REMS Education Program

An Interview with Kevin L. Zacharoff, MD

Dr. Zacharoff is a licensed, board-certified anesthesiologist with more than 25 years of clinical experience in anesthesiology and pain medicine, and has served as a consultant in the pain management field for 10 years. As Inflexxion’s Vice President of Medical Affairs, he has guided the development of a number of programs, including: strategic medical education programs, marketing direction, pharmaceutical sales representative training, and therapeutic relevance initiatives. Dr. Zacharoff is the Medical Director of PainEDU.org and painACTION.com.

Synne Wing Venuti, MSW: 

For those who don’t know, what is the ER/LA Opioid REMS?

Kevin L. Zacharoff, MD: In April 2011, the Food and Drug Administration (FDA) announced the elements of a Risk Evaluation and Mitigation Strategy (REMS) to help ensure that the benefits of extended-release and long-acting (ER/LA) opioid analgesics outweigh the risks. This REMS supports national efforts to try to address the growing prescription drug abuse epidemic. As part of the REMS, all manufacturers of ER/LA opioid analgesic have been required to collaboratively provide education for prescribers of these medications, which will be provided through accredited continuing education (CE) activities supported by independent educational grants from this group.

 

SV: How has the content for this educational program been determined?

KZ: The FDA has provided a “Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics” that focuses on the safe prescribing and management of ER/LA opioid analgesics, consisting of a core of content delivered in approximately three hours of education. While the blueprint content is directed to prescribers of ER/LA opioid analgesics, it may also be relevant for other healthcare professionals (e.g., pharmacists).

 

SV: What subject matter is covered by the FDA Blueprint?

KZ: There are six major educational topics covered by the blueprint:

1) Assessing Patients for Treatment with ER/LA Opioid Analgesic Therapy

2) Initiating Therapy, Modifying Dosing, and Discontinuing Use of ER/LA Opioid Analgesics

3) Managing Therapy with ER/LA Opioid Analgesics

4) Counseling Patients and Caregivers about the Safe Use of ER/LA Opioid Analgesics

5) General Drug Information for ER/LA Opioid Analgesics

6) Specific Drug Information for ER/LA Opioid Analgesics

 

SV: Where do I go to find out more about the REMS?

KZ: Click here for more information about the FDA’s extended release/long acting opioid REMS education program.