Naloxone for Opioid Overdose: Regulation and Policy Options

Naloxone for Opioid Overdose: Regulation and Policy Options

September 27, 2017
Naloxone for Opioid Overdose: Regulation and Policy Options
In the United States, the annual number of drug overdose
Federal Regulation of Naloxone
deaths involving opioids has more than quadrupled since
Naloxone is regulated under the Federal Food, Drug, and
1999, according to the Centers for Disease Control and
Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.), which
Prevention (CDC). Recent estimates (through the third
gives the Food and Drug Administration (FDA) in the
quarter of 2016) show that the age-adjusted rate of drug
Department of Health and Human Services (HHS) primary
overdose deaths has continued to rise. Research published
responsibility for ensuring the safety and effectiveness of
in the American Journal of Preventive Medicine finds that
drugs, regardless of whether they are controlled substances.
the proportion of drug overdose deaths involving opioids
See CRS Report R41983, How FDA Approves Drugs and
has been underestimated (Ruhm 2017). The prescription
Regulates Their Safety and Effectiveness. Naloxone is not
drug naloxone is currently the “only safe and appropriate
known to carry risk of addiction and is not regulated under
treatment” for opioid overdose, according to the Substance
the federal Controlled Substances Act.
Abuse and Mental Health Services Administration
(SAMHSA) Opioid Overdose Prevention Toolkit.
Representatives of the FDA and other HHS agencies have
publicly discussed two major options for increasing access
How Naloxone Works
to naloxone: (1) making naloxone available in easier-to-
The drugs commonly called opioids—whether prescription
administer forms and (2) making naloxone available
drugs (e.g., oxycodone) or street drugs (e.g., heroin)—are
without a prescription.
opioid agonists, meaning they bind to and activate opioid
receptors in the brain. Opioids relieve pain, may induce
Dosage Form
euphoria, and have other effects such as depressing both the
For more than 40 years, naloxone was available only in an
central nervous system and the respiratory system. In the
injectable form, which is difficult for nonprofessionals such
event of an overdose, these latter effects may manifest in a
as friends or family members to administer. Further, both
range of physical problems, including severe drowsiness,
medical professionals and nonprofessionals are at risk of
dangerously slow breathing, coma, and even death.
accidental needle sticks when giving injections. In recent
years, the FDA has approved naloxone in forms that are
Naloxone is an opioid antagonist, meaning it binds to
easier to administer.
opioid receptors but does not activate them. When
administered during an opioid overdose, naloxone
Table 1. Naloxone: Dosage Form
temporarily displaces opioid agonists from the opioid
receptors and blocks additional opioid agonists from
Dosage Form
Sold As
Year Approved
binding to the opioid receptors. By temporarily displacing
Injectable
naloxone (generic)
1971
and blocking opioid agonists, naloxone temporarily stops
their effects, thus reversing the overdose.
Auto-injector
Evzio®
2014
SAMHSA’s
Nasal spray
NARCAN®
2015
Opioid Overdose Prevention Toolkit includes
five steps for first responders to take in the event of an
Source: Data publicly available from the FDA’s Orange Book.
opioid overdose: (1) call for help (dial 911), (2) check for
Notes: Injectable naloxone is available as a generic drug marketed by
signs of opioid overdose, (3) support the individual’s
multiple manufacturers: Evzio® is a registered trademark of Kaléo,
breathing, (4) administer naloxone, and (5) monitor the
Inc., and NARCAN® is a registered trademark of Adapt Pharma
individual’s response.
Operations Limited.

