Here are some published case studies of MedDRA use by regulatory authorities.
Analysis of SMQs for Signal Detection
The EMA researchers in this study compared the timing of onset of a known safety signal (hyperglycaemia) for a marketed product using various MedDRA term levels (PT, HLT, HLGT) and for SMQ Hyperglycaemia/new onset diabetes mellitus. Proportional reporting ratios (PRRs) over time (“dynamic PRRs”) for each term level and for the SMQ were calculated and used for the comparison. The researchers reported that a significant PRR was found using SMQ Hyperglycaemia/new onset diabetes mellitus earlier than for any other term level studied. The study highlighted the potential for SMQs to be used early on in signal detection for risk management, and that further research in this area would be useful.
Newbould V, Halsey N, Tsintis P, Lerch M, Mozzicato P. Standardised MedDRA® Queries: Analysis of their signal detection capability. 22nd ICPE Meeting; 2006 Aug; Lisbon, Portugal; Abstract 87.
MedDRA Used by Regulatory Safety Officers to Monitor Vaccine Safety
During the H1N1 influenza outbreak in the USA in 2009, safety officers from the US Centers for Disease Control and Prevention (CDC) and US FDA monitored the Vaccine Adverse Event Reporting System (VAERS) for adverse events following immunisation with the H1N1 vaccine. Signs and symptoms in submitted adverse event reports were coded using MedDRA for the VAERS database. Using trends in reporting proportions (for reports with selected MedDRA terms), advanced signal detection methods (data mining) and clinical review of received reports, the safety officers concluded in their analysis that AE profile of the H1N1 vaccination was consistent with that of seasonal influenza vaccines.
Vellozzi C, Broder KR, Haber P, Guh A, Nguyen M, Cano M et al. Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the vaccine adverse event reporting system, United States, October 1, 2009–January 31, 2010. Vaccine 2010 Oct 21;28(45):7248-55.
MedDRA Used by Regulatory Authority to Monitor Reports of Drug-Induced Hepatotoxicity
The Serbian regulatory authority performed a retrospective observational study of spontaneously reported adverse drug reactions recorded in their database from January 1995 to December 2008. MedDRA was used to identify cases of hepatobiliary disorders; these reports were also studied for the types of drugs involved. The regulatory authority researchers concluded that anti-infective drugs, nervous system drugs, and herbal products were the most common drug classes reported for hepatotoxicity in Serbia. They also identified a need for additional education about adverse drug reactions and enhanced reporting by health care professionals in their country.
Petronijevic M, Ilic K, Suzuki A. Drug induced hepatotoxicity: data from the Serbian pharmacovigilance database. Pharmacoepidemiology and Drug Safety 2011 April;20:416-23.