Personalized medicine is broadly defined as the individual customization of health care — medical decisions, practices or treatment. For the community pharmacy industry, the impact of this trend is an over-the-horizon disruptor that will impact, among other things, the work flow in the retail pharmacy, the expectations of the pharmacists and the industry operating model. The industry is only beginning to become aware of the tectonic shift that is coming.


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Inside This Issue - Opinion

Personalized medicine and the future of pharmacy

May 19th, 2014
by Chris Paddison, Rodey Wing & Stephanie Young

Personalized medicine is broadly defined as the individual customization of health care — medical decisions, practices or treatment. For the community pharmacy industry, the impact of this trend is an over-the-horizon disruptor that will impact, among other things, the work flow in the retail pharmacy, the expectations of the pharmacists and the industry operating model. The industry is only beginning to become aware of the tectonic shift that is coming.

Historically, drug compounding was the most common example of personalized treatment in a retail pharmacy. More recently, Walgreens expanded into clinical and diagnostic testing with Theranos, a company that provides CLIA-certified laboratory services with the ability to utilize micro-samples. The advent of new companion diagnostic testing, including genetic testing, has expanded the breadth of feasible treatments and is another major step toward personalized medicine.

Genetic testing and companion testing to pharmaceutical interventions are becoming increasingly common. For example, over 50% of oncology agents under development have focused patient populations with an associated biomarker. Her2 testing was one of the first companion genetic tests offered by Genentech and Dako to ensure that the breast cancer treatment Herceptin would be effective.

The most recent test to be approved was the Cobas EGFR Mutation Test, a companion diagnostic for the lung cancer treatment Erlotinib (Tarceva). Companion testing that is co-developed during the clinical trial may also confer the advantage of increasing likelihood of Food and Drug Administration approval, making it a strategy that will more than likely be adopted with more complex biologics and molecules that will be hitting the market. Local pharmacies will have the ability to employ this information not only for counseling and therapy review but also for its required use in the customizing and compounding of personalized medications. This trend will drive a magnitude of change that is hard to contain and quantify.

In this new world of personalized medicine, the pharmacists will likely play the dual role of “detective” and “trusted counselor” to patients. Think of a world where the Drug Utilization Review (DUR) engine uses the person’s own genetic sequence to flag interactions. Where the pharmacy leaflet is customized to each individual patient and where the constant evolution of our knowledge of the human genome puts retail pharmacy in a state of constant flux. It is possible that the “trusted counselor/pharmacist” will become the nexus for genetic testing or, at a minimum, the intersection where genetic mapping meets medication therapy review.

Aside from the evolving role of the pharmacist in the brave new genomic world, the drug supply chain is likely to substantially shift. Final drug formulations won’t be done in large, central pharmacological “pill plants,” but closer to the patient in compounding centers.

The form these compounding centers take will be defined by underlying drug technology. At the extreme, sterile compounding will be centrally done under tight controls. It is also likely that final “adjustments” to oral solids will appear within the retail network in specialized compounding centers. The current move to specialty at retail is the start of this process of exploration. Regardless of the form, it is also almost certain that the retail operating model will be impacted as drug therapy formulation is moved closer and closer to the patient.

The challenges are daunting. The FDA now requires labeling for FDA-approved drugs with pharmacogenetic information in their labeling. The labeling for some (but not all) of the products includes specific actions to be taken, based on the biomarker information. Biomarkers in the table include, but are not limited to, germline or somatic gene variants, functional deficiencies, expression changes, and chromosomal ­abnormalities.

Pharmacogenetics education was not required until 2007; continuing education is only slowly catching up in this arena. Over 90% of respondents in a 2012 survey of pharmacists were interested in learning more about pharmacogenetic testing, but they have different preferences for how this education is administered. On genetic and pharmacogenetic questions, those out of school for more than five years scored significantly worse than those who were just out of school. Over 80% said they are only “fair or poor” when it comes to their current understanding of pharmacogenetic testing, and only 20% said they have a “good to excellent” understanding of ­genetics.

Today we are faced with the likelihood of the following:

• A growing demand for pharmacogenetic testing and personalized drug compounding
• An infrastructure and resource pool poorly prepared to meet the demand.
• A regulatory environment that needs to move beyond 50 versions of where you are licensed, where you are sitting and how many techs you are supervising.

