FDA Takes Steps to Reconcile Needs of Patients With Chronic Pain, Efforts to Curb Opioid Epidemic

On July 9, 2018, a panel discussion event held at the US Food and Drug Administration (FDA), titled a Public Meeting on Patient-Focused Drug Development for Chronic Pain, gathered patients — both adults and children — with chronic pain and FDA officials, in an effort to reconcile concerns around prescriptions of opioid medications with the needs of these patient populations.

Several questions were put forth to patients, in an endeavor to determine the most disabling symptoms, impact on daily life, as well as the variety of treatment options used, their effectiveness, drawbacks, treatment access challenges, and wishes for optimal treatment. “We’re hopeful that this meeting will provide valuable insights to inform our opioid policies and advance our efforts to develop better therapies,” noted FDA Commissioner Scott Gottlieb, MD, in a statement issued ahead of the day-long event. Dr Gottlieb acknowledged the necessity in some patient populations to use opioids long-term, as, in some instances, these medications might represent the only viable option. “At the FDA, we’re taking a number of new steps to address the need to aggressively confront the epidemic of addiction, while advancing policies to help make sure that patients with pain have access to appropriate, evidence-based care,” he added.

The Commissioner also noted that both healthcare providers (HCPs), who had displayed “cavalier” and/or liberal prescribing practices, and drug manufacturers, through the promotion of unapproved uses for opioid medications, shared the blame for the ongoing opioid epidemic. The agency issued a revised Blueprint titled FDA’s Opioid Analgesic [Risk Evaluation and Mitigation Strategy] Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain in January 2018. In this blueprint, information regarding available options for the management of both acute and chronic pain, the safe use of opioid medications, the array of nonopioid and nonpharmacologic options, and on treatment of opioid use disorder is available.

The agency is now mandating that HCPs involved in managing patients with pain, including prescribers but also nurse practitioners and pharmacists, be trained on all available treatment options for pain. In addition, the FDA encourages relevant professional societies to formulate evidence-based guidelines on the use of opioid medications for an array of medical conditions.

“Our goal is to support more rational prescribing practices, as well as identify and encourage development of new treatment options that don’t have the addictive features of opioids,” concluded Dr Gottlieb.

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Reference

US Food and Drug Administration (FDA). Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612779.htm?utm_campaign=07092018_Statement_FDA%20statement%20on%20balancing%20pain%20treatment%20while%20stemming%20opioid%20crisis&utm_medium=email&utm_source=Eloqua. Published July 9, 2018. Accessed July 9, 2018.