This study provides a nationally representative estimate of the activity of requesting or receiving free prescription drug samples among Medicare beneficiaries. We found that almost 50% of Medicare beneficiaries accessed drug samples, and that this was most common among beneficiaries who reported cost-related nonadherence to medications. Accessing drug samples was also common among many subgroups of beneficiaries, including those with higher incomes and prescription drug benefits, a finding also reported by Cutrona et al.24
These findings indicate that the request and receipt of drug samples is a common and widespread practice, and that policies restricting access to drug samples would affect a wide range of beneficiaries.
Our findings suggest that CRN is the factor most strongly related to accessing drug samples after adjustment for health status, socioeconomic characteristics, and drug coverage. One explanation for this finding is that many beneficiaries may be relying on drug samples to alleviate medication costs. Other studies describe the use of drug samples as an important strategy to reduce cost-related nonadherence to medications7,25
and a majority of physicians consider drug samples an important source of medications for indigent patients.10
However, another explanation is that drug samples may lead to CRN by inducing the use of expensive, brand-name medications in lieu of less expensive alternatives. Given the cross-sectional nature of the data, we are unable to disentangle this relationship and caution against attributing causality of accessing drug samples to CRN.
We also found that having prescription drug benefits does not reduce the likelihood of accessing drug samples. Although lack of prescription drug benefits doubles the odds of accessing drug samples, having employer-sponsored and partial drug coverage also increased the odds of drug sample access. This is partially explained by the out-of-pocket expenses known to result from prescription benefit design features such as benefit caps, high deductibles, and formulary restrictions.26,27
Another explanation is that the population of individuals with drug coverage who access drug samples represents a mixture of 2 subgroups: individuals struggling to afford their co-pays and individuals who prefer drug samples in lieu of paying for medications. At least 1 other study also reported a high prevalence (50%) of free drug sample receipt by elderly Preferred Provider Organization (PPO) enrollees with tiered drug benefits.12
Another part of the explanation for the use of drug samples across beneficiaries with and without drug benefits is that drug samples are distributed for non-economic reasons, including the initiation of therapeutic trials to evaluate early effectiveness, adverse effects or dose adjustment before the purchase of a full prescription.10
Clinical factors were also associated with increased drug sample access, including having a greater illness burden and having poorer health. This is not surprising given the large medication burden among many elderly individuals. We also found that race/ethnicity was an important factor, in that African-American , Hispanic, and other non-white beneficiaries were less likely to ask for or receive free prescription drug samples. Other studies have not explored racial or ethnic variation in the request and use of drug samples. It is unclear whether this represents an example of racial disparities in medication access, racial differences in patient–physician relationships and communication, or a far more complex relationship that we were unable to discern with our study variables. These findings merit further investigation.
The limitations of our study deserve comment. First, we were unable to measure the actual distribution or receipt of drug samples. Therefore, interpretation of our findings as estimates of actual use of drug samples in the Medicare population should be made cautiously. Second, we were unable to describe the characteristics of the medications being requested. It is therefore unclear if the drug samples requested or received were for essential (i.e., drugs whose withdrawal could have important effects on morbidity or mortality or drugs primarily used for symptomatic relief) or non-essential medications.28
Finally, we were unable to determine whether CRN led to drug sample requests or whether drug sample use led to CRN. Although we examined the effect of including CRN in the final model by conducting separate analyses stratifying models by CRN, and including and omitting CRN from the multivariable model, we found little difference among the models. Although the inclusion of CRN in the final model does not affect the other parameter estimates, we caution against inferring causality between CRN and drug sample access.
In summary, our study finds that requesting or receiving drug samples is common among a broad spectrum of Medicare beneficiaries. Of concern is our finding that this activity is more common among beneficiaries with CRN and poorer health. Many physicians dispense drug samples to help their patients reduce expenses,10
but growing concerns about relationships between physicians and the pharmaceutical industry have led to new policies restricting drug samples distribution.29,30
Because drug samples are distributed for a variety of reasons other than patient financial need, it is difficult to precisely estimate the impact that these policies will have on beneficiaries with CRN. Restricting access to drug samples may, paradoxically, reduce CRN by limiting the prescribing and use of expensive, brand-name drugs. In either case, it is clear that these policies will affect a wide spectrum of patients and will likely accelerate the current downward trend in the use of free drug samples by physicians.2–6
Although the Medicare Part D drug benefit will reduce CRN for many beneficiaries, multiple studies demonstrate that many patients will still experience significant out-of-pocket expenditures and will likely still experience cost-related nonadherence under Part D.31,32
In developing policies that restrict the use of samples, health care systems, medical groups, and individual physicians should consider the impact of such restrictions on patients who are reliant on samples and prone to cost-related medication nonadherence. Alternative options for providing essential medications to these high-risk patients should be considered.