Download Risk Evaluation and Mitigation Strategies for Opioid

REMS
RISK EVALUATION AND
MITIGATION STRATEGIES
FOR
LONG -ACTING OPIOID
ANALGESICS
Katherine E. Galluzzi, D.O., CMD, FACOFP dist.
Chair – AOA Council on Palliative Care Issues
EDUCATIONAL OBJECTIVES
 Acknowledge the importance of opioid analgesics for
treatment of patient with moderate-to-severe pain
 Understand the problem of misuse/abuse/diversion
in light of the increasing use of opioids as a mainstay
in the armamentarium against pain
 Seek to strike a balance between appropriate pain
control and responsible prescribing of long-acting
opioid analgesics
 Recognize the role of risk evaluation and mitigation
strategies in protecting both patient safety and
access to appropriate pain medications
The Bottom Line on Misuse/Diversion/Abuse
From the Physician’s Perspective
“If a clinician has the slightest inkling that a patient
presenting with severe pain has an ulterior motive
for wanting pain control interventions, the clinical
encounter becomes a ‘no win’ scenario from the
clinician’s perspective.
If he prescribes an opiate, he’ll be staring at the
ceiling in the middle of the night wondering if the
opiate is being sold on the street. If the clinician
doesn’t prescribe an opiate, he’ll be staring at the
ceiling wondering if he caused a patient to needlessly
endure ongoing pain.”
– Paul Grossman, MD, family physician
WHAT IS A REMS?
 REMS = Risk Evaluation and Mitigation Strategy
 Designed to manage a known or potential serious risk
 Allows appropriate patients continued access to
medications
 Ensures benefits outweigh any potential safety risks
 Not driven only by addiction or abuse –there is also a
need to ensure that healthcare professionals and patients
are fully aware of important safety messages, such as the
requirement for patients to be opioid-tolerant before
they can take certain medications
WHY BOTHER?
 Because proceeding without REMS is not an
option:
This is going to be mandated
by the FDA
 Reliance on products without REMS may
lead to inadvertent under-treatment of pain
in appropriate patients
THE MANDATE
 “We expect all companies marketing these products to
work with us [to implement REMS] expeditiously. If
not, we cannot guarantee that these products will
remain on the market”1
Bob A. Rappaport, MD
Director Division of Anesthesia, Analgesia and Rheumatology
Products
Center for Drug Evaluation and Research Food & Drug
Administration


Excerpt from presentation by Rappaport BA, March 3, 2009. REMS
for Opioid Analgesics: How Did We Get Here? Where are We Going?
http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyD
rugClass/UCM163672.pdf. Accessed September 2009.
REMS in Other Therapeutic Areas
 Risk management programs are not new to medicine
 Pain medications have not been singled out
 There are REMS for many other medications:
Product
Accutane (isotretinoin)
Entereg (alvimopan)
Nplate (romiplostim)
REMS program
iPLEDGE1
EASE Program2
NEXUS Program3
1. https://www.ipledgeprogram.com/. Accessed September 2009;
2. http://www.adolor.com/research/index.asp?page=enteregalvimopan.Accessed September 2009;
3. http://www.nplate.com/. Accessed September 2009.
LETS GET READY FOR REMS
 Opioids are effective analgesics
 However, nonmedical use including misuse, abuse, and

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

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diversion of opioids is increasing
It is critical to maintain access to these drugs for
appropriate patients
As such, it is vital that healthcare providers and patients
understand important opioid safety messages
It’s time to do the right thing –REMS are necessary to
ensure that the benefits of medications outweigh risks
Minimize harm to patients
REMS exist outside pain medicine, with proven success