title: Extended-release/long-acting opioid REMS may fill the need for prescribers' appropriate use education.
abstract: The Food and Drug Administration (FDA) is requiring manufacturers of long-acting and extended-release opioids to have a class-wide Risk Evaluation and Mitigation Strategy (REMS). The comprehensive risk management plan will include training for prescribers on the appropriate and safe use of these pain medications. The letter dated April 19, 2011 from FDA to manufacturers outlining the REMS requirements describes voluntary training that should be certified education "where practicable." The current report includes data from a recent comprehensive study of healthcare professionals and patients and highlights key insights that can guide the development of the opioid REMS training.
authors.affiliation: Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
authors.forename: Susan C
authors.initials: SC
authors.lastname: Nicholson
authors.forename: Kimberly
authors.initials: K
authors.lastname: Evanyo
authors.forename: Gregory D
authors.initials: GD
authors.lastname: Salinas
authors.forename: Nancy
authors.initials: N
authors.lastname: Roepke
authors.forename: B Stephen
authors.initials: BS
authors.lastname: Burton
authors.forename: Debi
authors.initials: D
authors.lastname: Susalka
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004345:Drug Industry; D011307:Drug Prescriptions; D004335:Drug and Narcotic Control / Q000379:methods*; D004502:Education, Medical, Continuing / Q000379:methods; D006266:Health Education; D006281:Health Occupations / Q000193:education*; D006801:Humans; D009293:Opioid-Related Disorders / Q000517:prevention & control; D018570:Risk Assessment / Q000379:methods; D012308:Risk Management / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations