Sen. Collins’ Committee Explores Ways to Improve Rx Drug Info Given to Consumers

WASHINGTON, DC – The U.S. Senate Special Committee on Aging, of which Senator Collins is Ranking Member, today held a hearing to examine ways to provide seniors and consumers with easy-to-read, accurate and up-to-date information about the uses and risks of their prescription drugs.

Patient advocates and others have long expressed concerns about the quality and consistency of medication information contained in the leaflets pharmacists give out with prescriptions. Presently, the U.S. Food and Drug Administration (FDA) does not regulate information included in these leaflets, which can be difficult to read and understand.  This is particularly true for older patients who may be taking multiple medications, and who may be experiencing vision or cognitive problems.

A 2008 FDA study found that, while 94 percent of consumers receive information leaflets with their new prescriptions, only 75 percent of these leaflets meet even minimum criteria for usefulness. The Institute of Medicine identified poor labeling as source of medication errors that injure at least 1.5 million Americans every year.  

Senator Collins said, “In an ideal world, all patients would receive extensive counseling about the risks, benefits and safe administration of their prescription drugs from their physicians and pharmacists. In the real world, however, these conversations are often limited and sometimes non-existent.”  She added, “Ensuring that patients have access to accurate, up-to-date, and consumer-friendly information about their prescription medications is therefore an important component of drug safety.”

Senator Nelson called this an important consumer protection issue.  

During the hearing, Senator Collins raised particular concerns about an FDA proposal to shift entirely to electronic labeling information in lieu of paper. Senator Collins expressed concern that many patients and health care providers still reside in rural areas with limited Internet access. She also noted that there are times when electronic technologies simply are not available due to temporary power outages or during the aftermath of natural disasters.

While expressing similar concern about a paperless system, one of the witnesses pointed out that military pharmacists and medical personnel practicing under extremely challenging situations and without Internet access because of security concerns would also be left without drug information if we were to eliminate paper and shift entirely to electronic labeling.

Witnesses also discussed the FDA’s proposal to consolidate written information in an effort to make it more concise and consistent. 

Hearing witnesses included: Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Doris Peter, PhD, Associate Director, Consumer Reports Health Ratings Center; Richard Scholz, Jacobs Scholz and Associates, LLC; Gerald McEvoy, Pharm.D., Editor in Chief, AHFS Drug Information and Consumer Medication Information, American Society of Health-System Pharmacists.