RISK EVALUATION AND MITIGATION STRATEGIES FOR

LONG-ACTING OPIOID ANALGESICS

REMS

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 StrategyDesigned to manage a known or potential serious risk Allows appropriate patients continued access to

medications Ensures benefits outweigh any potential safety risksNot 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, MDDirector 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/InformationbyDrugClass/UCM163672.pdf. Accessed September 2009.

REMS in Other Therapeutic Areas

Risk management programs are not new to medicine

Pain medications have not been singled outThere are REMS for many other medications:

Product REMS program

Accutane (isotretinoin) iPLEDGE1

Entereg (alvimopan) EASE Program2

Nplate (romiplostim) NEXUS Program31. https://www.ipledgeprogram.com/. Accessed September 2009; 2. http://www.adolor.com/research/index.asp?page=entereg-

alvimopan.Accessed September 2009; 3. http://www.nplate.com/. Accessed September 2009.

LETS GET READY FOR REMS

Opioids are effective analgesicsHowever, nonmedical use including misuse, abuse, and

diversion of opioids is increasingIt is critical to maintain access to these drugs for

appropriate patientsAs such, it is vital that healthcare providers and

patients understand important opioid safety messagesIt’s time to do the right thing –REMS are necessary to

ensure that the benefits of medications outweigh risksMinimize harm to patientsREMS exist outside pain medicine, with proven success