Florida Senate - 2020 COMMITTEE AMENDMENT Bill No. SB 714 Ì684054(Î684054 LEGISLATIVE ACTION Senate . House . . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Health Policy (Hutson) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete lines 70 - 148 4 and insert: 5 treatment of influenza pursuant to s. 465.1895, and the 6 preparation of prepackaged drug products in facilities holding 7 Class III institutional pharmacy permits. 8 Section 3. Section 465.1895, Florida Statutes, is created 9 to read: 10 465.1895 Testing for and treatment of influenza.— 11 (1) A pharmacist may test for and treat influenza if all of 12 the following criteria are met: 13 (a) The pharmacist has entered into a written protocol with 14 a supervising physician licensed under chapter 458 or chapter 15 459, and such protocol complies with the requirements in 16 subsection (5) and the Board of Medicine’s rules. 17 (b) The pharmacist uses an instrument and a waived test, as 18 that term is defined in 42 C.F.R. s. 493.2. 19 (c) The pharmacist uses a testing system that: 20 1. Provides automated readings in order to reduce user 21 subjectivity or interpretation of results. 22 2. Is capable of directly or indirectly interfacing with 23 electronic medical records systems. 24 3. Is capable of electronically reporting daily 25 deidentified test results to the appropriate agencies. 26 4. Uses an instrument that incorporates both internal and 27 external controls and external calibration that show the reagent 28 and assay procedure is performing properly. External controls 29 must be used in accordance with local, state, and federal 30 regulations and accreditation requirements. 31 (d) The pharmacist is certified to test for and treat 32 influenza pursuant to a certification program approved by the 33 Board of Medicine, in consultation with the board and the Board 34 of Osteopathic Medicine. The certification program must be 35 developed and implemented within 90 days after the date upon 36 which this section becomes effective and must require that the 37 pharmacist attend, on a one-time basis, 8 hours of continuing 38 education courses approved by the Board of Medicine. The 39 continuing education curriculum must be provided by an 40 organization of instruction approved by the Accreditation 41 Council for Pharmacy Education and must include, at a minimum, 42 point-of-care testing for influenza and the safe and effective 43 treatment of influenza. 44 (e) The pharmacist collects from the patient a full history 45 of the patient’s past and present medical conditions on a form 46 adopted by the Board of Medicine in rule which allows the 47 patient to check off medical conditions from a list and add 48 other conditions that are not listed. The history must be 49 maintained as part of the patient’s records in accordance with 50 subsection (3). 51 (f) The pharmacy in which a pharmacist tests for and treats 52 influenza prominently displays signage indicating that any 53 patient tested and treated at the pharmacy is advised to seek 54 followup care from his or her primary care physician or, if the 55 patient has no primary care physician, from the pharmacist’s 56 supervising physician. 57 (g) The pharmacist who tests for or treats influenza 58 provides the patient with the name and contact information for 59 the pharmacist’s supervising physician and a pamphlet or 60 brochure that meets criteria established by the Board of 61 Medicine in rule informing the patient that: 62 1. If the test indicates that the patient has influenza, 63 the patient is advised to seek followup care from the patient’s 64 primary care physician or, if the patient has no primary care 65 physician, from the pharmacist’s supervising physician; and 66 2. If the pharmacist treats the patient for influenza, the 67 pharmacist and the pharmacy where the testing and treating 68 occurred are liable for damages the patient suffers as a result 69 of an adverse reaction to the treatment. 70 (h) The pharmacist’s treatment is limited to medications 71 designed to treat influenza which are approved by the Board of 72 Medicine and which the Board of Medicine shall review annually. 73 (i) The pharmacist, prior to treating the patient, reviews 74 the patient’s current prescriptions and recent prescription 75 history to check for relative contraindications involving the 76 pharmacist’s intended treatment. 77 (2) A pharmacist may not enter into a written protocol 78 under this section unless he or she maintains at least $250,000 79 of professional liability insurance and is certified as required 80 in paragraph (1)(d). 81 (3) A pharmacist who tests for and treats influenza shall 82 maintain and make available patient records using the same 83 standards for confidentiality and maintenance of such records as 84 those that are imposed on health care practitioners under s. 85 456.057. Each patient’s records maintained under this subsection 86 must include confirmation that the requirements of paragraphs 87 (1)(e) and (1)(g) were fulfilled. Such records shall be 88 maintained for at least 5 years. 89 (4) The decision by a supervising physician licensed under 90 chapter 458 or chapter 459 to enter into a written protocol 91 under this section is a professional decision on the part of the 92 physician and a person may not interfere with a physician’s 93 decision regarding entering into such a protocol. A pharmacist 94 may not enter into a written protocol that is to be performed 95 while acting as an employee without the written approval of the 96 owner of the pharmacy. 97 (5) The Board of Medicine, in consultation with the board 98 and the Board of Osteopathic Medicine, shall adopt rules 99 establishing requirements for the written protocol within 90 100 days after the date upon which this section becomes effective. 