A.gilsenan_ispe poster b.indd
Evaluation of Current Risk Evaluation and Mitigation Strategies
Alicia Gilsenan, Elizabeth Andrews, Brian Calingaert, Debra Crozier, Abenah Vanderpuije
RTI Health Solutions, RTP, NC, United States
The role of the United States (US) Food and Drug Administration (FDA) with regard to
To review characteristics of active REMS in the US for drugs with signiﬁ cant known risks.
All REMS aimed at preventing birth defects or abuse/diversion included elements to assure safe use. Table 1
Table 2 displays drugs with approved REMS requiring components beyond a medication guide.
The requirement for medication guides and
postmarketing drug safety has increased over time (Figure 1).
shows drugs with approved REMS requiring a medication guide only.
other REMS components is becoming relatively common following the FDA
Table 1. Approved REMS With Medication Guide as Only REMS
Table 2. Drugs With Approved REMS With Additional Components
Amendments Act of 2007,1 which authorized
Figure 1. Drug Safety Timeline: Selected Events
For the ISPE abstract, we identiﬁ ed all drugs recognized by the FDA as having an active REMS as of
Reason(s) for REMS
Reason(s) for REMS
REMS are highly targeted to speciﬁ c events
October 31, 2008. To provide the most up-to-date information in this rapidly changing regulatory
Abacavir sulfate, abacavir sulfate Ziagen tablets and oral solution,
environment, REMS approved through July 31, 2009 are included in the results for the poster. This
patterns are emerging. However, details of
survey of programs updates a review previously published.2
Authors reviewed publicly available information (e.g., www.fda.gov,3 published articles, and
available. The lack of publicly available
Irritable bowel syndrome Ischemic colitis; complications
product labels) to identify the safety issue prompting the REMS; the original indication for the
Aplenzin extended-release tablets Depression
information limits the knowledge base upon
products; the nature of REMS elements, including medication guide, communication programs,
elements to assure safe use; and whether the REMS was approved at the time of or following drug
gastrointestinal recovery opioids immediately prior to
Arthritis, psoriasis, Crohn’s disease,
A total of 69 drugs were identiﬁ ed as having an approved REMS (14 “deemed” REMS as listed in
to FDC Act
the Federal Register4 and 55 subsequently listed on the FDA website3).
CER = comparative effectiveness research.
Of the 69 REMS, 52% (n = 36) required only medication guides, 28% (n = 19) required
Food and Drug Administration (FDA). Food and Drug
communication plans, 28% (n = 19) required elements of safe use (13/19 are for drugs deemed to
Administration Amendments Act of 2007 (P.L. 110-85).
Available at: http://frwebgate.access.gpo.gov/cgibin/getdoc.
Under the FDA Amendments Act of 2007,1 the FDA has enhanced responsibilities and
have approved REMS), and 13% (n = 9) required an implementation system.
authority with regard to pre- and postmarketing drug safety, including the authority to
The total number of REMS approved so far in 2009 (n = 31) accounts for 45% of all REMS
Andrews E, Gilsenan A, Cook S. Therapeutic risk
require risk evaluation and mitigation strategies (REMS) for certain drugs in order to
approved. Figure 2 shows the trend in REMS components over time since March 2008.
management interventions: feasibility and effectiveness. J
ensure that a drug’s beneﬁ ts outweigh its risks.
Food and Drug Administration (FDA). Approved risk
The FDA considers the following when determining whether to require a REMS for a
Figure 2. Trend in REMS 2008 to Present
evaluation and mitigation strategies (REMS). Available at:
• Estimated size of the population likely to use the drug involved
ucm111350.htm. Accessed August 4, 2009.
Department of Health and Human Services Food and Drug
• Seriousness of the disease or condition that is to be treated with the drug
Administration (FDA). Identiﬁ cation of drug and biological
Combination antiretroviral treatment Fatal and nonfatal hepatotoxicity
products deemed to have risk evaluation and mitigation
• Expected beneﬁ t of the drug with respect to such disease or condition
strategies for purposes of the Food and Drug
Administration Amendments Act of 2007. Federal Register
• Expected or actual duration of treatment with the drug
ugs with REMS
• Seriousness of any known or potential adverse events that may be related to the
drug and the background incidence of such events in the population likely to use the
• Whether the drug is a new molecular entity.
Elements of REMS may include one or more of the following components:
tal number of dr
CONFLICT OF INTEREST STATEMENT
• Communication plan to health care providers, which may include the following:
There are no conﬂ icts of interest.
Sending letters to health care providers
Disseminating information about the elements of the REMS to encourage
implementation by health care providers or to explain certain safety protocols
infectious disorders. With ribavirin - birth defects
(e.g., medical monitoring by periodic laboratory tests)
Figures 3 and 4 show the distribution of REMS by indication and the primary safety concern that prompted
Disseminating information to health care providers through professional societies
about any serious risks of the drug and any protocol to assure safe use
• Elements to assure safe use, which may include one or more of the following:
Figure 3. Distribution of REMS by Primary Indication Category
Figure 4. Distribution of REMS by Primary Safety Concern
Health care providers who prescribe the drug have particular training or experience or
Alicia Gilsenan, PhD
Pharmacies, practitioners, or health care settings that dispense the drug are specially
Drug is dispensed to patients only in certain health care settings (e.g., hospitals)
Drug is dispensed to patients with evidence or other documentation of safe-use
conditions (e.g., laboratory test results)
Each patient using the drug is subject to certain monitoring
Each patient using the drug is enrolled in a registry
Presented at: 25th International Conference
• Implementation system, which may require the sponsor to complete the following:
Monitor and evaluate implementation of elements to assure safe use by health care
providers, pharmacists, and other parties in the health care system who are
responsible for implementing such elements
Work to improve implementation of these elements by such persons.
MDD = major depressive disorder; MI = myocardial infarction; XR = extended release.
CNS = central nervous system; ITP = idiopathic thrombocytopenic purpura; PCA = patient-controlled analgesia.
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