Med. 2022;43(5):290-95. doi: 10.4082/kjfm.21.0193.

7. Godiyal S. Pharmacovigilance monitoring at different stages of drug development: in India. Euro J Pharm Med Res. 2019;6(12):262-7.

8. Alomar M, Tawfiq AM, Hassan N, Palaian S. Post-marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future. Ther Adv Drug Saf. 2020;11:2042098620938595. doi: 10.1177/2042098620938595.

9. Afsana M, Malleshwari N. Post-marketing surveillance and drug safety monitoring: ensuring patient wellbeing. Int J Trend Scie Res Dev. 2023;7(6):387-92.

10. Council for International Organizations of Medical Sciences. CIOMS Cumulative Pharmacovigilance GLOSSARY. Geneva;CIOMS:2021.

11. Desai M. Pharmacovigilance and spontaneous adverse drug reaction reporting: challenges and opportunities. Perspect Clin Res. 2022;13(4):177–9. doi: 10.4103/picr.picr_169_22.

12. Olson C. Pharmacovigilance. In: Embrey M, Ryan M, editors. MDS-3: Managing Access to Medicines and Health Technologies. Arlington, VA: Management Sciences for Health;2012.p.35.1-35.19.

13. Youseff A, Blanchard NL, Hammad TA. Strategic partnerships in pharmacovigilance: business, legal, and regulatory domains. Clin Ther. 2024;46(5):434-28. Doi: 10.1016/j.clinthera.2024.03.007.

14. Najafi S. Importance of pharmacovigilance and the role of healthcare professionals. J Pharmacovigil. 2018;6(1):252. doi: 10.4172/2329-6887.1000252.