Recent research suggests that those free prescription drug samples distributed to pediatric patients do not generally go to the needy children to whom they are intended and may lack appropriate safety controls. In other words, free prescription drug samples distributed to children may be unsafe.
The study, which was published in the October 2008 issue of Pediatrics, examined data on 10,295 children and adolescents from the 2004 Medical Expenditure Panel Survey and revealed that one in 20 American children received free drug samples in 2004. Among those who took at least one prescription drug that year, one in 10 received free samples. The researchers also discovered some of the most frequently distributed free samples may actually be unsafe, posing dangers to the young patients.
Four of the 15 most frequently distributed samples in 2004 were identified by the U.S. Food and Drug Administration (FDA) as having significant new safety concerns. Some concerns included new black box warnings or significant revisions to existing warnings. The top 15 samples included Strattera (atomoxetine) and Adderall (amphetamine/dextroamphetamine), drugs used to treat attention deficit hyperactivity disorder (ADHD), to name just two. Both medications are Schedule II controlled substances, meaning the medications are controlled and monitored by the Drug Enforcement Agency (DEA) due to their high potential for drug abuse.
While some physicians welcome free samples to better enable needy patients to receive drugs, the study found very few samples are actually distributed to the neediest pediatric patients. As a matter-of-fact, just 16 percent of the children who received free samples were uninsured for all or part of 2004; less than one-third came from low family incomes—defined as under $38,000 for a family of four. “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,” lead author Sarah Cutrona, a physician at Cambridge Health Alliance and an instructor of medicine at Harvard Medical School, said in a release from the alliance and Hasbro Children’s Hospital.
Neal LeLeiko, another of the study’s authors and director of the pediatric gastroenterology and nutrition at Hasbro and a professor of pediatrics at the Warren Alpert Medical School of Brown University, also expressed concern distributing drug samples to pediatric patients. “Previous findings in adults strongly suggest that free drug samples serve as a marketing tool. Our study shows that samples can pose a serious and unappreciated risk to our children,” LeLeiko said.
Meanwhile, the World Health Organization (WHO) reports that children are dying due to a lack of drugs tailored to their needs. Over half of the drugs used to treat children have not yet been specifically tested on children, despite that children metabolize medications differently than adults. Physicians often lack clear guidelines on the best drugs to use for children, also often guessing at prescribing the medications in correct dosages. Also, testing drugs on children is challenging since good ethical practice requires informed consent from people participating in clinical trials; difficult to obtain in the case of children.
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