Friday, November 19, 2010

Are free drug samples in the best interest of our patients?(COMMENTARY).

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Walk down the back halls of virtually any private medical office in the United States today, and you will find a well-stocked cabinet of free drug samples, delivered by pharmaceutical reps with the clear goal of increasing the subsequent prescriptions for that medication. As much as $15 billion worth of drug samples are distributed each year, and most ambulatory care offices gratefully receive them and then dispense them to their patients. (1)

Is this long-standing system in the best interest of the patient? Or is it more likely in the best interest of the profits of the pharmaceutical companies and their shareholders? Given that the AAPA's Guidelines for Ethical Conduct are based, in part, on the principles of beneficence (acting in the patient's best interest), nonmaleficence (placing no unnecessary burden on the patient), and justice (the fair distribution of risks, resources, and costs), (2) what are the ethical obligations of physician assistants in the area of free drug sample distribution?

The pharmaceutical industry relies on the distribution of free drug samples to inform prescribers about new medication options and, theoretically, to help millions of uninsured patients who might not be able to afford the sampled drug. (3) Samples are also a successful marketing tool, allowing sales representatives access to the prescriber, engendering brand loyalty, and increasing prescription rates for the newest, most profitable drugs.

Increasing evidence suggests that prescribers who rely heavily on free samples are more likely to prescribe more expensive, brand-name drugs even when equally effective, lower-cost alternatives are available. Patients who receive free samples usually also receive a follow-up prescription for that brand-name drug to continue their treatment. In such cases, providing free samples actually increases the costs to the patient. (4) The sales strategy is effective, and the prescriber is now the gateway to the market.

Prescribers who rely on free samples are more likely to prescribe a heavily advertised drug even if their initial drug choice was different. They are less likely to prescribe generic alternatives, more likely to depend on sales representatives for current drug information, and more likely to deviate from evidence-based guidelines. (1) And while providers embrace samples to distribute to their indigent patients, studies have found that low-income patients are actually less likely to receive samples than highest-income patients with continuous health insurance. (5)

Other potential pitfalls of drug sample distribution include the lack of pharmacy oversight of potential drug-drug interactions, the lack of patient-friendly drug education printouts, inconsistent record-keeping, increased risk of dispensing expired meds, erratic supply of samples, and compromised abilities to notify patients of a product recall, newly discovered complications, or black box warnings. (3,6)

The medical profession's relationship with the pharmaceutical industry has long been complex and conflicted. The literature supports the contentions that interactions with pharmaceutical representatives do influence medical decision-making7 and that the practice of free drug sampling is an effective marketing tool, albeit one that increases the overall cost to the patient. (4)

If giving free drug samples to patients is counterproductive, what should providers be doing instead? A growing number of hospitals have instituted policies that prohibit the use of free drug samples and have replaced them with a voucher system allowing patients to receive a free trial of a medication dispensed by the pharmacy. In addition, many large provider offices have closed their doors to pharmaceutical reps, cutting off their supply of free samples and free lunches. (8)

Progress toward a more patient-centered, evidence-based practice may require a fundamental change in the relationship between medical providers and pharmaceutical marketing. If we prescribing providers are committed to our integrity and professionalism, we need to seriously consider the benefits and harms of using free drug samples and make the decision that best upholds our profession's principles of beneficence, nonmaleficence, and justice. JAAPA


(1.) Miller DP, Mansfield RJ, Woods JB, et al. The impact of drug samples on prescribing to the uninsured. Southern Med J. 2008;101(9):888-893.

(2.) American Academy of Physician Assistants. Guidelines for Ethical Conduct for the Physician Assistant Profession. policymanual/19-EthicalConduct.pdf. Accessed October 1, 2010.

(3.) Chimonas S, Kassirer JP. No more free drug samples? PLos Med. 2009;6(5):e1000074. doi:10.1371/ journal.pmed.100 0074.

(4.) Alexander GC, Zhang J, Basu A. Characteristics of patients receiving pharmaceutical samples and association between sample receipt and out-of-pocket prescription costs. Med Care. 2008; 46(4):394-402.

(5.) Cutrona SL, Woolhandler S, Lasser KE, et al. Characteristics of recipients of free prescription drug samples: A nationally representative analysis. Am J Public Health. 2008;98(2):284-289.

(6.) Cutrona SL, Woolhandler S, Lasser KE, et al. Free drug samples in the United States: characteristics of pediatric recipients and safety concerns. Pediatrics. 2008;122(4):736-742.

(7.) Anderson BL, Silverman GK, Loewenstein GF, et al. Factors associated with physicians' reliance on pharmaceutical sales representatives. Acad Med. 2009;84(8);994-1002.

(8.) O'Reilly KB. Doctors increasingly close doors to drug reps, while pharma cuts ranks. American Medical News Web site. March 23, 2009. Accessed October 1, 2010.

Timothy F. Quigley, MPH, PA-C, DFAAPA, is a faculty member of the MEDEX Northwest PA program at the University of Washington School of Medicine in Seattle. He has indicated no relationships to disclose relating to the content of this article.

Source Citation
Quigley, Timothy F. "Are free drug samples in the best interest of our patients?" JAAPA-Journal of the American Academy of Physicians Assistants 23.11 (2010): 15. General OneFile. Web. 19 Nov. 2010.
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