Navigation Links
FDA Faults Drug Information for Consumers
Date:12/16/2008

Pamphlets given out by pharmacies aren't always easy to understand

TUESDAY, Dec. 16 (HealthDay News) -- The printed consumer information that accompanies new prescription drugs is often difficult to read or understand, the U.S. Food and Drug Administration said Tuesday.

In a new report, the FDA said the "consumer medication information" -- intended to spell out the proper use and risks of drugs -- failed to meet a Congressionally mandated goal that 95 percent of all new prescriptions be accompanied by useful guidance.

"The study reveals that consumers are not consistently getting the information they need to promote the safe and effective use of prescription medicines," Dr. Paul Seligman, associate director of safety policy and communication at the FDA's Center for Drug Evaluation and Research, said during a Tuesday teleconference.

"The current system has had more than a decade to get it right," Seligman said. "It's time to try a different approach with a greater chance of success."

Back in 1996, Congress stipulated that 95 percent of all new prescriptions coming from pharmacies be accompanied by useful consumer medication information by 2006.

The new report, Expert and Consumer Evaluation of Consumer Medication Information, said most consumers -- 94 percent -- received leaflets either stapled to the prescription or inside the bag. But only about three-quarters of this information met the minimum criteria for usefulness, the report said.

The FDA considers the information useful if it is scientifically accurate, unbiased and presented in a legible and easy-to-understand format. The information should include the drug's name, how it should be used, potential adverse reactions, and a reminder urging patients to talk to their health-care professional. It should also tell consumers how to know if the drug is effective and situations when it shouldn't be used.

The study found less than one in 10 leaflets met the criteria set for legibility and comprehensibility, Seligman said. "Leaflets for the same drug ranged from as few as 33 words to as many as 2,400 words, depending on the pharmacy where the information was distributed," he said.

The researchers evaluated the consumer information provided by 284 pharmacies for two drugs -- metformin, a diabetes drug used to lower blood sugar, and lisinopril (Prinivil), a medication for high blood pressure.

Seligman said there has been some improvement since the last FDA study, done in 2001, which found that 89 percent of patients received written information with their new prescriptions. But only about 50 percent of the information met the minimum standards for consumer usefulness.

To solve these problems, the FDA's Risk Communication Advisory Committee will hold a public meeting early in 2009 to discuss the study's findings. Also, the agency has created a Web site where the public can comment on the study and offer suggestions on ways to provide better prescription information.

The study was conducted by the University of Florida College of Pharmacy under a $350,000 FDA contract.

More information

To learn more about the new study and to offer comments, visit this FDA Web page.



SOURCES: Dec. 16, 2008, teleconference with Paul Seligman, M.D., M.P.H., associate director of safety policy and communication, U.S. Food and Drug Administration Center for Drug Evaluation and Research


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Association of Academic Health Centers Faults Bushs FY 2009 Budget
2. Colorado Among First States in Nation to Share Health Information Across Health Care Organizations
3. Kimball Health Services Selects HMS to Provide Information Technology Infrastructure
4. WellPoint Announces Collaborative Partnership to Expand Access to Health Care Provider Information
5. NeedyMeds.org Offers Information on Drug Discount Coupon
6. American Academy of Dermatology Issues Statement on FDA Report to Congress About Labeling Information on Indoor Tanning Devices
7. Highmark Blue Cross Blue Shield Provides Online Physician Quality Information to Members
8. Hospice Community Encouraged to Respond to Daschle Request to Participate in Information Gathering about Healthcare Concerns
9. OptumHealth Launched myOptumHealth.com, Health and Wellness Information Destination with Clinically Reviewed Content, Tools and Resources
10. Blue Cross Names New Chief Information Officer; Senior Vice President, Human Resources and Facilities
11. Dr. Charles Kennedy, Vice President of Health Information Technology for WellPoint, Inc., to Present Today at The 4th Annual World Healthcare Innovation and Technology Congress (WHIT v.4.0)
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Faults Drug Information for Consumers
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, and ... in the eye of the beholder, according to experts who offered insights and commentary ... of Managed Care. For the full issue, click here . , For the ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic ... Coating, Parenteral) - Global Forecast to 2021" report ... The global pharmaceutical excipients market is projected to ... of 6.1% in the forecast period 2016 to 2021. ...
Breaking Medicine Technology: