Ethnicity, genomics and personalized medicine

BY Jim Frederick

For well over a century, the Statue of Liberty has invited the world to “Give us your tired, your poor, your huddled masses yearning to breathe free.” Now, thanks to stunning advances in the sequencing of the human genome and patient-specific genetic research, America’s healthcare system is extending another invitation to this nation’s complex polyglot population: give us the rich diversity of your DNA.

Spawned by explosive advances in scientific knowledge about the human genome and personalized medicine, a revolution in patient care and medication management is on its way. Within a few years, pharmacogenomics will transform both the practice of pharmacy and the way medicines are prepared, prescribed and dispensed to patients for many chronic diseases. And it will allow prescribers and pharmacists to adapt medicines to the vast genetic diversity of America’s rich trove of ethnic groups and individual patients, based on those patients’ own ability to process and metabolize different 
drug compounds.

Researchers have found that more than half of all patients have variations in their DNA that can profoundly affect the way they react to many commonly prescribed medications. For instance, researchers have already established that “patients with a genetic variation in the gene identified as 2C19 are some three-and-a-half times more likely to have an adverse reaction” to the blood thinner Plavix (clopidogrel bisulfate), said Tasha Michaels, a clinical pharmacist with Kerr Drug who helped coordinate a six-month pharmacogenetic pilot program by Kerr in collaboration with the University of North Carolina’s Eshelman School of Pharmacy.

That study established the feasibility of a community pharmacy-based pharmacogenetic program and its acceptance by physicians and patients. The pilot — which involved a collaboration among pharmacists, physicians, Eshelman faculty and an outside genomic testing lab — demonstrated that pharmacists can screen participating patients, apply individualized genetic information from lab DNA tests to those patients at the pharmacy counter when dispensing prescriptions, adjust medications and dosages where needed in collaboration with the physician, and prevent drug mishaps or improve long-term patient outcomes.

Kerr’s Plavix pilot also demonstrated that pharmacists can perform the patient interventions required — including taking DNA samples from patients via buccal [cheek] swabs that “didn’t take that much more time” than a follow-up visit for medication therapy management would, Michaels said. “So you can easily work it into the pharmacy workflow.”
Drug labeling for more than 100 pharmaceutical therapies, including Plavix, has already been updated to include warnings of decreased response in individuals with certain genetic profiles. And in the not-too-distant future, predicts clinical pharmacist and former American Pharmacists Association officer Brad Tice, the vast majority of prescriptions dispensed will likely include specific genetic coding for 
each recipient.

“Pharmacogenomics is going to be as big for pharmacy as immunizations have been,” Tice told DSN Collaborative Care.
For some pharmacy practitioners, the new frontier of genomic-based medication therapy is already here. The advance units of community pharmacy, led by perennial retail health innovators like Kerr Drug and CVS Caremark, have already ventured into the fast-expanding world of genomic advances and pharmacogenetics with pilot programs or joint ventures that tailor drug therapy more effectively to individual patients, avoid some adverse drug reactions and in some cases, improve outcomes.

“The ultimate goal is to create ‘designer drugs’ matched to unique genetic profiles,” noted CVS Caremark in a report. Added Troyen Brennan, EVP and chief medical officer for CVS, “there is a growing desire by clients to tailor pharmaceutical treatment based on genetic inheritance.”

It’s what author Francis Collins calls “the revolution in personalized medicine” in his book, "The Language of Life: DNA and the Revolution of 
Personalized Medicine."

The dramatic gains made by scientists in gene sequencing have brought a more personalized form of drug therapy into focus. And the rapid growth of testing labs that can identify a specific patient’s genetic markers for his or her ability to metabolize or otherwise respond to specific drug compounds has brought the ability to tailor drug therapies to individual patients within reach of many community pharmacies.

“Pharmacogenetic testing is increasingly paving the way for more personalized drug management” and “should help improve drug response rates and reduce adverse events,” noted Howard McLeod, the Fred Eshelman Distinguished Professor of Pharmacogenomics and Individualized Therapy at the University of North Carolina’s Eshelman School of Pharmacy and director of the UNC Institute for Pharmacogenomics and 
Individualized Therapy.

Essentially, pharmacogenomics and pharmacogenetics — the two terms are often used interchangeably, even though they differ slightly in meaning — is the science of applying the fast-growing body of knowledge about the human genome to “how information in our genes influences our response to drugs,”McLeod said.

“In cancer and almost every other area of medicine, there are multiple drugs that work,” he noted. “But none of them work on more than half the patients. So when prescribers are faced with choosing what medicine to give a person, they often go with the drug they know best. And because there is often no way to know with great certainty how the drug may work on that individual, it may not be the one that will benefit the patient the most.”

