The FDA's proposed Prescription Medication Information (PMI) regulation aims to revamp consumer medication information, reducing prescription nonadherence and accidental misuse in the US.

The regulation would require FDA approval of prescription medication information for outpatient settings and blood transfusion clinics. Studies show that nonadherence and misuse contribute to hospitalizations, treatment failures, and deaths. Current sources of information are often lengthy, technical, or flawed. The proposed regulation focuses on key areas: drug name, safety information, side effects, and directions, with improved readability and consumer acceptance. The regulation could lead to improved healthcare decisions, cost savings, and estimated annualized savings of $120 million to $4.3 billion. Implementation can occur over five years without delaying drug approvals. Input from pharmacists is needed to address translation requirements, prioritize digital PMIs, and provide clear guidance on the use of different medication information formats.

Despite these suggestions, the PMI regulation has the potential to enhance patient safety and address inefficiencies in healthcare spending, making it crucial for pharmacists to provide feedback to ensure its effectiveness.