March-2026

Volume 12 - Issue 1

FDA initiates removal of ‘black box’ warnings from menopausal hormone replacement therapy products

To reduce the risk of medication errors, the Institute for Safe Medication Practices (ISMP) has developed Targeted Medication Safety Best Practices for Hospitals. These best practices aim to identify, inspire, and mobilize widespread adoption of consensusbased strategies addressing specific medication safety issues that continue to cause serious harm and fatalities in patients. Here are some selected best practices, chosen for our readers:

Best Practice 8:

Administer all medication and hydration infusions using a programmable infusion pump with dose error-reduction systems.

Rationale: To ensure the use of dose error-reduction technology to prevent infusion-related medication errors, which can result in patient harm.

Best Practice 9:

Ensure that all appropriate antidotes, reversal agents, and rescue agents are readily available.

• Establish standardized protocols and/or coupled order sets that allow for the emergency administration of these agents.
• Ensure that directions for use and administration are readily accessible in all clinical areas where these agents may be required.
• Clearly identify which agents can be administered immediately in emergency situations to prevent patient harm.

Best Practice 13:

Eliminate injectable promethazine from the formulary. Rationale: This best practice aims to eliminate the risk of serious tissue injury and amputations caused by inadvertent arterial injection or intravenous (IV) extravasation of injectable promethazine.

In 2023, the US Food and Drug Administration (FDA) began asking manufacturers to include administration recommendations in prescribing information and on carton and container labels (www.ismp.org/ext/1288). The FDA recommends deep intramuscular injection instead of IV administration.

Best Practice 14:

Proactively seek and utilize information about medication safety risks and errors that have occurred in other organizations, and take action to prevent similar errors.

Rationale: One of the most effective ways to prevent medication errors is to learn from incidents in other institutions and to use that information to identify potential risk points or practices