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Phasing in Pharmacogenetics: Cutting-Edge Genetic Testing

Phasing in Pharmacogenetics: Cutting-Edge Genetic Testing by Elements magazine | pbahealth.com


December 14, 2015


Is pharmacogenetic testing a service you ever thought you’d offer in your independent community pharmacy?

It’s not a goal for the future; it’s here today. Independent community pharmacies across the country are already offering this service to their patients to minimize the pain and frustration that comes with the trial-and-error process of finding the proper medication.

Pharmacogenetic testing provides insight into which medications will work best for patients based on their genetic makeup. It pinpoints what medications will and won’t work for that person, and which ones have the potential to improve that patient’s outcomes.

Independent community pharmacists have a trusting relationship with patients and are known for convenience, which makes them the ideal health care professionals to explain pharmacogenetic testing and to counsel patients about their lab results.

And because pharmacogenetic testing can improve the efficacy of a patient’s medication therapy, it can also boost adherence rates, positively influence Star Ratings and increase patient loyalty.

Health care professionals have been slow to adopt these tests because of the high costs associated with them, and these tests weren’t found in pharmacies—until now. Genetic tests are making their way into the marketplace, and now could be an optimal time to integrate them into your independent community pharmacy practice.

How independent community pharmacists handle genetic testing is still relatively new. We talked with two pharmacogenetic testing companies that offer genetic testing to patients through pharmacies—and the pharmacies using them—to get the scoop on how pharmacists can incorporate this innovative service into their practices.

Taking the first step 

RxGenomix, a pharmacogenomics research company based in Franklin, Tenn., helps health care providers understand the science of pharmacogenetics and how to incorporate it into their businesses.

“The first step in incorporating pharmacogenomics into pharmacy practice is having the knowledge and expertise to apply the science into practice,” said Angela Tice, Pharm.D., co-founder of RxGenomix.

In August 2015, the company began a pilot program in partnership with MaxusRx. The pilot program includes a 16-hour continuing education program for pharmacists to learn the basics of pharmacogenetic testing and step-by-step guidance for implementing genetic testing in their pharmacies.

Through the program, MaxusRx works with pharmacists to process test samples, to teach them to administer the tests in their practices, and to help them reach patients and physicians in their area. Then, RxGenomix pays pharmacists for consulting with patients on the results of the tests. The program is funded through a grant from the NACDS Foundation.

The program currently offers four test profiles: psychiatric medication, pain medication, cardiology, and a comprehensive test for all three categories.

Participation in the pilot program comes at no cost to the pharmacy, and patients’ insurance is billed for the test.

The no-cost investment, opportunity to improve patient outcomes, and ability to save patients and pharmacy staff time and money on ill-suited prescriptions attracted Osterhaus Pharmacy, an independent community pharmacy located in Maquoketa, Iowa, to participate in the pilot program.

“It’s truly moving us into personalized therapy,” said Matt Osterhaus, pharmacist and owner of Osterhaus Pharmacy, which offers a variety of advanced services to its patients such as a full-line of adult immunizations and medical equipment, including sleep apnea services, post-mastectomy services and prosthesis fittings. And now, genetic testing.

“If we can make a significant impact on how a patient responds to therapy by tailoring those medications that specifically work for them, or avoiding the ones that aren’t going to work for them, that’s a significant impact that we can have in enhancing patient care, and in the long-run in keeping the cost of health care down.”

“If we’re not wasting our time using medicines that don’t work, or using medicines that are going to adversely affect someone, we’ve got a lot of money to save down the line,” he said.

By participating in the pilot program, Osterhaus Pharmacy gets paid a fee for gathering the patient’s saliva sample, and another for completing the initial assessment of the results.

Each patient’s genetic test results are displayed in the program’s portal, and pharmacists interpret the results using the training they received during the continuing education program.

Osterhaus Pharmacy began exploring options for pharmacogenetics testing in December 2014. After completing the continuing education program through RxGenomix, the pharmacy has recently started offering genetic testing to patients.

“We got results back from our first three patients in the last few weeks,” Osterhaus said. And it’s already proven its value.

“The first patient we got results back for, we figured out that the antidepressant the patient was on was not likely to work well in her, so we were able to contact the physician and make a change,” he said. “Right off the bat we’re already seeing where this can really have an impact on patient care.”

Osterhaus said he looks forward to continuing to participate in the pilot program. “We think that pharmacogenomics belongs to the pharmacist,” he said. “As the information available gets more robust and there are more medications that there’s information on, we really think genetic testing is going to be an essential part of taking care of our patients in the future.”

Easy genetic testing

Harmonyx, a pharmacogenetic testing company based in Memphis, Tenn., offers a different approach to integrate pharmacogenetic testing into pharmacies.

