House Study Bill 611 - Introduced HOUSE FILE _____ BY (PROPOSED COMMITTEE ON EDUCATION BILL BY CHAIRPERSON JORGENSEN) A BILL FOR An Act permitting schools to stock, administer, and provide 1 epinephrine. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 6101YC (3) 85 je/rj
H.F. _____ Section 1. NEW SECTION . 280.16A Epinephrine auto-injector 1 supply. 2 1. For purposes of this section, unless the context 3 otherwise requires: 4 a. “Administer” means to directly apply an epinephrine 5 auto-injector to the body of an individual. 6 b. “Designated school personnel” means a school nurse or 7 other employee, agent, or volunteer of a school designated 8 by the board of directors of the school district or the 9 authorities in charge of the accredited nonpublic school who 10 has completed the training required under this section to 11 provide or administer an epinephrine auto-injector. 12 c. “Epinephrine auto-injector” means a single-use device 13 used for the automatic injection of a premeasured dose of 14 epinephrine into the human body. 15 d. “Physician” means the same as provided in section 280.16. 16 e. “Provide” means to supply one or more epinephrine 17 auto-injectors to an individual. 18 f. “School” means a public or accredited nonpublic school. 19 g. “Self-administration” means a student or other 20 individual’s discretionary use of an epinephrine auto-injector, 21 whether provided by the student or by designated school 22 personnel pursuant to this section. 23 2. Notwithstanding any contrary provision of law relating 24 to the prescribing, dispensing, providing, and administering 25 of prescription drugs: 26 a. A physician may prescribe epinephrine auto-injectors in 27 the name of a school for use in accordance with this section. 28 b. A pharmacist or physician may dispense epinephrine 29 auto-injectors pursuant to a prescription issued in the name 30 of a school. 31 c. A school may acquire and maintain a stock supply of 32 epinephrine auto-injectors pursuant to a prescription for use 33 in accordance with this section. 34 d. A school with such a prescription may enter into 35 -1- LSB 6101YC (3) 85 je/rj 1/ 7
H.F. _____ arrangements with manufacturers of epinephrine auto-injectors 1 or third-party suppliers of epinephrine auto-injectors to 2 acquire epinephrine auto-injectors at fair-market, free, or 3 reduced prices. 4 3. A school that acquires epinephrine auto-injectors 5 pursuant to this section shall store the epinephrine 6 auto-injectors in a location readily accessible in an emergency 7 and in accordance with the epinephrine auto-injector’s 8 instructions for use and any additional requirements that may 9 be established by the department of education or board of 10 medicine. Designated school personnel shall be responsible for 11 the storage, maintenance, and general oversight of epinephrine 12 auto-injectors acquired by the school. 13 4. Designated school personnel may, upon authorization 14 by the board of directors of the school district or the 15 authorities in charge of the accredited nonpublic school, do 16 all of the following: 17 a. Provide an epinephrine auto-injector to a student for 18 self-administration in accordance with a prescription specific 19 to the student that the school has on file. 20 b. Administer an epinephrine auto-injector to a student in 21 accordance with a prescription specific to the student that the 22 school has on file. 23 c. Administer an epinephrine auto-injector to a student or 24 other individual, on school premises, at a school-sponsored 25 event, or at any other time the student or individual is 26 subject to the school’s jurisdiction or supervision, who 27 the designated school personnel believes in good faith is 28 experiencing anaphylaxis in accordance with a standing protocol 29 from a physician, regardless of whether the student or other 30 individual has a prescription for an epinephrine auto-injector 31 or has previously been diagnosed with an allergy. 32 5. Designated school personnel, other than a school 33 nurse, shall complete an anaphylaxis training program prior 34 to providing or administering an epinephrine auto-injector 35 -2- LSB 6101YC (3) 85 je/rj 2/ 7
H.F. _____ pursuant to this section and at least every two years following 1 completion of the initial anaphylaxis training program. 2 Such training shall be conducted by a nationally recognized 3 organization experienced in providing training in emergency 4 health treatment or other entity or individual approved by 5 the board of medicine. The entity that conducts the training 6 shall issue a certificate, on a form developed or approved by 7 the board of medicine, to each individual who successfully 8 completes the anaphylaxis training program. Training may be 9 conducted online or in person. Training shall cover, at a 10 minimum, all of the following: 11 a. Techniques on how to recognize symptoms of severe 12 allergic reactions, including anaphylaxis. 13 b. Standards and procedures for the storage and 14 administration of an epinephrine auto-injector. 15 c. Emergency follow-up procedures. 16 6. A school that possesses and makes available a stock 17 supply of epinephrine auto-injectors pursuant to this 18 section shall submit to the department of education on a form 19 developed by the department a report of each incident that 20 involves a severe allergic reaction or the administration of 21 an epinephrine auto-injector. The department shall annually 22 publish a report that summarizes and analyzes all such reports 23 submitted to it on the department’s internet site. 24 7. A school that possesses and makes available epinephrine 25 auto-injectors; the board of directors of the school district 26 or the authorities in charge of the accredited nonpublic 27 school; the school’s employees, agents, and volunteers; a 28 physician who prescribes epinephrine auto-injectors to the 29 school; a pharmacist or physician who dispenses epinephrine 30 auto-injectors to the school pursuant to a prescription issued 31 in the name of the school; a manufacturer of epinephrine 32 auto-injectors or third-party supplier of epinephrine 33 auto-injectors from whom a school obtains epinephrine 34 auto-injectors; and an individual or entity that conducts the 35 -3- LSB 6101YC (3) 85 je/rj 3/ 7
