Reality and responsibility revisited: Stakeholder accountability in the effort to develop safer opioids


  • Steven D. Passik, PhD
  • Howard A. Heit, MD
  • Michael DeGeorge, PharmD



abuse-deterrent formulation, opioid, stakeholder, policy, epidemic


This supplement is dedicated to an exploration of the science, potential utility, and the current state of abuse-deterrent formulations (ADF) of opioid analgesics. There are many stakeholders in the search for safer pain treatments in general, and safer opioid therapy in particular. Healthcare providers, patients, third-party payors, law enforcement and government regulators, the pharmaceutical industry, and the media all have a stake in seeing pain treated and addiction and overdose avoided. As it applies to ADFs, obviously not everyone has a stake in seeing that ADFs succeed commercially; but all stakeholders certainly have a responsibility to see that any potential advance, including ADFs, in protecting the public health is fairly and thoroughly evaluated. Particularly at a time of crisis. In this article, we revisit the framework used by Passik, Heit, and Kirsh (2006) to evaluate stakeholders’ responsibilities with regard to both the opioid abuse and chronic pain epidemics. After evaluating the present status of aspirations delineated over a decade ago, we discuss the updated roles and responsibilities of each stakeholder, with emphasis on the role of ADFs as this technology was unavailable when the original manuscript was written.

Author Biographies

Steven D. Passik, PhD

Vice President of Scientific Affairs, Education, and Policy, Collegium Pharmaceuticals, Inc., Canton, Massachusetts

Howard A. Heit, MD

Assistant Clinical Professor, Georgetown University, Reston, Virginia

Michael DeGeorge, PharmD

Vice President of Medical Affairs, Collegium Pharmaceuticals, Inc., Canton, Massachusetts


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How to Cite

Passik, PhD, S. D., H. A. Heit, MD, and M. DeGeorge, PharmD. “Reality and Responsibility Revisited: Stakeholder Accountability in the Effort to Develop Safer Opioids”. Journal of Opioid Management, vol. 13, no. 6, Dec. 2017, pp. 391-6, doi:10.5055/jom.2017.0405.