| 47 | | - | SECTION 1. The legislature finds that on May 8, 2020, the Centers for Disease Control and Prevention reported that "the identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine preventable diseases" and suggested that a decrease in rates of routine childhood vaccinations were due to changes in health care access, social distancing, and other coronavirus disease 2019 (COVID-19) pandemic mitigation strategies. The legislature also finds that during the 2018-2019 flu season, nearly a third of all adult influenza vaccines were provided at a community pharmacy. Pharmacies are vital to the State's health care system because of their convenient points of access in their communities. Additionally, pharmacists are trusted health care professionals who have established relationships with their patients and often offer extended hours and added convenience. Pharmacists are well positioned to increase access to vaccinations, particularly in medically underserved areas or for certain populations who have a limited number of pediatricians or primary care providers. The legislature further finds that amendments made to the federal Public Readiness and Emergency Preparedness Act, Pub. L. 109-148, division C (PREP Act), during the COVID-19 pandemic authorized pharmacists and pharmacy interns to administer vaccines to persons three years of age or older. This authorization is currently slated to end on December 31, 2024. Prior to the amendments made to the PREP Act, Hawaii law only authorized pharmacists to administer a limited number of vaccines to children between the ages of eleven and seventeen and required a valid prescription before the vaccine could be administered. The legislature finds that permanently codifying in state law the amendments to the PREP Act that authorize pharmacists to vaccinate persons three years of age or older will continue to allow and expand the role of trained and certified pharmacists to administer vaccines to their communities in Hawaii. Additionally, as the department of health has ceased offering flu vaccinations for school-aged children at department schools, permanently authorizing pharmacists to vaccinate persons three years of age or older will ensure these children continue to be protected against influenza and other highly contagious diseases. Accordingly, the purpose of this Act is to: (1) Authorize licensed pharmacists to administer vaccines to persons three years of age or older; (2) Authorize pharmacy interns and pharmacy technicians under the direct supervision of a pharmacist to administer vaccines to persons three years of age or older, if certain requirements are met; and (3) Authorize licensed pharmacists to order the administration of vaccines for persons three years of age or older. SECTION 2. Section 461-1, Hawaii Revised Statutes, is amended by amending the definition of "practice of pharmacy" to read as follows: ""Practice of pharmacy" means: (1) The interpretation and evaluation of prescription orders; the compounding, dispensing, and labeling of drugs and devices (except labeling by a manufacturer, packer, or distributor of nonprescription drugs and commercially legend drugs and devices); the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records therefor; the responsibility for advising when necessary or where regulated, of therapeutic values, content, hazards, and use of drugs and devices; and the interpretation and evaluation of prescription orders to adjust the supply dispensed for purposes of medication synchronization pursuant to section 431:10A-606, 432:1-621, or 432D-30; (2) Performing the following procedures or functions as part of the care provided by and in concurrence with a ["health care facility"] health care facility and ["health care service"] health care service as defined in section 323D-2; [or a "pharmacy"; or a] pharmacy; licensed physician, [a] licensed physician assistant, or [a] licensed advanced practice registered nurse with prescriptive authority; or [a "managed care plan"] managed care plan as defined in section 432E-1, in accordance with policies, procedures, or protocols developed collaboratively by health professionals, including physicians and surgeons, pharmacists, physician assistants, and registered nurses, and for which a pharmacist has received appropriate training required by these policies, procedures, or protocols: (A) Ordering or performing routine drug therapy related patient assessment procedures; (B) Ordering drug therapy related laboratory tests; (C) Initiating emergency contraception oral drug therapy in accordance with a written collaborative agreement approved by the board, between a licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority and a pharmacist who has received appropriate training that includes programs approved by the Accreditation Council for Pharmacy Education (ACPE), curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board; (D) Administering drugs orally, topically, by intranasal delivery, or by injection, pursuant to the order of the patient's licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority, by a pharmacist having appropriate training that includes programs approved by the