ASHP InterSections ASHP InterSections

September 28, 2021

Pharmacogenomics: Trailblazers Welcome

Amanda Elchynski, Pharm.D.

AMANDA ELCHYNSKI, PHARM.D., HAD AN ‘AH-HA’ MOMENT in her third year of pharmacy school. During her studies, she worked as a community pharmacy intern, counseling patients, and performing all of the other duties of a pharmacist. Like many other pharmacists and health care providers, she also became frustrated seeing patients respond inconsistently to their medications.

A New Career Direction

“During that same year, I took a course on pharmacogenomics, and it really opened my eyes as to why the patients I was seeing were having these variable responses,” said Dr. Elchynski, who at the time, was a clinical pharmacogenetics fellow at the Center for Pharmacogenomics and Precision Medicine, Department of Pharmacotherapy and Translational Research at the University of Florida (UF) College of Pharmacy. She pointed to research showing that genes may account for up to 95% of the variability in response to medications and that a growing number of gene-drug pairs can help guide prescribing to optimize treatment efficacy and safety.

After realizing the value of pharmacogenomics in patient care, Dr. Elchynski completed a rotation in pharmacogenomics in the outpatient setting, where she reviewed results directly with patients and found that many patients were relieved to understand why their medication wasn’t working or was causing side effects.

“Finding out the results also made patients more amenable to changing medications,” noted Dr. Elchynski, who is now a Pharmacogenomics Coordinator at Arkansas Children’s Hospital. “I want to deliver this up-and-coming care approach and also help expand it from being available only to select groups and locations to being widely used as a standard of care,” she said.

While pharmacogenomics is an exciting and cutting-edge field, one of Dr. Elchynski’s preceptors said that, partly because they have limited exposure to the topic during their studies, only a small subset of students wants to enter a career in the field.

Educational Programs in Pharmacogenomics

Emily Cicali, Pharm.D

“It’s hard to think about pursuing something as a career path if you only hear about it for two or three hours in your entire pharmacy curriculum,” said Emily Cicali, Pharm.D., clinical assistant professor in the department of pharmacotherapy and translational research at UF College of Pharmacy.

She said pharmacogenomics is spread throughout the didactic pharmacy curriculum at UF because “it is a concept that transcends any specific disease state.” UF pharmacy students learn about the topic through core courses as well as elective opportunities, like a clinical application course, a summer intensive research program for students in the Pharm.D. program, a fourth-year pharmacogenomics elective advanced practice rotation, and pharmacogenomics residencies and fellowships, she said. The residency/fellowship offers pharmacists the opportunity “to live and breathe everything pharmacogenomics,” Dr. Cicali explained.

“Once residents gain baseline knowledge of the topic, they start writing consult notes, either in the form of recommendations for clinical interventions or as part of a clinical trial,” she explained. “And every resident does a deep dive into one gene-drug pair and creates a best practice alert for providers in the electronic health record, and they participate in a research project that’s pharmacogenomics related.”

Pharmacists considering a career in pharmacogenomics can look forward to employing both clinical and research skills, Dr. Cicali enthused. “It’s an evolving field, so you can combine skillsets in really interesting ways, like collecting metrics for clinical practice in order to show growth and sustainability of the program,” she said. “Every day is different, which is one of my favorite things about this work.”

Encouraging Patient-Learners

To help pique his own students’ interest in the field, ASHP Fellow George E. MacKinnon III, R.Ph., Ph.D., M.S., Founding Dean of the School of Pharmacy and professor in the genomic sciences and precision medicine center at the Medical College of Wisconsin, Milwaukee, and his colleagues have created a first-year pharmacy class on pharmacogenomics that turns students into “patient-learners.”

Julie Johnson, Pharm.D.

In addition to presenting the course material through conventional pedagogical approaches, students submit their own saliva for pharmacogenomics testing if they are willing to do so. They then discuss the results with their peers, focusing on the relevance of the results to their or their families’ medication histories, Dr. MacKinnon explained.

