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.