Education—for prescribers and for patients—is key to reducing risks associated with opioid use.
 

A new Food and Drug Administration risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids offers measures to lower risks and improve safe use of ER and LA opioids—while seeking to ensure that patients in pain have access to needed medications. The strategy, released on July 9, is part of a federal initiative to address widespread problems of prescription drug abuse, misuse, and overdose. 
 
“Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” said FDA Commissioner Margaret A. Hamburg, MD. FDA’s goal here, she said, “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.”
 
Opioid manufacturers to underwrite training for prescribers
Manufacturers of ER and LA opioids (there are more than 20) will be required to provide education programs to prescribers of these medications. Training will be based on learning objectives established by the FDA Blueprint (www.fda.gov/downloads/drugs/drugsafety/.../ucm277916.pdf), which contains the core messages that must be conveyed to prescribers about risks and appropriate prescribing practices for ER and LA opioids.
 
Accredited providers of continuing medical education (CME) will develop and deliver the opioid training activities; ER and LA opioid companies will support these programs through independent education grants.
 
Program curricula will include information on how to:

• weigh risks and benefits of opioid therapy
• select patients
• manage and monitor their ER and LA opioid therapy
• counsel patients on safe use of opioid therapies.

Prescribers will also be trained to recognize evidence of, and potential for, opioid misuse, abuse, and addiction, and will be given general and specific drug information for ER and LA opioids.
 
Teaching patients about safe use
The REMS requires opioid manufacturers to provide education materials to patients, too. These materials must be reviewed and approved by the FDA, and include:

• an updated, 1-page Medication Guide that contains consumer-friendly information on the safe use, storage, and disposal of ER and LA opioid medications
• a patient counseling document with: instructions to consult a health care provider before changing the dosage of an ER or LA opioid; signs of potential overdose, including emergency contact instructions; and advice on safe storage.

Companies will track programs’ effectiveness
The REMS calls for opioid manufacturers to achieve certain FDA-established goals for prescribers of ER and LA opioids who complete the training. They must periodically assess prescriber implementation of the REMS, the program’s success in meeting goals, and prescribers’ understanding of risk information over time.
 
Companies must also report to the FDA whether the REMS is impeding patients’ access to pain medication.
 
The FDA will review company assessments and might, if necessary, require implementation of additional elements to achieve program goals.
 
Participation by prescribers is voluntary—for now
Prescribers are not required to participate in a REMS training program for ER and LA opioids, and there are no conditions placed on them for prescribing these analgesics. The Obama Administration has, however, endorsed mandatory training on responsible opioid prescribing as part of a comprehensive plan to address prescription drug abuse; legislation on such a mandate is being pursued.
 
The first REMS continuing education activities for ER and LA opioids should be ready for prescribers by March 1 of next year.
 
For more information
See the FDA’s question-and-answer article at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm.
 
For the full list of ER and LA opioid products for which the opioid REMS is required, visit: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251735.htm.