关键词: 风湿免疫科, 超说明书用药, 处方分析, 风险

Abstract:

AIM: To investigate the application of the off-label drug in rheumatic immunology department so as to provide reference for establishing the standard for evaluation and management.   METHODS: Statistical data of the surrogate prescriptions of rheumatic immunology department in our hospital from April to June in 2016 were collected and were analyzed from the indications, the intended group, the dosage, the frequency, the route of administration and contraindication according to the instructions of the drug. Guideline of evidence-based medicine, relevant literature, clinical guidance and expert consensus were referred to evaluate their rationality.  RESULTS: 3 501 prescriptions from the outpatient clinic of the department of rheumatic immunology were included, 9 889 records involved. According to the prescription and medication record, the incidence rates were 47.50% and 27.69%, respectively. The specific drug use types included over-indication (87.73%), over-dosage (6.54%), over frequencies (5.08%), no usage information for children (0.55%) and usage exceed certain age (0.11%). Hydroxychloroquine sulfate tablets (1 091 records), methotrexate tablets (713 records) and thalidomide tablets (147 records) ranked the top 3 of the over-indications. Guideline of evidence-based medicine, and relevant literature could be selected to support the over-indication, but the quality of evidence remains difference. CONCLUSION: Off-label drug use in rheumatic immunology is common, which on one hand shows the development and information update of drug for rheumatic immune disease lags behind the development of medicine, on the other hand suggests that relevant laws, regulations or guidelines for off-label drug use should be formulate to regulate such behavior so as to protect the safety of patients as well as to avoid physician occupation risk.

Key words: rheumatic immunology, off-label drug use, prescription analysis, risk