standardized MedDRA Queries

Definition
Groupings of MedDRA terms from one or more System Organ Classes (SOCs) that relate to a defined medical condition or area of interest.

Purpose
To support the retrieval of potentially relevant safety reports that includes a broad selection of terms that may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc., that are associated with a given medical condition or area of interest
Benefits
Uniformity of search strategies and results across organizations
Reproducibility of search strategies and results from regulatory perspective
Convenience of pre-defined grouping based on a medical condition of interest
Maintenance by MSSO and standard frame of reference
Example
SMQs combine narrow and broad search strategies allowing as much safety related information as relevant to be tagged to the query.
Acute Renal Failure definition : Acute renal failure is a syndrome characterized by a relatively rapid decline in renal function that leads to the accumulation of water, crystalloid solutes, and nitrogenous metabolites in the body.
Acute Renal Failure Narrow SMQ: Acute prerenal failure, Anuria, Azotemia, Dialysis, Hemodialysis, Neonatal anuria, Nephropathy toxic, Oliguria, Peritoneal dialysis, Renal failure acute, Renal failure neonatal, Renal impairment neonatal, and Renal impairment, and Renal insufficiency.
Acute Renal Failure Broad SMQ: Albuminuria, Blood creatinine abnormal, Blood creatinine increased, Blood urea abnormal, Blood urea increased, Blood urea nitrogen/creatinine ratio increased, Creatinine renal clearance decreased, Edema due renal disease, Hepatorenal failure, Nephritis, Nephritis interstitial, Proteinuria, Renal clearance decreased, Renal function tests abnormal, Renal transplant, Renal tubular disorder, Renal tubular necrosis, Tubulointerstitial nephritis.
Development of SMQs
SMQs are developed by consortium of swiss based Council For International Organization Of Medical Sciences (CIOMS) and MSSO. They are tested on one instance of federal safety database and one industrial partner database.
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.