FDA takes the pain out of Rx info

New rule requires online data for health care providers and consumers

The Food and Drug Administration wants to make it easier for doctors and patients to get the most current updates on medications. And to do that, they are moving ahead with a plan to put information about regulated drugs and vaccines online.

The agency now requires manufacturers to submit prescription drug label information to the FDA in a new electronic format that some say could smooth the path toward a nationwide electronic health records exchange.

Under regulations effective earlier this month, companies must transmit all packaging materials to the FDA via an Extensible Markup Language format, known as Structured Product Labeling (SPL). The format will permit easier access to the latest drug data, FDA officials said.

"Currently, health care providers may be accessing information that is as much as a year out-of-date, thereby impacting the safety of patients," said FDA spokeswoman Kristen Neese.

The FDA also requires companies to describe their products using identical subheads and medical terms. FDA officials say universal vocabulary standards will reduce medical errors, which annually cause about 98,000 deaths in the United States.

SPL medication labels will become the bread and butter of the National Library of Medicine's new DailyMed Web site. In the future, that drug information will also be available at an FDA-hosted Web portal that will serve as a comprehensive source for information about all FDA-regulated products.

DailyMed will post product literature for most regulated prescription medications within a year, followed by over-the-counter drugs starting in November 2006.

The separate FDA portal will eventually list drug information, along with package data for vaccines, medical devices, veterinary drugs and food items.

Proponents of health information technology say a one-stop shop for free online information about FDA-regulated items will ease doctors now using paper into the Digital Age.

"It starts us down the road toward giving physicians benefits from being connected," said Scott Wallace, president and chief executive officer of the National Alliance for Health IT.

The labeling initiative is significant on the federal side, too. The FDA currently uses a paper-based system to disseminate information, Wallace said.

For example, many physicians learned about Merck's Vioxx recall from media reports before they received an official FDA announcement.

"Literally, they mail updates to physicians," Wallace said. He added that the National Library of Medicine, with 15 years of experience in health IT, should bring the FDA into the 21st century.

In medical centers, the database will ensure that caregivers deliver the appropriate drugs to the appropriate people, hospital operators say.

John Halamka, chief information officer at CareGroup Health System, a large medical group in eastern Massachusetts, said CareGroup's Beth Israel Deaconess Medical Center would be an early adopter for medication safety purposes. Beth Israel is a patient care center and a teaching and research affiliate of Harvard Medical School.

"It helps us with labeling and identification of medications, which ensures we are delivering the right drug by using consistent labeling information," said Halamka, who is also the CIO and an associate professor of emergency medicine at Harvard Medical School. "In our case, we will use that information to place bar codes on each medication we deliver."

Beth Israel will use medication ID bar codes, radio frequency identification on patients tags and RFID tags on caregivers to create an electronic medication administration record.

With the new data, when a medical center caregiver scans the three IDs, the record will contain reliable information about the patient's prescription drug history.

The SPL standard, which will replace the PDF, is part of an ongoing federal initiative to translate, repackage and freely distribute up-to-date medication information.

The vendor-neutral SPL format uses embedded computer tags to let consumers, health care providers and medical information providers electronically manage and search current drug label literature.

The electronic tags can instruct computers to search for specific drug information, such as product names, indications, dosages, methods of administration, warnings, and active and inactive ingredients.

Pharmaceutical companies say they will have to make some sacrifices to meet the new drug information requirements, but add that they will eventually benefit from the change.

"There are obviously going to be cost issues associated with the addition of any new technology," said Alan Goldhammer, associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), an organization representing major pharmaceutical research and biotechnology companies.

In general, the pharmaceutical industry is "very much in favor of it and [believes] that this is going to make things in the long run much easier for submitting drug data to the FDA," he said.

The new requirement was no surprise to the industry, because PhRMA and FDA officials had tested the format during a yearlong joint working group.

FDA officials said the Web sites would not feed individualized information to users.

In the past, companies in the business of making government information accessible and searchable have voiced concerns about government agencies offering free custom-tailored services, such as e-mail updates and personalized settings.

"All the data will be available to vendors to customize how they wish, since there are many parties that will want a customized look," said Janet Woodcock, deputy commissioner of operations at the FDA.

"FDA does not have the resources to provide such services, but the private sector can do it given the data," she added.

Accessing data anytime, anywhere

The Food and Drug Administration's new drug information system mirrors an October report by a federal commission of health care, information technology and government leaders that calls for standard product identifiers as part of a national strategy to make health care information accessible anytime, anywhere.

The Commission on Systemic Interoperability's strategy explicitly requires that the Department of Health and Human Services, which oversees the FDA and the National Library of Medicine, work with manufacturers of drugs, devices and test kits to produce standardized identifiers and vocabulary for labels and packaging.

Scott Wallace, chairman of the commission and president and chief executive officer of the National Alliance for Health IT, said the new labeling information is a great first step.

"There's really nothing wrong with the drug format, but we need to add two things on top of it for it to be useful in an interoperable medical information system," he said.

First, drug companies must work with HHS to assign RxNorm names to medications. RxNorm is a standardized nomenclature for clinical drugs based on ingredients, strengths and physical form, independent of brand and generic names.

Second, the FDA and the pharmaceutical industry must incorporate information into a searchable national database of drug interactions.

"Just dumping all of the information out there isn't necessarily going to make things better right away," Wallace said.

The commission envisions personal medication records that patients can access electronically.

They could enter FDA product codes from prescription drug bottles, and the system would instantly link to official drug information and alert patients if any of the drugs they are taking have been recalled or if they need to be aware of any potential adverse interactions.

Wallace said all drug dispensers -- hospitals, physicians and manufacturers -- need one authoritative database to consult for information that emerges after a drug's approval. The recent warnings about potential side effects for teenagers taking antidepressants are a case in point.

"We need…to have a good electronic system for the post-market surveillance of drugs," Wallace said, adding that the system for monitoring drugs after they are released is less rigorous than the process for approving them.

-- Aliya Sternstein


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