Individually tailored drug regimens based on pharmacogenetic testing are increasingly being used to improve response rates and decrease adverse events.
Kerr Drug and UNC Eshelman School of Pharmacy at the University of North Carolina Chapel Hill will be exploring the feasibility of a pharmacogenetic program for Plavix (clopidogrel bisulfate),an antiplatelet agent (blood thinner).
The study will investigate and evaluate the implementation of a pharmacogenetic program in a community pharmacy. “Because pharmacists have unique expertise in medication use and are point-of-care service providers, they can play an important role in facilitating pharmacogenetic testing and more personalized health care,” says Rebecca Chater, Executive Vice-President of Kerr Health. “This study will examine just how that role can be implemented.”
Significant inter-individual variability has been observed in the therapeutic response to clopidogrel (Plavix). Recent studies have identified genetic variations in the cytochrome P450 2C19 gene as key factors associated with differing clinical response to clopidogrel therapy. Drug labeling for many pharmaceutical therapies, including Plavix, has been updated to include warnings of decreased response in individuals with certain genetic profiles. “Pharmacogenetic testing is increasingly paving the way for more personalized drug management,” commented Dr. Howard McLeod, Director for Institute for Pharmacogenomics and Individualized Therapy, adding “increased utilization of pharmacogenetic testing should help improve drug response rates and reduce adverse events.”
The study involves a protocol jointly developed by Kerr Drug and UNC in which eligible individuals taking PLAVIX are offered an opportunity to participate in a pharmacogenetic study administered at the local community pharmacy. Participants are screened and receive counseling at the pharmacy. Test results are reviewed and interpreted by both the prescribing physician and the pharmacist. Recommendations for therapeutic adjustments to the participant’s regimen are discussed and implemented as needed. Test results and physician/prescriber recommendations are communicated to the participant and satisfaction with the program is assessed.
Over the planned six (6) month study, the feasibility of a community pharmacy based pharmacogenetic program and its acceptance by physicians and patients will be evaluated. The study will also explore barriers to implementation including physician and patient acceptance, reimbursement challenges, and regulatory requirements. The findings of the personalized drug therapy study are expected to be presented and published, which the collaborators hope will be used to facilitate introduction and expansion of pharmacogenetic testing and personalized drug therapies in a broader network of community pharmacies.