REMS gets backlash from ESA, opioid camps

Most press coverage and conference presentations on the topic of risk evaluation and mitigation strategies include the message that REMS programs will become increasingly used by the FDA in drug approvals. And if the recent past is any indicator, that should be so.

But the REMS momentum may be slowing, especially for programs addressing risks for classes of drugs. Among the REMS-required drug classes are erythropoietin-stimulating agents (ESAs) and opioids. Affected groups near the end of the supply chain are beginning to squawk, reports Pharmacy Practice News in two articles.

A clinical pharmacy manager, for example, says the ESA REMS is having a noticeable impact on pharmacists and clinicians. Hospitals and clinics that dispense ESAs must assign a point person to create a program that oversees the hospital's use of the drugs.

The ESA REMS program also requires that healthcare professionals give patients the medication guide. And for ESA use in cancer patients, doctors must register and undergo training before they can prescribe. They must discuss risks and benefits with patients and provide written acknowledgment of the discussion.

Oncologists feel this burden. Their trade group, the American Society of Clinical Oncology, says it supports efforts to promote patient safety. But "we strenuously object to duplicative requirements that further diminish time and resources available for patient care."

Likewise, the class-wide REMS program for long-acting opioids also has increasingly vocal critics. Its goal was to decrease abuse, misuse, addiction and overdose deaths, according to three industry watcher/practitioners. But meaningful metrics for drug abuse or misuse, and drug addiction and drug-related overdose deaths are hard to come by, especially because so many such deaths involve multiple drugs.

"In the absence of clear standards," the authors write, "outcomes cannot be measured, and without such measures, an accurate evaluation of specific REMS is impossible."

- see the ESA REMS article (registration required)
- here's the opioid REMS article (registration required)