The Genetic Information Nondiscrimination Act of 2007 has been introduced in Congress and is purportedly intended to modify several federal laws to prohibit employers and insurers from misusing a patient's genetic information. Similar legislation has been introduced annually for more than 10 years but has never passed. Soothsayers now say, however, that this legislation has a high likelihood of passage.
The growth in this segment of science is remarkable and exciting. Genetic tests are currently available for well over 1000 diseases, including several for relatively common conditions such as heart disease and colon cancer. The implications for health care organizations and providers are many, including the cost of care, protecting patients'privacy, and ethics-related issues.
Genetic testing and personalized treatment based on results will likely increase the cost of care. Pharmacists will need to strengthen relationships with hospital laboratories (or those entities which are performing the tests) and collaborate on recording results and treatment strategies with multiple disciplines. Pharmacy departments will need to budget for these personalized therapies, using statistics for the incidence of the condition and in collaboration with prescribers. It will be interesting (and essential) to monitor reimbursement by public and private insurers for these therapies and to determine an institutional policy on treatment options that are uninsured or otherwise not covered. I also wonder whether the growing trend toward "limited distribution systems"will be used by drug companies for these personalized therapies. If not, do pharmacy departments currently have the appropriate resources, such as staff, dedicated compounding facilities, expertise, etc, to support their own personalized therapy services?
The public debate largely surrounds protecting patients'privacy from employers and insurers to avoid discriminatory practices, not only relating to themselves but also to their biological families, whose insurance availability could be challenged if genetic predisposition were known. Given that compliance with the Health Insurance Portability and Accountability Act remains a challenge, I would suggest that pharmacists, as patient advocates, become involved as organizations develop policies on medical record documentation of genetic testing results while protecting patient privacy.
Finally, I suspect that a number of ethical issues will arise related to genetic testing and treatment beyond a patient's ability to pay. For example, if a patient's genetic test indicates that he or she does not have the appropriate test response, but the desperate patient argues for treatment with the drug, will we, or can we, deny treatment based on population statistics?
It seems as if we have much to ponder as this issue continues to evolve. Are we talking to all the right people?
Mr. McAllister is director of pharmacy at University of North Carolina (UNC) Hospitals and Clinics and associate dean for clinical affairs at UNC School of Pharmacy, Chapel Hill.
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