 |
|
|
 |
Michael Shannon, MD, MPH |
This spring, Children's Hospital Boston's harmacologist/toxicologist Michael Shannon, MD, MPH, chief emeritus of the Division of Emergency Medicine, along with Randy Prescilla, MD, of Anesthesia, Perioperative and Pain Medicine, is launching a groundbreaking new Clinical Pharmacology Unit that will serve as a clinical and research resource for physicians across the country. "We want to build a unified presence as a center for drug and clinical discovery," says Dr. Shannon. The unit will ultimately include
a drug development and clinical trials coordinating center and translational research program that
investigates adverse drug events and their mechanisms using pharmacogenetics and
pharmacogenomics as key research tools. It will be one of the only pediatric clinical pharmacology
programs in the United States.
The need for pharmacology research has never been
greater-a fact that's recently come into the media spotlight with the recall of children's cough and cold medicines. Because
children are so sensitive to poisoning-from both the
environment and medications-Dr. Shannon has spent the past 25 years at Children's working on poisoning prevention and means of protecting children from the threats of lead exposure, drug overdose, unsafe toys and other injuries.
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, passing the Best Pharmaceuticals for Children Act (BPCA) legislation in 2002 to establish a process for studying on-patent and off-patent drugs for use in pediatric populations. Dr. Shannon's program will promote BPCA efforts and respond to other demands for pediatric clinical studies, including those by the Food and Drug Administration (FDA) Modernization Act and FDA 1998 Pediatric Rule.
In addition to its research arm, the Clinical Pharmacology Unit will have two other major components: an American Board of Clinical Pharmacology (ABCP)-accredited clinical pharmacology fellowship training program and a clinical pharmacology consult service. The two-year fellowship program-one of the nation's only pediatric clinical pharmacology training programs-will offer both clinical and research experience to physicians and PharmDs, training those who wish to remain in academic medicine, where the need for pharmacology expertise is greatest. At the end of the fellowship, graduates will be eligible for board certification in Clinical Pharmacology. Of greater
importance, fellows will have all the skills necessary to meet the growing demand for experts in pediatric-focused drug discovery, development and safety.
The other major component of the program, the clinical
consultation service, has been designed to assist clinicians addressing difficulties that often arise around drug therapy in children. Working in partnership with the Program in Medical Toxicology, directed by Michele Burns Ewald, MD, of Emergency Medicine, the consult service will have 24-hour availability to Children's clinicians, offering the following services:
Pharmacokinetic analysis: This service will be particularly
targeted to patients with recurrent sub- or super-therapeutic serum drug concentrations or drug treatment failures.
Pharmacogenetic testing: This service will provide genotypic (identification of genetic polymorphisms) and phenotypic (use of probe drugs to identify aberrant metabolic pathways) testing to answer questions about drug behavior specific to the
individual child.
Adverse drug reaction investigations: In collaboration with the Program in Medical Toxicology, the service will investigate adverse drug reactions in an effort to identify their mechanisms and prevent future events. Such investigations will make use of all modern tools in laboratory and translational pharmacology/ toxicology, including pharmacogenetic testing, drug concentration measurement (using the appropriate biological specimen) and metabolic pathway analysis.
There will also be outpatient and inpatient services available through the consult service. Outpatient services will include pharmacokinetic and pharmacogenetic testing and adverse drug events analysis. Inpatient services will admit patients for
pharmacokinetic analysis and similar testing.
-
Approximately 80 percent of medications prescribed to children have
never been adequately tested in the pediatric population.
-
The dose of a drug given to children, when extrapolated from the adult dose, commonly leads to either drug underdose or drug overdose.
-
There is no scientific evidence that cough and cold medications improve the cough, congestion and coryza of upper respiratory tract infections in children.
-
Pharmacogenetics research has proven that individuals have widely
differing abilities to metabolize drugs.
-
Up to 15 percent of children are unable to metabolize codeine to its active analgesic form; such children will receive no pain relief from codeine-containing pain relievers.
-
Many adverse drug reactions can now be predicted and prevented by testing the child's genetic ability to metabolize the drug.
-
"Personalized medicine" in pediatric drug therapy means the right drug, in the right dose, will be given to the right child, every time.
-
Laboratory tests are now available that allow pediatricians to identify children who will not metabolize specific drugs in a typical fashion.
-
Pharmacogenetic testing is being used clinically; the FDA now
recommends prior genetic testing in children receiving warfarin, since gene abnormalities (polymorphisms) can result either in warfarin
underdosing or warfarin toxicity.
-
Drug-drug interactions and drug-food interactions are extremely
common. Foods as common as grapefruit juice can significantly alter a child's ability to metabolize certain drugs.
|
|
