House Study Bill 533 - Introduced SENATE/HOUSE FILE _____ BY (PROPOSED BOARD OF PHARMACY BILL) A BILL FOR An Act relating to the practice of pharmacy, and providing for 1 a repeal. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 5383DP (8) 88 pf/rh
S.F. _____ H.F. _____ DIVISION I 1 PHARMACY TECHNICIAN REGISTRATION 2 Section 1. Section 147.107, subsection 2, paragraph d, Code 3 2020, is amended to read as follows: 4 d. A pharmacist who dispenses prescription drugs, including 5 but not limited to controlled substances, for human use, 6 may delegate nonjudgmental dispensing functions only when 7 verification of the accuracy and completeness of the dispensing 8 is determined by the pharmacist in the pharmacist’s physical 9 presence. The pharmacist’s verification of the accuracy of the 10 prescription drug dispensed shall not be required when verified 11 by a certified pharmacy technician in a technician product 12 verification program or a tech-check-tech program as defined 13 in section 155A.3 . The pharmacist’s physical presence shall 14 not be required when the pharmacist is remotely supervising 15 pharmacy personnel operating in an approved a licensed 16 telepharmacy site or when utilizing an automated dispensing 17 system that utilizes an internal quality control assurance 18 plan. When utilizing a technician product verification program 19 or tech-check-tech program , or when remotely supervising 20 pharmacy personnel operating at an approved a licensed 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 for 24 dispensing. Automated dispensing verification, technician 25 product verification, and telepharmacy practice accuracy and 26 completeness remains the responsibility of the pharmacist and 27 shall be determined in accordance with rules adopted by the 28 board of pharmacy. 29 Sec. 2. Section 155A.3, subsection 46, Code 2020, is amended 30 by striking the subsection. 31 Sec. 3. Section 155A.6A, subsections 3 and 4, Code 2020, are 32 amended to read as follows: 33 3. A person who is in the process of acquiring national 34 certification as a pharmacy technician and who is in training 35 -1- LSB 5383DP (8) 88 pf/rh 1/ 10
S.F. _____ H.F. _____ to become a pharmacy technician shall register with the board 1 as a pharmacy technician. The registration shall be issued for 2 a period not to exceed one year and shall not be renewable. 3 4. The board shall adopt rules in accordance with 4 chapter 17A on matters pertaining to pharmacy technician 5 registration, application, forms, renewals, fees, termination 6 of registration, tech-check-tech programs, technician product 7 verification programs, national certification, training, and 8 any other relevant matters. 9 Sec. 4. Section 155A.33, Code 2020, is amended to read as 10 follows: 11 155A.33 Delegation of technical functions. 12 A pharmacist may delegate technical dispensing functions 13 to pharmacy technicians, but only if the pharmacist is 14 physically present to verify the accuracy and completeness 15 of the patient’s prescription prior to the delivery of the 16 prescription to the patient or the patient’s representative. 17 However, the physical presence requirement does not apply when 18 a pharmacist is utilizing an automated dispensing system or a 19 technician product verification program or when a pharmacist is 20 remotely supervising a certified pharmacy technician practicing 21 at a licensed telepharmacy site approved by the board . When 22 using an automated dispensing system or a technician product 23 verification program, or when remotely supervising a certified 24 pharmacy technician practicing at an approved a licensed 25 telepharmacy site, the pharmacist shall utilize an internal 26 quality control assurance plan that ensures accuracy for 27 dispensing. Verification of automated dispensing, technician 28 product verification, and telepharmacy practice accuracy and 29 completeness remains the responsibility of the pharmacist and 30 shall be determined in accordance with rules adopted by the 31 board. 32 DIVISION II 33 TELEPHARMACY PRACTICE 34 Sec. 5. Section 155A.13, subsection 3, Code 2020, is amended 35 -2- LSB 5383DP (8) 88 pf/rh 2/ 10
S.F. _____ H.F. _____ by adding the following new paragraph: 1 NEW PARAGRAPH . f. The board may adopt rules authorizing a 2 pharmacist or a certified pharmacy technician to supervise a 3 pharmacy support person registered pursuant to section 155A.6B 4 and working at a licensed telepharmacy site. 5 DIVISION III 6 OUTSOURCING FACILITY LICENSE 7 Sec. 6. Section 155A.13C, subsection 1, Code 2020, is 8 amended by adding the following new paragraph: 9 NEW PARAGRAPH . e. Submit evidence of a satisfactory 10 inspection conducted by the home state regulatory authority 11 or an entity approved by the board in the two-year period 12 immediately preceding the application which demonstrates 13 compliance with current good manufacturing practices. In 14 addition, the applicant shall submit evidence of correction of 15 all deficiencies discovered in such inspections and evidence of 16 compliance with all directives from the home state regulatory 17 authority or entity approved by the board. The board may 18 recover from an outsourcing facility, prior to the issuance 19 of a license or license renewal, the costs associated with 20 conducting an inspection by or on behalf of the board for 21 purposes of satisfying the requirements of this paragraph. 22 DIVISION IV 23 PRESCRIPTION ADAPTATION 24 Sec. 7. Section 155A.27, Code 2020, is amended by adding the 25 following new subsection: 26 NEW SUBSECTION . 8. A pharmacist, in exercising the 27 pharmacist’s professional judgment and acting in good faith to 28 meet the intent of the prescriber, may adapt a prescription for 29 a substance that is not a controlled substance in compliance 30 with this subsection. A pharmacist who adapts a prescription 31 in compliance with this subsection shall document the 32 adaptation in the patient’s record and notify the prescriber 33 of the adaptation. 34 a. No adaptation without prior consent. A pharmacist shall 35 -3- LSB 5383DP (8) 88 pf/rh 3/ 10
S.F. _____ H.F. _____ not adapt a prescription pursuant to this subsection without 1 prior consent of the prescriber if the prescriber has indicated 2 “no adaptation” on the prescription. 3 b. Quantity adaptation. A pharmacist may change the 4 quantity of the drug prescribed when deemed appropriate in 5 the professional judgment of the pharmacist including but not 6 limited to in any of the following situations: 7 (1) The prescribed quantity or package size is not 8 commercially available. 9 (2) The change in quantity is related to a change in dosage 10 form. 11 (3) The change in quantity is made to ensure the completion 12 of the prescriber’s intended duration of treatment. 13 (4) The change in quantity is made to extend a maintenance 14 drug for the limited quantity necessary to coordinate a 15 patient’s refills in a medication synchronization program. 16 c. Dosage form adaptation. A pharmacist may change 17 the dosage form of the drug prescribed if it is in the 18 best interest of patient care, as long as the prescriber’s 19 directions are also modified to equate to an equivalent amount 20 of drug dispensed as prescribed. 21 d. Completion of missing information. A pharmacist may 22 complete missing information on a prescription pursuant to 23 this subsection if there is sufficient evidence to support the 24 change. 25 e. Payment recoupment. A health benefit plan, as defined 26 in section 514J.102, a health carrier, as defined in section 27 514J.102, and a pharmacy benefits manager, as defined in 28 section 510B.1, shall not recoup payment from a pharmacy 29 following an audit on an otherwise valid prescription based 30 solely on a pharmacist’s adaptation of a prescription pursuant 31 to this subsection. 32 DIVISION V 33 EMERGENCY DISPENSING 34 Sec. 8. Section 155A.29, Code 2020, is amended to read as 35 -4- LSB 5383DP (8) 88 pf/rh 4/ 10
S.F. _____ H.F. _____ follows: 1 155A.29 Prescription refills. 2 1. Except as specified in subsection 2 or 3 , a prescription 3 for any prescription drug or device which is not a controlled 4 substance shall not be filled or refilled more than eighteen 5 months after the date on which the prescription was issued and 6 a prescription which is authorized to be refilled shall not be 7 refilled more than twelve times. 8 2. A pharmacist may exercise professional judgment by 9 refilling a prescription without prescriber authorization if 10 all of the following are true: 11 a. The pharmacist is unable to contact the prescriber after 12 reasonable effort efforts . 13 b. Failure to refill the prescription might result in 14 an interruption of therapeutic regimen or create patient 15 suffering. 16 c. The pharmacist informs the patient or the patient’s 17 representative at the time of dispensing, and the practitioner 18 at the earliest convenience that prescriber reauthorization is 19 required. 20 3. d. Prescriptions may be refilled once pursuant to this 21 subsection 2 for a period of time reasonably necessary for the 22 pharmacist to secure prescriber authorization. 23 3. a. In addition to the authorization for a pharmacist to 24 refill a prescription without prescriber authorization pursuant 25 to subsection 2, a pharmacist may exercise professional 26 judgment and refill a prescription for a chronic maintenance 27 drug without prescriber authorization if all of the following 28 are applicable: 29 (1) The pharmacist is unable, after reasonable efforts, to 30 obtain authorization from the prescriber or another health care 31 provider responsible for the patient’s care. 32 (2) In the pharmacist’s professional judgment, the refusal 33 to dispense the refill of the chronic maintenance drug will 34 endanger the patient’s life or health or will disrupt an 35 -5- LSB 5383DP (8) 88 pf/rh 5/ 10
