23andMe recieves approval for Direct-To-Consumer Pharmacogenetic Reports - What Pharmacists Can Do About It

23andMe a Missing Link?

Will their new reports enable pharmacists to talk pharmacogenetics with their patients?

Whats the big news about 23andMe?

At the end of October, it was announced that 23andMe received the first direct-to-consumer report on pharmacogenetics by the FDA. This will be classified as a "direct-to-consumer pharmacogenetic reports as moderate risk that have special controls to ensure safety, effectiveness and accuracy."

"We've continued to innovate through the FDA and pioneer safe, effective pathways for consumers to directly access genetic health information," said 23andMe co-founder and CEO Anne Wojcicki. "Pharmacogenetic reports are an important category of information for consumers to get access to and I believe this authorization opens the door for consumers to work with their health providers to better manage their medications."

This is an exciting development as it allows 23andMe to report on multiple gene variants that may impact how a patient metabolizes certain medications and clinical ramifications of practice. The press report gave the example of clopidogrel, which has been an issue in certain populations (e.g., Asian descent) as they may not metabolize the drug and thus at higher risk of recurrent MI. The reports that patients will receive let them know if they are slow or fast metabolizers, and are at risk of reduced clinical efficacy with certain medications.

Interestingly, the FDA put a hold-up on 23andMe to get this approval, based on the fact they wanted the reports to be appropriately interpreted by consumers. As noted in the PR, 23andMe had to demonstrate comprehension of the information provided concerning "treatment adherence." Their testing showed that over 97% of users understood that they should not discontinue their therapy without first talking to their prescriber. Lastly, they demonstrated that at least 90% of users comprehended the key concepts of the reports.

Rather interesting isn't it? For years, the topic of pharmacogenetics has been discussed, but the reality is that most of the opportunities for pharmacy are belayed. First, if a patient was genetically tested, they likely were doing so within a closeted institution and paying a hefty payment (and hopefully covered by their insurance) and then being treated internally with none of that data being shared outside. So most community pharmacists would never even know when to bring that into a conversation, despite a big educational push in the profession to consider it. Secondly, outside of data sharing, how to address and tackle issues of pharmacogenetics in everyday pharmacy practice I have never seen. Perhaps in an institutional or ambulatory practice setting, but community? No. So that brings me to the issue that this new approval brings to community pharmacy: What do we do if patients bring in their report to you and ask questions?

Now, I have to admit, I browse reddit, and user r/jackruby83 on the r/pharmacy subreddit hit it home I think, so I will borrow a lot from him (Jack, if you are reading, feel free to comment!). Jackruby83 actually pointed out the FDA approval letter, which upon further reading identified what variants are indicated for reporting by 23andMe, including:

 Copied from FDA letter to 23andMe

Copied from FDA letter to 23andMe

Other interesting items in the letter included:

  • "This report is for over-the-counter use by adults over the age of 18 and provides genetic information to inform discussions with a healthcare professional about metabolism of therapeutics. This report describes if a person has variants associated with metabolism of some therapeutics, but does not describe if a person will or will not respond to a particular therapeutic, and does not describe the association between detected variants and any specific therapeutic. The PGS Pharmacogenetic Reports are not a substitute for visits to a healthcare professional. The information provided by this report should not be used to start, stop, or change any course of treatment."

  • A warning statement that the user should not use the test results to stop or change any medication, and that medications should always be taken as prescribed by a healthcare professional

  • A limiting statement explaining that this test is not intended to inform the user about their current state of health, including whether or not the user should or should not take a medication, or how much of a medication the user should take, as appropriate

  • A prominent and conspicuous limiting statement that the test provides only a preliminary test result that needs to be confirmed using an independent pharmacogenetic test without such a limitation prior to making any medical decisions. Alternatively, appropriate design verification and validation activities, including the generation of robust analytical data demonstrating appropriate analytical accuracy and reliability of test results for each genetic variant included in the test report, must be performed that demonstrate that the test can be used to make well-informed clinical decisions.

  • The test report must include an appropriate description of how the test results should be used by healthcare providers who may receive the test results from their patients.

How does this impact pharmacists?

Now, putting this into perspective, the bottom line is that 23andMe results should not directly lead to any patient self-discontinuation of therapy or adjustments in personal care based on the results. I think that is the bottom line that would need to be discussed with a patient. Referral of the patient to their initial prescriber for a questionable agent is tantamount, especially given that the report should indicate that this is preliminary and they may undergo further testing to confirm or use for their care by their provider. Lastly, I would ask the patient for the section of the report intended to be used to discuss with a provider, as it may give further insights for you.

One thing that r/jackruby83 pointed out as a useful reference is CPIC's Library of Genes and Drugs that has some helpful literature related to the variants identified in the 23andMe report. So, while there may be some literature you get from say a Lexicomp/Micromedex interaction checker, this may be more in-depth reading if you want to have that type of discussion with a patient and need something to pull.

Honestly, I think this will be rather interesting to see how this pans out here in the community setting as I can honestly see patients who have been on drugs for years start asking what to do about these reports? Should they stop taking medication? Should they change to something else? What if they have been feeling fine, does this change anything? I think this comes back to the issue of genetic testing I mentioned earlier, as genetic counselors are often used at institutions and their duty is to explain this material in depth and provide a better perspective (and the time) that community pharmacy may not be able to depending on the day (hey, I know its vaccination season). I think some pharmacists may find this novel and enjoy the conversation with patients, and others may defer immediately to a provider, but I think those are all valid options as we figure out what patients make of it initially themselves.

In any event, I welcome your thoughts, feel free to comment!