The company provides pharmacies with genetic testing kits, which currently can test for four families of medications: antiplatelets, statins, and those used to treat ADHD and pain.

Using the testing kit is simple. The pharmacist consults the patient and supervises while the patient takes his or her own genetic sample by swabbing the inside of each cheek for 15 seconds.

The patient places the swab back in the kit and the pharmacist seals the envelope. The pharmacist enters the patient’s information into the Harmonyx portal for the lab order, including the name of the treating physician and a signed consent form. The order is then sent electronically to a licensed physician who reviews it upon arrival of the test kit. The physician then orders the test on behalf of the patient.

“Really all the pharmacist does is place the order into a queue for a network physician, and they’ll get the results back within 24 hours of when we receive the swabs,” said Robert Bean, founder and CEO of Harmonyx.

Copies of the lab results are returned to the pharmacist and to the treating physician. Patients can request their results when they purchase the test at the pharmacy and they’ll receive a copy through a patient portal, myHarmonyx.

Test results are organized into three color-coded categories that indicate how likely a patient is to metabolize a medication, in what Bean calls a “bin system” based on the patient’s genetic compatibility with the medication. The green bin means “try as directed,” yellow is “try with caution,” and red means “try an alternative.”

“We’re trying to keep our results very brief, very simple, and understandable so that people can actually apply this information to their lives,” Bean said.

The test for pain medications costs patients $99, which covers 21 medications; $89 for ADHD, which tests the efficacy of nine medications; $59 for antiplatelets, which tests the efficacy of the drug Plavix® (clopidogrel); and $49 for statins, which identifies if a patient is at risk for painful myopathy as a side effect of ZOCOR® (simvastatin).

“We think that by breaking up the genes that are relevant for that particular class of medication, it makes affordability for the patient more realistic,” said Todd Poley, marketing director for Harmonyx. “A child that’s on an ADHD medication doesn’t need to know if their antiplatelet medication is going to work or not work, so we give results based on that particular class of medication.”

And, offering Harmonyx comes at no cost to the pharmacy. Harmonyx also provides online training for pharmacists beginning genetic testing, which requires them to complete a series of training materials before they can order their first test.

Why pharmacists?

Tice of RxGenomix said that genetic testing is well-suited for independent community pharmacists.

Unlike other aspects of medication therapy management (MTM) that involve disease states, pharmacogenetics is specific to medication use, where pharmacists are the experts, Tice said. “This presents an enticing business opportunity,” she said.

“From a business perspective, providing pharmacogenomic testing for patients can be a differentiator for their practice and can help develop patients’ loyalty to their practice,” Tice said.

Bean of Harmonyx agrees that pharmacists are the health care professionals perfectly suited to provide genetic testing to ensure medications will work as intended for patients.

If a patient begins a medication that has a genetic test available and the patient doesn’t find out if his body can metabolize the drug, he could be wasting his time and money, or even damaging his health, Bean said.

“There’s no economic incentive in those tests for physicians,” Bean said. “They can’t do it in their offices, so they can’t bill insurance and make a profit on it, and no one is requiring them to do it. The only other person in the patient’s life who can stop the misuse of medicine is the pharmacist.”

Pharmacogenetics in practice

Currently, 1,750 pharmacies use Harmonyx, including Burnham Drugs in Gautier, Miss.

Burnham Drugs is the third location of a nine-pharmacy regional chain that has been in business for more than 100 years. The pharmacy offered its first Harmonyx test in 2014.

Greg Spanier, Pharm.D., owner of Burnham Drugs, said he had no idea that pharmacogenetic testing was available for use by community pharmacists until a representative from Harmonyx contacted him and he learned how it could help his patients, and thought it was worth a try.

“If your medication doesn’t metabolize well in your body, you’re just wasting time and money, and can put yourself at risk,” Spanier said. “An example would be a poor metabolizer of Plavix and increased risk for stroke, clot or another coronary event.”

Flower Mound Pharmacy in Flower Mound, Texas, has also offered Harmonyx for more than a year. The pharmacy is a full-service compounding and retail pharmacy that specializes in bioidentical hormones, food sensitivity and nutrition.

Because of the pharmacy’s focus on whole health and patient outcomes, Dennis Song, R.Ph., owner of Flower Mound Pharmacy, said integrating pharmacogenetics aligned perfectly with the services his pharmacy already provides.

“It’s more of a personal and custom medicine profile, and that’s what we do with compounding, so this is customization of the non-compounded medication,” Song said. “It’s a lot more cost-effective, and it’s time-effective.”

He said it highlights that his pharmacy can do more than dispense, and it complements his pharmacy’s other niche services, like nutrition counseling and hormone therapy.

“We always like to be cutting edge, and this has really enhanced that,” Song said.

