Groupings of MedDRA terms, ordinarily at the Preferred Term level that relate to a defined medical condition or area of interest. SMQs are intended to aid in the identification and retrieval of potentially relevant individual case safety reports. The included terms may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, among others.
Standard MedDRA Queries (SMQs) are a set of tools used in pharmacovigilance and clinical research to facilitate the identification and retrieval of potentially relevant individual case safety reports (ICSRs) from databases that use the Medical Dictionary for Regulatory Activities (MedDRA). MedDRA is a clinically validated international medical terminology used by regulatory authorities and the biopharmaceutical industry for the classification of medical information in regulatory communication, including the reporting of adverse drug reactions.
What are SMQs?
- Purpose: SMQs are designed to assist in the identification of specific areas of medical interest, potential safety signals, or areas of special interest within the MedDRA database.
- Structure: An SMQ is a group of MedDRA terms, often spanning multiple System Organ Classes (SOCs), that relate to a defined medical condition or area of interest.
- Flexibility: They can be used “as is” or modified according to the user’s requirements, providing a degree of flexibility in their application.
When to Use SMQs
SMQs are primarily used in pharmacovigilance for:
- Signal Detection: To identify potential safety issues with a drug by flagging reports of certain events more frequently than expected.
- Safety Data Analysis: For analyzing safety data in clinical trials or post-marketing surveillance to identify any trends or patterns in adverse events.
- Regulatory Reporting: To assist in fulfilling regulatory reporting requirements by identifying relevant cases that need to be reported to health authorities.
Examples of SMQ Use
- Hepatotoxicity: An SMQ for hepatotoxicity would include terms related to liver function abnormalities, such as elevated liver enzymes, jaundice, and hepatic failure. A drug being evaluated for potential liver toxicity could use this SMQ to aggregate and analyze all relevant reports.
- Cardiac Disorders: For a drug suspected of causing cardiac side effects, an SMQ focused on cardiac disorders would help in identifying cases with terms like myocardial infarction, arrhythmias, or heart failure.
- Psychiatric Events: If a medication is suspected of having psychiatric side effects, an SMQ encompassing terms like depression, psychosis, suicidal ideation, etc., would be useful for analysis.
Conclusion
SMQs are a vital tool in the domain of drug safety and pharmacovigilance, offering a structured and systematic approach to identifying and analyzing specific medical events or conditions. Their use facilitates the early detection of potential drug risks, thereby contributing to patient safety and effective drug regulation.