A Letter Released to Medical Practitioners on
March 2, 2010

New FDA Requirements Pending for
Prescribers of Opioids

You may have read recently about the FDA’s latest Risk Evaluation and Mitigation Strategies (REMS) governing opioids prescribed for pain management. In most FDA press releases, it would have been easy to miss the elements most important to prescribers. Implementation of the most onerous parts of the newest FDA REMS is still pending. The portion of the opioid REMS labeled “Elements to Assure Safe Use” directly affects prescribers. Pending REMS elements include:

• Healthcare providers who prescribe analgesic opioids will be required to have particular training, or experience, or special certification.
• Practitioners who dispense the drug will need to be specially certified.
• There must be ongoing evidence of safe use such as laboratory results.
• Each patient using the drug must be subject to ongoing monitoring.
• Each patient using the drug must be enrolled in a registry.
• Prescribers will need to enroll in a program requiring periodic retraining, recertification, and reenrollment.

Information about the pending requirements and programs governing prescribers can be obtained from the FDA website here:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm

The FDA has described prescription opioid analgesics as being “at the center of a major public health crisis of addiction, misuse, abuse, overdose, and death.” To support this assessment, John Jenkins, MD, of the FDA, states that hundreds of deaths are reported each year for opioid misuse, both intentional and accidental. Of particular interest to the FDA is new 2007 data showing that opioids taken for nonmedical purposes were obtained from drug dealers or strangers only 4.1% of the time. The majority of opioids taken for nonmedical purposes were received through a prescriber (18.1%) or through a friend or relative who had been prescribed the opioids (70.6%). The monthly number of people in the U.S. using opioids nonmedically is 5.2 million and on the rise.

At my private practice, The Center for Musculoskeletal and Pain Medicine, I practice interventional pain medicine. We use any number of strategies and treatments including opioids when indicated. My practice is very well prepared to implement opioid therapy in a way that will protect patients from diversion and misuses as well as keep all involved physicians safe from a regulatory perspective. You may call to receive more information or review past articles on our website (article directory / search feature)

When you have patients struggling with chronic or severe pain, remember
Dr. Neal Taub and The Center for Musculoskeletal and Pain Medicine.