Policy Problem: Access Is Limited
Prescription Requirement
Concern about opioid overdose deaths has led many people,
Naloxone is currently available only by prescription. The
including the members of the President’s Commission on
FFDCA offers two mechanisms by which naloxone could
Combating Drug Addiction and the Opioid Crisis, to call
become a nonprescription (over-the-counter) drug. One
for increased access to naloxone. Comparatively few people
mechanism is the submission of a new drug application
oppose expanded access to naloxone, arguing that such
(NDA) or a supplemental NDA, which would have to be
efforts implicitly condone opioid abuse. Naloxone must
submitted by the manufacturer. The other mechanism is via
often be administered by lay people outside a medical
rulemaking pursuant to 21 C.F.R. §310.200(b), which
setting (as described above); however, until recently
allows a prescription exemption when the Commissioner of
naloxone was available only in an injectable form, which
Food and Drugs finds that prescription-dispensing
may be difficult for a lay person to administer (see “Dosage
requirements are unnecessary for safe and effective use of a
Form” in the next column). Also, naloxone is currently
drug in self-medication (as directed by proposed labeling).
available by prescription only, which limits access (see
This process may be initiated by the commissioner or any
“Prescription Requirement” in the next column).
interested person (i.e., a citizen petition).
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Naloxone for Opioid Overdose: Regulation and Policy Options
Options in Health Policy
notifying physicians of patients who have been revived with
Many recent efforts to increase access to naloxone have
naloxone when experiencing an opioid overdose.
been undertaken by states or local communities. Indeed,
one of the recommendations from the President’s
Options in Law Enforcement Policy
Commission is that the Administration should provide
As with health policy, law enforcement policy related to
model legislation that states would be able to enact. A
naloxone has largely been undertaken by states or local
common strategy at the federal level is to provide support
communities. The federal role may be to encourage or
for state and local initiatives through grants or technical
facilitate state and local efforts.
assistance. Accordingly, many of the options described
below involve changes to state law.
Equipping Law Enforcement with Naloxone
Federal grants may support state and local efforts to equip
Third-Party Prescriptions
law enforcement officers with naloxone. In addition, federal
Laws allowing third-party prescriptions provide an
grants and/or technical assistance may support training in
exception to the usual requirement in state law that
how to administer naloxone.
prescriptions be written only for the person who will
actually take the medication. These laws allow prescriptions
911 Good Samaritan Laws
to be written for a family member or friend of an at-risk
Victims and witnesses of overdoses may hesitate to call 911
individual, rather than the individual himself or herself.
for fear of criminal prosecution on drug charges. Laws
providing immunity for those who act in good faith to seek
Standing Orders
medical care may allay such fears and increase treatment-
Some states have, in effect, made naloxone available
seeking behavior. A variation on 911 Good Samaritan laws
without a prescription from the patient’s perspective
allows judges to consider a good-faith 911 call as
through standing orders. When a prescriber issues a
potentially mitigating any sentencing for an overdose
standing order for naloxone, the drug may be dispensed to a
witness who is criminally prosecuted.
patient based on a set of criteria, without the prescriber
having examined the patient. Some states achieve a similar
Liability Protections
result using a different mechanism: they have laws
Laws establishing liability protections alleviate concerns of
authorizing pharmacists to dispense naloxone without a
prescribers or lay people acting in good faith. Such laws
prescription following a specified protocol.
may protect professionals who prescribe, dispense, or
administer naloxone from criminal or civil liability. Similar
Distribution Programs
laws may protect lay people who distribute naloxone kits or
Some state- and community-based programs have
administer naloxone from criminal or civil liability.
developed kits containing injectable naloxone, mucosal
atomization devices, and instructions for converting the
Related Federal Grant Programs
injectable naloxone into a nasal spray. Laws establishing
While many federal grant programs with broad purposes
naloxone distribution programs formalize a process for
might potentially allow grantees to use funds to support
training individuals at risk of opioid abuse and/or their
access to naloxone, the Comprehensive Addiction and
family members or friends, as well as providing them with
Recovery Act of 2016 (CARA, P.L. 114-198) authorized
naloxone kits.
several programs that explicitly address overdose reversal:
Educational Strategies
 Grants for Reducing Overdose Deaths (42 U.S.C.
Laws requiring educational strategies establish
§290dd-3)
requirements for educational activities beyond naloxone
 Opioid Overdose Reversal Medication Access and
distribution programs. For example, they may require
Education Grant Programs (42 U.S.C. §290ee)
pharmacists dispensing naloxone pursuant to a standing
 First Responder Training (42 U.S.C. §290ee-1)
order or protocol to provide certain instructions.
 State Demonstration Grants for Comprehensive Opioid
Abuse Response (42 U.S.C. §290ee-3)
Other Potential Health Policy Options
 Comprehensive Opioid Abuse Grant Program (42
The policy options above represent established practices
U.S.C. §3797ff et seq.)
that more states might be encouraged to adopt. Other
recommendations are less well-established. For example,
Note that authorized grant programs might not receive
some recommendations focus on reducing the cost of
funding in a given year. Also, funded grants accept
naloxone to patients by mandating insurance coverage of
applications only during defined periods. Search the
the drug, reducing the cost of naloxone to government
Catalog of Federal Domestic Assistance (www.cfda.gov) or
entities (e.g., state Medicaid agencies) by negotiating with
www.grants.gov to find specific grant opportunities.
the manufacturers, or reducing the cost of naloxone to state
and local entities by providing federal funds. The
Erin Bagalman, Analyst in Health Policy
President’s Commission also recommends adopting policies
Ada S. Cornell, Senior Research Librarian
to encourage prescribers to co-prescribe naloxone along
with opioid prescriptions, as well as exploring options for
IF10741

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Naloxone for Opioid Overdose: Regulation and Policy Options

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