PATIENTS IGNORE FDA'S BLACK BOX Rx LABELS

Pharmacy Times, Volume 0,0

The increasingly critical role of pharmacistsin helping to curb patient medicationerrors was underscored by newresearch findings that too many consumersare ignoring—or misinterpreting—FDA "black box" label warnings forprescription drugs. The study, publishedin the Journal of Pharmacoepidemiologyand Drug Safety, found that compliancewith the FDA label warnings varies significantlyfrom drug to drug.

Although the researchers identified ahigh level of compliance with Rx labelwarnings that caution against taking themedication while pregnant, they foundthat patients were significantly less likelyto heed prescription labeling calling forregular follow-up diagnostic tests byusers of a drug.

Additionally, the study findings suggestthat specific warnings are more effectivein securing patient compliance thanvaguely worded ones. In releasing thenew data, the researchers said that pharmacistsand regulators "need to find outhow we can communicate the contentof the warning clearly to clinicians andpatients."