ALEXANDRIA, Va. The National Association of Chain Drug Stores on Monday submitted comments to the Food and Drug Administration stating that it was concerned about the effectiveness of Medication Guides and regulations that could make their distribution increasingly inefficient and difficult.
NACDS believes pharmacists face large obstacles in complying with current requirements. The MedGuides are given to patients to inform them about health information for certain products that pose serious public health concerns.
“In recent years, the FDA has expanded the MedGuide program without evidence that MedGuides are the best way to communicate risk to patients,” the letter states. “Further, there is no organized, efficient, or uniform approach to assuring their distribution by manufacturers to retail pharmacies. Despite hearing from industry and provider groups that the program is seriously flawed, the FDA continues to underestimate the burdens faced by pharmacists in complying with the program.”
In the letter, NACDS proposes a “full and transparent review of the MedGuide program before imposing the burden associated with compliance on pharmacists and patients.”