|
HOUSE OF REPRESENTATIVES |
H.B. NO. |
1883 |
|
THIRTY-THIRD LEGISLATURE, 2026 |
|
|
|
STATE OF HAWAII |
|
|
|
|
|
|
|
|
||
|
|
||
A BILL FOR AN ACT
relating to epinephrine.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
SECTION 1. 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- Administration of epinephrine
auto-injector; county lifeguards; requirements; training; prescriptions;
limitation of liability. (a)
Beginning January 1, 2027, every county
lifeguard providing services at a county or state beach park shall be
authorized to administer an epinephrine auto-injector to render emergency care to
another person if:
(1) The epinephrine auto-injector is
legally obtained by prescription from an authorized health care provider or
from a county that acquired the epinephrine auto-injector pursuant to
subsection (d);
(2) The epinephrine auto-injector is
used on another person, with the expressed or implied consent of that person,
to treat anaphylaxis;
(3) The epinephrine auto-injector is
stored and maintained as directed by the manufacturer's instructions for that
product;
(4) The county lifeguard using the epinephrine
auto-injector has successfully completed a course of training with an
authorized training provider pursuant to subsection (b) and has a current
epinephrine auto-injector training
certification issued by the provider;
(5) The epinephrine auto-injector obtained
by a county lifeguard shall be used only when functioning within the course of
the county lifeguard's duties; and
(6) The emergency medical services
system is activated by calling 911 or otherwise alerting and summoning
additional emergency services personnel as soon as practicable when an epinephrine
auto-injector is used.
(b) Each county shall approve
authorized training providers and establish the minimum standards for training
and the use and administration of epinephrine auto-injectors pursuant to this
section. Each county may designate
existing training standards for the use and administration of epinephrine
auto-injectors by county lifeguards to satisfy the requirements of this section. A county shall issue an epinephrine
auto-injector training certification to
each county lifeguard who completes the training required under this
section. Each training certification
shall be valid for two years. Minimum
standards for epinephrine auto-injector training shall include:
(1) Techniques for recognizing
circumstances, signs, and symptoms of anaphylaxis;
(2) Standards and procedures for proper
storage and emergency use of epinephrine auto-injectors;
(3) Emergency follow-up procedures,
including activation of the emergency medical services system by calling 911 or
otherwise alerting and summoning additional emergency services personnel;
(4) Compliance with all applicable rules
governing the training, indications, use, and precautions concerning
epinephrine auto-injectors;
(5) Written material covering the
information required under this subsection, including the manufacturer product
information sheets on commonly available models of epinephrine auto-injectors;
and
(6) Proof of completion of a training
course in cardiopulmonary resuscitation and the use of an automatic external
defibrillator for infants, children, and adults that complies with county
requirements and standards for county lifeguards.
(c) An authorized health care
provider may issue a prescription for an epinephrine auto-injector to a county
lifeguard for the purpose of rendering emergency care to another person upon
presentation of a current epinephrine auto-injector certification card issued
by a county demonstrating that the county lifeguard is trained and qualified to
administer an epinephrine auto-injector pursuant to this section or any other
law, rule, or ordinance.
(d) An authorized health care
provider may issue a prescription for an epinephrine auto-injector to a county
if the county provides proof to the authorized health care provider that it
employs at least one county lifeguard who is trained and has a current epinephrine
auto-injector certification card issued pursuant to subsection (b).
(e) A county that possesses and
makes available epinephrine auto-injectors to be administered by county
lifeguards pursuant to this section shall create and maintain an operations
plan that includes:
(1) The name and contact number for the
authorized health care provider who prescribed an epinephrine auto-injector;
(2) Where and how the epinephrine
auto-injector will be stored;
(3) The names of the designated county
lifeguards who have completed the training program required by this section and
who are authorized to administer the epinephrine auto-injector;
(4) How and when the epinephrine
auto-injector will be inspected for an expiration date;
(5) A process to replace the expired
epinephrine auto-injector, including the proper disposal of the expired
epinephrine auto-injector or used epinephrine auto-injector in a sharps
container; and
(6) A process for recording and
reporting each incident that involves the use of an epinephrine auto-injector.
(f) A county that possesses and
makes available epinephrine
auto-injector and its employees,
agents, and other individuals; a county lifeguard that administers an
epinephrine auto-injector; an authorized health care provider who prescribes an epinephrine auto-injector to a county or county lifeguard; a
pharmacist who dispenses an epinephrine auto-injector to a county or county lifeguard pursuant to
section 328‑ ; or an authorized training provider
described in subsection (b) 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 an epinephrine
auto-injector in accordance with
this section shall not be deemed the practice of medicine or any other
profession that otherwise requires licensure.
