FDA official sees hope in electronic health records

Posted: March 22, 2012

Janet Woodcock, who leads the federal government's efforts in evaluating pharmaceuticals, said Wednesday in Center City that she hopes increased use of electronic health records will help doctors prescribe the right drugs, patients understand and follow their treatment plans, and regulators learn more quickly of problems with medicines after they enter the market.

Woodcock said that regulators and pharmaceutical companies, which can spend 10 years and $1 billion to move a drug through the approval process, could better predict effectiveness of new drugs if there was a system for collecting data from real-world use of existing medicines.

As of now, there is only a requirement for companies to forward reports of adverse events, which they resist. Others can file such reports, but that process is ineffective because it is patchy, anecdotal, and slow.

"It really disappoints the public and results in spasms of hostility against the regulators, the drug-development community, and sometimes the medical community," Woodcock said. "The public thinks, 'How could you have been prescribing this in the dark for so long?'?"

Woodcock, who is the director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, spoke at the PharmEHR Summit at the Hyatt at the Bellevue.

Electronic health records and Internet tools are becoming more a part of health care every day, but the enthusiasm for and smoothness of the transition vary.

Some doctors and other providers, whatever the legibility of their handwriting, lament that they spend too much time with patients entering data in a computer.

Haddon Heights doctor A.J. Higgins, a fellow of the American Academy of Family Physicians, told the audience that doctors who assume their every instruction is followed might be humbled by data showing patients don't always take prescribed medicine.

Jodi Daniel, a director with the Office of the National Coordinator for Health Information Technology, said it was possible that the stacks of manila folders in most medical offices might be gone in her lifetime.

GlaxoSmithKline North American pharmaceuticals president Deirdre Connelly told the audience the company hopes to use electronic tools to provide individual doctors - and, increasingly the hospital groups who make purchasing decisions - more useful information when they need it. She noted that such descriptions should include benefits and risks of any drug.

Within certain guidelines, U.S. doctors can legally prescribe whatever they see fit, but companies cannot promote drugs "off-label," meaning for uses not approved by the FDA, and penalties have reached into the billions of dollars. Woodcock said a good electronic health records system could help attack that problem.

"The drug may be dispensed and used for a condition totally unrelated to what the drug was approved for," Wood cock said. "In some cases, it's highly appropriate, some cases wildly inappropriate. We don't have a really good method to distinguish these."

Contact David Sell at 215-854-4506 or dsell@phillynews.com, or follow on Twitter @PhillyPharma. Read his PhillyPharma blog on philly.com.

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