Physician Orders Open Door for Greater Access to Overdose Rescue Drug
Tex Med. 2016;112(9):49-54.
By Joey Berlin
Mark Kinzly has experienced the power of naloxone firsthand.
Mr. Kinzly, cofounder of the Texas Overdose Naloxone Initiative (TONI), says he's battled opioid addiction off and on since 1978. He says he has used the opioid antagonist on people he knows more than 50 times to reverse overdoses. Twice he's been the recipient of naloxone. He says the last time was during his most recent relapse in 2012.
"It allowed me to get back in recovery," he said. "I [was] 12 years clean and relapsed and overdosed twice in that episode. And my last time, it allowed me to get some clarity and get the help that I needed, which absolutely saved my life and has allowed me to stay clean ever since."
As opioid overdoses continue to take a toll nationally, so continues the push to spread naloxone to every corner of Texas where it can bring drug users back from the brink. Since a 2015 state law made it legal for laypeople to administer naloxone outside a medical care setting, TONI and other organizations have worked to take advantage of the law. Several standing pharmaceutical orders, including one from the Texas Pharmacy Association (TPA), have expanded naloxone access in Texas.
"I felt the standing order was important because we're currently in a historic opioid epidemic in our country and our state," said Austin addiction psychiatrist Carlos Tirado, MD, who issued the standing order for TPA.
But as naloxone becomes more available on paper, the skyrocketing cost of the drug, which has grabbed the attention of lawmakers in Washington, DC, is hindering efforts to enhance access.
New Law, New Opportunity
During last year's session, the Texas Legislature passed Senate Bill 1462 by Sen. Royce West (D-Dallas), clearing the way for physicians to prescribe an opioid antagonist to anyone in danger of experiencing an opioid-related overdose or to anyone in a position to help the opioid user. The Texas Medical Association strongly supported the law, which allows anyone witnessing a person experiencing an overdose to administer naloxone on the spot. The person administering the naloxone can do so by either intravenous or intramuscular injection or by intranasal spray. SB 1462 took effect Sept. 1, 2015. (See "A True Antidote," October 2015 Texas Medicine, pages 41–47.)
U.S. Centers for Disease Control and Prevention (CDC) data show prescription opioids and heroin killed more people in 2014 than any other year on record. According to CDC, more than 28,000 people died in 2014 from opioids, including more than 14,000 from overdoses involving prescription opioids. Texas had 2,601 drug overdose deaths in 2014, according to CDC data, a rate of 9.7 per 100,000 population. Almost 2 million Americans abused or were dependent on prescription opioids in 2014.
Alicia Kowalchuk, DO, an assistant professor in Baylor College of Medicine's Department of Family and Community Medicine, says TONI approached her last winter and asked her if she'd be willing to write a standing order if the organization could find a willing pharmacy partner. TONI distributes naloxone and trains addicts and their loved ones on how to use it.
Dr. Kowalchuk says many of the other states that have passed similar legislation have had a physician step up to write a blanket order like the one she wrote for Walgreens.
The month following Dr. Kowalchuk's order, TPA announced it would implement a physician's standing order authorizing pharmacists to dispense naloxone after they had completed a one-hour training course accredited by the Accreditation Council for Pharmacy Education. That order took effect Aug. 1.
Justin Hudman, TPA's director of public affairs, says the standing order includes all the available formulations of naloxone, also known by the trade name Narcan.
"They would need to get some basic education in how to educate the patient because, as we know, this is a little bit different than the normal counseling," Mr. Hudman said of pharmacists taking the education course to act under the standing order. "The individuals who receive it need to have a basic understanding of what to look for as far as what will be warning signs or signs of an overdose, so it's a little bit different … than when they would be taking it themselves."
In late July, CVS Health announced it had established a standing order to make naloxone available without a prescription at all of its pharmacies in Texas, as well as locations in 30 other states.
According to an interactive policy map at lawatlas.org, 39 states now have laws immunizing a layperson administrator of naloxone from criminal prosecution. Thirty states, including Texas, have laws shielding a prescriber of naloxone from criminal prosecution for prescribing it to a layperson.
