Opioid Crisis and Naloxone
In August 2017, in light of his campaign commitments to respond to the opioid crisis, Donald Trump directed his administration to ‘Use All Appropriate Authority to Respond to Opioid Emergency’.
Three months later, in November, Governor Chris Christie (R-N.J.) his team released a report outlining the steps to be taken in curbing the impact of the crisis. On the seventh page of the report, a remedy know to the medical community since the early ’70s received a glowing endorsement, ‘We recommended that all law enforcement officers across the country be equipped with life-saving naloxone’.
The report not only suggested that naloxone be used, but that the federal government fund its deployment on the basis of data collected by various healthcare providers and government agencies.
The Surgeon General of the United States Public Health Service, Jerome Adams, has publicly endorsed the widespread deployment of naloxone in the U.S. in light of the prevalence of opiate related deaths. Adams’ opinion was shaped by a personal connection to the opioid crisis, according to an account that he shared back when he was sworn in September 2017: “I was not able to prevent my family from going down the pathway of addiction,” and this experience combined with his professional expertise led him to the belief that “everyone can save a life by understanding and possessing naloxone.”
His endorsement reiterates the reports finding, that between 21,089 in 2010 to 42,249 in 2016, lining up with the flourishing of super-potent synthetic opiates like Fentenyl and Oxycodone. In response to this, his office recommends that citizens learn the signs of an opiate overdose.
Meanwhile on the global stage, the World Health Organization (WHO) recommends nalaxone based on the estimated 69,000 opiate deaths that happen each year—most of which could be prevented with the use of naloxone and basic life support techniques.
With major public health outlets in the U.S. and abroad recommending the public’s use of naloxone, it leads one to wonder: what is naloxone, how does it work and if it’s so great—why isn’t it more widely available?
Naloxone: Chemistry and Policy
Naloxone, a cousin of morphine, has been around since the 1960’s, when chemists in the United States and Great Britain discovered the use of the compound. It is an ‘antagonist’ of opioid receptors—meaning that it attaches itself to the same receptors in the brain that opioids—like morphine, hydromorphone, and heroin—attach to, and halting their effects.
It saves the lives by reversing the key terminal side effect of opioids, respiratory depression. This is why Nalaxone holds the promise that it does, since anyone with minimal training, can end an overdose, returning a victim to consciousness and ordinary breathing.
While the risks of unclean needles used to administer opiates, unknown adulterants in pills and powders bought by users, and psycho-social problem of addiction remain—at least addicts in the throws of an overdose have a chance to live another day. Even though administering the drug is relatively simple, there is little consensus around how to harness it for a maximum public health benefit.
According to the Substance Abuse and Mental Health Services Association (SAMHSA), all 50 states have Naloxone access in some capacity, but there are three models that it is distributed through: traditional, third party and nonpatient specific.
It can be obtained 50 states through the traditional model, requiring patients see a doctor who writes them a prescription that they fill at a pharmacy.
45 states operate with a third party system, allowing someone that isn’t directly at risk to obtain the prescription for use on a high-risk person that they regularly associate with.
49 states allow some form of nonpatient specific access, whether this means visiting a community training session to obtain the drug, or getting it through a standing order from a prescriber.
There is no unifying federal policy on this issue, but overall, the drug is becoming easier to access. For a more detailed description of how each state handles Naloxone policy, I recommend SAMHSA’s guide.
In my home state, Minnesota, Nalaxone was made available through a 2014 law known as Steve’s law, The law authorizes first responders, peace officers, members of community nonprofits to administer the drug. It also permits individuals trained to recognize and respond to an opiate overdose to carry the drug.
There is one catch though—it must be traceable to a standing prescription from a licensed physician. No matter who administers the drug at a scene, as long as the administration is made in good faith, whether it is done by a medical professional or a random citizen, as long as they contact 911 first, there are no consequences.
The nonprofit that wrote this legislation, entitled the Steve Rummler Hope Network, has also provided training in 67 counties, and with several methods of administering the drug. At one of their intramusclar injection training sessions, I was given a bag containing three doses of Nalaxone, three sealed and sterile syringes, and gloves—and training in how to use it.
According to representatives with the organization, most requests for their training are for the autoinjector and the nasal spray, the least popular was the manual injection method, since many people are uncomfortable with the prospect of drawing the solution and inject it on their own, rather than have an automated route do the heavy lifting. Naturally, the easiest way is the one most preferred, but the company—who provides free samples of all forms of the drug that they train people to administer—are concerned by this trend.
Intranasal doses are about 35 times as expensive as the intramuscular injection with an MSRP between $110-$120. The MSRP for an autoinjector unit costs roughly $4,500. To accomplish its mission, the company wants to get the drug in as many hands as possible, but doses of this kind allow them to train and deploy less of the drug overall.
With the law as it stands in Minnesota, one can only obtain Nalaxone through physician’s standing order. The Steve Rummler Hope Network has forged ties with physicians in the state and pharmaceutical distributors to provide the drug to its trainees, but orders for the autoinjector mean that nonfinancial resources must be pledged toward getting the drug. Greater demand for these other forms, rather than the standards needle method, means that fewer doses of the medication overall will be available to the public—and fewer lives saved as a result.
FDA Convenes Nalaxone Committees
With the growing awareness of Naloxone’s potential benefits, the policy and public conversations have shifted in the direction of how its benefits might best be realized.
On December 17th and 18th, a joint meeting of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee will take place in Washington. These committees will discuss their findings and come to an agreement about what to present in their joint recommendation to the agency and take comment from members of the public.
Topics on the agenda include: how to increase access to the drug, whether it should be coprescribed alongside some, or all, opioid drugs, and whether access should be linked to the amount of opiate prescriptions that doctors are allowed to prescribe each year. Members of the public are encouraged to comment on these issues as well, so that their feedback will be reflected in the agency’s decisions on the matter.