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Journal of Pain & Palliative Care Pharmacotherapy Volume 24, 2010 - Issue 4
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ARTICLES

Legal Liability Perspectives on Abuse-Deterrent Opioids in the Treatment of Chronic Pain

David B. Brushwood David B. Brushwood, RPh, JD, is Professor of Pharmaceutical Outcomes and Policy at the College of Pharmacy, University of Florida, Gainesville, Florida, USA; Ben A. Rich, JD, PhD, is Professor and Alumni Association Endowed Chair of Bioethics, University of California Davis School of Medicine, Sacramento, California, USA; John J. Coleman, PhD, is President of Prescription Drug Research Center, Fairfax, Virginia, USA; Jennifer Bolen, Esq, is the Founder of The Legal Side of Pain, Lenoir City, Tennessee, USA; Winston Wong, PharmD is Associate Vice President, Pharmacy Management at CareFirst BlueShield, Baltimore, Maryland, USA.
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Ben A. Rich David B. Brushwood, RPh, JD, is Professor of Pharmaceutical Outcomes and Policy at the College of Pharmacy, University of Florida, Gainesville, Florida, USA; Ben A. Rich, JD, PhD, is Professor and Alumni Association Endowed Chair of Bioethics, University of California Davis School of Medicine, Sacramento, California, USA; John J. Coleman, PhD, is President of Prescription Drug Research Center, Fairfax, Virginia, USA; Jennifer Bolen, Esq, is the Founder of The Legal Side of Pain, Lenoir City, Tennessee, USA; Winston Wong, PharmD is Associate Vice President, Pharmacy Management at CareFirst BlueShield, Baltimore, Maryland, USA.
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John J. Coleman David B. Brushwood, RPh, JD, is Professor of Pharmaceutical Outcomes and Policy at the College of Pharmacy, University of Florida, Gainesville, Florida, USA; Ben A. Rich, JD, PhD, is Professor and Alumni Association Endowed Chair of Bioethics, University of California Davis School of Medicine, Sacramento, California, USA; John J. Coleman, PhD, is President of Prescription Drug Research Center, Fairfax, Virginia, USA; Jennifer Bolen, Esq, is the Founder of The Legal Side of Pain, Lenoir City, Tennessee, USA; Winston Wong, PharmD is Associate Vice President, Pharmacy Management at CareFirst BlueShield, Baltimore, Maryland, USA.
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Jennifer Bolen David B. Brushwood, RPh, JD, is Professor of Pharmaceutical Outcomes and Policy at the College of Pharmacy, University of Florida, Gainesville, Florida, USA; Ben A. Rich, JD, PhD, is Professor and Alumni Association Endowed Chair of Bioethics, University of California Davis School of Medicine, Sacramento, California, USA; John J. Coleman, PhD, is President of Prescription Drug Research Center, Fairfax, Virginia, USA; Jennifer Bolen, Esq, is the Founder of The Legal Side of Pain, Lenoir City, Tennessee, USA; Winston Wong, PharmD is Associate Vice President, Pharmacy Management at CareFirst BlueShield, Baltimore, Maryland, USA.
&
Winston Wong David B. Brushwood, RPh, JD, is Professor of Pharmaceutical Outcomes and Policy at the College of Pharmacy, University of Florida, Gainesville, Florida, USA; Ben A. Rich, JD, PhD, is Professor and Alumni Association Endowed Chair of Bioethics, University of California Davis School of Medicine, Sacramento, California, USA; John J. Coleman, PhD, is President of Prescription Drug Research Center, Fairfax, Virginia, USA; Jennifer Bolen, Esq, is the Founder of The Legal Side of Pain, Lenoir City, Tennessee, USA; Winston Wong, PharmD is Associate Vice President, Pharmacy Management at CareFirst BlueShield, Baltimore, Maryland, USA.
Pages 333-348 | Received 20 Sep 2010, Accepted 22 Sep 2010, Published online: 06 Dec 2010

REFERENCES

  • Passik SD. Issues in Long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84:593–601.
  • Anon. Substance Abuse and Mental Health Services Administration. Results from the 2008 National Survey on Drug Use and Health: National Findings. Available at: http://www.oas. samhsa.gov/nsduh/2k8nsduh/2k8Results.pdf. Published 2008. Last accessed July 7, 2010.
  • Gilson AM, Joranson DE, Maurer MA. Improving state pain policies: recent progress and continuing opportunities. CA Cancer J Clin. 2007;57:341–353.
  • Pain & Policy Studies Group. Achieving Balance: A Progress Report Card (Fourth Edition, 2008) at 8. http://www.painpolicy. wisc.edu/Achieving_Balance/PRC2008.pdf.
