FDA Study : Much of Private-Sector Consumer Medication Information Not Consistently Useful
A study released today by the U.S. Food and Drug Administration found that the
printed consumer medication information (CMI) voluntarily provided with new
prescriptions by retail pharmacies does not consistently provide easy-to-read,
understandable information about the use and risks of medications. The study,
Expert and Consumer Evaluation of Consumer Medication Information, showed that
while most consumers (94 percent) received CMI with new prescriptions, only
about 75 percent of this information met the minimum criteria for usefulness as
defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all
new prescriptions to be accompanied by useful CMI by 2006.
"The current voluntary system has failed to provide consumers with the quality
information they need in order to use medicines effectively and safely,” said Janet
Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and
Research. “Because the congressional goals have not been met, the FDA intends
to seek public comment on initiatives that can be used to meet the goals."
CMI has been defined as being useful if it includes scientifically accurate, unbiased
information that is presented in an understandable and legible format. Specifically,
CMI should include the drug name and uses, how to monitor for improvement in
the condition being treated, contraindications (situations when the medicine
should not be used), symptoms of serious or frequent adverse reactions and what
to do, and certain general information, including statements encouraging patients
to talk to their health care professional.
"We need to work with pharmacy operators, drug manufacturers, health care
professionals, and consumers to come up with a sensible, comprehensive and more
effective solution,” said Woodcock.
In early 2009, the FDA Risk Communication Advisory Committee will hold a public
meeting to discuss the study’s findings. In addition, the FDA has created a Web
site to receive public comment on the study and solicit feedback on the best ways
to provide useful prescription information to consumers.
The FDA regulates prescription drug labeling written for health care professionals
and Medication Guides and Patient Package Inserts written for consumers, but the
agency does not review or approve CMI leaflets. The agency’s role, as set forth
by Congress, has been to encourage the private sector to provide this
information, supply the companies with the necessary guidance and evaluate the
private sector’s progress.
The FDA-sponsored study was conducted by the National Association of Boards of
Pharmacy through a subcontract with researchers at the University of Florida,
College of Pharmacy. Shoppers trained to simulate patients visited pharmacies
randomly selected throughout the United States. The shoppers gave the
pharmacists prescriptions for two commonly prescribed drugs, metformin and
lisinopril, and collected the CMI provided with the prescriptions. Expert and
consumer panels evaluated the quantity and quality of this information.
There were some improvements shown by the new study when compared to a
similar evaluation of CMI in 2001, Evaluation of Written Prescription Information
Provided in Community Pharmacies, 2001. That study revealed that 89 percent of
patients received written information when their new prescriptions were filled, but
only about 50 percent of the CMI met minimal criteria for usefulness.
Expert and Consumer Evaluation of Consumer Medication Information, 2008
BeMedWise Program at NeedyMeds encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, BeMedWise does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not BeMedWise.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.