ALEXANDRIA, Va. An appeal from the National Association of Chain Drug Stores to simplify the daunting patient-education prescription drug guidelines now imposed on community pharmacies has won support from a key member of the Senate Appropriations Committee.
Under rules imposed by the Food and Drug Administration in March, 240 prescription products now require Medication Guides, also known as MedGuides, to help patients understand their medications. NACDS has lobbied the Senate committee for a change in the rules, noting that the MedGuides are "difficult to obtain by pharmacists in an efficient manner," and that requiring them on so many products could overwhelm patients.
U.S. Sen. Jack Reed, D-R.I., a key member of the committee, responded by inserting language to simplify the MedGuide requirements into the official report that accompanies the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Bill for Fiscal Year 2008.
"The FDA initially intended the program to produce MedGuides for a limited number of prescription products every year," noted the committee in its report. "This unanticipated volume of Medguides creates significant administrative burdens for pharmacy providers and has the potential to diminish the usefulness of the program by overwhelming patients with multiple pages of written material."
NACDS president and chief executive officer Steven Anderson praised Reed for having "brought to light flaws in the current MedGuides system. He called the move "an important step toward meaningful reform that will benefit patients, and the ability of community pharmacy to serve patients," and pledged that NACDS would continue to push for a simpler MedGuide system.