For many decades pharmacists have used patient characteristics to individualize drug therapy, initially deploying simple patient characteristics such as age, body weight and/or renal function to determine appropriate dosages. This process has continued to grow in sophistication and now utilizes genetics and many other biological and pharmacological variables. In that respect, the concept of “precision medicine” is not new, yet it clearly garnered unprecedented visibility when President Obama announced the “Precision Medicine Initiative” (PMI) in January 2015. The PMI garnered rare bi-partisan support and was widely hailed as a path forward in healthcare. A major goal of the PMI is to enroll by 2020 one million or more US participants (adults initially) in a longitudinal research program designed to improve the prevention and treatment of diseases, based on assessments of lifestyle, environmental and genetic differences across the cohort. In October 2016, NIH renamed the PMI Cohort Program the “All of Us” Research Program, ostensibly to better reflect the core values of this initiative, described as “the largest health and medical research program in precision medicine.” The All of Us effort also includes a biobank to store DNA from all participants in the study, for subsequent use in assessing genetic determinants of health and treatment response.

Pharmacogenomics has been a prominent component of the PMI from the outset, in part because genetics had already been established as a major determinant of inter-patient differences in response to many medications (reviewed in Relling and Evans, Nature, 2015). Pharmacogenomics remains a burgeoning area of research that is being increasingly used clinically in many areas of therapeutics and is now an essential component of contemporary pharmacy and medical education.

Not surprisingly, I have been asked on multiple occasions whether there would be value in establishing board certification of “pharmacogenomics” as a pharmacy specialty. This question has merit, given the rapidly evolving science and the complexity of translating genomics to guide drug therapy in the clinic. In my view, there are many parallels of pharmacogenomics to other areas of focused expertise within the pharmacy profession, such as pharmacokinetics, pharmacodynamics and pharmacoeconomics. Special knowledge and skills in each of these areas are important in almost every area of pharmacy practice, and none of these currently stand alone as a clinical specialty. The prevailing view is that pharmacogenomics will continue to grow in importance across all domains of pharmacy practice, and for that reason I think it should remain a core component of knowledge in all areas of clinical practice for which BPS offers board certification. There will of course be great value if a subset of our profession develops an extraordinary level of expertise via specialized PGY2 training and via the development of research programs that focus on pharmacogenomic discovery and implementation science to expand and accelerate meaningful clinical translation.

It is clear that pharmacists will continue to play a critical role in advancing “Precision Medicine” (and “Precision Pharmacy”) by driving pharmacogenomic discoveries and leading their evidenced-based translation in all areas of clinical therapeutics. As has been its tradition, BPS will continue to monitor developments in this space as practice and therapeutics evolve, to ensure we meet contemporary needs of the profession. In my view, for the foreseeable future we should continue to integrate pharmacogenomics into all areas of clinical practice and not carve it out as a stand-alone practice specialty, because pharmacogenomics without state-of-the-art therapeutics, is merely genomics.

William Evans, Pharm.D.

 

Reference:

Relling MV and Evans ME: Pharmacogenomics in the Clinic. Nature 2015, 526:343-50. (PMID:26469045)

The views expressed here are those of Dr. Evans, and are not intended to represent those of the entire BPS Board.