FDA Posts Draft Guidelines for Continuing Education CME to be Offered to Prescribers of Long-Acting Opioids

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Since May 11, 2011 the FDA has worked with developers and marketers of long-acting, extended-release opioid drugs to develop a prescriber education program assuring that the drugs will be prescribed appropriately and used safely.
The FDA cites public health estimates that more than 35 million Americans age 12 and older have reported non-medical use of opioid analgesics during 2010, up from 29 million in 20021.  In 2009, nearly 342,000 emergency department visits were associated with non medical use of opioid analgesics. In 2007, nearly 28,000 Americans died from unintended consequences of drug use, and of these, nearly 12,000 involved prescription drug pain relievers.
On November 4, 2011, the FDA posted draft guidelines for the continuing education of professionals who prescribe the drugs.  The draft provides the basic outline and central messages the FDA wants conveyed to prescribers in a 2 to 3-hour education module.  The final guidelines will be posted on the FDA web site for use by continuing education providers and staffs.
The draft guidelines cover 7 basic areas of interest to prescribers:  

• Why prescriber education is so important

• Assessing patients for treatment with long-acting opioids  

• Initiating therapy, modifying dosage, and discontinuing use  

• Therapy management  

• Counseling patients and caregivers on safe use

• General opioid drug information

• Product-specific drug information

 The FDA intends prescriber training to be conducted by accredited, independent continuing education providers.  The instruction will be free to prescribers.  Costs will be covered by unrestricted grants to accredited continuing education providers funded by the sponsors.