WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems
Shanthi N Pal1, Chris Duncombe, Dennis Falzon
1Quality Assurance and Safety: Medicines, Essential Medicines and Health Products, WHO, 20 Avenue Appia 1211, Geneva 27, Switzerland. pals@who.int
Drug Safety
|January 19, 2013
Summary
National pharmacovigilance systems need better methods beyond spontaneous reporting to quantify adverse drug reactions (ADRs). Cohort event monitoring and targeted spontaneous reporting offer complementary approaches for improved medicine safety monitoring.
Area of Science:
- Pharmacovigilance and Drug Safety
- Public Health
- Pharmaceutical Medicine
Background:
- National pharmacovigilance systems predominantly use spontaneous reporting for suspected adverse drug reactions (ADRs).
- Spontaneous reporting systems, while cost-effective, are limited by underreporting and poor data quality, hindering accurate ADR rate estimation.
- Public health programs require robust methods to quantify and characterize medicine risks for safe use and public confidence.
Purpose of the Study:
- To introduce and discuss two complementary methods for monitoring quantitative aspects of medicine safety.
- To address the limitations of spontaneous reporting in pharmacovigilance.
- To enhance the identification of specific risk factors, high-risk groups, and ADR characterization.
Main Methods:
- Introduction of Cohort Event Monitoring (CEM) as a supplementary pharmacovigilance tool.
- Introduction of Targeted Spontaneous Reporting (TSR) to enhance data quality and focus.
- Discussion of the implementation of CEM and TSR within WHO public health programs.
Main Results:
- CEM and TSR are presented as methods to complement traditional spontaneous reporting systems.
- The paper outlines the advantages and disadvantages of both CEM and TSR.
- Guidance is provided on the practical application of these methods in clinical settings.
Conclusions:
- CEM and TSR offer valuable additions to pharmacovigilance, addressing limitations of spontaneous reporting.
- These methods can improve the quantitative assessment of medicine safety and risk identification.
- Implementation of CEM and TSR can enhance public health programs' ability to monitor and manage drug-related risks.
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