  • Dowling LS, Gatchel RJ, Adams LL, Stowell AW, Bernstein D. An evaluation of the predictive validity of the pain medication questionnaire with a heterogeneous group of patients with chronic pain. J Opioid Manag. 2007;3:257–266.
  • Burchman SL, Pagel PS. Implementation of a formal treatment agreement for outpatient management of chronic nonmalignant pain with opioid analgesics. J Pain Symptom Manage. 1995;10:556–563.
  • Nafziger AN, Bertino JS Jr. Utility and application of urine drug testing in chronic pain management with opioids. Clin J Pain. 2009;25:73–79.
  • Manchikanti L, Whitfield E, Pallone F. Evolution of the National All Schedules Prescription Electronic Reporting Act (NASPER): a public law for balancing treatment of pain and drug abuse and diversion. Pain Physician. 2005;8: 335–347.
  • Bhamb B, Brown D, Hariharan J, Anderson J, Balousek S, Fleming MF. Survey of select practice behaviors by primary care physicians on the use of opioids for chronic pain. Curr Med Res Opin. 2006;22:1859–1865.
  • Inciardi JA, Surratt HL, Cicero TJ, Kurtz Sp, Martin SS, Parrino MW. The “black box” of prescription drug diversion. J Addict Dis. 2009;28:332–347.
  • Inciardi JA, Surratt HL, Cicero TJ, Rosenblum A, Ahwah C, Bailey JE, Dart RC, Burke, JJ. Prescription drugs purchased through the Internet: who are the end users? Drug Alcohol Depend. 2010;110:21–29.
  • Joranson DE, Gilson AM. Drug crime is a source of abused pain medications in the United States. J Pain Symptom Manage. 2005;30:299–301.
  • Webster LR. Update on abuse-resistant and abuse-deterrent approaches to opioid formulations. Pain Med. 2009;10(Suppl 2):S124-S133.
  • Fishbain D, Johnson S, Webster L, Greene L, Faysal J. Review of regulatory programs and new opioid technologies in chronic pain management: balancing the risk of medication abuse with medical need. J Managed Care Pharm. 2010;16:276–288.
  • Jones KW. Medication risk must be balanced with benefit, not fear. Ann Pharmacother. 2010;44:737–739.
  • Annas GJ. Standard of care—in sickness and in health and in emergencies. N Engl J Med. 2010;362:2126–2131.
  • Greenberg MD. Medical malpractice and new devices: defining an elusive standard of care. Health Matrix. 2009;19:423–425.
  • Bolen J. Taking back your turf: understanding the role of law in medical decision making in opioid management. Pain Med. 2005;1:125–130.
  • Wilsey BA, Fishman SM, Ogden C. Prescription opioid abuse in the emergency department. J Law Med Ethics. 2005;33:770–781.
  • Fudala PJ, Johnson RE. Development of opioid formulations with limited diversion and abuse potential. Drug Alcohol Depend. 2006;83(Suppl 1):S40–S47.
  • Gilson AM, Kreis PG. The burden of the nonmedical use of prescription opioid analgesics. Pain Med. 2009;10(Suppl 2):S89-S110.
  • Strassels SA. Economic burden of prescription opioid misuse and abuse. J Manag Care Pharm. 2009;15:556–562.
  • Clark HW, Sees KL. Opioids, chronic pain, and the law. J Pain Symptom Manage. 1993;8:297–305.
  • Smith HS, Kirsh KL, Passik SD. Chronic opioid therapy issues associated with opioid abuse potential. J Opioid Manag. 2009;5:287–300.
  • Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: Institute of Medicine; 2000.
  • Grabowski H, Wang YR. Do faster Food and Drug Administration drug reviews adversely affect patient safety? An analysis of the 1992 Prescription Drug User Fee Act. J Law Econ. 2008;51:377–412.
  • Smith H, Bruckenthal P. Implications of opioid analgesia for medically complicated patients. Drugs Aging. 2010;25:417–433.
  • Gourlay DL, Heit HA. Pain and addiction: managing risk through comprehensive care. J Addict Dis. 2008;27:23–30.
  • Walley AY, Farraar D, Cheng DM, Alford DP, Samet JH. Are opioid dependence and methadone maintenance treatment (MMT) documented in the medical record? A patient safety issue. J Gen Intern Med. 2009;24:1007–1011.
  • Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6:107–112.
  • Gourlay DL, Heit HA. Universal precautions revisited: managing the inherited pain patient. Pain Med. 2009;10(Suppl 2):S115-S123.
  • Katz NP, Adams EH, Benneyan JC, Foundations of opioid risk management. Clin J Pain. 2007;23:103–118.
  • Weissman DE, Haddox JD. Opioid pseudoaddiction—an iatrogenic syndrome. Pain 1989;32:363–366.
