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Pharmacovigilance in Israel - tools, processes, and actions
Eyal Schwartzberg1,2,3, Matitiahu Berkovitch4, Dorit Dil Nahlieli5
1Pharmaceutical & Enforcement Divisions, Ministry of Health, 39 Yirmiyahu St., Jerusalem, Israel. eyal.s@moh.gov.il.
Israel Journal of Health Policy Research
|August 2, 2017
Summary
Israel
Area of Science:
- Pharmacovigilance
- Drug Safety
- Regulatory Science
Background:
- Post-marketing drug safety monitoring is crucial due to limited initial data.
- Pharmacovigilance (PV) is essential for identifying and mitigating medication risks.
- The Israeli Ministry of Health (MOH) established a dedicated PV department in 2012.
Purpose of the Study:
- To characterize the pharmacovigilance tools and activities implemented in Israel.
- To assess the effectiveness of the Israeli MOH's PV system.
Main Methods:
- Analysis of Individual Case Safety Reports (ICSRs) submitted to a central database.
- Characterization of ICSRs by seriousness, source, drug category, and reporting format.
- Review and assessment of safety signals and resulting regulatory actions.
Main Results:
- Over 16,409 ICSRs received, identifying 850 safety signals.
- PV activities included leaflet updates, health alerts, and product recalls.
- Risk Management Plans (RMPs) were incorporated in 2015.
Conclusions:
- The Israeli MOH has effectively implemented PV tools.
- These tools ensure the safety of health consumers in Israel.
- The system demonstrates robust drug safety monitoring practices.
