1. Black Box Warning
What You Need To Know

2. Black Box Warning – What is it?
Sample:
A Black Box Warning is a written warning enclosed in a black border, hence the term, “black box” warning (see sample)

3. Black Box Warning – What is it?
Samples:
Black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug
This appears on the label of a prescription medication to alert the individual about any important safety concerns, such as serious side effects or life-threatening risks.

4. Black Box Warning – What is it? - cont’d
The black box warning indicates a need to closely evaluate and monitor the potential risks of the medication, or an adverse reaction to the drug that may lead to death or serious injury
This does not mean the drug is contraindicated in any way, but a means of communication from the FDA to highlight the potential risk in taking the drug so these risks may be taken into consideration

5. Black Box Warning – What to do
Nurses Role :
Provide education to patient and/or family regarding potential serious side effects
Emphasize importance of adherence to directions for the use of the drug as this is essential to its effectiveness
Monitor patient closely and instruct patient to immediately report any serious side effects experienced

6. Black Box Warning Safety Strategies
CHSB maintains and updates a Medication Safety Action Plan for Black Box Warnings and other significant FDA Alerts.
This action plan is available to staff and physicians for reference.
Safety strategies include: increased monitoring requirements, restrictions/ guidelines for use, eMAR and Omnicell alerts.

7. Black Box Warning
Through coordinated efforts, significant improvements in the safe use of medications can be made and may reduce preventable harm from medication misuse, abuse and errors

8. Thank You