More states requiring that physicians 'co-prescribe' naloxone
A naloxone kit.
In a growing number of states, including in New England, patients who get opioids for serious pain may leave their doctors’ offices with a second prescription — for naloxone, a drug that can save their lives if they overdose on the powerful painkillers.
New state laws and regulations in California, Virginia, Arizona, Ohio, Washington, Vermont and Rhode Island require physicians to “co-prescribe” or at least offer naloxone prescriptions when prescribing opioids to patients considered at high risk of overdosing. Patients can be considered at high risk if they need a large opioid dosage, take certain other drugs or have sleep apnea or a history of addiction.
Such co-prescribing mandates are emerging as the latest tactic in a war against an epidemic of prescription and illegal opioids that has claimed hundreds of thousands of lives over the past two decades.
The Food and Drug Administration is considering whether to recommend naloxone co-prescribing nationally (an FDA subcommittee recently voted in favor), and other federal health officials already recommend it for certain patients. And the companies that make the drug are supportive of the moves. It’s not hard to see why: An FDA analysis estimated that more than 48 million additional naloxone doses would be needed if the agency officially recommended co-prescribing nationally.
Most states have limited the volume of opioids doctors can prescribe at one time and dramatically expanded access to naloxone. In California, for example, pharmacists can provide naloxone directly to consumers who are taking illegal or prescription opioids or know someone who is.
In the states with co-prescribing rules, patients aren’t required to fill their naloxone prescriptions, and those with cancer or who are in nursing homes or hospice typically are exempted.
Kristy Shepard of Haymarket, Va., was surprised to find a naloxone prescription waiting for her recently when she went to the pharmacy to pick up her opioid meds. Her first instinct was not to fill it. She did so only after the nurse in her doctor’s office pressured her to. The doctor had never talked to her about Virginia’s new co-prescribing law, she said.
“It’s so silly. I didn’t feel like I needed it. Unless I plan to hurt myself, I’m not likely to overdose,” said Shepard, 41, a registered nurse and hospital administrator who can no longer work and has applied for disability benefits.
But it may not be as difficult as some people think to overdose on prescription painkillers.
“You can take pain meds responsibly, and you can be at risk for an accidental overdose even when you’re doing everything right,” said Dr. Nathan Schlicher, an emergency medicine physician in Washington state and a member of the state hospital association’s opioid task force.
Two million Americans have an addiction to prescription painkillers, according to the FDA. And nearly 218,000 people in the U.S. died from overdosing on them from 1999 to 2017, according to the Centers for Disease Control and Prevention. During that same period, prescription opioid deaths rose fivefold, the CDC data show.
In California, doctors wrote nearly 22 million opioid prescriptions in 2017 and 1,169 people died that year from overdosing on prescription opioids. Common prescription opioids include Vicodin, OxyContin, Percocet, morphine, codeine and fentanyl.
To counter this trend, “states are scrambling for any policy lever they can find,” said Kitty Purington, senior program director at the National Academy for State Health Policy.
Even before the state mandates, pain specialists considered it good practice to prescribe naloxone along with opioid painkillers for some patients, particularly those with a history of substance abuse.
Doctor lobbying groups typically resist government rules regarding their practice, but medical associations in some states supported or at least remained neutral on naloxone co-prescribing mandates.
The companies that make the drug have spent hundreds of thousands of dollars collectively lobbying for their interests at the state level.
Kaléo, which makes the naloxone auto-injector Evzio, spent $77,200 in 2017-18 lobbying California lawmakers on bills expanding access to naloxone, including the state’s co-prescribing law, which requires doctors to offer prescriptions for naloxone to high-risk patients who get opioids.
In December, Kaléo introduced a lower-cost generic version of the injector after a Senate investigation found the company had raised the price of its branded version 600 percent from 2014 to 2017, to $4,100 for two injectors.
Adapt Pharma, which makes the naloxone nasal spray Narcan, spent $48,000to lobby California lawmakers on the co-prescribing legislation.
One advantage of the co-prescribing rules is that they foster important doctor-patient conversations about the risks of opioids, said Dr. Farshad Ahadian, medical director at the University of California San Diego Health Center for Pain Medicine.
“Most providers probably feel that it’s better for physicians to self-regulate rather than practice medicine from the seat of the legislature,” Ahadian said. “The truth is there’s been a lot of harm from opioids, a lot of addiction. It’s undeniable that we have to yield to that and to recognize that public safety is critical.”
But some doctors — not to mention patients — have reservations about the new requirements. Some physicians say it will be nearly impossible for states to enforce the mandates. Others worry that prescribing naloxone to patients who live alone is useless, because it typically must be administered by another person — ideally one who has been trained to do it.
Patients fear that naloxone prescriptions could unfairly stigmatize them as drug addicts and cause life insurers to deny them coverage.
Shepard, the disabled Virginia nurse and a mother of four, said she worries that her naloxone prescription could affect her chances of getting additional life insurance — a pressing question, she said, as her lupus worsens over time.
Katie O’Leary, a pain patient in Los Angeles, is wary of state mandates requiring doctors to prescribe the antidote naloxone along with opioid painkillers to reverse the effects of overdosing. “So many patients already jump through so many hoops to get their meds,” she says.
And a Boston-area nurse who worked at an addiction treatment program was turned down by two life insurers simply because she carried naloxone for her patients.
