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Curbing the Opioid Epidemic in the United States

Curbing the Opioid Epidemic in the United States VIEWPOINT Curbing the Opioid Epidemic in the United States The Risk Evaluation and Mitigation Strategy (REMS) historically had limited direct influence. In 2007, the Food Lewis S. Nelson, MD and Drug Administration Amendments Act (FDAAA) pro- Jeanmarie Perrone, MD vided the FDA with the regulatory authority to require post- marketing studies and to mandate the implementation of a HRONIC PAIN IS A MULTIDIMENSIONAL PROBLEM, WITH risk evaluation and mitigation strategy, or REMS, for drugs significant influence on the culture and economy that are efficacious but have the potential for serious harm. of the United States. Although chronic pain asso- Two opioid-related REMS have since been constructed: one Cciated with cancer is distinct from that associ- for extended-release and long-acting (ER/LA) opioids and ated with musculoskeletal or functional pain syndromes, another for transmucosal immediate-release fentanyl (TIRF) common treatment strategies for both include the admin- products, such as fentanyl lozenges. Each will replace a mul- istration of opioids. Although it appears logical to pre- titude of existing REMS for individual opioids in their cat- scribe potent analgesics to patients with chronic noncan- egory with a single class-wide system. A REMS for short- cer pain, the data to support the effectiveness of http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Curbing the Opioid Epidemic in the United States

JAMA , Volume 308 (5) – Aug 1, 2012

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Publisher
American Medical Association
Copyright
Copyright 2012 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.8165
pmid
22851109
Publisher site
See Article on Publisher Site

Abstract

VIEWPOINT Curbing the Opioid Epidemic in the United States The Risk Evaluation and Mitigation Strategy (REMS) historically had limited direct influence. In 2007, the Food Lewis S. Nelson, MD and Drug Administration Amendments Act (FDAAA) pro- Jeanmarie Perrone, MD vided the FDA with the regulatory authority to require post- marketing studies and to mandate the implementation of a HRONIC PAIN IS A MULTIDIMENSIONAL PROBLEM, WITH risk evaluation and mitigation strategy, or REMS, for drugs significant influence on the culture and economy that are efficacious but have the potential for serious harm. of the United States. Although chronic pain asso- Two opioid-related REMS have since been constructed: one Cciated with cancer is distinct from that associ- for extended-release and long-acting (ER/LA) opioids and ated with musculoskeletal or functional pain syndromes, another for transmucosal immediate-release fentanyl (TIRF) common treatment strategies for both include the admin- products, such as fentanyl lozenges. Each will replace a mul- istration of opioids. Although it appears logical to pre- titude of existing REMS for individual opioids in their cat- scribe potent analgesics to patients with chronic noncan- egory with a single class-wide system. A REMS for short- cer pain, the data to support the effectiveness of

Journal

JAMAAmerican Medical Association

Published: Aug 1, 2012

References