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REMS

The Emerging Solutions in Pain Responsible Opioid Prescribing Initiative is a collection of applied clinical educational activities, tools, and resources developed to comply with the FDA Risk Evaluation Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics to assure that your patients will have access to the care they need.



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The following activities and resources comprise the Emerging Solutions in Pain Responsible Opioid Prescribing Initiative. Individual Legal/Regulatory Commentaries will be available at the completion of each associated REMS Activity Module.

REMS Activity, Module #1
Patient Assessment for Treatment with ER/LA Opioid Analgesia
Jeffrey A. Gudin, MD and W. Clay Jackson, MD, DipTh
Resource #1: Legal/Regulatory Commentary
Substandard Practices That Can Lead to Liability for the Prescriber
Jennifer Bolen, JD
REMS Activity, Module #2
Treating Patients with ER/LA Opioid Analgesics: Initiating, Modifying and Discontinuing Therapy
Jeffrey A. Gudin, MD and Bill McCarberg, MD, FABPM
Resource #2: Legal/Regulatory Commentary
Common Substandard Practices in Initiating Treatment in Patients Using Opioids
Jennifer Bolen, JD
REMS Activity, Module #3
Managing Therapy with ER/LA Opioids
Jeffrey A. Gudin, MD and Bill McCarberg, MD, FABPM
Resource #3: Legal/Regulatory Commentary
Best Practices in Modifying Treatment
Jennifer Bolen, JD
REMS Activity, Module #4
The Patient as an Integrated Member of the Treatment Team: Clinical Steps for Effective Patient Education
Jeffrey A. Gudin, MD and W. Clay Jackson, MD, DipTh
Resource #4: Legal/Regulatory Commentary
Avoiding Substandard Patient Counseling
Jennifer Bolen, JD
REMS Activity, Module #5
Extended-release/Long-acting Opioid Analgesics: Applied Pharmacology in the Clinical Setting
Jeffrey A. Gudin, MD and Bill McCarberg, MD, FABPM
Resource #5: Legal/Regulatory Commentary
Best Practices for ER/LA Opioids
Jennifer Bolen, JD
REMS Activity, Module #6
Clinician Guide to the Extended-release and Long-acting Opioid Analgesics
Jeffrey A. Gudin, MD and Bill McCarberg, MD, FABPM
Resource #6: Legal/Regulatory Commentary
Good Faith Prescribing of ER/LA Opioids
Jennifer Bolen, JD

Organizations participating in the ESP Responsible Opioid Prescribing Initiative include:

American Academy of Pain Management MediCom Worldwide, Inc. Dental Learning Systems Primary Care Network
   
Dental Learning Systems
 

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 US Food & Drug Administration (FDA).