  • Moore TM, Jones T, Browder J, Daffron S, Passik SD. A comparison of common screening methods for predicting aberrant behavior among patients receiving opioids for chronic pain management. Pain Med. 2009;10:1426–1433.
  • Passik SD, Kirsh, KL. The interface between pain and drug abuse and the evolution of strategies to optimize pain management while minimizing drug abuse. Exp Clin Psychopharmacol. 2008;16:400–404.
  • Noah L. Advertising prescription drugs to consumers: assessing the regulatory and liability issues. Ga Law Rev. 1997;32:141–180.
  • 21 U.S.C. 353(b) (2009).
  • Outterson K. The legal ecology of resistance: the role of antibiotic resistance in pharmaceutical innovation. Cardozo Law Rev. 2010;31:613–678.
  • Furrow BR. Pain management and provider liability: no more excuses. J Law Med Ethics. 2001;22:28–43.
  • Rich BA. The politics of pain: rhetoric or reform? DePaul J Health Care. 2005;8:519–558.
  • Collen M. Opioid contracts and random drug testing for people with chronic pain—think twice. J Law Med Ethics. 2009;37:841–844.
  • Drapp JC. The national standard of care in medical malpractice actions: does small area analysis make it another legal fiction? Quinnipiac Health Law J. 2003;6:95–131.
  • Bradford GE, Meyers DG. The legal and regulatory climate in the State of Missouri for complementary and alternative medicine—honest disagreement among competent physicians or medical McCarthyism? U.K. Law Rev. 2001;70: 55–102.
  • Wininger PJ. Pharmaceutical overpromotion liability: the legal battle over rural prescription drug abuse. Kentucky Law J. 2004;93:269–294.
  • Hines N. Why technology provides compelling reasons to apply a Daubert analysis to the legal standard of care in medical malpractice cases. Duke Law Tech Rev. 2006;18:1–36.
  • Bolen J. Pain and the courtroom—paving the way for a long overdue showdown. Pain Med. 2008;9:750–751.
  • 21 C.F.R. 1306.04 (2009).
  • 459 F.3d 463 (4th Cir. 2006).
  • AnonVa. pain doctor sentenced to 57 months in prison. AMA News. 2007;50:14.
  • Hassman, Fed. Reg., Vol. 75, No. 35, Tuesday, February 23, 2010, pages 8193 to 8237.
  • Hassman, Fed. Reg., Vol. 75, No. 35, at page 8195, citing Paul J. Caragine, Jr., 63 FR 51592 (1998).
  • Hassman. at 8227.
  • 667 So.2d 1380 (Fla. App. 1996).
  • 930 So.2d 659 (Fla. App. 2006).
  • Rich BA. A prescription for the pain: the emerging standard of care for pain management. Wm Mitchell Law Rev. 2000;26:1–91; Furrow, BR. Pain management and provider liability: no more excuses. J Law Med Ethics. 2001;28:33–41.
  • Blaufuss JR. A painful catch-22: why tort liability for inadequate pain management will make for bad medicine. Wm Mitchell Law Rev. 2005;31;1093–1032.
  • Ducharme J. Clinical guidelines and policies: can they improve emergency department pain management? J Law Med Ethics. 2005;33;783–791.
  • Mello MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. 149 U. Penn. L. Rev. 645;2001.
  • Shackelton RJ, Marceau LD, Link CL, McKinlay JB. The intended and unintended consequences of clinical guidelines. J Eval Clin Pract. 2009;15:1035–1042.
  • Davis J. Clinical guidelines as a tool for legal liability. An international perspective. Med Law. 2009;28:603–613.
  • Brushwood DB. Clinical practice guidelines and the standard of care. Am J Health Syst Pharm. 2000;57:159–161.
  • Anon. Model policy for the use of controlled substances for the treatment of pain. J Pain Palliat Care Pharmacother. 2005;19:73–78.
  • Fishman SM. Responsible Opioid Prescribing. Washington, DC: Federation of State Medical Boards; 2007:22.
  • Anon. A joint statement from 21 health organizations and the Drug Enforcement Administration. Promoting pain relief and preventing abuse of pain medications: a critical balancing act. J Pain Symptom Manage. 2002;24:147.
  • Anon. Prescription pain medications: frequently asked questions and answers for health care professionals, and law enforcement personnel. J Pain Palliat Care Pharmacother. 2005;19:71–104.
  • Gilson AM, Joranson, DE. Is the DEA's new “prescription series” regulation balanced? J Pain Palliat Care Pharmacother. 2008;22:218–220.
  • Chou R, Fanciullo G, Fine P, Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2010;10:113–130.
  • Rich BA. A prescription for pain: the emerging standard of care for pain management. Wm Mitchell Law Rev. 2000;26:1–91.
  • Burt RA. Doctors vs. lawyers: the perils of perfectionism. St Louis U Law J. 2009;53;1177–1187.
  • Katz NP, Adams EH, Chilcoat H, Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007;23:648–660.
  • Lahmeyer HW, Craig RJ. Pentazocine—naloxone: another “addiction-proof” drug of abuse. Int J Addict. 1987;22: 1163–1166.
  • Webster LR. Update on abuse-resistant and abuse-deterrent approaches to opioid formulations. Pain Med. 2009;10(Suppl 2):S124-S133.
  • Katz NP. Abuse-deterrent opioid formulations: are they a pipe dream? Curr Rheumatol Rep. 2008;10:11–18.
  • Webster LR, Bath B, Medve RA. Opioid formulations in development designed to curtail abuse: who is the target? Expert Opin Investig Drugs. 2009;18:255–263.
  • Katz NP, Adams EH, Benneyan JC, Foundations of opioid management. Clin J Pain. 2007;23:103–118.
  • Starrels JL, Becker WC, Alford DP, Kapoor A, Williams AR, Turner BJ. Systematic review: treatment agreements and urine drug testing to reduce opioid misuse in patients with chronic pain. Ann Intern Med. 2010;152:712–720.
  • Annas GJ. Doctors, drugs, and driving—tort liability for patient-caused accidents. N Engl J Med 2008;359:521–525.
  • Fishbain DA, Lewis JE, Gao J, Cole B, Rosomoff RS. Alleged breaches of “standards of medical care” in a patient overdose death possibly related to chronic opioid analgesic therapy, application of the controlled substances model guidelines: case report. Pain Med. 2009;10:565–577.
  • Reynolds MJ. Morphine or malpractice: should courts recognize a legal duty to prescribe opiates for treating chronic pain? St. John's J Legal Comment. 2000;15:79–108.
  • Durning K. No pain no gain? Who will make the greatest sacrifices in curbing opioid analgesic diversion and abuse? Kentucky Law J. 2005;93:199–241.
  • Hafemeister TL, Spinos S. Lean on me: a physician's fiduciary duty to disclose an emergent medical risk to the patient. Wash U Law Rev. 2009;86:1167–1210.
  • Cotton VR. Legal risks of “curbside” consults. Am J Cardiol. 2010;106:135–138.
  • Nuttall LM. Foreseeability vs. public policy considerations in determining the duty of physicians to non-patients-Lester v. Hall. New Mexico Law Rev. 2000;30:351–359.
  • Carmack J. Defining the scope of a physician's duty of care to third parties. Tenn Law Rev. 2004;71:797–815.
  • Eippert T. A proposal to recognize a legal obligation on physicians to provide adequate medication to alleviate pain. J Law Health. 1998;12:381–405.
  • Castellano G. The criminalization of treating end of life patients with risky pain medication and the role of the extreme emergency situation. Fordham Law Rev. 2007;76: 203–234.
  • Huang SW. The Omnibus Reconciliation Act of 1990: redefining pharmacists’ legal responsibilities. Am J Law Med. 1998;24:417–442.
  • Jayawant SS, Ralkrishnan R. The controversy surrounding OxyContin abuse: issues and solutions. Clin Ther Risk Manag. 2005;1:77–82.
  • Trescot AM, Boswell MV, Alturi SL, Opioid guidelines in the management of chronic non-cancer pain. Pain Physician. 2006;9:1–39.
  • Gatchel RJ. Is fear of prescription drug abuse resulting in sufferers of chronic pain being undertreated? Expert Rev Neurother. 2010;10:637–639.
  • Moss v. Meyer, 454 N.E.2d 48 (Ill. App. Ct. 1983).
  • Hooks-Superx v. McLaughlin, 642 N.E.2d 514 (Ind. 1994).
  • Oken R. Curing health care providers’ failure to administer opioids in the treatment of severe pain. Cardozo Law Rev. 2002;23:1917–1992.
  • Peters PG. The quiet demise of deference to custom: malpractice law at the millennium. Washington & Lee Law Rev. 2000;57:163–204.
  • Kaufman SR, Shim JK, Russ AJ. Revisiting the biomedicalization of aging; clinical trends and ethical challenges. Gerontologist. 2004;44:731–738.
  • Johnson SH. The social, professional, and legal framework for the problem of pain management in emergency medicine. J Law Med Ethics. 2005;33:741–755.
  • Hoffman DE, Tarzian AJ. Achieving the right balance in oversight of physician opioid prescribing for pain: the role of state medical boards. J Law Med Ethics. 2003;31:21–31.

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