Another Look At Labeling

Drug companies have gone to considerable lengths to meet FDA’s newer labeling requirements of recent years. Yet the agency and others are still finding a lot of room for improvement in label content and distribution.

Patients too often leave pharmacies without the manufacturer-supplied Med Guides required with certain prescription drugs, an FDA official noted at the agency’s recent public workshop, Providing Effective Information to Consumers about Prescription Drug Risks and Benefits. 

The consumer medical information (CMI) that pharmacies routinely print out with dispensed scripts continues to vary widely in content and quality. Surveys in 2001 and last year by the National Association of Boards of Pharmacy show the leaflets basically haven’t improved much in seven years.

The agency is considering having one standard document covering pharmacies and manufacturers for dispensing with the prescription drug. Would such uniformity assure that patients receive the information they need for taking their medicines safely?

An article in the October issue of the New England Journal of Medicine (NEJM) argues that important information on drugs’ safety and effectiveness too often goes missing in FDA-approved labeling and review documents. Clinicians and ultimately their patients could make better decisions if the data behind a drug’s approval were more complete and accessible.

“The NEJM article is clearly saying consumers need more and better information,” says Tom Henderson, vp, sales and marketing North America, Chesapeake Pharmaceutical and Healthcare Packaging.

“The formats we have today are good ones. But the Med Guide is essentially a Q & A covering directions for patient use. My question is whether you can really convey the complexity of some of these prescription drugs in the current formats,” he says.

In “Lost in Transmission–FDA Information That Never Reaches Clinicians,” the authors cite examples where critical data on a drug’s efficacy or harmful effects is absent from the package insert or hidden deep within FDA review documents. Patients are not told of reviewers’ uncertainties or if a drug’s approval was a close call, the authors say.

“A sense of uncertainty about the net benefit of drugs is almost always lost.  FDA approval does not mean that a drug works well; it means only that the agency deemed its benefits to outweigh its harms.

“Since the nature–or even existence–of review uncertainty is not addressed in the label, clinicians cannot distinguish drugs that reviewers endorsed enthusiastically from those they viewed with great skepticism,” they write.

The authors recommend that FDA drug review documents include a standardized executive summary that would include the main results of phase 3 trials, highlight reviewers’ uncertainties, and note if approval was contingent on a post approval study. They call for the use of Prescription Drug Fact Boxes-an approach FDA is currently reviewing-that would feature data tables of benefits and harms.

“The experts are saying that key drug facts are not included in FDA labeling, and FDA is saying the information being provided to consumers is inadequate,” says Henderson.

“Part of preventive medicine is involving patients more in their care by providing critical and accessible information. The position of the Pharmaceutical Printed Literature Association is that this information is available. We need to find a way to use it.”

Dave Vaczek