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Keep an eye on black box warnings

Staff Development Weekly: Insight on Evidence-Based Practice in Education, February 14, 2008

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When it comes to medication management, the black box label-a recent focus area garnering more intense scrutiny among hospitals-is designed to warn prescribers of potentially life-threatening complications associated with specific drugs. The warnings are meant to help medical professionals provide the maximum benefit to the patient by prescribing the drug while avoiding common risks and complications. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to label a prescription medication with a black box warning (the strongest warning the FDA can require). The label essentially tells both the prescribing physician and the patient that the medication carries potentially life-threatening adverse effects.

Below are tips for black box warnings:

• Educate. Make sure your staff members and physicians are aware of guidelines such as black box warnings.
• Let the pharmacist be your guide. The pharmacist should take the lead while working with hospital staff members to develop strong guidelines and protocols to make sure medications are controlled and distributed properly.
• Have a system. By establishing a proper system for high-risk medications, including dose limits, packaging adjustments such as preprinted labels, dose limits, and a system of double checks, you can lower the risk of misuse.

To get more information, go to Briefings on The Joint Commission (BOJ). For the cost of just three stories, you can get the entire February issue of BOJ. Click here to choose between the PDF and HTML versions for just $30. Subscribers to the online version of BOJ have free access to this article. Subscribers to the print newsletter can find this article in their February issue.

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