Opening the typical medicine cabinet might shock many Americans. Instead of shaving cream and aspirin, many families now have diabetic, hypertensive and psychotropic drugs in their cupboards. And they’re not just for the adults.
According to Medco Health Solutions, Inc. (Medco), the nation’s largest pharmacy benefits manager, more than 25 percent of American children take a prescription for a chronic ailment. Of this number, nearly seven percent take two or more drugs. These staggering statistics expose a key truth: there are few studies that address patient safety issues relative to juvenile use of adult prescriptions.
According to Medco, children were the leading demographic for pharmaceutical increases in 2009. While drugs for allergies and asthma have shown an increase, the past decade has also been marked by substantial increases in pediatric prescriptions for conditions not commonly identified with youthful populations.
Drugs for mental health conditions, diabetes, obesity and cardiac conditions are on the rise. While these chronic conditions might be lifestyle issues, the fundamental concern is that many of these medications were not tested for use in the pediatric population. Only 10 percent of licensed therapeutics have been adequately tested in children, according to researchers at Duke University.
Pediatric prescription concerns are not a new issue. In 2002, Congress passed the Best Pharmaceuticals for Children Act (BPCA). Reauthorized in 2007, the BPCA, along with the Food and Drug Administration Amendments Act of 2007, provided patent exclusivity for certain medications being tested for pediatric use, extended authority for pediatric testing of drugs and incentives for seeking to improve pediatric labeling.
Additionally, last year, the National Institutes of Health (NIH) announced the Pediatric Trials Network (PTN) initiative, designed to reduce the risks associated with pediatric medication dosing, efficacy and safety. Collaborating with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the BPCA Program and Duke Clinical Research Institute, PTN will establish a scientific, technical and administrative infrastructure for conducting safe pediatric clinical trials.
In the absence of study, medical professionals, pharmaceutical companies, the federal government and parents might not fully understand the potential side effects, proper dosing and contraindications for medications now being prescribed. In promoting a healthier nation, these stakeholders must do their respective parts in testing and monitoring pediatric prescription usage.