Challenges in the development of prescription opioid abuse-deterrent formulations

Clinical Journal of Pain

Volumn 23, Issue 8, 2007, Pages 648-660

  Katz, Nathaniel P ^a,o   Adams, Edgar H ^c   Chilcoat, Howard ^d   Colucci, Robert D ^e   Comer, Sandra D ^g   Goliber, Philip ^f   Grudzinskas, Charles ⁱ   Jasinski, Donald ^j   Lande, Stephen D ^l   Passik, Steven D ^h   Schnoll, Sidney H ^k   Sellers, Edward ⁿ   Travers, Debra ^m   Weiss, Roger ^b  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c Dept of Stat and Clin Programming   (United States)

^d GLAXOSMITHKLINE   (United States)

^e Colucci and Associates LLC ^*  (United States)

^f Penwest Pharmaceuticals Co   (United States)

^g College of Physicians and Surgeons ^*  (United States)

^h MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

ⁱ NDA Partners LLC   (United States)

^j JOHNS HOPKINS BAYVIEW MEDICAL CENTER   (United States)

^k PINNEY ASSOCIATES   (United States)

^l Interactive Forums Inc   (United States)

^m Endo Pharmaceuticals   (United States)

ⁿ UNIVERSITY OF TORONTO   (Canada)

^o Analgesic Research   (United States)

more..

Author keywords

Abuse deterrent; Abuse resistant; Opioid analgesics; Prescription opioid abuse

Indexed keywords

ANALGESIC AGENT; ATOMOXETINE; ATROPINE PLUS DIPHENOXYLATE; BENZODIAZEPINE; DRONABINOL; ESZOPICLONE; FENTANYL; HYDROCODONE; HYDROMORPHONE; METHADONE; MORPHINE; NALOXONE; NARATRIPTAN; OPIATE; OXYCODONE; PETHIDINE; PLACEBO; SUFENTANIL; TRAMADOL;

CHRONIC PAIN; CLINICAL TRIAL; CONSENSUS; COST EFFECTIVENESS ANALYSIS; COST OF ILLNESS; DRUG DESIGN; DRUG EFFICACY; DRUG FORMULATION; DRUG LABELING; DRUG MISUSE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HEALTH CARE PERSONNEL; HEROIN DEPENDENCE; HUMAN; MEDICAL LIABILITY; OPIATE ADDICTION; OUTCOME ASSESSMENT; PAIN; PRESCRIPTION; PRIORITY JOURNAL; RATING SCALE; REIMBURSEMENT; REVIEW; RISK BENEFIT ANALYSIS; TOXICITY TESTING; UNITED STATES; URINALYSIS; WITHDRAWAL SYNDROME;

ANALGESICS, OPIOID; ANIMALS; CHEMISTRY, PHARMACEUTICAL; HUMANS; LEGISLATION, DRUG; OPIOID-RELATED DISORDERS; POPULATION SURVEILLANCE; PRESCRIPTIONS, DRUG; RESEARCH DESIGN; SUBSTANCE ABUSE DETECTION; TERMINOLOGY;

EID: 34648813683     PISSN: 07498047     EISSN: None     Source Type: Journal    
DOI: 10.1097/AJP.0b013e318125c5e8     Document Type: Review

References (60)

