MedDRA unleashed

MedDRA stands for Medical Dictionary for Regulatory Activities

WHO-ART would be WHO's Adverse Reaction Terminology

ICD-9CM is International Classification of Diseases, 9th Revision Clinical Modification

A more rarer abbreviation : MSSO stands for Maintenance Service and Support Organization

History

Just as they did with James Bond 007, MedDRA was originally developed by UK's regulatory authority. Medicines Control Agency (MCA), and is a terminology for classifying adverse effects and medical history.

Applications of MedDRA

• Data Capture and Coding : mainly efficacy data and post-market safety surveillance
  
• Data Retrieval : Safety data reporting and pharmacovigilance, periodic safety reports
  
• Data Analysis : End of trial safety data tabulation, thresholding (as a cut-off)
  
• Regulatory Actions : Product label creating and maintenance

MedDRA hierarchy

The dictionary is structured into 5 levels namely : System Organ Class (SOC) > High level term group (HLGT) > High Level Term (HLT) > Preferred Term (PT) > Lowest Level Term (LLT). The association between PT and LLT is one to one, and for the rest it is many to one.

How to get MedDRA

MedDRA is a licensed software for non-regulators, and comes as a ASCII text file separated by $ signs. The data can be then easily fed into any relational database system such as mysql, oracle etc.,

What is the role of MSSO ?

MedRA is handled by www.meddramsso.com which is responsible change requests, help desk and handling the user group. One of the early issues with MedDRA adoption was the need to translate from COSTART or WHO-ART to MedDRA. The more recent issue has been the need to keep up with the new updates in MedDRA. MSSO tries to soothe the pain felt by companies in this process of changes and updates.

Want to learn more ?

You are welcome to contact us at contact@clinnovo.com if you wish to get trained in this area. Safety informatics is a very attractive career and we will discuss that soon.