Ohio Administrative Code
Title 4729:5 - Dangerous Drugs
Chapter 4729:5-3 - Disposal of Controlled Substances
Section 4729:5-3-19 - Naloxone for emergency use and distribution via automated mechanisms
Universal Citation: OH Admin Code 4729:5-3-19
Current through all regulations passed and filed through September 16, 2024
(A) As used in this rule, "tamper-evident" means a package, storage container or other physical barrier that is sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.
(B) In accordance with section 4729.515 of the Revised Code, a terminal distributor of dangerous drugs may acquire and maintain a supply of naloxone for use in emergency situations and for distribution through an automated mechanism. The naloxone may be maintained at a location other than the location licensed as a terminal distributor of dangerous drugs.
(C) In the case of naloxone for use in emergency situations, a terminal distributor of dangerous drugs shall do all of the following:
(1)
Provide written materials regarding the emergency
administration of naloxone to any individual who accesses the naloxone, to
include:
(a)
Specific instruction to summon emergency services pursuant
to division (D)(2) of section
4729.515 of the Revised
Code.
(b)
Procedures for administering naloxone contained within
the kit, including the possible administration of multiple
doses.
(c)
Performing rescue breathing and the use of a face
shield or other rescue breathing barrier device, which shall be provided with
the naloxone.
(d)
Proper method for placing an individual into the
recovery position.
(2)
Specify a process
to be used to notify the terminal distributor that the naloxone has been
accessed within a reasonable time of its being accessed, which may include any
of the following:
(a)
Documented checks of the emergency naloxone and its
required components, to be conducted at least every thirty days, by an employee
of the terminal distributor of dangerous drugs. The terminal distributor shall
include a telephone number where persons can report that the emergency naloxone
has been used and needs replenishment.
(b)
An automated
alert that notifies the terminal distributor when the emergency naloxone is
accessed.
(c)
Any other method approved by the board's executive
director or the director's designee.
(3)
Except in
instances where naloxone is not commercially available, including the absence
of a manufacturer for the drug or the lack of a readily available supply of the
drug from a manufacturer or wholesaler, a terminal distributor of dangerous
drugs shall replace any naloxone and, if missing or used, any required
components (instructions, rescue breathing barrier device, etc.) no later than
forty-eight hours following notification that naloxone has been accessed in
accordance with paragraph (C)(2) of this rule.
(4)
Maintain the
naloxone in accordance with the manufacturer's or distributor's
instructions.
(a)
All naloxone maintained for emergency use in accordance
with this paragraph shall be sealed in a tamper-evident manner to ensure the
integrity of the drug.
(b)
Any naloxone that shows sign of tampering or
adulteration shall be immediately removed by the terminal distributor of
dangerous drugs and replaced within forty-eight hours of discovering the
naloxone has been tampered with or is adulterated.
(c)
A terminal
distributor shall develop and implement a policy to ensure that naloxone that
exceeds its manufacturer's expiration date is removed and properly
disposed.
(5)
A terminal distributor maintaining naloxone in
accordance with this paragraph shall:
(a)
Maintain a
complete list that includes the address and description of the location (e.g.
first floor hallway, second floor conference room, etc.) of where the terminal
distributor maintains the naloxone for emergency use. The list shall be
immediately available for inspection upon request of an employee of the
board.
(b)
Keep a record of the naloxone maintained for emergency
use that includes the name, strength, dosage form, national drug code and
expiration date. Records shall be readily retrievable and maintained for a
period of three years.
(c)
Ensure the naloxone is maintained in a container or
device that is securely fastened to a permanent structure and is clearly marked
to indicate naloxone is available for emergency use.
(6)
The requirements
of this paragraph shall not apply to a service entity that maintains naloxone
for emergency administration in accordance section
4729.514 of the Revised
Code.
(D) In the case of naloxone for distribution through an automated mechanism, a terminal distributor of dangerous drugs shall do all the following:
(1)
Ensure the mechanism is securely fastened to a permanent
structure or is of an appropriate size and weight to reasonably prevent it from
being removed from its intended location.
(2)
Develop a process
to be used to monitor and replenish the inventory of naloxone maintained in the
automated mechanism, which may include any of the following:
(a)
Documented checks
of the mechanism, to be conducted at least every thirty days, by an employee of
the terminal distributor of dangerous drugs.
(b)
An electronic
system to monitor the inventory of naloxone within the
mechanism.
(c)
Any other method approved by the Board's executive
director or the director's designee.
(3)
Provide written
educational materials to the person accessing the naloxone appropriate to the
dosage form of naloxone distributed, including, but not limited to, all of the
following:
(a)
Risk factors of opioid overdose.
(b)
Strategies to
prevent opioid overdose.
(c)
Signs of opioid overdose.
(d)
Steps in
responding to an overdose, including:
(i)
The proper method
for placing an individual into the recovery position.
(ii)
Specific
instruction to summon emergency services pursuant to division (D)(2) of section
4729.515 of the Revised
Code.
(e)
Information on naloxone.
(f)
Procedures for
administering naloxone.
(g)
Proper storage and expiration of naloxone product
distributed.
(h)
Information on where to obtain a referral for substance
abuse treatment.
(i)
Information, as required in paragraph (D)(4) of this
rule, on where individuals may call for additional questions regarding naloxone
administration. The telephone number must include the hours where an
appropriately trained representative is available to answer
questions.
(4)
Provide a telephone number where individuals can call
representatives with the requisite training necessary to answer questions
regarding naloxone administration.
(5)
Maintain the
naloxone in accordance with the manufacturer's or distributor's
instructions.
(a)
Any naloxone that shows sign of tampering or
adulteration shall be immediately removed by the terminal distributor of
dangerous drugs.
(b)
A terminal distributor shall develop and implement a
policy to ensure that naloxone that exceeds its manufacturer's expiration date
is removed and properly disposed.
(6)
A terminal
distributor maintaining naloxone in accordance with this paragraph shall:
(a)
Maintain a
complete list that includes the address and description of the location (e.g.
first floor hallway, second floor conference room, etc.) of where the terminal
distributor maintains an automated mechanism. The list shall be immediately
available for inspection upon request of an employee of the
board.
(b)
Maintain a record of the naloxone stored within the
automated mechanism that includes the name, strength, dosage form, national
drug code and expiration date. Records shall be readily retrievable and
maintained for a period of three years.
(7)
Naloxone removed
from an automated mechanism shall not be returned to the mechanism or
transferred in accordance with rule
4729:5-3-09 of the
Administrative Code, except if it was removed by an employee of the terminal
distributor of dangerous drugs.
(E) The state board of pharmacy may grant variances from this rule in cases in which:
(1)
The applicable
provision is not statutorily mandated.
(2)
Granting the
variance would not:
(a)
Be contrary to public interest; or
(b)
Compromise the
integrity of the drug.
(3)
No party will be
injured by the granting of the variance.
(F) An approval for a variance pursuant to paragraph (E) of this rule may be revocable, may be granted for a limited period or may be granted subject to the conditions as the state board of pharmacy may prescribe.
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