“Getting some perspective as to what this testing really means gets students very excited about the topic,” he said. “The reality is that 97% of us have a clinically significant gene variant that could result in sub-optimal therapy or side effects, and these could be mitigated if we guide treatment with pharmacogenomics.”

MacKinnon is confident the field will attract an increasing number of students and pharmacists, given the growing importance he expects it to play in clinical practice.

“I think it will become our bread and butter and no different than what we started doing 30 years ago in the hospital setting, when pharmacists began pharmacokinetic monitoring in our patients receiving anti-infectives, theophylline, and other agents that were managed for optimal outcomes and reduced toxicities,” said Dr. MacKinnon.

Opportunities and Professional Growth

Trained graduates with expertise in pharmacogenomics can expect a growing number of job opportunities, agreed long-time ASHP member Julie Johnson, Pharm.D., Dean and Distinguished Professor of the UF College of Pharmacy said.

“The number of health systems hiring people with this expertise in the field is rapidly expanding,” she said, noting that UF has 16 faculty members focused on the clinical and research aspects of pharmacogenomics.

“I see a lot of demand moving forward, but if pharmacists are not there to lead pharmacogenomics at an institution, [administrative] leaders will turn to nurses or physicians or genetic counselors to do so,” she noted. “For people who are creative, innovative, and entrepreneurial, I think there are a ton of ways to be a trailblazer, like implementing pharmacogenomics in the healthcare setting, being a leader in research or working in the private sector to develop tools to help advance the field.”

 

By David Wild

 

 

September 8, 2021

Pharmacists at the Helm of Pharmacogenomics Efforts

Pat Peters and his daughter, Trish Brown

AFTER SUFFERING A HEART ATTACK IN 2014, Pat Peters needed a percutaneous coronary intervention (PCI) – a procedure that many Americans undergo each year. However, unlike most other patients, Peters was lucky to have a seasoned genetic counselor and pharmacogenomics advocate by his side.

Pharmacogenomics Impact

“When my dad’s physician placed an order for clopidogrel as antiplatelet therapy, I knew from a pharmacogenomics test that he was one of the [small number] of the population that are CYP2C19 poor metabolizers, so clopidogrel would have been ineffective for him,” said Pat’s daughter, Trish Brown, who is director of AMR Payer Partnerships and Field Market Access at Illumina, a genetic sequencing company based in San Diego.

With over 20 years of experience in the genomics industry, Brown knew pharmacogenomics could immensely improve treatment decisions and improve the likelihood a drug will be safe and effective. With that in mind, she had her father’s genome preemptively tested for known gene-drug pairs. When it came time for the discussion with the cardiologist about post-PCI antiplatelet therapy, Brown informed the physician of her father’s CYP2C19 status.

“Thankfully, the cardiologist accepted the genomic results and chose an alternative agent, but unfortunately, there was no place to include the test results in the EHR other than as a PDF attached to a clinical encounter, where it would really just sit and not be seen,” Brown said, noting the hospital also did not have any staff that knew how to order or interpret genetic test results.

Pioneering Pharmacogenomics

Peters’ experience stands in contrast to the care pharmacists at St. Jude Children’s Research Hospital in Memphis, Tennessee, help provide. For the past 30 years, pharmacists have been incorporating pharmacogenomics results to help their physicians make the best treatment decisions possible.

Mary Relling, Pharm.D.

Although the hospital’s patient population is almost entirely pediatric, there was one instance where pharmacogenomics proved invaluable when a patient needed antiplatelet therapy, explained Mary Relling, Pharm.D., who holds an endowed chair in the Department of Pharmacy and Pharmaceutical Sciences at the hospital.

“This particular patient was ordered clopidogrel, and we had tested her CYP2C19 status in advance and found she lacked the gene needed to activate clopidogrel. Thus the drug would have been ineffective for preventing stroke,” said Dr. Relling, who spoke during a Pharmacogenomics Virtual Summit jointly organized by ASHP and the American Medical Association.