Personalized Medicine In Practice

 
Rose has seasonal allergies and is visiting her drug store to pick up an over-the-counter antihistamine. She likes to pay in the back, as the line is usually shorter and the pharmacist knows her well. Rose has been coming by more frequently, as she has recently been prescribed Tamoxifen for her breast cancer.
As she chats with her pharmacist, Rose complains that some of her previous medications haven’t been effective and hopes that everything will work out well with her treatment; she worries about relapse. The pharmacist, looking at her current medication and past history, realizes there may be a reason behind her concerns. He checks her medication and medical records (synchronized with the local accountable care organization), including DNA sequence (the result of the genomic mapping service provided by the pharmacy chain) and starts to review the markers on her DNA.
 
Inhibition of CYP2D6, a protein linked to metabolic activity, from drugs including O-T-C antihistamines has been connected with a decreased efficacy in Tamoxifen treatment. Drug interactions can lead to decreased CYP2D6 activity, but some individuals also have a genetic predisposition indicated by DNA markers.
 
Her pharmacist asks her to step into the consultation room to discuss what he is seeing. He brings one of the breast cancer specialists he has available in by video conference. In the end, he saves the video conference and uploads the counseling session along with Rose’s prescription and O-T-C records to the attending physician.
 
The pharmacist recommends discontinuing the antihistamine and offers information on further genetic services available at the pharmacy. He suggests she follow up with her physician regarding additional options to ensure her Tamoxifen treatment remains effective. He would be happy to video conference with her physician when she meets with him next.
 
Rose’s data is flagged in the system to ensure that future drug interactions can be monitored and to trigger a series of proactive follow-up protocols to reach out to Rose over the coming weeks and months.

In our example (see sidebar), Rose would be able to obtain genetic testing services and counseling at her local pharmacy. She also expects that her pharmacist will use this information to ensure that she is getting the most out of her medication therapies. Everyone expects these types of patient-pharmacist interactions to occur without disrupting the convenience of “… picking up my Lisinopril at the drive-thru.” Few experts today believe all three will be possible in the ­future.

Herein lies the dramatic change that will impact the infrastructure the industry has spent the past decades ­building.

• The retail infrastructure built for pour-and-count “product-centricity” will shift to increasingly sophisticated health care “patient-centricity.”
• Information technology infrastructure built for store-level efficiency will now need to share vast amounts of information with a diverse group of health care stakeholders.
• Rewards and incentives that often recognized individual entrepreneurial skills will now need to help them collaborate and function as team members.

Though they will likely face additional regulatory demands, pharmacies that can coordinate with strategic partners to deliver these services will have a significant advantage as personalized medicine moves from rare to ubiquitous. Success operating retail pharmacies in the genetic testing environment will require significant changes and retooling of the operating model.

The successful integration of genetic testing into retail pharmacies requires new models and approaches:

• For the genetic tests, partnering with manufacturers and suppliers to deliver/administer these tests efficiently and learning to interpret and communicate results of genetic testing is likely to occur. Integrating the testing insights into the pharmacy work flow and service offering will be the next large challenge. Making the vast amounts of information available during consultation or triggering consultation based on the insights will require upgrading myriad pharmacy operating systems. With so much data at the pharmacists’ fingertips, this opens up the ability for pharmacists to be a significant touch point, along with the treating physician, for post-marketing studies.
• For services such as compounding, specialized centers will likely emerge. Compounding at retail may very well be the extension of specialty at retail. The challenge with compounding in the community pharmacy setting, like the challenge of specialty at retail, is driven by infrequency, time consumption and knowledge.

Genetic testing is the wave of the future and it will be common in the next few years and likely ubiquitous over the next decade, as costs are expected to drop below $1,000 for an individual genomic map. To stay relevant, pharmacies must stay ahead of the curve by allowing pharmacists to seek additional education opportunities, looking for strategic partnerships, and creating value for patients who are facing an increasingly complex treatment world.

Testing services and compounding are only two examples of the future of personalized medicine being realized now. Any steps pharmacies can take to make it easier for patients to understand outcomes of genetic testing and potential drug interactions will be crucial. Pharmacists should not only participate in, but drive toward the future pharmacogenetic ecosystem.

CHRIS PADDISON is a partner with A.T. Kearney specializing in the health care sector. RODEY WING is a manager with A.T. Kearney specializing in consumer health care and retail pharmacies. STEPHANIE YOUNG is a consultant with A.T. Kearney specializing in consumer health care.

 

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