PHILADELPHIA – A two-day summit in Philadelphia that brought physicians, EHR vendors, pharmaceutical executives and the Food and Drug Administration together shed light on the role of EHRs in drug regulatory and marketing issues.
The PharmEHR Summit was held April 6-7 by PDR Network, a distributor of drug labeling information, product safety Alerts and REMS programs.
Edward Fotsch, MD, the CEO of PDR Network, presented survey findings of 100,000 physicians, a broad range of pharmaceutical and device executives and major national EHR executives who were polled by PDR.
The survey showed that more than 30 percent of physicians had already adopted an EHR.
Equally impressive, Fotsch said, is that a third of the respondents said they would be buying an EHR in the next 24 months.
But just having the technology is only half the battle, according to David Voran, MD, a primary care physician from the Missouri-based Heartland Clinic who spoke at the summit. What is really missing is connectivity, he said, and unfortunately that hinges on “changes in policy and procedure and culture rather than the technology itself.”
“Until we start focusing on the connectivity between offices and healthcare facilities we are always going to be behind the eight-ball,” Voran said.
Fotsch said a presentation by Janet Woodcock, MD, director of the Center for Drug Evaluation and Research for the FDA, revealed how "expansive" the FDA's views are on drug and device roles that can be achieved through the EHR.
Woodcock spoke about some “secondary uses” of EHRs, for example, using them to help keep clinical trials in the United States rather than “fleeing out of this country.” Or how they could aid prescription drug monitoring programs like state registries for opioid prescriptions.
“Drug therapy in this country is not what it should be,” said Woodcock. “From the FDA’s standpoint the move into EHRs and e-prescribing is a tremendous opportunity to improve drug therapy in the U.S.”
From comments made by Jeffrey E. Shuren, MD, director of the Center for Devices and Radiological Health for the FDA, it’s clear that the FDA considers EHRs a medical device, but that doesn't mean the agency will necessarily regulate them like drugs and other devices. With the excepted recommendations coming from the Institute of Medicine this fall, however, "something is going to happen" on EHR regulation, said Fotsch.
