HLS 20RS-629 ORIGINAL 2020 Regular Session HOUSE BILL NO. 467 BY REPRESENTATIVE AMEDEE HEALTH SERVICES: Requires the provision of certain information to patients or parents of patients prior to administration of an immunization or a vaccine 1 AN ACT 2To amend and reenact R.S. 37:1218(3) and 1218.1(A) and to enact R.S. 37:936, 980, 3 1218(6), 1274.2, and 1360.31.1 and Part XIII-A of Chapter 11 of Title 40 of the 4 Louisiana Revised Statutes of 1950, to be comprised of R.S. 40:2199.11, relative to 5 the administration of immunizations and vaccines; to require that certain healthcare 6 providers and facilities furnish information to patients or parents of patients prior to 7 the administration of an immunization or vaccine; to provide specifications for such 8 information to be furnished to patients or parents of patients; and to provide for 9 related matters. 10Be it enacted by the Legislature of Louisiana: 11 Section 1. R.S. 37:1218(3) and 1218.1(A) are hereby amended and reenacted and 12R.S. 37:936, 980, 1218(6), 1274.2, and 1360.31.1 are hereby enacted to read as follows: 13 §936. Administration of immunizations and vaccines; requirements 14 Prior to administering an immunization or a vaccine to a patient, a registered 15 nurse shall provide to the patient, or, if the patient is a minor, the parent or guardian 16 of the patient, thorough information in writing, verbally, or electronically concerning 17 the immunization or vaccine that addresses, at minimum, all of the following: 18 (1) The diseases or conditions that the immunization or vaccine is intended 19 to prevent or treat. 20 (2) The effectiveness of the immunization or vaccine. Page 1 of 7 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 20RS-629 ORIGINAL HB NO. 467 1 (3) Any contraindications associated with the immunization or vaccine. 2 (4) The possible side effects of the immunization or vaccine. 3 (5) The ingredients of the immunization or vaccine. 4 (6) Instructions for submitting a report to the Vaccine Adverse Event 5 Reporting System, the cooperative program of the United States Centers for Disease 6 Control and Prevention and the United States Food and Drug Administration for 7 vaccine safety, or its successor program. 8 * * * 9 §980. Administration of immunizations and vaccines; requirements 10 Prior to administering an immunization or a vaccine to a patient, a practical 11 nurse shall provide to the patient, or, if the patient is a minor, the parent or guardian 12 of the patient, thorough information in writing, verbally, or electronically concerning 13 the immunization or vaccine that addresses, at minimum, all of the following: 14 (1) The diseases or conditions that the immunization or vaccine is intended 15 to prevent or treat. 16 (2) The effectiveness of the immunization or vaccine. 17 (3) Any contraindications associated with the immunization or vaccine. 18 (4) The possible side effects of the immunization or vaccine. 19 (5) The ingredients of the immunization or vaccine. 20 (6) Instructions for submitting a report to the Vaccine Adverse Event 21 Reporting System, the cooperative program of the United States Centers for Disease 22 Control and Prevention and the United States Food and Drug Administration for 23 vaccine safety, or its successor program. 24 * * * 25 §1218. Administration of influenza immunization 26 A pharmacist may administer an influenza immunization to any person seven 27 years of age or older without a prescription or medical order contingent upon all of 28 the following provisions: 29 * * * Page 2 of 7 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 20RS-629 ORIGINAL HB NO. 467 1 (3) The pharmacist shall report all adverse events he observes or which are 2 reported to him to the Vaccine Adverse Events Event Reporting System (VAERS), 3 the cooperative program of the CDC and the United States Food and Drug 4 Administration for vaccine safety, or its successor program; and further, the 5 pharmacist shall refer the patient with an adverse event to the influenza 6 immunization for appropriate medical care. 7 * * * 8 (6) Prior to administering an influenza immunization to a patient, the 9 pharmacist shall provide to the patient, or, if the patient is a minor, the parent or 10 guardian of the patient, thorough information in writing, verbally, or electronically 11 concerning the immunization that addresses, at minimum, all of the following: 12 (a) The effectiveness of the immunization. 13 (b) Any contraindications associated with the immunization. 14 (c) The possible side effects of the immunization. 15 (d) The ingredients of the immunization. 16 (e) Instructions for submitting a report to the Vaccine Adverse Event 17 Reporting System described in Paragraph (3) of this Section. 