HB4462ham002 99TH GENERAL ASSEMBLY

Rep. Michelle Mussman

Filed: 3/29/2016

09900HB4462ham002 LRB099 16680 NHT 46202 a

AMENDMENT TO HOUSE BILL 4462

AMENDMENT NO. ______. Amend House Bill 4462 by replacing everything after the enacting clause with the following:

"Section 1. Short title. This Act may be cited as the Epinephrine Auto-Injector Act.

Section 5. Definitions. As used in this Act:

"Administer" means to directly apply an epinephrine auto-injector to the body of an individual.

"Authorized entity" means any entity or organization, other than a school covered under Section 22-30 of the School Code, in connection with or at which allergens capable of causing anaphylaxis may be present, including, but not limited to, independent contractors who provide student transportation to schools, recreation camps, colleges and universities, day care facilities, youth sports leagues, amusement parks, restaurants, sports arenas, and places of employment. The Department shall, by rule, determine what constitutes a day care facility under this definition.

"Department" means the Department of Public Health.

"Epinephrine auto-injector" means a single-use device used for the automatic injection of a pre-measured dose of epinephrine into the human body.

"Health care practitioner" means a physician licensed to practice medicine in all its branches under the Medical Practice Act of 1987, a physician assistant under the Physician Assistant Practice Act of 1987 with prescriptive authority, or an advanced practice nurse with prescribing authority under Article 65 of the Nurse Practice Act.

"Pharmacist" has the meaning given to that term under subsection (k-5) of Section 3 of the Pharmacy Practice Act.

"Undesignated epinephrine auto-injector" means an epinephrine auto-injector prescribed in the name of an authorized entity.

Section 10. Prescription to authorized entity; use; training.

(a) A health care practitioner may prescribe epinephrine auto-injectors in the name of an authorized entity for use in accordance with this Act, and pharmacists and health care practitioners may dispense epinephrine auto-injectors pursuant to a prescription issued in the name of an authorized entity. Such prescriptions shall be valid for a period of 2 years.

(b) An authorized entity may acquire and stock a supply of undesignated epinephrine auto-injectors pursuant to a prescription issued under subsection (a) of this Section. Such undesignated epinephrine auto-injectors shall be stored in a location readily accessible in an emergency and in accordance with the instructions for use of the epinephrine auto-injectors. The Department may establish any additional requirements an authorized entity must follow under this Act.

(c) An employee or agent of an authorized entity or other individual who has completed training under subsection (d) of this Section may:

(1) provide an epinephrine auto-injector to any individual on the property of the authorized entity whom 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 an epinephrine auto-injector or has previously been diagnosed with an allergy; or

(2) administer an epinephrine auto-injector to any individual on the property of the authorized entity whom the employee, agent, or other individual believes in good faith is experiencing anaphylaxis, regardless of whether the individual has a prescription for an epinephrine auto-injector or has previously been diagnosed with an allergy.

(d) An employee, agent, or other individual authorized must complete an anaphylaxis training program before he or she is able to provide or administer an epinephrine auto-injector under this Section. Such training shall be valid for a period of 2 years and 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. The Department may approve specific entities or individuals or may approve classes of entities or individuals to conduct training.

Training shall include, but is not limited to:

(1) how to recognize signs and symptoms of an allergic reaction, including anaphylaxis;

(2) how to administer an epinephrine auto-injector; and

(3) a test demonstrating competency of the knowledge required to recognize anaphylaxis and administer an epinephrine auto-injector.

Training may also include, but is not limited to:

(A) a review of high-risk areas on the authorized entity's property and its related facilities;

(B) steps to take to prevent exposure to allergens;

(C) emergency follow-up procedures; and

(D) other criteria as determined in rules adopted pursuant to this Act.

Training may be conducted either online or in person. The Department shall approve training programs and list permitted training programs on the Department's Internet website.

Section 15. Costs. Whichever entity initiates the process of obtaining undesignated epinephrine auto-injectors and providing training to personnel for carrying and administering undesignated epinephrine auto-injectors shall pay for the costs of the undesignated epinephrine auto-injectors.

Section 20. Limitations. The use of an undesignated epinephrine auto-injector in accordance with the requirements of this Act does not constitute the practice of medicine or any other profession that requires medical licensure.

