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2.

Risk evaluation and mitigation strategies: impact on patients, health care providers, and health systems.

Shane R.

Am J Health Syst Pharm. 2009 Dec 15;66(24 Suppl 7):S6-S12. doi: 10.2146/ajhp090461.

PMID:
19966079
3.

The Food and Drug Administration Amendments Act of 2007: drug safety and health-system pharmacy implications.

Meyer BM.

Am J Health Syst Pharm. 2009 Dec 15;66(24 Suppl 7):S3-5. doi: 10.2146/ajhp090460.

PMID:
19966078
4.

Understanding risk evaluation and mitigation strategies in organ transplantation.

Gabardi S.

Pharmacotherapy. 2011 Jul;31(7):714-22. doi: 10.1592/phco.31.7.714. Review.

PMID:
21923459
5.

Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed.

Nicholson S, Peterson J, Yektashenas B.

Expert Opin Drug Saf. 2012 Mar;11(2):299-314. doi: 10.1517/14740338.2012.650689. Epub 2012 Jan 10. Review.

PMID:
22233294
6.

Risk evaluation and mitigation strategies (REMS): educating the prescriber.

Nicholson SC, Peterson J, Yektashenas B.

Drug Saf. 2012 Feb 1;35(2):91-104. doi: 10.2165/11597840-000000000-00000. Review.

PMID:
22171604
7.

Examination of risk evaluation and mitigation strategies and drug safety in the US.

Rodriguez-Monguio R, Spielberger K, Seoane-Vazquez E.

Res Social Adm Pharm. 2014 Jan-Feb;10(1):232-8. doi: 10.1016/j.sapharm.2013.03.005. Epub 2013 Apr 20.

PMID:
23611865
8.
9.

The FDA and drug safety: a proposal for sweeping changes.

Furberg CD, Levin AA, Gross PA, Shapiro RS, Strom BL.

Arch Intern Med. 2006 Oct 9;166(18):1938-42.

PMID:
17030825
10.

NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper: Recommendations for Stakeholders.

Johnson PE, Dahlman G, Eng K, Garg R, Gottlieb S, Hoffman JM, Howell P, Jahanzeb M, Johnson S, Mackler E, Rubino M, Sarokhan B, Marc Stewart F, Tyler T, Vose JM, Weinstein S, Li EC, Demartino J; NCCN Oncology Risk Evaluation and Mitigation Strategies (REMS) Work Group.

J Natl Compr Canc Netw. 2010 Sep;8 Suppl 7:S7-S27.

PMID:
20947724
11.

Evolution of opioid risk management and review of the classwide REMS for extended-release/long-acting opioids.

Stanos S.

Phys Sportsmed. 2012 Nov;40(4):12-20. doi: 10.3810/psm.2012.11.1975. Review.

PMID:
23306411
12.

Managing risk in developing transplant immunosuppressive agents: the new regulatory environment.

Gabardi S, Halloran PF, Friedewald J.

Am J Transplant. 2011 Sep;11(9):1803-9. doi: 10.1111/j.1600-6143.2011.03653.x. Epub 2011 Aug 9.

13.

The US Food and drug administration: drug information resource for formulary recommendations.

Marchand HC, Ros BJ, Fine AM, Kremzner ME.

J Manag Care Pharm. 2012 Nov-Dec;18(9):713-8.

14.

Risk evaluation and mitigation strategies: assessment of a medical center's policies and procedures.

Childs L, Alexander E, Duong MT.

Am J Health Syst Pharm. 2012 May 15;69(10):885-9. doi: 10.2146/ajhp110356.

PMID:
22555085
15.

Risk evaluation mitigation strategies: the evolution of risk management policy.

Hollingsworth K, Toscani M.

Popul Health Manag. 2013 Apr;16(2):132-7. doi: 10.1089/pop.2012.0021. Epub 2012 Oct 31. Review.

PMID:
23113627
17.

A guide to understanding and implementing risk evaluation and mitigation strategies in organ transplantation.

Gabardi S, Tichy EM.

Prog Transplant. 2013 Mar;23(1):58-62; quiz 63. doi: 10.7182/pit2013816.

PMID:
23448822
18.

Primary care physician opinion survey on FDA opioid risk evaluation and mitigation strategies.

Slevin KA, Ashburn MA.

J Opioid Manag. 2011 Mar-Apr;7(2):109-15.

PMID:
21561034
19.

Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective.

Wright C 4th, Schnoll S, Bernstein D.

Ann N Y Acad Sci. 2008 Oct;1141:284-303. doi: 10.1196/annals.1441.026. Review.

PMID:
18991964
20.

Assessment of risk evaluation and mitigation strategies in oncology: summary of the oncology risk evaluation and mitigation strategies workshop.

Frame JN, Jacobson JO, Vogel WH, Griffith N, Wariabharaj D, Garg R, Zon R, Stephens CL, Bialecki AM, Bruinooge SS, Allen SL.

J Oncol Pract. 2013 Mar;9(2):e24-39. doi: 10.1200/JOP.2012.000620.

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