Avoiding potentially ineffective care in this patient “goes to show that while it’s usually a minority of the population that has a high-risk genotype, for that small percentage of patients, pharmacogenomics testing can yield a really big benefit,” she said.

Pharmacogenomics is deeply embedded at St. Jude, with Dr. Relling and her team regularly testing for genes like thiopurine methyltransferase (TPMT) and CYP2D6, which affect the metabolism of medications more commonly used there, like thiopurines for leukemia and codeine for pain.

Implementing Actionable Findings

Since 2011, pharmacists at St. Jude leading the PG4KDS program have tested for hundreds of gene variants and used those genetic data to improve medication efficacy and safety outcomes. They have so far enrolled nearly 6,000 patients and implemented 14 genes affecting 66 drugs, Dr. Relling said.

“We want to implement as many actionable findings into the electronic health record as we can, along with decision support tools, and we want to provide specific recommendations to help make better treatment decisions,” explained Dr. Relling.

One of Dr. Relling’s most significant contributions to the field of pharmacogenomics was co-founding the Clinical Pharmacogenetics Implementation Consortium (CPIC) in 2009. The 400 members of CPIC, from 269 institutions in 36 countries, generate peer-reviewed and evidence-based guidelines for providers, pharmacists, and laboratories to follow.

“We want to make these guidelines freely available to whichever institutions and laboratories want to incorporate pharmacogenomics into routine care,” Dr. Relling said. She noted that while institutions using pharmacogenomics are in the minority today, “the number is slowly growing.”

Incorporating Findings in the EHR

While Dr. Relling and her CPIC partners are developing guidelines for pharmacogenomics-based decision making, affiliates of the Implementing Genomics in Practice (IGNITE) Consortium are focusing on how best to incorporate and implement these results into the healthcare workflow.

At the University of Alabama at Birmingham School of Medicine, which is an IGNITE affiliate, Nita Limdi, Pharm.D., Ph.D., MSPH, director of the program for translational pharmacogenomics and associate director of the Hugh Kaul Precision Medicine Institute, and her colleagues are documenting what they believe will be better outcomes when genomic information is used to guide the treatment of patients like Pat Brown undergoing PCI.

To improve the chances that pharmacogenomics results are integrated into the treatment decision-making process, Dr. Limdi and a health system informatics team are developing a “genomic medicine landing page” in their EHR, where pharmacogenomic results and recommendations will be housed.

“Our position has always been that once you find something that is important to patient care, you put it in the hands of clinicians,” said Dr. Limdi, an ASHP member.

Preemptive Whole Panel Testing

Dr. Limdi hopes to further expand use of pharmacogenomics at her institution through in-house whole-panel preemptive and reactive testing. She and her team are in the process of validating the system and plan to offer it to all hospital service lines.

Nita Limdi, Pharm.D., Ph.D., MSPH

“While most testing has been done reactively— for a patient who has not responded to treatment with an antidepressant, for example — I believe it will become fairly routine to do whole-panel testing preemptively,”Dr. Limdi said.

Dr. Limdi’s conviction that pharmacogenomics holds great value is partly rooted in her experience as a pharmacist specializing in neurosciences, when she observed patients inconsistently responding to drugs like warfarin and anti-epileptics.

“Coming from that service line gave me a really deep appreciation for how much of the variability in drug response can be accounted for by genomic factors and how useful it is to have that genomic information in the patient’s record,” she said.

Pharmacogenomics Pharmacist Teams

In another effort to increase the use of pharmacogenomics at her institution, Dr. Limdi is building a team of specialized pharmacogenomics pharmacists who will lead testing efforts at her hospital. An innovative part of the model is that these pharmacogenomics pharmacists will mentor clinical pharmacists in the use of pharmacogenomics as it applies to their specialty.

