Hospital pharmacists driving pharmacogenetics forward

Personalized Medicine

For many years, the field of pharmacogenetics has been confined to the research realm, where genetic tests to identify targeted therapies tailored to individual patients were more a futuristic concept than daily practice. However, technology has made great leaps and personalized medicine based on genetic tests is quickly being adopted by hospitals and community pharmacies. In fact, 138 drugs currently have genetic data in their FDA-approved product labeling.

Genetics affect efficacy

With the increase in spending and use of medications coupled with the rapid decline in genetic testing costs, hospital pharmacists have an opportunity to take the lead in developing and directing pharmacogenetics programs.

According to Phil Empey, PharmD, PhD, Associate Professor at the University of Pittsburgh School of Pharmacy, medications don’t always work. Empey explained that cancer drugs are ineffective for 75% of patients, Alzheimer drugs are ineffective for 70% of patients, and osteoporosis medications are ineffective for 52% of patients, just to name a few.

This is why we need to get better at prescribing therapies, Empey noted during a session about pharmacogenetics at the 2014 American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting.

Decision-making process

One of the key factors in using genetic tests to tailor therapies is making sense of the data available. The Clinical Pharmacogenetics Implementation Consortium (CPIC) was formed in 2009 to address some of the barriers to implementation of pharmacogenetic tests into clinical practice. Currently, CPIC has information about “1,500 associations between genetics and drug effects, and currently 29 [of those associations are] at level 1A, which means either there is prospective randomized data or a large institution where it is deployed in clinical practice,” Empey explained.

“CPIC has also published 18 guidelines in a structured format to allow us to take this scientific information and translate it into clinical guidelines at our own institutions.”

At the University of Pittsburgh School of Pharmacy, Empey tells his students to carefully think through decisions about how to use genetic information to make a test recommendation or a medication decision. According to Empey, the following factors must be considered:

  • Functional consequence. Understand whether the variance in a genetic sequence translates to a change in activity of a protein.
  • How common the variant frequency is in the population? Is it something that is found in 1 in 10,000 people or 1 in 10 people?
  • Drug dependence on the pathway
  • Active moiety and therapeutic index
  • Concomitant drug therapy and clinical factors
  • Are there clinical outcome data? What do established guidelines recommend?
  • Is there a genetic test?

Barriers to routine implementation

With more than 100 drugs with pharmacogenetic information listed on FDA-approved product labeling, why aren’t genetic tests the standard of care? Empey listed several barriers including little cost effectiveness data, few drug or dose selection algorithms, and slow turnaround times for test results.

“Patients have concerns about what should be tested, where the information is stored, and whether the results will be given back to them,” said Empey. There are also legal, ethical, and privacy issues, and a knowledge gap for health professionals.

Even though pharmacogenetics has been in the pharmacy curriculum for a while, it has only been taught for the last 5 to 10 years or so, noted Empey. “We have a large practice pool that has had no training in this area whatsoever, and they are being approached by patients with questions,” he said. “We need to find a way to educate the entire provider system” including in the pharmacy, the physician, and other clinic realms.

Last year, the University of Pittsburgh School of Pharmacy integrated optional personal genomic testing into a core course of the PharmD curriculum to enhance pharmacogenetics education, according to Empey. Student pharmacists were offered genetic testing, and about 90% of them elected to participate in the exercise, he noted. Students worked with real individual- and population-level data, which allowed for increased pharmacogenetics content hours, ethics training, and expertise from content specialists, Empey added. Barriers remain, he said, but personalized medicine is here and it is being led by pharmacogenetics, which creates an unprecedented opportunity for pharmacists to lead the implementation process to improve patient care.

Clinical decision support

An electronic health record (EHR) with clinical decision support is essential for the implementation of pharmacogenetics, according to James M. Hoffman, PharmD, MS, Medication Outcomes and Safety Officer, Associate Member of Pharmaceutical Sciences at St. Jude Children’s Research Hospital. “Many people think of clinical decision support as passive, where information is put in the EHR and clinicians can look it up,” said Hoffman.

But when it comes to pharmacogenetics, the results from a genetic test might be put in the EHR months or years before a relevant drug is used, explained Hoffman. It is important to have the capability to deliver that information to the right people at the right time. Without clinical decision support, that valuable information may never be used, Hoffman noted.

Useful pharmacogenetic clinical decision support needs to be timely, where an interruptive message is sent at the right time before a clinician prescribes a particular medication, Hoffman added. The message must also be targeted in that it reaches the right people who can take action. Hoffman explained how St. Jude integrated pharmacogenetics into the EHR with clinical decision support.

“Our program is preemptive,” he explained. “We approach patients early on in their time at St. Jude to be enrolled in this protocol.”

Currently, more than 2,000 patients are enrolled in St. Jude’s pharmacogenetic protocol. “The idea is that we [test] a panel of more than 200 genes and keep [the results] in a research database,” said Hoffman. “We systematically migrate over genes and drugs as the evidence matures … and that information is used [to direct] patient care routinely.”

Getting started

Julie A. Johnson, PharmD, BCPS, is Dean and Distinguished Professor, and Director of the Personalized Medicine Program, at the University of Florida. Johnson and her team launched the university’s personalized medicine program in June 2012. She shared several insights and words of wisdom with ASHP attendees about how to develop a personalized medicine program.

“First, don’t reinvent the wheel,” said Johnson. “There are increasing numbers of us who have done it.” Many examples for how to establish a program are out there, Johnson noted. She recommended using the CPIC as a resource and following the CPIC guidelines.

She also advised health systems to take it slow. “You’re not going to do everything at once,” said Johnson. “You’re going to do it in baby steps, and my recommendation is to focus on an area where there is local interest or demand for that test.”

Johnson also noted that many health systems don’t have a pharmacogenetics expert on staff. There needs to be a plan for finding the necessary expertise, she explained. She suggested having staff complete a short course or mini-sabbatical at an institution that has already implemented a pharmacogenetics program or hiring a resident trained in pharmacogenetics.

Pharmacy leadership

Johnson pointed out that pharmacists can be involved in many areas in the implementation process, not just in terms of patient care, but also in the clinical implementation.

“Pharmacogenetics testing is increasingly common in the clinical setting,” said Johnson. “Pharmacists have to be prepared for that.” Johnson explained that pharmacists are well positioned to be health care team leaders in pharmacogenetics.

“We can take this opportunity, learn, and be at the front. Otherwise, [others] will push us aside. The charge for pharmacy is to embrace this and take the opportunity to take leadership role.”

For more information about the CPIC and the organization’s guidelines, visit www.pharmgkb.org/page/cpic/.