Off-label Drug Use in Zhongshan Municipal Tantou Hospital: Analysis of 15 460 Prescriptions

OBJECTIVE: To investigate the off-label drug use in outpatient prescriptions in Zhongshan Municipal Tanzhou Hospital( hereinafter referred to as hospital ) to promote clinical safe and rational use of drugs.METHODS: From January 2011 to July 2014,a certain ratio of prescriptions per day were randomly sampled from our hospital for evaluation of the conformity between the prescriptions and the package inserts in terms of indications,target population,dosage and frequency of administration,route of administration,contraindications and incompatibility. The prescriptions found to be of inconformity with drug package inserts were regarded as off-label ones. RESULTS: A total of 64 930 prescriptions were sampled,accounting for 3. 36% of total. 15 460 were off-label prescriptions,accounting for 23. 81% of the total prescriptions sampled. In terms of off-label types,administration frequency( 67. 35%),indications( 20. 66%),and route of administration( 11. 51%) ranked among the top three; in terms of departments,the Department of Pediatrics( 42. 80%),the Emergency Department( 38. 38%) and the Department of Internal Medicine( 7. 63%) dominated the top three places. The off-label use in 79. 33% were caused by non-standard operations of physicians and doctors,and in 7. 68% caused by lack of support of considerable clinical trial data or lack of evidence-based medicine data; the off-label prescriptions supported by evidence-based medicine data of multicenter samples accounted for 12. 99%. CONCLUSIONS: The off-label use was frequent in our hospital,therefore,it is important for hospitals develop appropriate measures to improve the rational level in dug use.