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Abstract

Objective

To review the components of the Congressional mandate for risk evaluation and mitigation strategies (REMS) managed by the Food and Drug Administration and assess their impact on health care providers practicing within the organ transplant arena.

Data Sources and Extraction

A non-date-limited search of MEDLINE and EMBASE (January 2007-June 2012) was conducted by using the following search terms: risk evaluation and mitigation strategies, REMS, and organ transplant, including a query of the individual organs. Information from the Federal Register and the Food and Drug Administration was also evaluated.

Data Synthesis

REMS are strategies implemented to manage known or potential risks associated with medications and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product. Elements of REMS programs may consist of 3 levels: a medication guide, communication plan, and elements to assure safe use. A medication guide is used to help prevent serious adverse events, aid in patients' decision making, and enhance medication adherence. Communication plans help educate health care providers and encourage adherence with REMS. The elements to assure safe use is a restrictive process implemented when it is deemed necessary to ensure safe access for patients to products with known serious risks. In transplant medicine, REMS currently exist for belatacept (medication guide and communication plan) and the mycophenolic acid derivatives (medication guide and elements to assure safe use).

Conclusion

REMS are another step in the evolution of the development and marketing of pharmaceutical agents. Use of REMS in solid-organ transplant is becoming common. Transplant clinicians must provide required patient education and become involved with other aspects of REMS implementation to reduce the serious risks of pharmaceuticals and to improve patients' outcomes.

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References

Danovitch

. Immunosuppressive medications and protocols for kidney transplantation. In: Danovitch

, ed. Handbook of Kidney Transplantation. 5th ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2009:77–126.

Baciu

Stratton

Burke

. Committee on the Assessment of the US Drug Safety System. The Future of Drug Safety: Promoting and Protecting the Health of the Public. 1st ed. Washington, DC: The National Academies Press; 2006.

Psaty

Korn

. Congress responds to the IOM drug safety report-in full. JAMA. 2007;298:2185–187.

Hamburg

Sharfstein

. The FDA as a public health agency. N EnglJ Med. 2009;360:2493–2495.

Dabu-Bondoc

Franco

. Risk-benefit perspectives in COX-2blockade. CurrDrugSaf 2008;3:14–23.

Rizzo

Brouwers

Hurley

. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. J Clin Oncol. 2010;28:4996–5010.

Chaggar

Shaw

Williams

. Review article: Thiazolidinediones and heart failure. Diab Vase Dis Res. 2009;6: 146–152.

Brower

. FDA finalizes REMS program for ESAs; Amgen continues to study risks. J Natl Cancer Inst. 2010;102:592–593.

Food and Drug Administration. Food and Drug Administration Amendment Act of 2007. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_publicJaws&docid=f:publ085.110. Accessed July 15, 2012.

10.

Leiderman

. Risk management of drug products and the US Food and Drug Administration: Evolution and context. Drug Alcohol Depend. 2009;105(suppl 1):S9–S13.

11.

Food and Drug Administration. Guidance for Industry. Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS assessments, and Proposed REMS Modifications. 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf. Accessed July 15, 2012.

12.

White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system. J Am Pharm Assoc. 2009;49:729–743.

13.

Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies (REMS). 2012. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucmlll350.htm. Accessed August 15, 2012.

14.

Identification of drug and biological products deemed to have Risk Evaluation and Mitigation Strategies for purposes of the Food and Drug Administration Act of 2007. Federal Register. 2008;73(60). http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf. Accessed August 30, 2012.

15.

Food and Drug Administration. Guidance for Industry. Medication Guides—Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244570.pdf. Accessed July 15, 2012.

16.

Einecke

Sis

Reeve

. Antibody-mediated microcirculation injury is the major cause of late kidney transplant failure. Am J Transplant. 2009;9:2520–2531.

17.

Food and Drug Administration. BLA 125288 Nulojix (belatacept) 2011. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM261934.pdf. Accessed July 15, 2012.

18.

Risk Evaluation and Mitigation Strategies for Increased Risk of PTLD, Predominantly Involving the CNS, and PML With Nulojix. 2011. http://www.nulojix.com/hcp/rems.aspx. Accessed July 15,2012.

19.

Food and Drug Administration. Single Shared System for Mycophenolate. 2012. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM321261.pdf. Accessed October 11, 2012.

20.

McCaughan

. The risk of risk management. In:. The RPM Report. 2007:1–6. http://www.elsevierbi.com/publications/rpm-report/3/1/the-risk-of-risk-management. Accessed December 11,2012.

A Guide to Understanding and Implementing Risk Evaluation and Mitigation Strategies in Organ Transplantation