Dosing and Monitoring: Children and Adolescents

American culture places a great value on our children. In accordance with this, parents seek out the best health care, wanting to ensure the well-being of their children. Despite this, physicians have been forced to treat children with medications lacking FDA indications for pediatric use. Off-label use to treat childhood disorders has been the rule rather than the exception, with clinicians relying on limited literature or clinical lore to make important medical decisions. The treatment of psychiatric disorders in children has been no exception. Medications approved for adults gradually make their way into the armamentarium of child and adolescent psychiatrists, often without adequate dosing guidelines. The past two decades have seen a dramatic increase in the number of studies looking specifically at pediatric psychopharmacology, but there have been difficulties in obtaining funding for such work. Pediatric studies have also been hampered by the lack of understanding of the biologic nature of many psychiatric disorders. Numerous factors have worked together to begin changing these problems. In 1994, the FDA enacted the Pediatric Labeling Regulation, which encouraged pharmaceutical firms to submit applications for a change in labeling for pediatric indications if a review of the literature showed that enough data existed to warrant a pediatric indication. As part of the Food and Drug Administration Modernization Act of 1997 (enacted in 1998), pediatric exclusivity could be extended by 6 months for medications whose manufacturers submitted pediatric studies in compliance with the act’s regulations. In addition, the Pediatric Rule, effective April 1999, required certain manufacturers—namely those of products that would either be used in a “substantial” number of pediatric patients or provide children a meaningful therapeutic benefit over existing treatments—to conduct studies that would be adequate to provide labeling for pediatric indications. In addition, the NIMH funded the Research Units in Pediatric Psychopharmacology (RUPP) network. RUPP is composed of research units in academic centers across the country devoted to conducting studies to test the efficacy and safety of medications commonly used by practitioners to treat children and adolescents but not yet adequately tested. The number of pediatric studies and submissions to the FDA has subsequently increased dramatically. Clearly this has allowed new funding sources to assist in the development of pharmacological trials. It has also assisted in allaying the resistance that is often seen toward treatment studies in young children. As public awareness of psychiatric disorders has grown, resistance toward research has begun to diminish. As our knowledge of pediatric psychopharmacology increases, it becomes increasingly difficult to keep track of the available options for treatment. While it is beyond the scope of this book to cover all the factors that make the treatment of children different from that of adults, we have attempted to compile a practical guide for those “in the trenches.” Medications commonly used in children and adolescents, as well as general dosing guidelines, have been provided. In addition to the dosing and monitoring tables that follow, there are a number of overarching “principles” to keep in mind in treating this vulnerable population. The latest recommendations for use of psychotropic medication from the American Academy of Child and Adolescent Psychiatry (AACAP) greatly expanded guidelines for clinicians. These guidelines for dosing and monitoring in children and adolescents will follow the AACAP’s lead. Psychiatrists, pediatric neurologists, and pediatricians whose patients may present on a medication they are less familiar with will hopefully find this guide helpful. We hope the following will enhance the ease with which you practice, and we look forward to your suggestions for future updates. — Editorial Director, James M. La Rossa Jr., contributed to the 2018 update of this work