Some of the variations are related to ethnicity. “There’s not that much ethnic variation for a drug like Plavix,” observed Michaels. “But there’s definitely more of a variable response for other drug classes,” based on “various enzymes” common to different racial groups that affect how they react to various molecular compounds. For instance, said Michaels, Asians tend to break down alcohol in their systems differently than other groups due to differences in their DNA.

APhA defines pharmacogenomics, or PGx, as “the use of patient-specific genetic characteristics to guide medication therapy, in order to maximize safety and efficacy, and narrow the drug choices for an individual patient.”

“Although the distinctions between PGx and pharmacogenetics are minimal, PGx generally refers to the study of the interactions among multiple genes/gene products and drug response, whereas pharmacogenetics is often used to describe the effects of a single gene,” noted the 
pharmacy group.

In the Journal of the American Pharmacists Association, APhA asserted that pharmacogenomics “will further enhance the community pharmacist’s ability to individualize therapy during medication processing or extensive MTM [i.e., medication therapy management].”
To that end, APhA said, “Pharmacists must take steps to assess the entire clinical picture and use pharmacogenomics where appropriate to optimize drug therapy.”

The tools to do so are increasingly within the reach of many pharmacists — and the need for their involvement in this expanding field of medicine is clear. “We know the genomic profiles already on 50% of medications, … and all new drugs are going to have it. So I really see pharmacists as being the provider,” Tice said. “There are not enough genetic counselors in the United States, and they’re going to mainly be focused on hereditary diseases, not as much on medication applications. So there’s even more of a need for pharmacists to step up in this area.”

What’s more, the APhA reported, “Pharmacogenomic testing technology has made conducting pharmacogenomics testing in community pharmacies possible. Pharmacists must arm themselves with the knowledge and skills specific to pharmacogenomics in order to fully integrate this expanding area into patient care and turn this into a great opportunity.”

Hurdles remain, however, for any pharmacy looking to apply pharmacogenetics to its practice model. “Despite many scientific discoveries and Food and Drug Administration-mandated drug labeling changes, neither pharmacists nor other healthcare providers recognize pharmacists as the pharmacogenomics expert,” 
APhA reported.

What’s more, noted the organization in a report in late 2012, “few primary care practitioners use the pharmacogenetic information contained in package inserts to order those pharmacogenetic tests that influence prescribing, even though we know that 1-in-4 prescription drugs dispensed is metabolized by 
polymorphic pathways.”

Another big challenge is the lack, thus far, of a clear and established payment standard for pharmacists who provide genetic-driven drug therapy and counseling, Tice said. “There are a lot of issues there. But just on a basic payment model, when the clinical justification can be established that we can test enough people to determine those who metabolize [a drug differently] … at some point, it becomes valuable from a prior-authorization perspective to pay a pharmacist to do the DNA test in certain criteria and provide counseling to the patient. It may be drug dependent, but you see a lot of the major plans are paying for these tests to be done. It’s growing very quickly.”

Lynn Dressler, assistant professor in the Division of Pharmaceutical Outcomes and Policy at the University of North Carolina’s Eshelman School of Pharmacy, and associate director of policy and ethics for its Institute for Pharmacogenomics, is one pharmacy researcher focused on “how pharmacogenomics will improve patient outcomes and change the standard of care in medicine,” according to UNC.

“I do think there’s information in your DNA that could be useful to your doctors and pharmacists, and to you as an individual, but it’s not the only piece of information that is helpful,” Dressler said. “Our lifestyle and environmental exposures also are contributing factors.”

Related: Study finds improvements in cardiovascular health among South Asians who receive culturally relevant coaching


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Clinicians share research, earn more CE credits at this year’s RCEC

BY Antoinette Alexander

The 2013 Retail Clinician Education Congress is just around the corner, and this year’s confab will feature a new wrinkle that attendees should be sure not to miss: RCEC poster session.

The sixth annual RCEC conference, which is hosted by The Drug Store News Group in conjunction with the Convenient Care Association, will be held May 14 to 16 at the Planet Hollywood Resort in Las Vegas.

“Based on clinician feedback from previous years, we are so excited to introduce the poster session at this year’s Retail Clinician Education Congress. The poster session gives participating clinicians an opportunity to share their research and hard work with their peers.

They also exemplify all the amazing services being provided by caring clinicians throughout the retail clinic industry in communities across the country,” said Tine Hansen-Turton, executive director of the Convenient Care Association.

Based on feedback from previous conference attendees, an open call for proposals for RCEC was held earlier this year. Retail clinicians and organizations were encouraged to submit topics for continuing education breakout panel sessions and posters.

The poster session at this year’s RCEC not only represents an important opportunity for healthcare providers to share research, programs and results with their peers, but it also increases the number of CE credits that clinicians can earn at RCEC.

