Current status and evolving role of abuse-deterrent opioids in managing patients with chronic pain
DOI:
https://doi.org/10.5055/jom.2011.0066Keywords:
opioid, abuse, abuse resistant, abuse deterrent, chronic pain, risk evaluationAbstract
Opioids are widely used for the treatment of patients with chronic pain; yet, the increase in their abuse, misuse, and diversion is an ongoing focus of regulatory, governmental, and legal scrutiny. As a consequence, clinicians are faced with numerous challenges in an effort to use opioids in appropriate patients with pain while minimizing the potential for opioid abuse, misuse, and diversion. Policies and programs such as state prescription monitoring programs, which have been in existence for decades, are but one attempt to address some of the issues regarding the prescribing of opioids. Another is a risk evaluation and mitigation strategy for opioids under consideration by the US Food and Drug Administration. At the clinical level, a universal precautions and risk management package that includes risk assessment and patient monitoring is a recommended approach. This approach can also include the use of abuse-deterrent and abuse-resistant formulations designed to reduce the nonmedical use of opioids. Several of these opioid formulations have been approved or should soon be on the market for use in the United States; however, their role and other questions regarding their use remain unanswered. The authors offer their clinical perspective on several of these key questions.References
Dworkin RH, O’Connor AB, Backonja M, et al.: Pharmacologic management of neuropathic pain: Evidencebased recommendations. Pain. 2007; 132(3): 237-251.
Pergolizzi J, Boger RH, Budd K, et al.: Opioids and the management of chronic severe pain in the elderly: Consensus statement of an International Expert Panel with focus on the six clinically most often used World Health Organization Step III opioids (buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone). Pain Pract. 2008; 8(4): 287-313.
Moulin DE, Clark AJ, Gilron I, et al.: Pharmacological management of chronic neuropathic painÑConsensus statement and guidelines from the Canadian Pain Society. Pain Res Manag. 2007; 12(1): 13-21.
Attal N, Cruccu G, Haanpaa M, et al.: EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006; 13(11): 1153-1169.
Tan T, Barry P, Reken S, et al.: Pharmacological management of neuropathic pain in non-specialist settings: Summary of NICE guidance. BMJ. 2010; 340: c1079.
Chou R, Fanciullo GJ, Fine PG, et al.: Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009; 10(2): 113-130.
Belouin SJ, Reuter N, Borders-Hemphill V, et al.: Substance Abuse and Mental Health Services Administration. Prescribing trends for opioids, benzodiazepines, amphetamines, and barbiturates from 1998-2007; 2008. Available at https://nac.samhsa.gov/DTAB/Presentations/Aug08/SeanBelouinDTAB0808_508.pdf. Accessed June 21, 2010.
Anonymous: Substance Abuse and Mental Health Services Administration. Results from the 2008 National Survey on Drug Use and Health: National findings; 2009. Available at http://www.oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.pdf. Accessed May 24, 2010.
Inciardi JA, Surratt HL, Cicero TJ, et al.: The “black box” of prescription drug diversion. J Addict Dis. 2009; 28(4): 332-347.
Inciardi JA, Surratt HL, Cicero TJ, et al.: Prescription opioid abuse and diversion in an urban community: The results of an ultrarapid assessment. Pain Med. 2009; 10(3): 537-548.
Joranson DE, Gilson AM: Drug crime is a source of abused pain medications in the United States. J Pain Symptom Manage. 2005; 30(4): 299-301.
Inciardi JA, Surratt HL, Cicero TJ, et al.: Prescription drugs purchased through the internet: Who are the end users? Drug Alcohol Depend. 2010; 110(1-2): 21-29.
Treatment episode data set (TEDS) highlights - 2007. National admissions to substance abuse treatmetn services; 2009. Substance Abuse and Mental Health Services Administration. Available at http://wwwdasis.samhsa.gov/teds07/tedshigh2k7.pdf. Accessed May 19, 2010.
Anonymous: Drug Abuse Warning Network. National estimates of drug-related emergency department visits, 2004-2008; 2010. Available at https://dawninfo.samhsa.gov/data/default.asp?met=All. Accessed May 21, 2010.
Anonymous: National Drug Intelligence Center, US Department of Justice. National Drug Threat Assessment 2010: Controlled prescription drugs; 2010. Available at http://www.justice.gov/ndic/pubs38/38661/rx.htm#Top. Accessed July 12, 2010.
Birnbaum HG, White AG, Reynolds JL, et al.: Estimated costs of prescription opioid analgesic abuse in the United States in 2001: A societal perspective. Clin J Pain. 2006; 22(8): 667-676.
McAdam-Marx C, Roland CL, Cleveland J, et al.: Costs of opioid abuse and misuse determined from a Medicaid database. J Pain Palliat Care Pharmacother. 2010; 24(1): 5-18.
White AG, Birnbaum HG, Mareva MN, et al.: Direct costs of opioid abuse in an insured population in the United States. J Manag Care Pharm. 2005; 11(6): 469-479.