ACPE, curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board; (E) Administering[: (i) Immunizations] immunizations orally, by injection, or by intranasal delivery, to persons [eighteen] three years of age or older by a pharmacist having appropriate training that includes programs approved by the ACPE, curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board[; (ii) Vaccines to persons between fourteen and seventeen years of age pursuant to section 461-11.4; and (iii) Human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, and influenza vaccines to persons between eleven and seventeen years of age] pursuant to section 461-11.4; (F) As authorized by the written instructions of a licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority, initiating or adjusting the drug regimen of a patient pursuant to an order or authorization made by the patient's licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority and related to the condition for which the patient has been seen by the licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority; provided that the pharmacist shall issue written notification to the patient's licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority or enter the appropriate information in an electronic patient record system shared by the licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority, within twenty-four hours; (G) Transmitting a valid prescription to another pharmacist for the purpose of filling or dispensing; (H) Providing consultation, information, or education to patients and health care professionals based on the pharmacist's training and for which no other licensure is required; or (I) Prescribing and dispensing an opioid antagonist pursuant to section 461-11.8; (3) The offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of pharmacy; (4) Prescribing and dispensing contraceptive supplies pursuant to section 461-11.6; and (5) Notwithstanding any other law to the contrary, and in accordance with the requirements of section 461-11.2, ordering, performing, and reporting the results of the following CLIA-waived tests: (A) Blood glucose; (B) Hemoglobin A1C; (C) Hepatitis C; (D) Human immunodeficiency virus; (E) Influenza; (F) Respiratory syncytial virus; (G) SARS-CoV-2; or (H) Streptococcal pharyngitis." SECTION 3. Section 461-8, Hawaii Revised Statutes, is amended by amending subsection (e) to read as follows: "(e) A pharmacist who administers any vaccine to persons [between the ages of fourteen and seventeen years or administers the human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, or influenza vaccine to persons between eleven and seventeen years of age] three years of age or older pursuant to section 461-11.4 shall complete a training program approved by the board within every other biennial renewal period and submit proof of successful completion of the training program to the board[; provided that the pharmacist shall meet these requirements prior to] before administering any vaccine to persons [between the ages of fourteen and seventeen years or administering the human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, or influenza vaccine to persons between eleven and seventeen years of age.] three years of age or older." SECTION 4. Section 461-11.4, Hawaii Revised Statutes, is amended by amending subsections (a) through (d) to read as follows: "(a) A pharmacist, pharmacy intern, or pharmacy technician under the direct supervision of a pharmacist may administer[: (1) A vaccine to persons between fourteen and seventeen years of age pursuant to a valid prescription; and (2) A human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, or influenza vaccine to persons between eleven and seventeen years of age pursuant to a valid prescription. The pharmacist] a vaccine to a person three years of age or older; provided that: (1) The vaccine is authorized or approved by the United States Food and Drug Administration; (2) The vaccine has been ordered by a pharmacist and administered in accordance with the recommendations of the Advisory Committee on Immunization Practices of the United States Department of Health and Human Services; (3) The pharmacy intern or pharmacy technician has completed a practical training program approved by the Accreditation Council for Pharmacy Education that includes hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency responses to vaccines; (4) The pharmacy technician has a Certified Pharmacy Technician certification from either the Pharmacy Technician Certification Board or National Healthcareer Association; (5) The pharmacist, pharmacy intern, or pharmacy technician has a current certificate in basic cardiopulmonary resuscitation; (6) The pharmacist has completed a minimum of two credit hours in immunization-related continuing education courses during each licensing biennium; (7) The pharmacist is in compliance with all applicable recordkeeping and reporting requirements, including complying with adverse events reporting requirements; (8) The pharmacist, pharmacy intern, or pharmacy technician has reviewed the patient's vaccination records before administering the vaccine; (9) The pharmacist has informed the patient and the patient's primary guardian or