Naloxone for Opioid Overdose: Considerations for Congress

Naloxone for Opioid Overdose: Considerations for Congress

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September 11, 2023
Naloxone for Opioid Overdose: Considerations for Congress
Opioids, such as heroin, fentanyl, and some prescription
a syringe into a mist for intranasal use, though this process
pain medications (including morphine and oxycodone), are
requires multiple steps for use during an overdose. In 2015,
substances that act on receptors in the body important in
the FDA approved naloxone in a more user-friendly nasal
regulating pain and emotion. As opioid agonists, these
spray form (Narcan®), and a generic nasal spray in 2019
substances attach to and activate opioid receptors that can
(Table 1). In March 2023, FDA approved Narcan as an
relieve pain, induce euphoria, or depress the central nervous
over-the-counter drug (OTC), and a second nasal spray,
and respiratory systems. In an overdose, opioids cause
RiVive, in July 2023. Naloxone is currently available in
dangerously slow breathing, coma, and even death. In 2021,
several prescription and nonprescription (i.e., OTC) forms.
opioids were involved in over 80,000 overdose deaths in the
Depending on the strength of the formulation and the
United States.
overdose circumstances, multiple doses of naloxone may be
needed for effectiveness.
Opioid Overdose Reversal Medications:
Naloxone
Table 1. Naloxone Nasal Spray Product Examples
Naloxone is a medication that can reverse an opioid
Product and
FDA
overdose. As an opioid antagonist, it attaches to opioid
Manufacturer
Formulation
Status
receptors but does not activate them. When administered
Narcan® by Emergent
4 mg naloxone
during an opioid overdose, naloxone temporarily displaces
OTC
BioSolutions
HCI nasal spray
opioid agonists from the opioid receptors and blocks
additional opioid agonists from attaching, thus temporarily
RiVive by Harm Reduction
3 mg naloxone
OTC
stopping their effects and reversing the overdose.
Therapeutics
HCI nasal spray
(Naloxone is the most commonly used, though not the only,
Naloxone HCI (generic) by
4 mg naloxone
OTC
opioid overdose reversal medication. Nalmefene, another
Padagis Israel Pharmaceuticals HCI nasal spray
opioid antagonist, works in a similar manner.) Naloxone
Naloxone HCI (generic) by
4 mg naloxone
Rx
can cause withdrawal symptoms to an opioid user, though it
Teva Pharmaceuticals
HCI nasal spray
is mostly harmless when administered to someone not using
Kloxxado by Hikma
8 mg naloxone
opioids. Naloxone only works to counteract the effects of
Rx
Pharmaceuticals
HCI nasal spray
opioid drugs; it has no effect in reversing overdoses from
Source: FDA Orange Book: Approved Drug Products with Therapeutic
other substances. Comparable overdose reversal
Equivalence Evaluations. (List is not exhaustive.)
medications for non-opioid drugs, such as
Notes: FDA=U.S. Food and Drug Administration;
methamphetamine and cocaine, do not yet exist.
HCI=hydrochloride (a salt included for drug administration);
Federal Regulation of Naloxone
OTC=available over-the-counter (i.e., without a prescription),
mg=mil igram, Rx=available by prescription only.
Naloxone is regulated under the Federal Food, Drug, and
Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.), which
Considerations for Congress
gives the U.S. Food and Drug Administration (FDA)
primary responsibility for ensuring the safety and
Naloxone is effective only if it is available and
administered during an overdose. As such, Congress may
effectiveness of drugs. (See CRS Report R41983, How
FDA Approves Drugs and Regulates Their Safety and
have an interest in increasing accessibility of the drug. Most
Effectiveness.) Naloxone is not a controlled substance and
determinations on distribution and use of naloxone are
does not carry risk of misuse.
made at the state and local levels, though Congress has
some relevant authorities. A common strategy at the federal
Until 2023, naloxone was available only by prescription. To
level, for instance, is to provide support for state and local
initiatives through grants or technical assistance.
increase accessibility of naloxone, many states issued
standing orders or third-party prescriptions, which allow
Distribution of Naloxone
pharmacists to dispense naloxone without a prescription.
Naloxone is currently distributed by pharmacies, health care
These state laws also permit broad distribution and use of
naloxone via community organizations and schools.
facilities, and entities outside the traditional health care
system, such as harm reduction organizations, first
Naloxone Formulations
responders, prisons, and schools. According to a March
From its approval in 1971 through 2014, naloxone was
2023 report by the Reagan-Udall Foundation, nearly half
available only in an injectable form. This formulation can
(45%) of the 17 million doses of naloxone distributed in the
United States in 2021 were distributed outside retail
be difficult for nonprofessionals to administer and poses
risks of needle sticks when giving injections. An
pharmacies and health care facilities. In these instances,
atomization attachment can transform liquid naloxone from
local health departments, harm reduction organizations, first
responder groups, schools, and other community
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Naloxone for Opioid Overdose: Considerations for Congress
organizations may purchase or receive doses of naloxone to
determined by state or local governments. Federal agencies
further distribute or administer. These doses may be
provide grants and technical assistance for education and
purchased directly from manufacturers by organizations, or
training in how to administer naloxone via professional
by states using federal or state funds.
development for first responders or school personnel, for
example, or to the public via awareness campaigns.
Figure 1. Naloxone Nasal Spray
Table 2. Selected Federal Grant Programs for Opioid
Overdose Reversal Drugs
Program
Authorization
Appropriation
State Opioid
42 U.S.C. §290ee-
$1.5 bil ion for
Response (SOR)
3a; $1.75 bil ion for
FY2023
each of FY2023-
FY2027
Grants to Prevent
42 U.S.C. §290bb-
$16 mil ion for
Prescription
22
FY2023
Drug/Opioid
Overdose-Related
Deaths (PDO)
First Responder
42 U.S.C. §290ee-1;
$56 mil ion for
Training
$36 mil ion for each FY2023

