Senate File 2322 - Introduced SENATE FILE 2322 BY COMMITTEE ON STATE GOVERNMENT (SUCCESSOR TO SSB 3146) A BILL FOR An Act relating to the practice of pharmacy, including the 1 administration of certain drugs and vaccines and the 2 establishment of technician product verification programs. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 5378SV (1) 87 ss/rh
S.F. 2322 Section 1. Section 147.107, subsection 2, Code 2018, is 1 amended to read as follows: 2 2. a. A pharmacist, physician, dentist, podiatric 3 physician, or prescribing psychologist who dispenses 4 prescription drugs, including but not limited to controlled 5 substances, for human use, may delegate nonjudgmental 6 dispensing functions to staff assistants only when verification 7 of the accuracy and completeness of the dispensing is 8 determined by the pharmacist or practitioner in the 9 pharmacist’s or practitioner’s physical presence. However, the 10 physical presence requirement does not apply when a pharmacist 11 or practitioner is utilizing an automated dispensing system ; 12 when a pharmacist is utilizing a tech-check-tech program, as 13 defined in section 155A.3 ; or when a pharmacist is remotely 14 supervising a certified pharmacy technician practicing 15 at a telepharmacy site approved by the board of pharmacy . 16 When using an automated dispensing system , the pharmacist 17 or practitioner shall utilize an internal quality control 18 assurance plan that ensures accuracy for dispensing. When 19 using a tech-check-tech program or when remotely supervising 20 a certified pharmacy technician practicing at an approved 21 telepharmacy site, the pharmacist shall utilize an internal 22 quality control assurance plan, in accordance with rules 23 adopted by the board of pharmacy, that ensures accuracy 24 for dispensing. Verification of automated dispensing , 25 tech-check-tech, and telepharmacy practice accuracy and 26 completeness remains the responsibility of the pharmacist 27 or practitioner and shall be determined in accordance with 28 rules adopted by the board of pharmacy, the board of medicine, 29 the dental board, the board of podiatry, and the board of 30 psychology for their respective licensees. 31 b. A dentist, physician, podiatric physician, or prescribing 32 psychologist who dispenses prescription drugs, other than drug 33 samples, pursuant to this subsection , shall report the fact 34 that they dispense prescription drugs with the practitioner’s 35 -1- LSB 5378SV (1) 87 ss/rh 1/ 7
S.F. 2322 respective board at least biennially. 1 c. A physician, dentist, podiatric physician, or prescribing 2 psychologist who dispenses prescription drugs, other than drug 3 samples, pursuant to this subsection , shall offer to provide 4 the patient with a written prescription that may be dispensed 5 from a pharmacy of the patient’s choice or offer to transmit 6 the prescription orally, electronically, or by facsimile in 7 accordance with section 155A.27 to a pharmacy of the patient’s 8 choice. 9 d. A pharmacist who dispenses prescription drugs, including 10 but not limited to controlled substances, for human use, may 11 delegate nonjudgmental dispensing functions to a certified 12 pharmacy technician only when verification of the accuracy and 13 completeness of the dispensing is determined by the pharmacist 14 in the pharmacist’s physical presence. The pharmacist’s 15 verification of the accuracy of the prescription drug dispensed 16 shall not be required when verified by a certified pharmacy 17 technician in a technician product verification program or a 18 tech-check-tech program as defined in section 155A.3. The 19 pharmacist’s physical presence shall not be required when 20 the pharmacist is remotely supervising pharmacy personnel 21 operating in an approved telepharmacy site or when utilizing 22 an automated dispensing system that utilizes an internal 23 quality control assurance plan. When utilizing a technician 24 product verification program or tech-check-tech program, or 25 when remotely supervising pharmacy personnel operating at an 26 approved telepharmacy site, the pharmacist shall utilize an 27 internal quality control assurance plan, in accordance with 28 rules adopted by the board of pharmacy, that ensures accuracy 29 for dispensing. Automated dispensing verification, technician 30 product verification, and telepharmacy practice accuracy and 31 completeness remains the responsibility of the pharmacist and 32 shall be determined in accordance with rules adopted by the 33 board of pharmacy. 34 Sec. 2. Section 155A.3, Code 2018, is amended by adding the 35 -2- LSB 5378SV (1) 87 ss/rh 2/ 7