Dr. Kowalchuk, who administered naloxone in her residency days, notes there's a difference between the version of naloxone physicians use in a hospital setting and the product the standing orders make available. Physicians in a hospital setting typically administer the drug at higher doses than laypeople administer in the commercial product. The higher dose can cause acute withdrawal.
"Typically, in the hospital we were always told, 'Push and duck,' because the person's going to come up very not happy with you," Dr. Kowalchuk said. "That's not a concern so much with these overdose kit products because it's enough of a dose to … reverse the respiratory depression and the overdose, but it's usually not enough to put them in acute withdrawal. Although sometimes it takes a little bit of the high away, and so they'll want to use again.
"That's where you really need the education of the person who's going to be using the overdose kit for their loved one or their associate, and that they do need to stay with the person, encourage them not to use [the opiate] on top of it, and get them appropriate medical care emergently."
Noting naloxone use isn't a "be-all, end-all," she says the effects of the naloxone overdose kit last only between 30 minutes to 90 minutes, while the effects of opioids can last four hours to 12 hours or more.
"They still need treatment immediately after this kit is used for them," she said.
In addition to supporting SB 1462, TMA has adopted comprehensive policy on opioid overdose prevention and prescription drug monitoring. TMA advocates legislation reducing barriers for medical professionals to prescribe naloxone to family members and friends of an opioid user and also supports "Good Samaritan" legislation that would, in certain situations, legally protect drug users who request emergency assistance for a fellow user who overdoses. TMA wants to continue working with lawmakers to develop a Good Samaritan law for Texas.
The national prevalence of opioid overdoses got lawmakers in Washington, DC, involved this year. In mid-July, following calls from President Barack Obama for $1.1 billion in funding to fight opioid addiction, Congress passed the Comprehensive Addiction and Recovery Act, which includes expanded access to naloxone for law enforcement agencies and first responders. The bill did not include funding for the measure, which congressional Republicans said would come later this year, according to reports.
Along with opioid overdose deaths, federal lawmakers have taken a keen interest in something else climbing to troubling new heights: naloxone prices.
In June, Politico reported prices of some versions of naloxone had increased by as much as 17-fold since 2014. That same month, U.S. Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) announced they had written to five pharmaceutical companies to find out what the companies were doing to "ensure continued and improved access to naloxone," to prompt the companies to explain the price changes, and to describe the resources they had to prevent access problems and shortages.
The Los Angeles Times reported in July the companies had separately defended their naloxone prices. One manufacturer, Kaléo, had increased the wholesale price of its naloxone auto-injector to $4,500, a dramatic hike from a $690 wholesale price in 2014. Kaléo said it increased the price for its version of the drug, Evzio, after it decided to cover patient copays, the Times reported. Lora Grassilli, a spokesperson for Kaléo, told the Times the company had donated auto-injectors to more than 250 companies and that the list price was "not a true net price to anyone." She said Kaléo had offered customers discounts and rebates.
"It is a concern," Mr. Hudman said of the price hikes. "And it's very disappointing that that has occurred because I know initially, when we started working on the standing order, [with] the automated version, we understood it was somewhere around the $2,000 range for two dosages. I recently just had a pharmacist quote me $4,000. That's unfortunate because the goal of getting it into people's hands is obviously going to be impacted by cost. And if people can't afford it, then it's not going to help, and it's not going to be available to help."
One key question, he says, is how insurance companies will handle naloxone as it becomes more available and more expensive. Medicaid in Texas does cover all formulations of naloxone, which is on the program's preferred drug list.
Kaléo's website says it has enhanced its patient access program to minimize out-of-pocket costs for Evzio, adding that commercially insured patients can usually obtain the drug with no out-of-pocket charge, even if their plan doesn't cover it.
"Today, a physician can prescribe any of the three formulations of naloxone," Dr. Tirado said. "What a patient can actually get covered entirely hinges on their pharmacy benefit plan.
"In the total range of costs that health plans pay for medication, even with the price increase of naloxone, it's still within a reasonably priced range when you compare it to other high-cost pharmaceuticals, for instance. However, the price has certainly gone up quite a bit, and health plans, regulators, and consumers should certainly demand that the price of this medication does not become inflated. There is too much at stake for people not to have access to this medication."
