The Formulary Files

Include pharmacogenomic data in P&T decisions

Incorporating pharmacogenomic (PGx) information into an institutional formulary can be a daunting task because few standardized methods exist, making the analysis of clinical PGx data at the formulary level particularly difficult. Researchers at the University of North Carolina conducted a Medline search for articles that used terms such as “formularies, hospital,” and “pharmacogenetics.” This yielded no results. The terms were then searched separately, with the additional terms “rational drug therapy” and “essential medicines list.” Results were published in the Annals of Pharmacotherapy.

Mary W. Roederer, PharmD, research assistant professor at the Institute for Pharmacogenomics and Individualized Therapy at the University of North Carolina Eshelman School of Pharmacy in Chapel Hill and one of the authors, says all health systems and managed care organizations have a process for making formulary decisions, but she hopes her article will prompt decision makers to always consider PGx issues. Are there any PGx data? Are there polymorphisms or genes that are relevant to how the drug is metabolized or transported? Are there genes that affect the drug target?

She says many people who evaluate medications are very competent clinicians, but they can be intimidated by the concept of PGx. In addition, a lot of people say the field of PGx is not ready for prime time. But while the field is relatively young, decision makers need to at least consider it and use it to help make decisions. “Pharmacogenomics is just one more piece of the puzzle when deciding what therapies to include in the formulary,” she says. Roederer hopes these questions elicit thought-provoking conversation when decision makers are considering therapies where clinically useful PGx information exists while completing the objective risk-benefit analysis of a traditional P&T committee.

Questions to ask when considering PGx information
Type of question Question
Efficacy What added value does the PGx information provide in regard to individualizing patient care?
Efficacy and safety Does an opportunity exist for patients to utilize a PGx diagnostic test that will optimize medication effectiveness and decrease the maintenance monitoring of the medication?
Safety If the two medications are similarly effective, but the medication with PGx information provides a reduction in serious adverse effects in the long term, are the reduced adverse effects enough to justify switching therapies?
Safety Does the medication that has a known PGx relationship narrow it to specific indications and does it require formulary restriction for the specified indications with prescribing limited to specialty clinicians?
Safety Are certain populations at risk for adverse effects?
Pharmacoeconomics Is the PGx therapy more cost-effective than conventional therapy for the short term or long term?

Source: Poppe LB, Roederer MW. Global formulary review: How do we integrate pharmacogenomic information? Published online, April 12, 2011. Abstract available here: Permission to reprint is granted by the publisher.

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