Nothing in this Act shall limit the amount of epinephrine auto-injectors that an authorized entity or individual may carry or maintain a supply of.

Section 85. Rulemaking. The Department shall adopt any rules necessary to implement and administer this Act.

Section 90. The School Code is amended by changing Section 22-30 as follows:

(105 ILCS 5/22-30)

Sec. 22-30. Self-administration and self-carry of asthma medication and epinephrine auto-injectors; administration of undesignated epinephrine auto-injectors; administration of an opioid antagonist.

(a) For the purpose of this Section only, the following terms shall have the meanings set forth below:

"Asthma inhaler" means a quick reliever asthma inhaler.

"Epinephrine auto-injector" means a single-use device used for the automatic injection of a pre-measured dose of epinephrine into the human body.

"Asthma medication" means a medicine, prescribed by (i) a physician licensed to practice medicine in all its branches, (ii) a licensed physician assistant with prescriptive authority, or (iii) a licensed advanced practice nurse with prescriptive authority for a pupil that pertains to the pupil's asthma and that has an individual prescription label.

"Opioid antagonist" means a drug that binds to opioid receptors and blocks or inhibits the effect of opioids acting on those receptors, including, but not limited to, naloxone hydrochloride or any other similarly acting drug approved by the U.S. Food and Drug Administration.

"School nurse" means a registered nurse working in a school with or without licensure endorsed in school nursing.

"Self-administration" means a pupil's discretionary use of his or her prescribed asthma medication or epinephrine auto-injector.

"Self-carry" means a pupil's ability to carry his or her prescribed asthma medication or epinephrine auto-injector.

"Standing protocol" may be issued by (i) a physician licensed to practice medicine in all its branches, (ii) a licensed physician assistant with prescriptive authority, or (iii) a licensed advanced practice nurse with prescriptive authority.

"Trained personnel" means any school employee or volunteer personnel authorized in Sections 10-22.34, 10-22.34a, and 10-22.34b of this Code who has completed training under subsection (g) of this Section to recognize and respond to anaphylaxis.

"Undesignated epinephrine auto-injector" means an epinephrine auto-injector prescribed in the name of a school district, public school, or nonpublic school.

(b) A school, whether public or nonpublic, must permit the self-administration and self-carry of asthma medication by a pupil with asthma or the self-administration and self-carry of an epinephrine auto-injector by a pupil, provided that:

(1) the parents or guardians of the pupil provide to the school (i) written authorization from the parents or guardians for (A) the self-administration and self-carry of asthma medication or (B) the self-carry of asthma medication or (ii) for (A) the self-administration and self-carry of an epinephrine auto-injector or (B) the self-carry of an epinephrine auto-injector, written authorization from the pupil's physician, physician assistant, or advanced practice nurse; and

(2) the parents or guardians of the pupil provide to the school (i) the prescription label, which must contain the name of the asthma medication, the prescribed dosage, and the time at which or circumstances under which the asthma medication is to be administered, or (ii) for the self-administration or self-carry of an epinephrine auto-injector, a written statement from the pupil's physician, physician assistant, or advanced practice nurse containing the following information:

(A) the name and purpose of the epinephrine auto-injector;

(B) the prescribed dosage; and

(C) the time or times at which or the special circumstances under which the epinephrine auto-injector is to be administered.

The information provided shall be kept on file in the office of the school nurse or, in the absence of a school nurse, the school's administrator.

(b-5) A school district, public school, or nonpublic school may authorize the provision of a student-specific or undesignated epinephrine auto-injector to a student or any personnel authorized under a student's Individual Health Care Action Plan, Illinois Food Allergy Emergency Action Plan and Treatment Authorization Form, or plan pursuant to Section 504 of the federal Rehabilitation Act of 1973 to administer an epinephrine auto-injector to the student, that meets the student's prescription on file.