Clark RE, Samnaliev M, McGovern MP: Impact of substance disorders on medical expenditures for medicaid beneficiaries with behavioral health disorders. Psychiatr Serv. 2009; 60(1): 35-42.
McCarty D, Perrin NA, Green CA, et al.: Methadone maintenance and the cost and utilization of health care among individuals dependent on opioids in a commercial health plan. Drug Alcohol Depend. 2010; 111(3): 235-240.
Anonymous: The National Center on Addiction and Substance Abuse at Columbia University. National survey of American attitudes on substance abuse XIV: Teens and parents; 2009. Available at http://www.casacolumbia.org/articlefiles/380-2009%20Teen%20Survey%20Report.pdf. Accessed May 24, 2010.
National drug control strategy. President of the United States; 2010. Available at http://www.whitehousedrugpolicy.gov/publications/policy/ndcs10/ndcs2010.pdf. Accessed May 24, 2010.
Anonymous: The National Center on Addiction and Substance Abuse at Columbia University. Under the counter: The diversion and abuse of controlled prescription drugs in the U.S.; 2005. Available at http://www.casacolumbia.org/templates/Publications_Reports.aspx#r19. Accessed May 24, 2010.
Passik SD, Kirsh KL, Donaghy KB, et al.: Pain and aberrant drug-related behaviors in medically ill patients with and without histories of substance abuse. Clin J Pain. 2006; 22(2): 173-181.
Turk DC, Swanson KS, Gatchel RJ: Predicting opioid misuse by chronic pain patients: A systematic review and literature synthesis. Clin J Pain. 2008; 24(6): 497-508.
Baldacchino A, Gilchrist G, Fleming R, et al.: Guilty until proven innocent: A qualitative study of the management of chronic non-cancer pain among patients with a history of substance abuse. Addict Behav. 2010; 35(3): 270-272.
Bhamb B, Brown D, Hariharan J, et al.: Survey of select practice behaviors by primary care physicians on the use of opioids for chronic pain. Curr Med Res Opin. 2006; 22(9): 1859-1865.
Merrill JO, Rhodes LA, Deyo RA, et al.: Mutual mistrust in the medical care of drug users: The keys to the “narc” cabinet. J Gen Intern Med. 2002; 17(5): 327-333.
Berg KM, Arnsten JH, Sacajiu G, et al.: Providers’ experiences treating chronic pain among opioid-dependent drug users. J Gen Intern Med. 2009; 24(4): 482-488.
Gunderson EW, Coffin PO, Chang N, et al.: The interface between substance abuse and chronic pain management in primary care: A curriculum for medical residents. Subst Abus. 2009; 30(3): 253-260.
Gunderson EW, Levin FR, Smith L: Screening and intervention for alcohol and illicit drug abuse: A survey of internal medicine housestaff. J Addict Dis. 2005; 24(2): 1-18.
Wilsey BL, Fishman SM, Crandall M, et al.: A qualitative study of the barriers to chronic pain management in the ED. Am J Emerg Med. 2008; 26(3): 255-263.
Savage S, Covington EC, Heit HA, et al.: American Pain Society. Definitions related to the use of opioids for the treatment of pain. A consensus document from the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine; 2001. Available at http://www.ampainsoc.org/advocacy/opioids2.htm. Accessed May 24, 2010.
Katz NP, Adams EH, Chilcoat H, et al.: Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007; 23(8): 648-660.
Webster LR, Bath B, Medve RA: Opioid formulations in development designed to curtail abuse: Who is the target? Expert Opin Investig Drugs. 2009; 18(3): 255-263.
National Prescription Drug Threat Assessment 2009. National Drug Intelligence Center, Drug Enforcement Administration; 2010. Available at http://www.justice.gov/ndic/pubs33/33775/diversion.htm#Top. Accessed July 2, 2010.
McCormick CG, Henningfield JE, Haddox JD, et al.: Case histories in pharmaceutical risk management. Drug Alcohol Depend. 2009; 105 (Suppl 1): S42-S55.
Henningfield JE, Schuster CR: Risk management and postmarketing surveillance of CNS drugs. Drug Alcohol Depend. 2009; 105 (Suppl 1): S56-S64.
Guidance for industry. Format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications; 2009. US Food and Drug Administration. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf. Accessed June 15, 2010.
Barthwell AG, Barnes MC, Leopold VR, et al.: Center for Lawful Access and Abuse Deterrence. National prescription drug abuse prevention strategy; 2009. Available at http://claad.org/downloads/Nat_Prescipt_Drug_Abuse_Prev_Strat_2009.pdf. Accessed May 21, 2010.
Anonymous: National Alliance for Model State Drug Laws. Prescription drug monitoring programs: A brief overview; 2009. Available at http://www.namsdl.org/documents/PDMPsBriefOverviewApril2009.pdf. Accessed May 21, 2010.
Gilson AM, Kreis PG: The burden of the nonmedical use of prescription opioid analgesics. Pain Med. 2009; 10 (Suppl 2): S89-S100.
Wang J, Christo PJ: The influence of prescription monitoring programs on chronic pain management. Pain Physician. 2009; 12(3): 507-515.
