Free drug samples not only do little to equalize medication access in the pediatric population, but they also may pose safety concerns in young patients, results of a recent study show.
The practice of providing free drug samples to children in nonurgent situations should be carefully reconsidered–and perhaps abandoned, the investigators concluded (Pediatrics 2008;122;736-42).
Study author Sarah L. Cutrona of Harvard Medical School, Boston, and her colleagues said the findings show that free drug samples tend to go to children with the best health care–rather than those with the greatest financial need.
The findings were based on nationally representative longitudinal survey data from 10,295 U.S. residents under age 18 years from the Agency for Healthcare Research and Quality 2004 Medical Expenditure Panel Survey, the researchers reported.
About 5% of the children in the survey received at least one free drug sample in 2004, and 10% of the children who received a prescription medication received a free drug sample that year. On multivariate analyses, routine health care access, defined for the study as three or more provider visits in 2004, was found to be associated with the receipt of free samples, but insurance status and family income was not found to play a role in determining which children received samples.
That is, poor children, defined as those from families with incomes less than 200% of the federal poverty level, were no more likely to receive free samples than those from families with incomes of 400% of the poverty level or greater (3.8% vs. 5.9%; odds ratio 0.78), and those who were uninsured for part or all of the year were no more likely to receive samples than those who were insured for the entire year, (4.5% vs. 5.1%; OR 1.05).
In addition, Hispanic and nonwhite children were much less likely to receive free samples, compared with non-Hispanic white children (2.4% and 3.5%, respectively, vs. 6.2%; OR 0.51 and 0.72, respectively). Factors indicative of health care access also were associated with free sample receipt. For example, among those who received more free samples, those who had more visits to medical or dental providers (OR of 1.77 for two vs. one visit, and OR of 3.25 for three or more vs. one visit), those who used office-based primary care vs. those with no usual site of care (OR of 1.52), and those who received more medications in 2004 were more likely to receive free samples (OR 1.06 for incremental increase of one drug).
The high prevalence of drug sample use among pediatric patients also is of concern because the 15 most frequently distributed sample drugs in 2004 included two schedule II controlled medications (Strattera and Adderall). In addition, these two drugs, along with two others (Elidel and Advair) required a new or revised black box warning between 2004 and 2007.
The study–the first to look at free drug sample practices in the pediatric population–is an interesting and helpful study that draws attention to the widespread practice, Dr. David Fassler, clinical professor of psychiatry at the University of Vermont, Burlington, said in an interview.
“The authors raise legitimate questions about the potential safety of current practices with respect to free samples. In particular, they report that controlled substances and treatments not generally considered 'first line' were included in the list of medications most commonly distributed as free samples. “Of particular concern, they also note that a significant number of very young children (under 2 years of age) received samples of medications which are specifically contraindicated for this age group,” Dr. Fassler said.
However, based on the methodology employed, the study raises more questions than it answers, he said.
“For example, did the kids actually take the medication received as a free sample? Did the families subsequently receive a prescription for ongoing treatment? Does the availability of free samples influence a physician's overall prescription pattern? The authors have opened an interesting avenue of inquiry. I expect these and other questions will be addressed in subsequent studies,” he added.
The authors stated they had no financial relationships relevant to this study.
Dr. Fassler said he had no conflicts of interest with respect to this issue.