Free Drug Samples in the United States: Characteristics of Pediatric Recipients and Safety Concerns

Although the use of free drug samples by adults has received increasing national attention,1–4 little is known about free sample distribution in pediatric populations. Studies of free sample use among adults have addressed safety concerns,5–6 health professionals’ diversion of samples for self-administration or resale,7–9 and the contribution of samples to increasing drug costs.2,10 In addition, numerous adult studies suggest that free samples influence the prescribing behavior of physicians and trainees.2,9–15 Physicians alter their prescribing patterns when using samples, choosing medications that are more expensive,2 less likely to be first-line agents,11 and less likely to be consistent with the physicians’ own, self-described, prescribing preferences.10 In a recent report, the Institute of Medicine called for further investigation of sample use.16 Concerns cited in the report include the lack of documentation of sample medications and the bypassing of standard prescribing and dispensing services, including counseling and drug interaction checks. Free sample distribution seems to be common in pediatric populations. A national survey of physicians published in 2007 found that 78% of physicians reported receiving drug samples for their patients; more than one third of respondents to that survey were either pediatricians or family practitioners.17 Information on the safety of free samples for children is limited. Samples often have inadequate or absent labeling regarding pediatric dosing.6 Child-resistant packaging (or warnings that the packaging is not child-resistant), instructions to keep the drug out of the reach of children, and instructions on seeking advice in the case of accidental overdose also are absent for a large proportion of samples.6 Moreover, sample distribution removes a layer of redundancy in prescribing (ie, pharmacist review and instructions before the first dose), which may allow physician and patient errors to go unnoticed. Despite safety and prescribing concerns, samples have several potential benefits. Samples can be a convenient way to test a flavor or preparation to determine whether a child will tolerate the medicine, before the prescription is filled. Samples may be used to establish goodwill or to form a bond between a health care practitioner and a patient or parent. In addition, many physicians describe free samples as a valuable way to provide medications to needy patients.18 This view is espoused by the Pharmaceutical Research and Manufacturers of America, whose vice president wrote, “Many uninsured and low-income patients benefit from these free samples, which often serve as a safety net.”19 No national study has described characteristics of pediatric free sample recipients. We examined factors associated with free sample receipt in a pediatric population by using nationally representative data for 2004. We investigated whether samples were given primarily to poor and uninsured children, we characterized the medications most frequently sampled, and we identified safety concerns associated with those medications.