The changing landscape of opioid prescribing: Long-acting and extended-release opioid class-wide risk evaluation and mitigation strategy

Therapeutics and Clinical Risk Management

Volumn 8, Issue , 2012, Pages 209-217

  Gudin, Jeffrey A ^a  

^a ENGLEWOOD HOSPITAL AND MEDICAL CENTER   (United States)

Author keywords

Extended release opioid; FDA; Long acting opioid; Primary care; REMS; Risk

Indexed keywords

BUPRENORPHINE; HYDROMORPHONE; MORPHINE; NARCOTIC ANALGESIC AGENT; OXYCODONE;

ARTICLE; CHRONIC PAIN; DRUG ABUSE; DRUG FORMULATION; DRUG MISUSE; DRUG OVERDOSE; DRUG SAFETY; HEALTH CARE SYSTEM; HISTORY; HUMAN; PAIN; PATIENT COUNSELING; PATIENT EDUCATION; PRESCRIPTION; PREVALENCE; PRIMARY MEDICAL CARE; RISK ASSESSMENT; RISK EVALUATION AND MITIGATION STRATEGY;

EID: 84871338857     PISSN: 11766336     EISSN: 1178203X     Source Type: Journal    
DOI: 10.2147/TCRM.S28764     Document Type: Article

References (39)

