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FDA’s Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics

The focus of the FDA’s Blueprint is to teach prescribers of extended-release (ER) and long-acting (LA) opioid analgesics its risk evaluation and mitigation strategy (REMS). The FDA has decided to implement this strategy into the medical community because opioid misuse and abuse, which often results in injury and death, has become a major public health problem. There are two major teaching points: 1) safe prescribing habits; and 2) patient education of the risks of taking these analgesics. The strategy (REMS) will be shared with clinicians during at least three hours of CME training.

As stated in the FDA’s Blueprint, “Health care professionals who prescribe ER/LA opioid analgesics have a responsibility to help ensure the safe and effective use of these drug products.” This includes evaluating the risk factors for opioid abuse as part of the medical and psychosocial history and to identify those patients who are “opioid tolerant.” Because human behavior is difficult, if not impossible even for mental health professionals to predict, this will be a large challenge, especially since studies have found that 26% of opioid users were dependent on opioids (with a lifetime dependence of 36%).

For further information, visit the FDA’s website: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310870.htm

Questions:

  1. Are you a prescriber of ER/LA opioid analgesics?
  2. Will you enroll in the educational program mandated by the FDA to prescribe ER/LA opioid analgesics?
  3. Do you find the mandated education through Pharma-funded CME activities contradictory in light of the past years of severe scrutiny over Pharma-funded CME activities in other therapeutic areas? Are these disorders less of a public health issue than opioid analgesics prescribed for pain management?

Post your answers in the comment section below!