The decision to prescribe naloxone “is something that should be between a doctor and a patient, because every situation is unique,” said Katie O’Leary, a 31-year-old movie production company office manager who lives in Los Angeles and was diagnosed with complex regional pain syndrome about five years ago.
“So many patients already jump through so many hoops to get their meds,” O’Leary said. “And if you live alone and don’t have family or friends to take care of you, the naloxone might not be something that could actually help.”
Opioid addiction and overdoses are a complex problem, and naloxone is just one part of the solution, said Dr. Ben Bobrow, a professor of emergency medicine at the University of Arizona College of Medicine.
“In the past, pain was the fifth vital sign; we thought we were doing a bad job if we were undertreating pain,” Bobrow said. “Inadvertently, we were harming people. We ended up getting all these people hooked. Now it’s our job to help them find other [ways] of treating their pain.”
Martha Bebinger: Boston nurse denied life insurance because she has naloxone prescription
Isela was denied life insurance because her medication list showed a prescription for the opioid-reversal drug naloxone.
— Photo by Jesse Costa for WBUR
BOSTON
Bloodwork was supposed to be the last step in Isela’s application for life insurance. But when she arrived at the lab, her appointment had been canceled.
“That was my first warning,” Isela said. She contacted her insurance agent and was told her application was denied because something on her medication list indicated that Isela uses drugs. Isela, a registered nurse who works in an addiction treatment program at Boston Medical Center, scanned her med list. It showed a prescription for the opioid-reversal drug naloxone — brand name Narcan.
“But I’m a nurse, I use it to help people,” Isela told her agent. “If there is an overdose, I could save their life.”
That’s a message public health leaders aim to spread far and wide. “Be prepared. Get Naloxone. Save a life,” was the message at the top of a summary advisory from the U.S. surgeon general in April.
But some life insurers consider the use of prescription drugs when reviewing policy applicants. And it can be difficult, some say, to tell the difference between someone who carries naloxone to save others and someone who carries naloxone because they are at risk for an overdose.
Primerica is the insurer Isela said turned her down. (We agreed to use just Isela’s first name because she is worried about how this story might affect her ongoing effort to get life insurance.) The company said it can’t discuss individual cases. But in a prepared statement, Primerica noted that naloxone has become increasingly available over the counter.
“Now, if a life insurance applicant has a prescription for naloxone, we request more information about its intended use as part of our underwriting process,” said Keith Hancock, the vice president for corporate communications. “Primerica is supportive of efforts to help turn the tide on the national opioid epidemic.”
After Primerica turned her down, Isela applied to a second life insurer and was again denied coverage. But the second company told her it might reconsider if she obtained a letter from her doctor explaining why she needs naloxone. So, Isela did contact her primary care physician — and then realized that her doctor had not prescribed the drug.
Isela bought naloxone at a pharmacy. To help reduce overdose deaths, Massachusetts and many other states have established a standing order for naloxone — one prescription that works for everybody. Isela couldn’t just give her insurer that statewide prescription; she had to find the doctor who signed it. As it happens, that physician — Dr. Alex Walley — also works at Boston Medical Center.
Walley is an associate professor of medicine at Boston University; he also works in addiction medicine at Boston Medical Center and is the medical director for the Opioid Overdose Prevention Pilot Program at the Massachusetts Department of Public Health.
“We want naloxone to be available to a wide group of people — people who have an opioid use disorder themselves, but also [those in] their social networks and other people in a position to rescue them,” Walley said.
He said he has written a half-dozen letters for other BMC employees denied life or disability insurance because of naloxone, and that troubles him.
“My biggest concern is that people will be discouraged by this from going to get a naloxone rescue kit at the pharmacy,” Walley said. “So this has been frustrating.”
The life insurance hassle — and threat of being turned down — has discouraged Isela and some of her fellow nurses. She is not carrying a naloxone kit outside the hospital right now because she doesn’t want it to show up on her active medication list until the life insurance problem is sorted out.
“So if something were to happen on the street, I don’t have one — just because I didn’t want another conflict,” Isela said.
BMC has alerted the state’s Division of Insurance, which has said in a written response that it is reviewing the cases and drafting guidelines for “the reasonable use of drug history information in determining whether to issue a life insurance policy.”
But Isela isn’t a drug user. And yet, she is being penalized as if she were.
Michael Botticelli, who runs the Grayken Center for Addiction Medicine at BMC, said friends and family members of patients with an addiction must be able to carry naloxone without fear that doing so will send them to the insurance reject pile.Jewr
“It’s incumbent on all of us to make sure that we try to kind of nip this in the bud,” he said, “before it is any more wide-scale.”
Botticelli said increased access to naloxone across Massachusetts is one of the main reasons overdose deaths are down in the state. The most recent state report showed 20 fewer fatalities through the first nine months of 2018 compared with the same period in 2017.
Botticelli relayed his concerns in a letter to Dr. Jerome Adams, the U.S. surgeon general, who says he contacted the National Association of Insurance Commissioners. That group says it has not heard of any cases of life insurance applicants being denied because they purchased naloxone.
Adams said it’s good to — as Botticelli suggests — nip the problem in the bud.
“Naloxone saves lives,” Adams said, “and it is important that all Americans know about the vital role bystanders can play in preventing opioid overdose deaths when equipped with this lifesaving medication.”
Isela said the second company that rejected her has agreed to let her reapply, in light of Walley’s letter stating that she carries the drug so that she can reverse an overdose. Isela is in the process of reapplying.
This story is part of a partnership that includes WBUR, NPR and Kaiser Health News.