MedGuides Empower Patients

The 2006 deadline is fast approaching for the congressional mandate that states 95% of new prescriptions filled must be accompanied by useful written information. The Pharmaceutical Printed Literature Association (PPLA) is not very optimistic that this deadline will be met. Last month, PPLA issued a white paper titled “The Void in Useful Consumer Rx Information: Past, Present, and Future.” The paper, which can be downloaded from the PPLA Web site at www.pplaonline.org, explores the state of useful printed prescription information for patients as well as approaches toward realizing Congress’s goals.

“Consumers need reliable information to ensure that they take their prescription medications properly,” says Peter Mayberry, PPLA executive director. “Unfortunately, as our white paper details, consumers are not getting that information from their pharmacies.”

One form of patient prescription drug information PPLA advocates is the use of patient package inserts (PPIs) or medication guides, also known as MedGuides. FDA regulates only a small portion of prescription information that consumers receive, the paper points out. In the 1990s, FDA proposed rules that would have required MedGuides with most prescription drugs, but Congress placed a moratorium on FDA action until 2006. Currently, the agency requires MedGuides to accompany only a limited number of drug products that pose a serious or significant health concern.

Last month, FDA added another drug category to the list. The agency announced a strategy to safeguard children treated with antidepressant medication. The strategy included developing a MedGuide and adding a black box warning to the labeling of all antidepressant medications describing the increased risk of suicidal behavior in children who take the drugs. According to a press release issued by the agency, FDA will work with the manufacturers of antidepressant medications to make the MedGuides available as soon as possible. FDA also intends to work with manufacturers to implement unit-of-use packaging for all antidepressants as a means of ensuring that patients receive a MedGuide with every prescription or refill.

FDA’s decision has been grabbing headlines. Despite the controversy surrounding the use of antidepressants in children and the possible risks involved, the agency’s actions have been met with nods of ap-proval. The industry recognizes the need for educating the public and healthcare professionals about the risks involved in taking antidepressants—or any prescription medication. The consensus seems to be that consumers should have access to accurate, comprehensible information that will help them comply with drug regimens, understand the risks involved, and make informed decisions.

PPLA is urging FDA to resurrect its MedGuide proposal, which would require medication guides for drugs most likely to cause harm if not taken properly and PPIs for all drugs not accompanied by MedGuides. Hopefully, the association’s white paper and FDA’s black box warning for all antidepressants will continue to draw attention to the issue and inspire further discussions.

Kassandra Kania, Managing Editor