EXPLANATION-Matter enclosed in bold-faced brackets [thus] in this bill is not enacted and is intended to be omitted in the law. FIRST REGULAR SESSION [PERFECTED] SENATE SUBSTITUTE FOR SENATE COMMITTEE SUBSTITUTE FOR SENATE BILL NO. 41 102ND GENERAL ASSEMBLY INTRODUCED BY SENATOR THOMPSON REHDER. 0719S.04P KRISTINA MARTIN, Secretary AN ACT To repeal section 338.010, RSMo, and to enact in lieu thereof two new sections relating to the administration of medications by pharmacists. Be it enacted by the General Assembly of the State of Missouri, as follows: Section A. Section 338.010, RSMo, is repealed and two new 1 sections enacted in lieu thereof, to be known as sections 2 338.010 and 338.012, to read as follows:3 338.010. 1. The "practice of pharmacy" [means] 1 includes: 2 (1) The interpretation, implementation, and evaluation 3 of medical prescription orders, in cluding any legend drugs 4 under 21 U.S.C. Section 353 [;], and the receipt, 5 transmission, or handling of such orders or facilitating the 6 dispensing of such orders; 7 (2) The designing, initiating, implementing, and 8 monitoring of a medication therapeu tic plan [as defined by 9 the prescription order so long as the prescription order is 10 specific to each patient for care by a pharmacist ] in 11 accordance with the provisions of this section ; 12 (3) The compounding, dispensing, labeling, and 13 administration of drugs and devices pursuant to medical 14 SS SCS SB 41 2 prescription orders [and administration of viral influenza, 15 pneumonia, shingles, hepatitis A, hepatitis B, diphtheria, 16 tetanus, pertussis, and meningitis vaccines by written 17 protocol authorized by a physician for persons at least 18 seven years of age or the age recommended by the Centers for 19 Disease Control and Prevention, whichever is higher, or the 20 administration of pneumonia, shingles, hepatitis A, 21 hepatitis B, diphtheria, tetanus, pertussis, meningitis, a nd 22 viral influenza vaccines by written protocol authorized by a 23 physician for a specific patient as authorized by rule ]; 24 (4) The ordering and administration of vaccines 25 approved or authorized by the U.S. Food and Drug 26 Administration, excluding va ccines for cholera, monkeypox, 27 Japanese encephalitis, typhoid, rabies, yellow fever, tick - 28 borne encephalitis, anthrax, tuberculosis, dengue, Hib, 29 polio, rotavirus, smallpox, and any vaccine approved after 30 January 1, 2023, to persons at least seven year s of age or 31 the age recommended by the Centers for Disease Control and 32 Prevention, whichever is older, pursuant to joint 33 promulgation of rules established by the board of pharmacy 34 and the state board of registration for the healing arts 35 unless rules are established under a state of emergency as 36 described in section 44.100; 37 (5) The participation in drug selection according to 38 state law and participation in drug utilization reviews; 39 (6) The proper and safe storage of drugs and devices 40 and the maintenance of proper records thereof; 41 (7) Consultation with patients and other health care 42 practitioners, and veterinarians and their clients about 43 legend drugs, about the safe and effective use of drugs and 44 devices; 45 SS SCS SB 41 3 (8) The prescribing and dispensing of any nicotine 46 replacement therapy product under section 338.665; 47 (9) The dispensing of HIV postexposure prophylaxis 48 pursuant to section 338.730; and 49 (10) The offering or performing of those acts, 50 services, operations, or tr ansactions necessary in the 51 conduct, operation, management and control of a pharmacy. 52 2. No person shall engage in the practice of pharmacy 53 unless he or she is licensed under the provisions of this 54 chapter. 55 3. This chapter shall not be const rued to prohibit the 56 use of auxiliary personnel under the direct supervision of a 57 pharmacist from assisting the pharmacist in any of his or 58 her duties. This assistance in no way is intended to 59 relieve the pharmacist from his or her responsibilities fo r 60 compliance with this chapter and he or she will be 61 responsible for the actions of the auxiliary personnel 62 acting in his or her assistance. 63 4. This chapter shall [also] not be construed to 64 prohibit or interfere with any legally registered 65 practitioner of medicine, dentistry, or podiatry, or 66 veterinary medicine only for use in animals, or the practice 67 of optometry in accordance with and as provided in sections 68 195.070 and 336.220 in the compounding, administering, 69 prescribing, or dispensing o f his or her own prescriptions. 