(b-10) The school district, public school, or nonpublic school may authorize a school nurse or trained personnel to do the following: (i) provide an undesignated epinephrine auto-injector to a student for self-administration only or any personnel authorized under a student's Individual Health Care Action Plan, Illinois Food Allergy Emergency Action Plan and Treatment Authorization Form, or plan pursuant to Section 504 of the federal Rehabilitation Act of 1973 to administer to the student, that meets the student's prescription on file; (ii) administer an undesignated epinephrine auto-injector that meets the prescription on file to any student who has an Individual Health Care Action Plan, Illinois Food Allergy Emergency Action Plan and Treatment Authorization Form, or plan pursuant to Section 504 of the federal Rehabilitation Act of 1973 that authorizes the use of an epinephrine auto-injector; (iii) administer an undesignated epinephrine auto-injector to any person that the school nurse or trained personnel in good faith believes is having an anaphylactic reaction; and (iv) administer an opioid antagonist to any person that the school nurse or trained personnel in good faith believes is having an opioid overdose.

(c) The school district, public school, or nonpublic school must inform the parents or guardians of the pupil, in writing, that the school district, public school, or nonpublic school and its employees and agents, including a physician, physician assistant, or advanced practice nurse providing standing protocol or prescription for school epinephrine auto-injectors, are to incur no liability or professional discipline, except for willful and wanton conduct, as a result of any injury arising from the administration of asthma medication, an epinephrine auto-injector, or an opioid antagonist regardless of whether authorization was given by the pupil's parents or guardians or by the pupil's physician, physician assistant, or advanced practice nurse. The parents or guardians of the pupil must sign a statement acknowledging that the school district, public school, or nonpublic school and its employees and agents are to incur no liability, except for willful and wanton conduct, as a result of any injury arising from the administration of asthma medication, an epinephrine auto-injector, or an opioid antagonist regardless of whether authorization was given by the pupil's parents or guardians or by the pupil's physician, physician assistant, or advanced practice nurse and that the parents or guardians must indemnify and hold harmless the school district, public school, or nonpublic school and its employees and agents against any claims, except a claim based on willful and wanton conduct, arising out of the administration of asthma medication, an epinephrine auto-injector, or an opioid antagonist regardless of whether authorization was given by the pupil's parents or guardians or by the pupil's physician, physician assistant, or advanced practice nurse.

(c-5) When a school nurse or trained personnel administers an undesignated epinephrine auto-injector to a person whom the school nurse or trained personnel in good faith believes is having an anaphylactic reaction, or administers an opioid antagonist to a person whom the school nurse or trained personnel in good faith believes is having an opioid overdose, notwithstanding the lack of notice to the parents or guardians of the pupil or the absence of the parents or guardians signed statement acknowledging no liability, except for willful and wanton conduct, the school district, public school, or nonpublic school and its employees and agents, and a physician, a physician assistant, or an advanced practice nurse providing standing protocol or prescription for undesignated epinephrine auto-injectors, are to incur no liability or professional discipline, except for willful and wanton conduct, as a result of any injury arising from the use of an undesignated epinephrine auto-injector or the use of an opioid antagonist regardless of whether authorization was given by the pupil's parents or guardians or by the pupil's physician, physician assistant, or advanced practice nurse.

(d) The permission for self-administration and self-carry of asthma medication or the self-administration and self-carry of an epinephrine auto-injector is effective for the school year for which it is granted and shall be renewed each subsequent school year upon fulfillment of the requirements of this Section.

(e) Provided that the requirements of this Section are fulfilled, a pupil with asthma may self-administer and self-carry his or her asthma medication or a pupil may self-administer and self-carry an epinephrine auto-injector (i) while in school, (ii) while at a school-sponsored activity, (iii) while under the supervision of school personnel, or (iv) before or after normal school activities, such as while in before-school or after-school care on school-operated property or while being transported on a school bus.

(e-5) Provided that the requirements of this Section are fulfilled, a school nurse or trained personnel may administer an undesignated epinephrine auto-injector to any person whom the school nurse or trained personnel in good faith believes to be having an anaphylactic reaction (i) while in school, (ii) while at a school-sponsored activity, (iii) while under the supervision of school personnel, or (iv) before or after normal school activities, such as while in before-school or after-school care on school-operated property or while being transported on a school bus. A school nurse or trained personnel may carry undesignated epinephrine auto-injectors on his or her person while in school or at a school-sponsored activity.

