Pharmacoepidemiology and drug safety · 2026
Assessment of Off-Label Psychotropic Drug Use in Children and Adolescents: A Multi-Center Cross-Sectional Study in China.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Teng Yue-Peng, Li Cai-Dong, Lei Wen-Juan, Wu Jun, Wang Ya-Ya, Meng Min, Li Liu-Cheng, Yue Cui-Li
Аннотация
PURPOSE: This study aimed to assess the use of psychotropic drugs in children and adolescents and their off-label use in clinical settings across multiple hospitals in China, as well as to further analyze the influencing factors of off-label use and evidence-based medical evidence.
METHODS: A multi-center retrospective cross-sectional investigation was conducted in secondary and tertiary public hospitals. The study collected prescriptions for patients under 18 years old, which contained psychotropic drugs, including antidepressants, antianxiety drugs, antipsychotics, mood stabilizers, and psychostimulants. Evidence for the prescription was determined by the clinical practice guidelines and Thomson Grades in the Micromedex. Logistic regression analysis was used to explore the influencing factors of off-label use of psychotropic drugs.
RESULTS: A total of 1261 medical records involving 34 kinds of psychotropic drugs for 813 children and adolescent patients were identified. Among them, off-label medical records accounted for 74.2% (936 medical orders), and the three most-used off-label drugs include fluvoxamine, tandospirone, and sertraline. Among patients with off-label drug use, the incidence was significantly higher in females than in males, while the incidence in adolescents (12-17 years old) was significantly higher than that in children (2-11 years old) (p < 0.05). The types of off-label drug use among all the included psychotropic drugs were mainly over-age (45.9%) and unapproved indication use (36.2%). Multiple logistic regression revealed that female (OR = 1.134, 95% CI [1.027, 1.749], p = 0.031) and adolescent (OR = 2.520, 95% CI [1.181, 5.374], p = 0.017) were related to a higher risk of off-label use of psychotropic drugs when compared to male and children, respectively. Twenty-one kinds (61.8%) of off-label drug types were identified, among which 15 kinds of psychotropic drug use were not supported by evidence-based medical evidence.
CONCLUSION: Off-label use of psychotropic drugs is highly prevalent in children and adolescents. The use of psychotropic drugs should be based on instructions and evidence-based medical evidence to ensure their rational use in these patient populations. The drug administration should standardize the practice of pediatric prescription in the future.
METHODS: A multi-center retrospective cross-sectional investigation was conducted in secondary and tertiary public hospitals. The study collected prescriptions for patients under 18 years old, which contained psychotropic drugs, including antidepressants, antianxiety drugs, antipsychotics, mood stabilizers, and psychostimulants. Evidence for the prescription was determined by the clinical practice guidelines and Thomson Grades in the Micromedex. Logistic regression analysis was used to explore the influencing factors of off-label use of psychotropic drugs.
RESULTS: A total of 1261 medical records involving 34 kinds of psychotropic drugs for 813 children and adolescent patients were identified. Among them, off-label medical records accounted for 74.2% (936 medical orders), and the three most-used off-label drugs include fluvoxamine, tandospirone, and sertraline. Among patients with off-label drug use, the incidence was significantly higher in females than in males, while the incidence in adolescents (12-17 years old) was significantly higher than that in children (2-11 years old) (p < 0.05). The types of off-label drug use among all the included psychotropic drugs were mainly over-age (45.9%) and unapproved indication use (36.2%). Multiple logistic regression revealed that female (OR = 1.134, 95% CI [1.027, 1.749], p = 0.031) and adolescent (OR = 2.520, 95% CI [1.181, 5.374], p = 0.017) were related to a higher risk of off-label use of psychotropic drugs when compared to male and children, respectively. Twenty-one kinds (61.8%) of off-label drug types were identified, among which 15 kinds of psychotropic drug use were not supported by evidence-based medical evidence.
CONCLUSION: Off-label use of psychotropic drugs is highly prevalent in children and adolescents. The use of psychotropic drugs should be based on instructions and evidence-based medical evidence to ensure their rational use in these patient populations. The drug administration should standardize the practice of pediatric prescription in the future.