/publications/issue/2005/2005-03/2005-03-9317

Genetic Lab Tests—Pharmacy Implications

Author: James C. McAllister III, MS, FASHP, Pharmacy TimesEditor, Health-Systems Pharmacy Section

A December 23, 2004, FDA press release announced the approval of a new laboratory test. It described the lab test system as one "?that will allow physicians to consider unique genetic information from patients in selecting medications and doses of medications for a wide variety of common conditions?."While the news was exciting, I was disappointed that the FDA again failed to acknowledge that pharmacists are medicationuse experts who also might benefit by using test results in collaboratively managing drug therapy.

The test is the AmpliChip Cytochrome P450 Genotyping Test (Roche Molecular Systems), which is intended to help identify patients who have genetic variations that affect metabolism of selected drugs. Undoubtedly, other similar tests are in development and will eventually be approved as well. If the test's effectiveness is substantiated, more effective and timely dosage adjustments can be made, drug interactions may be avoided, and drug effectiveness may be more accurately projected.

This precedent-setting approval begs numerous questions. Will manufacturers' representatives be calling on pharmacists to make them aware of its availability? How much will the test add to the cost of care? How will pharmaceutical companies, which manufacture drugs that could be impacted by the test, respond to the test's value, accuracy, or reliability? How will the test be managed within the hospital? To whom will results be reported?

It seems to me that this product and similar tests should be reviewed and approved by the Pharmacy and Therapeutics Committee. As with the evaluation of pharmaceuticals, evidence- based literature should be reviewed to determine appropriate patient selection and use. Moreover, a number of other questions should be asked and answered. Once test results are back, should the pharmacist be authorized to make changes in drug therapy as indicated? What information should be documented in the patient's medical record? Will patients need to be notified that genetic information will be documented in their chart? Should we create a mechanism to capture the results of this test and permanently highlight them in the chart, as we do for allergies, so that test results are immediately available during each health care encounter and the test need not be repeated?

I have presented just a few thoughts about what debates and discussions this new advancement may generate. Pharmacists clearly need to learn about the new test and to participate in discussions in our hospitals about how the technology and the results will be used. It is highly likely that precedents will be established for these new technologies, and we need to ensure that pharmacists are at the table when decisions are made.