FDA Considers Limiting Outpatient Opioid Prescriptions

By Kelly Burch 06/18/19

The FDA is taking feedback from the public as it weighs the decision to reduce high-dose prescription painkillers delivered in outpatient settings. 

doctor discussing limiting outpatient opioid prescriptions

Advisors for the Food and Drug Administration (FDA) met last week to discuss a possible cap on high-dose opioids delivered in an outpatient setting, a move that is intended to reduce the risk of addiction and dependency. 

According to MedPage Today, the meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesia Drug Products Advisory Committee included presentations by doctors, and discussions by policymakers. 

In a memorandum released ahead of the meeting, advisors for the FDA said that the conference aims to address dual concerns. 

“When considering regulatory strategies relating to opioid analgesics, FDA always considers two fundamental public health goals: 1. We want to reduce opioid misuse, abuse, addiction, overdoses and deaths. 2. We want to ensure that products are available to meet the medical needs of people living with debilitating pain,” the memo read. 

“We are also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients,” Judy Staffa, associate director for the Public Health Initiatives Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research (CDER), wrote in the memorandum that was sent to conference attendees. 

Restricting highly addictive high-dose opioids while also meeting the needs of patients with chronic pain has been a delicate balancing act that many people feel has not been addressed well by federal regulators. The meeting last week was an attempt to continue discussions about how best to serve both needs. 

"There is a strong need to bring together the community of stakeholders to consider the collective scientific understanding of the issues relating to higher daily doses and higher dosage strength opioid analgesic products and potential strategies to reduce risks to patient and public health," Staffa wrote. 

Dr. Ning Hu, medical officer of the CDER's Division of Anesthesia, Analgesia, and Addiction Products, said that high-dose opioids are dangerous, but so is uncontrolled pain, which—in the most severe cases—can cause people to consider suicide.

Many prescribers followed the CDC’s 2016 guidelines for prescribing opioids, but those were interpreted too drastically, Hu wrote. 

“The guidelines were misinterpreted and misapplied, contributing to substantial harms to patients, particularly patients with chronic pain who were forced to taper their previously stable opioid doses to lower doses, or who were forced to discontinue their opioids through forced tapers or patient abandonment,” Hu wrote. 

In addition to the discussions happening at the conference, the FDA has opened public comment on the issue of high-dose opioids. Public comment will remain open through June 30, and is available here

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Kelly Burch writes about addiction and mental health issues, particularly as they affect families. Follow her on TwitterFacebook, and LinkedIn.