Hearing Explores Ways to Improve Prescription Drug Information Given to Consumers

WASHINGTON, DC – The U.S. Senate Special Committee on Aging held a hearing on Wednesday, December 11 to explore various ways to make medication information leaflets that pharmacists staple or put inside the bag with a consumer’s prescription more clear, up-to-date and easy to read.

The panel heard from the U.S. Food and Drug Administration (FDA) and took recommendations from Consumer Reports and others. The committee  also examined legislation filed recently to address the issue.

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 duplicative, incomplete, as well as difficult to read and understand.

The hearing came at the request of Sen. Kirsten Gillibrand (D-NY), who introduced legislation, (S. 752) in April to require the FDA to approve and standardized patient medication information given to consumers. She got involved in the issue after a teenager in her state committed suicide in 2007 after his parents say he took a prescription allergy medication with an undisclosed side effect of depression.

In 2011, Consumer Reports found that drug-safety leaflets given to consumers at five different pharmacies were nearly impossible to read, had inconsistent information about side effects or used confusing medical jargon – mirroring results of a similar study the FDA conducted in 2008. According to the FDA’s findings, only 75 percent of medication information leaflets met even minimum criteria for usefulness and ranged in length from 2,482 words to as few as 33.

Elderly patients have particular difficulty reading and understanding drug labeling and information. In a survey reported in Health Affairs in 2007, 40 percent reported problems in reading their drug labels and even fewer reported that they had a clear understanding of the instructions. An estimated 1.5 million medication errors occur annually in the United States, according to a 2006 Institute of Medicine report. Poor labeling was identified in as a critical source of those errors.

SENATE SPECIAL COMMITTEE ON AGING

HEARING: Protecting Seniors from Medication Labeling Mistakes

3:45 p.m. Wednesday, December 11, 2013

Dirksen Senate Office Building, Room 562

Witnesses:

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

 

 

To watch the hearing, as well as access Member statements and witness testimony click here.