Source: Centers for Disease Control and Prevention.
of FY2019-FY2023
Improving Access
42 U.S.C. §290dd-3; $1.5 mil ion for
Cost of Naloxone
to Overdose
$5 mil ion for the
FY2023
The price of over-the-counter products is determined by
Treatment
period of FY2023-
individual retailers. When Narcan became available on
FY2027
store shelves without a prescription in September 2023,
Harm Reduction
Section 2706 of the
$30 mil ion in
Emergent BioSolutions announced a Manufacturer’s
Grant Program
American Rescue
P.L. 117-2
Suggested Retail Price of $45 for a two-dose carton (and
Plan Act (P.L. 117-
(available until
$41 for public interest partners). Costs for prescription-only
2)
expended)
forms of naloxone are subject to many factors (see CRS
Rural Emergency
42 U.S.C. §254c-15;
$10.5 mil ion for
Report R44832, Frequently Asked Questions About
Medical Services
such sums as
FY2023
Prescription Drug Pricing and Policy). While prescription
Training Grant
necessary for each
naloxone dispensed at pharmacies or health facilities may
of FY2019-FY2023
be covered by many insurance plans and by Medicare and
Comprehensive
34 U.S.C. §10701 et $190 mil ion for
Medicaid, the outlook for private and public coverage of
Opioid, Stimulant,
seq.
FY2023
OTC naloxone is less clear.
and Substance Use
Program
Federal Funding for Naloxone
Source: CRS.
Naloxone distributed at no cost to consumers or insurance
programs may be supported by a blend of federal, state, and
Notes: Authorizations included here typical y cite drugs approved
private funding. States and localities may use state funds or
under the FFDCA for emergency treatment of an opioid overdose;
opioid settlement money to acquire naloxone (some
they do not explicitly name naloxone. See authorizations for
settlement agreements include specific naloxone
al owable uses of funds. This list is not exhaustive; other grants may
purchasing, donation, or availability requirements). Most
also al ow for the purchase and distribution of naloxone. For SOR
federal funding supporting substance use treatment and
grant information, see CRS In Focus IF12116, Opioid Block Grants.
harm reduction (including naloxone purchasing and
Good Samaritan Laws and Liability Protections
distribution) is in the form of block grants to states. There is
no national stockpile of naloxone, or any federal
Witnesses of overdoses sometimes hesitate to intervene or
requirement for states to procure and distribute a certain
call 911 for fear of criminal prosecution on drug charges.
amount. Some federal programs directly support overdose
Laws providing immunity for those who act in good faith to
reversal medication training and distribution (Table 2).
seek medical care may allay such fears and increase
treatment-seeking behavior. Similarly, liability protections
Education, Training, and Accessibility
for people who distribute naloxone kits or administer
Federal law requires all prescribers of controlled substances
naloxone may also encourage bystanders to act during a
to complete training in using FDA-approved medications
suspected overdose.
for the treatment of opioid use disorder. Mandates for co-
prescribing naloxone with opioid pain medications are
Johnathan H. Duff, Analyst in Health Policy
determined by states. Similarly, requirements for naloxone
Ada S. Cornell, Senior Research Librarian
access in specific locations, such as schools, are mostly
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Naloxone for Opioid Overdose: Considerations for Congress

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