A new report published in the Journal of the American Medical Association has shown that when children need certain prescription medicine, such as anesthetics, statins, morphine, or prednisone for asthma, doctors sometimes have to guess the dosage based on the child’s weight.
The reason doctors must estimate the dosage is that approximately half of the prescription medications typically administered to children have no information about proper pediatric doses printed on their labels.
U.S. Food and Drug Administration researchers studied 461 drugs listed in the Physicians’ Desk Reference and found only 231 had enough information matched to them that would be effective in guiding physicians to give the proper dose to children. For 105 new drugs approved by the FDA from 2002 to 2008, only 43 included adequate information on dosages for children. For newborns, the situation is even worse, with about ninety percent of drugs having never been tested for use in infants.
When doctors prescribe medications, they sometimes guess based on the child’s weight, but children’s organs can function differently from those of adults. Medication errors cause many health problems and even deaths each year. Even when there is no error, adverse reactions to medications cause about 100,000 deaths each year.
While the problem is still severe, the overall situation is actually better now than in years past. The Pediatric Research Equity Act, which was passed in 2003 and reauthorized in 2007, makes it possible for the FDA to require additional testing on drugs that could be used extensively on children.
Also, the Best Pharmaceuticals for Children Act extended a provision from a previous regulation, which allows pharmaceutical companies that conduct tests for pediatric medications an extra six months of market exclusivity. The goal of allowing this extra six months was to provide a financial incentive to those pharmaceutical companies who were doing pediatric drug testing, to help prevent medication errors and adverse medication reactions in children. Nevertheless, more progress is needed toward appropriate administration of pediatric drugs.
Robert Briskman is a Chicago medical malpractice lawyer and Chicago medical malpractice attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit https://briskmanandbriskman.com/.