The U.S. opiate epidemic leads to about 16,000 deaths a year. Activists have proposed solutions, and many states have passed legislation to allow physicians to prescribe naloxone, permit pharmacists to distribute naloxone over the counter without a prescription, provide legal protection to those who report overdoses, and allow first responders such as police and firefighters to administer the medication. Opponents have argued that this may increase opiate use by lessening overdose fear. Still, widespread availability of opiate reversal agents has the potential to save many lives, and efforts to improve access should be commended.
On the surface, the solution seems simple, cost-effective, safe, and free from problems. Naloxone is deemed to be inexpensive, often quoted at $3 per dose, but increased demand has raised the price to as much as $42 per dose, according to NPR. There are multiple studies that show the medication can be safely and effectively administered both intramuscularly and intranasally. In skilled hands, naloxone has been found to be effective, and the medication can clearly be lifesaving.
Below are some of the potential issues and problems that should be addressed, or at least anticipated.
First responders will likely have to decide if they are going to administer the medication by injection or intranasally.
If they are going to inject the medication, providers will be required to either draw up the medication or to carry prefilled syringes. With injections comes the risk of needle-stick exposures with patients who are at particularly high risk for HIV and hepatitis and often have an altered mental status or may be inherently violent.
Intranasal administration is an excellent alternative that has been shown to be effective.
Although naloxone is generally heat stable, some experts are recommending special storage for the medication. Naloxone should be protected from light and stored at room temperature (20–25º C, or 68–77º F).1 There may be issues with the drug if it is stored in a vehicle that is not climate controlled.2
Risks and Liability
There are five areas of potential liability:
- It is entirely unclear whether there is potential liability for nonadministration or poor administration of the medication in cases where the patient dies or suffers a bad outcome. Although unlikely, with terminal patients, there may even be potential liability for causing pain by reversing their analgesics.
- There is a potential for needle stick to the provider. Many of opiate overdose patients are at high risk for hepatitis or HIV.
- Although infrequent, most providers can recount a story of violent behavior after reversal of opiate overdose. This may be due to rapid reversal or coingestion of another drug, such as cocaine or methamphetamine. Presently, naloxone administration is often done with many providers available to potentially restrain the patient.
- Many of the opiates on the streets have half-lives longer than that of the naloxone. Naloxone’s effects last 30–75 minutes, which should provide ample time to obtain additional medical assistance. However, what happens when the patient responds to naloxone and is wide-awake? Can the patient legally refuse care, and will first responders assume liability if the patient is allowed to refuse?
- Although rare, rapid reversal of opiate depression by naloxone has been reported to result in vomiting, diaphoresis, tremulousness, tachycardia, elevated blood pressure, seizures, pulmonary edema, ventricular dysrhythmias, rapid pulmonary edema, and even cardiac arrest.3
There will likely need to be some type of necessary training. Depending on the route of administration, training costs may vary. Each agency will need to determine what training is necessary to assess the patient, administer the medication, and provide further stabilizing care until additional help arrives. Even an hour of annual training can be a significant cost to a department.
The Medication Cost of a Potential Solution
In anticipation of the above challenges, a company has come up with an answer, but that answer does not come without a price.
A temperature-stable naloxone and intramuscular delivery device that makes an inadvertent needle stick virtually impossible has been developed. Recently, this device, called Evzio, received FDA approval.
According to representatives of Kaléo, which makes Evzio, pricing has not been fully worked out, and there will likely be volume and institutional discounts. However, according to a New York Times article, the cost could be in the hundreds of dollars for each device.4
Lastly, how are first responders going to get reimbursed for medication replacement? They do not typically bill insurers or patients, and regardless, many of these patients do not have any coverage or the ability to pay.
With all advances come potential difficulties. Naloxone administration has the potential to save many lives. It is important to realize the potential unintended consequences so that first responders develop a program that is safe to the patient and provider, effective, and sustainable.
Dr. Kivela is managing partner at Napa Valley Emergency Medical Group, medical director of Medic Ambulance, and part owner of Elan Medical Corporation. He is Vice President of the ACEP Board of Directors.
State Naloxone Laws
There are 28 jurisdictions that have passed a naloxone law.
* Prescribers immune from civil liability.
+ Lay administrator immune from civil liability.
* + California
* + Colorado
* + Connecticut
+ District Of Columbia
* + Georgia
* + Michigan
* + Minnesota
* + North Carolina
* + New Jersey
* + New Mexico
+ New York
* + Pennsylvania
+ Rhode Island
* + Tennessee
* + Utah
* + Vermont
* + Wisconsin
Source: LawAtlas: The Policy Surveillance Portal
- Ogbur O. Naloxone–hydrochloride injection (Narcan, Evzio). MedicineNet. Available at http://www.medicinenet.com/naloxone-injection/article.htm. Accessed Jan. 5, 2015.
- World Health Organization. Accelerated stability studies of widely used pharmaceutical substances under simulated tropical conditions. Available at http://apps.who.int/medicinedocs/es/d/Jh1808e. Accessed Jan. 5, 2015.
- Naloxone. PDR Network. Available at http://www.pdr.net/drug-summary/naloxone-hydrochloride?druglabelid=777. Accessed Jan. 5, 2015.
- Rosenthal E. For drugs that save lives, a steep cost. The New York Times. April 27, 2014. SR4.