New Naloxone Laws Seek to Prevent Opioid Overdoses

This article was originally published by Stateline, an initiative of The Pew Charitable Trusts.

It’s increasingly likely that someone you know has the opioid overdose rescue drug naloxone in their pocket or medicine cabinet. In fact, a new mobile app, NaloxoFind, will tell you whether anyone nearby is carrying the lifesaving drug.

In the last five years, at least 46 states and the District of Columbia enacted so-called good Samaritan laws, allowing private citizens to administer the overdose-reversal medication without legal liability. And all but four states — Connecticut, Idaho, Nebraska and Oregon — have called on pharmacies to provide the easy-to-administer medication to anyone who wants it without a prescription, according to the Network for Public Health Law.

But a handful of states are going even further by requiring doctors to give or at least offer a prescription for the overdose rescue drug to patients taking high doses of opioid painkillers.

New naloxone co-prescribing laws in Arizona, California, Florida, Ohio, New Mexico, Rhode Island, Vermont, Virginia and Washington state also call on doctors to discuss the dangers of overdose with these high-risk patients. Tennessee lawmakers this year passed a similar bill, which is awaiting the governor’s signature.

“By offering a naloxone prescription to a patient, the physician is saying ‘I’m so concerned this medication might kill you that you need an antidote in the house, so a family member can rescue you.’ That gets their attention,” said Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University and director of Physicians for Responsible Opioid Prescribing, an organization that promotes safe painkiller prescribing.

Legal experts say these new laws — which have been endorsed by the federal government as well as the medical community — are likely to spread.

Last April, U.S. Surgeon General Jerome Adams recommended widespread use of naloxone, and since then, the U.S. Department of Health and Human Services has called on physicians to co-prescribe naloxone to patients taking relatively high doses of opioid painkillers and to educate patients on the risk of overdose.

In 2016, the U.S. House of Representatives passed a bill, the Co-Prescribing to Reduce Opioid Overdoses Act, that ultimately was included in the Comprehensive Addiction and Recovery Act of 2016. Although never funded, it would have provided $5 million in federal grants to support co-prescribing naloxone.

In addition, an advisory committee to the U.S. Food and Drug Administration voted in December to recommend that all physicians co-prescribe naloxone for patients on high doses of opioid pain medications.

People taking more than the equivalent of 50 mg of morphine a day are more than twice as likely to overdose compared with those taking lower doses, according to the U.S. Centers for Disease Control and Prevention.

Even physicians, who typically object to government-mandated medical rules, have signed on to the initiative. Following the surgeon general’s directive last year, the American Medical Association announced that it also encouraged physicians to co-prescribe naloxone for all patients at risk of overdose.

From 1999 to 2017, nearly 218,000 people died in the United States from overdoses related to prescription opioids. And in more than 40% of those deaths, bystanders were present, yet naloxone was rarely administered by a layperson, the CDC reported based on medical examiner reports.

Ensuring that naloxone gets into the hands of people who are most likely to witness an overdose, namely the family and friends of people taking long-term, high doses of pain medications, could change that, Kolodny said.

Most often sold as a nasal spray known as Narcan, naloxone was approved by the FDA in 1971. Local drugstores in 2017 sold about 800,000 doses of naloxone to individuals who wanted to be prepared if someone close to them lost consciousness and a drug overdose was suspected.

And thousands of doses have been given away free to anyone who signs up for a quick training session at local health departments, community health centers and harm reduction centers.

But most naloxone doses go to hospitals, nursing homes, health management organizations, community clinics, prisons and universities, which purchased roughly 5 million units of the drug in 2017, according to market research data analyzed by the FDA.

A Question of Cost

Requiring all doctors to prescribe naloxone to everyone who takes prolonged high-dose opioid medications would sharply increase the number of naloxone doses in the hands of bystanders and potentially inflate the cost of U.S. health care substantially, some critics have said.

Mary Ellen McCann, a member of the FDA advisory board and associate professor of anesthesia at Harvard Medical School, voted against the co-prescribing proposal. She described co-prescribing as “an expensive way to saturate the population with naloxone,” according to news reports from Reuters and other media outlets.

“I’m concerned about a person going in with a broken arm and ending up with $30 of a codeine product and a (naloxone) autoinjector at $4,000-plus,” she said.

Rather than purchasing an autoinjector, people can choose to buy the much less expensive nasal spray.

An FDA advisory panel estimated that 48 million more doses of naloxone would be needed if all states required doctors to co-prescribe naloxone for patients on high doses of opioids.

Thom Duddy, vice president of corporate communications for Emergent Biosolutions, the maker of Narcan, said the company is prepared to meet that demand. Already, the company has seen a spike in sales in the eight states that have enacted co-prescribing laws, he said.

In California, for example, retail sales of the drug more than quadrupled in the first four weeks after the law took effect, according to company sales data.

A two-pack of Narcan costs $125; an off-label nasal spray that requires some assembly costs around $40; and an EpiPen-like dispenser sold as Evzio costs $4,100.

U.S. Senate lobbying records show that Narcan’s and Evzio’s makers, Emergent Biosolutions and Kaléo, respectively, have lobbied on naloxone access in recent years, as have first responders, medical associations and the insurance industry. The records don’t, however, show how much was spent on that specific issue and what position the organizations took on the matter.

In November, the U.S. Senate Permanent Subcommittee on Investigations reported that Evzio’s Richmond, Virginia-based manufacturer, Kaléo, had hiked its price more than 600% as the opioid epidemic worsened.

Following the report, the manufacturer announced in December that it would offer a two-dose carton of a generic version of its autoinjector at a list price of $178 in mid-2019.

In April, the FDA announced approval of a generic, over-the-counter version of naloxone nasal spray that does not require assembly. Teva North America, which will sell the generic version, did not return a call from Stateline regarding what it will charge or when the rescue drug will be made available.