Risk evaluation and mitigation strategies (REMS) for extended-release and long-acting opioid analgesics: Considerations for palliative care practice

Journal of Pain and Palliative Care Pharmacotherapy

Volumn 26, Issue 2, 2012, Pages 136-143

  Gudin, Jeffrey ^a  

^a ENGLEWOOD HOSPITAL AND MEDICAL CENTER   (United States)

Author keywords

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

Indexed keywords

BUPRENORPHINE; FENTANYL; HYDROMORPHONE; LONG ACTING DRUG; METHADONE; MORPHINE SULFATE; MORPHINE SULFATE PLUS NALTREXONE; OPIATE; OXYCODONE; OXYMORPHONE; TAPENTADOL;

ANALGESIA; ARTICLE; CHRONIC PAIN; DRUG CAPSULE; DRUG CONTROL; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG MONITORING; DRUG OVERDOSE; DRUG RELEASE; DRUG SAFETY; DRUG STORAGE; DRUG SURVEILLANCE PROGRAM; DRUG TOLERANCE; FOOD AND DRUG ADMINISTRATION; GERIATRIC PATIENT; HUMAN; MEDICATION THERAPY MANAGEMENT; OPIATE ADDICTION; PALLIATIVE THERAPY; PATIENT EDUCATION; PATIENT SELECTION; PRIMARY MEDICAL CARE; TABLET;

ANALGESICS, OPIOID; HUMANS; OPIOID-RELATED DISORDERS; PAIN; PALLIATIVE CARE; PATIENT EDUCATION AS TOPIC; RISK ASSESSMENT; RISK MANAGEMENT; SEVERITY OF ILLNESS INDEX; SLEEP PHASE CHRONOTHERAPY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84863592227     PISSN: 15360288     EISSN: 15360539     Source Type: Journal    
DOI: 10.3109/15360288.2012.679724     Document Type: Article

References (37)

