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. 2012 Oct 30;9(2):e24–e39. doi: 10.1200/JOP.2012.000620

Table 1.

New REMS Approved Between March 25, 2008 and October 1, 2011, Categorized by REMS Elements

REMS Elements (in addition to a timetable for submission of assessment of the REMS) Description of the Elements (as defined by statutory language in FDAAA) No.7
Medication Guide (MG)

  1. Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations, and

  2. Patient package insert

 124*
Communication Plan (CP), which can be used alone or with an MG Such plan may include

  1. Sending letters to health care providers

  2. Disseminating information about the element of the REMS to encourage implementation by health care providers of components that apply to such health care providers, or to explain certain safety protocols; or

  3. Disseminating information to health care providers through professional societies about any serious risks of the drug and any protocol to ensure safe use

 40
Elements to assure safe use (ETASU), which can be used alone or with a CP and/or MG ETASU shall include one or more goals to mitigate a specific serious risk, and may require that

  1. Health care providers who prescribe the drug have particular training or experience, or are specially certified

  2. Pharmacies, practitioners, or health care settings that dispense the drug are specially certified

  3. The drug be dispensed to patients only in certain health care settings, such as hospitals

  4. The drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results

  5. Each patient using the drug be subject to monitoring, or

  6. Each patient using the drug be enrolled in a registry

 21
Implementation system (with ETASU only) The element to ensure safe use may include a system through which the applicant is able to take reasonable steps to

  1. Monitor and evaluate implementation of such elements by health care providers, pharmacists, and other parties in the health care system who are responsible for implementing such elements, and

  2. Work to improve implementation of such elements by such persons

 †
Total new REMS approved 185

Abbreviations: FDAAA, US Food and Drug Administration Amendments Act of 2007; REMS, Risk Evaluation and Mitigation Strategies.

*

Since October 1, 2011, changes have been made to these REMS programs.8

†

This number was not provided in the presentation.