In February 2016, the FDA published a special report in the New England Journal of Medicine, alerting the medical community, including providers, policymakers, and drug manufacturers about “the growing epidemic of opioid abuse, addiction, and overdose—an epidemic directly related to the increasingly widespread use of powerful opioid pain medications” (Califf RM, et al. N Engl J Med. 2016;374:1480-1485).
In their report, Robert M. Califf, MD, newly appointed Commissioner of the FDA, Janet Woodcock, MD, Director, FDA’s Center for Drug Evaluation and Research, and former FDA Acting Commissioner Stephen Ostroff, MD, highlight the extent of the problem, outlining steps the FDA is taking to address key issues related to overdosing and overprescribing of opioids for pain management.
Abuse of prescription opioids has reached an alarming reality, representing a true medical crisis in the United States. In 2014, an estimated 19,000 deaths resulted from an overdose of prescription opioids, exceeding deaths from motor vehicle–related accidents.
The FDA outlines 10 key issues related to this epidemic of opioid abuse, noting that better education of opioid prescribers is a key weapon to combat the increasing reports of overdosing and deaths in the United States associated with abuse and misuse of prescription opioids. Another key issue is the need for a better evidence base, particularly for the long-term use of prescription opioids.
“Until clinicians stop prescribing opioids far in excess of clinical need, this crisis will continue unabated,” wrote Drs Califf, Woodcock, and Ostroff.
Individual and Societal Risk
The first issue related to balancing the requirements of individual patients for safe and effective pain medications with the societal and individual risk for opioid abuse and misuse. To address this problem, the FDA plans to consult with partners, including the National Academy of Medicine, to develop a framework for opioid review, approval, and monitoring.
Need for Timely Action
Another issue is the need for flexibility in initiating timely action to address the evolving threat of opioid misuse. The FDA Science Board convened in March 2016 to advise on the role of pharmaceuticals in pain management, the development of alternative pain medication, and postmarketing surveillance activities. Future coordinated actions will address the Risk Evaluation and Mitigation Strategy (REMS) programs for extended-release and long-acting opioids (which are funded by pharmaceutical manufacturers); extending prescriber education; and expanding the REMS program to include immediate-release opioids, thereby increasing the number of prescribers being trained on pain management and the safe prescribing of opioids.
Labeling and Postmarketing Surveillance
Labeling and postmarketing surveillance requirements for pharmaceutical companies will be reevaluated, and the pharmaceutical companies will be required to generate postmarketing data on the long-term impact of extended-release and long-acting opioid use to provide better evidence regarding the serious risks associated with the misuse and abuse of opioids.
Thus far, more than 38,000 prescribers have participated in voluntary REMS education programs that are funded by pharmaceutical manufacturers. These results will be evaluated and inform approaches going forward. At this time, the FDA supports mandatory education for prescribers, as opposed to the current situation, in which prescriber participation in REMS education programs is voluntary.
The FDA will continue to support abuse-deterrent formulations of opioids and opioid derivatives, and encourage the development of more effective abuse-deterrent features. The FDA will also prioritize expanding public access to naloxone, which can reverse overdose and avoid deaths if initiated promptly. Over-the-counter availability of naloxone is under consideration.
Alternatives for Pain Management
The FDA will work closely with the pharmaceutical industry and the National Institutes of Health to develop nonopioid, nonaddictive alternatives for the management of chronic pain. Developing approaches other than pharmacotherapies to controlling chronic pain is also an urgent priority, according to the FDA.
New Guidelines on Opioid Use
The Centers for Disease Control and Prevention has drafted clear guidelines for the prescription of opioids to control chronic pain; the FDA supports this process and plans to support the finalized guidelines. In addition, the FDA supports the Surgeon General’s engaging the clinical community in restricting the inappropriate prescribing of opioids, treating opioid addiction, and reinforcing evidence-based approaches to treating chronic pain while sparing the use of opioids.
Managing Chronic Pain in Children
The use of opioids in children with severe and chronic pain is a separate issue that needs immediate attention. Physicians need high-quality evidence to guide their treatment decisions, and the FDA supports this effort, as well as the need for new pediatric opioid labeling guided by this evidence.
“In some cases, children with serious [pain-related] conditions are being treated with opioids in the absence of adequate knowledge about correct indications and dosing. We must all work together to ensure that all appropriate therapeutic options for pain are available to children,” and that “they are prescribed and handled in an impeccably judicious manner, guided by the best and most current scientific evidence,” Dr Califf and colleagues wrote.
Improving Evidence Base
A better evidence base to guide the treatment of chronic pain is needed, especially regarding the long-term use of opioid medications.
The FDA and the US Department of Health & Human Services are mandating industry-funded studies to provide better evidence for opioid use, the biologic phenomenon of pain, and the development of new and alternative approaches to pain prevention and management.
Mandatory Prescribers’ Education
In an accompanying, impassioned editorial by Daniel P. Alford, MD, MPH, Medical Director, Office-Based Opioid Treatment, Boston Medical Center, MA, Dr Alford calls for mandatory—not voluntary—prescriber education regarding opioids (Alford DP. N Engl J Med. 2016;374:301-303).
“Education has the potential to both reduce overprescribing and ensure that patients in need retain access to opioids,” Dr Alford suggested, adding that prescribing opioids has increased dramatically in recent decades, and that has been directly linked to the increasing misuse of and associated deaths from opioids.
He said that mandatory education should go beyond opioid prescribing to include pain management designed for the entire healthcare team, and supported by enhanced clinical systems, including decision-making tools in electronic medical records.