Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe.

ABSTRACT:

Background and objective

Risk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death. In accordance with the guideline on good pharmacovigilance practices, the European Medicines Agency Pharmacovigilance Risk Assessment Committee requested to conduct two studies to evaluate the effectiveness of these risk minimization measures.

Methods

In Belgium, France, Germany, Spain, and the UK, surveys were conducted to assess physicians' knowledge on the updated domperidone labeling information, and a drug-utilization study (DUS) was conducted using healthcare databases to assess domperidone prescribing patterns before and after the RMM. Four DUS sensitiv

SUBMITTER: Fife D 

PROVIDER: S-EPMC6800405 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature