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Getting Serious About Opioid Regulation

Getting Serious About Opioid Regulation Evaluation of Extended-Release/Long-Acting Opioid Prescribing REMS Program by the US FDA Review Clinical Review & Education JAMA. 2019;321(7):676-685. doi:10.1001/jama. 22. Ratanawongsa N, Thomas PA, Marinopoulos postmarketing drug safety. JAMA. 2011;306(14): 2019.0235 SS, et al. The reported validity and reliability of 1595-1596. doi:10.1001/jama.2011.1457 methods for evaluating continuing medical 20. Office of Inspector General, US Department of 26. Baumgaertner E. F.D.A. did not intervene to education: a systematic review. Acad Med. 2008; Health and Human Services. FDA lacks curb risky fentanyl prescriptions. New York Times. 83(3):274-283. doi:10.1097/ACM.0b013e3181637925 comprehensive data to determine whether Risk August 2, 2018. https://www.nytimes.com/2018/ Evaluation and Mitigation Strategies improve drug 23. Kirkpatrick D, Kirkpatrick J. Evaluating Training 08/02/health/fda-fentanyl-opioid-epidemic- safety. https://oig.hhs.gov/oei/reports/oei-04-11- Programs: The Four Levels. 3rd ed. San Francisco, CA: overdose-cancer.html. Accessed October 7, 2018. 00510.pdf. Published 2013. Accessed October 7, Berrett-Koehler Publishers Inc; 2006. 27. Sarpatwari A, Curfman G. Mitigating health 24. Malterud K. Qualitative research: standards, risks of prescription drugs: lessons from FDA 21. Kern DE, Thomas PA, Howard DM, Bass EB. challenges, and guidelines. Lancet. 2001;358 oversight of opioid products. JAMA. 2019;321(7): Curriculum Development for Medical Education: (9280):483-488. doi:10.1016/S0140-6736(01) 651-653. doi:10.1001/jama.2019.0236 A Six-Step Approach. Baltimore, MD: Johns Hopkins 05627-6 University Press; 1998. 25. Qato DM, Alexander http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Getting Serious About Opioid Regulation

JAMA Internal Medicine , Volume 180 (2) – Mar 1, 2020

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Publisher
American Medical Association
Copyright
Copyright 2019 American Medical Association. All Rights Reserved.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2019.5443
Publisher site
See Article on Publisher Site

Abstract

Evaluation of Extended-Release/Long-Acting Opioid Prescribing REMS Program by the US FDA Review Clinical Review & Education JAMA. 2019;321(7):676-685. doi:10.1001/jama. 22. Ratanawongsa N, Thomas PA, Marinopoulos postmarketing drug safety. JAMA. 2011;306(14): 2019.0235 SS, et al. The reported validity and reliability of 1595-1596. doi:10.1001/jama.2011.1457 methods for evaluating continuing medical 20. Office of Inspector General, US Department of 26. Baumgaertner E. F.D.A. did not intervene to education: a systematic review. Acad Med. 2008; Health and Human Services. FDA lacks curb risky fentanyl prescriptions. New York Times. 83(3):274-283. doi:10.1097/ACM.0b013e3181637925 comprehensive data to determine whether Risk August 2, 2018. https://www.nytimes.com/2018/ Evaluation and Mitigation Strategies improve drug 23. Kirkpatrick D, Kirkpatrick J. Evaluating Training 08/02/health/fda-fentanyl-opioid-epidemic- safety. https://oig.hhs.gov/oei/reports/oei-04-11- Programs: The Four Levels. 3rd ed. San Francisco, CA: overdose-cancer.html. Accessed October 7, 2018. 00510.pdf. Published 2013. Accessed October 7, Berrett-Koehler Publishers Inc; 2006. 27. Sarpatwari A, Curfman G. Mitigating health 24. Malterud K. Qualitative research: standards, risks of prescription drugs: lessons from FDA 21. Kern DE, Thomas PA, Howard DM, Bass EB. challenges, and guidelines. Lancet. 2001;358 oversight of opioid products. JAMA. 2019;321(7): Curriculum Development for Medical Education: (9280):483-488. doi:10.1016/S0140-6736(01) 651-653. doi:10.1001/jama.2019.0236 A Six-Step Approach. Baltimore, MD: Johns Hopkins 05627-6 University Press; 1998. 25. Qato DM, Alexander

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Mar 1, 2020

References