Drug warning lables not heeded

By HSC Staff Writer • Published: March 10th, 2006
Category: Health in a Heartbeat

Major new research suggests many doctors who prescribe high-risk medications to patients often do so without heeding F-D-A warnings designed to ensure the safe use of medications that carry serious risks.

In a nationwide survey of more than nine-hundred-thousand ambulatory care patients, about four of every ten patients received prescriptions for drugs with Black Box Warnings… that’s the Food and Drug Administration’s strongest label for high-risk medication.

The Harvard-led study was described recently in an online version of a major medical journal. Nearly a billion-and-a-half prescriptions are written yearly in ambulatory care settings. The study reveals that so-called B-B-W… or Black Box Warning… drugs are prescribed often. But in some categories, prescribing is inconsistent with the warnings.

B-B-Ws are warnings printed in a black frame in the package insert of a drug. They’re intended to alert prescribers to the extreme risks associated with certain drugs.

To examine prescribing compliance, researchers considered B-B-W drugs requiring laboratory monitoring, either when a patient begins taking the medication or for the duration of the prescription. They also looked at drugs deemed unsafe to take with other specific medications, or those considered unsafe to take during pregnancy.

Most noncompliance problems occurred when patients should’ve received lab tests as they began a medication. Half of all prescriptions weren’t accompanied by a lab test when they should have been.

Researchers are calling for stepped-up efforts to clearly communicate the risks and safe use of medications to both doctors and patients, and to encourage monitoring compliance.