January 15, 2019
Genetic testing assessing personal family ancestry has been on the rise in recent years. Companies including ancestry.com, 23andMe and others have assisted consumers in tracking down family member ancestors, but their data has also been used in solving crimes based upon DNA evidence.1 These companies have decided to add to their suite of services pharmacogenomics testing of drug therapy.
Recently, the FDA has cleared the first DNA test by the 23andme Personal Genome Service (PGS). The pharmacogenetic report will provide information on a number of variants including CYP2C19, CYP2C9, CYP3A5, CYP2D6 and others.2 The report describes variants associated with the metabolism of therapeutics. However, it does not describe if a person will or will not respond to a therapeutic agent or does it describe the association between the detected variant and any specific therapeutic agent.2
I am in favor of providing new tools to assess potential drug interactions but the label for this service states the following information “only be used to guide discussions with their health care provider”. The PGS report is not a substitute for visits to a healthcare professional.2 Honestly, I do not see providers including physicians, nurses or physician assistants to be of much assistance in providing this service. Although I respect all my colleagues, I do not see any of these health care providers to provide expertise on this subject. I believe a pharmacist is the ideal health care provider to assist patients in understanding this information and how it may relate to their drug therapy. Should pharmacists take advantage to offer this service? However, billing for these services may be a bit more complicated.
Since the future is now that companies are providing this service, pharmacists should begin collaborating with these companies to provide this service to their customers. In addition, a mechanism should be in place for financial billing for these services. Until pharmacists begin taking advantage of opportunities to demonstrate their value for their unique knowledge of this topic, these services will be offered by our health care colleagues.
NBC News. This is just the beginning: Using DNA and genealogy to crack years-old cases. Available at https://www.nbcnews.com/news/us-news/just-beginning-using-dna-genealogy-crack-years-old-cold-cases-n892126. Accessed October 29, 2018.
FDA US. Food and Drug Administration. 23andme Personal Genome Service (PGS) Pharmacogenetics Reports. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180028.pdf. Accessed November 1, 2018.
Michael J. Cawley, PharmD, RRT, CPFT, FCCM, is a professor of clinical pharmacy at the Philadelphia College of Pharmacy, University of the Sciences. He has more than 25 years of experience practicing in the areas of medical, surgical, trauma, and burn intensive care as both a critical care clinical pharmacist and registered respiratory therapist.
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