The Division of Clinical Pharmacology’s mission is to conduct and support investigator-initiated clinical studies to promote and enhance the development, rational use and individualization of new and existing drug therapies in neonates, infants, children, adolescents and young adults.
Our faculty conducts clinical, translational and basic research that helps clinicians increase drug efficacy and reduce toxicity by optimizing drug selection and individualizing drug dosing. In addition, division members provide multimodality clinical pharmacology teaching and training that enhances the knowledge of residents, fellows and faculty.
We also provide inpatient and outpatient clinical consultation to improve rational therapy using therapeutic drug management (TDM) and pharmacogenetic testing. The Laboratory of Applied Pharmacokinetics and Therapeutic Drug Management offers services to patients with recurrent sub- or super-therapeutic drug concentrations or drug treatment failures.
Research That Leads to Results
Research interests include pharmacogenetics, population pharmacokinetic-pharmacodynamic (PK / PD) analysis and modeling (pharmacometrics), as well as clinical trial design and simulation. As part of the Genetic Pharmacology Service, the division is investigating new methods to reduce adverse reactions by identifying genetic variations in drug metabolism, providing dose recommendations based on the patient’s drug metabolizing genotype / phenotype and delineating clinically significant drug interactions. The goal of these studies is to:
- Develop dosing algorithms and expert systems for individualized drug therapy
- Provide customized drug dosing recommendations to pediatric patients based on TDM results
- Allow patients to achieve the best possible clinical outcome with the least amount of side effects
- Develop new approaches for how we study the effects of medications in children
We Want Safe Medication for Children
The need for pharmacology research has never been greater − a fact that was illustrated with the recall of children’s cough and cold medicines. During the past 10 years, Congress and the National Institutes of Health (NIH) have made it clear that safe drug therapy for children is a priority. Congress passed the Best Pharmaceuticals for Children Act (BPCA) and it was signed in 2002 to establish a process for studying on-patent and off-patent drugs for use in pediatric populations. Our program promotes BPCA efforts and responds to other demands for pediatric clinical drug studies, including those by the Food and Drug Administration (FDA) Modernization Act and the FDA 1998 Pediatric Rule.
Important Facts about Medications and Children
- Many routinely prescribed medications have not been well studied in the pediatric population. This is particularly true for critically ill newborns, where up to 75 percent of the medications used have never been adequately studied.
- Pharmacokinetic study and therapeutic drug management can help tailor the dose to individual needs, prevent drug-drug interactions and avoid adverse events in pediatric patients.
- Pharmacogenetics research has shown that children have widely differing abilities to metabolize drugs.
- Cincinnati Children’s is one of the first hospitals to offer genetic testing to help pediatricians and nurse practitioners choose and dose medication that best meets the needs of the individual patient.