Anonymous: National Alliance for Model State Drug Laws. Status of state prescription drug monitoring programs; 2010. Available at http://www.namsdl.org/documents/StatusofStatesApril222010.pdf. Accessed May 26, 2010.
Katz N, Houle B, Fernandez KC, et al.: Update on prescription monitoring in clinical practice: A survey study of prescription monitoring program administrators. Pain Med. 2008; 9(5): 587-594.
Baehren DF, Marco CA, Droz DE, et al.: A statewide prescription monitoring program affects emergency department prescribing behaviors. Ann Emerg Med. 2009; 56(1): 19-23.
Pradel V, Frauger E, Thirion X, et al.: Impact of a prescription monitoring program on doctor-shopping for high dosage buprenorphine. Pharmacoepidemiol Drug Saf. 2009; 18(1): 36-43.
Simeone R, Holland L: An evaluation of prescription drug monitoring programs; 2006. Simeone Associates, Inc. Available at http://www.simeoneassociates.com/simeone3.pdf. Accessed May 27, 2010.
Webster LR, Fine PG: Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010; 11(7): 602-611.
Passik SD: Reducing risk: Practical strategies for prescribing analgesics. Paper presented at the American Conference on Pain Medicine, New York, NY, April 5, 2008.
Lee KW, Brown JW, Strehlow MD, et al.: ACCESS 2008: Assessing risk of opioid abuse in primary care. Paper presented at the American Academy of Pain Medicine, San Antonio, TX, February 3-6, 2010.
Butler SF, Budman SH, Fernandez KC, et al.: Development and validation of the Current Opioid Misuse Measure. Pain. 2007; 130(1-2): 144-156.
Wilsey BL, Fishman SM, Casamalhuapa C, et al.: Documenting and improving opioid treatment: The Prescription Opioid Documentation and Surveillance (PODS) System. Pain Med. 2009; 10(5): 866-877.
Passik SD, Kirsh KL, Whitcomb L, et al.: A new tool to assess and document pain outcomes in chronic pain patients receiving opioid therapy. Clin Ther. 2004; 26(4): 552-561.
St. Marie B: Coexisting addiction and pain. In St. Marie B (ed.): Core Curriculum for Pain Management Nursing. 2nd ed. Dubuque, IA: Kendall Hunt, 2010: 626-627.
Wang HY, Friedman E, Olmstead MC, et al.: Ultra-low-dose naloxone suppresses opioid tolerance, dependence and associated changes in mu opioid receptor-G protein coupling and Gbetagamma signaling. Neuroscience. 2005; 135(1): 247-261.
Webster LR, Butera PG, Moran LV, et al.: Oxytrex minimizes physical dependence while providing effective analgesia: A randomized controlled trial in low back pain. J Pain. 2006; 7(12): 937-946.
Coleman JJ, Bensinger PB, Gold MS, et al.: Can drug design inhibit abuse? J Psychoactive Drugs. 2005; 37(4): 343-362.
Stauffer J, Setnik B, Sokolowska M, et al.: Subjective effects and safety of whole and tampered morphine sulfate and naltrexone hydrochloride (ALO-01) extended-release capsules versus morphine solution and placebo in experienced nondependent opioid users: A randomized, double-blind, placebocontrolled, crossover study. Clin Drug Investig. 2009; 29(12): 777-790.
Butler SF, Black R, Grimes Serrano JM, et al.: Estimating attractiveness for abuse of a not-yet-marketed “abuse-deterrent” prescription opioid formulation. Pain Med. 2010; 11(1): 81-91.
Tompkins DA, Lanier RK, Harrison JA, et al.: Human abuse liability assessment of oxycodone combined with ultra-low-dose naltrexone. Psychopharmacology (Berl). 2010; 210(4): 471-480.
Katz N, Sun S, Johnson F, et al.: ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules in the treatment of chronic pain of osteoarthritis of the hip or knee: Pharmacokinetics, efficacy, and safety. J Pain. 2010; 11(4): 303-311.
Approved risk evaluation and mitigation strategies (REMS); 2010. US Food and Drug Administration. Available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm. Accessed May 28, 2010.
Katz N: Abuse-deterrent opioid formulations: Are they a pipe dream? Curr Rheumatol Rep. 2008; 10(1): 11-18.
Butler SF, Benoit CM, Budman SH, et al.: Development and validation of an opioid attractiveness scale: A novel measure of the attractiveness of opioid products to potential abusers. Harm Reduct J. 2006; 3(1): 5.
Mahon WJ: Coalition Against Insurance Fraud. Prescription for peril. How insurance fraud finances theft and abuse of addictive prescription drugs; 2007. Available at http://www.insurancefraud.org/downloads/drugDiversion.pdf. Accessed August 5, 2010.
Budman SH, Grimes Serrano JM, Butler SF: Can abuse deterrent formulations make a difference? Expectation and speculation. Harm Reduct J. 2009; 6: 8.
Published
How to Cite
Issue
Section
License
Copyright 2005-2024, Weston Medical Publishing, LLC
All Rights Reserved