Mr. Kinzly says the higher prices remove the ability for TONI to get naloxone into the parts of the community that cannot afford it. He says TONI has "probably distributed $300,000 to $400,000 worth of naloxone in the state of Texas free of charge to the citizens," but won't be able to continue to do so because of the increasing costs.
"We were getting it very cheap with the ability to distribute it throughout the state," he said. "We gave it to all people that we train, we were able to get it to organizations that work with high-risk individuals, and that's all going to go away because people can't afford it."
He says TONI looks for alternative routes to obtain and distribute naloxone, including reaching out to philanthropists and working with pharmaceutical companies to improve access.
Awareness and Stigma
Austin obstetrician-gynecologist Kim Carter, MD, a member of TMA's Task Force on Behavioral Health workgroup on opioid overdose prevention, says the death of pop star Prince in April has helped raise awareness of prescription painkiller abuse. Health officials in Minnesota announced Prince died from an overdose of the synthetic opioid Fentanyl. One week before Prince died, first responders reportedly revived the singer with a shot of Narcan after he lost consciousness on a plane, which made an emergency landing.
"I think it's been very helpful to use him as an example because he completely passed out without being somnolent before he passed out, which is exactly what happens," Dr. Carter said. "You don't get sleepy and appear drunk with some of these meds. You just quit breathing."
Even as awareness may increase, stigmatization of drug addicts remains a potential barrier. Dr. Tirado says that stigma is "clearly one of the hopefully last great hurdles that we have to overcome" in treating chronic addiction. He says medicine has largely accepted that addictions are disorders with a biological basis much like other chronic diseases, even if some say that science isn't settled.
"The medical community by and large understands that this disorder is more than just having a weak will or being an unfit or delinquent person or a person fundamentally lacking in moral character," Dr. Tirado said. "As more good research on the neurobiology of addiction comes out, and as more pharmacotherapies for addiction come out, we're going to see even more awareness and acceptance of the fact that addiction, if we're really going to deal with it effectively in our culture, is better addressed as a chronic relapsing condition, as a public health matter, and not necessarily as a legal and moral matter."
Dr. Tirado challenged the notion that making naloxone readily available to reverse overdoses enables addicts to continue giving in to their addictions. He says he's sensitive to the emotional side of that concern but finds the logic behind it troubling. He says he has personally treated patients rescued from overdose who have become stable, productive citizens.
"There isn't a shred of rigorous evidence that opioid addicts misuse naloxone as a 'get-out-of-jail-free card' to allow them to keep using heroin. There may be a few anecdotes here and there, but this is by no means a common practice."
Judgments about whether certain people are deserving of having their lives saved, Dr. Tirado says, "get us on shaky ethical and moral grounds. If we have a person who is diabetic and morbidly obese who falls over in the middle of a shopping mall with cardiac arrest, is someone going to deliberate whether or not that person has been observing their dietary and medication requirements and losing appropriate amounts of weight in order to deserve to be defibrillated?" he said. "I don't think that we go through a similar mental exercise when we're talking about resuscitating someone who's gone into cardiac arrest."
Dr. Kowalchuk says the Walgreens standing order will be key not only in saving the lives of opioid users but also in giving their families a sense of empowerment.
"If they have a loved one that they're concerned about their opiate use [who's] living with them, for example, previously they could've felt pretty helpless about that," she said. "But this is at least enough to have something emergently on board, in their home, that they feel like they have a sense of control over that."
Joey Berlin can be reached by phone at (800) 880-1300, ext. 1393, or (512) 370-1393; by fax at (512) 370-1629; or by email.
Opioid Deaths on the Rise
Opioid overdose deaths increased a drastic 200 percent from 2000 to 2014, according to a U.S. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report released at the beginning of this year. CDC also found:
- In 2014, 28,647 drug overdose deaths involved some type of opioid, accounting for 61 percent of all drug overdose deaths.
- Synthetic opioids other than methadone accounted for the largest increase in the rate of drug overdose deaths from 2013 to 2014, nearly doubling to 1.8 per 100,000 population.
- Heroin overdose death rates rose by 26 percent from 2013 to 2014 and more than tripled since 2010, with 3.4 heroin overdoses per 100,000 population in 2014.
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