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

2. Ronald J. Crossno, MD FAAFP FAAHPM

3. 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.

4. 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  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!

5. 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, NCHS data brief, no 81. Hyattsville, MD: National Center for Health Statistics National Center for Injury Prevention and Control. Division of Unintentional Injury Prevention. Policy Impact. Prescription Painkiller Overdoses. Nov 2011.

6. 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

7. 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

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

9. 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