caregiver of the importance of a well-child visit with a pediatrician or other licensed primary care provider and has referred the patient as appropriate; and (10) Where a prescription has been ordered by a person other than the pharmacist, the pharmacist, pharmacy intern, or pharmacy technician shall verify that the prescriber or the prescriber's authorized agent is the patient's medical home. (b) After the vaccination is administered, the pharmacist, pharmacy intern, or pharmacy technician under the direct supervision of a pharmacist shall immediately provide to the patient a vaccination record including the following information: (1) The patient's name and date of birth; (2) The type of vaccine administered; and (3) The date and location that the vaccine was administered. (c) The pharmacist, pharmacy intern, or pharmacy technician under the direct supervision of a pharmacist shall make a good faith effort to provide within seventy-two hours to the medical home and within five business days to the department of health immunization registry the same information provided to the patient pursuant to subsection (b) as well as the following: (1) The name of the vaccine product that was administered, including the manufacturer, lot number, and expiration date; (2) The method of administration; and (3) The anatomical site of administration. (d) [All] In addition to the requirements of subsection (a), all pharmacists, pharmacy interns, and pharmacy technicians under the direct supervision of a pharmacist who administer vaccines to persons [between the ages of fourteen and seventeen years or administer human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, and influenza vaccines to persons between the ages of eleven and seventeen years] three years of age or older shall complete a training program approved by the Accreditation Council of Pharmacy Education for which a certificate of completion is issued. The pharmacist, pharmacy intern, or pharmacy technician shall complete the training program and submit the completion certificate for the training program to the board [prior to] before administering any vaccine to persons [between the ages of fourteen and seventeen years and prior to administering any human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, or influenza vaccine to persons between the ages of eleven and seventeen years.] three years of age or older." SECTION 5. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored. SECTION 6. This Act shall take effect on July 1, 3000. |
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| 47 | + | SECTION 1. The legislature finds that on May 8, 2020, the Centers for Disease Control and Prevention reported that "the identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine preventable diseases" and suggested that a decrease in rates of routine childhood vaccinations were due to changes in health care access, social distancing, and other coronavirus disease 2019 (COVID-19) pandemic mitigation strategies. The legislature also finds that during the 2018-2019 flu season, nearly a third of all adult influenza vaccines were provided at a community pharmacy. Pharmacies are vital to the State's health care system because of their convenient points of access in their communities. Additionally, pharmacists are trusted health care professionals who have established relationships with their patients and often offer extended hours and added convenience. Pharmacists are well positioned to increase access to vaccinations, particularly in medically underserved areas or for certain populations who have a limited number of pediatricians or primary care providers. The legislature further finds that amendments made to the federal Public Readiness and Emergency Preparedness Act, Pub. L. 109-148, division C (PREP Act), during the COVID-19 pandemic authorized pharmacists and pharmacy interns to administer vaccines to children between the ages of three and seventeen. This authorization is currently slated to end on December 31, 2024. Prior to the amendments made to the PREP Act, Hawaii law only authorized pharmacists to administer a limited number of vaccines to children between the ages of eleven and seventeen and required a valid prescription before the vaccine could be administered. The legislature finds that permanently codifying in state law the amendments to the PREP Act that authorize pharmacists to vaccinate children between the ages of three and seventeen will continue to allow and expand the role of trained and certified pharmacists to administer vaccines to their communities in Hawaii. Additionally, as the department of health has ceased offering flu vaccinations for school-aged children at department schools, permanently authorizing pharmacists to vaccinate children between the ages of three and seventeen will ensure these children continue to be protected against influenza and other highly contagious diseases. Accordingly, the purpose of this Act is to: (1) Authorize licensed pharmacists to administer vaccines to persons three years of age or older; (2) Authorize pharmacy interns and pharmacy technicians under the direct supervision of a pharmacist to administer vaccines to persons between the ages of