18 §1218.1. Administration of immunizations and vaccines other than influenza 19 immunizations 20 A. A pharmacist may administer to an individual age seventeen or older an 21 immunization or a vaccine without a patient-specific prescription or medical order 22 if the immunization or the vaccine is administered in conformance with the most 23 current immunization administration protocol as set forth by the United States 24 Centers for Disease Control and Prevention Advisory Committee on Immunization 25 Practice. At the time that a pharmacist administers an immunization or vaccine under 26 the provisions of this Section, the pharmacist shall also inform the individual that the 27 administration of an immunization or vaccine under this Section is not to be 28 construed as being in lieu of an annual checkup with the individual's primary care 29 or family physician. Additionally, in connection with the administration of Page 3 of 7 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 20RS-629 ORIGINAL HB NO. 467 1 immunizations and vaccines, the pharmacist shall comply with all of the following 2 requirements: 3 (1) The pharmacist shall report each immunization to the Louisiana 4 Department of Health, office of public health's Louisiana Immunization Network for 5 Kids Statewide at the time of the immunization or as soon as reasonably practicable 6 thereafter, as this is the official state vaccination record. 7 (2) The pharmacist shall report all adverse events he observes or which are 8 reported to him to the Vaccine Adverse Events Event Reporting System, the 9 cooperative program of the United States Centers for Disease Control and Prevention 10 and the United States Food and Drug Administration for vaccine safety, or its 11 successor program; and further, the pharmacist shall refer the patient with an adverse 12 event to an immunization for appropriate medical care. 13 (3) The pharmacist shall maintain for at least two years a record of each 14 immunization administered. 15 (4) The pharmacist shall obtain the appropriate credentials to administer 16 immunizations from the board, as administratively defined, prior to administering 17 any such immunization. 18 (5) The pharmacist shall request the name of a patient's primary care 19 provider prior to the administering of any immunization. If the patient identifies 20 such primary care provider to the pharmacist, the pharmacist shall notify the primary 21 care provider, by written or electronic communication, as soon as reasonably 22 possible thereafter that the immunization was administered. 23 (6) Prior to administering an immunization or a vaccine to a patient, the 24 pharmacist shall provide to the patient, or, if the patient is a minor, the parent or 25 guardian of the patient, thorough information in writing, verbally, or electronically 26 concerning the immunization or vaccine that addresses, at minimum, all of the 27 following: 28 (a) The diseases or conditions that the immunization or vaccine is intended 29 to prevent or treat. Page 4 of 7 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 20RS-629 ORIGINAL HB NO. 467 1 (b) The effectiveness of the immunization or vaccine. 2 (c) Any contraindications associated with the immunization or vaccine. 3 (d) The possible side effects of the immunization or vaccine. 4 (e) The ingredients of the immunization or vaccine. 5 (f) Instructions for submitting a report to the Vaccine Adverse Event 6 Reporting System described in Paragraph (2) of this Subsection. 7 * * * 8 §1274.2. Administration of immunizations and vaccines; requirements 9 Prior to administering an immunization or a vaccine to a patient, a physician 10 shall provide to the patient, or, if the patient is a minor, the parent or guardian of the 11 patient, thorough information in writing, verbally, or electronically concerning the 12 immunization or vaccine that addresses, at minimum, all of the following: 13 (1) The diseases or conditions that the immunization or vaccine is intended 14 to prevent or treat. 15 (2) The effectiveness of the immunization or vaccine. 16 (3) Any contraindications associated with the immunization or vaccine. 17 (4) The possible side effects of the immunization or vaccine. 18 (5) The ingredients of the immunization or vaccine. 19 (6) Instructions for submitting a report to the Vaccine Adverse Event 20 Reporting System, the cooperative program of the United States Centers for Disease 21 Control and Prevention and the United States Food and Drug Administration for 22 vaccine safety, or its successor program. 