Washington, Oct 6 : A study by physicians from Cambridge Health Alliance and Hasbro Children's Hospital has revealed that free prescription drug samples distributed to children may be unsafe.
The study is the first to look at free drug sample use among children.
The physicians, who also serve as researchers at Harvard Medical School and the Warren Alpert Medical School of Brown University, found that kids commonly receive free drug samples from their doctors.
The U.S. Food and Drug Administration identified significant new safety concerns for four of the top 15 most frequently distributed samples in 2004.
These four medications acquired new black box warnings or had significant revisions to existing black box warnings issued since 2004.
Also, two of the top 15 sample medications given to children were schedule II controlled substances (drugs controlled and monitored by the Drug Enforcement Agency due to high potential for abuse).
Distribution of these medications, Strattera (atomoxetine) and Adderall (amphetamine/dextroamphetamine), carries risk, especially when drug sample closets in physician's offices (or home medicine cabinets) are not strictly monitored.
Some physicians support the use of free drug samples as a way of getting medications to indigent patients, but lead author Dr. Sarah Cutrona and colleagues found that few free samples in their study go to needy children. More than 80 percent of children receiving samples were insured all year.
On the other hand, approximately 16 percent were uninsured for all or part of 2004, and less than one-third had low family incomes. Minority children were less likely to receive free samples than white non-Hispanic children, and free sample receipt was positively associated with markers reflecting access to health care.
The researchers concluded that free sample distribution does not equalize medication access for needy children.
"New medications are frequently released before their safety profile is fully understood, and samples tend to be newer medications. Free samples encourage the casual use of medications in our children before enough is known about potential harm," Cutrona said.
The study appears in the October 2008 issue of Paediatrics.