Survey on off-label uses of drugs in 24 hospitals / 中国药学杂志

ABSTRACT

OBJECTIVE: To investigate the off-label uses of drugs in domestic hospitals, so as to provide baseline data for policy-making and strategy for risk management. METHODS: The off-label uses of drugs in 24 hospitals were collected and analyzed according to the categories of drugs and off-label uses and the strength of evidence for the off-label use of drugs. RESULTS: One thousand six hundred and fifty-two cases of off-label uses involving 998 drugs were included in this study. The top three hospitals with the largest numbers of off-label uses were Beijing Hospital (297 cases, 18.0%), Peking University Third Hospital (282 cases, 17.1%) and Yantai Yuhuangding Hospital (256 cases, 15.5%). There were 998 kinds of drugs which had off-label uses in these 24 hospitals. The top three categories of drugs with the highest frequncies of off-label uses were antineoplastics (388 cases, 23.5%), immunomodu-latingagents (315 cases, 19.1%), and cardiovascular system agents (177 cases, 10.7%). The off-label use of drugs concentrated in indication (1493 cases, 90.4%), dosage (349 cases, 21.1%), route and administration (154 cases, 9.3%), and population (65 cases, 3.9%) in this study. One thousand one hundred and fifty-five (73.3%) off-labels were supported by foreign package inserts, international guidelines, domestic guidelines, expert consensus, monographs and literatures. CONCLUSION: Off-label uses of drugs existed widely in these 24 hospitals, which pose potential risk on medication safety and efficacy, law responsibility and ethical issues. The government should accelerate the development and promulgation of correspondent law to promote rational use of drugs. And the relevant associations should develop guidelines for off-label uses and provide reliable evidence for safe medication.