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Summit shows EHRs' potential on drug regulation, marketing

April 18, 2011 | Molly Merrill, Associate Editor

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PHILADELPHIA – A two-day summit in Philadelphia that brought physicians, EHR vendors, pharmaceutical executives and the FDA together provided a lot of information on the impact EHRs may have have on drug regulatory and marketing issues.

The PharmEHR Summit was held April 6 and 7 by PDR Network, a distributor of drug labeling information, product safety Alerts and REMS programs, including Physicians' Desk Reference (PDR), a commonly used drug information reference available in the U.S.

[See also:  Doctors stress importance of reporting EHR problems.]
 
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 execs who were polled by PDR.

Some of the biggest take-aways from the survey concerned the large adoption of EHRs by doctors already, said Fotsch, who said the survey showed that more than 30 percent had already adopted an EHR. 

"Equally impressive were the findings that a third of respondents said they would be buying an EHR in the next 24 months," he added.

The survey also found that more than 70 percent of doctors would find it valuable if their EHR included drug related information or services, said Fotsch.

That's exactly the aim of the PDR network, he says, which is working in this space with the FDA and vendors to make sure that information such as FDA drug labeling or real-time drug alerts can be made available through EHRs.

[See also: New service allows docs to check drug labeling via EHRs.]

Jeffrey E. Shuren, MD, director, Center for Devices and Radiological Health for the FDA, gave one of the key note speeches at the summit. Fotsch said that Shuren's comments made it clear that the FDA considers EHRs a medical device, but that doesn't mean they 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.

Janet Woodcock, MD, director, Center for Drug Evaluation and Research for the FDA, gave another of the summit's keynotes. Fotsch said her presentation revealed how "expansive" the FDA's views were on drug and device roles that can be achieved through the EHR. For example she talked about having the capability in EHRs to track devices and improve clinical trials, as well as create patient financial assistance programs for drugs.

Fotsch says PRD Network plans on holding the event next year as well.

Related Topics:
  • Edward Fotsch
  • FDA
  • PDR Network
  • pharmaceutical
  • Philadelphia
  • Business Intelligence
  • Electronic Health Records
  • Privacy and Security
  • Quality and Safety

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