S.F. 2322 following new subsections: 1 NEW SUBSECTION . 42A. “Statewide protocol” means a framework 2 developed and issued by the board that specifies the conditions 3 under which pharmacists are authorized to dispense a medication 4 or category of medications when providing a clinical service. 5 NEW SUBSECTION . 43A. “Technician product verification” 6 means the process by which a certified pharmacy technician 7 provides the final product verification for prescription 8 drugs or devices filled or prepared by a registered pharmacy 9 technician, pharmacist-intern, or with an automated dispensing 10 system. 11 Sec. 3. Section 155A.6A, subsection 4, Code 2018, is amended 12 to read as follows: 13 4. The board shall adopt rules in accordance with 14 chapter 17A on matters pertaining to pharmacy technician 15 registration, application, forms, renewals, fees, termination 16 of registration, tech-check-tech programs, technician product 17 verification programs, national certification, training, and 18 any other relevant matters. 19 Sec. 4. Section 155A.33, Code 2018, is amended to read as 20 follows: 21 155A.33 Delegation of technical functions. 22 A pharmacist may delegate technical dispensing functions 23 to pharmacy technicians, but only if the pharmacist is 24 physically present to verify the accuracy and completeness 25 of the patient’s prescription prior to the delivery of the 26 prescription to the patient or the patient’s representative. 27 However, the physical presence requirement does not apply 28 when a pharmacist is utilizing an automated dispensing system 29 or a tech-check-tech technician product verification program 30 or when a pharmacist is remotely supervising a certified 31 pharmacy technician practicing at a telepharmacy site approved 32 by the board. When using an automated dispensing system or 33 a tech-check-tech technician product verification program, 34 or when remotely supervising a certified pharmacy technician 35 -3- LSB 5378SV (1) 87 ss/rh 3/ 7
S.F. 2322 practicing at an approved telepharmacy site, the pharmacist 1 shall utilize an internal quality control assurance plan that 2 ensures accuracy for dispensing. Verification of automated 3 dispensing, tech-check-tech technician product verification , 4 and telepharmacy practice accuracy and completeness remains the 5 responsibility of the pharmacist and shall be determined in 6 accordance with rules adopted by the board. 7 Sec. 5. NEW SECTION . 155A.33A Technician product 8 verification programs. 9 1. A pharmacist in charge of a pharmacy located in this 10 state may formally establish a technician product verification 11 program to optimize the provision of pharmacist patient care 12 services. The board shall require a pharmacist in charge 13 intending to implement a technician product verification 14 program to submit a program plan for board consideration and 15 approval. The plan shall demonstrate that onsite practice 16 hours for a pharmacist will not be reduced but will be 17 redistributed directly to patient care activities. 18 2. The board shall adopt rules for the development, 19 implementation, and oversight of technician product 20 verification programs. The rules shall address program policy 21 and procedures, pharmacist and pharmacy technician training, 22 program quality assurance and evaluation, recordkeeping, 23 redistribution of pharmacist activities, and other matters 24 necessary for the development, implementation, and oversight 25 of the program. 26 Sec. 6. NEW SECTION . 155A.46 Statewide protocols. 27 1. a. A pharmacist may, pursuant to statewide protocols 28 developed by the board in consultation with the department 29 of public health and consistent with subsection 2, order and 30 administer the following to patients ages eighteen years and 31 older: 32 (1) Naloxone. 33 (2) Nicotine replacement tobacco cessation products. 34 (3) An immunization or vaccination recommended by the 35 -4- LSB 5378SV (1) 87 ss/rh 4/ 7
