*Risk Evaluation and Mitigation Strategy Welcome! REMS*: Prescriber Education That is Relevant, Case-Based, and Addresses Tough Issues *Risk Evaluation and Mitigation Strategy

Ronald J. Crossno, MD FAAFP FAAHPM

This workshop is presented by AGS in collaboration with the American Academy of Hospice and Palliative Medicine. AAHPM is a member of the Collaborative on REMS Education (CO*RE), 10 interdisciplinary organizations working together to improve pain management and prevent adverse outcomes.

Commercial Support Disclosure Statement This educational activity is supported by an independent educational grant from the ER/LA Opioid Analgesic REMS Program Companies (RPC).  Please see www.er-la-opioidREMS.com for a listing of the member companies. This activity is intended to be fully-compliant with the ER/LA Opioid Analgesic REMS education requirements issued by the U.S. Food & Drug Administration (FDA). You are the first to participate in an education program funded that is approved by the FDA!

In 2008, 36,500 Americans died from drug poisonings Nearly 14,800 deaths involved prescription opioid analgesics It is important that we recognize and help to mitigate the risks of misuse, abuse, and diversion so that these medications – critical to the high quality care we provide – remain accessible to those in need. Warner M, et al. Drug poisoning deaths in the United States, 1980-2008. NCHS data brief, no 81. Hyattsville, MD: National Center for Health Statistics. 2011. National Center for Injury Prevention and Control. Division of Unintentional Injury Prevention. Policy Impact. Prescription Painkiller Overdoses. Nov 2011.

History This Risk Evaluation and Mitigation Strategy is part of a larger public health initiative from the White House Approved by the FDA July 2012 Twenty companies representing 30 products form the REMS Program Companies (RPC) Key elements of the REMS Training for Prescribers Updated Medication Guide Patient Counseling Document Assessment and Audit AAHPM has been a part of this process with CO*RE since 2010

Prescriber Responsibility: to Help Ensure Safe & Effective Use of ER/LA Opioid Products Appropriate prescribing practices & patient education Expected results of this REMS education are that the prescriber will: Understand how to assess patients for treatment w/ ER/LA opioids Be familiar w/ how to initiate therapy, modify dose, & discontinue use of ER/LA opioids Know how to manage ongoing therapy with ER/LA opioids Know how to counsel patients & caregivers about the safe use of ER/LA opioids, including proper storage & disposal Be familiar w/ general & product-specific drug information concerning ER/LA opioids As defined by the FDA

Prescribers of ER/LA opioids should balance: The benefits of prescribing ER/LA opioids to treat pain The risks of serious adverse outcomes

Products Covered By the ER/LA Opioid Analgesics REMS Program Brand name products Avinza® morphine sulfate ER capsules Butrans® buprenorphine transdermal system Dolophine® methadone hydrochloride tablets Duragesic® fentanyl transdermal system *Embeda® morphine sulfate/naltrexone ER capsules EXALGO® hydromorphone hydrochloride ER tablets Kadian® morphine sulfate ER capsules MethadoseTM methadone hydrochloride tablets MS Contin® morphine sulfate CR tablets Nucynta® ER tapentadol ER oral tablets Opana® ER oxymorphone hydrochloride ER tablets OxyContin® oxycodone hydrochloride CR tablets †Palladone® hydromorphone hydrochloride ER capsules Generic products Fentanyl ER transdermal systems Methadone hydrochloride tablets Methadone hydrochloride oral concentrate Methadone hydrochloride oral solution Morphine sulfate ER tablets Morphine sulfate ER capsules Oxycodone hydrochloride ER tablets *Not currently available or marketed due to a voluntary recall, but is still approved †No longer being marketed, but is still approved CR=controlled-release; ER=extended-release; LA=long-acting