title: Class-wide REMS for extended-release and long-acting opioids: potential impact on pharmacies.
abstract: OBJECTIVE
  To provide an update on the recently approved class-wide risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids and to discuss the potential impact on pharmacy practice.
  
  
  METHODS
  In mid-2011, the Food and Drug Administration notified drug manufacturers that a single, class-wide REMS would be required for ER and LA opioids. This regulation was the result of a multiyear process that incorporated input from government, drug manufacturers, medical associations, and other stakeholders.
  
  
  CONCLUSIONS
  The goal of the class-wide REMS for ER/LA opioids is to reduce addiction, unintentional overdose, and death resulting from inappropriate prescribing, misuse, and abuse. To accomplish these goals, this REMS focuses on physician education on safe and appropriate prescribing and patient counseling on the risks of opioids. Although voluntary, a movement to require physician education to obtain or renew Drug Enforcement Administration licensing is occurring. Pharmacists are not included in the class-wide REMS per se. Pharmacists play an important role in overall risk reduction and are critical to the success of the class-wide REMS.
  
  
  CONCLUSIONS
  Although the changing requirements for prescribing ER/LA opioids will not have a direct effect on pharmacist workflow, the pharmacist-patient interaction remains critical for overall risk reduction with this class of medication.
authors: Massachusetts College of Pharmacy and Health Sciences University, Boston, MA 02115, USA. michele.matthews@mcphs.edu
authors: Michele L
authors: ML
authors: Matthews
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004348:Drug Labeling; D062787:Drug Overdose / Q000517:prevention & control; D006801:Humans; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D010593:Pharmaceutical Services / Q000458:organization & administration*; D010595:Pharmacists / Q000458:organization & administration; D010818:Practice Patterns, Physicians' / Q000592:standards; D011369:Professional-Patient Relations; 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