WHO adverse reaction terminologies
The World Health Organization (WHO) has developed two main adverse reaction terminologies:
1. WHO Adverse Reaction Terminology (WHO-ART):
- Developed in 1968 and maintained by the Uppsala Monitoring Centre (UMC), WHO Collaborating Centre for International Drug Monitoring.
- A hierarchical thesaurus for coding adverse reaction terms, built as a four-level structure:
- System Organ Class (SOC) (e.g., Blood and blood forming organs)
- High-Level Terms (HLT) (e.g., Coagulation disorders)
- Preferred Terms (PT) (e.g., Thrombosis)
- Included Terms (IT) (e.g., Clot formation)
- Used for coding clinical information related to adverse drug reactions, particularly in pharmacovigilance.
- Limitations: No longer actively maintained, complex and dynamic nature, may not capture all aspects of an adverse reaction.
2. Medical Dictionary for Regulatory Activities (MedDRA):
- Developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- A standardized medical terminology for regulatory purposes, including adverse events and reactions.
- More comprehensive and complex than WHO-ART, with five levels:
- System Organ Class (SOC)
- System Organ System Preferred Term (SOC PT)
- High-Level Term (HLT)
- Preferred Term (PT)
- Lowest Level Terms (LLT)
- Used by regulatory agencies worldwide for safety reporting and assessment of drugs and medical devices.
- Advantages: More comprehensive, actively maintained, standardized for global use.
- Disadvantages: Can be complex and difficult to navigate for non-experts.
Here’s a comparison table to summarize the key differences:
| Feature | WHO-ART | MedDRA |
|---|---|---|
| Year of development | 1968 | 1996 |
| Maintenance | No longer actively maintained | Actively maintained |
| Levels | 4 | 5 |
| Focus | Adverse drug reactions | Regulatory activities (adverse events and reactions) |
| Advantages | Simple, widely used in pharmacovigilance | Comprehensive, standardized for global use |
| Disadvantages | Limited scope, may not capture all aspects of an adverse reaction | Complex, can be difficult to navigate for non-experts |
Additional resources:
- WHO Adverse Reaction Terminology (WHO-ART): https://who-umc.org/about-uppsala-monitoring-centre/
- Medical Dictionary for Regulatory Activities (MedDRA): https://www.meddra.org/
Suggested readings:
Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise
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