September 01, 2011

Samples Provide Greater Choice and a Faster Start of Treatment - At No Cost

Samples have been a staple of all industries, and the pharmaceutical industry is no exception. Each year millions of patients benefit from receiving a sample of a medication to test efficacy and tolerability of new medications. So why is there a concerted effort to ban samples?

In late July, Aurora Health Care clinics, Wisconsin's largest hospital system, composed of 900 affiliated doctors, decided to no longer dispense free brand-name medication samples. Jeff Bailet, a senior vice president with Aurora Health Care, said the decision to stop dispensing free samples was primarily prompted by safety concerns. Concerns about whether the practice was driving up health costs played a lesser role, he said.

The decision, which took effect Aug. 1, affects Aurora Medical Group doctors at about 160 clinics, which log more than 3 million patient visits a year. Aurora joins the University of Wisconsin Hospital and Clinics and Froedtert Hospital, which already have policies severely limiting the use of free samples. UW first implemented restrictions on samples in 2000 and extended it to all of its clinics in 2009.

According to an article from the Journal Sentinel, “the practice of providing free samples has come under fire in recent years because it is believed to add cost to the health care system by encouraging the use of expensive brand-name drugs instead of cheaper and often more proven generics.” The article also claimed that there have “been concerns about safety because the practice requires doctors to act as pharmacists.” Of course the Sentinel did not include any of the positive benefits that come from using free samples or include any proponents of free samples in their “balanced” article.

Lee Vermeulen, director of the Center for Clinical Knowledge Management with the UW Health System, claimed that samples are merely a “marketing tool,” and that samples were “systematically driving care toward more expensive new medicine.”

Some argue that eliminating free samples harms poor people and those without prescription drug coverage. However, Vermeulen said “it makes no sense to start people on an expensive drug they won't be able to afford. He noted that financial assistance programs exist for those who can't afford their medication.”

Lee Shapley, a fourth-year medical student at Oregon Health and Science University and director of the American Medical Student Association’s (AMSA) PharmFree Scorecard claimed that “often, the samples go to people with higher incomes who can afford to stay on the drug once the sample runs out” and not the most needy.

Unfortunately, critics like Shapely and Vermeulen, who argue that free samples inflate the cost of medical care, ignore the plain and simple numbers. Prescription drugs only account for 10 cents out of every dollar spent on health care. In fact, if free samples are removed, costs may increase because patients may be more likely to run out of medications or have adverse consequences to medications they were unable to try because samples were unavailable.

Bailet recognized that Aurora’s new policy has met some resistance among doctors because this “is something they have been doing in their practice for years.” He noted that “a few exceptions will be allowed, such as in cases of a patient who has to learn how to inject a drug or use an inhaler or eye dropper.”

About 175 doctors in community-based clinics affiliated with Froedtert Hospital stopped dispensing free samples in 2006, said Mark Lodes, chief medical officer of the Froedtert & Medical College Clinical Practice Group. "We felt the pressure of pharmaceutical reps in our clinics was driving prescribing practices of physicians," he said. Two years after the ban was implemented, use of generics jumped 15%, Lodes said.

Several years ago, a policy restricting free samples also was implemented at the main Froedtert campus in Wauwatosa, said Todd Karpinski, director of pharmacy at Froedtert. Samples are allowed only as a temporary bridge for self-pay patients trying to get financial assistance or as a trial to see whether the drug works, he said.

Karpinski said the goal is to keep patients off more expensive drugs because once they have been on them for a prolonged period, it is hard to switch them to a cheaper drug.

Discussion

In response to this article, Joseph Hammang, senior director of science policy at Pfizer Inc. and a neuroscientist, asserted that insurers and lawmakers in Wisconsin who are banning samples are whittling “away at the tremendous value brought by the pharmaceutical industry.”

Hammang, who is a Wisconsin native and a graduate of the University of Wisconsin-Madison, noted that the original Sentinel article praised the Aurora decision to ban samples, “claiming that free samples ultimately drive up health care costs and citing a 2008 study that drew this conclusion without considering other factors that influence cost.”

Consequently, Hammang recognize that “drug starters, or samples, provide greater choice and a faster start of treatment - at no cost. When treating a patient, the physician looks at all the available options to determine the right therapy. What's important is that the patient receives the treatment agreed upon with the physician. Drug starters provide a no-cost way to help make that determination.” By removing free starters, Hammang asserted that, “doctors and patients lose yet another avenue for deciding the best treatment.”

Sadly, Hammang noted that, “this whittling away is happening in other arenas, too. Some clinics have banned visits by pharmaceutical representatives, isolating physicians from vital information on the latest treatments. Some academic medical institutions have adopted policies that discourage collaboration with industry, compromising innovation that can lead to new medicines and new uses of existing medicines. Through formularies and financial inducements, some insurers pressure doctors to limit drug treatments to a narrow selection of drugs, usually generics, rather than the full range of options for patients.”

Hammang also pointed out how, “rarely is it noted that prescription medicines make up only about 10 cents of every dollar spent on health care. Or that numerous studies, including a recent one published in the Journal of the American Medical Association, show drug therapy actually lowers the overall cost of health care. Or that pharmaceutical companies spend 17% of their income on research, more than any other industry. Or that drug innovation has greatly increased life expectancy for patients suffering from a huge array of diseases, from heart disease to cancer to HIV to diabetes to childhood diseases and many more.”

Accordingly, what Hammang finds “most disturbing is that society is so quick to sacrifice quality care on the altar of cost - even, ironically, when the cost is zero, as with drug starters. It's easy, if misguided, to demonize an industry and those who see its value. Far better for society to let a single principle guide our discussion on health care: What's best for the patient.”

Conclusion

Some concerns about the use of samples rest on the fact that doctors often do not keep a good tally of when samples expire and could inadvertently hand out old medicines. Another risk of free samples is that bypassing pharmacists is risky because a pharmacist may view a database on a patient's other prescriptions and notice potentially dangerous interactions.” Despite these worries, few specific examples of patient harm resulting from such adverse interactions have been reported.

While critics will continue to claim that such “samples induce prescriptions for more costly brand-name medicines when cheaper generics might be available,” this claim clearly ignores the obvious benefit a free prescription has for a patient: it allows the individual, through the advice of their physician, to try something before making a decision. This gives the patient a number of options: stay with the free sample, move to the generic, get the brand name, or try something else completely. What is unsafe about a doctor giving his or her patient a free choice?

If a patient is concerned about a free sample, they can simply ask: “Am I being prescribed this medication because the drug rep just came by and dropped all these drug samples, or is it really the best medicine for me?"

Samples enable patients and physicians to try a medicine and evaluate tolerance, assess effectiveness, and adjust dosage before committing to a full prescription regimen, while saving money. In addition, samples help some patients get on a drug quickly without having to wait for a prescription to be filled, and save patients money. For example, Pfizer said in the last five years it has helped six million patients receive more than 48 million Pfizer prescriptions, the equivalent of $5.7 billion worth of free medicines and savings.

Ultimately, institutions and academic medical centers need to reevaluate their policies on samples because a complete ban will have harmful effects for patients.