Flower Mound Pharmacy orders about 30 genetic tests per month, which Song attributes to the partnership with Harmonyx that helps them market to physicians. He said most of their patients who order tests come to their pharmacy after a physician referral.

“We make it a routine to visit the physicians and tell them that this is a service we offer that no one else does,” Song said.

Rx Unlimited, LLC, an HIV specialty pharmacy in Beverly Hills, Calif., only orders about two tests a month through Harmonyx, but because it’s no cost and no liability, the pharmacy still sees value in offering the testing.

“We’ve seen some ADD or ADHD patients asking, ‘What’s a better form of treatment?’ and ‘What might work better?’ because their dose is no longer effective or not as effective,” said Brian Goldstein, owner of Rx Unlimited. “The test costs $89, so for a better result and a happier life, patients are willing torisk that $89.”

A move for better business

Providing in-pharmacy genetic testing may not be a high revenue service yet, but it does offer other benefits.

While Harmonyx does include a small revenue opportunity—15 percent of the price of each test the pharmacy sells—the real monetary gain from genetic testing comes indirectly, according to Bean.

As adherence becomes an important factor in how insurance companies reimburse pharmacies, Bean said genetic testing matters because patients who take medications that are pharmacogenetically matched to their bodies are more likely to refill their prescriptions.

“If you take a statin and you experience muscle pain because you have the mutation in the SLC01B1 gene, you’re likely not going to keep taking that statin after your body aches. You’re just going to quit,” Bean said. “So, the adherence to statins is directly linked to the ability to metabolize the drug.”

Bean said independent community pharmacies are especially well suited to take advantage of genetic testing and to recommend it because of their strong relationships with patients.

“If it were just about getting a bottle of pills filled, it could be done anywhere,” he said. “Independent pharmacists have the all-important relationships with those patients.”

Spanier of Burnham Drugs said he believes the tests do increase patient adherence, especially the statin and antiplatelet tests.

“Since you can’t feel your blood thicken or your cholesterol go down, if you have the test and you are shown proof that, genetically, your body is metabolizing the medication well, you would be more apt to take the medication as prescribed,” Spanier said.

The adherence benefits of genetic testing stretch to ADHD medication, too. Song of Flower Mound Pharmacy said parents are often apprehensive about their child beginning a medication treatment program in this class and a test could help ease their minds.

“Now, they can be assured that their child is on the right medication—and that it’s going to work,” Song said. “With that drug class alone, it increases adherence.”

Providing pharmacogenetic testing for patients can be a differentiator for your practice, and it can help develop loyal patient relationships, said Tice of RxGenomix.

Patients will easily see that no other health care professional is talking to them about how their DNA could affect their medication—the area where pharmacists are the experts.

“This is an emerging market. If pharmacists seize the opportunity to establish this capability within their practices, they could significantly increase their role in the health care process,” Tice said.

Communicating with patients

Spanier said that his patients are generally welcoming to the idea of pharmacogenetic testing after a simple explanation.

“This is a godsend,” he said. “You just don’t realize how many times families have to try out a medication that is expensive—even with insurance—just to have to try a new one two weeks later.”

Song said his patients were also surprisingly receptive to genetic tests, and are happy with the price point of the tests, too.

“I was thinking they would be a little apprehensive about having their genes tested and their DNA shared, but no, no,” Song said. “There is full trust, and the test is confidential and secure.”

The future of pharmacogenetics

Bean said he believes that it’s just a matter of time before pharmacogenetics goes mainstream, and that independent community pharmacies are the early adopters who can make genetic testing a part of regular treatment.

“Just like independent pharmacies were pioneers with vaccinations in the pharmacy setting, they are paving the way for pharmacogenetics and personalizing prescription therapy,” Bean said.

Bean said Harmonyx is planning to bring more tests to the market over the next few months, including a folic acid test and an antidepression test.

And to the degree that science supports it, Bean said Harmonyx will continue to expand the variety of tests it offers.

“It’s going to be counter-cultural for a long time, but it’s about patient rights. It’s about patients not being subjected to trial-and-error prescriptions,” he said.

Interested in incorporating pharmacogenetics into your independent community pharmacy? Learn more about Harmonyx at harmonyxdiagnostics.com and about RxGenomix at rxgenomix.com


Pharmacogenetics vs. pharmacogenomics

What’s in a word? While “pharmacogenetics” and “pharmacogenomics” are often used interchangeably, the two terms do have subtle differences.

Pharmacogenetics is considered the branch of pharmacology concerned with the effect genetic factors have on a patient’s reaction to drugs, while pharmacogenomics is regarded as the science of ways to compensate for those genetic differences.

However, both are still loosely defined and one is often substituted for the other.

Sources: “Pharmacogenetics and Pharmacogenomics,” British Journal of Clinical Pharmacology; Merriam-Webster.

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