US food and drug Administration's risk evaluation and mitigation strategy for extended-release and long-acting opioids: Pros and cons, and a European perspective

Drugs

Volumn 72, Issue 18, 2012, Pages 2327-2332

  Mercadante, Sebastiano ^a   Craig, David ^b   Giarratano, Antonello ^c  

^a LA MADDALENA CANCER CENTER   (Italy)

^b H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF PALERMO   (Italy)

Author keywords

Health policy; Opioid abuse; Opioid analgesics; Risk management

Indexed keywords

OPIATE;

ANALGESIA; CLINICAL EVALUATION; DRUG ABUSE; DRUG MARKETING; DRUG MISUSE; DRUG RELEASE; DRUG UTILIZATION; FOOD AND DRUG ADMINISTRATION; HUMAN; OPIATE ADDICTION; PATIENT SAFETY; PRESCRIPTION; REVIEW; RISK EVALUATION AND MITIGATION STRATEGY; RISK MANAGEMENT;

ANALGESICS, OPIOID; CHRONIC PAIN; DELAYED-ACTION PREPARATIONS; EUROPE; HUMANS; OPIOID-RELATED DISORDERS; RISK ASSESSMENT; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84871331531     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11642230-000000000-00000     Document Type: Review

References (29)

1. Reid MC, Engles-Horton LL, Weber MB, et al. Use of opioid medications for chronic noncancer pain syndromes in primary care. J Gen Intern Med 2002; 17; 173-9
2. Breivik H, Collett B, Ventafridda V, et al. Survey of chronic pain in Europe; prevalence, impact on daily life, and treatment. Eur J Pain 2006; 10; 287-333
3. Zorba Paster R. Chronic pain management issues in the primary care setting and the utility of long-acting opioids. Expert Opin Pharmacother 2010; 11; 1823-33
4. 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; 113-30
5. Rosenblum A, Joseph H, Fong C, et al. Prevalence and characteristics of chronic pain among chemically dependent patients in methadone maintenance and residential treatment facilities. JAMA 2003; 290; 2370-8
6. Gudin JA. The changing landscape of opioid prescribing and extended-release opioid class-wide risk evaluation and mitigation strategy. Ther Clin Risk Manage 2012; 8; 209-17
7. 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
8. Summary minutes of the joint meeting of the Anesthetic and Life Support Drugs Advisor Committee (ALSDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM); July 22-23, 2010; Adelphi (MD) (online). Available from URL; :http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM224672.pdf. Accessed 2012 Oct 1.
9. Robert Lowes. Tighten opioid label restrictions, physicians tell FDA. online. Available from URL; :http://www.medscape.com/viewarticle/768214. Accessed 2012 Oct 24.
10. Chou R, Fanciullo GJ, Fine PG, et al. American Academy of pain medicine opioids guidelines panel; clinical guidelines for the use of chronic opioid therapy in chronic non-cncer pain. J Pain 2009; 10; 113-30
11. Fishbain DA, Cole B, Lewis J, et al. What percentage of chronic non malignant pain patients exposed to chronic opioid analgesic therapy develop abuse addiction and or aberrant drug-related behaviours? Pain Med 2008; 9; 444-59
12. Hojsted J, Sjogren P. Addiction to opioids in chronic pain patients; a literature review. Eur J Pain 2007; 11; 490-518
13. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid-overdose deaths. JAMA 2011; 305; 1315-21
14. Argoff CE, Passik SD. Abuse-deterrent opioid formulations; from science to practice. online. Available from URL; :http://www.medscape.org/viewarticle/ 705952. Accessed 2012 Oct 24.
15. Shane R. Risk evaluation and mitigation strategies; impact on patients, health care providers, and health systems. Am J Health Syst Pharm 2009 15; 66 (24 Suppl. 7); S6-12
16. Gudin J. risk evaluation and mitigation strategies (REMS) for extended-release and long-acting opioid analgesics; considerations palliative care practice. J Pain Palliate Care Pharmacother 2012; 26; 136-43
17. Nicholson S, Peterson J, Yektashenas B. Pharmaceutical industry perspective on risk evaluation and mitigation strategies; manufacturer take heed. Expert Opin Drug Saf 2012; 11; 299-314
18. US Department of Health and Human Services. US FDA. FDA opioid REMS meeting with industry (May 16, 2011). online. Available from URL; :http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258184.htm. Accessed 2012 Oct 1.
19. US Food and Drug Administration, Approved risk evaluation and mitigation strategies (REMS) December 12, 2011 update. online. Available from URL; :http://www.pharmasug.org/proceedings/2012/IB/PharmaSUG-2012-IB02.pdf. Accessed 2012 Oct 1.
20. Craig DS. Are opioid risk evaluation and mitigation strategies (REMS) interrupting your sleep? J Pain Palliat Care Pharmacoth 2012; 26; 134-5
21. Fiore K. Critics; opioid REMS misses mark on patient education. Medpage TODAY, 2012 Aug 1. online. Available from URL; :http://www.medpagetoday.com/ InOtherWords/33938. Accessed 2012 Oct 1.
22. Centers for Disease Control and Prevention. Prescription painkiller overdoses; methadone. online. Available from URL; :http://www.cdc.gov/features/ vitalsigns/methadoneoverdoses/. Accessed 2012 Oct 1.
23. Slevin KA, Ashburn MA. Primary care physician opinion survey on FDA opioid risk evaluation and mitigation strategies. J Opioid Manag 2011; 7; 109-15
24. Substance Abuse and Mental Health Services Administration. Results from the 2010 national survey on drug use and health; summary of national findings. Rockville (MD); Substance Abuse and Mental Health Services Administration; 2011-NSDUH Series H-41, HHS Publication No. (SMA) 11-4658
25. Peppin JF, Coleman JJ, Kirsh KL. Issues and critiques of the forthcoming risk evaluation and mitigation strategy (REMS) for opioids in pain management. Issues Law Med 2011; 27; 91-119
26. OPEN Minds. The white paper on opioids and pain; a pan-European challenge. 2005 Jun. online. Available from URL; :http://www.dgss.org/fileadmin/ pdf/50616-White-Paper.pdf. Accessed 2012 Oct 1.
27. Cherny NI, Baselga J, de Conno F, et al. Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe; a report from the ESMO EAPC Opioid Policy Initiative. Ann Oncol 2010; 21; 615-26
28. Hutchinson K, Moreland A, de Williams A, et al. Exploring beliefs and practice of opioid prescribing for persistent non-cancer pain by general practitioners. Eur J Pain 2007; 11; 93-8
29. European Monitoring Centre for Drugs and Drug Addiction. 2010 Annual report on the state of the drugs problem in Europe. Lisbon; EMCDDA, 2010 Nov. online. Available from URL; :http://www.emcdda.europa.eu/publications/annual- report/2010. Accessed 2012 Oct 1.