EXPERT ANALYSIS FROM PAIN CARE FOR PRIMARY CARE

LAKE BUENA VISTA, FLA. – If the Food and Drug Administration moves to require some form of certification to prescribe opioids, an educational program based on the FDA’s own risk evaluation and mitigation strategy (REMS) report of 2012 is already in place to fulfill that purpose, according to a pain specialist who explained the principles of this program at Pain Care for Primary Care.

Some form of certification process for opioid prescribing has been discussed for many years, explained David E. J. Bazzo, MD , clinical professor of family medicine at the University of California, San Diego, but “there has been renewed interest as a result of the continuing public health crisis regarding opioid overdoses.”

The core curriculum provided by the Collaborative for REMS Education (CO*RE) curriculum is based on clinical competencies to meet the requirements of the FDA REMS blueprint , which was issued in July 2012. The focus of REMS is on opioids with an extended-release (ER) or long-acting (LA) formulation. It is not the only such program available, but Dr. Bazzo noted that CO*RE was actually initiated in 2010 and provided some of the basis for the FDA REMS that followed 2 years later.

The CO*RE program, which can be completed at no cost, is available online . Those who complete the program are provided with a completer certificate, which Dr. Bazzo expects to be honored by the FDA if it does decide to require proof of competency. The program involves the participation of 13 organizations, such as the American Pain Society (APS), the American Society of Addiction Medicine (ASAM), and the American College of Emergency Physicians (ACEP).

There is a substantial possibility that the FDA will move to require competency for opioid prescribers. At a recent joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee in which modifications in the REMS were discussed, the majority of those on both advisory committees endorsed mandatory training.

“Why is education so important? It is because we are in a super tough position,” Dr. Bazzo explained. He suggested that physicians need effective agents for controlling pain, but the mortality and morbidity associated with opioids has steadily increased despite the FDA REMS.

“Deaths due to drug abuse or poisoning are just the beginning. For every death, there are 10 treatment admissions for abuse, and 130 people who are addicted,” said Dr. Bazzo, citing data from the Centers for Disease Control and Prevention (CDC).

In addition to an introduction, which outlines the goals of appropriate opioid prescribing, the CO*RE curriculum consists of six units. The first focuses on assessing candidates for opioid therapy, which includes instructions on history taking and documenting the findings. Tools for assessing risks posed by opioids, particularly for abuse, are also outlined.

The second unit describes best practices for initiating therapy, modifying doses, and discontinuing opioids, the third unit provides information on monitoring adherence and aberrant behavior in patients, and the fourth unit provides information about how to counsel patients about what constitutes appropriate use of opioids and the risks of inappropriate use. The fifth unit is largely an overview of key information in the previous four units and the sixth unit outlines the specific features of currently available opioids.

“The bottom line for the program overall is learning how to balance risks and benefits,” Dr. Bazzo explained. He suggested that many clinicians do not fully grasp that opioids are not stand-alone medications but a tool within a more comprehensive strategy for improving function.

“When we give analgesics for chronic pain, the goal is not to eliminate pain. If this is your goal, you will fail 99.9999% of the time. The goal is to improve function,” Dr. Bazzo said. He characterized treatment of chronic pain “as a team sport” that involves a collaboration between specialists and patients to achieve specific endpoints.

“It is a little like treating hypertension. You adjust medications until you get to the goal,” Dr. Bazzo said. This involves defining the goal before the treatment is initiated and then documenting progress toward that goal to guide treatment strategies.

The CO*RE REMS program is consistent with the CDC Guideline for Prescribing Opioids for Chronic Pain ( MMWR. 65[1];1–49 ). It is part of a nationwide effort to reduce deaths related to opioid use.

“The problems with opioids can be greatly reduced if clinicians recognize and adhere to best practices,” Dr. Bazzo maintained.

Dr. Bazzo reports no potential financial conflicts of interest. The meeting was held by the APS and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

imnews@frontlinemedcom.com

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