|NACDS Presses for Simplification of MedGuides||| Print ||
The National Association of Chain Drug Stores’ (NACDS) efforts to reduce the burdensome requirements of Medication Guides (MedGuides) for a growing number of prescription drugs has received key support from a member of the Senate Appropriations Committee.
U.S. Senator Jack Reed (D-RI) incorporated language that would simplify MedGuide requirements into the official report accompanying the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Bill for fiscal year 2008.
NACDS expressed concern to the Senate Appropriations Committee that FDA’s MedGuide program is not adequately assisting patients in understanding the risks associated with certain medications. As of March 2007, there were 240 prescription products requiring MedGuides. However, not only are these guides difficult for pharmacists to obtain, but there is the potential to reduce the usefulness of the program by overwhelming patients with multiple pages of written material. This is the message conveyed in the committee report. It urged the FDA to work with the various stakeholders to develop improvements to the program. These would include procedures to ensure efficient distribution and flexibility in providing MedGuides to patients, such as distribution via email, formatting modifications to assist with electronic printing, measures to avoid duplicate and excessive Med- Guides, and the use of a standard MedGuide for a class of drugs. The committee also urged the FDA to submit a report on the progress it is making toward these improvements within 120 days of enactment of the act, including whether any legislative action is needed.
“This is an important step toward meaningful reform that will benefit patients and the ability of community pharmacy to serve patients,” notes NACDS President and CEO Steven Anderson.