FDA initiates opioid training program
  • Tue, 07/10/2012 - 4:14pm

Yesterday, the U.S. Food and Drug Administration released a consumer update regarding its approval of a risk management plan that will train health care professionals and educate patients about the proper use of opioid medications.

Its website states that the FDA will require over 20 opioid companies to develop a program to inform and instruct health care professionals to safely prescribe extended-release and long-lasting opioids analgesics. Health care professionals often prescribe this class of pain-relieving drugs to patients for the management of moderate to severe chronic pain, but these drugs can be dangerous if misused.

“There are a limited number of options available for the treatment of pain. Opioids are one option, but they carry a significant risk of misuse, abuse, overdose and death. We are trying to help physicians manage the risks and improve the safety of using these medicines,” states Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction Products.

The FDA website says that the program, called the Risk Evaluation and Mitigation Strategy (REMS), will also require opioid companies to develop new ways of managing extended-release and long-lasting opioid treatments for patients and health care professionals to decrease the potential risk of overdose or death.

Opioids belong to a class of drugs called narcotics and can be administered in the form of pills, liquids and skin patches, according to the FDA’s website. Extended-release and long-lasting opioids pose more of a risk than immediate-release opioids, the FDA says, because they remain in the body for long periods of time.

The FDA’s website states that the agency will require opioid companies to provide further education for health care professionals hosted by authorized providers for free or at nominal costs. Medication Guides and Counseling Guides will inform patients about the safety of each product and will give instruction for each individual medication.

The website goes on to day that, within three years of instigating the REMS program, the FDA hopes to train 60 percent of the 320, 000 prescribers of extended-release and long-lasting opioids. The agency will also assess the companies over time to evaluate the program’s usefulness.

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About the Contributor

Jessica Davids
Cleveland
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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