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PHARMACOGENETICS

Discordance Between Availability of Pharmacogenetics Studies and Pharmacogenetics-Based Prescribing Information for the Top 200 Drugs

Assistant Professor, College of Pharmacy, Department of Pharmacy Practice and Center for Pharmacogenomics, University of Florida, Gainesville, FL

Glenn D Pebanco, BS

PharmD Student, College of Pharmacy, University of Florida

Christina L Aquilante, PharmD

Assistant Professor, School of Pharmacy, Department of Clinical Pharmacy, University of Colorado at Denver and Health Sciences Center, Denver, CO

Tobias Gerhard, BS

Graduate Student, College of Pharmacy, Department of Pharmacy Health Care Administration, University of Florida

Amber L Beitelshees, PharmD MPH

Post-Doctoral Associate, College of Pharmacy, Department of Pharmacy Practice and Center for Pharmacogenomics, University of Florida

Bach Nhi Beasley, PharmD

Senior Clinical Pharmacology and Biopharmaceutics Reviewer, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD

Abraham G Hartzema, PharmD MSPH PhD FISPE

Professor, Perry A Foote Eminent Scholar, Chair in Health Outcomes and Pharmacoeconomics, College of Pharmacy, Department of Pharmacy Health Care Administration, University of Florida

Reprints: Dr. Zineh, College of Pharmacy, Department of Pharmacy Practice and Center for Pharmacogenomics, University of Florida, PO Box 100486, Gainesville, FL 32610-0486, fax 352/273-6121, zineh{at}cop.ufl.edu

BACKGROUND: Despite growing numbers of pharmacogenetics studies, little pharmacogenetics-based prescribing information is available to practitioners. It is possible that the lack of prescribing data for commonly used drugs is due to a paucity of evidencebased pharmacogenetics literature for these agents.

OBJECTIVE: To investigate the relationship between pharmacogenetics prescribing data in drug package inserts (PIs) and pharmacogenetics research literature for agents represented in the top 200 prescribed drugs for 2003.

METHODS: A PubMed search (to August 7, 2004) was performed to identify pharmacogenetics studies relevant to the top 200 drugs. These data were compared with PIs for drugs in the top 200 list that contained pharmacogenetics prescribing information.

RESULTS: Pharmacogenetics data in the literature were available for 71.3% of the top 200 drugs. The gene involved coded for a drug-metabolizing enzyme in 34.5% of the literature sampled. The remaining 65.5% of the pharmacogenetics studies contained information largely related to genetic variability in target proteins and drug transporters. Three drugs with PIs containing pharmacogenetics prescribing information deemed to be useful to guide therapy were in the top 200 list (celecoxib, fluoxetine, pantoprazole). There was no consensus on the strength of association between genetic variability and drug response for these agents.

CONCLUSIONS: The lack of specific pharmacogenetics-based prescribing information in PIs for commonly used drugs does not seem to be related to a paucity of pharmacogenetics data in the research literature. Rather, other factors including, but not limited to, the uncertain clinical relevance of genetic associations may make practical prescribing recommendations difficult.

Key Words: package insert, pharmacogenetics, pharmacogenomics, polymorphism, prescribing, top 200 drugs

Published Online, March 7, 2006. www.theannals.com, DOI 10.1345/aph.1G464