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

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

Abstract


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.


Keywords


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

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References


Passik SD, Heit H, Kirsh KL: Reality and responsibility: A commentary on the treatment of pain and suffering in a drug-using society. J Opioid Manag. 2006; 2 (3): 123-127.

Sullivan A: The opioid epidemic is this generation's AIDs Crisis. NY Magazine, Daily Intelligencer. Available at http://nymag.com/daily/intelligencer/2017/03/the-opioid-epidemic-isthis-generations-aids-crisis.html. Accessed June 20, 2017.

Passik SD: Responding rationally to recent reports of abuse diversion of Oxycontin. (Letter) J Pain Sympt Manage. 2001; 21 (5): 359-360.

Prescription Opioid Overdose Data. Centers for Disease Control and Prevention. Available at https://www.cdc.gov/drugoverdose/data/overdose.html. Accessed June 20, 2017.

Glod GA: The other victims of the opioid epidemic. N Engl J Med. 2017; 376 (22): 2101-2102.

Butler SF, Fernandez K, Benoit C, et al.: Validation of the revised screener and opioid assessment for patients with pain (SOAPP-R). J Pain. 2008; 9 (4): 360-372.

Becker WC, Meghani SH, Barth KS, et al.: Characteristics and outcomes of patients discharged from the Opioid Renewal Clinic at the Philadelphia VA Medical Center. Am J Addict. 2009; 18 (2): 135-139.

Haller DL, Acosta MC, Lewis D, et al.: Hair analysis Versus conventional methods of drug testing in substance abusers seeking organ transplantation. Am J Transplant. 2010; 10(5): 1305-1311.

Becker WC, Fiellin DA: Abuse-deterrent opioid formulations-Putting the potential benefits into perspective. N Engl J Med. 2017; 376 (22): 2103-2105.

Gourlay D, Heit H, Almahrezi A: Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Med. 2005; 6 (2): 107-112.

Dowell D, Haegerich TM, Chou R: CDC guideline for prescribing opioids for chronic pain-United States, 2016. MMWR Recomm Rep. 2016; 65 (1): 1-49.

Cicero TJ, Ellis MS, Kasper ZA: Relative preferences in the abuse of immediate-release versus extended-release opioids in a sample of treatment-seeking opioid abusers. Pharmacoepidemiol Drug Saf. 2017; 26 (1): 56-62.

Iwanicki JL, Severtson SG, McDaniel H, et al.: Abuse and diversion of immediate release opioid analgesics as compared to extended release formulations in the United States. PLoS One. 2016; 11 (12): 1-12. Available at http://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0167499&type=printable. Accessed October 16, 2017. doi: 10.1371/journal.pone.0167499.

Savage SR, Kirsh KL, Passik SD: Challenges in using opioids to treat pain in persons with substance use disorders. Addict Sci Clin Pract. 2008; 4 (2): 4-25.

Gourlay DH, Heit H, Caplan YH: Urine Drug Testing in Clinical Practice-The Art and Science of Patient Care. 6th Edition. Center for Independent Healthcare Education. Available at http://www.remitigate.com/wp-content/uploads/2015/11/Urine-Drug-Testing-in-Clinical-Practice-Ed6_2015-08.pdf. Accessed June 20, 2017.

Cheatle, MD, Gallagher, RM, O'Brien, CP: Low risk of producing an opioid use disorder in primary care by prescribing opioids to prescreened patients with chronic noncancer pain. Pain Med. 2017. doi: 10.1093/pm/pnx032. [Epub ahead of print]

Fudin J, Pratt Cleary J, Schatman ME: The MEDD myth: The impact of pseudoscience on pain research and prescribing-guideline development. J Pain Res. 2016; 9: 153-156.

Passik SD, Kirsh KL: Will the number of milligrams of an opioid dose ever re-achieve the truly meaningless status it deserves? J Pain Palliat Care Pharmacother. 2007; 21 (1): 39-41.

FDA Facts: Abuse-Deterrent Opioid Medications. Available at https://www.fda.gov/newsevents/newsroom/factsheets/ucm514939.htm. Published April 21, 2017. Accessed June 20, 2017.

Conrad C, Bradley HM, Broz D, et al.: Centers for disease control and prevention (CDC). Community outbreak of HIV infection linked to injection drug use of oxymorphone—Indiana, 2015. MMWR Morb Mortal Wkly Rep. 2015; 64 (16): 443-444.




DOI: http://dx.doi.org/10.5055/jom.2017.0405

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