H.F. _____ training required by this section shall not be liable for 1 damages for any injuries that result from the administration, 2 self-administration, provision, or failure to administer, 3 self-administer, or provide an epinephrine auto-injector that 4 may constitute negligence, regardless of whether authorization 5 was provided by a student’s parent or guardian or by a 6 student’s health care provider. This immunity does not apply 7 to acts or omissions constituting gross, willful, or wanton 8 negligence. The immunity from liability provided under this 9 section is in addition to and not in lieu of that provided 10 under sections 135.147 and 613.17. The administration or 11 provision of an epinephrine auto-injector in accordance with 12 this section shall not be considered the practice of medicine. 13 8. No later than January 1, 2015, the department of 14 education, in consultation with the board of medicine and 15 education and health care stakeholders, shall develop and make 16 available to all schools guidelines for the management of 17 students with life-threatening allergies. The guidelines shall 18 include but not be limited to all of the following: 19 a. Education and training for school personnel on the 20 management of students with life-threatening allergies, 21 including training relating to the administration of an 22 epinephrine auto-injector. 23 b. Procedures for responding to life-threatening allergic 24 reactions. 25 c. A process for the development of individualized health 26 care and allergy action plans for every student with a known 27 life-threatening allergy. 28 d. Protocols to prevent exposure to life-threatening 29 allergens. 30 9. The department of education, the board of medicine, and 31 the board of pharmacy shall adopt rules to administer this 32 section, including but not limited to standards and procedures 33 for the prescription, dispensation, storage, provision, 34 administration, and replacement of epinephrine auto-injectors, 35 -4- LSB 6101YC (3) 85 je/rj 4/ 7
H.F. _____ and training and authorization to be required for designated 1 school personnel. 2 EXPLANATION 3 The inclusion of this explanation does not constitute agreement with 4 the explanation’s substance by the members of the general assembly. 5 This bill permits a physician to prescribe epinephrine 6 auto-injectors in the name of a school. The bill permits a 7 pharmacist or physician to dispense auto-injectors pursuant 8 to a prescription issued in the name of a school. The bill 9 permits a school to acquire and maintain a stock supply 10 of auto-injectors pursuant to a prescription for use in 11 accordance with the bill. The bill permits a school with such 12 a prescription to enter into arrangements with manufacturers of 13 auto-injectors or third-party suppliers of auto-injectors to 14 acquire auto-injectors at fair-market, free, or reduced prices. 15 These permissions apply notwithstanding any contrary provision 16 of law relating to the prescribing, dispensing, providing, and 17 administering of prescription drugs. 18 The bill defines “school” as a public or accredited 19 nonpublic school. The bill defines “epinephrine auto-injector” 20 as a single-use device used for the automatic injection of a 21 premeasured dose of epinephrine into the human body. 22 The bill requires a school that acquires epinephrine 23 auto-injectors to store the auto-injectors in a location 24 readily accessible in an emergency and in accordance with 25 the auto-injector’s instructions for use and any additional 26 requirements established by the department of education or 27 board of medicine. Designated school personnel shall be 28 responsible for the storage, maintenance, and general oversight 29 of auto-injectors acquired by the school. The bill defines 30 “designated school personnel” as a designated school nurse or 31 designated other employee, agent, or volunteer of a school who 32 has completed the training required by the bill to provide or 33 administer an auto-injector. The bill defines “provide” as 34 supplying one or more auto-injectors to an individual. The 35 -5- LSB 6101YC (3) 85 je/rj 5/ 7
H.F. _____ bill defines “administer” as directly applying an auto-injector 1 to the body of an individual. 2 The bill permits designated school personnel, upon 3 authorization, to provide an epinephrine auto-injector 4 to a student for self-administration in accordance with 5 a prescription specific to the student; administer an 6 auto-injector to a student in accordance with a prescription 7 specific to the student; or administer an auto-injector 8 to a student or other individual, on school premises, at a 9 school-sponsored event, or at any other time the student 10 or individual is subject to the school’s jurisdiction or 11 supervision, who the designated school personnel believes in 12 good faith is experiencing anaphylaxis in accordance with a 13 standing protocol from a physician, regardless of whether 14 the student or other individual has a prescription for an 15 epinephrine auto-injector or has previously been diagnosed with 16 an allergy. 17 The bill requires designated school personnel, other than 18 a school nurse, to complete an anaphylaxis training program. 19 Training must be conducted as approved by the board of 20 medicine. Training must cover the recognition of symptoms of 21 severe allergic reactions, including anaphylaxis, the storage 22 and administration of epinephrine auto-injectors, and emergency 23 follow-up procedures. 24 The bill requires a school to submit a report of incidents 25 involving a severe allergic reaction or the administration of 26 an epinephrine auto-injector to the department of education, 27 and the department to annually publish a summary report on the 28 department’s internet site. 29 A school, its directors, employees, agents, and volunteers, 30 and associated physicians, pharmacists, manufacturers, 31 third-party suppliers, and training providers are not 32 liable for damages for any injuries that result from the 33 administration, self-administration, provision, or failure 34 to administer, self-administer, or provide an auto-injector 35 -6- LSB 6101YC (3) 85 je/rj 6/ 7
H.F. _____ that may constitute negligence, regardless of whether 1 authorization was provided by a student’s parent or guardian 2 or by a student’s health care provider. This immunity does 3 not apply to acts or omissions constituting gross, willful, 4 or wanton negligence. The administration or provision of 5 an auto-injector in accordance with the bill shall not be 6 considered the practice of medicine. 7 The bill requires the department of education, in 8 consultation with others, to develop and make available to 9 all schools guidelines for the management of students with 10 life-threatening allergies no later than January 1, 2015. 11 The bill requires the adoption of rules. 12 -7- LSB 6101YC (3) 85 je/rj 7/ 7