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FDA Cracks Down on Precription Opioid Abuse

August 22, 2012

The FDA now requires drug manufactures to create Risk Evaluation and Mitigation Strategy for drugs such as Drugs like OxyContin, Avinza, Dolophine, Duragesic, and eight other brand names.

Last  month, the U.S. Food and Drug Administration (FDA) approved an initiative that aims to prevent future abuse of extended release and long-acting opioids. The program, known as a Risk Evaluation and Mitigation Strategy (REMS), primarily requires opioid manufactures to educate doctors about proper pain management, patient selection, and how to ensure that the benefits of the drug outweigh the risks. 

Drugs like Oxycontin, Avinza, Dolophine, Duragesic, and eight other brand names are among the most commonly abused prescription drugs and tend to lead to overdoses, addiction, and thousands of deaths across the U.S. 

The FDA estimates that 23 million people were prescribed ER/LA opioid drugs in 2011 and many are at high risk of abusing them because many people are not aware of the risks. FDA commissioner, Dr. Margaret Hamburg says, “The FDA’s goal with this risk evaluation and mitigation strategy approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”

The FDA and the Obama administration aim to shed light on issues of misprescribing and overprescribing while improving awareness about the dangers of opioid drugs. Since July 9, 2012, the FDA is now notifying opioid makers that they must propose a REMS plan within 120 days. In hopes of tackling the prescription drug epidemic, the FDA wants the plan to include a way to keep track of whether the numbers of misuse, addiction, and mis-prescribed are coming down. Read more…

Gil Kerlikowske, director of the Office of National Drug Control Policy, said:

“We commend the FDA for taking action to save lives by increasing access to prescriber education. Since day one, the Obama Administration has been laser focused on addressing the prescription drug abuse epidemic and today’s action is an important contribution to this comprehensive effort.”

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