Pediatric pharmacology: interview with Dr Carlton Lee

Rebecca Aris interviews Dr Carlton Lee in pharmaphorum’s pediatric care themed month to hear his views on the changing face of pediatric pharmacology.

Dr Carlon Leee is a pediatric Clinical pharmacist by training and currently works as a Clinical Pharmacy Specialist in Pediatrics for the department of pharmacy at The Johns Hopkins Hospital where he provides clinical services to the inpatient General Pediatrics unit and ambulatory Pediatric Cystic Fibrosis clinic. In addition, he serves as the Program Director to the Post-Graduate Year two Pediatric Pharmacy Residency program and provides clinical education to pharmacy residents.

Here he speaks with pharmaphorum on the challenges associated with pediatric pharmacology and how he expects this area to develop over the next ten years.

Interview summary

RA: How have you seen pediatric pharmacology change over the course of your career?

CL: Within the past two decades I have witnessed the actions of the NIH sponsored Pediatric Pharmacology Research Units, Best Pharmaceutical for Children Act and Pediatric Research Equity Act, which were the stimulus for increasing much-needed clinical pediatric pharmacology studies to support pediatric drug development. Despite the progress, there remains continued work on studying new and existing drugs such that children can truly benefit from the available technologies in a safe and efficacious manner.

“…there remains continued work on studying new and existing drugs such that children can truly benefit from the available technologies…”

RA: What are the biggest challenges in pediatric pharmacology?

CL: Funding continues to be a challenge for all medical research. Also, having the necessary infrastructure to support these studies at your institution is essential. Therefore, we need to be more creative by having our academic centers partner with the pharmaceutical industry to serve the common goal in developing pharmaceuticals for children the right way.

RA: What recent research in pediatric pharmacology has had the most impact on clinical practice?

CL: It’s difficult to single out one particular research project but there have been recent advances in the available methodologies that have and will make pediatric pharmacokinetic and pharmacodynamics studies more plausible. These advances include sensitive drug assays requiring less patient blood volumes (e.g. dry blood spot drug sampling and more sophisticated LC / MS / MS assays; and population pharmacokinetic / pharmacodynamics data analysis methodologies with sparse data points). Collectively, these advances should further the development of medications for children.

RA: You have lectured widely about cystic fibrosis and pharmacology in the pediatric population, what are your key take home messages in such lectures?

CL: The key take home message is that Pediatric Cystic Fibrosis patients have altered drug disposition which may affect aspects of drug absorption, distribution, metabolism and excretion and any new drug introduced to these patients should be studied for altered pharmacokinetics. Additionally, you need to account for the maturational differences in drug disposition as well.

“…we need to be more creative by having our academic centers partner with the pharmaceutical industry to serve the common goal in developing pharmaceuticals for children the right way.”

RA: You help to develop safe tools for Pediatric Outpatient Prescribing, what key considerations have to be made when prescribing in this setting?

CL: These tools are currently a work in progress and have their limitations. For instance, several drugs used in children have multiple indications for use and are dosed at different levels. These systems may not be as sophisticated enough to account for these differences and may be need to have much broader dose checking limits to accommodate for all indications. Also, simply relying on these computerized systems is a false sense of security and is not a substitute for common sense.

RA: Finally, what changes do you expect to see in the pediatric pharmacology space over the next ten years?

CL: If the economy and availability of research funding remains stagnant, I would anticipate the need for stronger academic and industry partnerships for advancing pediatric pharmacology research and drug development.

RA: Thank you for your time.

About the interviewee:

Dr. Lee earned his Doctor of Pharmacy from the University of the Pacific School of Pharmacy in Stockton, California, and his Masters of Public Health from the Johns Hopkins School of Hygiene and Public Health. He completed his hospital pharmacy residency at Johns Hopkins Hospital and a fellowship in pharmacokinetics/pharmacodynamics at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Dr. Lee has over 28 years of Pediatric Clinical Pharmacology experience at Hopkins with teaching responsibilities to pharmacy and medical residents and students. His current clinical practice area is in acute care General Pediatrics and ambulatory Pediatric Cystic Fibrosis. He currently serves as the Residency Program Director for the PGY-2 Pediatric Pharmacy Specialty program and is a Clinical Pharmacy Specialist in Pediatrics for the Department of Pharmacy at The Johns Hopkins Hospital. He also serves as a Clinical Professor at the University of Maryland School of Pharmacy and Associate Professor in Pediatrics at the Johns Hopkins University School of Medicine.

He has published several articles and medical text chapters; most notably, he is the editor to the Formulary section to the Harriet Lane Handbook for the past 23 years. Dr. Lee has been named in “Who’s Who in America” and is a fellow of the American Society of Health-System Pharmacists and Pediatric Pharmacy Advocacy Group.

His clinical research experience have been in Phase I/IV pharmacokinetic/drug development studies in Cystic Fibrosis and HIV/AIDS; and developing safe tools for Pediatric Outpatient Prescribing. Dr. Lee is currently a co-investigator for evaluating Granulocyte Macrophage Colony Stimulating Factor’s (GMCSF) effect as an immunomodulator in a NIH RO-1 NIH grant; and a phase I trial on the use of Clonidine in infants with hypoxic ischemic encephalopathy during therapeutic hypothermia. He is also involved with Pediatric Antimicrobial Drug Development trials of approved antibiotics in adults that have not been studied in children.

How can we be more creative around developing pharmaceuticals for children ?