101 At a minimum, the written protocol shall include: 102 (a) The terms and conditions required in s. 465.189(7). 103 (b) Specific categories of patients for whom the 104 supervising physician authorizes the pharmacist to test for and 105 treat influenza. 106 (c) The supervising physician’s instructions for the 107 treatment of influenza based on the patient’s age, symptoms, and 108 test results, including negative results. 109 (d) A process and schedule for the supervising physician to 110 review the pharmacist’s actions under the written protocol. 111 (e) A process and schedule for the pharmacist to notify the 112 supervising physician of the patient’s condition, tests 113 administered, test results, and course of treatment. 114 (6) When the patient has a primary care provider, a 115 pharmacist who provides testing for or treatment of influenza 116 under this section shall notify the patient’s primary care 117 provider within 2 business days after providing any such testing 118 or treatment. 119 (7) If a pharmacist tests for and treats influenza for a 120 patient under this section, the pharmacist or his or her 121 designee must follow up with the patient 3 days later to 122 determine whether the patient’s condition has improved, and if 123 the patient informs the pharmacist that his or her condition has 124 not improved, the pharmacist shall do all of the following: 125 (a) Recommend that the patient seek treatment from the 126 patient’s primary care physician or, if the patient has no 127 primary care physician, from the pharmacist’s supervising 128 physician. 129 (b) Inform the patient’s primary care physician that the 130 patient’s condition failed to improve 3 days after treatment or, 131 if the patient has no primary care physician, the pharmacist 132 shall so inform the pharmacist’s supervising physician. 133 (c) Document in the patient’s record maintained under 134 subsection (3) whether the followup required under this 135 subsection occurred or whether attempts to contact the patient 136 were unsuccessful. 137 (8) A pharmacist may not test for or treat influenza under 138 this section for a patient who: 139 (a) Is younger than 18 years of age; 140 (b) Is older than 75 years of age; 141 (c) Refuses to provide a medical history under paragraph 142 (1)(e); or 143 (d) Provides a medical history under paragraph (1)(e) 144 indicating a history of conditions relating to heart disease, 145 bronchial disorders, pneumonia, chronic obstructive pulmonary 146 disease, asthma, or any other medical conditions as determined 147 by the Board of Medicine in rule on an annual basis. 148 (9) A supervising physician who enters into a written 149 protocol with a pharmacist under this section must be a primary 150 care physician who is actively practicing in the community in 151 which the pharmacist tests and treats under this section 152 according to Board of Medicine rule. A supervising physician may 153 not enter into such a protocol with pharmacists employed at more 154 than four pharmacy locations. 155 (10) Implementation of this section is contingent upon the 156 enactment of an appropriation within the General Appropriations 157 Act which is sufficient to fund the Board of Medicine’s efforts 158 to carry out its duties as required under this section. 159 160 ================= T I T L E A M E N D M E N T ================ 161 And the title is amended as follows: 162 Delete lines 3 - 18 163 and insert: 164 of influenza; amending s. 381.0031, F.S.; requiring 165 specified licensed pharmacists to report certain 166 information to the Department of Health; amending s. 167 465.003, F.S.; revising the definition of the term 168 “practice of the profession of pharmacy”; creating s. 169 465.1895, F.S.; authorizing pharmacists to test for 170 and treat influenza and providing requirements 171 relating thereto; requiring the written protocol 172 between a pharmacist and a supervising physician to 173 contain certain information, terms, and conditions; 174 requiring the Board of Medicine, in consultation with 175 the Board of Pharmacy and the Board of Osteopathic 176 Medicine, to develop a specified certification program 177 for pharmacists within a specified timeframe; 178 requiring a pharmacist to collect a medical history 179 before testing and treating a patient; requiring a 180 pharmacy in which a pharmacist tests for and treats 181 influenza to display and distribute specified 182 information; providing limitations on the medications 183 a pharmacist may administer to treat influenza; 184 requiring pharmacists to review certain information 185 for a specified purpose before testing and treating 186 patients; requiring a pharmacist who tests for and 187 treats influenza to maintain professional liability 188 insurance in a specified amount; providing 189 recordkeeping requirements for pharmacists who test 190 for and treat influenza; providing that a person may 191 not interfere with a physician’s professional decision 192 to enter into a written protocol with a pharmacist; 193 providing that a pharmacist may not enter into a 194 written protocol under certain circumstances; 195 requiring the Board of Medicine, in consultation with 196 the Board of Pharmacy and the Board of Osteopathic 197 Medicine, to adopt rules within a specified timeframe; 198 requiring pharmacists to notify a patient’s primary 199 care provider and follow up with the treated patient 200 within specified timeframes; prohibiting a pharmacist 201 from testing or treating patients under certain 202 circumstances; specifying circumstances under which a 203 physician may supervise a pharmacist under a written 204 protocol; providing a contingency on implementation; 205 providing an effective date.