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How to connect medication management and black box labels

Accreditation Connection, February 15, 2008

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.

Federal and state regulators have recently increased their focus about how potentially dangerous drugs are monitored and how they interact with patients.

In fact, the California Department of Public Health (CDPH) recently released a memorandum regarding the requirement to have policies and procedures in place regarding black box warnings.

According to the CDHP memo, "It is the department's expectation that appropriate safeguards for all medications are in place that acknowledge and manage each of the medication's inherent risks with its benefits. Medications that have a boxed warning pose an additional challenge to promote safe use in light of their potential for serious adverse consequences."

Access the full story in the February issue of Briefings on The Joint Commission; access is free for subscribers, nonsubscribers can sign up for a 30-day free trial of BOJExtra! or purchase a copy of the story for $10 by clicking here.

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