(e-10) Provided that the requirements of this Section are fulfilled, a school nurse or trained personnel may administer an opioid antagonist to any person whom the school nurse or trained personnel in good faith believes to be having an opioid overdose (i) while in school, (ii) while at a school-sponsored activity, (iii) while under the supervision of school personnel, or (iv) before or after normal school activities, such as while in before-school or after-school care on school-operated property. A school nurse or trained personnel may carry an opioid antagonist on their person while in school or at a school-sponsored activity.

(f) The school district, public school, or nonpublic school may maintain a supply of undesignated epinephrine auto-injectors in any secure location that is accessible before, during, and after school where an allergic person is most at risk, including, but not limited to, classrooms and lunchrooms. A physician, a physician assistant who has been delegated prescriptive authority in accordance with Section 7.5 of the Physician Assistant Practice Act of 1987, or an advanced practice nurse who has been delegated prescriptive authority in accordance with Section 65-40 of the Nurse Practice Act may prescribe undesignated epinephrine auto-injectors in the name of the school district, public school, or nonpublic school to be maintained for use when necessary. Any supply of epinephrine auto-injectors shall be maintained in accordance with the manufacturer's instructions.

The school district, public school, or nonpublic school may maintain a supply of an opioid antagonist in any secure location where an individual may have an opioid overdose. A health care professional who has been delegated prescriptive authority for opioid antagonists in accordance with Section 5-23 of the Alcoholism and Other Drug Abuse and Dependency Act may prescribe opioid antagonists in the name of the school district, public school, or nonpublic school, to be maintained for use when necessary. Any supply of opioid antagonists shall be maintained in accordance with the manufacturer's instructions.

(f-3) Whichever entity initiates the process of obtaining undesignated epinephrine auto-injectors and providing training to personnel for carrying and administering undesignated epinephrine auto-injectors shall pay for the costs of the undesignated epinephrine auto-injectors.

(f-5) Upon any administration of an epinephrine auto-injector, a school district, public school, or nonpublic school must immediately activate the EMS system and notify the student's parent, guardian, or emergency contact, if known.

Upon any administration of an opioid antagonist, a school district, public school, or nonpublic school must immediately activate the EMS system and notify the student's parent, guardian, or emergency contact, if known.

(f-10) Within 24 hours of the administration of an undesignated epinephrine auto-injector, a school district, public school, or nonpublic school must notify the physician, physician assistant, or advanced advance practice nurse who provided the standing protocol or prescription for the undesignated epinephrine auto-injector of its use.

Within 24 hours after the administration of an opioid antagonist, a school district, public school, or nonpublic school must notify the health care professional who provided the prescription for the opioid antagonist of its use.

(g) Prior to the administration of an undesignated epinephrine auto-injector, trained personnel must submit to their his or her school's administration proof of completion of a training curriculum to recognize and respond to anaphylaxis that meets the requirements of subsection (h) of this Section. Training must be completed annually. Trained personnel must also submit to his or her school's administration proof of cardiopulmonary resuscitation and automated external defibrillator certification. The school district, public school, or nonpublic school must maintain records related to the training curriculum and trained personnel.

Prior to the administration of an opioid antagonist, trained personnel must submit to their school's administration proof of completion of a training curriculum to recognize and respond to an opioid overdose, which curriculum must meet the requirements of subsection (h-5) of this Section. Training must be completed annually. Trained personnel must also submit to the school's administration proof of cardiopulmonary resuscitation and automated external defibrillator certification. The school district, public school, or nonpublic school must maintain records relating to the training curriculum and the trained personnel.

(h) A training curriculum to recognize and respond to anaphylaxis, including the administration of an undesignated epinephrine auto-injector, may be conducted online or in person.

Training shall include, but is not limited to:

(1) how to recognize signs and symptoms of an allergic reaction, including anaphylaxis;

(2) how to administer an epinephrine auto-injector; and

(3) a test demonstrating competency of the knowledge required to recognize anaphylaxis and administer an epinephrine auto-injector.

