FDA Approves Opioids REMS

To reduce opioid painkiller abuse and misuse risks as much as possible, the FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for a class of opioid medications, known as extended-release (ER) and long-acting (LA) opioid analgesics used in pain treatments.  The FDA’s risk management plan affects more than 20 ER/LA opioid companies.  The companies will be required to make educational training available for health care professionals on the safe prescribing of ER/LA opioid medications, as well as carry out other new activities to reduce the risks of these drugs.  Companies that make ER/LA opioid analgesics are required to make available for free or at nominal cost continuing education courses from accredited providers.  The FDA noted that it expects companies to train at least 60 percent of the 320,000 prescribers of ER/LA opioids within three years from when training is available. 

Centers for Disease Control and Prevention (CDC) statistics show that 15,597 Americans died from overdoses involving opioids in 2009, an almost four-fold increase from 1999.

Opioids—named as such because they are synthetic versions of opium—are narcotics that work by changing the way the brain perceives pain.  Opioids available in pills, liquids and skin patches as treatment for moderate to severe chronic pain.  ER/LA opioids are more of a safety concern than immediate-release formulas because they are stronger and either stay in the body longer or are released into the body over longer periods of time.  The drugs that will be required to have a REMS include:

  • Avinza
  • Butrans (transdermal buprenorphine)
  • Dolophine (methadone)
  • Duragesic (transdermal fentanyl)
  • Embeda
  • Exalgo (hydromorphone)
  • Kadian
  • MS Contin
  • Opana ER (oxymorphone).
  • Oramorph (all morphines)
  • OxyContin (oxycodone)

The intent of the REMS is to train health care professionals on how to properly prescribe and instruct patients on safe use.  According to the agency, health care professionals who participate in the REMS program will have more knowledge and awareness and can have frank conversations with their patients about the risks and appropriate use of opioids.  A new patient counseling document will be available for prescribers to use when talking to their patients about these medications. 

The REMS also includes an updated Medication Guide—a plain language paper handout for patients that the pharmacist will provide when a patient receives an ER/LA opioid medication to explain the proper usage of opioid painkillers.  The paper handout could be tailored further for individual medications, such as any instructions regarding interactions with food and beverages.

The first continuing education activities under the REMS will likely be offered to prescribers by March 1, 2013.