The US Opioid Crisis: Current Federal and State Legal Issues

Anesthesia and Analgesia

Volumn 125, Issue 5, 2017, Pages 1675-1681

  Soelberg, Cobin D ^a   Brown, Raeford E ^b   Du Vivier, Derick ^a   Meyer, John E ^a   Ramachandran, Banu K ^c  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b UNIVERSITY OF KENTUCKY   (United States)

^c OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONTROLLED SUBSTANCE; ILLICIT DRUG; NALOXONE; OPIATE; PRESCRIPTION DRUG; NARCOTIC ANALGESIC AGENT;

CHRONIC PAIN; DRUG INDUSTRY; DRUG INTOXICATION; ELECTRONIC PRESCRIBING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HUMAN; LAW SUIT; LEGAL ASPECT; MEDICAL EDUCATION; MORTALITY; PRACTICE GUIDELINE; PRESCRIPTION DRUG MISUSE; PRESCRIPTION DRUG MONITORING PROGRAM; PRIORITY JOURNAL; REVIEW; UNITED STATES; DRUG CONTROL; EPIDEMIC; GOVERNMENT REGULATION; HEALTH CARE PLANNING; HEALTH CARE POLICY; LEGISLATION AND JURISPRUDENCE; MANAGEMENT; OPIOID-RELATED DISORDERS; PATIENT SAFETY;

ANALGESICS, OPIOID; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; EPIDEMICS; GOVERNMENT REGULATION; HEALTH POLICY; HUMANS; OPIOID-RELATED DISORDERS; PATIENT SAFETY; POLICY MAKING; PRESCRIPTION DRUG MISUSE; STATE HEALTH PLANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85032454239     PISSN: 00032999     EISSN: 15267598     Source Type: Journal    
DOI: 10.1213/ANE.0000000000002403     Document Type: Review

References (37)