three and seventeen, if certain requirements are met; and (3) Authorize licensed pharmacists to order the administration of vaccines for persons between the ages of three and seventeen. SECTION 2. Section 461-1, Hawaii Revised Statutes, is amended by amending the definition of "practice of pharmacy" to read as follows: ""Practice of pharmacy" means: (1) The interpretation and evaluation of prescription orders; the compounding, dispensing, and labeling of drugs and devices (except labeling by a manufacturer, packer, or distributor of nonprescription drugs and commercially legend drugs and devices); the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records therefor; the responsibility for advising when necessary or where regulated, of therapeutic values, content, hazards, and use of drugs and devices; and the interpretation and evaluation of prescription orders to adjust the supply dispensed for purposes of medication synchronization pursuant to section 431:10A-606, 432:1-621, or 432D-30; (2) Performing the following procedures or functions as part of the care provided by and in concurrence with a ["health care facility"] health care facility and ["health care service"] health care service as defined in section 323D-2; [or a "pharmacy"; or a] pharmacy; licensed physician, [a] licensed physician assistant, or [a] licensed advanced practice registered nurse with prescriptive authority; or [a "managed care plan"] managed care plan as defined in section 432E-1, in accordance with policies, procedures, or protocols developed collaboratively by health professionals, including physicians and surgeons, pharmacists, physician assistants, and registered nurses, and for which a pharmacist has received appropriate training required by these policies, procedures, or protocols: (A) Ordering or performing routine drug therapy related patient assessment procedures; (B) Ordering drug therapy related laboratory tests; (C) Initiating emergency contraception oral drug therapy in accordance with a written collaborative agreement approved by the board, between a licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority and a pharmacist who has received appropriate training that includes programs approved by the Accreditation Council for Pharmacy Education (ACPE), curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board; (D) Administering drugs orally, topically, by intranasal delivery, or by injection, pursuant to the order of the patient's licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority, by a pharmacist having appropriate training that includes programs approved by the ACPE, curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board; (E) Administering[: (i) Immunizations] immunizations orally, by injection, or by intranasal delivery, to persons [eighteen] three years of age or older by a pharmacist having appropriate training that includes programs approved by the ACPE, curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board[; (ii) Vaccines to persons between fourteen and seventeen years of age pursuant to section 461-11.4; and (iii) Human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, and influenza vaccines to persons between eleven and seventeen years of age] pursuant to section 461-11.4; (F) As authorized by the written instructions of a licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority, initiating or adjusting the drug regimen of a patient pursuant to an order or authorization made by the patient's licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority and related to the condition for which the patient has been seen by the licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority; provided that the pharmacist shall issue written notification to the patient's licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority or enter the appropriate information in an electronic patient record system shared by the licensed physician, physician assistant, or advanced practice registered nurse with prescriptive authority, within twenty-four hours; (G) Transmitting a valid prescription to another pharmacist for the purpose of filling or dispensing; (H) Providing consultation, information, or education to patients and health care professionals based on the pharmacist's training and for which no other licensure is required; or (I) Prescribing and dispensing an opioid antagonist pursuant to section 461-11.8; (3) The offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of pharmacy; (4) Prescribing and dispensing contraceptive supplies pursuant to section 461-11.6; and (5) Notwithstanding any other law to the contrary, and in accordance with the requirements of section 461-11.2, ordering, performing, and reporting the results of the following CLIA-waived tests: (A) Blood glucose; (B) Hemoglobin A1C; (C) Hepatitis C; (D) Human immunodeficiency virus; (E) Influenza; (F) Respiratory syncytial virus; (G) SARS-CoV-2; or (H) Streptococcal pharyngitis." SECTION 3. Section 461-8, Hawaii Revised Statutes, is amended by amending subsection (e) to read as follows: "(e) A pharmacist who administers any vaccine to persons between the ages of [fourteen] three and seventeen years [or administers the