Risk Evaluation and Mitigation Strategy (REMS)

In July 2012, the U.S. Food and Drug Administration (FDA) introduced new safety guidelines for long-acting (LA) and extended-release (ER) narcotics, also called opioids or opioid medicines, in the form of a risk evaluation and mitigation strategy (REMS). LA and ER opioid medications are widely prescribed for moderate-to-severe pain that requires treatment for a prolonged period of time.

Pain Medicine Image

LA and ER narcotic pain relievers are associated with a high risk for abuse and overdose. They are stronger than traditional narcotics because they either stay in the body longer or are slowly released into the body over time. According to the Centers for Disease Control and Prevention (CDC), opioid overdose resulted in four times more deaths in the United States in 2009 than in 1999. In 2008, 14,800 deaths in the U.S. involved narcotic pain relievers and in 2009, that number rose to about 15, 600.

LA/ER narcotic pain relievers are available as pills, liquids and skin patches. According to the FDA, the new risk evaluation mitigation strategy involves the following medications:

  • Avinza
  • Embeda
  • Hydromorphone (Exalgo)
  • Kadian
  • Methadone (Dolophine)
  • Morphine (e.g., Oramorph)
  • MS Contin
  • Oxycodone (OxyContin )
  • Oxymorphone (Opana ER )
  • Transdermal buprenorphine (Butrans )
  • Transdermal fentanyl (Duragesic)

The goals of the new REMS are to evaluate the abuse risk for LA and ER prescription pain medications, help reduce this risk, and improve the safety of these medicines for patients who need them. To help ensure that the program achieves its goals, the Food and Drug Administration will review periodic assessments conducted by the drug manufacturers and may make additional recommendations and requirements based on these assessments.

Components of the risk evaluation and mitigation strategy for LA/ER narcotic pain relievers are the following:

  1. Provide proper training for health care providers who prescribe LA and ER opioids. According to the new REMS, companies that manufacture these narcotic pain relievers will be required to make education programs available to prescribers. This training, which will not be mandatory, will include comprehensive information about long-acting and extended-release opioids as well as information about:
    • Weighing the risks and benefits of treatment with LA/ER narcotic pain relievers
    • Determining which patients are good candidates for treatment with LA/ER narcotic pain relievers
    • Monitoring patients who are undergoing treatment
    • Counseling patients about using LA/ER narcotic pain relievers safely
    • Recognizing evidence of, and potential for, narcotic abuse and addiction
  2. Provide FDA-approved patient education information and educational materials about using LA and ER opioids safely. This information is to be presented in a consumer-friendly format and will include:
    • Instructions for proper storage and disposal of the medications to protect family members and household visitors from accidental exposure
    • Signs of overdose
    • Emergency contact information
    • Warnings to contact a health care provider before changing medication dosages and frequency of dosing
    • Potential food, beverage and drug interactions
    • List of do’s and don’ts specific to the type of medication prescribed
  3. Drug manufacturers and the FDA will conduct periodic assessments to evaluate the effectiveness of the REMS program. The success of the program will be measured, in part, by the percentage of health care providers who complete the training provided. The assessments also will attempt to determine if the program has prevented patients needing LA/ER narcotics from having access to the pain medications.

Source: U.S. Food and Drug Adminstration (FDA)

Publication Review By: the Editorial Staff at Healthcommunities.com

Published: 11 Jul 2012

Last Modified: 11 Jul 2012