Investigation on Management Status of Off-Label Drug Use in 146 Medical Institutions
OBJECTIVE:To investigate the management status of off-label drug use in 146 medical institutions,so as to provide reference for improving the management level of off-label drug use.METHODS:Off-label drug use management in 146 medical institutions was investigated by questionnaire survey,including 104 tertiary hospitals and 42 secondary hospitals.Basic situation,management status,existing problems and successful experience were statistically analyzed.RESULTS:There were different degrees of off-label drug use in 146 medical institutions,of which 125(85.62%)carried out off-label drug use management.The management measures included establishment of management system(125/125,100.00%),formulation of off-label drug use catalogue(106/125,84.80%),and supervision for rationality of use process(112/125,89.60%).Totally 97.26%(142 cases)of the respondents believed that sufficient evidence-based basis was the premise of off-label drug use.The proportion of medical institutions with sufficient evidence of off-label drug use was"about 50%"in 33.56%(49 institutions),"almost all"in 34.25%(50 institutions),and"few"in 30.14%(44 institutions).Off-label drug use management had problems such as clinicians'lack of cooperation/attention,non-use in accordance with prescribed procedures(116/146,79.45%),widespread off-label phenomenon,and difficulty in comprehensive management(73/146,50.00%).Management of off-label drug use can be improved by multi-department cooperation,clear responsibilities,hierarchical management according to the level of evidence or risk,and the introduction of information management.CONCLUSIONS:The phenomenon of off-label drug use is widespread,and medical institutions have made some success in the management of off-label drug use,yet there are also difficulties.Successful experience should be promoted to improve the management level of off-label drug use in medical institutions,so as to standardize the behavior of off-label drug use.
Off-label drug useManagement statusEvidence based basisInformed consent