By John Carruthers, staff writer, January 03, 2011
The issue of whether or not to accept and dispense drug samples from pharmaceutical representatives is a hotly debated one among physicians and others in the health care industry.Proponents point to sampling programs as a way to match the best drug to a patient’s need, and as a way to ease the financial burden on poor patients. Others counter that most samples are for expensive, name-brand drugs that treat chronic disease and that the practice harms the overall patient population through increased cost and encouraging the use of these more expensive agents.
Medicine’s relationship with the pharmaceutical industry is one that’s constantly in the spotlight. Even prior to health system reform, increased scrutiny led to a series of industry-supported voluntary guidelines that attempted to address what many saw as an inappropriate influence by drug companies on the prescribing patterns of physicians. Even with the recent prohibition of most gifts from pharmaceutical representatives — a voluntary precautionary step implemented in January 2009 by the trade group Pharmaceutical Research and Manufacturers of America (PhRMA) — the use of drug samples remains a contentious issue. With the passage of health system reform, the spotlight remains on medicine and its relationship with industry.
“The current mindset of the government and medicine toward pharmaceutical companies puts them in a very awkward role. We’ve had a very dramatic decrease in the number of samples available,” dermatologist Steve Wolverton, M.D., professor of clinical dermatology at Indiana University, said. “So in this case it’s a frustrating casualty of some of the health care reform, but it was happening long before the health care bill.” [pagebreak]
Both sides of the prescription sample issue often bring up the cost to patients — either as the main benefit or the biggest detriment of sampling. Given that sample supply can be inconsistent, patients cannot depend on free samples from the physician’s office past the first time. For Medicare and Medicaid patients or uninsured and underinsured patients, this fact means that name-brand samples (the majority of them) are either a one-and-done proposition or an expense that can quickly add up.
“The reality is that most of the things that Medicare patients are eligible for are generic. Samples tend to come up most when you have a new drug that has a specific benefit,” Dr. Wolverton said. “There’s no way that Medicaid is going to pay for a trade name product. So the first issue you think of, cost savings to the people in need, isn’t always guaranteed.”
Another physician who acknowledges this sentiment is Ali Alikhan, M.D., resident physician in the Mayo Clinic department of dermatology, who co-authored “Drug samples in dermatology: Special considerations and recommendations for the future” in the June 2010 issue of the Journal of the American Academy of Dermatology. [pagebreak]
“Samples could indirectly add to the cost of medication because a lot of these products are newer products that are being promoted, and could possibly be used as a gift to family and friends,” Dr. Alikhan said. “A lot of them can be equal to the generics in treatment, and only add on to the cost for the patient. There might be an equivalent generic medication that works just as well. On the other hand, the sample may be a newer, more effective treatment or an established treatment with a better vehicle or fewer side effects.”
Yet from a co-pay standpoint, the sampling of multiple drugs may allow patients to save much-needed money for prescriptions, according to internist and physician blogger Matthew Mintz, M.D., who views drug co-pays as an investment for patients. He said that in an era of increasing co-pays which already have patients spending a lot of money for their prescriptions, the ability to find the right drug before financially committing to a certain one can be invaluable for struggling patients.
“I think it’s important to be able to offer patients samples of multiple medications, because it gives the patient a chance to try out the drugs without a long-term commitment. If you go to the pharmacy, you put down your $30 co-pay, that’s a commitment,” Dr. Mintz said. “I’d rather give a patient a week’s supply, a two-week supply, to see if it’s going to agree with their system. Otherwise, we have to start another drug, and that’s another copay. As copays get higher and higher, it’s more of an investment.” [pagebreak]
In the case of many patients, Dr. Mintz said, there’s a small window in which to find the right drug, financially commit to filling the prescription, and begin treatment.
