Naloxone: Increasing Access to Reduce Overdose-Related Deaths
By Krystalyn Weaver, PharmD, RPh, Director, Policy and State Relations, National
Alliance of State Pharmacy Associations. Reprinted by permission of the author.
With deaths from prescription drug abuse reaching an all time high, doubling from
1999 to 2013i, health care professionals, policy makers, and advocates are looking
for solutions to address the issue. While some states have taken action to restrict
access to prescription narcotics – prescription drug monitoring programs, limits on
days supply that can be dispensed, encouragement of the use of abuse deterrent
formulations – others are looking to increase access to life-saving opioid reversal
agents.
Naloxone is an opioid antagonist that antagonizes opioid effects by competing for
the same receptor sites. It has no addictive potential, and has virtually no
pharmacological effects if the patient has not taken an opioid. Naloxone has
traditionally been used in the hospital setting and is sometimes referred to with the
trade name Narcan® which is no longer on the market. However, there are now
ways to access naloxone products that can be administered outside of the hospital
or other healthcare settings through the use of an auto-injector or with a kit that
adapts the injectable formulation into a product that can be administered
intranasally.
Evzio®, Naloxone Auto-injector
New to the market in 2014, Evzio® is a naloxone product delivered via an autoinjector that provides visual and auditory cues for administration by a family
member or caregiver, with no medical training. Designed to be pocket sized and
withstand “temperature excursions” up to 104°F, it is meant to be kept on hand by
those who may need it – or their caregivers.ii To assist patients with cost, the
manufacturer, Kaléo, offers a patient savings card and patient assistance program
for those who qualify.iii
Naloxone, Intranasal Kits
Another method of using naloxone in the outpatient setting is intranasal
administration of the injectable product. Of note, there have been no FDA approved
products marketed using this approach, though one may be approved in the future.
According to Pharmacy Times, it has been reported that the FDA has granted Fast
Track designation to a product in development by Adapt Pharma.iv Despite a lack of
FDA approval, there has been significant attention given to intranasal naloxone use,
due to the low cost of obtaining the kits used to adapt the injectable product.
Pharmacist Involvement
Pharmacists have the opportunity to play a key role in addressing America’s
prescription drug overdose crisis. Pharmacists are in a key position to identify
patients who are obtaining prescriptions from multiple prescribers or are at risk of
overdose due to abuse, medication interactions, or comorbidities. Some states have
implemented policies that allow pharmacists to dispense naloxone to not only
patients at risk of overdose, but also to their caregiver. Others, starting with New
Mexico and California are allowing pharmacists to directly prescribe naloxone to
patients who are in need of access to the life saving drug. In lieu of prescriptive
authority for the lifesaving drug, pharmacists in Rhode Island, Washington, and
elsewhere have entered into collaborative practice agreements with prescribers in
order to more easily provide their patients with access to naloxone.
All pharmacists should be sure they are up-to-date on the products currently
available on the market and fully understand the risks and benefits of naloxone use
so that they can identify and counsel the patients who need it. To learn more, many
resources are available from the Centers for Disease Control and Prevention or from
the Office of National Drug Control Policyv,vi.
Centers for Disease Control and Prevention. National Vital Statistics System mortality data.
Accessed March 2015. Available at: http://www.cdc.gov/nchs/deaths.htm
ii Kaleo. Size and Storage of EVZIO. Accessed March 2015. Available at:
http://evzio.com/hcp/about-evzio/size-and-storage-of-evzio.php
iii Kaleo. EVZIO Savings Program. Accessed March 2015. Available at:
http://evzio.com/hcp/patient-savings/evzio-savings-program.php
iv Pharmacy Times. FDA Fast-Tracks Naloxone Nasal Spray. Accessed March 2015. Available
at: http://www.pharmacytimes.com/product-news/FDA-Fast-Tracks-Naloxone-NasalSpray
v Centers for Disease Control and Prevention, Home & Recreational Safety. Prescription
Drug Overdose in the United States: Fact Sheet. Accessed March 2015. Available at:
http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html
vi Office of National Drug Control Policy. Prescription Drug Abuse. Accessed March 2015.
Available at: https://www.whitehouse.gov/ondcp/prescription-drug-abuse
i