S.F. _____ H.F. _____ essential drug therapy for a chronic condition of the patient. 1 b. The pharmacist may dispense an amount of the chronic 2 maintenance drug not to exceed the amount of the most recent 3 prescription or the standard quantity of the drug dispensed. 4 c. The pharmacist shall dispense the chronic maintenance 5 drug refill in accordance with standard procedures and 6 documentation requirements adopted by rule of the board. 7 d. For the purposes of this subsection, “chronic maintenance 8 drug” means a drug, other than a controlled substance, that is 9 prescribed to a patient to be taken on a recurring basis, and 10 is used as a life saving rescue drug for a chronic condition or 11 is essential to the continuation of drug therapy for a chronic 12 condition. 13 4. An authorization to refill a prescription drug order 14 shall be transmitted to a pharmacy by a prescriber or the 15 prescriber’s authorized agent pursuant to section 155A.27 , 16 except that prescription drug orders for controlled substances 17 shall be transmitted pursuant to section 124.308 , and, if not 18 transmitted directly by the practitioner, shall also include 19 the name and title of the practitioner’s agent completing the 20 transmission. 21 DIVISION VI 22 IMMUNIZATIONS 23 Sec. 9. Section 155A.46, subsection 1, paragraph d, Code 24 2020, is amended to read as follows: 25 d. Prior to the ordering and administration of a vaccination 26 non-influenza vaccine or immunization authorized by this 27 subsection , pursuant to statewide protocols, a licensed 28 pharmacist shall consult and review the statewide immunization 29 registry or health information network. The board shall 30 adopt rules requiring the reporting of the administration of 31 vaccines and immunizations authorized by this subsection to 32 a patient’s primary health care provider, primary physician, 33 and a statewide immunization registry or health information 34 network. A licensed pharmacist shall not be required to report 35 -6- LSB 5383DP (8) 88 pf/rh 6/ 10
S.F. _____ H.F. _____ to a statewide immunization registry or health information 1 network the administration of an influenza vaccine administered 2 to patients ages eighteen and older. 3 DIVISION VII 4 COLLABORATIVE PHARMACY PRACTICE 5 Sec. 10. Section 124.101, Code 2020, is amended by adding 6 the following new subsections: 7 NEW SUBSECTION . 4A. “Collaborative pharmacy practice” means 8 the same as defined in section 155A.3. 9 NEW SUBSECTION . 4B. “Collaborative pharmacy practice 10 agreement” means the same as defined in section 155A.3. 11 Sec. 11. Section 124.308, subsection 2, paragraph c, 12 subparagraph (7), Code 2020, is amended to read as follows: 13 (7) A prescription issued pursuant to an established and 14 valid collaborative pharmacy practice agreement, standing 15 order, or drug research protocol. 16 Sec. 12. NEW SECTION . 124.308A Collaborative pharmacy 17 practice. 18 Notwithstanding any provision to the contrary, a pharmacist 19 may engage in a collaborative pharmacy practice under a 20 collaborative pharmacy practice agreement to provide patient 21 care and drug therapy management services to a patient. 22 Sec. 13. Section 155A.3, Code 2020, is amended by adding the 23 following new subsections: 24 NEW SUBSECTION . 5A. “Collaborative pharmacy practice” means 25 a practice of pharmacy whereby a pharmacist provides patient 26 care and drug therapy management services, not otherwise 27 permitted to be performed by a pharmacist, to patients under a 28 collaborative pharmacy practice agreement. 29 NEW SUBSECTION . 5B. “Collaborative pharmacy practice 30 agreement” means a written agreement between one or more 31 pharmacists and one or more physicians, advanced registered 32 nurse practitioners, advanced practice registered nurses, or 33 dentists that provides for a collaborative pharmacy practice 34 and defines the nature, scope, conditions, and limitations of 35 -7- LSB 5383DP (8) 88 pf/rh 7/ 10
S.F. _____ H.F. _____ the patient care and drug therapy management services to be 1 provided by the pharmacist or pharmacists. 2 Sec. 14. Section 155A.27, subsection 2, paragraph b, 3 subparagraph (10), Code 2020, is amended to read as follows: 4 (10) A prescription issued pursuant to an established and 5 valid collaborative pharmacy practice agreement, standing 6 order, or drug research protocol. 7 Sec. 15. NEW SECTION . 155A.47 Collaborative pharmacy 8 practice. 9 Notwithstanding any provision to the contrary, a pharmacist 10 may engage in a collaborative pharmacy practice under a 11 collaborative pharmacy practice agreement to provide patient 12 care and drug therapy management services to a patient. 13 DIVISION VIII 14 PHARMACY PILOT OR DEMONSTRATION RESEARCH PROJECTS 15 Sec. 16. NEW SECTION . 155A.48 Pilot or demonstration 16 research projects. 17 1. Notwithstanding any provision of section 147.107, 18 subsection 2, or section 155A.33 to the contrary, the board may 19 approve a pilot or demonstration research project of innovative 20 applications in the practice of pharmacy to provide enhanced 21 patient care. 22 2. The board shall adopt rules pursuant to chapter 17A for 23 application for and approval of such projects. The rules may 24 include exceptions to any existing rules under the purview 25 of the board as necessary for completion of the project, 26 limited to the duration of the project. The board may approve 27 a project for no more than eighteen months. The board may 28 extend or renew a project in accordance with board rules. All 29 projects shall comply with the rules adopted for such projects. 30 3. The board shall not approve any project that expands the 31 practice of pharmacy as defined in section 155A.3. 32 Sec. 17. REPEAL. 2011 Iowa Acts, chapter 63, section 36, 33 is repealed. 34 EXPLANATION 35 -8- LSB 5383DP (8) 88 pf/rh 8/ 10
S.F. _____ H.F. _____ The inclusion of this explanation does not constitute agreement with 1 the explanation’s substance by the members of the general assembly. 2 This bill relates to pharmacy practice. 3 Division I of the bill eliminates the tech-check-tech 4 program. The board of pharmacy (board) adopted administrative 5 rules to implement and establish a technician product 6 verification program as authorized by 2018 Iowa Acts, chapter 7 1142, enacting Code section 155A.33A. Division I also 8 eliminates the one-year registration limitation for a person in 9 training to become a pharmacy technician and makes conforming 10 terminology changes. 11 Division II of the bill authorizes the board to adopt rules 12 to authorize a pharmacist or a certified pharmacy technician 13 to supervise a pharmacy support person working at a licensed 14 telepharmacy site. 15 Division III of the bill requires a drug compounding 16 outsourcing facility seeking licensure in the state to 17 have been inspected by the facility’s home state regulatory 18 authority or other entity approved by the board in the two-year 19 period immediately preceding the application, which inspection 20 demonstrates compliance with federal current good manufacturing 21 practices. The bill also allows the board to recover costs 22 associated with conducting an inspection to satisfy the 23 inspection requirement. 24 Division IV of the bill authorizes a pharmacist to make 25 certain adaptations to prescriptions for substances that are 26 not controlled substances when appropriate to fulfill the 27 prescriber’s intent of the prescription medication therapy. 28 Any adaptation made must be documented in the patient’s record 29 and the prescriber must be notified of the adaptation of the 30 prescription. The bill prohibits a third-party payer from 31 recouping payment for the prescription as a result of an 32 audit of an otherwise valid prescription based solely on the 33 pharmacist’s adaptation of the prescription. 34 Division V authorizes a pharmacist to refill a prescription 35 -9- LSB 5383DP (8) 88 pf/rh 9/ 10
S.F. _____ H.F. _____ for a chronic maintenance drug, excluding controlled 1 substances, if the pharmacist, after reasonable efforts, is 2 unable to obtain authorization from the prescriber when, in 3 the pharmacist’s professional judgment, the patient’s life or 4 health will be endangered or an essential drug therapy will be 5 disrupted. 6 Division VI amends requirements to exempt influenza vaccines 7 from the requirement that a licensed pharmacist review the 8 statewide immunization registry or health information network 9 prior to the ordering and administration of a vaccine or 10 immunization authorized pursuant to statewide protocols. The 11 bill also exempts influenza vaccines from the requirement that 12 a licensed pharmacist report to the statewide immunization 13 registry or health information network following administration 14 of an influenza vaccine pursuant to statewide protocols to a 15 patient aged 18 or older. 16 Division VII defines and authorizes collaborative pharmacy 17 practice between pharmacists and physicians, advanced 18 registered nurse practitioners, advanced practice registered 19 nurses, and dentists under both Code chapters 124 (controlled 20 substances) and Code chapter 155A (pharmacy). 21 Division VIII codifies the provisions of 2011 Iowa 22 Acts, chapter 63, section 36, relating to pharmacy pilot or 23 demonstration research projects. The bill language differs 24 from these provisions by eliminating language limiting the 25 projects to those based solely on prescription verification 26 and by eliminating the requirement that the board report the 27 approval or denial of projects to the chairpersons and ranking 28 members of the joint appropriations subcommittee on health and 29 human services. 30 -10- LSB 5383DP (8) 88 pf/rh 10/ 10