1. Joranson DE, Ryan KM, Gilson AM, et al. Trends in medical use and abuse of opioid analgesics. JAMA. 2000;283:1710-1714.
2. Passik SD, Kirsh KL, McDonald MV, et al. A pilot survey of aberrant drug-taking attitudes and behaviors in samples of cancer and AIDS patients. J Pain Symptom Manage. 2000;19:274-286.
3. Compton WM, Volkow ND. Major increases in opioid analgesic abuse: concerns and strategies. Drug Alcohol Depend. 2006;81:103-107.
4. Musto DF. The American Disease: Origins of Narcotic Control. 3rd ed. New York: Yale University Press; 1999.
5. Meldrum ML. A capsule history of pain management. JAMA. 2003;290:2470-2475.
6. Hosztafi S. The history of heroin. Acta Pharm Hung. 2001;71:233-242.
7. Sunshine A, Axtmayer R, Olson N, et al. Analgesic efficacy of pentazocine versus a pentazocine-naloxone combination following oral administration. Clin J Pain. 1988;4:35-40.
8. Reed DA, Schnoll SH. Abuse of pentazocine-naloxone combination. JAMA. 1986;256:2562-2564.
9. Baum C, Hsu JP, Nelson RC. The impact of the addition of naloxone on the use and abuse of pentazocine. Public Health Rep. 1987;102:426-429.
10. Savage SR, Joranson DE, Covington EC, et al. Definitions related to the medical use of opioids: evolution towards universal agreement. J Pain Symptom Manage. 2003;26:655-667.
11. Schnoll SH, Finch J. Medical education for pain and addiction: making progress toward answering a need. J Law Med Ethics. 1994;22:252-256.
12. Hays LR. A profile of OxyContin addiction. J Addict Dis. 2004;23:1-9.
13. Potter JS, Hennessy G, Borrow JA, et al. Substance use histories in patients seeking treatment for controlled-release oxycodone dependence. Drug Alcohol Depend. 2004;76:213-215.
14. Perry S, Heidrich G. Management of pain during debridement: a survey of U.S. burn units. Pain. 1982;13:267-280.
15. Porter J, Jick H. Addiction rare in patients treated with narcotics. NEJM. 1980;302:123.
16. Medina JL, Diamond S. Drug dependency in patients with chronic headaches. Headache. 1977;17:12-14.
17. Adams EH, Breiner S, Cicero TJ, et al. A comparison of the abuse liability of tramadol, NSAIDs, and hydrocodone in patients with chronic pain. J Pain Symptom Manage. 2006;31:465-476.
18. Ives TJ, Chelminski PR, Hammett-Stabler CA, et al. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Services Res. 2006;6:46.
19. Dunbar SA, Katz NP. Chronic opioid therapy for nonmalignant pain in patients with a history of substance abuse: report of 20 cases. J Pain Symptom Manage. 1996;11:163-171.
20. Compton P, Darakjian J, Miotto K. Screening for addiction in patients with chronic pain and "problematic" substance use: evaluation of a pilot assessment tool. J Pain Symptom Manage. 1998;16:355-363.
21. Katz N, Fanciullo GJ. Role of urine toxicology testing in the management of chronic opioid therapy. Clin J Pain. 2002;18 (4 suppl):S76-S82.
22. Fanciullo G, Katz N. The role of urine toxicology screening in patients on chronic opioid therapy. Abstract presented at the American Academy of Pain Medicine, February 15-18, 2001, Miami, FL.
23. Belgrade M. Urine toxicology testing in patients with chronic pain. Abstract presented at the American Pain Society Annual Meeting, Phoenix, AZ. April 19-22, 2001.
24. Savage SR. Assessment for addiction in pain-treatment settings. Clin J Pain. 2002;18(4 suppl):S28-S38.
25. Passik SD, Portenoy RK, Ricketts PL. Substance abuse issues in cancer patients. Part 2: evaluation and treatment. Oncology (Williston Park). 1998;12:729-734. Discussion 736, 722-741.
26. Monahan G. Drug use/misuse among health professionals. Subst Use Misuse. 2003;38:1877-1881.
27. Gastfriend DR. Physician substance abuse and recovery: what does it mean for physicians - and everyone else? JAMA. 2005;293:1513-1515.
28. Boisaubin EV, Levine RE. Identifying and assisting the impaired physician. Am J Med Sci. 2001;322:31-36.
29. Markel H. When health professionals abuse drugs and alcohol: personal problems and public health consequences. Medscape Public Health & Prevention. June 29, 2004. Available at: http://www.medscape.com/ viewarticle/481520. Accessed September 1, 2005.
30. Knisely JS, Campbell ED, Dawson KS, et al. Tramadol post-marketing surveillance in health care professionals. Drug Alcohol Depend. 2002;68:15-22.
31. Domino KB, Hornbein TF, Polissar NL, et al. Risk factors for relapse in health care professionals with substance use disorders. JAMA. 2005;293:1453-1460.
32. Passik SD, Kirsh KL, Whitcomb L, et al. Pain clinicians' rankings of aberrant drug-taking behaviors. J Pain Palliat Care Pharmacother. 2002;16:39-49.
33. Katz NP, Adams EH, Benneyan JC, et al. Foundations of opioid risk management. Clin J Pain. 2007;23:103-118.
