pharmacogenomics: PROMISE, POTENTIAL, POSSIBILITIES...NOW ALL WE NEED IS THE PROOF!

Pharmacogenomics definitely has promise, potential, and possibilities—that’s why it’s been on GSC’s radar for years. But… we don’t want to prematurely jump on the pharmacogenomics bandwagon. We need to look before we leap by ensuring that its use is backed by solid scientific evidence. In fact, we’re even adding to the body of evidence with a new study of our own. And not just any study, a study that will fill a critical gap in the existing research. Here’s the scoop…

There’s the promise…And then there’s the reality – the scientific reality

There’s no doubt, drug therapy is often an important part of treating health conditions. And finding the right drug at the right dose can certainly be a challenge that takes time and risks harmful side-effects. Accordingly, the promise of pharmacogenomics as a way to potentially bypass drugs that don’t work and go right to the most effective option is definitely alluring.

Just imagine being able to discover in advance which drug a plan member will respond to... and what the right dose is… and avoid harmful side-effects… and prevent waste? In addition to having an impact on plan member health, in theory pharmacogenomics could also impact benefits plans. Definitely pharmacogenomics is something we need to keep a close eye on and approach with an open mind—but an open mind that is fueled by science.

A review of the scientific evidence around pharmacogenomics reveals a range of issues. The least of which is that there simply isn’t a lot of research to draw on. And of the research that does exist—as well as some research in progress—there could potentially be bias depending on the organizations involved. In addition, although some pilot projects are already underway, it’s not clear yet whether pharmacogenomics testing has a positive effect on patient outcomes or not. And without that, what we have been seeing in the flood of articles and presentations in our industry may be more hype, and hope, over real-world evidence. We need higher-quality research.

For example, a high-quality process-oriented study (and award-winning!) is the Canadian study—The Innovative Canadian Pharmacogenomic Screening Initiative in Community Pharmacy (ICANPIC) study.¹ It found that not only are community pharmacists receptive to adopting pharmacogenomics screening into practice, but they also have the skills to interpret pharmacogenomics results and intervene to try to improve patient outcomes.
We had a chance to touch base with the study author, and community pharmacist, John Papastergiou, who explained the findings. “After reviewing the study participants’ pharmacogenomics testing reports, the pharmacists identified clinically significant drug therapy problems and forwarded recommendations for optimizing medications to the study participants’ doctors.”

This paves the way for future research to shift gears away from a focus on process issues toward a focus on whether pharmacogenomics influence patient outcomes. As John explains, “this study shows that it is viable for pharmacists to use pharmacogenomics testing to intervene in patient care in the community pharmacy setting. So new research needs to take the discussion to the next level; it needs to focus on whether intervention based on pharmacogenomics testing makes a difference in terms of patient outcomes.”

It’s clear that there is a gap in the research. In fact, a big gaping hole regarding the inherent value of pharmacogenomics in influencing patient outcomes. Time to fill the gap!

Going for gold… The gold standard in evidence

As you know we’re always talking (OK, nagging and insisting) about the importance of basing coverage decisions on high-quality scientific evidence. But we don’t just talk-the-talk, we also walk-the-walk by not just reviewing research, but also by doing actual studies as Ned Pojskic, GSC’s pharmacy strategy leader, explains: “While monitoring the emerging evidence, we are encouraged by the pilot projects going on out there because this type of testing will contribute to the overall body of evidence. However, these pilots will not conclusively answer the fundamental question around the inherent value of pharmacogenomics testing. This is because, as helpful as pilots are, they are geared to investigating operational aspects like implementation best practices. Although those running pilots will often say that, as part of the pilot, they will investigate what happens, they are not structured to achieve this".

“By contrast, to conclusively answer the value question requires a study design that is considered the gold standard in scientific research— a randomized controlled trial. So that’s where GSC is jumping in with our new study that aims to answer the fundamental question: Does intervening with pharmacogenomics testing affect patient outcomes?”

Since John Papastergiou’s ICANPIC study demonstrated that community-based pharmacies are ideally suited to leveraging pharmacogenomics testing, the pharmacy setting is exactly where we are setting up our new study. It is being run out of two large, urban, high-volume pharmacies in downtown Toronto meaning the study results will reflect the use of pharmacogenomics in a realworld setting—pharmacies with large customer bases and broad demographics. And of course, we’re going for the gold standard…

Randomized – Blinded – Long term

Here’s how it works… First, the pharmacists enrol study participants based on a screening questionnaire that asks about their satisfaction with their current medication. John shared with us the importance of having a screening tool. “Use of a screening tool will make sure that patients actually have an issue with their medication by, for example, asking questions like: Do you feel your medication is working? Are you experiencing any side-effects? Are you looking for more from your therapy?” Based on the screening, a patient is successfully enrolled if they are currently on a psychiatric drug, are having issues with their current medication, and provide informed consent. We’re aiming for over 200 participants.

