Table 2.
Challenges and potential solutions for implementation of pharmacogenetic testing
Challenge | Potential solution |
---|---|
Lack of pharmacogenetic education for physicians | Mandatory pharmacogenetic courses in medical school and periodically during professional careers |
Concerns for reduced drug efficacy in variant carriers treated at lower doses | Conduct of prospective pharmacogenetic studies to demonstrate noninferior drug efficacy in variant carriers receiving reduced doses vs fully dosed wildtype patients |
Lack of adoption of pharmacogenetic guidelines by regulatory agencies for approved drugs | Proactive pharmacogenetic guidance from regulatory agencies during the drug approval process could decrease the number of drugs that require label updates after approval. Adoption of pharmacogenetics testing could also be enhanced by prospectively demonstrating improvement in quality of life and integration of pharmacogenetics into routine germline or somatic testing |
Lack of standardization of guidelines, genotyping panels, genotype-phenotype translation | Collaboration between pharmacogenetic consortia to achieve harmonization of guidelines |
Need for resources and an efficient institutional infrastructure | Assembly of a multidisciplinary team of pharmacogenetic advocates (including a physician champion) and seek for initial funding from local or institutional sources. Initial testing could be launched on a small scale (e.g., reactive testing for a limited number of gene-drug pairs) |
Limited insurance coverage | Recognition by insurance companies of clinically actionable gene-drug interactions as defined by regulatory agencies or consortia (e.g., CPIC level A and B) |