Status and analysis of off-label drug use in department of ophthalmology

Abstract

Objective: To investigate and analyze the status of off-label drug use in department of ophthalmology of Beijing Tongren Hospital. Methods: Cross-sectional study. Prescription evaluation, off-label drug use application and temporary medicine purchase application were collected from January 2013 to March 2015. The off-label use of medication in department of ophthalmology were filtered out and analyzed according to the category of medications, the category of the off-label use of medication and the strength of evidence for the off-label use of medication. Results: Thirty-seven items of off-label uses of medication were included in this study. The off-label use of medication focused on the indications (19 items, 51.4%) and route of administration (18 items, 48.6%) in this study. Nineteen category of medication were involved, which accounted for 1.3% (19/1 462) drugs in the hospital formulary.The top 2 category of medication were adrenocorticoid drugs (21.1%, 4/19) and antitumor drugs (21.1%, 4/19). There are evidence to support 37 items of off-label drug uses. 5 items (13.5%) of off-label drug uses were labeled uses approved by Food and Drug Administration. One item (2.7%) of off-label drug use was in accord with international guidelines. Twenty items (54.1%) of off-label drug uses were in accord with expert consensus. Eight off-labels were evaluated by Micromedex, while the other 78.4% (29 items) were not evaluated by Micromedex. Conclusions: The off-label use of medications exists widely in department of ophthalmology, having its necessity and rationality. But we should pay attention to its standard management. (Chin J Ophthalmol, 2017, 53: 300-304).