Abstract
A Risk Evaluation and Mitigation Strategies (REMS) program is a risk management plan that uses risk minimization strategies beyond approved drug labeling to manage serious risks associated with a medication.
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References
FDA US Food and Drug Administration. Questions and answers: FDA approves a class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines. www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm284717.htm. Updated January 5, 2012. Accessed February 1, 2013.
TIRF REMS ACCESS. TIRF REMS Access Program Home. What is the TIRF REMS Access Program? www.tirfremsaccess.com. Accessed February 1, 2013.
Anderson R, Saiers JH, Abram S, Schlicht C, et al. Accuracy in equianalgesic dosing. Conversion dilemmas. J Pain Symptom Manage. 2001;21:397-406.
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© 2013 Springer Healthcare
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Taylor, D. (2013). TIRF REMS Access Program. In: Managing Cancer Breakthrough Pain. Springer Healthcare, Tarporley. https://doi.org/10.1007/978-1-908517-83-8_6
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DOI: https://doi.org/10.1007/978-1-908517-83-8_6
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