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Safety Alerts: An Observational Study in Portugal
Sara Soares1, Fátima Roque2, António Teixeira Rodrigues1
1Institute for Research in Biomedicine - iBiMED & Health Sciences Program, University of Aveiro, Campus Universitário de Santiago, Aveiro, Portugal.
Clinical Therapeutics
|August 11, 2015
Summary
Portuguese drug safety alerts are crucial for healthcare professionals. Analysis of alerts from the National Authority of Medicines and Health Products I.P. (INFARMED) highlights key safety measures and their impact on medicine use.
Area of Science:
- Pharmacovigilance and Drug Safety
- Regulatory Science
- Public Health
Background:
- Marketing authorization approval provides limited pre-market safety data.
- Post-authorization pharmacovigilance is essential for ongoing drug safety monitoring.
- National authorities issue safety alerts to inform healthcare professionals about new safety information.
Purpose of the Study:
- To analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED).
- To understand the types of safety issues and measures communicated through these alerts.
Main Methods:
- Observational study of INFARMED safety alerts from January 2002 to December 2014.
- Data abstraction included active substance, adverse event, and safety measures.
- Classification of active substances using Anatomical Therapeutic Chemical (ATC) codes.
Main Results:
- 304 out of 562 published alerts were included in the analysis.
- The musculoskeletal system (n=53) and nervous system (n=42) were the most frequent ATC categories for alerts.
- Most frequent safety measures included communication to professionals/public (n=128) and updates to product information (n=66).
- 26 marketing authorizations were suspended and 10 revoked during the study period.
Conclusions:
- Post-marketing safety alerts are valuable resources for healthcare professionals.
- Alerts aid in improving medicine prescription and usage.
- This knowledge supports the scientific community in developing further research.
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