FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone.

Area of Science:

• Public Health
• Pharmacology
• Consumer Safety

Background:

• The opioid crisis necessitates increased naloxone accessibility.
• Over-the-counter (OTC) naloxone sales face industry-perceived barriers.
• The FDA developed a model drug facts label to assess consumer understanding for safe OTC use.

Purpose of the Study:

• To evaluate consumer comprehension of a model drug facts label for OTC naloxone.
• To determine if the label provides adequate information for safe and effective naloxone use by consumers.

Main Methods:

• A label-comprehension study involving 710 adults and adolescents.
• Structured interviews assessed understanding of key naloxone label statements.
• Eight primary endpoints with target comprehension thresholds (80-90%) were evaluated.

Main Results:

• Six of eight primary endpoints met or exceeded comprehension thresholds.
• High comprehension for 'Check for suspected overdose' (95.8%) and 'Give the first dose' (98.2%).
• Comprehension of 'Call 911 immediately' (90.3%) and the composite 'Check, give, and call' (81.1%) were noted.

Conclusions:

• Consumers demonstrated sufficient understanding of most naloxone label instructions.
• The model drug facts label is adequate for OTC naloxone product development.
• The FDA's label design supports increased access to naloxone for the opioid crisis.