human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, or influenza vaccine to persons between eleven and seventeen years of age] pursuant to section 461-11.4 shall complete a training program approved by the board within every other biennial renewal period and submit proof of successful completion of the training program to the board[; provided that the pharmacist shall meet these requirements prior to] before administering any vaccine to persons between the ages of [fourteen] three and seventeen years [or administering the human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, or influenza vaccine to persons between eleven and seventeen years of age]." SECTION 4. Section 461-11.4, Hawaii Revised Statutes, is amended by amending subsections (a) through (d) to read as follows: "(a) A pharmacist, pharmacy intern, or pharmacy technician under the direct supervision of a pharmacist may administer[: (1) A vaccine to persons between fourteen and seventeen years of age pursuant to a valid prescription; and (2) A human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, or influenza vaccine to persons between eleven and seventeen years of age pursuant to a valid prescription. The pharmacist] a vaccine to a person between three and seventeen years of age; provided that: (1) The vaccine is authorized or approved by the United States Food and Drug Administration; (2) The vaccine has been ordered by a pharmacist and administered in accordance with the recommendations of the Advisory Committee on Immunization Practices of the United States Department of Health and Human Services; (3) The pharmacy intern or pharmacy technician has completed a practical training program approved by the Accreditation Council for Pharmacy Education that includes hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency responses to vaccines; (4) The pharmacy intern or pharmacy technician has a Certified Pharmacy Technician certification from either the Pharmacy Technician Certification Board or National Healthcareer Association; (5) The pharmacist, pharmacy intern, or pharmacy technician has a current certificate in basic cardiopulmonary resuscitation; (6) The pharmacist has completed a minimum of two credit hours in immunization-related continuing education courses during each licensing biennium; (7) The pharmacist is in compliance with all applicable recordkeeping and reporting requirements, including complying with adverse events reporting requirements; (8) The pharmacist, pharmacy intern, or pharmacy technician has reviewed the patient's vaccination records before administering the vaccine; (9) The pharmacist has informed the patient and the patient's primary guardian or caregiver of the importance of a well-child visit with a pediatrician or other licensed primary care provider and has referred the patient as appropriate; and (10) Where a prescription has been ordered by a person other than the pharmacist, the pharmacist, pharmacy intern, or pharmacy technician shall verify that the prescriber or the prescriber's authorized agent is the patient's medical home. (b) After the vaccination is administered, the pharmacist, pharmacy intern, or pharmacy technician under the direct supervision of a pharmacist shall immediately provide to the patient a vaccination record including the following information: (1) The patient's name and date of birth; (2) The type of vaccine administered; and (3) The date and location that the vaccine was administered. (c) The pharmacist, pharmacy intern, or pharmacy technician under the direct supervision of a pharmacist shall make a good faith effort to provide within seventy-two hours to the medical home and within five business days to the department of health immunization registry the same information provided to the patient pursuant to subsection (b) as well as the following: (1) The name of the vaccine product that was administered, including the manufacturer, lot number, and expiration date; (2) The method of administration; and (3) The anatomical site of administration. (d) [All] In addition to the requirements of subsection (a), all pharmacists, pharmacy interns, and pharmacy technicians under the direct supervision of a pharmacist who administer vaccines to persons between the ages of [fourteen] three and seventeen years [or administer human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, and influenza vaccines to persons between the ages of eleven and seventeen years] shall complete a training program approved by the Accreditation Council of Pharmacy Education for which a certificate of completion is issued. The pharmacist, pharmacy intern, or pharmacy technician shall complete the training program and submit the completion certificate for the training program to the board [prior to] before administering any vaccine to persons between the ages of [fourteen] three and seventeen years [and prior to administering any human papillomavirus, Tdap (tetanus, diphtheria, pertussis), meningococcal, or influenza vaccine to persons between the ages of eleven and seventeen years]." SECTION 5. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored. SECTION 6. This Act shall take effect on July 1, 3000. |
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