Extended-release/long-acting opioid REMS may fill the need for prescribers' appropriate use education

Journal of Opioid Management

Volumn 8, Issue 4, 2012, Pages 212-216

  Nicholson, Susan C ^a   Evanyo, Kimberly ^a   Salinas, Gregory D ^b   Roepke, Nancy ^b   Burton, B Stephen ^b   Susalka, Debi ^b  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b CE Outcomes LLC   (United States)

Author keywords

Opioids; Pain treatment information; REMS

Indexed keywords

OPIATE;

ARTICLE; DRUG MANUFACTURE; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; MEDICAL EDUCATION; PAIN; PRACTICE GUIDELINE; PRESCRIPTION; RISK EVALUATION AND MITIGATION STRATEGY; RISK MANAGEMENT; TIMED DRUG RELEASE;

ANALGESICS, OPIOID; DELAYED-ACTION PREPARATIONS; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; DRUG PRESCRIPTIONS; EDUCATION, MEDICAL, CONTINUING; HEALTH EDUCATION; HEALTH OCCUPATIONS; HUMANS; OPIOID-RELATED DISORDERS; RISK ASSESSMENT; RISK MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84866757547     PISSN: 15517489     EISSN: None     Source Type: Journal    
DOI: 10.5055/jom.2012.0118     Document Type: Article

References (5)

1. US Department of Health and Human Services, Food and Drug Administration: Opioid REMS Meeting Invitation Template. Available at http://www.fda.gov/ downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM163652.pdf. Accessed January 18, 2012.
2. US Department of Health and Human Services, Food and Drug Administration: Letter sent to opioid manufacturers outlining opioid REMS implementation. Available at http://www.fda.gov/downloads/Drugs/DrugSafety/ InformationbyDrugClass/UCM251595.pdf. Accessed January 18, 2012.
3. US Department of Health and Human Services, Food and Drug Administration: List of long-acting and extended-release opioid products required to have an opioid REMS. Available at www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ ucm251735.htm. Accessed January 18, 2012.
4. Accreditation Council for Continuing Medical Education: ACCME standards for commercial support: Standards to ensure the independence of CME activities. Available at http://cme.med.miami.edu/documents/scs.pdf. Accessed January 26, 2012.
5. Salinas GD, Susalka D, Burton BS, et al.: Risk assessment and counseling behaviors of healthcare professionals managing patients with chronic pain: A national multi-faceted assessment of physicians, pharmacists, and their patients. J Opioid Manage. 2012 (in press).