19 January, 2006 21:46 GMT
FDA officials described current labeling practices as complex, dense in presentation and difficult to navigate.Because of that, crucial information can be easily overlooked, doctors said.
Drug manufacturers now have to make their drug inserts easier to understand so that doctors and consumers have the most important information at hand before a drug is prescribed.
Dangerous drug interactions, possible adverse reactions, recent changes to the drug, dosages and safety information are among nearly a dozen new features to be prominently summarized in quick-reference style on each label.
The new rules, announced Wednesday by the
Food and Drug Administration, require all newly approved drugs and those approved within the past five years to comply with the new label format. The change is the first revision in 25 years, officials said.
Summaries at a Glance
The rules were prompted in part by some 300,000 preventable adverse reactions reported every year as a result of confusing and inconsistent drug information, Surgeon General Richard Carmona said Wednesday.
Doctors, pharmacists and other providers will be the front-line beneficiaries of the new labeling, designed to provide at-a-glance summaries of the most important prescribing information.
But consumers who receive prescription medication in the manufacturer's packaging also will benefit.
"Patients are overwhelmed, bombarded with infomercials ... purporting to cure everything: Take this medication, take that. We recognize this is confusing to the patient," Carmona said. "Prescription drug information often reads like drug disclaimers. We need to do away with that."
Adverse-Reaction Reporting
The new rules require the following:
A table of contents for easy reference to more detailed or expanded information.
The date of the drug's initial approval so that a physician or patient will know how long the product has been on the market.
A toll-free phone number and Internet address for people to report suspected adverse reactions.
Providers say the new labeling will make prescription medicine safer and more efficient.
"I think that's a very good idea," said pharmacist Jason Schmitz of Clifton Family Prescription Shop in Wichita, Kansas.
"Even though a pharmacist is supposed to process all those things in their mind as they're filling a prescription, if you have a visual cue to remind you of these items we need to watch out for, that will make our job easier," he said. "It will also help prevent errors."
Doctors Stopped Using Inserts
FDA officials described current labeling practices as complex, dense in presentation and difficult to navigate.
Because of that, crucial information can be easily overlooked, doctors said.
"Most doctors have sort of long ago stopped using those inserts because ... we found it wasn't in a very useful format," said family physician Joe Davison. "It was laid out so poorly ... there might be some sort of thing in there that says, 'Gosh, doctors, watch the liver,' but we may miss that completely because you didn't see it."
The new labels will have a patient counseling information section that promotes doctor-patient communication and helps providers advise their patients about limitations and potential risks with their medication.
The FDA also plans to put the streamlined data online for easy access and reference, officials said.
"We hope we'll revolutionize safety and the ability to use medications in the best way possible," said Janet Woodcock, the FDA's deputy commissioner for operations.
Reach Andi Atwater at 268-6642 or aatwater@wichitaeagle.com
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