ABSTRACT
Off-label use is widely happened in medical practice. But for now, there is no clear legalistic demarcation for the behaviour of off-label use. Even in medical and legal fields, the consensus has not been reached. Once the behaviour of off-label use caused medical damage, it is difficult for appraisal profession to provide a clear demarcation. This article reviews the status of clinical domestic and foreign off-label use, the research status in the fields of laws and regulations and the basic consensus of domes-tic off-label use, for peer reference.
ABSTRACT
Objective To determine the off -label use of antibacterial agents,we investigated and analyzed the current status about off -label use of antibacterial agents.Methods The random sampling was conducted to select the outpatient prescription including antibacterial agents from January to April in 2016.According to drug instructions,the off -label drug use of prescription was analyzed.Results 1 264 prescriptions involving 58 kinds of drugs were analyzed.The main categories of off -label drug use were no pediatric and elderly information(23.42%), indication(4.1 5%),dosage (6.31 %),dosage range (62.95%)and administration route (3.1 5%).Conclusion The off -label use of antibacterial agents is common in our hospital.It's in need to regulate off -label drug use.