MedDRA and Standardized MedDRA Queries: Navigating the Language of Safety
MedDRA, the Medical Dictionary for Regulatory Activities, provides a standardized language for recording and reporting adverse events and reactions associated with drugs and medical devices. It’s a vital tool for pharmacovigilance, ensuring accurate and consistent communication about safety concerns across different countries and languages.
Standardized MedDRA queries are specific searches within the MedDRA terminology that help you retrieve relevant information efficiently. This can involve filtering by:
- System Organ Class (SOC): E.g., “Nervous System”
- High-Level Term (HLT): E.g., “Headache”
- Preferred Term (PT): E.g., “Migraine”
- Lowest Level Term (LLT): E.g., “Throbbing headache on right side”
By combining these filters, you can create precise queries to find specific adverse events within MedDRA’s vast terminology.
Here are some examples of standardized MedDRA queries:
- Find all adverse events related to the liver:
(SOC="Hepatobiliary and Biliary Tract Disorders")
- Find all types of headache:
(HLT="Headache")
- Find all skin reactions to antibiotics:
(SOC="Skin and Subcutaneous Tissue Disorders") AND (PT="Allergic Dermatitis") AND (Qualifier="Drug Induced") AND (ATC="J01")
Benefits of using standardized MedDRA queries:
- Improved accuracy: Reduces the risk of misinterpreting or miscoding adverse events.
- Enhanced data analysis: Facilitates efficient data mining and trend identification.
- Global communication: Enables consistent reporting and sharing of safety information across countries.
Here are some resources to learn more about MedDRA and standardized queries:
- MedDRA website: https://www.meddra.org/
- ICH Harmonised MedDRA Standard: https://database.ich.org/sites/default/files/E2F_Guideline.pdf
- Uppsala Monitoring Centre (UMC) MedDRA training: https://who-umc.org/about-uppsala-monitoring-centre/
Remember, using standardized MedDRA queries is crucial for ensuring accurate and efficient communication about drug and medical device safety. It’s a valuable tool for healthcare professionals, researchers, and regulators alike in promoting patient safety globally.
Suggested readings:
Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise