FIRST REGULAR SESSION SENATE BILL NO. 659 102ND GENERAL ASSEMBLY INTRODUCED BY SENATOR MCCREERY. 2427S.01I KRISTINA MARTIN, Secretary AN ACT To repeal section 338.010, RSMo, and to enact in lieu thereof two new sections relating to contraceptives. Be it enacted by the General Assembly of the State of Missouri, as follows: Section A. Section 338.010, RSMo, is repealed and two new 1 sections enacted in lieu thereof, to be known as sections 2 338.010 and 338.720, to read as follows:3 338.010. 1. The "practice of pharmacy" means the 1 interpretation, implementation, and evaluation of medical 2 prescription orders, including any l egend drugs under 21 3 U.S.C. Section 353; the receipt, transmission, or handling 4 of such orders or facilitating the dispensing of such 5 orders; the designing, initiating, implementing, and 6 monitoring of a medication therapeutic plan as defined by 7 the prescription order so long as the prescription order is 8 specific to each patient for care by a pharmacist; the 9 compounding, dispensing, labeling, and administration of 10 drugs and devices pursuant to medical prescription orders 11 and administration of viral influenza, pneumonia, shingles, 12 hepatitis A, hepatitis B, diphtheria, tetanus, pertussis, 13 and meningitis vaccines by written protocol authorized by a 14 physician for persons at least seven years of age or the age 15 recommended by the Centers for Disease Co ntrol and 16 Prevention, whichever is higher, or the administration of 17 pneumonia, shingles, hepatitis A, hepatitis B, diphtheria, 18 SB 659 2 tetanus, pertussis, meningitis, and viral influenza vaccines 19 by written protocol authorized by a physician for a specific 20 patient as authorized by rule; the participation in drug 21 selection according to state law and participation in drug 22 utilization reviews; the proper and safe storage of drugs 23 and devices and the maintenance of proper records thereof; 24 consultation with pat ients and other health care 25 practitioners, and veterinarians and their clients about 26 legend drugs, about the safe and effective use of drugs and 27 devices; the prescribing and dispensing of any nicotine 28 replacement therapy product under section 338.665; the 29 dispensing of HIV postexposure prophylaxis pursuant to 30 section 338.730; the dispensing of self -administered 31 hormonal contraceptives under section 338.720; and the 32 offering or performing of those acts, services, operations, 33 or transactions necessar y in the conduct, operation, 34 management and control of a pharmacy. No person shall 35 engage in the practice of pharmacy unless he or she is 36 licensed under the provisions of this chapter. This chapter 37 shall not be construed to prohibit the use of auxili ary 38 personnel under the direct supervision of a pharmacist from 39 assisting the pharmacist in any of his or her duties. This 40 assistance in no way is intended to relieve the pharmacist 41 from his or her responsibilities for compliance with this 42 chapter and he or she will be responsible for the actions of 43 the auxiliary personnel acting in his or her assistance. 44 This chapter shall also not be construed to prohibit or 45 interfere with any legally registered practitioner of 46 medicine, dentistry, or podiatry, or veterinary medicine 47 only for use in animals, or the practice of optometry in 48 accordance with and as provided in sections 195.070 and 49 SB 659 3 336.220 in the compounding, administering, prescribing, or 50 dispensing of his or her own prescriptions. 51 2. Any pharmacist who accepts a prescription order for 52 a medication therapeutic plan shall have a written protocol 53 from the physician who refers the patient for medication 54 therapy services. The written protocol and the prescription 55 order for a medication th erapeutic plan shall come from the 56 physician only, and shall not come from a nurse engaged in a 57 collaborative practice arrangement under section 334.104, or 58 from a physician assistant engaged in a collaborative 59 practice arrangement under section 334.73 5. 60 3. Nothing in this section shall be construed as to 61 prevent any person, firm or corporation from owning a 62 pharmacy regulated by sections 338.210 to 338.315, provided 63 that a licensed pharmacist is in charge of such pharmacy. 64 4. Nothing in this section shall be construed to apply 65 to or interfere with the sale of nonprescription drugs and 66 the ordinary household remedies and such drugs or medicines 67 as are normally sold by those engaged in the sale of general 68 merchandise. 69 5. No health carrier as defined in chapter 376 shall 70 require any physician with which they contract to enter into 71 a written protocol with a pharmacist for medication 72 therapeutic services. 73 6. This section shall not be construed to allow a 74 pharmacist to diagno se or independently prescribe 75 pharmaceuticals. 76 7. The state board of registration for the healing 77 arts, under section 334.125, and the state board of 78 pharmacy, under section 338.140, shall jointly promulgate 79 rules regulating the use of protocols for prescription 80 orders for medication therapy services and administration of 81 SB 659 4 viral influenza vaccines. Such rules shall require 82 protocols to include provisions allowing for timely 83 communication between the pharmacist and the referring 84 physician, and any other patient protection provisions 85 deemed appropriate by both boards. In order to take effect, 86 such rules shall be approved by a majority vote of a quorum 87 of each board. Neither board shall separately promulgate 88 rules regulating the use of prot ocols for prescription 89 orders for medication therapy services and administration of 90 viral influenza vaccines. Any rule or portion of a rule, as 91 that term is defined in section 536.010, that is created 92 under the authority delegated in this section shal l become 93 effective only if it complies with and is subject to all of 94 the provisions of chapter 536 and, if applicable, section 95 536.028. This section and chapter 536 are nonseverable and 96 if any of the powers vested with the general assembly 97 pursuant to chapter 536 to review, to delay the effective 98 date, or to disapprove and annul a rule are subsequently 99 held unconstitutional, then the grant of rulemaking 100 authority and any rule proposed or adopted after August 28, 101 2007, shall be invalid and void. 102 8. The state board of pharmacy may grant a certificate 103 of medication therapeutic plan authority to a licensed 104 pharmacist who submits proof of successful completion of a 105 board-approved course of academic clinical study beyond a 106 bachelor of science i n pharmacy, including but not limited 107 to clinical assessment skills, from a nationally accredited 108 college or university, or a certification of equivalence 109 issued by a nationally recognized professional organization 110 and approved by the board of pharmacy . 