70 [2. Any pharmacist who accepts a prescription order 71 for a medication therapeutic plan shall have a written 72 protocol from the physician who refers the patient for 73 medication therapy services. ] 5. A pharmacist with a 74 certificate of medication therapeutic plan authority may 75 provide medication therapy services pursuant to a written 76 protocol from a physician licensed under chapter 334 to 77 SS SCS SB 41 4 patients who have established a physician -patient 78 relationship, as described in subdivision (1) of subsection 79 1 of section 191.1146, with the protocol physician. The 80 written protocol [and the prescription order for a 81 medication therapeutic plan ] authorized by this section 82 shall come only from the physician [only,] and shall not 83 come from a nurse engaged in a collaborative practice 84 arrangement under section 334.104, or from a physician 85 assistant engaged in a collaborative practice arrangement 86 under section 334.735. 87 [3.] 6. Nothing in this section shall be construed as 88 to prevent any person, firm or corporation from owning a 89 pharmacy regulated by sections 338.210 to 338.315, provided 90 that a licensed pharmacist is in charge of such pharmacy. 91 [4.] 7. Nothing in this section shall be construed to 92 apply to or interfere with the sale of nonprescription drugs 93 and the ordinary household remedies and such drugs or 94 medicines as are normally sold by those engaged in the sale 95 of general merchandise. 96 [5.] 8. No health carrier as defined in chapter 376 97 shall require any physician with which they contract to 98 enter into a written protocol with a pharmacist for 99 medication therapeutic services. 100 [6.] 9. This section shall not be construed to allow a 101 pharmacist to diagnose or independently prescribe 102 pharmaceuticals. 103 [7.] 10. The state board of registration for the 104 healing arts, under section 334.125, and the state board of 105 pharmacy, under section 338.140, shall jointly promulgate 106 rules regulating the use of protocols [for prescription 107 orders] for medication therapy services [and administration 108 of viral influenza vaccines ]. Such rules shall require 109 SS SCS SB 41 5 protocols to include provisions allowing for timely 110 communication between the pharmacist and the [referring] 111 protocol physician or similar body authorized b y this 112 section, and any other patient protection provisions deemed 113 appropriate by both boards. In order to take effect, such 114 rules shall be approved by a majority vote of a quorum of 115 each board. Neither board shall separately promulgate rules 116 regulating the use of protocols for [prescription orders 117 for] medication therapy services [and administration of 118 viral influenza vaccines ]. Any rule or portion of a rule, 119 as that term is defined in section 536.010, that is created 120 under the authority delega ted in this section shall become 121 effective only if it complies with and is subject to all of 122 the provisions of chapter 536 and, if applicable, section 123 536.028. This section and chapter 536 are nonseverable and 124 if any of the powers vested with the gene ral assembly 125 pursuant to chapter 536 to review, to delay the effective 126 date, or to disapprove and annul a rule are subsequently 127 held unconstitutional, then the grant of rulemaking 128 authority and any rule proposed or adopted after August 28, 129 2007, shall be invalid and void. 130 [8.] 11. The state board of pharmacy may grant a 131 certificate of medication therapeutic plan authority to a 132 licensed pharmacist who submits proof of successful 133 completion of a board -approved course of academic clinical 134 study beyond a bachelor of science in pharmacy, including 135 but not limited to clinical assessment skills, from a 136 nationally accredited college or university, or a 137 certification of equivalence issued by a nationally 138 recognized professional organization and app roved by the 139 board of pharmacy. 140 SS SCS SB 41 6 [9.] 12. Any pharmacist who has received a certificate 141 of medication therapeutic plan authority may engage in the 142 designing, initiating, implementing, and monitoring of a 143 medication therapeutic plan as defined by a [prescription 144 order] written protocol from a physician that [is] may be 145 specific to each patient for care by a pharmacist. 