New drug labels to clarify usage
Published: Thursday, January 19, 2006 at 6:01 a.m.
Last Modified: Wednesday, January 18, 2006 at 11:29 p.m.
The confusing tangle of information found on the labels of prescription drugs will soon undergo a major revision, a move federal drug regulators hope will reduce the injuries and deaths caused by medical errors.
The changes, announced Wednesday by the Food and Drug Administration, are intended to clarify the flood of information that doctors routinely confront when assessing the safety of prescription drugs. The new rule does not affect the drug information sheets that patients routinely receive, but is likely to result in major changes to drug advertisements and may offer some liability protections to drug makers.
Some 300,000 people are injured and nearly 100,000 are killed in hospitals every year because of medical errors, studies show. Prescribing errors are a major cause.
But studies show that fewer than one in 10 physicians routinely read drug labels, which provide the most complete information about a drug's dangers and uses. And when they do read labels, studies also show, doctors learn little. Major changes to drug labels have in the past done little to stop dangerous prescribing habits by physicians.
"I think labels are really confusing now," Dr. Charles Gerson, a gastroenterologist in Manhattan, said in an interview. "There are a million little bits of information, and it's not easy to find what you're looking for."
Under the new rule, drug labels will for the first time have a highlights section that summarizes the vital information needed to prescribe a drug safely. This new section will first list safety warnings and then summarize any recent changes. Advice about how to use and dose a drug will follow, and there will be a new section telling doctors what they should tell patients.
"Avoiding preventable medication errors is a vital issue," Dr. Andrew C. von Eschenbach, the drug agency's acting commissioner, said in a news conference announcing the rule. "This initiative is a significant step towards facilitating that future."
The rule has been under review for more than five years and represents the first major change to drug labels in 25 years. It affects the accordianlike inserts included with some boxed prescription drugs. These inserts, also found in medical reference books, are referred to variously as "professional labels," "package inserts" or "prescription information."
But the rule does not address the information sheets routinely provided to patients by pharmacists. These sheets are lightly regulated and often fail to include important drug warnings.
Dr. Sidney M. Wolfe, director of the health research group at Public Citizen, the consumer advocacy group, called for similar changes to the patient information sheets. The new rule, Wolfe said, "widens the gap between the now-better information the doctor gets and the terrible information the patient gets."
Drug agency officials estimate that the nation spends $4 billion to $4.8 billion on medical errors that could be avoided "through measures that provide better information to doctors, such as prescription drug labeling." Agency officials would not estimate the number of lives that might be saved by the simpler labeling.
Drug advertising may change considerably in the wake of the new rule, agency officials said. The highly detailed and rarely read pages of small print that are included in newspaper and magazine advertisements will most likely disappear. In their place will be shorter, clearer statements about common drug risks. Television commercials may also have to change how they discuss risk information, officials said.
Trial lawyers reacted angrily to a preamble to the new rule stating that the rule pre-empts, or supersedes, state liability statutes.
In the preamble, the agency listed six claims against drugmakers that would be prohibited as a result of the rule, including claims that a drugmaker should have put into a label's "highlights" section a risk warning included elsewhere in its label, or claims that a drugmaker should have included a warning that the drug agency deemed unnecessary.
"Overwarning, just like underwarning, can similarly have a negative effect on patient safety and public health," the preamble states.
Drug agency officials have for years made similar arguments in some product liability trials, but the preamble may provide broader protections to drug makers, former agency lawyers said.
"It will make it impossible to file liability claims," said Peter Barton Hutt, a former general counsel for the agency who is now in private practice. Other lawyers suggested that the preamble would provide far less protection to drug makers.
Rep. Maurice D. Hinchey, D-N.Y., said that the liability provisions of the new rule showed that the drug agency "has once again gone to bat for the drug industry."
Chris Mather, a spokeswoman for the Association of Trial Lawyers of America, called the preamble "the scariest example yet of how much power drug makers have in our political process." Mather said that the drug agency did not have the authority to issue such a waiver.
Drug labels had become confusing for several reasons, said Dr. Janet Woodcock, deputy commissioner of the FDA. First, liability and marketing concerns had gradually displaced physician education as the principal focus of label writers, Woodcock said. Second, far more is known now about how drugs work in the body than was the case 20 or 30 years ago, and much of that information has to be included in drug labels, she said.
And third, "There are more drugs than ever, and physicians have less time than ever in every patient encounter," Woodcock said.
The new label rule will apply to all new drug approvals, to drugs approved within the past five years, and to any drug for which a major label revision is requested.
Older drugs can avoid the requirements, although Woodcock said that doctors were often already far more familiar with the risks and benefits of older medicines.
The rule will further efforts to make medical information easily available through computers, and it will encourage efforts to get doctors to prescribe medicines electronically because all new drug labels will be structured similarly and will be easy to search electronically, Woodcock said.
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