111 9. Any pharmacist who has received a certificate of 112 medication therapeutic plan authority may engage in the 113 SB 659 5 designing, initiating, implementing, and monitoring of a 114 medication therapeutic plan as defined by a prescription 115 order from a physician that is specific to each patient for 116 care by a pharmacist. 117 10. Nothing in this section shall be construed to 118 allow a pharmacist to make a therapeutic substitution of a 119 pharmaceutical prescribed by a physician unless authorized 120 by the written protocol or the physician's prescription 121 order. 122 11. "Veterinarian", "doctor of veterinary medicine", 123 "practitioner of veterinary medicine", "DVM", "VMD", "BVSe", 124 "BVMS", "BSe (Vet Science)", "VMB", "MRCVS", or an 125 equivalent title means a person who has received a doctor's 126 degree in veterinary medicine from an accredited school of 127 veterinary medicine or holds an Educational Commission for 128 Foreign Veterinary Graduates (EDFVG) certificate issued by 129 the American Veterinary Medical Association (AVMA). 130 12. In addition to other requirements established by 131 the joint promulgation of rules by the board of pharmacy and 132 the state board of registration for the healing arts: 133 (1) A pharmacist shall administer vaccines by protocol 134 in accordance with treatment guidelines established by the 135 Centers for Disease Control and Prevention (CDC); 136 (2) A pharmacist who is administering a vaccine shall 137 request a patient to remain in the pharmacy a safe amount of 138 time after administering the vaccine to observe any adverse 139 reactions. Such pharmacist shall have adopted emergency 140 treatment protocols; 141 (3) In addition to other requirements by the board, a 142 pharmacist shall receive additional training as required by 143 the board and evidenced by receivi ng a certificate from the 144 SB 659 6 board upon completion, and shall display the certification 145 in his or her pharmacy where vaccines are delivered. 146 13. A pharmacist shall inform the patient that the 147 administration of the vaccine will be entered into the 148 ShowMeVax system, as administered by the department of 149 health and senior services. The patient shall attest to the 150 inclusion of such information in the system by signing a 151 form provided by the pharmacist. If the patient indicates 152 that he or she does no t want such information entered into 153 the ShowMeVax system, the pharmacist shall provide a written 154 report within fourteen days of administration of a vaccine 155 to the patient's health care provider, if provided by the 156 patient, containing: 157 (1) The identity of the patient; 158 (2) The identity of the vaccine or vaccines 159 administered; 160 (3) The route of administration; 161 (4) The anatomic site of the administration; 162 (5) The dose administered; and 163 (6) The date of administration. 164 338.720. 1. For purposes of this section, "self - 1 administered hormonal contraceptive" shall mean a drug 2 composed of a combination of hormones that is approved by 3 the Food and Drug Administration to prevent pregnancy. 4 2. A pharmacist may dispense self -administered 5 hormonal contraceptives to a person under a prescription 6 order for medication therapy services as described in 7 section 338.010. A prescription order for a self - 8 administered hormonal contraceptive shall have no exp iration 9 date. 10 3. The board of pharmacy, under section 338.140, and 11 the board of registration for the healing arts, under 12 SB 659 7 section 334.125, shall jointly promulgate rules regulating 13 the use of protocols for prescription orders for self - 14 administered hormonal contraceptives. Any rule or portion 15 of a rule, as that term is defined in section 536.010, that 16 is created under the authority delegated in this section 17 shall become effective only if it complies with and is 18 subject to all of the provisions of chapter 536 and, if 19 applicable, section 536.028. This section and chapter 536 20 are nonseverable, and if any of the powers vested with the 21 general assembly pursuant to chapter 536 to review, to delay 22 the effective date, or to disapprove and annul a rule are 23 subsequently held unconstitutional, then the grant of 24 rulemaking authority and any rule proposed or adopted after 25 August 28, 2023, shall be invalid and void. 26 4. The rules adopted under this section shall require 27 a pharmacist to: 28 (1) Complete a training program approved by the board 29 of pharmacy that is related to dispensing self -administered 30 hormonal contraceptives under this section; 31 (2) Provide a self-screening risk assessment tool that 32 the patient shall use prior to the p harmacist's dispensing 33 the self-administered hormonal contraceptive under this 34 section; 35 (3) At least once every twelve months, verbally refer 36 the patient to the health care provider with whom the 37 pharmacist has a prescription order before dispens ing the 38 self-administered hormonal contraceptive to the patient; 39 (4) Provide the patient with a written record of the 40 self-administered hormonal contraceptive dispensed and 41 advise the patient to consult with a health care provider; 42 and 43 SB 659 8 (5) Dispense the self-administered hormonal 44 contraceptive to the patient as soon as practicable. 45 5. All state and federal laws governing insurance 46 coverage of contraceptive drugs, devices, products, and 47 services shall apply to self -administered hormonal 48 contraceptives dispensed by a pharmacist under this section. 49 6. The provisions of this section shall terminate upon 50 the enactment of any laws allowing the provision of hormonal 51 contraceptives from a pharmacist without a prescription. 52 7. Nothing in this section shall be construed to allow 53 a pharmacist to make a therapeutic substitution of a 54 pharmaceutical prescribed by a physician unless authorized 55 by the written protocol or the physician's written 56 prescription order. 57