1. Chou R, Fanciullo GJ, Fine PG, et al. Opioid treatment guidelines: clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130.
2. Trescot AM, Helm S, Hansen H, et al. Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) guidelines. Pain Physician. 2008;(special issue 11):S5-S62.
3. Governale L. Outpatient Prescription Opioid Utilization in the US, Years 2000-2009. US Food and Drug Administration; 2010. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/DrugSafetyandRiskManagementADvisoryCommittee/UCM220950.pdf. Accessed January 27, 2012.
4. Centers for Disease Control. National Vital Statistics System. Unintentional Drug Poisoning in the United States. Centers for Disease Control; 2010. http://www.cdc.gov/HomeandRecreationalSafety/pdf/ poison-issue-brief.pdf. Accessed January 27, 2012.
5. US Department of Health and Human Services. SAMHSA. Office of Applied Studies. Results from the 2009 National Survey on Drug Use and Health: National Findings. Volume 1. Summary of National Findings. http://oas.samhsa.gov/NSDUH/2k9NSDUH/2k9ResultsP.pdf. Accessed January 27, 2012.
6. Katz NP, Birnbaum HG, Castor A. Volume of prescription opioids used nonmedically in the United States. J Pain Palliat Care Pharmacother. 2010;24(2):141-144.
7. US General Accounting Office. Prescription Drugs, OxyContin Abuse and Diversion, and Efforts to Address the Problem. US General Accounting Office; 2003. http://www.gao.gov/new.items/d04110.pdf. Accessed January 27, 2012.
8. US Food and Drug Administration. Questions and answers: FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for long-acting and extended-release opioids. US Food and Drug Administration; 2011. Available from: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ ucm251752.htm. Accessed January 27, 2012.
9. Martins SS, Storr CL, Zhu H, Chilcoat HD. Correlates of extramedical use of OxyContin versus other analgesic opioids among the US general population. Drug Alcohol Depend. 2009;99(1-3):58-67.
10. Reder RF, Oshlack B, Miotto JB, Benziger DD, Kaiko RF. Steady-state bioavailability of controlled-release oxycodone in normal subjects. Clin Ther. 1996;18(1):95-105.
11. Shram MJ, Sathyan G, Khanna S, et al. Evaluation of the abuse potential of extended release hydromorphone versus immediate release hydromorphone. J Clin Psychopharmacol. 2010;30(1):25-33.
12. US Food and Drug Administration. Post-approval REMS notification letter. http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM251595.pdf. Accessed January 27, 2012.
13. US Food and Drug Administration. Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications. US Food and Drug Administration; 2009. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM184128.pdf. Accessed January 27, 2012.
14. Off ice of National Drug Control Policy. Epidemic: responding to America's prescription drug abuse crisis. http://www.whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf. Accessed January 27, 2012.
15. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011; 305(13):1315-1321.
16. Dunn KM, Saunders KW, Rutter CM, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010;152:85-92.
17. Chabal C, Erjavec MK, Jacobson L, Mariano A, Chaney E. Prescription opiate abuse in chronic pain patients: clinical criteria, incidence, and predictors. Clin J Pain. 1997;13:150-155.
18. Katz N, Sherburne S, Beach M, et al. Behavioral monitoring and urine toxicology testing in patients receiving long-term opioid therapy. Anesth Analg. 2003;97:1097-1102.
19. Manchikanti L, Pampati V, Damron KS, et al. Prevalence of opioid abuse in interventional pain medicine practice settings: a randomized clinical evaluation. Pain Physician. 2001;4(4):358-365.
20. Fishbain DA, Cole B, Lewis J, Rosomoff HL, Rosomoff RS. What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drugrelated behaviors? A structured evidence-based review. Pain Medicine. 2008;9(4):444-459.
21. Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance use disorders in a primary care sample receiving daily opioid therapy. J Pain. 2007;8(7):573-582.
22. Fleming MF, Davis J, Passik SD. Reported lifetime aberrant drug-taking behaviors are predictive of current substance use and mental health problems in primary care patients. Pain Medicine. 2008;9(8):1098-1106.
23. Belgrade MJ, Schamber CD, Lindgren BR. The DIRE score: predicting outcomes of opioid prescribing for chronic pain. J Pain. 2006;7(9): 671-681.
24. Butler SF, Budman SH, Fernandez K, Jamison RN. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004;112:65-75.
25. Butler SF, Fernandez K, Benoit C, Budman SH, Jamison RN. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain. 2008;9(4):360-372.
26. Carrington Reid M, Engles-Horton L, Weber M, et al. Use of opioid medications for chronic noncancer pain syndromes in primary care. J Gen Intern Med. 2002;17:173-179.
27. Webster LR, Webster RM. Predicting aberrant behaviors in opioidtreated patients: preliminary validation of the Opioid Risk Tool. Pain Medicine. 2005;6(6):432-442.
28. Thalomid (thalidomide) capsules. Risk management plan. NDA 20-785. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ UCM222649.pdf. Accessed January 27, 2012.
29. US Food and Drug Administration. Approved risk evaluation and mitigation strategies (REMS). December 12, 2011 update. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm. Accessed January 27, 2012.
30. Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/ UCM217510.pdf. Accessed January 27, 2012.
31. Medication guide. EXALGO (hydromorphone HCl) Extended-release tablets. Hazelwood, MO: Mallinckrodt Inc, a Covidien company; 2010.
32. Medication guide. BUTRANS CIII (buprenorphine). Stamford, CT: Purdue Pharma LP; 2010.
33. Medication guide. OXYCONTIN (oxycodone hydrochloride controlledrelease) Tablets. Stamford, CT: Purdue Pharma LP; 2010.
34. US Food and Drug Administration. Medication disposal: questions and answers. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186188.htm. Accessed January 27, 2012.
35. US Food and Drug Administration. Disposal of unused medicines: what you should know. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm. Accessed January 27, 2012.
36. Medical Board of California. New laws related to continuing medical education. http://www.mbc.ca.gov/licensee/continuing_education_laws.html. Accessed January 27, 2012.
37. US Food and Drug Administration. Controlled substances act. Title 21 - Food and drugs; Chapter 13 - Drug abuse prevention and control; Subchapter I - Control and enforcement. Part C - Registration of manufacturers, distributors, and dispensers of controlled substances. http://www.fda.gov/regulatoryinformation/legislation/ucm148726.htm. Accessed January 27, 2012.
38. US Food and Drug Administration. FDA opioid REMS meeting with industry, May 16, 2011. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258184.htm. Accessed January 27, 2012.
39. Fine PG, Portenoy RK. Ad Hoc Expert Panel on Evidence Review and Guidelines for Opioid Rotation. Establishing "best practices" for opioid rotation: conclusions of an expert panel. J Pain Symptom Manage. 2009; 38(3):418-425.