NCPA responded to an FDA request for comment on the burden of regulations around medication guides for prescription drug products, in which the agency estimated that in the next three years, it will take dispensers approximately 10 seconds on average to provide a medication guide to a patient. We argued that may be a significant underestimate, especially where the FDA previously estimated a time frame of three minutes. We questioned whether the estimate accurately reflects the time spent counseling patients when questions arise, workflow interruptions, the need for reprints when guides are lost or damaged, and printing, paper, toner, and maintenance costs.
We also argued that the FDA is unclear on the precise administrative burden to pharmacies, saying the agency must consider the direct and hidden costs to community pharmacists.
Read the NCPA comment letter here.
