Study Finds No Income Level Differences in Children Receiving Free Drug Samples, Indicates Samples Could Increase Children’s Health Risks

Children from low-income families are no more likely to receive no-cost prescription drug samples than children in families with higher incomes, but no-cost samples that children do receive could put them at risk, according to a study published Monday in the journal Pediatrics, the New York Times reports (Harris, New York Times, 10/6).

For the study, the first to examine the effect of no-cost drug samples in children, researchers analyzed data from a 2004 in-depth CDC survey on how U.S. residents received health care. In total, researchers analyzed data from 10,295 U.S. residents younger than age 18.

Researchers found that one in 20 U.S. residents younger than age 18 received at least one no-cost drug sample in 2004. Of all U.S. residents younger than age 18 who received a prescribed medication, one in 10 received at least one no-cost sample (Rubin, USA Today, 10/6). According to the study, children whose families' incomes were below 200% of the federal poverty level were no more likely to receive no-cost samples in part because children from low-income families are less likely to see a physician. However, the study found that uninsured children who do see a physician are more likely to receive no-cost drug samples than children from families with high incomes.

In 2004, more than 500,000 U.S. children received no-cost samples of prescription drugs that FDA later required to have stronger safety warnings on their labels. The drugs included attention deficit hyperactivity disorder drugs Adderall and Strattera, asthma drug Advair and eczema treatment Elidel (New York Times, 10/6).

Study lead author Sarah Cutrona, an internist at Cambridge Health Alliance and a instructor at Harvard University, said that no-cost samples typically are for the newest drugs, which often have not been subject to thorough evaluation. She also said that no-cost samples "encourage a casual attitude toward medications" because they circumvent pharmacists who conduct important safety checks. She noted that no-cost samples often lack child safety caps, information on doses for children and instructions on procedures in the event of an accidental overdose (USA Today, 10/6). Cutrona added that further research is needed to weigh the risks and benefits of free samples.

Comments
Sidney Wolfe, director of the health research group for Public Citizen, said the practice of providing no-cost samples to patients encouraged physicians "to overuse dangerous drugs." Andrew Racine, director of general pediatrics at Children's Hospital at Montefiore, said, "As a physician, the way you should be making treatment decisions should not be based on which sales representatives come to your door," adding, "This is just a marketing technique."

Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, said that no-cost "samples helped improve the quality of life for millions of Americans, regardless of their income" (New York Times, 10/6). He added that the samples provide physicians with "valuable firsthand experience with new treatment options and can also play a valuable role in fostering the appropriate use of medicines" (USA Today, 10/6).

An abstract of the study is available online.