Do pharmaceutical marketing and pricing practices reduce compliance with cardiovascular medications?

Cardiovascular disease (CVD) is the most prevalent condition treated in primary care practice and contributes to the socioeconomic and racial/ethnic inequities in health that characterize the U.S. Treating hypertension and hyperlipidemia, CVD’s major risk factors, can significantly reduce the risk of severe cardiovascular outcomes. Although safe and effective medications are available for this purpose, maintaining healthy blood pressure and cholesterol is difficult, particularly for people from disadvantaged populations. Conventional wisdom says that providing free pharmaceutical samples should help patients to take their medicine but a recent study in Medical Care found that “individuals receiving samples have higher prescription expenditures than their counterparts.” The authors concluded that “these findings suggest that sample recipients remain disproportionately burdened by prescription costs even after sample receipt.”1 While there are many factors that contribute to this problem, here we examine the role of prescription medication marketing practices and costs on patient adherence to prescribed medications.

Adherence to prescribed medications for the control of chronic conditions may be particularly difficult for many disadvantaged populations for multiple reasons, including sociocultural influences that inhibit productive patient-physician communication, low health literacy, and difficulty adjustinglifestyle and health behaviors, among others. These factors have been described in the medical literature and are often the target of patient-level interventions. However another significant but less-studied influence on adherence is the inability of patients to consistently fill prescriptions because of cost of medications. Numerous studies have shown that lower income and/or uninsured patients frequently forgo needed medical care because of cost2,3,4,5,6 delay filling and refilling prescriptions because of cost,7 or share prescriptions with friends and family members because of cost.8 Given these data, we wonder why cost has been given so little attention, and propose that pharmaceutical industry marketing practices might be a factor in compliance.

The pharmaceutical industry continues to develop and market new classes of medications to treat hypertension and hyperlipidemia, even though effective medications to treat these conditions have been available for many years. While the new medications are typically considerably more expensive, they are heavily advertised for any improvement in effectiveness, specificity in their action, and reduced side effects than the earlier drugs. However, there are convincing data showing that in many cases established therapies can be about as effective as the newer medications for many patients.9,10 For example, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial showed that thiazide-type diuretics are as effective as newer antihypertensive medications, such as an angiotensin converting enzyme (ACE) inhibitor, in reducing blood pressure and cardiovascular complications.9 We acknowledge that contradictory evidence also exists.11 Appropriate decisions about which of the available medication therapies should be prescribed to individual patients include clinical considerations, tolerance of side effects, and other patient-level factors. To date, cost seems to have been of less immediate concern for many prescribing physicians.

To understand why cost might not be routinely considered as a primary factor in clinical decision making, we must take a look at the way medications are marketed. The largest domain of pharmaceutical marketing is the direct promotion of medications to physicians by pharmaceutical representatives, termed “detailing.” Such interactions with pharmaceutical representatives are frequent, occur in multiple clinical settings, and begin as early as medical school. Pharmaceutical representatives have a well-established role in the clinical setting that may extend beyond educating physicians about new medications. Data indicate that this marketing behavior is likely to have had an impact on CVD treatment patterns in particular as the medications to treat its major risk factors are among the most marketed medications, and marketed medications tend to overwhelm the market share of all medications for a particular condition. For example, those medications that are marketed for hyperlipidemia account for about two-thirds of the market share of medications to treat this condition.12

A recent anthropological assessment argues that pharmaceutical representatives create a”culture of gift exchanges” in hospitals and clinics.13 Gifts can include early data on “cutting edge” treatments, supplies for both home and office, opportunities to attend professional conferences, staff lunches, and so on. Some analysts argue that this gift culture creates a conflict of interest for physicians, influencing them to make inappropriate clinical decisions. In this view, pharmaceutical representatives may negatively influence clinical practice not by encouraging physicians to ignore good clinical practice when prescribing medications (that is, accounting for clinical considerations, tolerance of side effects, and other patient-level factors). Rather, sales people may lead physicians to make questionable medication choices when factors other than these clinical benefits are the primary factors at stake. Specifically, interactions with pharmaceutical representatives may lead physicians to prescribe the newest and/or most costly medications to some patients for whom less expensive, cost-effective treatment alternatives are also available. (See Peay and Peay,14 for a discussion of this issue.) This practice would not only increase medical costs, but could also lead to poor medication access and adherence, and ultimately lead to poorer patient outcomes – particularly for the most disadvantaged patients.

