Navigation Links
FDA Looks to Crack Down on Misuse of Opioid Painkillers
Date:4/20/2011

By Amanda Gardner
HealthDay Reporter

TUESDAY, April 19 (HealthDay News) -- U.S. health officials unveiled Tuesday a new plan to try to curb misuse of extended-release and long-acting opioid pain killers such as OxyContin, morphine and methadone.

The new Risk Evaluation and Mitigation Strategy (REMS) is part of a larger multi-agency initiative announced Tuesday by the White House to reduce overall prescription drug abuse in the United States.

"This new REMS will provide tools to doctors and other prescribers for appropriate pain management to reduce risks and at the same time preserve access for patients and appropriate management of pain for those suffering from moderate to severe pain," said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, the agency that launched the new program.

For now, the initiative will be limited to extended-release and long-acting products, which, Woodcock said, "have a much greater risk than immediate-release because they contain more medicine."

She did not rule out the possibility that the approach could be expanded to include immediate-release drugs in the future.

Right now, the action affects 16 companies that make both branded and generic products. The products affected are known under their generic names as hydromorphone, methadone, morphine, oxycodone, oxymorphone, transdermal fentanyl and transdermal buprenorphine.

According to Woodcock, about 23 million prescriptions are dispensed each year for extended-release and long-acting opioids, which represented about 10 percent of the opioid market in 2009.

But, abuse and misuse is also extensive, with the FDA estimating that 33 million Americans aged 12 and older used such a drug for non-medical purposes in 2007, up from 29 million people in 2002.

Some 50,000 emergency room visits in 2006 were related to opioids, officials said.

"This is a large and growing problem and, despite a number of efforts over the years, it continues to grow," Woodcock said. "It's clear we have a huge problem on our hands."

One of the main components of the new FDA program will be educating doctors and other prescribers on proper ways to prescribe opioids, as well as how to identify appropriate patients for these drugs.

"If a prescriber has a concern that a patient might unintentionally or intentionally misuse the drug, they need to know how to spot these individuals," Woodcock said.

Doctors will also get materials on how to educate their patients, not only on proper use of opioids but also on proper storage and disposal.

Manufacturers will be required to use one central system to provide these educational materials, Woodcock said. And the FDA will monitor company-generated literature to make sure it isn't promotional but is effective, she added.

Companies have 120 days to issue a draft REMS and Woodcock hoped matters will be completed by early 2012.

"In the meantime, doctors should be prescribing opioids as they have been doing and we hope they thoroughly discuss risks and benefits with their patients," Woodcock said. "People taking opioids should continue to take them as directed and, if they have concerns, should consult a health-care professional."

More information

The U.S. National Institute on Drug Abuse has more on opioids.

SOURCE: April 19, 2011, teleconference with Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Scanning for skin cancer: Infrared system looks for deadly melanoma
2. Lighthouse International Introduces a New, Customizable, Low-Vision Simulator That Shows How the World Looks to People Who Are Visually Impaired
3. Vaccine for Asbestos-Related Cancer Looks Safe
4. Heart Aflutter? Remarkable New Images Show What it Looks Like in 4-D
5. Study Looks At Cost-Effectiveness of ECG in Hyperactive Kids
6. An Earth Day View of Green Building: Earth Advantage Institute Looks 10 Years Forward
7. Cruise Plastic Surgery Looks at Mommy Makeovers from the Husband's Perspective and Offers Tips
8. National Insurance Company Looks to Indianapolis-based TriDigital Solutions for Affordable CD Replication and Mailing Project
9. If the water looks and smells bad, it may be toxic
10. New Procedure for Aortic Valve Replacement Looks Promising
11. Research looks at stuttering differences in boys, girls
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... , ... May 27, 2016 , ... With over 60 ... walk, the demand for a sustainable product to aid in the rehabilitation process has ... in the recovery of individuals with hemiplegia due to stroke. , Ekso Bionics has ...
(Date:5/27/2016)... New York, NY (PRWEB) , ... May 27, ... ... caregivers to casual readers, this installment is bolstered by inspiring human-interest stories, courtesy ... trends and tech within the industry, from leading advocates, associations and industry leaders ...
(Date:5/27/2016)... ... 27, 2016 , ... Beleza Medspa has initiated a new program ... is the first time that Coolsculpting is being used for for more than just ... ensure they meet the prescribed body-fat standard, measured by the circumference-based tape method. ...
(Date:5/27/2016)... New York, NY (PRWEB) , ... May 27, 2016 , ... ... bolstered by inspiring human interest stories, which come courtesy of leaders in the nursing ... within the industry, from leading advocates and associations—namely Abilene Christian University. , As ...
(Date:5/27/2016)... , ... May 27, 2016 , ... ... name in the pharmaceutical, medical and food industries. Aside from its GMP accreditation, ... (SIC), providing proof of successfully certified products, services and staff. , Validation Center ...
Breaking Medicine News(10 mins):
(Date:5/26/2016)... , May 26, 2016 Since ... matured into an essential life science tool for conducting ... applications. BCC Research reveals in its new report that ... growth phase, one powered by a range of new ...      (Logo: http://photos.prnewswire.com/prnh/20140723/694805 ) , ...
(Date:5/25/2016)... GERMANTOWN, Maryland , May 25, 2016 ... bedient dringenden Bedarf zur ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt ... und Entwicklungsvereinbarung mit Therawis Diagnostics GmbH zur Entwicklung ... zu sein. Ein erstes Projekt wird die Entwicklung ...
(Date:5/25/2016)... , May 25, 2016  According to Kalorama ... $381 billion in 2015.  Though these are challenging ... of opportunity for success for companies that remain ... search of new growth prospects medical device companies ... research and development (R&D) than do companies in ...
Breaking Medicine Technology: