Dianne Murphy, M.D., is director of FDA’s Office of Pediatric Therapeutics. Dr. Murphy graduated from the Medical College of Virginia and completed her residency in pediatrics at the University of Virginia in Charlottesville. She has been with FDA since 1998.
Would you know what to do if your medication didn't seem right? What if it were discolored, chipped, or labeled with the incorrect product name? These are examples of drug quality problems that should be reported to the Food and Drug Administration's (FDA) Drug Quality Reporting System (DQRS).
FDA created the system in 1971 to minimize consumer exposure to unsafe, ineffective, and poor quality drugs. Reporting drug quality problems is voluntary, but essential.
“One DQRS report can lead to a drug...
A: For drugs, a child is defined as a person up to 17 years of age. For devices, 21 years of age is the upper limit.
Q: Are medications that are intended for children clinically tested on children?
A: If the product is to be used only for children, then it must be studied in the pediatric population. However, many therapies are developed for adults and then used in children without having been studied in children. Therefore, most marketed products that are mostly used in adults have not been studied in children—even though they may be used by doctors to treat children.
There has been improvement in this area in regard to prescription drugs. As of 2008, an estimated 50 to 60 percent of prescription drugs used to treat children have been studied in some part of the pediatric population. Still, the likelihood that a medicine has actually been studied in neonates—children less than a month old—is close to zero.
So nearly a decade into the 21st Century, most medicines intended for children, including many over-the-counter (OTC) products, haven’t been clinically studied in children—and certainly not in all age populations that comprise the branch of medicine known as “pediatrics.”
Q: How can parents find out if a medication has been tested for its effects on children?
A: With prescription medications, there is a “Pediatric” section in the labeling that states whether the medication has been studied for its effects on children. The label will also tell you what ages have been studied.
Most OTC products other than those for fever or pain have not actually been studied in children for effectiveness, safety, or dosing. They were approved for marketing many decades ago under a process where an expert panel looked at the evidence, including literature, and decided if a product should continue to be sold OTC.