1128张免疫抑制剂处方超说明书用药情况及其不良反应风险分析.

OBJECTIVE: To investigate the current status of off-label drug use of immunosuppressants prescriptions in a grade III level A hospital(hereinafter referred to as "the hospital"), so as to probe into the risk of off-label drug use and promote the rational drug use. METHODS: Immunosuppressants prescriptions from the outpatient department of the hospital from Jul. 2016 to Jun. 2018 were selected, and all off-label drug use prescriptions were screened for statistical analysis. The basis of off-label drug use was analyzed according to domestic and foreign literature reports, guidelines and Micromedex tools. Risk matrix method was used to evaluate the risk level of adverse drug reactions of off-label drug use. RESULTS: Within the statistical interval, there were 1 128 off-label drug use of immunosuppressants prescriptions in the hospital, and the main types were drugs with off-label indications. Evidence types were respectively foreign guidelines(94 prescriptions, 8.3%), domestic guidelines(396 prescriptions, 35.1%), expert consensus(596 prescriptions, 52.8%) and other literature(42 prescriptions, 3.7%). Among the 25 off-label drug use of immunosuppressants, 11(44.0%) off-label drug use had been included by Micromedex. The risk of renal toxicity of cyclosporine, respiratory disorders of mycophenolate mofetil, renal toxicity of lymphoma, non-melanoma and tacrolimus, respiratory distress syndrome and other adverse drug reactions were rated as grade E, which was considered as the severe risk. CONCLUSIONS: The off-label use of immunosuppressants in the outpatient department of the hospital is supported by relevant evidence, but the quality of the evidence is different and there is a risk of severe adverse drug reactions. In clinical practice, it is suggested that the hospital should establish the off-label drug use evaluation group to form consensus among experts in the hospital as soon as possible,so as to avoid medical risks as far as possible and promote the rational drug use. [ABSTRACT FROM AUTHOR]