“The idea is to have our pharmacogenomics service line start by doing all the initial genotype interpretation and consults, but as they hand off those results to clinical pharmacists embedded in different units, they will also shepherd them so they can be proficient in interpreting results on their own,” said Dr. Limdi.

If the model proves successful, it could be adopted at other institutions to integrate pharmacogenomics testing into routine clinical care, she suggested. As the demand for pharmacogenomics services increases, a highly specialized pharmacogenomics service team would be free to manage more complex cases, such as those with polygenic drug response signatures.

Pharmacogenomics programs like those at St. Jude’s and the University of Alabama are only two examples of the initiatives pharmacists are leading across the country. Dr.  Limdi believes this is an area of care that will grow tremendously in the coming years. “This is very much an evolving field, and I’m really excited about the possibilities it will bring,” she said.

 

By David Wild

February 28, 2012

From the President

Stan Kent, M.S., FASHP

Personalized medicine: It sounds like something you would read about in a novel or see in a movie. But recent scientific advances are leading to the identification of a growing number of genes implicated in diseases like cancer, heart disease, diabetes and obesity.

In this issue of InterSections, we explore the role of pharmacists in the emerging sciences. More and more pharmacists are becoming deeply involved in pharmacogenomics, gene therapy, biosimilar drug therapy and nanomedicine, among others. As we see in “The Next Frontier: Pharmacy and the Emerging Sciences,” this is not a field for people who thrive on instant gratification. That’s because the payoff—if there is a payoff—usually doesn’t arrive for years, maybe decades, after the work begins. But the rewards, in terms of better identification, prevention and treatment, are enormous.

Pharmacists in hospitals and health systems all over the country are re-evaluating their practice models to meet the needs of their patient populations. At Children’s Hospital Central California (CHCC) in Madera, Pharmacy Service Director Richard Sakai, Pharm.D., FASHP, FCSHP, decided to institute a decentralized pharmacy model to help increase patient safety and allow pharmacists to apply and hone their clinical skills.

Dr. Sakai, though, wanted to avoid putting his pharmacists in satellite pharmacies that can isolate practitioners. So he persuaded the nursing and medical staff to provide pharmacists with space on the units themselves. His staff members join team rounds and are supported in their clinical decision-making by a high-end robot in the central pharmacy.

Pharmacists are making an impact on patient care in a different way at University of Wisconsin Health in Madison. The pharmacy team there established an anticoagulation stewardship program (ASP) that has been responsible for impressive systemwide improvements in the numbers of patients who suffer postoperative venous thromboembolisms (VTEs).

The program is designed to ensure that at least 90 percent of inpatients receive appropriate VTE prophylaxis within 24 hours of admission, and to reduce by at least 25 percent the observed-to-expected rate of preventable postoperative VTEs. As you’ll see in the story, “UW Health Goes the Extra Mile to Prevent VTEs,” the numbers bear out the success of this exciting program.

Finally, students at the University of Utah College of Pharmacy are finding novel challenges through a clerkship program that sends them halfway across the world to learn about health care in a Third World country. The university’s Thailand clerkship, now in its 16th year, features a packed itinerary that includes seminars on leprosy, malaria, avian influenza, dengue fever and tuberculosis, among others.

According to students who have participated, the clerkship is an eye-opening experience. Justin Palfreyman, a pharmacy resident at McKay Dee Hospital in Ogden, Utah, said he was caught off guard by the magnitude of the differences between the Thai and U.S. health systems. The trip “definitely made me more appreciative of our health care system,” he said. “Even though it has many flaws, I realized that things could be much worse.”

May we all come to appreciate the many advantages of working as health care providers in the United States, while striving to improve care where we can. This issue of InterSections surely demonstrates how we can do that on many fronts. Enjoy!

Stan Kent, M.S., FASHP

Editor’s Note: ASHP President Stan Kent, M.S., FASHP, is assistant vice president, NorthShore University Health System, Evanston, Ill.

 

 

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