Analysis and considerations of off-label use of drugs

With the constant updating of medical research practice and growing prosperity of pharmaceutical market,conflict between the profits of pharmaceutical manufacturers and values of medicine,and some subjective and objective factors,such as package inserts and the limits of medical practices,off-label use of medicines becomes inevitable,which is a definitely existing phenomenon in clinical pharmacotherapy.Nowadays,only seven countries have laws related to off-label drug use,includingAmerica,Germany,Italy,Netherland,New Zealand,India and Japan.Although there is no legal or authoritative definition of off-label drug use in China,medical personnel have a consensus that part of off-label drug use is desirable,which has its rationality and necessity.While the key point is how to guide and regulate the off-label use of medicine better,which can not only ensure the safety of patients in treatment,but also can avoid occupational risks of medical institutions and medical staff.This review briefly introduces the definition of off-label drug use,current situation of domestic and international off-label drug use,causes and attitude of management,and finally suggestions and recommendations for regulating off-label drug use in China were put forwards.