Chapter 8 Guideline for Evaluation of Off-label Uses
Due to the progress of evidence-based medicine,the lack of timely update of instructions,and the special treatment needs of patients,off-label uses of drugs become inevitable in clinical practice.How to evaluate off-label uses,establish evaluation standards,and ensure the maximum responsible and rational use of drugs is an urgent issue.This chapter introduces the current situation of off-label uses and developed the evaluation process of off-label uses.The safety,effectiveness,economy,and pharmacokinetics of off-label uses,which are needed to be evaluated and focused on,are described by using the method of evidence-based evaluation.The aim is to standardize the evaluation of off-label uses of drugs and provide important decision basis for clinical treatment.