146 [10.] 13. Nothing in this section shall be construed 147 to allow a pharmacist to make a therapeutic substitution of 148 a pharmaceutical prescribed by a physician unless authorized 149 by the written protocol or the physician's prescription 150 order. 151 [11.] 14. "Veterinarian", "doctor of veterinary 152 medicine", "practitioner of veterinary medicine", "DVM", 153 "VMD", "BVSe", "BVMS", "BS e (Vet Science)", "VMB", "MRCVS", 154 or an equivalent title means a person who has received a 155 doctor's degree in veterinary medicine from an accredited 156 school of veterinary medicine or holds an Educational 157 Commission for Foreign Veterinary Graduates (EDFV G) 158 certificate issued by the American Veterinary Medical 159 Association (AVMA). 160 [12.] 15. In addition to other requirements 161 established by the joint promulgation of rules by the board 162 of pharmacy and the state board of registration for the 163 healing arts: 164 (1) A pharmacist shall administer vaccines by protocol 165 in accordance with treatment guidelines established by the 166 Centers for Disease Control and Prevention (CDC); 167 (2) A pharmacist who is administering a vaccine shall 168 request a patient to remain in the pharmacy a safe amount of 169 time after administering the vaccine to observe any adverse 170 reactions. Such pharmacist shall have adopted emergency 171 treatment protocols; 172 SS SCS SB 41 7 [(3)] 16. In addition to other requirements by the 173 board, a pharmacist shall receive additional training as 174 required by the board and evidenced by receiving a 175 certificate from the board upon completion, and shall 176 display the certification in his or her pharmacy where 177 vaccines are delivered. 178 [13.] 17. A pharmacist shall inform the patient that 179 the administration of [the] a vaccine will be entered into 180 the ShowMeVax system, as administered by the department of 181 health and senior services. The patient shall attest to the 182 inclusion of such information in the s ystem by signing a 183 form provided by the pharmacist. If the patient indicates 184 that he or she does not want such information entered into 185 the ShowMeVax system, the pharmacist shall provide a written 186 report within fourteen days of administration of a vac cine 187 to the patient's health care provider, if provided by the 188 patient, containing: 189 (1) The identity of the patient; 190 (2) The identity of the vaccine or vaccines 191 administered; 192 (3) The route of administration; 193 (4) The anatomic site of the administration; 194 (5) The dose administered; and 195 (6) The date of administration. 196 18. A pharmacist licensed under this chapter may order 197 and administer vaccines approved or authorized by the U.S. 198 Food and Drug Administration to add ress a public health 199 need, as lawfully authorized by the state or federal 200 government, or a department or agency thereof, during a 201 state or federally declared public health emergency. 202 338.012. 1. A pharmacist with a certificate of 1 medication therapeutic plan authority may provide influenza, 2 SS SCS SB 41 8 group A streptococcus, and COVID -19 medication therapy 3 services pursuant to a statewide standing order issued by 4 the director or chief medical officer of the department of 5 health and senior se rvices if that person is a licensed 6 physician, or a licensed physician designated by the 7 department of health and senior services. 8 2. The state board of registration for the healing 9 arts, pursuant to section 334.125, and the state board of 10 pharmacy, pursuant to section 338.140, shall jointly 11 promulgate rules to implement the provisions of this 12 section. Any rule or portion of a rule, as that term is 13 defined in section 536.010, that is created under the 14 authority delegated in this section shall become effective 15 only if it complies with and is subject to all of the 16 provisions of chapter 536 and, if applicable, section 17 536.028. This section and chapter 536 are nonseverable and 18 if any of the powers vested with the general assembly 19 pursuant to chapter 536 to review, to delay the effective 20 date, or to disapprove and annul a rule are subsequently 21 held unconstitutional, then the grant of rulemaking 22 authority and any rule proposed or adopted after August 28, 23 2023, shall be invalid and void. 24