Conference attendees can earn CE credit and mingle with the authors to learn more about their presentations by attending the Poster Session/Meet The Author events. The posters will remain up on display throughout the conference.

At press time, there were 16 posters slated to be presented at this year’s conference. Topics include, but are not limited to, infectious diseases, immunizations, weight management, eczema and the differentiation of a sore throat.

“We are excited to have this [poster session] available this year, and we feel that it really gives the attendees the chance to participate and present to their peers. We are excited to grow it in future years,” said Suzanne Feeney, director of CE and clinical content for The Drug Store News Group. “And the fact that they can get CE for it is something that we are pleased about. We are pleased to be able to offer 0.1 hours of CE for each poster reviewed.”

In all, the three-day educational and networking forum offers retail clinicians 15 to 18 hours of live CE, and also serves as a platform to honor those providers and key executive leaders whose work throughout the year has distinguished them among their peers in retail health care. The annual Clinician Awards for Retail Excellence (CARE) awards honor the “Unsung Heroes” who work tirelessly each day to help further the cause of retail-based health care.

During the event, the winner of this year’s Loretta Ford CARE Lifetime Achievement Award also will be announced. Past winners of the Lifetime Achievement Award include Loretta Ford, who helped revolutionize the nursing profession more than 40 years ago with her work in cofounding the nation’s first pediatric nurse practitioner program; Mona Counts, who opened one of the first all-nurse-practitioner practices in the United States; Shirley Chater, former commissioner of the U.S. Social Security Administration; and Hal Rosenbluth, cofounder of Take Care Health Systems.

The conference is under accreditation process for between 15 and 18 hours of CE by Partners in Healthcare Education, an approved provider of Nurse Practitioner Continuing Education by the American Academy of Nurse Practitioners, provider No. 031206.


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AHRQ announces winners of Evidence-Based Care Challenge

BY Antoinette Alexander

The Agency for Healthcare Research and Quality, which is an agency within the Department of Health and Human Services, has announced the winners of its Evidence-Based Care Challenge, a pilot project developed to increase awareness and use of evidence-based healthcare tools in the retail health setting.

The EBC Challenge, launched by AHRQ through the Community Forum with American Institutes for Research and a subcontract to AcademyHealth, ran from June 18 to 
Oct. 19, 2012.

Nurse practitioners, physician assistants, researchers and other professionals worked to find creative ways to translate existing AHRQ research reports into provider-friendly resources for use in retail settings. Challenge entrants were asked to use research findings from the AHRQ Health Literacy report, plus either the Otitis Media report or the Screening for Obesity in Children and Adolescents report as a basis for their submission.

An independent panel of experts selected the winning teams on the basis of effectiveness, usefulness, scalability, creativity and 
team composition.

Coming in at first place was the QR Medica team for its beta-version Web site featuring evidence-based content on Otitis media for both healthcare providers and patients. Future versions of the website may include content on other key conditions commonly treated in the convenience care setting.

First-place team members included:

  • Team Lead: Kelly McGee of Take Care Health Services in New Albany, Ohio;

  • Melinda McGaughy of Take Care Health Services in Heath, Ohio;

  • Paul Vineyard, freelance IT;

  • Janet Schmittgen of Walgreens in Heath, Ohio;

  • Christine Lake, a nursing student at the American Institute of

  • Alternative Medicine in Columbus, Ohio;

  • Jordan A. McGaughy, a nursing student at Central Ohio Technical College in Newark, Ohio; and

  • Amanda McGaughy, a nursing student at Ohio State University in Columbus.

Coming in at second place was the PAWS team, which developed a double-sided brochure on Otitis media intended to help patients navigate treatment decisions with their provider at the point of care.

Members of PAWS team included:

  • Team lead: Janette Capaci of CVS Caremark’s Minute Clinic in Lexington, 
S.C.; and

  • CVS Caremark members in Lexington: Larry Powers, Patti Langston, Kristy Clark, Amanda Matthews, Deborah Boland, Maria Taylor, Cheryl Lee, Brandon Batchelor and Coulton Giles.

Taking third place was the Tympanic Trio for its paper brochure “flipbook” on Otitis media with images on both sides of every page. The resource is designed so that as care providers view clinical information on one side of a page, patients simultaneously see useful information in plain language on the opposite side.

Members of the Tympanic Trio included:

  • Team Lead: Nicola Archie of MinuteClinic in Tampa, Fla.; and

  • MinuteClinic members: Tara Jones and Richard Kuehne.

In addition, AHRQ expressed its interest in hearing from health professionals in the retail health setting and for professionals to continue to look for ways to engage with its Effective Health Care Program. The EHC Program funds individual researchers, research centers and academic organizations to produce effectiveness and comparative effectiveness research. Research findings are translated into useful formats for consumers, clinicians and policy-makers.


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Which area of the industry do you think Amazon's entry would shake up the most?