And, as John explains, the community pharmacy setting should produce a good cross-section of participants, not just retirees who have the time to get involved. “We know from my previous research that the community pharmacy actually draws a good mix of the older and younger generations. In addition, as a pharmacy owner myself, I see interaction with the pharmacist across generations first hand. The young populations are drawn into the pharmacy due to two main drivers: convenience and accessibility. With long business hours, they can have immediate access to a pharmacist and also conveniently access services like quickly getting their flu shot. The new study should be able to draw this kind of cross-section from young to old.”

John also explains how the new study’s focus on psychiatric drugs is especially important. “The evidence around early optimization of therapy, particularly for depression, shows that the earlier patients are on the right therapy for them, generally the better they do down the road. We also find that patients on psychiatric medications receive a high degree of intervention usually due to the drugs’ side-effects. So if a pharmacogenomics test can help get a patient on the right therapy quicker with less trial and error in prescribing, that is a very important tool.”

Next, our researchers randomly assign each participant to either a control group or an intervention group. It’s randomized— assignment to each group is not influenced by any factors. Technically, this is referred to as a randomized controlled trial. And it’s blinded—participants don’t know which group they are in. This all goes on behind the scenes. Then all participants—whether control group or intervention group—do a pharmacogenomics test. This ensures no potential bias is introduced by one group perceiving they received more care than other participants. The pharmacist receives the results in about a week.

The actual test is a simple process where the participant supplies a cheek swab and a lab analyzes the DNA cells collected by the swab. The DNA analysis indicates things like whether the person’s genetic makeup will or will not tolerate certain types of drugs. In addition, it indicates variables like whether the patient is a slow or fast metabolizer, which influences how quickly a drug works. This in turn will influence what should be considered the most appropriate dose and frequency of dosage.

Next, all participants meet with a pharmacist to receive what is considered the “standard of care.” This includes activities like a medication review and, as needed, working with the participant’s doctor to optimize drug therapy. However, the pharmacist only reviews the intervention group’s pharmacogenomics tests. As a result, if the pharmacist has medication modification recommendations for the participant’s doctor, they are based on the pharmacogenomics test. By contrast, although the control group receives the identical standard of care from the pharmacist as the intervention group, any medication modification recommendations are not based on the pharmacogenomics test. There is no access to the control group’s test results by the pharmacist or participant until after the study.

Finally, the participant meets with the pharmacist at one, three, and six months making it a long-term trial. And voilà, by the end of 2018 we hope to have all the data in! Then we’ll get cracking on the analysis to see if intervention by way of pharmacogenomics testing had an impact on patient outcomes. (Be sure to catch John discussing the study in this Inside Story’s companion podcast.)

Let the evidence speak for itself

As it is well established by the hierarchy of evidence that anecdotal evidence is at the bottom of that hierarchy and systematic reviews are at the very top, our study methodology—a randomized controlled study—ensures that it meets the criteria as the “best available evidence.” In addition, the long-term nature of the study will allow us to fill the gap in the research and accurately assess whether pharmacogenomics testing did—or did not—have a unique contribution in influencing patient outcomes. That unique aspect is the key to this study. A great deal of evidence has already shown that when community pharmacies deliver clinical services, patient outcomes improve. The question then is whether pharmacogenomics testing can improve patient outcomes over and above those very valuable pharmacy services.

Pharmacogenomics definitely holds promise with lots of potential and possibilities. And now it won’t be too long until we have the proof regarding the inherent value of pharmacogenomics in influencing patient outcomes. And in turn, we’ll have additional insight to help guide coverage decisions. As John sums it up, “This study’s setting with actual patients at community pharmacies should help address what is lacking in the research, which is the ability to apply results in the real world regarding whether pharmacogenomics influences patient outcomes or not.” Say goodbye to the research gap and say hello to decision-making based on the best available evidence!

Click here to download the full publication

Sources:
¹ The Innovative Canadian Pharmacogenomic Screening Initiative in Community Pharmacy (ICANPIC) study, John Papastergiou, Peter Tolios, Wilson Li, and Jane Li, Journal of the American Pharmacists Association, September – October 2017. Retrieved March 2018: http://www.japha.org/article/S1544-3191(17)30685-4/fulltext