Bill Text: HI HB872 | 2025 | Regular Session | Introduced
Bill Title: Relating To Health.
Spectrum: Strong Partisan Bill (Democrat 12-1)
Status: (Introduced) 2025-01-23 - Referred to HLT, CPC, referral sheet 3 [HB872 Detail]
Download: Hawaii-2025-HB872-Introduced.html
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HOUSE OF REPRESENTATIVES |
H.B. NO. |
872 |
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THIRTY-THIRD LEGISLATURE, 2025 |
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STATE OF HAWAII |
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A BILL FOR AN ACT
relating to health.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
SECTION 1. The legislature finds that a food allergy reaction can cause symptoms that range from mild to life-threatening. In the United States, food allergy is the leading cause of severe, life-threatening allergic reactions, known as anaphylaxis, outside the hospital setting. Anaphylaxis is characterized by rapid onset and the involvement of multiple organ systems, including the skin, respiratory system, gastrointestinal tract, and cardiovascular system. Common triggers of anaphylaxis include foods, insect stings, medications, and latex particles. People who have previously experienced only mild symptoms may suddenly experience a life-threatening reaction.
The legislature further finds that the first-line treatment for anaphylaxis is epinephrine, also known as adrenaline. Epinephrine is available by prescription in an auto-injector and works to reverse the life-threatening symptoms. For this reason, the timely administration of epinephrine reduces the risk of fatal or debilitating outcomes associated with anaphylaxis, particularly when medical assistance may be delayed, unavailable, or distant.
The legislature recognizes that one public health strategy to reduce adverse outcomes related to allergic reactions is to substantially increase access to epinephrine by allowing various entities to stock a supply of undesignated epinephrine. Through this strategy, public safety improves as epinephrine availability increases, improving survival rates and health outcomes for persons affected by severe allergies. This strategy was recognized on the federal level through the signing of the School Access to Emergency Epinephrine Act in 2013, which encouraged schools to plan for severe allergic reactions.
The legislature notes that more than thirty states have enacted this strategy into law; however, Hawaii has yet to implement this strategy.
Accordingly, the purpose of this Act is to authorize health care practitioners to make undesignated prescriptions of epinephrine for the purpose of stocking a supply at various types of businesses and government offices.
SECTION 2. Chapter 27, Hawaii Revised Statutes, is amended by adding a new section to part III to be appropriately designated and to read as follows:
"§27- Supply of auto-injectable epinephrine. (a) A practitioner, including practitioners
employed by the department of health, may prescribe auto-injectable epinephrine
in the name of the State for use in accordance with this section. Departments and agencies may acquire and
stock a supply of auto-injectable epinephrine pursuant to prescriptions issued
under this subsection.
(b) Each department and agency shall permit
employees and agents to volunteer to provide or administer auto-injectable
epinephrine to any individual who the employee or agent believes in good faith
is experiencing anaphylaxis, regardless of whether the individual has a
prescription for auto-injectable epinephrine or has previously been diagnosed
with an allergy.
(c) Any employee or agent who volunteers to
administer auto-injectable epinephrine shall receive instruction in the proper
administration of auto-injectable epinephrine by a practitioner.
(d) A department or an agency that possesses and
makes available auto-injectable epinephrine and its employees, agents, and
other individuals; a practitioner who prescribes or dispenses auto-injectable
epinephrine to a department or an agency; and a pharmacist or practitioner who
dispenses auto-injectable epinephrine to a department or an agency shall not be
liable for any injuries or related damages that result from any act or omission
taken pursuant to this section; provided that this immunity shall not apply to
acts or omissions constituting wilful or wanton misconduct
(e) As used in this section:
"Auto-injectable epinephrine" means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.
"Practitioner"
means an individual licensed by the State or authorized by the laws of the
State to prescribe prescription drugs within the scope of the person's practice."
SECTION 3. Chapter 46, Hawaii Revised Statutes, is amended by adding a new section to part V to be appropriately designated and to read as follows:
"§46- Supply of auto-injectable epinephrine. (a) A practitioner, including practitioners
employed by the department of health, may prescribe auto-injectable epinephrine
in the name of a county for use in accordance with this section. County departments and agencies may acquire
and stock a supply of auto-injectable epinephrine pursuant to prescriptions
issued under this subsection.
(b) Each county department and agency shall
permit employees and agents to volunteer to provide or administer
auto-injectable epinephrine to any individual who the employee or agent believes
in good faith is experiencing anaphylaxis, regardless of whether the individual
has a prescription for auto-injectable epinephrine or has previously been
diagnosed with an allergy.
(c) Any employee or agent who volunteers to
administer auto-injectable epinephrine shall receive instruction in the proper
administration of auto-injectable epinephrine by a practitioner.
(d) A county department or agency that possesses
and makes available auto-injectable epinephrine and its employees, agents, and
other individuals; a practitioner who prescribes or dispenses auto-injectable
epinephrine to a department or an agency; and a pharmacist or practitioner who dispenses
auto-injectable epinephrine to a department or an agency shall not be liable
for any injuries or related damages that result from any act or omission taken
pursuant to this section; provided that this immunity shall not apply to acts
or omissions constituting wilful or wanton misconduct
(e) As used in this section:
"Auto-injectable epinephrine" means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.
"Practitioner"
means an individual licensed by the State or authorized by the laws of the
State to prescribe prescription drugs within the scope of the person's
practice."
SECTION 4. Chapter 302A, Hawaii Revised Statutes, is amended by adding a new section to part III, subpart F, to be appropriately designated and to read as follows:
"§302A- Auto-injectable epinephrine. (a) A practitioner, including practitioners
employed by the department of health or the department, may prescribe
auto-injectable epinephrine in the name of the public school for use in
accordance with section 302A-1164 and in accordance with protocol specified by
the practitioner. Public schools may
acquire and stock a supply of auto-injectable epinephrine pursuant to
prescriptions issued under this subsection.
(b) As used in this section:
"Auto-injectable epinephrine" means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.
"Practitioner"
means an individual licensed by the State or authorized by the laws of the
State to prescribe prescription drugs within the scope of the person's
practice."
SECTION 5. Chapter 328, Hawaii Revised Statutes, is amended by adding a new section to be appropriately designated and to read as follows:
"§328- Auto-injectable epinephrine; authority to
prescribe and dispense a supply. (a)
A practitioner may prescribe auto-injectable epinephrine in the name of
an authorized entity for purposes of this section.
(b)
A pharmacist may dispense auto-injectable epinephrine pursuant to a
prescription issued in accordance with subsection (a).
(c)
An authorized entity may acquire and stock a supply of auto-injectable
epinephrine pursuant to a prescription issued under subsection (a). The auto-injectable epinephrine shall be
stored in a location readily accessible in an emergency and in accordance with
the auto-injectable epinephrine's instructions for use and any additional
requirements that may be established by the department. An authorized entity shall designate employees
or agents who have completed the training required by subsection (e) to be
responsible for the storage, maintenance, control, and general oversight of
auto-injectable epinephrine acquired by the authorized entity.
(d)
An employee or agent of an authorized entity, or any other individual,
who has completed the training required by subsection (e) may use
auto-injectable epinephrine prescribed pursuant to subsection (a) to:
(1) Provide auto-injectable epinephrine to any individual who the employee, agent, or other individual believes in good faith is experiencing anaphylaxis, or to the parent, guardian, or caregiver of such individual, for immediate administration, regardless of whether the individual has a prescription for auto-injectable epinephrine or has previously been diagnosed with an allergy; and
(2) Administer auto-injectable epinephrine to
any individual who the employee, agent, or other individual believes in good
faith is experiencing anaphylaxis, regardless of whether the individual has a
prescription for auto-injectable epinephrine or has previously been diagnosed
with an allergy.
(e)
An employee, agent, or other individual described in subsection (c) or (d)
shall complete an anaphylaxis training program and repeat such training at
least every two years following completion of the initial anaphylaxis training
program. The training shall be conducted
by a nationally recognized organization experienced in training laypersons in
emergency health treatment or an entity or individual approved by the
department. Training may be conducted
online or in person and, at a minimum, shall cover:
(1) How to recognize signs and symptoms of severe allergic reactions, including anaphylaxis;
(2) Standards and procedures for the storage and administration of auto-injectable epinephrine; and
(3) Emergency follow-up procedures.
