Open Access Open Access  Restricted Access Subscription or Fee Access

FDA and Abuse Deterrent Opioids: Don’t fix the blame. Fix the problem

Peter J. Pitts

Abstract


There is no such thing as a medicine that is 100 percent abuse-proof. The only abuse-proof medicine is one that is never prescribed—and for the hundreds of millions of Americans suffering from chronic pain that isn’t a viable option. Advancing the regulatory science of abuse deterrence is an important step in the right direction.


Keywords


FDA, Abuse Deterrent Opioids, chronic pain

Full Text:

PDF

References


US Food and Drug Administration: Collaborating to Reduce Preventable Harm from Medications. Available at: http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ Accessed September 8, 2016.

US Food and Drug Administration: 2015 Meeting Materials, Science Board to the FDA. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm431539.htm Accessed September 8, 2016.

Butler SF, Cassidy TA, Chilcoat H, et al.: Abuse rates and routes of administration of reformulated extended-release oxycodone: Initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain. 2013; 14(4): 351-358. Available at: http://www.jpain.org/article/S1526-5900(12)00803-6/fulltext Accessed September 8, 2016.

Dart RC, Surratt HL, Cicero TJ, et al.: Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med. 2015; 372: 241-248. Available at: http://www.nejm.org/doi/pdf/10.1056/NEJMsa1406143 Accessed September 8, 2016.

Health Canada: Regulatory Update—Health Canada confirms proposed regulations requiring tamper resistance for Oxycodone will not move forward at this time. Available at http://news.gc.ca/web/article-en.do?nid=1045259 Accessed September 8, 2016.




DOI: https://doi.org/10.5055/jom.2016.0346

Refbacks

  • There are currently no refbacks.