1. Day JC. Population Projections of the United States by Age, Sex, Race, and Hispanic Origin: 1995 to 2050. US Bureau of the Census, Current Population Reports. Washington, DC: us Government Printing Office; 1996. Publication No. P25-1130.
2. World Health Organization. Cancer: who's pain ladder. Available at: Http://www.who.int/cancer/palliative/painladder/ en/. Accessed December 7, 2011.
3. Governale L. Outpatient presciption opioid utilization in the US, years 2000-2009. US Food and Drug Administration Drug Safety and RiskManagement Advisory Committee Meeting. July 2010. Available at: Http://www.fda.gov/ downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ DrugSafetyandRiskManagementADvisoryCommittee/ UCM220950.pdf. Accessed November 16, 2011.
4. Olsen Y, Daumit GL, Ford DE. Opioid prescriptions by US primary care physicians from 1992 to 2001. J Pain. 2006;7:225-235.
5. Parsells Kelly J, Cook S, Kaufman D, Anderson T, Rosenberg L, Mitchell A. Prevalence and characteristics of opioid use in the US adult population. Pain. 2008;138:507-513.
6. US Department of Health and Human Services, Centers for Disease Control and Prevention. Unintentional drug poisoning in the United States. July 2010. Available at: Http://www.cdc.gov/HomeandRecreationalSafety/pdf/poisonissue- brief.pdf. Accessed November 16, 2011.
7. US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Results From the 2009 National Survey on Drug Use and Health: VOLUME 1. Summary of National Findings. Rockville, MD: OFFICE of Applied Studies; 2010. NSDUH Series H-38A, HHS Publication No. SMA 10- 4586Findings. Available at: Http://oas.samhsa.gov/NSDUH/ 2k9NSDUH/2k9ResultsP.pdf. Accessed November 16, 2011.
8. Katz NP, Birnbaum HG, Castor A. Volume of prescription opioids used nonmedically in the United States. J Pain Palliat Care Pharmacother. 2010;24:141-144.
9. US Department of Health and Human Services, US Food and Drug Administration. Food and Drug Administration Amendments Act (FDAAA) of 2007. Available at: Http://www.fda.gov/RegulatoryInformation/Legislation/ federalfooddrugandcosmeticactfdcact/significantamendments tothefdcact/ foodanddrugadministrationamendmentsactof2007/ default.htm. Updated October 21, 2009. Accessed November 16, 2011.
10. US Department of Health and Human Services, US Food and Drug Administration. Post-Approval REMS notification letter. Available at: Http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM251595. pdf. Accessed November 16, 2011.
11. 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;2:113-130.
12. US General Accounting Office. Prescription drugs, Oxy- Contin Abuse and Diversion, and Efforts to Address the Problem. Washington, DC: us General Accounting Office; 2003. Publication No. GAO-04-110. Available at: Http://www.gao.gov/new.items/d04110.pdf. Accessed July 29, 2011.
13. US Department of Health and Human Services, US Food and Drug Administration. Questions and answers: fda requires a risk evaluation and mitigation strategy (REMS) for long-Acting and extended-Release opioids. Available at: Http:// www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ ucm251752.htm. Updated April 14, 2011. Accessed July 29, 2011.
14. 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;99:58-67.
15. Childers JW, Arnold RM. "I feel uncomfortable 'calling a patient out:"' educational needs of palliative medicine fellows in managing opioid misuse. J Pain Symptom Manage. 2012;43(2):253-260.
16. Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: A controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004;164: 83-94.
17. Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic nonsmall-Cell lung cancer. N Engl J Med. 2010;363:733-742.
18. Ciemins EL, Blum L, Nunley M, Lasher A, Newman JM. The economic and clinical impact of an inpatient palliative care consultation service: A multifaceted approach. J Palliat Med. 2007;10:1347-1355.
19. Penrod JD, Deb P, Dellenbaugh C, et al. Hospital based palliative care consultation: Effects on hospital cost. J Palliat Med. 2010;13:973-979.
20. Morrison RS, Penrod JD, Cassel JB, et al; Palliative Care Leadership Centers' Outcomes Group. Cost savings associated with US hospital palliative care consultation programs. Arch Intern Med. 2008;168:1783-1790.
21. Ńũnez-Olarte JM, Alvarez-JIḾenez P. Emerging opioid abuse in terminal cancer patients taking oral transmucosal fentanyl citrate for breakthrough pain. J Pain Symptom Manage. 2011;42:e6-E8.
22. Patterson TL, Jeste DV. The potential impact of the baby-Boom generation on substance abuse among elderly persons. Psychiatr Serv. 1999;50:1184-1188.
23. US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Office of Applied Studies Rockville, MD: OFFICE of Applied Studies; 2010. Publication No. TEDS 229. Available at: Wwwdasis.samhsa. gov/teds08/teds2k8natweb.pdf. Accessed January 12, 2012.TEDS Report: CHANGING Substance Abuse Patterns Among Older Admissions: 1992 and 2008
24. Andersen L, Remington P, Trentham-DIETZ A, Reeves M. Assessing a decade of progress in cancer control. Oncologist. 2002;7:200-204.
25. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose-Related deaths. JAMA. 2011;305:1315-1321.
26. 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.
27. US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration. Drug Abuse Warning Network (Dawn Excel Files).National estimates, drugrelated emergency department visits, 2004-2009-All visits [patient demographics tabs: 55 to 64 and 65 and older]. Available at: Http://www.samhsa.gov/data/DAWN.aspx. Accessed January 10, 2012.
28. Smith H, Bruckenthal P. Implications of opioid analgesia for medically complicated patients. Drugs Aging. 2010;27: 417-433.
29. US Department of Health and Human Services, 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. Rockville, MD: us Department of Health and Human Services; 2009. Available at: Http://www. fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM184128.pdf. Accessed January 10, 2012.
30. US Department of Health and Human Services, US Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies (REMS). Available at: Http://www.fda.gov/ Drugs/DrugSafety/ PostmarketDrugSafetyInformationfor PatientsandProviders/ucm111350.htm. Updated December 12, 2011. Accessed January 12, 2012.
31. US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research. Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. July 2010. Available at: Http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/ Drugs/AnestheticAndLife SupportDrugsAdvisoryCommittee/UCM217510.pdf. Accessed January 10, 2012.
32. Exalgo (hydromorphone HCl) Extended-RELEASE Tablets CII [medication guide]. Hazelwood, MO: MALLINCKRODT Inc.; 2010.
33. Butrans CIII (buprenorphine) [medication guide]. Stamford, CT: PURDUE Pharma L.P.; 2010.
34. OxyContin (oxycodone hydrochloride controlled-Release) Tablets [medication guide]. Stamford, CT: PURDUE Pharma L.P.; 2010.
35. US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research. Blueprint for prescriber continuing education program. Released October 25, 2011. Available at: Http://www.fda. gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/ UCM277916.pdf. Accessed December 6, 2011.
36. US Department of Health and Human Services, US Food and Drug Administration. FDA opioid REMS meeting with industry (May 16, 2011). Silver Spring, MD. Available at: Http:// www.fda.gov/Drugs/DrugSafety/ InformationbyDrugClass/ ucm258184.htm. Accessed August 24, 2011.
37. Dusetzina SB, Higashi AS, Dorsey ER, et al. Impact of FDA drug risk communications on health care utilization and health behaviors: A systematic review. Med Care. 2012 Jan 18 [Epub ahead of print]. doi:10.1097/MLR. 06013e318245a160.