| ABSTRACTThe current situation of off label utilization in children and factors associated with this issue were analyzed and summarized via studying published literatures around the world including research papers, systemic reviews, legal frameworks and regulation documents. At present, most developed countries in the world have legislated or implemented corresponding policies for off label uses of medicines to ensure the safety and effectiveness of off label prescribing in pediatric patients,there is no unified regulation for the off label uses medicines in children from the national level of Chinese government. There is relatively higher risk of adverse events with off label prescribing in pediatric patients. We should better understand the factors associated with the off label uses and learn from the developed countries for their regulatory strategies. Through adding prerequisites for off label use, hierarchical management, and encouraging more clinically relevant medical research, it will reduce inappropriate use, enhance patient safety and effectiveness. |