1. Morone NE Weiner DK. Pain as the fifth vital sign: exposing the vital need for pain education. Clin Ther. 2013; 35: 1728 1732.
2. Pain as the 5th Vital Sign Toolkit. 2000. Washington, DC: Department of Veteran Affairs, National Pain Management Coordinating Committee; Available at: https://www.va.gov/PAINMANAGEMENT/docs/Pain-As-the-5th-Vital-Sign-Toolkit.pdf. Accessed March 17, 2017.
3. Joint Commission on Accreditation of Healthcare Organizations Pain Standards for 2001. Chicago, IL: 2001. Available at: https://www.jointcommission.org/assets/1/6/2001-Pain-Standards.pdf. Accessed March 22, 2017.
4. Governale L. Outpatient Prescription Opioid Utilization in the U.S., Years 2000-2009. 2010. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration, Office of Surveillance and Epidemiology; Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM220950.pdf. Accessed March 22, 2017.
5. Rudd RA Seth P David F Scholl L. Increases in drug and opioid-involved overdose deaths-United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016; 65: 1445 1452.
6. Dart RC Surratt HL Cicero TJ. Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med. 2015; 372: 241 248.
7. Katz J. Drug deaths in America are rising faster than ever. New York Times. 2017. Available at: https://www.nytimes.com/interactive/2017/06/05/upshot/opioid-epidemic-drug-overdose-deaths-Are-rising-faster-Than-ever.html?-r=0. Accessed June 9, 2017.
8. Chisholm L Greene A Hedberg K. Oregon Prescription Drug Overdose, Misuse, and Dependency Prevention Plan. 2015. Salem, OR: Oregon Health Authority, Public Health Division, Injury and Violence Prevention Program; Available at: https://public.health.oregon.gov/PreventionWellness/SubstanceUse/Opioids/Documents/prescription-drug-overdose-state-plan.pdf. Accessed April 4, 2017.
9. Gwira Baumblatt JA Wiedeman C Dunn JR. High-risk use by patients prescribed opioids for pain and its role in overdose deaths. JAMA Intern Med. 2014; 174: 796 801.
10. Young JH. The long struggle for the law. Food and Drug Administration Website. Available at: https://www.fda.gov/aboutfda/whatwedo/history/centennialoffda/thelongstruggleforthelaw/default.htm. Accessed March 10, 2017.
11. 59th US Congress (1906). Public Law Number 59-384, 34 Stat. 768. US Food and Drug Administration.
12. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 9 (2016).
13. Abuse-Deterrent Opioids-Evaluation and Labeling Guidance for Industry. 2015. Rockville, MD: US Department of Health and Human Services, Food and Drugs Administration, Center for Drug Evaluation and Research; Available at: https://www.fda.gov/downloads/Drugs/Guidances/UCM334743.pdf. Accessed March 20, 2017.
14. General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products-Guidance for Industry. 2015. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; Available at: https://www.fda.gov/downloads/Drugs/./Guidances/UCM492172.pdf. Accessed March 22, 2017.
15. Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids. 2017. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration, Division of Drug Information; Available at: https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm. Accessed May 28, 2017.
16. Medication Guides. US Department of Health and Human Services, Food and Drug Administration, Division of Drug Information; 2017. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. Accessed May 28, 2017.
17. Goertz R. AAFP Maintains Mandatory CME to Prescribe Opioids is Unnecessary, 2011. Available at: http://www.aafp.org/news/opinion/20110824opioidsvoices.html. Accessed May 28, 2017.
18. News Release. FDA requests removal of Opana ER for risks related to abuse. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm. Accessed June 9, 2017.
19. 21 C.F.R. Sec. 310.200.
20. Naloxone Access: Status of State Laws Maps 2015. Charlottesville, VA: National Alliance for Model State Drug Laws; Available at: http://www.namsdl.org/library/CDB12DB5-BFD8-3229-21ED6E823A01FEDA/. Accessed April 10, 2017.
21. Historical Perspectives History of the CDC. MMWR Morb Mortal Wkly Rep. 1996; 45: 526 530.
22. Dowell D Haegerich TM Chou R. CDC Guidelines for Prescribing Opioids for Chronic Pain-United States 2016. MMWR Morb Mortal Wkly Rep. 2016; 65: 1 49.
23. Shah A Hayes CJ Martin BC. Characteristics of initial prescription episodes and likelihood of long-Term opioid use-United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017; 66: 265 269.
24. Deyo RA Hallvik SE Hildebran C. Association between initial opioid prescribing patterns and subsequent long-Term use among opioid-naïve patients: A statewide retrospective cohort study. J Gen Intern Med. 2017; 32: 21 27.
25. Levy B Paulozzi L Mack KA Jones CM. Trends in opioid analgesic-prescribing rates by specialty, U.S., 2007-2012. Am J Prev Med. 2015; 49: 409 413.
26. Food and Drugs-Drug Abuse Prevention and Control, 21 U.S.C. § 13 (2012).
27. Fed. Reg. Vol. 82, No. 53 (Tuesday, March 21, 2017), at 14490-14494.
28. Shepherd J. Combating the prescription painkiller epidemic: A national prescription drug reporting program. Am J Law Med. 2014; 40: 85 112.
29. Meara E Horwitz JR Powell W. State legal restrictions and prescription-opioid use among disabled adults. N Engl J Med. 2016; 375: 44 53.
30. Dowell D Zhang K Noonan RK Hockenberry JM. Mandatory provider review and pain clinic laws reduce the amount of opioids prescribed and overdose death rates. Health Aff. 2016; 35: 1876 1883.
31. Bao Y Pan Y Taylor A. Prescription drug monitoring programs are associated with sustained reductions in opioid prescribing by physicians. Health Aff. 2016; 35: 1045 1051.
32. Gawande AA. It's time to adopt electronic prescriptions for opioids. Ann Surg. 2017; 265: 693 694.
33. Dineen KK DuBois JM. Between a rock and a hard place: can physicians prescribe opioids to treat pain adequately while avoiding legal sanction? Am J Law Med. 2016; 42: 7 52.
34. Requirements of Prescription, 21 U.S.C. § 1306.11 (2016).
35. Jones CM Paulozzi LJ Mack KA. Sources of prescription opioid pain relievers by frequency of past-year nonmedical use: United States, 2008-2011. JAMA Intern Med. 2014; 174: 802 803.
36. Lewis ET Cucciare MA Trafton JA. What do patients do with unused opioid medications? Clin J Pain. 2014; 30: 654 662.
37. 201 KAR 9:310. Continuing medical education.