The dronedarone shared-care clinical model and database: a coordinated paradigm to optimize management of evolving clinical recommendations.

Introduction Dronedarone, a non-iodinated derivative of amiodarone, has been approved for use as a second-line agent for atrial fibrillation (AF). Following reports of possible liver injury during routine post-license monitoring, the European Medicines Agency (EMA) recommended regular liver function test (LFT) monitoring. Despite this recommendation, an audit of patients in our multi-center region who were prescribed dronedarone found that on-going LFT monitoring was inconsistent or absent, leading to potential safety concerns. Thus, we assessed whether the setting up of a clinical database of all patients prescribed dronedarone and a dedicated monitoring clinic would improve coordination of follow-up between primary and secondary care, and the implementation of monitoring guidelines.