Genetic Lab Tests—Pharmacy Implications

A December 23, 2004, FDA pressrelease announced the approvalof a new laboratory test. Itdescribed the lab test system as one"?that will allow physicians to considerunique genetic information frompatients in selecting medications anddoses of medications for a wide varietyof common conditions?."While thenews was exciting, I was disappointedthat the FDA again failed to acknowledgethat pharmacists are medicationuseexperts who also might benefit byusing test results in collaborativelymanaging drug therapy.

The test is the AmpliChip CytochromeP450 Genotyping Test (Roche MolecularSystems), which is intended to help identifypatients who have genetic variationsthat affect metabolism of selected drugs.Undoubtedly, other similar tests are indevelopment and will eventually beapproved as well. If the test's effectivenessis substantiated, more effective andtimely dosage adjustments can be made,drug interactions may be avoided, anddrug effectiveness may be more accuratelyprojected.

This precedent-setting approval begsnumerous questions. Will manufacturers'representatives be calling on pharmaciststo make them aware of itsavailability? How much will the testadd to the cost of care? How will pharmaceuticalcompanies, which manufacturedrugs that could be impactedby the test, respond to the test's value,accuracy, or reliability? How will thetest be managed within the hospital?To whom will results be reported?

It seems to me that this product andsimilar tests should be reviewed andapproved by the Pharmacy andTherapeutics Committee. As with theevaluation of pharmaceuticals, evidence-based literature should bereviewed to determine appropriatepatient selection and use. Moreover, anumber of other questions should beasked and answered. Once test resultsare back, should the pharmacist beauthorized to make changes in drugtherapy as indicated? What informationshould be documented in thepatient's medical record? Will patientsneed to be notified that genetic informationwill be documented in theirchart? Should we create a mechanismto capture the results of this test andpermanently highlight them in thechart, as we do for allergies, so that testresults are immediately available duringeach health care encounter and thetest need not be repeated?

I have presented just a few thoughtsabout what debates and discussionsthis new advancement may generate.Pharmacists clearly need to learn aboutthe new test and to participate in discussionsin our hospitals about howthe technology and the results will beused. It is highly likely that precedentswill be established for these new technologies,and we need to ensure thatpharmacists are at the table when decisionsare made.