OCTOBER 01, 2007

Congressional leaders raised concerns that the "FDA's MedGuide program is not adequately assisting patients in understanding the risks associated with certain medications." These concerns may lead to e-mailed MedGuides and other changes in the way that the FDA requires pharmacists to inform patients about prescription drugs.

A new report issued by the Senate Appropriations Committee also suggests that the explosive growth of MedGuide leaflets may be creating a burden for pharmacists as well as a source of confusion for patients. Although the "FDA initially intended the program to produce MedGuides for a limited number of prescription products every year," at the end of March 2007 the pamphlets were required to be dispensed with 240 prescription products.

"This unanticipated volume of Med- Guides 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," the Senate report warned.

To address these problems, the committee urged FDA officials to work with patient groups, manufacturers, and national pharmacy associations to design improvements to the program. The Senate panel also suggested a series of MedGuide improvements, including the following:

• New procedures to ensure efficient distribution from manufacturers to community pharmacies

• Offering pharmacists flexibility in providing MedGuides to patients via e-mail

• The creation of a uniform MedGuide for each class of drugs to avoid duplicate and excessive MedGuides


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