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New Safety Measures for Opioid Medications

Summary: 
Today, the FDA approved a plan to increase the safety of how opioid drugs are prescribed and used.

Today, the Food and Drug Administration (FDA) approved a plan designed to increase the number of health care professionals who are trained on how to properly prescribe certain types of painkillersand help patients use prescribed medications safely. The Risk Evaluation and Mitigation Strategy (REMS) targets extended-release (ER) and long-acting (LA) opioid drugs, including prescription medications containing oxycodone hydrochloride.

The new FDA plan is the latest step in a multi-agency Federal effort to address prescription drug abuse, a major public health problem in the United States. These drugs, used for treating patients with severe, persistent pain, provide needed relief for millions but also pose a serious risk of abuse, overdose, and death. Nearly 15,000 Americans died from unintended consequences of pain reliever use in 2008, according to the Center for Disease Control.

The REMS plan will affect more than 20 companies that manufacture opioid analgesics, requiring them to make continuing education programs available for prescribers based on models developed by the FDA. These programs will help prescribers weigh the risks and benefits of opioid therapy, manage and monitor patients correctly, and counsel patients more effectively. Opioid manufacturers must also provide prescribers and patients with information regarding the safe use of these drugs and the risks involved.

In April, 2011, as part of its comprehensive plan to address the epidemic of prescription drug abuse, the Obama Administration called for training prescribers in proper use of ER and LA opioid analgesics. The FDA continues to support this approach by including company and prescriber compliance as part of its REMS plan.