Off-label prescription is when doctors prescribe drugs approved by the FDA to treat some other diseases and treat another disease. This practice is more common when treating children and adolescents with neural health disorders because many drugs belonging to psychotropic have not received FDA approval for use in the pediatric population (Chen et al., 2021). In performing the role of a Psychiatric-Mental Health Nurse Practitioner (PMHNP), evidence-based treatment is essential to ensure proper drug’s effectiveness and safety. This discussion will focus on FDA approved and off-label medication in treating Tourette syndrome.
Case Study: Tourette syndrome
FDA-Approved Medication: Aripiprazole (Abilify)
Aripiprazole (Abilify) is an FDA-approved medication used to manage Tourette syndrome in children and adolescent up to the age of 18 years. Advantages of Aripiprazole include enhancement of focus neural functions and control of muscle excitation (Johnson et al., 2023). The clinical trials have depicted a substantial reduction in Tourette syndrome symptoms when utilized correctly. However, it has side effects like insomnia, blurring of vision and increased constipation.
Off-label medication: Clonidine (Catapres)
Clonidine (Catapres) is an alpha-2A adrenergic receptor agonist approved for hypertension treatment, though it is used in Tourette syndrome management. Catapres has an extended-release form making it better and easily tolerated for treating for Tourette syndrome despite being initially an off-label medicine. The advantages of Clonidine are increased attention, decreased impulsivity, and muscles hyperactivity (Ueda& Black, 2021). Possible side effects of Clonidine include drowsiness, fatigue, and low blood pressure. The risk assessment has to consider these possible unfavorable outcomes, especially among children with existing cardiac disorders.
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Non-pharmacological Intervention Behavioral Therapy
Behavioral therapy is one of the critical approaches in Tourette syndrome treatment in early childhood. It aims to alter behavior by implementing reinforcement techniques and training the parents. Behavioral treatment effectively affects a child’s Tourette syndrome management and enhances social interaction and academic accomplishment due to increased adaptation to social stigma (Van & Tripp, 2020). The first advantage is that behavioral therapy is free from pharmacological side effects. Nonetheless, the effectiveness of behavior therapy relies on commitment and implementation processes.
A risk assessment identifies the treatment plans possible based on the child’s background, symptoms, and the family’s wishes. Aripiprazole provides substantial improvement of symptoms but with adverse gastrointestinal effects. Secondly, clonidine is helpful in children’s medication, but it should be used under careful supervision because of its hypotensive action. Although it has been clear that behavioral therapy does not have significant side effects, most require the families’ commitment (Van & Tripp, 2020). Behavioral treatment is not very effective applied alone for moderate to severe forms of Tourette syndrome.
The American Academy of Pediatrics (AAP) guidelines encourage pharmacotherapy and behavior therapy for Tourette syndrome. These guidelines promote the pharmacological treatment and lift FDA-approved stimulants as first-line treatment while recommending Clonidine for children who cannot tolerate aripiprazole (Chen et al., 2021). Finally, cognitive-behavioral therapy is highly preferred, along with drugs.
Conclusion
Adherence to the principles and standards of evidence-based medicine entails the knowledge and use of various medications mentioned by the FDA, off-label drugs, and non-pharmacological therapies to treat Tourette syndrome in children and adolescents. For instance, both aripiprazole and clonidine are commonly used to help control the symptoms of Tourette syndrome, while there is also a role for behavioral therapy. The risk assessment always considers the benefits against the costs during the treatment process. However, medication guidelines must be upheld during all times of the medication process. Consequently, illustrating and analyzing these factors assist PMHNPs in reaching the best decision when attending to children with Tourette syndrome.
References
Chen, S., Barner, J. C., & Cho, E. (2021). Trends in off-label use of antipsychotic medications among Texas Medicaid children and adolescents from 2013 to 2016. Journal of Managed Care & Specialty Pharmacy, 27(8), 1035-1045.
Johnson, K. A., Worbe, Y., Foote, K. D., Butson, C. R., Gunduz, A., & Okun, M. S. (2023). Tourette syndrome: clinical features, pathophysiology, and treatment. The Lancet Neurology, 22(2), 147-158.
Ueda, K., & Black, K. J. (2021). Recent progress on Tourette syndrome. Faculty Reviews, 10.
Van der Oord, S., & Tripp, G. (2020). How to improve behavioral parent and teacher training for children with ADHD: Integrating empirical research on learning and motivation into treatment. Clinical child and family psychology review, 23(4), 577-604.
