This nationally representative survey of Medicare beneficiaries indicates that use of free samples is widespread among older adults, while participation in industry-sponsored patient assistance programs appears extremely limited. Those with less education, lower income and lacking a primary care physician were less likely to receive free samples. Seniors who expressed a willingness to and experience with discussing medication costs with their doctors were much more likely to receive free samples than those who did not have these discussions. In contrast, while few seniors participated in industry-sponsored PAPs, participation was higher among those with low income and those lacking prescription coverage.
Two prior studies of free sample receipt in the Medicare population reported similar rates of use, but these studies used pre-Part D data.25,26
In the most recent of these studies, low-income seniors and racial/ethnic minorities in the 2004 Medicare Current Beneficiary Survey (MCBS) were less likely to ask for or receive samples, similar to our findings post Part D.25
We additionally found that one-third of those who had used PAPs, who presumably have the greatest need for financial assistance, did not report any free sample use.
The important question of whether prescription samples and PAPs are truly helping those in need versus driving the use of higher cost drugs warrants further study.10,13,27
Ideally, patients with lower income and those most in need would receive the majority of free samples if they had a clear indication for a brand-name drug over a generic equivalent. The high prevalence of cost-related non-adherence among lower income seniors23
could be partially mitigated by use of free samples. On the other hand, samples have the potential to increase costs and the use of brand name drugs.10,28–30
It is possible, in fact, that lower income seniors are receiving fewer samples precisely because they have higher rates of generic drug use, and that increasing the use of samples among this group might increase their use of more expensive medications.
Due to the controversy surrounding the provision of free samples, there are efforts underway to limit and regulate their distribution.31
In a 2009 report on conflicts of interest in medicine, the Institute of Medicine recommended that physicians and training programs limit (and in some cases prohibit) the use of free drug samples, except in situations for patients with financial difficulty.32
The Medicare Payment Advisory Commission (MedPAC) recently recommended tracking the distribution of free samples to physician practices by pharmaceutical companies.33
It will be important to understand how these policy changes affect the use of free samples.
Our survey is the first that directly asks a national sample of seniors whether they receive drugs through patient assistance programs. PAPs cover a majority of the top-selling medications in the US18,20
, and most of the programs base eligibility partially on income, although income cutoffs vary, with some as high as 750% of the federal poverty limit.20
Slightly more than a quarter of these programs did not require documentation of income in 2007 and about half allowed patients to have existing prescription coverage.20
The industry emphasizes the important role these programs play in helping people pay for prescription drugs27,34
, yet our survey finds that only 1.3% of Medicare beneficiaries report program participation. It may be that the PAPs are geared towards those under the age of 65, and in fact a survey of these patient assistance programs found that only 29% provided assistance for patients enrolled in Part D, with an additional 17% assisting Part D beneficiaries only if they are in the coverage gap.20
While there is some concern that these programs may lead patients towards a brand-name product when other less costly alternatives are available20,35
, the low rate of PAP use among Medicare beneficiaries may mean this is less of a problem. Alternatively, given the high-rate of cost-related nonadherence observed among low-income seniors and those lacking prescription coverage, many seniors could potentially benefit from these programs.
Reporting discussing medication costs with one’s physician had a strong positive association with free sample receipt as well as participation in PAPs. Seniors who talked about the cost of their medications with their doctor were significantly more likely than those who did not to receive samples (67.6% vs. 44.4%, p
0.001) and to use patient assistance programs (1.9% vs. 0.9%, p
0.001). While we are unable in a cross-sectional survey to infer a causal relationship between these behaviors, communication about drug costs was a more important predictor of free sample receipt in multivariable analyses than either income or drug coverage. Evidence suggests that communication with patients about costs can improve adherence to medication36
, but that these conversations are still rare.21,22,37–39
Our results reinforce this important association between doctor–patient communication and management of prescription costs.
There are potential differences in how doctor–patient communication could affect receipt of samples and participation in PAPs. Physician offices are the key source of prescription samples for patients. While over 90% of PAPs required patients in 2007 to submit prescriptions to receive assistance and almost half delivered the medication to the doctor’s office rather than directly to the patient20
, patients likely have more flexibility to enroll in PAPs outside of the doctor’s visit. Nonetheless, the physician plays a central role in both of these processes because they are ultimately responsible for the prescription. Improved doctor–patient communication does not necessarily have to lead to greater participation in these programs; it would, however, open the door to participation for many patients who could benefit and would encourage honest discussions about the risks and benefits of participation in the programs.
The results of this study must be interpreted in the context of the study design. First, the survey achieved a modest response rate (56%) and did not include institutionalized Medicare beneficiaries or those younger than age 65. Because the most vulnerable seniors are not represented, we may underestimate the socioeconomic disparity in free sample use. Second, we assigned the 20% of beneficiaries reporting multiple sources of drug coverage to one primary source using a pre-defined hierarchy; we may have thus overlooked the effect of secondary sources of coverage in helping patients afford prescriptions (such as VA or employer plans). However, the distribution of coverage sources in our sample using the hierarchical approach is similar to national data from the Department of Health and Human Services.40
Third, our question about prescription assistance programs asks respondents whether they receive any of their medications through programs sponsored by manufacturers that make their drugs, and thus asks about current use. As a result, our analysis may underestimate the number of people who have ever used these programs. Finally, the study is cross-sectional, and as such, we cannot infer a causal relationship between doctor–patient communication and receipt of assistance with prescription medications.