Development and Evaluation of a Pharmacogenomics Educational Program for Pharmacists
Formea, Christine M., Nicholson, Wayne T., McCullough, Kristen B., Berg, Kevin D., Berg, Melody L., Cunningham, Julie L., Merten, Julianna A., Ou, Narith N., Stollings, Joanna L., American Journal of Pharmaceutical Education
Since the human genome project was completed in 2003, pharmacogenomics has become a rapidly expanding area of science that blends molecular pharmacology and genomics. (1) This burgeoning field investigates the important contribution of genetic inheritance in the variability of drug response. (2,3) A wide range of medication effects can be explained by genomic differences, which include but are not limited to toxic adverse effects and lack of efficacy.
The United States Food and Drug Administration (FDA) added pharmacogenomics testing requirements for several drugs, including cetuximab, dasatinib, maraviroc, and trastuzumab, and has recommended testing for abacavir, carbamazepine, mercaptopurine, and irinotecan, among others. (4) In 2007, the FDA changed warfarin labeling to include pharmacogenomics testing considerations, and in 2010, announced the addition ofa black-box warning for clopidogrel based on pharmacogenomics metabolism concerns. (5,6) The FDA also has updated the pimozide drug label to include dosing information for CYP2D6 poor metabolizers. (7) These labeling changes are among the first tangible steps toward individualized medication dosing based on a patient's genetic information.
Rapid technological advancements in molecular pharmacology and genetics are facilitating the push to translate laboratory discoveries to the patient bedside. As drug experts and point-of-care providers, pharmacists are well-positioned to lead this new era of individualized medicine. (8,9) Pharmacogenomics has moved beyond the limited confines of a laboratory environment and now represents an opportunity for clinical pharmacists to deliver enhanced patient care at the bedside and at the outpatient pharmacy window in an integrated clinical manner. (10-12)
An assessment of the pharmacogenomics educational needs of hospital and outpatient pharmacists was performed to facilitate the development of a pharmacogenomics educational program. (13) Results of the needs assessment showed that although pharmacists believed that pharmacogenomics knowledge was important to the pharmacy profession, they lacked the knowledge and self-confidence to make therapeutic recommendations based on pharmacogenomics test results. (13) Similarly, a community pharmacy survey found that pharmacists were not confident in their knowledge of genetic testing and pharmacogenomics. (14) These results suggest that pharmacists would benefit from a clinically relevant pharmacogenomics educational program. Using this information as background, the objective of this study was to measure the impact of a case-based pharmacogenomics education program for pharmacists at 1 campus of a large, academic, multicampus healthcare system.
A previously conducted needs-assessment survey guided the development and delivery strategies for a case-based educational program. (13) The pharmacy department at Mayo Clinic, Rochester, Minnesota, mandated the educational program for inpatient, outpatient, and administration pharmacists located on the study campus. The required educational program consisted of a 1-hour, case-based presentation focusing on fundamental principles of pharmacogenomics, including metabolic, labeling, and genomic considerations. The learning objectives for the fundamentals-of-pharmacogenomics education program included that participants be able to justify the importance of pharmacogenomics in pharmacy practice; explain pharmacogenomics concepts; evaluate pharmacokinetic alterations caused by polymorphisms; describe tests for pharmacogenomics issues; and specify FDA labeling requirements for pharmacogenomics. The concepts of pharmacogenomics were explored through patient cases based on drug-gene pairs including: abacavir (HLA-B*5701), mercaptopurine (thiopurine methyltransferase), warfarin (CYP2C9 and VKORC1), and codeine and tamoxifen (CYP2D6).
The Accreditation Council for Pharmacy Education (ACPE)-accredited educational program was presented live on 3 different occasions at various campus locations. …