Training may also include, but is not limited to:

(A) a review of high-risk areas within a school and its related facilities;

(B) steps to take to prevent exposure to allergens;

(C) emergency follow-up procedures;

(D) how to respond to a student with a known allergy, as well as a student with a previously unknown allergy; and

(E) other criteria as determined in rules adopted pursuant to this Section. It must include, but is not limited to:

(1) how to recognize symptoms of an allergic reaction;

(2) a review of high-risk areas within the school and its related facilities;

(3) steps to take to prevent exposure to allergens;

(4) how to respond to an emergency involving an allergic reaction;

(5) how to administer an epinephrine auto-injector;

(6) how to respond to a student with a known allergy as well as a student with a previously unknown allergy;

(7) a test demonstrating competency of the knowledge required to recognize anaphylaxis and administer an epinephrine auto-injector; and

(8) other criteria as determined in rules adopted pursuant to this Section.

In consultation with statewide professional organizations representing physicians licensed to practice medicine in all of its branches, registered nurses, and school nurses, the State Board of Education shall make available resource materials consistent with criteria in this subsection (h) for educating trained personnel to recognize and respond to anaphylaxis. The State Board may take into consideration the curriculum on this subject developed by other states, as well as any other curricular materials suggested by medical experts and other groups that work on life-threatening allergy issues. The State Board is not required to create new resource materials. The State Board shall make these resource materials available on its Internet website.

(h-5) A training curriculum to recognize and respond to an opioid overdose, including the administration of an opioid antagonist, may be conducted online or in person. The training must comply with any training requirements under Section 5-23 of the Alcoholism and Other Drug Abuse and Dependency Act and the corresponding rules. It must include, but is not limited to:

(1) how to recognize symptoms of an opioid overdose;

(2) information on drug overdose prevention and recognition;

(3) how to perform rescue breathing and resuscitation;

(4) how to respond to an emergency involving an opioid overdose;

(5) opioid antagonist dosage and administration;

(6) the importance of calling 911;

(7) care for the overdose victim after administration of the overdose antagonist;

(8) a test demonstrating competency of the knowledge required to recognize an opioid overdose and administer a dose of an opioid antagonist; and

(9) other criteria as determined in rules adopted pursuant to this Section.

(i) Within 3 days after the administration of an undesignated epinephrine auto-injector by a school nurse, trained personnel, or a student at a school or school-sponsored activity, the school must report to the State Board of Education in a form and manner prescribed by the State Board the following information:

(1) age and type of person receiving epinephrine (student, staff, visitor);

(2) any previously known diagnosis of a severe allergy;

(3) trigger that precipitated allergic episode;

(4) location where symptoms developed;

(5) number of doses administered;

(6) type of person administering epinephrine (school nurse, trained personnel, student); and

(7) any other information required by the State Board.

If a school district, public school, or nonpublic school maintains or has an independent contractor providing transportation to students who maintains a supply of undesignated epinephrine auto-injectors, then the school district, public school, or nonpublic school must report that information to the State Board of Education upon adoption or change of the policy of the school district, public school, nonpublic school, or independent contractor, in a manner as prescribed by the State Board. The report must include the number of undesignated epinephrine auto-injectors in supply.

(i-5) Within 3 days after the administration of an opioid antagonist by a school nurse or trained personnel, the school must report to the State Board, in a form and manner prescribed by the State Board, the following information:

(1) the age and type of person receiving the opioid antagonist (student, staff, or visitor);

(2) the location where symptoms developed;

(3) the type of person administering the opioid antagonist (school nurse or trained personnel); and

(4) any other information required by the State Board.

(j) By October 1, 2015 and every year thereafter, the State Board of Education shall submit a report to the General Assembly identifying the frequency and circumstances of epinephrine administration during the preceding academic year. Beginning with the 2017 report, the report shall also contain information on which school districts, public schools, and nonpublic schools maintain or have independent contractors providing transportation to students who maintain a supply of undesignated epinephrine auto-injectors. This report shall be published on the State Board's Internet website on the date the report is delivered to the General Assembly.

On or before October 1, 2016 and every year thereafter, the State Board shall submit a report to the General Assembly and the Department of Public Health identifying the frequency and circumstances of opioid antagonist administration during the preceding academic year. This report shall be published on the State Board's Internet website on the date the report is delivered to the General Assembly.

(k) The State Board of Education may adopt rules necessary to implement this Section.

(l) Nothing in this Section shall limit the amount of epinephrine auto-injectors that any type of school or student may carry or maintain a supply of.

(Source: P.A. 98-795, eff. 8-1-14; 99-173, eff. 7-29-15; 99-480, eff. 9-9-15; revised 10-13-15.)".