Direct-to-consumer genetic testing: Top five things pharmacists should know

More and more companies are marketing direct-to-consumer (DTC) tests for a growing range of health conditions and traits directly to consumers online or in stores, including in pharmacies. But the kits are often marketed without the proper evidence to support the results, and little regulation exists.

According to the National Library of Medicine, the most popular tests use genetic variations to make predictions about health, provide information about common traits, and offer clues about a person’s ancestry. Here’s what pharmacists should know.

1. Understand that the information from the test will not provide everything needed to make sound clinical recommendations. For example, if a pharmacist is approached by a patient who has received pharmacogenetic testing results through a DTC testing company, the pharmacist should convey to the patient that they should not change how they take their medication without first speaking to their health care provider.

2. Know how to evaluate a product and a lab, especially if recommending testing for a patient. Pharmacists should confirm that the testing laboratory is Clinical Laboratory Improvement Amendments (CLIA) certified (search CMS’ “Laboratory Demographics Lookup” portal at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information).

3. Little regulation of DTC testing exists. Currently, there is only one FDA-approved DTC pharmacogenomics product—23andMe’s Personal Genome Service Pharmacogenetic Reports test—which can bypass a health care practitioner completely. However, FDA stated that the testing results information should not be used to “start, stop, or change any course of treatment.”

4. Review the level of evidence for any recommendations. Evidence-based guidelines, such as those from the Clinical Pharmacogenetics Implementation Consortium, should serve as a basis for interpretation of pharmacogenomic data. In certain cases, FDA-approved package labeling can be useful, although pharmacogenomics data is not consistently presented there. Pharmacists trained in pharmacogenomics should interpret any results in direct collaboration with the patient’s primary care provider, as well as the patient.

5. For pharmacists selling DTC products, make sure you know the resources in your community for patients to follow-up with. If a pharmacist does not have training or expertise, they should not hesitate to tell the patient these type of DTC data should be interpreted by an individual with expertise in the field.

Information provided with help from David Kisor, PharmD, director of pharmacogenomics at Manchester University College of Pharmacy in Indiana; Amina Abubaker, PharmD, AAHIVP, owner of Rx Clinic Pharmacy in Charlotte, NC; and Jessica Sinclair, PharmD, clinical pharmacist at Rx Clinic Pharmacy.

For the full article, please visit www.pharmacytoday.org for the March 2020 issue of Pharmacy Today.