23 * * * 24 §1360.31.1. Administration of immunizations and vaccines; requirements 25 Prior to administering an immunization or a vaccine to a patient, a physician 26 assistant shall provide to the patient, or, if the patient is a minor, the parent or 27 guardian of the patient, thorough information in writing, verbally, or electronically 28 concerning the immunization or vaccine that addresses, at minimum, all of the 29 following: Page 5 of 7 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 20RS-629 ORIGINAL HB NO. 467 1 (1) The diseases or conditions that the immunization or vaccine is intended 2 to prevent or treat. 3 (2) The effectiveness of the immunization or vaccine. 4 (3) Any contraindications associated with the immunization or vaccine. 5 (4) The possible side effects of the immunization or vaccine. 6 (5) The ingredients of the immunization or vaccine. 7 (6) Instructions for submitting a report to the Vaccine Adverse Event 8 Reporting System, the cooperative program of the United States Centers for Disease 9 Control and Prevention and the United States Food and Drug Administration for 10 vaccine safety, or its successor program. 11 Section 2. Part XIII-A of Chapter 11 of Title 40 of the Louisiana Revised Statutes 12of 1950, comprised of R.S. 40:2199.11, is hereby enacted to read as follows: 13 PART XIII-A. IMMUNIZATIONS AND VACCINES ADMINISTERED 14 AT LICENSED HEALTHCARE FACILITIES 15 §2199.11. Immunizations and vaccines administered at licensed healthcare 16 facilities; requirements 17 A. Each healthcare facility licensed by the Louisiana Department of Health 18 in accordance with the provisions of this Chapter at which immunizations or 19 vaccines are administered shall ensure that prior to the administration of an 20 immunization or a vaccine to a patient, the patient, or, if the patient is a minor, the 21 parent or guardian of the patient, is provided thorough information in writing, 22 verbally, or electronically concerning the immunization or vaccine that addresses, 23 at minimum, all of the following: 24 (1) The diseases or conditions that the immunization or vaccine is intended 25 to prevent or treat. 26 (2) The effectiveness of the immunization or vaccine. 27 (3) Any contraindications associated with the immunization or vaccine. 28 (4) The possible side effects of the immunization or vaccine. 29 (5) The ingredients of the immunization or vaccine. Page 6 of 7 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 20RS-629 ORIGINAL HB NO. 467 1 (6) Instructions for submitting a report to the Vaccine Adverse Event 2 Reporting System, the cooperative program of the United States Centers for Disease 3 Control and Prevention and the United States Food and Drug Administration for 4 vaccine safety, or its successor program. 5 B. The Louisiana Department of Health shall promulgate all such rules in 6 accordance with the Administrative Procedure Act as are necessary to implement the 7 provisions of this Part. DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] HB 467 Original 2020 Regular Session Amedee Abstract: Requires the provision of information to patients, or parents of patients who are minors, prior to the administration of an immunization or a vaccine and provides specifications for such information. Proposed law requires that prior to administering an immunization or a vaccine to a patient, the physician, physician assistant, registered nurse, practical nurse, or pharmacist administering the immunization or vaccine shall provide to the patient, or, if the patient is a minor, the parent or guardian of the patient, thorough information in writing, verbally, or electronically that addresses, at minimum, all of the following: (1)The diseases or conditions that the immunization or vaccine is intended to prevent or treat. (2)The effectiveness of the immunization or vaccine. (3)Any contraindications associated with the immunization or vaccine. (4)The possible side effects of the immunization or vaccine. (5)The ingredients of the immunization or vaccine. (6)Instructions for submitting a report to the federally managed Vaccine Adverse Event Reporting System. Proposed law requires all healthcare facilities licensed by the La. Department of Health at which immunizations or vaccines are administered to ensure that prior to the administration of an immunization or a vaccine to a patient, the patient, or, if the patient is a minor, the parent or guardian of the patient, is provided thorough information in writing, verbally, or electronically concerning the immunization or vaccine that addresses, at minimum, all of the factors enumerated above. (Amends R.S. 37:1218(3) and 1218.1(A); Adds R.S. 37:936, 980, 1218(6), 1274.2, and 1360.31.1 and R.S. 40:2199.11) Page 7 of 7 CODING: Words in struck through type are deletions from existing law; words underscored are additions.