FDA Proposes Doctor-Friendly Labels For Prescription Drugs
In an effort to reduce medication errors, the FDA announced plans yesterday to clarify and simplify the warning labels that accompany prescription drugs, the New York Times reports. The decision comes in the wake of several "highly publicized drug withdrawals" in which doctors inappropriately prescribed medications that had serious side effects. The proposal calls for the "package inserts" that accompany medications to be updated so that doctors can more easily discern the risks of every drug. According to the Times, the inserts are "cumbersome, and doctors often ignore them." FDA commissioner of food and drugs Jane Henney said, "Physicians told us that they weren't using the current label because its format is just too dense" (Stolberg, New York Times, 12/22). The changes in the labeling include:
- Inserts will list the proper dose for the drug.
- Inserts will begin with a "highlights section," complete with the "most important warning" for the drug.
- Inserts will instruct doctors whether "additional warnings have been added in the last year."
- Inserts will list the drug's side effects, and then an FDA phone number, in bold print, for doctors to report "any suspected problems in their patients." The AP/Philadelphia Inquirer reports that this represents a "major change," as the FDA to date has relied on voluntary reporting, which few doctors do.
- The "old-fashioned" insert details will now include an index for each topic.
- Inserts will conclude with a "patient counseling" section that includes "everything patients should know before filling the prescription" (Neergaard, AP/Philadelphia Inquirer, 12/22).
The labeling changes, which the New York Times compares to those made to food labels by the FDA in the early 1990s, will initially only apply to newer prescription drugs, because these medications are less familiar to doctors and manufacturers of older products need time to complete new labeling. The FDA's proposal, published in today's Federal Register, will be open to public comment for 90 days (New York Times, 12/22). The FDA will then "issue a final regulation sometime next year," Henney said (Rubin, USA Today, 12/22).
Health professionals generally praised the proposed changes, but warned that they were not a cure-all for the broad problem of medical errors (New York Times, 12/22). Jerry Avorn, associate professor of medicine at Harvard Medical School, said, "This really is a big improvement in terms of organization and ordering, and it's actually written in English, which is a refreshing change" (USA Today, 12/22). Dr. Alan Goldhammer, associate vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said that drug companies "would certainly be able to get behind" the proposal if it improved patient safety (New York Times, 12/22). And Dr. Jay Cohen, a drug-safety expert at the University of California-San Diego called the changes a "great step, a badly needed step" (AP/Philadelphia Inquirer, 12/22).
Many experts believe, however, that the problem of prescription drug errors extends beyond warning labels. According to a 1999 Institute of Medicine report, up to 7,000 Americans die each year due to medication errors. The Times reports that mistakes can result from poor handwriting, drugs with names that sound alike and a "fragmented health care system" in which one doctor may not know what another doctor has prescribed to the same patient. "Even with the perfect label, drugs may still not be used perfectly," Dr. Raymond Woosley, chair of Georgetown University's pharmacology department, said (New York Times, 12/22). Avorn added, "Medication errors really have more to do with physician education and health care delivery systems than they have to do with the organization of a piece of paper that may or may not be looked at." He also criticized the FDA for limiting the labeling changes to new drugs, saying they should also be found on the "most commonly used drugs" (USA Today, 12/22).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.