FDA approved a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid medications.

On July 9th the FDA approved a new strategy to improve the safe use of extended-release and long-acting opioids. The plan is designed to ensure that health care professionals are trained on how to properly prescribe these medicines and how to instruct their patients about using them safely. The main component of this plan will be special continuing education classes for the clinicians prescribing the products.  The classes will be offered by the drug companies through accredited providers and should be available starting in March or April of 2013.  Also included in the plan will be a plain language Medication guide provided to the patient with the prescription.

The following medications will be covered by this plan:

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

For more information click here to visit the FDA’s website on the program.

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