The Status On The Off-label Use Of Antidepressants In Inpatients With Mental Disorders

Background:Off-label use has always been a controversial topic,but it has to be mentioned because of it is common and inevitable in clinical treatment.In the clinical practice of psychiatry in China,off-label use is very common,and there is a considerable clinical demand,but its status is still embarrassed for that it is reasonable but not legal,in addition,irrational drug use is also very common.Although rational off-label use has certain therapeutic value,its risk should not be ignored.The risk of irrational off-label use is more challenging to patients and doctors.How to consider off-label use is to be a difficult problem.Antidepressants,as one of the most rapidly developed and widely used psychoactive drugs,the off-label of it is not uncommon.However,there is lack of systematic study on the off-label use of psychoactive drugs,especially of antidepressants,no matter at home and abroad.Therefore,it is very necessary to definite the current situation of off-label use of antidepressants,and it has clinical significance of establishing the standard of use of antidepressants.Objective:To investigate the off-label use of antidepressants in inpatients with mental disorders of mental health institutions,so as to provide the basic data for formulating the rational strategy of off-label use,and better to regulate the clinical use of drugs.Methods:It was a retrospective study,and a total of 544 discharged psychiatric patients from January 1,2017 to December 31,2017,who used antidepressants,were selected by stratified sampling method.We used the Hospital Electronic Medical Record System to query case information,and used the self-designed questionnaire to collect information on general demography and antidepressants of these inpatients.We judged the off-label use of antidepressants from three aspects:indications,dosage,and population,according to the drug directions approved by CFDA.The research used the Epi Data3.1software of Chinese version to input and check the data,and then to export the data to the SPSS20.0 software to perform the statistical analysis.Results:1.The total usage rate of the off-label prescribing of antidepressants was 44.3%,the usage rate of over-indication which was the first type was32.2%,the usage rate of over-dosage was 12.7%and the usage rate of over-population was 2.4%.There was no significant difference in the rate of off-label use of antidepressants between male and female(?~2=0.089,P=0.765).2.93.4% of the form of off-label use of antidepressants was off-label using in single aspect,and the rate of only over-indication was the highest,accounting for 66.4%;There were at most two aspects of off-label use of antidepressants in one inpatient(6.7%),including over-indication and over-dosage,over-indication and over-population,over-population and over-dosage;We did not find that three aspects of off-label use of antidepressants were found in one inpatient in the research.3.The usage rate of over-indication was 100%in Schizophrenia,neurotic disorders(somatoform disorders,stress-related disorders,dissociative(conversion)disorders),non-organic insomnia,organic disorders,and mental disorders caused by psychoactive substances;The usage rate of over-indication in anxiety disorder was 84.4%;Other bipolar disorder(40.0%)and obsessive-compulsive disorder(16.7%)also existed over-indication use of antidepressants.4.Seven antidepressants were overdosed in all.The overdose range of Doxetine was 60-120 mg/d,followed by Sertraline(225-300 mg/d),Paroxetine(60-80 mg/d for depression,anxiety disorder),Escitalopram(25 mg/d for under 65 years old,30 mg/d for over 65 years old),Mirtazapine(60 mg/d),Riboxetine(16 mg/d).5.The over-population use of antidepressants was reflected in children,adolescents and the elderly;The usage rate of over--population in children and adolescents(22.9%)was more higher than that in the elderly(3.5%),with statistical significance(?~2=15.286,P<0.001).6.Three antidepressants of the most highest rate of off-label use were Fluoxetine(62.5%),Mianserine(47.5%)and Riboxetine(47.4%);Five antidepressants(Citalopram,Minapram,Doxepin,Clomipramine,and Agomolatine)were not off-label used.Conclusion:Off-label use of antidepressants was a common phenomenon in research unit,and the over-indication use of antidepressantswasthemostcommonaspect.Inaddition,over-population and over-dosage use of antidepressants was also existed.Furthermore,there were at most two aspects of off-label use of antidepressants in one inpatient.It suggests us to strengthen the standardized management of antidepressants and to discuss the rationality of off-label use.