So exactly how might pharmaceutical marketing practices mask real cost considerations? One way is the distribution of free product samples. Free samples of medication (“sampling”) are given to physicians to pass along to their patients, a key part of the gift culture previously described. The stated intent of sampling is to allow patients to have access to a free short-term trial of a new medication to determine drug tolerance, side effects, and clinical response, before making a commitment to purchase a longer term supply of the medication. However, physicians frequently report that they give samples in order to provide free or low-cost medications to their uninsured/underinsured patients.15,16

Studies suggest that most physicians recognize that medication cost may be a substantial barrier to patients’ ability to adhere to prescribed medication regimens, and believe that cost should be a consideration when making treatment choices for patients. (See Alexander et al.17,18,19 for discussions of this issue.) However few physicians actually take the necessary steps to adequately monitor either cost or cost-related adherence, by, for example, initiating conversations about medication-taking behaviors, the out-of-pocket costs of medications, and the potential for cost to be a barrier to filling or refilling prescriptions and medication adherence.17,20,21 For physicians who are made aware of cost concerns, the sample closet is frequently thought to be their only resource. Surprisingly few physicians are aware of strategies other than pharmaceutical sponsored medication samples to help patients reduce their financial burdens due to the cost of multiple medications.17,22 Alternatives can include suggesting behavior modification, prescribing generic medications, using pharmaceutical sponsored Medication Assistance Programs, and referring patients to 340B Drug Pricing Programs (federal programs that entitle health centers to purchase/distribute medications at Medicaid prices or lower). Thus, despite the concern about the problems associated with pharmaceutical marketing in general, many physicians strongly support “sampling.”

What is the harm of “sampling?” While potential harms have not yet been described fully, the availability of samples may influence medication choices when there are many medication options available to the physician. For example, while it is possible that use of samples encourages adherence to prescribed medications, it is also possible that the use of samples reduces adherence because patients who are used to receiving free samples only take these expensive medications when samples are available. Additionally, because the large number of uninsured/underinsured patients, the ongoing availability of samples cannot be assured. Thus, reliance on samples alone for uninsured/underinsured patients is an inadequate long-term strategy to provide access to pharmaceuticals. Additionally, the distribution of samples presents a great potential for medical errors due to inadequate labeling and record keeping, in addition to the previously discussed concerns about inappropriate treatment choices. Beginning in 2004, the Joint Commission on Accreditation of Healthcare Organizations requires that accredited health care organizations follow specific guidelines for managing medications that includes processes for ordering and prescribing, preparing and dispensing, administering, monitoring, selecting and procuring, and storing medications, including samples. Because the nature of relationships with pharmaceutical representatives was intentionally informal (as part of a “gift culture” described above), shifting the system of documenting the receipt/distribution of samples received from pharmaceutical representatives from an informal to a formal system has been difficult for many safety net settings.

We believe rigorously designed observational and experimental studies are warranted to determine whether the potential cost saving benefit of having samples available equals the potential harm that this practice might cause for the treatment of cardiovascular disease and its major risk factors in primary care settings. Such studies will also help to address the larger question about whether pharmaceutical marketing practices in general make it more or less difficult for physicians to address medication cost concerns of their patients, and, ultimately to improve adherence to necessary treatments for the major risk factors for cardiovascular disease and reduce health disparities.

Nancy Sohler, Ph.D., MPH, is an assistant medical professor of health policy at the Sophie Davis Medical School of the City University of New York.

Jonathan N. Tobin, Ph.D., is the President/CEO of Clinical Directors Network, a primary care practice-based research network and clinician training organization that works with medically underserved communities. He is also Professor and Director of Education and Training at the Institute for Public Health Sciences of Yeshiva University.

Andrea Cassells, MPH, is the Director of Clinical Affairs at Clinical Directors Network in New York City.

For More Information

Organizations working to change health harming practices of the pharmaceutical industry:

The Prescription Project 
Prescription Access Litigation 
Consumers Union Prescription for Change 
Marketing Overdose (Consumers International) 
Pushing Prescriptions (Center for Public Integrity) 
Center for Medical Consumers

 

References

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