TABLE 6-4Example of an Adapted Benefit-Risk Framework for Approval of Opioid Products

Decision FactorEvidence and UncertaintiesConclusions and Reasons
Characteristics of Opioid
How Opioid Fits Among Currently Available Pain Treatment Options
Benefits Observed in Clinical Trials, Overall
  • Benefits to patients
  • Public health benefits
Risks Observed in Clinical Trials
  • Risks to patients
  • Public health risks
Predicted Benefits/Risks to Families of Patients
Predicted Benefits/Risks to Society, Overall
  • Special communities
  • Subpopulations
Diversion Potential
Predicted Effects on Use of Other Opioids or Illicit Drugs
Risk Management, Overall
  • Potential for off-label use
  • Advertising/promotion

From: 6, Opioid Approval and Monitoring by the U.S. Food and Drug Administration

Cover of Pain Management and the Opioid Epidemic
Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editors.
Washington (DC): National Academies Press (US); 2017 Jul 13.
Copyright 2017 by the National Academy of Sciences. All rights reserved.

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