对儿科超说明书用药问题的述评

A review of off-label drug use in pediatrics

超说明书用药是指为患者应用的药物超出了国家药监部门认可的、由生产厂家提供的药品说明书所界定的范围。由于已上市药品的注册用法可能未包括目前最佳的治疗方案,无法满足临床治疗的需求,故临床医生可能会选择超说明书的用药方案来保证患者获得目前最佳的治疗效果。因此,在临床上出现超说明书用药是不可避免的。但因超说明书用药而引起的争议、医疗纠纷等情况时有发生。在儿科临床领域中,超说明书用药所面临的用药风险和法律问题较多。本次研究主要是从超说明书用药的含义与立法现状、儿科超说明书用药的成因、严峻性、危害性及对此类现象进行监管等方面进行综述。

Off-label drug use refers to the use of drugs for patients beyond the scope of the drug specification approved by the national drug administration and provided by the manufacturer.Since the registered usage of the marketed drug may not include the current best treatment regimen and cannot meet the needs of clinical treatment,the clinician may choose the off-label medication regimen to ensure that the patient receives the current best treatment effect.Therefore,off-label drug use is inevitable in clinical practice.However,the disputes and medical disputes caused by off-label drug use occur from time to time.In the clinical field of pediatrics,offlabel drug use faces many risks and legal problems.This study summarized the meaning and legislative status of off-label drug use,the causes,severity,harmfulness of off-label drug use in pediatrics,and the supervision of such phenomena.