Diagnostic-Linked Pharmacotherapies: Embracing Future Opportunities

The pharmacist’s role in health care is advancing at a rapid pace as they become an even more crucial member of the health care team and an integral part of patients’ well-being and safety. New laws at the state level enable pharmacists to prescribe and monitor drug therapies in ways historically reserved for physicians; as such, we are at a juncture where we can better express the full scope the PharmD and clinical knowledge obtained with it. However, we must ensure to an even greater extent that what we do is scientifically sound and based on our full understanding of health and disease.

As newer technologies continue to emerge, so does the need for medicine to become more individualized and tailored to the patient. Due to extensive drug knowledge, pharmacists can practice in this specific niche, but only where the scientific literature clearly supports such activities. Many pharmacists either attended schools before the “age of genomics” or had less than adequate education in the area. Thus, it is imperative that we educate ourselves, not only to keep up, but also to help lead health care forward.

Multiple states, including California and Colorado, now allow pharmacists to prescribe birth control and tobacco cessation products, demonstrating that our knowledge and roles are being advocated for, recognized, and increasing. Instead of making appointments with primary care providers, our patients can simply visit us to determine their eligibility for such prescriptions. These medications, however, do not require diagnostics. Precision medicine fits this unique patient paradigm and allows pharmacists to become cautiously optimistic about integrating such practice—if they understand the reality behind the link.

To date, very few red or green lights exist in personalized health care, and bits and pieces must be integrated slowly and carefully to transition toward a more personalized health care paradigm. In 2017, for example, the FDA approved 2 new drugs that were based on specific genetic features in patients: Vertex Pharmaceuticals’ ivacaftor (Kalydeco) received expanded approval for 23 additional rare mutations and is now indicated for up to 33 mutations,¹ and Merck’s pembrolizumab (Keytruda) was approved for patients whose cancers have specific genetic features.² While these may appear to be examples of treatments for clear genetic mutations, the science behind each is a bit murkier, and many current payment schemes could help or hinder the field.

Pharmacists’ expansion into precision medication enables us to practice to the full scope of our license and degree and play a more active role in improving the lives of our patients. However, increasing burdens on an already full workload may make many of us feel that we are not adequately prepared for the task and may not contribute as effectively as we would like. Increased pressures around communication may become a hindrance as our systems are not intimately linked with the prescribers on our health care team. Reimbursement might be another challenge we must overcome to be appropriately compensated for our time and services rendered.

These are just a few issues that we will need to work through and evaluate regarding opportunity costs. Will the pros outweigh the cons for each? These decisions will be made at all levels—local, state, and national—but ultimately will affect the entire pharmacy profession.

The most important question at this point: are we ready?

Haroon Mesdaq is a 2018 PharmD candidate at the Campbell University College of Pharmacy & Health Sciences in Buies Creek, North Carolina, where he is also pursuing a master’s in clinical research through the school’s dual degree program.

Gary Keil, PhD, RPh, is a facilitator and national co-director of programs for the Pharmacy Leadership and Education Institute, a member of the Gratitude Parade board of directors, and an ambassador for the Scare Your Soul Challenge. A registered pharmacist for 27 years, he earned his RPh at the University of Wyoming and a PhD in neuropharmacology at Oregon State University.

References

• FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis [press release]. Silver Spring, MD: US Food and Drug Administration; May 17, 2017. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm559212.htm. Accessed January 29, 2018.
• FDA approves first cancer treatment for any solid tumor with a specific genetic feature [press release]. Silver Spring, MD: US Food and Drug Administration; May 23, 2017. www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm. Accessed January 29, 2018.