Examining the Role of REMS in Opioid Safety


An expert questions why the risks and side effects of warfarin are explained much more carefully to patients than those of opioids.

During a session presented at the PAINWeek 2011 conference, held Sept. 7-10, 2011, in Las Vegas, Kevin Zacharoff, MD, compared the risk management approach taken by physicians when putting a patient on warfarin with that taken by physicians who prescribe opioids for pain patients. In contrast with the uneven approach to informing patients about the risks and side effects associated with opioids, Zacharoff said that “When putting a patient on warfarin, there’s no thought about the discussion of risks and no problem starting the process of treatment.”

He said that nobody would prescribe warfarin without clearly and thoroughly explaining to the patient the potentially serious side effects associated with the drug; it’s easy to have a straightforward and informative conversation that leaves the patient with a clear understanding of the issues. Yet, when it comes to opioids, too many physicians don’t have that conversation with the patient, and too many patients remain unaware of the risks.

Zacharoff, however, isn’t convinced. “If you can have that talk with warfarin, you can do that with opioids. All of the tools, all of the thinking, all of the processes, all of the paradigms with opioids need to mirror what goes on with patients on anticoagulant therapy,” he said.

The lack of education and awareness of the risks associated with prescription opioid medications has, along with other factors, contributed to a severe increase in opioid abuse, misuse, and diversion over the last 20 years, leading to a concomitant increase in the number of unintended deaths associated with this class of medication.

The statistics on non-medical use of opioids are particularly eye-opening. The National Survey on Drug Use and Human Health found that in 2009, there were 2.6 million new users of prescription pain medications, 2.2 million of whom were non-medical users. In 2008, more than 13% of all Americans aged 12 and older had used a prescription pain medication non-medically at least once in their lifetime, according to the data.

Where are all of these opioids coming from? Zacharoff said that in 2009, 28% of opioids were prescribed by family practitioners and 14% were written by internal medicine physicians. Dentists also wrote a substantial number of prescriptions. According to CDC data, in 2009, 76% of opioids used for non-medical purposes were prescribed to someone other than the user; 20% of opioids used non-medically were prescribed to the user.

Clearly, opioids continue to have a far-reaching public health impact in the United States. And because consumers, drug makers, and the health care community have not been successful in ensuring the safe and appropriate use of these medications, the federal government has shown an increasing willingness to step in and mandate that all stakeholders take specific actions to rectify the situation. Most meaningfully, the Food and Drug Administration Amendments Act of 2007 authorized the FDA to require certain drug manufacturers to submit a proposed Risk Evaluation and Mitigation Strategy (REMS) if the FDA determined that a REMS is necessary to ensure that the benefits of the drug continue to outweigh the risks.

However, although REMS enforcement means that drug manufacturers face substantial fines, if the plans are not followed, “it all eventually ends up on the doorstep of health care providers and patients,” Zacharoff said. The goal of REMS is to help providers and patients think about how to use opioids safely and effectively, and the FDA believes that opioid REMS will reduce the risks associated with the drugs while ensuring continued access to them for patients with legitimate medical needs, he noted.

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