WASHINGTON — Naloxone should be prescribed together with opioids for patients considered at risk for overdosing, such as when they receive very high opioid doses, the Department of Health and Human Services (HHS) said.
“Given the scope of the opioid crisis, it’s critically important that healthcare providers and patients discuss the risks of opioids and how naloxone should be used in the event of an overdose,” said Adm. Brett Giroir, MD, assistant secretary for health and senior advisor for opioid policy at HHS, in a statement. “We have begun to see some encouraging signs in our response to the opioid crisis, but we know that more work is required to fully reverse the decades-long epidemic. Co-prescribing naloxone when a patient is considered to be at high risk of an overdose, is an essential element of our national effort to reduce overdose deaths and should be practiced widely.”
The guidance released Wednesday for healthcare providers and patients reinforces and expands on earlier guidance from the CDC, the statement noted. It recommends that clinicians prescribe or co-prescribe naloxone “to individuals at risk for opioid overdose, including, but not limited to: individuals who are on relatively high doses of opioids, take other medications which enhance opioid complications, or have underlying health conditions. By co-prescribing, or prescribing naloxone to at-risk individuals, patients and their loved ones could be better equipped for possible complications of overdose, including slowed or stopped breathing.”
Clinicians should also educate patients and those who are likely to respond to an overdose, including family members and friends, on when and how to use naloxone in its variety of forms, the statement said.
The HHS announcement came a few days after an FDA advisory committee voted 12-11 in favor of adding language to opioid drug labels recommending naloxone co-prescribing for all or some patients. “The close vote was the result of advisory committee members questioning whether co-prescribing necessarily addresses the opioid crisis at hand, while others said that co-prescribing is already the standard of care and therefore should be added to the labeling,” according to an article on the Regulatory Affairs Professionals Society website.
Congress also has addressed the co-prescribing issue. In 2016, the House passed the Co-Prescribing to Reduce Overdoses Act sponsored by Rep. John Sarbanes (D-Md.). The bill, which became part of the Comprehensive Addiction and Recovery Act, authorized 5 years of grants aimed at increasing co-prescribing of naloxone in high-risk patients who are prescribed opioids; however, funds were never appropriated for the grant program.
Sarbanes applauded the new HHS guidelines, calling them “an important and encouraging step forward in our fight against the opioid epidemic.”
“By getting more affordable and easy-to-use overdose reversal drugs into the hands of patients and communities across the country, we can save countless lives,” he said in a press release issued Thursday.
Co-prescription programs are proven ways to reduce overdose deaths, the congressman noted. “The Veterans Health Administration has successfully distributed naloxone to all veterans being treated for a substance use disorder or to those who take high doses of opiates. Through this important program, the VA [Department of Veterans Affairs] has successfully reduced opioid overdose deaths among veterans.”
Wednesday’s announcement was not HHS’s first action to encourage naloxone availability. In April 2018, Surgeon General Jerome Adams, MD, issued an advisory encouraging more individuals, including family, friends, and those who are personally at risk for an opioid overdose, to carry naloxone, the agency noted in the press release.