|Project Title||Quantitative Assessment of the Impact of Nitrosamine Contamination and Angiotensin Receptor Blockers (ARB) Recall on ARB Utilization: A Multinational Study|
The purpose of this international descriptive study is to examine changes in ARB utilization suspected to have resulted from the July 2018 recall of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) contaminated angiotensin receptor blockers (ARBs) initiated by FDA and international regulatory agencies. The project seeks to query several data sources using the Sentinel Common Data Model (SCDM). The FDA will conduct US based analyses in their Sentinel System. The international participants will conduct the same analyses in their data sources which include: United Kingdom (Clinical Practice Research Datalink (CPRD)), Canada (Canadian Network for Observational Drug Effect Studies (CNODES)), Denmark (Danish National Prescription Database (DNPR)).
Tuesday, August 18, 2020