| ABSTRACT Objective:To investigate the current status of off label use on indication of bevacizumab in six major cities across the country, and to provide evidence based evidence and reference for further promoting the rational use of drugs and regulating the behavior of super instructions. Methods:Based on the hospital information system, the off label drug use of bevacizumab was collected in general hospitals of six major cities (Beijing, Shanghai, Guangzhou, Chengdu, Shenyang and Zhengzhou) from 2011 to 2017 with the search fields of "city, year and original diagnosis", and the data were summarized and analyzed by Microsoft Excel. Results:In this study, a total of 6 092 prescriptions with definite diagnosis were retrieved. The proportion of BEVs used for CFDA approved indications (colorectal cancer, non small cell lung cancer) was 62.51% (3 808/6 092). A total of 2 284 prescriptions (37.49%, 2 284/6 092) were provided for off label drug use of BEV. Involving diseases of various systems, the number of diseases was as high as 45. Among them, retinopathy, melanoma and breast cancer were the top three diseases in off label drug use. The BEV super instruction drug had the following characteristics: ①The proportion of off label use of BEV and the type of disease in different areas had regional characteristics. Among the first tier cities (Beijing, Shanghai and Guangzhou), Beijing was the city with the highest proportion of BEV off label use; ②there were certain rules for the use of BEV super instructions in different years. Regression analysis showed that the overall frequency of BEV use showed an increasing trend in 2011 2017. At the same time, the number of BEV super instructions was increased by more than 20% every year, and the average annual growth rate was maintained at 52.52%. The types of diseases applied in the BEV super instruction also increased from 13 in 2011 to 33 in 2017; ③There were differences in the application of BEV in outpatient and inpatient patients. Among the 6 092 cases with definite diagnosis in this study, there were 1 583 outpatient prescriptions, accounting for 25.98% (1 583/6 092), and 4 509 inpatient prescriptions, accounting for 74.02% (4 509/6 092). Among them, 65.82% (1 042/1 583) of the out patient prescriptions for off label use of BEV were mainly used for ophthalmic diseases, including retinopathy, macular degeneration and retinal vein occlusion. However, in the inpatient prescription, the proportion of off label drug use of BEV was slightly lower, 26.88% (1 212/4 509). The off label drug use was mainly caused by solid tumors, such as melanoma, breast cancer and ovarian cancer. Conclusion:At present, the phenomenon of off label drug use of BEV is common in large general hospitals in China. In order to further promote clinical rational drug use and reduce drug risks, relevant national administrative departments should speed up the construction of laws and regulations on off label drug use. |
