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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary
The greatest problem in drug labeling is how to improve the quality of the data presented to the prescriber, particularly information concerning drug-drug interactions. Currently, the information available is not helpful in managing patients in real time, and drug interactions are found only on newer product labels, not the older ones, said Dr. Kahn.
In the present regulatory environment, all possible adverse reactions are included on labeling because exclusion of information could potentially represent great legal liability. “There is a common misconception that FDA regulations require that every single potential adverse reaction report be listed on the label, but that is not the case.” said Rachel Behrman of the FDA. Processing excess information is an inconvenience experienced not only by prescribers. The burden of so much content impacts pharmacists as well. “Part of the reason for the information overload in pharmacies sometimes is the concern of the pharmacy owner or operator hearing that if they don’t let the pharmacists see all of the information, all of the potential interactions, all of the theoretical interactions, that they will somehow be held liable for missing something down the road,” said Dr. Staffa.
NEW LABEL REQUIREMENTS
The FDA estimates that 300,000 preventable adverse events occur each year in the United States because of confusing medical information (FDA, 2006). The development of content for the label is a result of collaboration among the FDA, industry, and U.S. Pharmacopeia (USP) standards. Although companies write label drafts, only the FDA has authority over the final content. After approval, a label change can be requested by the FDA, but the company is not required by law to comply (Ray and Stein, 2006), although the FDA does have absolute authority to withdraw the drug.
To address concerns about labeling, the FDA has recently changed the format of drug labels in an attempt to make the information more useful. The new labels have a brief highlights section (see Figure 6-1) that summarizes information contained in the boxed warning, indications and usage, and dosage and administration. It also refers the health-care professional to the appropriate section of the full prescribing information (FDA, 2006).
Manufacturers must add any new information learned in the preceding year to the highlights section in an effort to keep physicians updated on new indications and interactions. A toll-free number and Internet address will be provided on the label to make reporting incidents more convenient. A table of contents and the date of initial drug approval will also appear on the product labeling. As of December 2006, all marketed