Experiences with Patient Refusal of Off-Label Prescribing of Psychotropic Medications to Children and Adolescents in Japan.

Objective: In child and adolescent psychiatry, the off-label prescribing of psychotropic medications is common. The purpose of this study was to examine the experiences of Japanese child and adolescent psychiatrists with off-label prescribing to children and/or adolescents (hereafter referred to as "children") and to identify the factors associated with these experiences.

Methods: A prospective questionnaire was sent to 1628 psychiatrists belonging to the Japanese Society for Child and Adolescent Psychiatry. Stepwise logistic regression analyses were used to determine whether demographic characteristics or categories of psychotropic medications were able to independently predict patient refusals of off-label prescribing.

Results: The final sample included 447 psychiatrists, and 93% of the respondents (416/447) had experiences with off-label prescribing to children. In addition, 39.7% of the respondents (165/416) experienced patient refusal of off-label prescribing when they informed the children and/or parents of the prescribing. The most commonly prescribed off-label psychotropic medications were antipsychotics (82.0%). Patient refusal was significantly more frequent when the respondents informed parents (p=0.02) and children (p<0.01) about off-label prescribing than when they did not. A stepwise logistic regression analysis revealed that informing parents (odds ratio [OR], 2.73; 95% confidence interval [CI], 1.09-6.82) or children (OR, 1.70; 95% CI, 1.12-2.58) about off-label prescribing and antidepressant use (OR, 2.98; 95% CI, 1.25-7.10) increased the odds of patient refusal of off-label prescribing; however, prescribers' years in practice decreased the odds (OR, 0.98; 95% CI, 0.96-1).

Conclusions: Off-label prescribing of psychotropic medications is common among child and adolescent psychiatrists in Japan. Furthermore, the psychiatrists' experiences with patient refusal of off-label prescribing were significantly associated with informing the parents/patients about off-label prescribing, particularly with regard to use of antidepressants. Further studies are required to support the development of decision making among clinicians.