34. Swanson JM, Volkow ND. Serum and brain concentrations of methylphenidate: implications for use and abuse. Neurosci Biobehav Rev. 2003;7:615-621.
35. US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Premarketing Risk Assessment. Available at: http://www.fda.gov/cder/guidance/6357fnl.htm. Accessed September 30, 2006.
36. US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Development and Use of Risk Minimization Action Plans. Available at: http://www.fda.gov/cder/guidance/6358fnl.htm. Accessed September 30, 2006.
37. US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Available at: http://www.fda.gov/cder/ guidance/6359OCC.htm. Accessed September 30, 2006.
38. US Food and Drug Administration, Department of Health and Human Services. Janssen Pharmaceutica, Inc, Warning Letter. Available at: http://www.fda.gov/ foi/warning_letters/g4628d.htm. Accessed September 30, 2006.
39. National Institutes of Health. Effective Medical Treatment of Opiate Addiction. NIH Consensus Statements. 1997:1-38.
40. Carter C, Goldfarb N, Hartmann C, et al. Chronic pain management in managed care organizations: a national survey of medical directors. P&T. 2003;28:179-215.
41. White AG, Birnbaum HG, Mareva MN, et al. Direct costs of opioid abuse in an insured population in the United States. J Manage Care Pharm. 2005;11:469-479.
42. Substance Abuse and Mental Health Services Administration, US Department of Health and Human Services. National Survey on Drug Abuse and Health. 2003. Available at: http://www.oas.samhsa.gov/nhsda.htm. Accessed August 1, 2005.
43. National Institute of Health. The NIH Guide: New Directions in Pain Research I. Washington, DC: GPO; 1998.
44. Katz N, Buse DC, Budman SH, et al. Development and preliminary experience with an ease of extractability rating system for prescription opioids. Drug Dev Ind Pharm. 2006;32:727-746.
45. Griffiths RR, Bigelow GE, Ator NA. Principles of initial experimental drug abuse liability assessment in humans. Drug Alcohol Depend. 2003;70:S41-S54.
46. Butler SF, Katz N, Budman SH, et al. Development and validation of a scale to measure attractiveness of prescription opioid products to potential prescription opioid abusers: the Opioid Attractiveness Scale. Abstract presented at the American Pain Society Annual Meeting, Boston, MA. March 30-April 2, 2005.
47. Hard ML, Schuller R, Horbay GLA, et al. Relative abuse liability of opioid dosage forms in Canada: assessing the potential for tampering. Abstract presented at the College on Problems of Drug Dependence Impact of Drug Formulation on Abuse Liability, Safety and Regulatory Decisions Conference, Washington, DC. April 19-20, 2005.
48. Zalman M, Kramer E, Wright I. Methods for retrospective analysis of abuse of study medication in completed clinical trials. Abstract presented at the 67th Annual Scientific Meeting of the College on Problems of Drug Dependence, Orlando, FL. June 17-20, 2005.
49. Passik SD, Portenoy RK, Ricketts PL. Substance abuse issues in cancer patients. Part 1: prevalence and diagnosis. Oncology (Williston Park). 1998;12:517-521, 524.
50. Dasgupta N, Brownstein J, Schnoll SH, et al. Geospatial modeling of disparate data sources on abuse of prescription opioids. Abstract presented at the 67th Annual Scientific Meeting of the College on Problems of Drug Dependence, Orlando, FL. June 17-20, 2005.
51. Weiss RD, Griffin ML, Hufford C. Craving in hospitalized cocaine abusers as a predictor of outcome. Am J Drug Alcohol Abuse. 1995;21:289-301.
52. Gowing LR, Ali RL, White JM. The management of opioid withdrawal. Drug Alcohol Rev. 2000;19:309-318.
53. Handelsman L, Cochrane KJ, Aronson MJ, et al. Two new rating scales for opiate withdrawal. Am J Drug Alcohol Abuse. 1987;13:293-308.
54. Wesson DR, LingW. The Clinical OpiateWithdrawal Scale (COWS). J Psychoactive Drugs. 2003;35:253-259.
55. Peachey JE, Lei H. Assessment of opioid dependence with naloxone. Br J Addict. 1988;83:193-201.
56. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV). Washington, DC: American Psychiatric Association; 1994.
57. Butler SF, Budman SH, Fernandez K, et al. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004;112:65-75.
58. Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the opioid risk tool. Pain Med. 2005;6:432-442.
59. Chabal C, Erjavec MK, Jacobson L, et al. Prescription opiate abuse in chronic pain patients: clinical criteria, incidence, and predictors. Clin J Pain. 1997;13:150-155.
60. Katz N, Chilcoat H, Butler S, et al. Prescription opioid abuse: review of current surveillance systems. Abstract presented at the College on Problems of Drug Dependence Annual Meeting, Scottsdale, AZ. June 19, 2006.