S.F. 2322 United States centers for disease control and prevention 1 advisory committee on immunization practices in its approved 2 vaccination schedule for adults. 3 (4) An immunization or vaccination recommended by the 4 United States centers for disease control and prevention for 5 international travel. 6 (5) A Tdap (tetanus, diphtheria, acellular pertussis) 7 vaccination in a booster application. 8 (6) Other emergency immunizations or vaccinations in 9 response to a public health emergency. 10 b. A pharmacist may, pursuant to statewide protocols 11 developed by the board in consultation with the department 12 of public health and consistent with subsection 2, order and 13 administer the following to patients ages six months and older: 14 (1) A vaccine or immunization for influenza. 15 (2) Other emergency immunizations or vaccines in response 16 to a public health emergency. 17 c. A pharmacist may, pursuant to statewide protocols 18 developed by the board in consultation with the department 19 of public health and consistent with subsection 2, order and 20 administer the final two doses in a course of vaccinations for 21 HPV to patients ages eleven years and older. 22 d. Prior to the ordering and administration of a vaccination 23 or immunization authorized by this subsection, pursuant to 24 statewide protocols, a licensed pharmacist shall consult 25 and review the statewide immunization registry or health 26 information network. The board shall adopt rules requiring the 27 reporting of the administration of vaccines and immunizations 28 authorized by this subsection to a patient’s primary health 29 care provider, primary physician, and a statewide immunization 30 registry or health information network. 31 2. A pharmacist administering a prescription drug, product, 32 test, or treatment pursuant to subsection 1 shall do all of the 33 following: 34 a. Maintain a record of all prescription drugs, products, 35 -5- LSB 5378SV (1) 87 ss/rh 5/ 7
S.F. 2322 tests, and treatments administered pursuant to this section. 1 b. Notify the patient’s primary health care provider 2 of any prescription drugs, products, tests, or treatments 3 administered to the patient, or enter such information in a 4 patient record system also used by the primary health care 5 provider, as permitted by the primary health care provider. If 6 the patient does not have a primary health care provider, the 7 pharmacist shall provide the patient with a written record of 8 the prescription drugs, products, tests, or treatment provided 9 to the patient and shall advise the patient to consult a 10 physician. 11 c. Complete annual continuing pharmacy education related to 12 administration protocols recognized and approved by the board. 13 Sec. 7. REPEAL. Sections 155A.34 and 155A.44, Code 2018, 14 are repealed. 15 EXPLANATION 16 The inclusion of this explanation does not constitute agreement with 17 the explanation’s substance by the members of the general assembly. 18 This bill alters the practice of pharmacy by modifying 19 the circumstances under which a pharmacist can delegate 20 prescription verification duties to employees. The bill 21 also permits pharmacists to prescribe and administer certain 22 medications and treatments. 23 The bill creates a technician product verification program 24 by which a pharmacist can instruct a pharmacy technician 25 to verify the accuracy of any dispensed prescriptions and 26 undertake other technical functions for the purpose of 27 allowing the pharmacist to spend more time on patient care 28 activities. The bill directs the board of pharmacy to adopt 29 rules establishing the requirements for technician product 30 verification programs. 31 The bill also permits pharmacists to order and administer 32 to a person 18 years of age or older naloxone, nicotine 33 replacement, tobacco cessation products, immunizations 34 or vaccinations recommended by the United States centers 35 -6- LSB 5378SV (1) 87 ss/rh 6/ 7
S.F. 2322 for disease control and prevention advisory committee on 1 immunization practices in its approved vaccination schedule 2 for adults, immunizations recommended by the United States 3 centers for disease control and prevention for international 4 travel, Tdap vaccinations in booster applications, and other 5 emergency immunizations or vaccinations in response to a 6 public health emergency, pursuant to statewide protocols 7 adopted by the board of pharmacy in consultation with the 8 department of public health. A pharmacist may also administer, 9 pursuant to statewide protocols, to patients six months of 10 age or older a vaccine or immunization for influenza and 11 other emergency immunizations or vaccinations in response to 12 a public health emergency. A pharmacist may administer to 13 patients 11 years of age or older the final two doses in a 14 course of vaccinations for HPV pursuant to statewide protocols. 15 A pharmacist must keep a record of all prescription drugs, 16 products, and treatments administered, notify the patient’s 17 primary health care provider or provide a written record to the 18 patient, consult the statewide immunization registry or health 19 information network, and complete annual continuing pharmacy 20 education related to the protocols adopted by the board. 21 -7- LSB 5378SV (1) 87 ss/rh 7/ 7