007.01.16 Ark. Code R. 001
Current through Register Vol. 49, No. 10, October, 2024
Rule 007.01.16-001 - Rules and Regulations Pertaining to Public Access to Auto-Injectable EpinephrineSECTION I - AuthorityThe following regulations have been hereby promulgated pursuant to Act 1108 of 2015, codified at Arkansas Code §§ 20-13-403 and 20-13-408.
SECTION II - PurposeThe purpose of these regulations is to expand public access to auto-injectable epinephrine and to expand immunity to include an authorized entity that provides prescribed auto-injectable epinephrine.
SECTION III - DefinitionsAs used in this section:
(1) "Authorized entity" means an entity or organization at which or in connection with which allergens capable of causing an anaphylactic reaction may be present, including without limitation: (E) Colleges and Universities;(F) Before and After School programs; and(G) Summer and recreational camps(2) "Auto-injectable epinephrine" means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body;(3) "Certificate" means a certificate issued under this subchapter to authorize the receipt, possession, and administration of prescribed auto-injectable epinephrine;(4) "Expected user" means an authorized entity's employee or agent who is responsible for the storage, maintenance, and general supervision of auto-injectable epinephrine acquired by the authorized entity;(5) "Healthcare professional" means a licensed physician, chiropractor, dentist, optometrist, podiatrist, or other licensed healthcare professional; (6) "Physician" means an individual licensed to practice medicine in the State of Arkansas under the Arkansas Medical Practices Act, § 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-401 et seq.; and(7) "Self-administration" means a person's discretionary use of auto-injectable epinephrine pursuant to a prescription or written direction from a healthcare professional.SECTION IV - Eligibility for CertificateA person may receive a certificate under this subchapter only if the person:
(1) Is eighteen (18) years of age or older;(2) Has, or reasonably expects to have, regular contact with at least one (1) other person as a result of the person's relationship or occupational or volunteer status, including without limitation: (D) A school nurse, school teacher, or other school employee;(H) An authorized entity; and(3) Has been properly instructed by a physician or has completed an anaphylaxis training program conducted by a nationally recognized organization experienced in training laypersons in emergency health treatment or other person approved by the Department of Health. The instruction shall minimally include recognition of the symptoms of systemic reactions to insect stings and other allergic reactions and the proper administration of an injection of epinephrine.(4) A certificate issued pursuant to these Rules and Regulations expires two (2) years after the date of issuance. A new certificate may be issued to the individual upon proof of completion of the knowledge and skills course described in Section VIII of these Rules.SECTION V - Authority of Certificate HolderThe certificate also shall authorize the certificate holder to possess, provide, and administer in an emergency situation when a physician is not immediately available - the prescribed epinephrine to a person who:
(1) Has contact with the certificate holder as a result of the certificate holder's relationship or occupational or volunteer status under § 20-13-404(2); and(2) Appears to be suffering a severe adverse reaction to an insect sting or other allergic reaction.SECTION VI - Immunity(A) A person or entity that in good faith renders emergency care or treatment by the use of auto-injectable epinephrine is immune from civil liability resulting from: (1) The emergency care or treatment; and(2) Any good faith act or omission to provide or arrange for further medical treatment.(B) A person or entity granted immunity under subsection (a) of this section includes without limitation: (1) A physician or medical facility that distributes auto- injectable epinephrine or issues a certificate under this subchapter;(2) A person or entity that provides auto-injectable epinephrine training to an expected user or authorized entity;(3) A person or entity responsible for the location where the auto-injectable epinephrine is located or used; and(4) A certificate holder.(C) The immunity under subsection (a) of this section does not apply if the cause of action results from gross negligence or willful or wanton misconduct.(D) Immunity under this section is in addition to the immunity provided to an individual acting as a "Good Samaritan" under the provisions of § 17-95-101.SECTION VII - Administration of Act(A) The Department of Health shall prepare a certificate form for use by a physician as authorized under this subchapter. (1) A copy of a certificate issued under this subchapter shall be forwarded by the issuing physician to the department.(2) The department shall maintain the copy on file and make it available for public inspection.(B) Certificates of training issued pursuant to Section IV (3) will be accepted and kept on file by the Arkansas Department of Health.SECTION VIII - Auto-injectable epinephrine use by an authorized entity(A) In order to ensure the public health and safety, an authorized entity that acquires auto-injectable epinephrine shall ensure that:(1) An expected user: (a) Completes appropriate knowledge and skills courses at least one (1) time every two (2) years in anaphylaxis and auto-injectable epinephrine use; and(b) Obtains a certificate under this subchapter;(2) The auto-injectable epinephrine is maintained according to the manufacturer's operational guidelines and instructions in a locked, secure location; and(3) A person who renders emergency care or treatment to a person having an anaphylactic reaction by using auto-injectable epinephrine activates the emergency medical services system as soon as possible and immediately reports the use of auto-injectable epinephrine to the medical provider responding to the emergency.(B) An authorized entity and its expected users may:(1) Obtain a prescription in the name of the authorized entity for epinephrine auto-injectors and acquire epinephrine auto-injectors under the prescription;(2) Provide auto-injectable epinephrine for immediate self-administration to an individual who the authorized entity or expected user 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;(3) Administer auto-injectable epinephrine directly to an individual who the authorized entity or expected user believes in good faith is experiencing anaphylaxis, regardless of whether the individual has a prescription for auto-injectable epinephrine or has been previously diagnosed with an allergy.(C) An authorized entity that possesses and makes available auto- injectable epinephrine shall: (1) Submit to the Department of Health a report of each incident on the authorized entity's premises in which the authorized entity provides or administers auto-injectable epinephrine. The report shall include the following:(a) the name and address of the authorized entity;(b) the name and certificate number of the person administering auto-injectable epinephrine;(c) the age of the person receiving the injection; and(d) the name of the emergency medical service contacted after the injection was administered. The department shall annually publish a report that summarizes and analyzes the reports submitted under this subdivision; and
(2) Notify an agent of emergency communications, 911, or vehicle dispatch center of the existence, location, and type of auto-injectable epinephrine.007.01.16 Ark. Code R. 001