FDA: Prescription labels must recommend availability of naloxone

Healthcare professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment for opioid use disorder (OUD), according to the U.S. Food and Drug Administration (FDA).

Toward that goal, the agency on Thursday said it would require drug manufacturers to include information about naloxone, the overdose-reversal medication, on the labels of opioid painkillers.

“Even during this global pandemic, we have continued to prioritize addressing the opioid crisis,” FDA Commissioner Stephen Hahn said. “Today’s action can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose.”

The FDA’s action follows the release on July 15 of preliminary data from the Centers for Disease Control and Prevention (CDC) showing that drug deaths in America — which in 2018 decreased for the first time in 25 years — increased last year and now continue rising against the backdrop of the COVID-19 pandemic.

According to the CDC, almost 72,000 Americans died from drug overdoses last year, a 5 percent increase over 2018. The pandemic has public health officials fearing that 2020 could see even higher numbers.

For instance, U.S. Assistant Secretary for Health Brett Giroir on Thursday said during a USC Institute for Addiction Science webinar that the pandemic thus far has caused unprecedented levels of stress and other life disruptions, which may exacerbate substance use disorders and interfere with individuals’ recovery.

“We understand that there is an extraordinary amount of work to do, especially now as we are also dealing with the COVID-19 pandemic that could markedly affect our nation’s mental health and risk of substance use,” Admiral Giroir said in a statement earlier this month.

Policymakers are addressing barriers to care that individuals with substance use disorder are facing through innovative and flexible healthcare practices and other services, he added.

Such barriers include the prescription requirement that exists for all three FDA-approved forms of naloxone (injectable, auto-injector and nasal spray), which are less accessible to people who are not under the care of a healthcare provider or who are not keen about admitting to substance abuse issues, according to the FDA.

In response, the agency is working with other federal, state and local officials, as well as healthcare professionals, patients and communities nationwide, to help boost the availability of naloxone and combat opioid overdoses.

At the same time, most states and the District of Columbia have passed laws that allow pharmacists to dispense naloxone under a standing order, which takes the place of an individual prescription, while other states have given pharmacists direct authority to prescribe and sell naloxone to consumers, the FDA says.

Nevertheless, the agency is worried that many pharmacists may be unaware of the standing orders and direct authority in their states or are unwilling to provide all forms of naloxone to consumers without an individual prescription, hence the new required labeling changes, which recommend that healthcare professionals consider prescribing naloxone when they prescribe medicines to treat OUD.

The FDA also is requiring that its recommendations be added to the prescribing information for opioid pain medicines and medicines to treat OUD, including buprenorphine, methadone and naltrexone.

“We will use all available tools to address this [opioid] crisis,” said Dr. Hahn of the FDA, “and we know efforts to increase access to naloxone have the potential to put an important medicine for combating opioid overdose and death in the hands of those who need it most — those at increased risk of opioid overdose and their friends and family.”

The labeling changes also recommend that a naloxone prescription should be considered for patients prescribed opioids who have household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose, according to the FDA.

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