The failure of a county to possess or administer an epinephrine
auto-injector shall not result in civil liability. This section shall not eliminate, limit, or
reduce any other immunity or defense that may be available under state law.
(g) This section shall not be
construed to limit or restrict the ability of county lifeguards to administer
epinephrine, including the use of epinephrine auto-injectors, as is otherwise
permitted under any other law, rule, or ordinance.
(h) Nothing in this section shall
preclude a county from requiring additional training or certification for the
administration of epinephrine auto-injectors beyond that which is required under this section.
(i) As used in this section:
"Anaphylaxis" means a potentially life-threatening
hypersensitivity or allergic reaction to a substance, whose symptoms include
but are not limited to shortness of breath, wheezing, difficulty breathing,
difficulty talking or swallowing, hives, itching, swelling, shock, or asthma
and whose causes include but are not limited to insect stings or bites, foods,
drugs, and other allergens.
"Anaphylaxis" includes idiopathic or exercise-induced anaphylaxis.
"Authorized health care provider" means a physician licensed
under chapter 453, a physician assistant licensed under chapter 453 and
practicing under the authority and supervision of a licensed physician, or an
advanced practice registered nurse with prescriptive authority licensed under
chapter 457.
"County lifeguard" means an ocean safety officer, a water
safety officer, or a life guard employed by a county. "County lifeguard" includes a
member of a county fire department who is providing lifeguard services at a
state or county beach park.
"Epinephrine auto-injector" means a disposable delivery device
designed for the automatic injection of a premeasured dose of epinephrine into
the human body to prevent or treat a life-threatening allergic reaction.
"Pharmacist" means a pharmacist who is licensed or otherwise
authorized to engage in the practice of pharmacy under chapter 461."
SECTION 2. Chapter 328, Hawaii Revised Statutes, is amended by adding a new section to part I to be appropriately designated and to read as follows:
"§328- Epinephrine auto-injectors; county
lifeguards; dispensing by pharmacists for emergency care. (a) A pharmacist may dispense epinephrine
auto-injectors to a county lifeguard or a county for the purpose of rendering
emergency care in accordance with section 46- upon receipt of
a written order from a health care provider that specifies the quantity of
epinephrine auto-injectors to be dispensed to a county lifeguard or county.
(b) A health care provider shall
only issue a prescription for an epinephrine auto-injector upon presentation of
a current epinephrine auto-injector training certification issued pursuant to section 46- (b). Each additional epinephrine auto-injector
shall require a new prescription.
(c) In addition to any other
requirement for labeling of prescription drugs pursuant to federal or state
law, a pharmacist shall label each dispensed epinephrine auto-injector with the
following:
(1) The name of the person to whom the
prescription was issued;
(2) The designations "section
46- county lifeguard" and "first aid purposes
only"; and
(3) The dosage, use, and expiration date.
(c) Each dispensed prescription
shall include the manufacturer's product information sheet for the epinephrine
auto-injector.
(d) As used in this section:
"County lifeguard" has the same meaning as in section 46‑ .
"Epinephrine auto-injector" has the same meaning as in section
46‑ .
"Health care provider" means a physician licensed under chapter
453, a physician assistant licensed under chapter 453 and practicing under the
authority and supervision of a licensed physician, or an advanced practice
registered nurse with prescriptive authority licensed under chapter 457."
SECTION 3. 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
an epinephrine auto-injector in
section 46- or 328- ; expedited partner therapy in section 453-52; or an opioid antagonist in section 461-11.8, 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;
(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 46- , 328- , 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; provided that:
(A) Except as otherwise authorized for an epinephrine auto-injector in section 46- or 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 an epinephrine auto-injector in section 46- or 328- ; expedited partner therapy in section 453-52; or for an opioid antagonist in section 461-11.8, 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; 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
an epinephrine auto-injector in
section 46- or 328- , expedited partner
therapy in section 453-52; or for an opioid antagonist in section
461-11.8, 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;
(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 an epinephrine auto-injector in section 46- or 328- ; expedited partner therapy in section 453-52; or for an opioid antagonist in section 461-11.8, the name of the patient;
(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 4. Section 328-17.7, Hawaii Revised Statutes, is amended 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
an epinephrine auto-injector in
section 46- or 328- ; expedited partner therapy in section 453-52; or for
an opioid antagonist in section 461-11.8, the patient, including name, address,
and telephone number;
(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 5. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.
SECTION 6. This Act shall take effect upon its approval.
|
INTRODUCED BY: |
_____________________________ |
|
|
|
Report Title:
Epinephrine Auto-Injectors; Counties; County Lifeguards; Emergency Care; Beach Parks; Training; Prescriptions; Health Care Providers; Pharmacists; Liability
Description:
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.