(f)
An authorized entity that possesses and makes available auto-injectable
epinephrine and its employees, agents, and other individuals; a practitioner who prescribes or dispenses auto-injectable
epinephrine to an authorized entity; a pharmacist or practitioner who dispenses auto-injectable epinephrine to an
authorized entity; and an individual or entity that conducts the training
described in subsection (e) shall not be liable for any injuries or related
damages that result from any act or omission taken pursuant to this section;
provided that this immunity shall not apply to acts or omissions constituting
wilful or wanton misconduct. The
administration of auto-injectable epinephrine in accordance with this section shall
not be deemed the practice of medicine or any other profession that otherwise
requires licensure. This section shall
not eliminate, limit, or reduce any other immunity or defense that may be
available under state law. An entity
located in the State shall not be liable for any injuries or related damages
that result from the provision or administration of auto-injectable epinephrine
outside of the State if the entity:
(1) Would not have been liable for such
injuries or related damages had the provision or administration occurred within
this state; or
(2) Is not liable for such injuries or related
damages under the law of the state in which such provision or administration
occurred.
(g)
An authorized entity that possesses and makes available auto-injectable
epinephrine shall submit to the department, on a form developed by the
department, a report including each incident on the authorized entity's
premises that involves the administration of auto-injectable epinephrine
pursuant to subsection (e) and any other information deemed relevant by the
department. The department shall
annually publish a report that summarizes and analyzes all reports submitted to
it under this subsection.
(h)
The department shall establish requirements regarding the storage,
maintenance, control, and oversight of the auto-injectable epinephrine,
including but not limited to any temperature limitations and expiration of such
auto-injectable epinephrine.
(i)
The department shall, through rule or other guidance, identify the types
of entities and organizations that are considered authorized entities no later
than January 1, 2026, and shall review and update such rule or guidance at
least annually thereafter.
(j)
As used in this section:
"Authorized entity" means
agricultural entities, churches, conservation entities, corporate offices,
daycare centers, hotels, private schools, restaurants, and other entities as
approved by the department under subsection (i).
"Auto-injectable epinephrine" means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body."
SECTION 6. Section 328-16, Hawaii Revised Statutes, is amended as follows:
1. By amending subsections (a) through (c) to read:
"(a) A prescription drug shall be dispensed only if its label bears the following:
(1) The name, business address, and telephone number of the seller. The business address shall be the physical location of the pharmacy or the dispensing practitioner's office;
(2) [Except as otherwise authorized
for expedited partner therapy in section 453-52 or an opioid antagonist in
section 461-11.8, the] The name of
the person for whom the drug was prescribed or the name of the owner of the
animal for which the drug was prescribed[;], except as otherwise
authorized for:
(A) A supply of epinephrine under sections 27- , 46- , 302A- , and 328- ;
(B) Expedited partner therapy in section 453-52; or
(C) An opioid antagonist in section 461-11.8;
(3) The serial number of the
prescription;
(4) The date the prescription was
prepared;
(5) The name of the practitioner if
the seller is not the practitioner;
(6) The name, strength, and quantity
of the drug;
(7) The "use by" date for
the drug, which shall be:
(A) The expiration date on the manufacturer's container; or
(B) One year from the date the drug is dispensed,
whichever is earlier;
(8) The number of refills available,
if any;
(9) In the case of the dispensing of an equivalent generic drug product, the statement "same as (brand name of the drug product prescribed or the referenced listed drug name)", or words of similar meaning;
(10) In the case of the dispensing of an interchangeable biological product, the statement "interchangeable with (brand name of the biological product prescribed or the referenced biological drug name)", or words of similar meaning; and
(11) Specific directions for the drug's use; provided that if the specific directions for use are too lengthy for inclusion on the label, the notation "take according to written instructions" may be used if separate written instructions for use are actually issued with the drug by the practitioner or the pharmacist, but in no event shall the notation "take as directed", referring to oral instructions, be considered acceptable.
If any prescription for a drug does not indicate the number of times it may be refilled, if any, the pharmacist shall not refill that prescription unless subsequently authorized to do so by the practitioner or pursuant to section 461-11.9. The act of dispensing a prescription drug other than a professional sample or medical oxygen contrary to this subsection shall be deemed to be an act that results in a drug being misbranded while held for sale.
(b) In addition to the requirements enumerated in subsection (a), a prescription drug shall be dispensed only:
(1) By a pharmacist pursuant to a valid prescription or section 453-52, 461-1, 461-11.8, or 461-11.9;
(2) By a medical oxygen distributor pursuant to a prescription or certificate of medical necessity; provided that the drug to be dispensed is medical oxygen; or
(3) By a practitioner to an ultimate user[;],
except as provided for a supply of epinephrine under sections 27- ,
46- , 302A- , and 328- ;
provided that:
(A) Except as otherwise authorized for a supply of epinephrine under sections 27- , 46- , 302A- , and 328- and expedited partner therapy in section 453-52, the practitioner shall inform the patient, before dispensing any drug other than a professional sample, that the patient may have a written, orally ordered, or electronically transmitted or conveyed prescription directed to a pharmacy or a medical oxygen distributor of the patient's own choice;
(B) The practitioner shall promptly record in the practitioner's records:
(i) The prescription in full;
(ii) The name, strength, and quantity of the drug, and specific directions for the drug's use;
(iii) The date the drug was dispensed;
(iv) [Except as otherwise authorized for
expedited partner therapy in section 453-52 or for an opioid antagonist in
section 461-11.8, the] The name and address of the person for whom
the drug was prescribed or the name of the owner of the animal for which the
drug was prescribed[;], except as otherwise authorized for a supply
of epinephrine under sections 27- , 46- ,
302A- , and 328- ; expedited partner therapy
in section 453-52; or an opioid antagonist in section 461-11.8; and
(v) Prescription drugs dispensed or prescribed for expedited partner therapy as authorized under section 453-52 or for an opioid antagonist in section 461-11.8;
(C) The records described in subparagraph (B) shall be subject to the inspection of the department or its agents at all times; and
(D) No undisclosed rebate, refund, commission, preference, discount, or other consideration, whether in the form of money or otherwise, has been offered to the practitioner as compensation or inducement to dispense or prescribe any specific drug in preference to other drugs that might be used for the identical therapeutic indication.
(c) A prescription may be communicated in writing, orally, or by electronic transmission, and shall include the following information:
(1) The authorization of the practitioner noted as follows:
(A) Written prescriptions shall include the original signature of the practitioner;
(B) Oral
prescriptions shall be promptly recorded by the pharmacist or medical oxygen
distributor and shall include the practitioner's oral code designation; and
(C) Electronic
prescriptions shall be irrefutably traceable to the prescribing practitioner by
a recognizable and unique practitioner identifier such as:
(i) A bitmap or graphic image of the prescriber's handwritten signature and the prescriber's oral code designation (or license number or other identifier if the prescriber is an out-of-state practitioner);
(ii) An electronic
signature;
(iii) A digital signature; or
(iv) By other means as approved by the director;
(2) The date of issuance;
(3) The practitioner's name, business telephone
number, and business address, unless the practitioner is otherwise uniquely
identified and the pharmacy or medical oxygen distributor dispensing the
prescription has the prescriber's contact information on file accessible within
the dispensing area;
(4) The name, strength, and quantity of the drug
to be dispensed, and specific directions for the drug's use;
(5) [Except as otherwise authorized for
expedited partner therapy in section 453-52 or for an opioid antagonist in
section 461-11.8, the] The name and address of the person for whom
the prescription was written or the name of the owner of the animal for which
the drug was prescribed, unless the pharmacy or medical oxygen distributor
dispensing the prescription has the address on file accessible within the
dispensing area[;], except as otherwise authorized for:
(A) A supply of epinephrine under sections 27- , 46- , 302A- , and 328- ;
(B) Expedited partner therapy in section 453-52; or
(C) An opioid antagonist in section 461-11.8;
(6) The room number and route of administration,
if the patient is in an institutional facility; and
(7) The number of allowable refills, if the
prescription is refillable. If the
number of refills authorized by the practitioner is indicated using the terms
"as needed" or "prn", the prescription may be refilled up
to twelve months from the date the original prescription was written. After the twelve-month period, the "as
needed" or "prn" prescription may be refilled for a subsequent
three-month period; provided:
(A) The prescription is refilled only once during the three-month period;
(B) The refill does not
exceed a thirty-day supply of the drug;
(C) The refill does not
provide any amount of the drug fifteen months beyond the date the original
prescription was written;
(D) In the case of
medical oxygen, the duration of therapy indicated on a certificate of medical
necessity shall supersede any limitations or restrictions on refilling; and
(E) Subparagraphs (A) to (D) shall apply only to pharmacies and medical oxygen distributors practicing in the State."
2. By amending subsection (g) to read:
"(g) Any drug other than medical oxygen dispensed pursuant to a prescription shall be exempt from the requirements of section 328-15 (except paragraphs (1), (9), (11), and (12), and the packaging requirements of paragraphs (7) and (8)), if the drug bears a label containing:
(1) The name and address of the pharmacy;
(2) The serial number and the date of the prescription or of its filling;
(3) The name of the practitioner;
(4) [Except as
otherwise authorized for expedited partner therapy in section 453-52 or for an
opioid antagonist in section 461-11.8, the]
The name of the patient[;],
except as otherwise authorized for:
(A) A supply of epinephrine under sections 27- , 46- , 302A- , and 328- ;
(B) Expedited partner therapy in section 453-52; or
(C) An opioid antagonist in section 461-11.8;
(5) The directions for use; and
(6) Any cautionary statements contained in the prescription.
This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of subsection (a), (b), (c), or (d)."
SECTION 7. Section 328-17.7, Hawaii Revised Statutes, is amended by amending subsection (a) to read as follows:
"(a) Every practitioner,
pharmacist, or medical oxygen distributor who compounds, sells, or delivers any
prescribed drug to a patient or a patient's agent shall maintain records that
identify:
(1) The specific drug product dispensed, including:
(A) The product's national drug code (NDC) number; or
(B) The brand name or the established name and the name or commonly accepted abbreviation of the principal labeler of the drug product dispensed, the product strength, and the dosage form;
(2) The quantity of the drug;
(3) Directions for use;
(4) The number of allowable refills;
(5) The date of initial
dispensing and the dates of all refilling;
(6) The date of any transfer of the prescription;
(7) The name, business address, and telephone
number of the recipient pharmacist or medical oxygen distributor for any
transfer of prescription;
(8) The prescribing practitioner, including name,
business address, and telephone number;
(9) The format (oral, written, or electronic) in
which the prescription was received;
(10) [Except as otherwise authorized for
expedited partner therapy in section 453-52 or for an opioid antagonist in
section 461-11.8, the] The patient, including name, address, and
telephone number[;], except as otherwise authorized for:
(A) A supply of epinephrine under sections 27- , 46- , 302A- , and 328- ;
(B) Expedited partner therapy in section 453-52; or
(C) An opioid antagonist in section 461-11.8;
(11) The date of prescribing; and
(12) The name of the practitioner, pharmacist, or
medical oxygen distributor dispensing the drug.
Every prescription dispensed shall have the name of the pharmacist, dispensing practitioner, or medical oxygen distributor responsible for the dispensing appended to the prescription record, and every prescription record shall be preserved and legible for a period of not less than five years. The prescription records shall be subject at all times to the inspection of the director of health or the director's agent."
SECTION 8. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.
SECTION 9. This Act shall take effect upon its approval.
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INTRODUCED BY: |
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Report Title:
Health; Epinephrine; Stock; State; Counties; Public Schools
Description:
Authorizes health care practitioners to make undesignated prescriptions of epinephrine for the purpose of stocking a supply at various types of businesses and state and county government offices, including public schools.
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.
