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REMS Evaluation
Specifying a priority metrics and outcomes of interest is critical to provide objective evaluations of opioid REMS.  More than a decade of opioid risk management indicates that both intended and unintended consequences of a REMS should be included.  Intended consequences of a REMS Program:

  • Monitored drug is not prescribed to inappropriate patient (i.e., high potency opioid to opioid naïve patient)
  • Monitored drug in not involved in poisonings to young children out of proportion to other opioid products
  • High potency opioid product is not used by new initiates to prescription opioid abuse out of proportion to other opioid products
  • Diversion of prescription opioid is not out of proportion to other opioid products
Unintended Consequence of a REMS Program:
  • Access to prescription opioids to legitimate pain patients is not substantially decreased by the REMS
  • A clinically undesirable shift in prescribing. For example, potential for increased prescribing of immediate-release opioid products for cancer patients following institutions of REMS for extended-release products.

Food and Drug Administration - Postmarket Drug Safety Information