ATLANTA — The US Food and Drug Administration and the American Medical Association last week launched an online educational course to improve physicians’ basic knowledge of pharmacogenomics.
“A critically important factor” in advancing the science of pharmacogenomics “is education,” Felix Frueh, head of the FDA’s Interdisciplinary Pharmacogenomics Research Group, said as he announced the launch of the Website at the Drug Information Association’s annual meeting here this week.
The Website went live last week. The FDA received an unrestricted educational grant from Roche for the project.
Frueh described the course as an introductory online educational tool for pharmacogenomics. “It’s a very basic beginner-level course. It has use cases so it’s supposed to be illustrative. It offers [continuing medical education] credit. And best of all, it’s free,” he said.
The agency is currently developing the next course, which will focus on pharmacogenomic examples from a variety of therapeutic areas. It will be available in the fall.
Surveys show that physicians have a low comfort level when it comes to genomics. Joanne Armstrong, regional medical director of women’s health at Aetna, noted at the DIA meeting that there is a shortage of formally trained geneticists. An assessment of non-genetic MDs show that 72 percent rate their own genetic knowledge as “poor,” Armstrong said.
At the DIA meeting, there were three one-and-a-half-hour sessions focused on pharmacogenomics and personalized medicine, which could count toward CME credit. “A lot of doctors say that in medical school they spent about an hour on pharmacogenomics,” quipped Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology and Biopharmaceutics. “Now you have a lot more [information about PGx] than most doctors.”
Earlier this year, Frueh discussed with Pharmacogenomics Reporter the agency’s plans to introduce two CME courses in 2007, one with the AMA and one with the American College of Clinical Pharmacology.
While the recently launched AMA course for MDs focuses on the clinical applicability of pharmacogenomics, the ACCP’s course will address PGx from a more mechanistic and molecular perspective for PhDs and PharmDs [see PGx Reporter 01-03-2007].
“It’s a very basic beginner-level course. It has use cases so it’s supposed to be illustrative. It offers [continuing medical education] credit. And best of all it’s free.”
The AMA online course initially submits a short quiz to gauge the participant’s basic genetic literacy. Based on one’s performance, the program suggests taking a review of genetic organization and structure, or one can choose to continue with the PGx course.
The course addresses the genetic control of drug metabolism and response, discusses pharmacogenomic information in drug labels, provides clinical examples of patients whose genetics have clearly impacted their response to drugs, and introduces some available tests that aid in prescribing certain drugs affected by a patient’s genetic background.
At its annual meeting last year, the AMA adopted a directive promising to maintain a “visible presence in genetics and molecular medicine,” which includes the development of Web-based resources and educational materials to inform physicians about relevant clinical practice issues related to genomics. The course with the FDA falls under this directive.
At FDA, the idea for the course developed out of an internal assessment of its staff. According to Frueh, a review within the agency revealed that the FDA’s staff had limited knowledge about pharmacogenomics. In identifying a need to communicate effectively about PGx within the agency, the FDA created its own education programs in 2004 and decided to develop the CME courses for health care professionals.
“This Continuing Medical Education course is an introduction to pharmacogenomics, the influence of a patient's genetic background on drug response, and is intended for physicians who have had little exposure to the topic in clinical practice, or who want to better understand the current levels of pharmacogenomic information in prescription drug labeling,” an introduction to the online AMA course states.