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:6/27/2016)... ... 27, 2016 , ... A revolution is underway. Brooklyn-based ... experience for the millions of people who require these medical transport services annually. ... through the use of technology. Now, SmartEMS has put forth an industry-changing app ...
(Date:6/26/2016)... (PRWEB) , ... June 27, 2016 , ... Quality metrics ... yet in many ways they remain in the eye of the beholder, according to ... a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... Aliso Viejo, California (PRWEB) , ... June 26, 2016 , ... ... for Final Cut Pro X. , "Film editors can give their videos a whole ... artistically," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified ... be personalized through a fitness app. The fitness app plans to fix the two major ... only offer a one size fits all type program , They don’t eliminate ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)...   Bay Area Lyme Foundation , collaborating ... for Tick Borne Illness , Harvard Medical School ... Medicine, University of California, Berkeley, and the Veterans ... finalists of Lyme Innovation , the first ... scientists, clinicians, researchers, entrepreneurs, and investors from several ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
(Date:6/24/2016)... June 24, 2016 Research and Markets ... for Companion Diagnostic Tests" report to their offering. ... Companion Diagnostics The World Market for Companion ... medicine diagnostics. Market analysis in the report includes the following: ... (In Vitro Diagnostic Kits) by Region (N. America, EU, ROW), ...
Breaking Medicine Technology: