Strong Opioids May Trigger Shortage of Overdose Antidote

Imagine you’re a paramedic responding to an opioid overdose. You shoot a dose of naloxone, the drug used to revive overdose victims, into someone’s system—and it doesn’t work.

You do it again. Then again.

Naloxone has become a key ingredient in fighting the opioid epidemic. First responders use it to revive those near death, doctors prescribe it to fend off cravings, and addicts need it to live semi-normal lives. But synthetic drugs like fentanyl are more powerful than their precursors, which sometimes forces first responders to use multiple doses to reverse them.

States have depended on naloxone—or Narcan, the branded nose-spray version—for years. Now the Food and Drug Administration is stepping in and trying to push naloxone availability to the next level. It’s considering requiring co-prescribing naloxone “with all or some opioid prescriptions.” But a cloud of potential shortages hangs over the agency, especially as the amount of doses patients might need has risen and as drug supply chains overall are delicate.

“The average amount of Narcan that is required to produce the effects we’re looking for has risen significantly from when the crisis started three or four years ago,” Christopher Stawasz, regional director for American Medical Response Inc.’s New Hampshire operation said. AMR is the largest ambulance company in the country and Stawasz’s home base of New Hampshire has the third highest overdose rate of any state.

Damage or production troubles at one plant can cause a ripple effect for the entire country. Narcan is manufactured by ADAPT Pharma. Naloxone, the generic version that’s injected, is sold by multiple companies including Pfizer Inc. and Mylan NV.

Prescriptions for naloxone have skyrocketed in the last few years. In January 2016 there were roughly 5,900 prescriptions for naloxone written. By September 2018 that number had reached 69,000, according to Bloomberg data. That’s more than a 1,000 percent increase.

In mid-2017 there was national concern relating to the shortage of naloxone, and Pfizer announced a recall of two batches of naloxone in June. The agency wouldn’t answer specific questions sent by Bloomberg Law about how it plans to combat shortages. It did acknowledge the potential need for “manufacturing volume growth for naloxone, and the risk of drug shortages of this product that could come from a sudden spike in prescribing,” in a public statement.

Naloxone isn’t currently in shortage and officials in New Hampshire, West Virginia, and Pennsylvania, say they their first responders right now don’t have trouble accessing it.

However, the potential for naloxone shortages hang over Stawasz, who said, “We’re always worried about supply chain issues.”

Naloxone Use Spiked

Part of the massive increase in prescriptions may be due to multiple doses.

Almost 40 percent of patients given naloxone for an overdose in Pennsylvania required two doses, according to the state’s Department of Health, and 4 percent required more. The Centers for Disease Control ranks Pennsylvania fifth in the country for drug overdose deaths.

An increase in the availability of opioids fentanyl and carfentanil throughout the state “has increased the amount of naloxone needed to revive someone,” said Nate Wardle, a spokesman for the Pennsylvania Department of Health. Fentanyl and carfentanil are synthetic and more potent than traditional opioids like heroin. Fentanyl can be prescribed as a painkiller but can also be made and sold illegally.

President Trump just signed a massive opioid bill into law Oct. 24, but some states took their drug problems into their hands long ago. New Hampshire and Pennsylvania already have naloxone co-prescribing programs, for example.

In Pennsylvania, patients who also have sleep disorders, coexisting psychiatric conditions, a history of substance use, or other circumstances are given naloxone along with their opioid medication. Patients can use naloxone in emergency situations to be revived when they’ve overdosed, but they can also use it to control drug cravings.

Stawasz isn’t sure if co-prescribing directly caused overdose deaths to decrease, but drug deaths have plummeted in New Hampshire in the past few years. There were 66 suspected overdose deaths in Manchester, the state’s largest city, in 2017, compared to 90 deaths in 2016, according to data from the New Hampshire medical examiner’s office.

If there are shortages in the future, states will look to the federal government to do something about it.

“The federal government, through the FDA, can also extend expiration dates when there is an emergency need, it is clinically appropriate and there is market demand,” Wardle said.