“The parallel I give is that my wife and I have young kids, and can only go out so often. If we get to see a movie once a month, we’re lucky. So when we do go, we only go to the movies that we know are going to be good,” he said. “We can’t take a chance on an indie film that may or may not be good on the one day a month that we go out. I think patients have a big investment when it comes to prescriptions, and they don’t want to take a chance. For that scenario, samples are important.”
While he recognizes that a small number of physicians may inadvertently prescribe more expensive drugs because of drug samples, Dr. Mintz believes that the overall potential harm to the patient population is extremely small.
“The people who are anti-sample, I think, are concerned that since it increases prescribing, doctors are prescribing more expensive, not exactly necessary, products. I think that because we are so restricted by formularies, and because doctors these days are so well-aware of high co-pays, I don’t think a doctor is going to prescribe a Crestor or a Lipitor more often than not when a generic statin will do,” Dr. Mintz said. “There’s no question that it’s not probably 100 percent true, but I don’t think that the vast majority of the samples themselves are influencing prescription writing to the patient’s detriment, even though it clearly influences the overall prescribing.” [pagebreak]
Educating the patient
When a patient receives drug samples, they’re often able to skip the visit to the pharmacy entirely. While patients may appreciate the convenience, it does deprive them of the opportunity to ask questions of the pharmacist. This means that the responsibility to educate the patient falls entirely to the physician.
“Some of our research showed that the packaging of the product might be nondescript or might not be completely effective in educating patients on proper use. There’s also some issue in our research that by skipping the pharmacist visit the patient may have a lower quality drug education,” Dr. Alikhan said. “Doctors should teach their patients how to use the drug, what side effects to expect, and when to begin noticing the drug’s positive effects. When the patient isn’t going to visit the pharmacist, that burden of education is on us. We don’t want a patient going home, applying a medication, and having a side effect they’re unaware of.”
Though this may increase the amount of time physicians have to spend with each patient, the hidden benefit may come in the form of increased patient adherence, according to Dr. Alikhan. [pagebreak]
“Two of the most significant benefits of talking with the patients about how to use the sample are increasing adherence by starting the therapy in the office and also increasing adherence by giving the patient a choice in the vehicle, which is very specific to dermatology,” he said. “For example, we can give our patients the chance to see if the product is too greasy, or what the spreadability is like, or any local side effects to consider before they go and fill the full prescription. It also gives the physician the opportunity to educate the patient on proper medication use in the office. It could help preclude a patient buying an expensive medication that they find intolerable, or that they have sensitivity and allergies to, so they won’t use.”
In addition to patient education, another physician responsibility in this case is effective documentation of sample distribution. Dr. Alikhan and his colleagues found multiple cases of waste through large amounts of expired samples, and in the rare case of a recall, physicians must be able to call up information on which patients received which lot numbers.
“One maybe unexpected slight nuance or downside to samples is that you have to keep track of who has received samples in case there is a certain lot of the drug that has been recalled. So I think a small downside is a need for further record keeping,” Dr. Wolverton said. “This is something that your nurse can do in about 30 seconds, but it’s something else to add into your process. Though if the sample only covers a day or two of use, you don’t really have to keep track the medication will be gone by the time a recall notice comes through.”
Dr. Alikhan’s recommendations for sample use
In his June 2010 paper in the Journal of the American Academy of Dermatology, “Drug samples in dermatology: Special considerations and recommendations for the future,” Ali Alikhan, MD, and his co-authors recommend a series of considerations to ensure deliberate, ethical sample use.
- Samples should not be used as gifts.
- Samples should not discourage use of a less-expensive product if the less-expensive product is appropriate.
- Samples dispensed should be documented reasonably.
- Samples should not reduce office efficiency.
- Personal and family use of samples by physicians should be limited.
- Patients should be properly instructed on medication use.
- Samples in academic centers should provide a valuable learning experience for resident physicians and students.
- Meetings between physicians and pharmaceutical representatives should be educational, informative, and ethical.
- Storage and use of samples should be done in such a manner that controls theft and misuse.