Our study demonstrates that free samples are widely distributed to children and are associated with significant safety concerns. One in 20 US children received a free sample in 2004, and 1 of 10 using a prescription medication received a free sample that year. Neither income nor insurance status was a significant predictor of free sample receipt. Characteristics significantly associated with greater free sample receipt included white race/non-Hispanic ethnicity, a greater number of provider visits and a greater number of medications, supporting the conclusion that it is not financial need but rather access to medical care that is the primary mediator of free sample receipt.
After we controlled for health care access, we found that uninsured children seemed significantly more likely to receive free samples than continuously insured children. This apparent reversal of our univariate findings offers important insight into the controversy that surrounds free sample distribution. We think this finding reflects the sincere efforts of doctors to put free samples in the hands of needy children once those children arrive in the office. Despite such good intentions, however, system-wide barriers that prevent access to medical care prevent free samples from being targeted to the most disadvantaged children.
Although we know of no previous studies that focused on characteristics of pediatric free sample recipients, our findings regarding the role of access to medical care in free sample receipt are consistent with those of our previous study,1
which analyzed free drug sample receipt in a nationally representative sample that included both adults and children. Our findings also are consistent with those of a recently published national physician survey.17
Campbell et al17
found that physicians in hospitals or clinics (who treat larger proportions of poor and uninsured patients) are far less likely than physicians in group or solo practice settings to be given samples from the pharmaceutical industry. Their study, like ours, found little relationship between a physician’s free sample receipt and the proportion of patients with Medicaid coverage or without insurance in that physician’s practice. Of note, compared with family practitioners, pediatricians were one half as likely to report receiving free samples (OR: 0.56; 95% CI: 0.33–0.94) for use in their practices.
If, as our study indicates, free samples fail to improve equality of medication access on a national scale, then their continued presence in family medicine and pediatric practices across the country may be difficult to justify. Moreover, samples have the potential to harm as well as to help. New medications frequently are released onto the market before their safety profile is fully understood,21
and samples tend to be newer medications.22
If samples influence provider prescribing, as many studies have indicated,9–15
then the use of free samples may increase pediatric prescriptions for newer medications. Our study showed that, of the 15 medications most frequently distributed as free samples in 2004, 4 (27%) received new or revised black box warnings in the subsequent 2 years. Free samples may encourage the use of medications in children before enough is known about potential harm.
In addition, we found that several of the 15 most frequently distributed free samples were broad-spectrum antibiotics or medications not considered to be first-line therapy. Samples that encourage providers to prescribe newer and broader-spectrum antibiotics exacerbate antibiotic misuse and may contribute directly to increased antimicrobial resistance.
Our finding that 1 of the top 15 sample medications was a schedule II controlled substance raises other safety concerns. Personal and unsupervised use of free samples by doctors, nurses, office staff members, and pharmaceutical representatives is common.8,9,23
Occasionally, even patients may have unsupervised access to office sample closets.5
Even in less drastic situations, the informality of free sample distribution may inadvertently communicate a lax attitude toward medication risks. Physicians, nurses, or office staff members may distribute free samples to patients without proper directions for administration or warnings about adverse effects and potential adverse reactions. Distribution of free samples to patients bypasses the pharmacist and thus skips a crucial safety checkpoint.
In addition, samples’ child-safety packaging and instructions6
often are inadequate for children. When studying the labels of 35 high-use drug samples, Dill and Generali6
found that 54% lacked child-resistant packaging or warnings that the packaging was not child-resistant, 40% lacked the instruction “Keep out of reach of children,” and 91% lacked the instruction “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.”
Our study has several limitations. We were unable to determine the extent to which drug samples are made available to safety net institutions on a national scale. If hospitals serving low-income patients prohibit the distribution of samples, then this could account for some of the disparities we report.
It is possible that some medications reported as free samples actually were free drugs provided by community clinics. On the whole, however, we think that the total number of free samples we report here is more likely to be an underestimate. Parents responding to the survey on behalf of adolescents might have been unaware of some free samples the adolescents received, particularly contraceptives or treatments for sexually transmitted diseases. Respondents might have forgotten to report samples that were received for a short time earlier in the interview reference period, although the relatively short duration of the interview reference periods (2–6 months) should minimize this recall bias. Poor or uninsured respondents might have perceived receipt of free samples as shameful or embarrassing and underreported these events; it is not our experience, however, that free samples carry such a stigma. Free samples obtained through mail order directly from manufacturers might have been undercounted but, as of 2002, the majority of such programs required that applications be filled out by a physician and that (in ~83% of cases) samples be delivered to the doctor’s office.24
Therefore, we think that most such free medications would be classified as free samples in the MEPS data. Free samples that were followed by filled prescriptions within a single interview reference period might have been undercounted. We do not have information on the total number of pills received as samples; therefore, we are unable to determine the proportion of total medications represented by free samples. Such information would be useful to obtain in future studies.