Florida Senate - 2020 CS for SB 714 By the Committee on Health Policy; and Senator Hutson 588-03836-20 2020714c1 1 A bill to be entitled 2 An act relating to the testing for and treatment of 3 influenza; amending s. 381.0031, F.S.; requiring 4 specified licensed pharmacists to report certain 5 information to the Department of Health; amending s. 6 465.003, F.S.; revising the definition of the term 7 “practice of the profession of pharmacy”; creating s. 8 465.1895, F.S.; authorizing pharmacists to test for 9 and treat influenza and providing requirements 10 relating thereto; requiring the written protocol 11 between a pharmacist and a supervising physician to 12 contain certain information, terms, and conditions; 13 requiring the Board of Medicine, in consultation with 14 the Board of Pharmacy and the Board of Osteopathic 15 Medicine, to develop a specified certification program 16 for pharmacists within a specified timeframe; 17 requiring a pharmacist to collect a medical history 18 before testing and treating a patient; requiring a 19 pharmacy in which a pharmacist tests for and treats 20 influenza to display and distribute specified 21 information; providing limitations on the medications 22 a pharmacist may administer to treat influenza; 23 requiring pharmacists to review certain information 24 for a specified purpose before testing and treating 25 patients; requiring a pharmacist who tests for and 26 treats influenza to maintain professional liability 27 insurance in a specified amount; providing 28 recordkeeping requirements for pharmacists who test 29 for and treat influenza; providing that a person may 30 not interfere with a physician’s professional decision 31 to enter into a written protocol with a pharmacist; 32 providing that a pharmacist may not enter into a 33 written protocol under certain circumstances; 34 requiring the Board of Medicine, in consultation with 35 the Board of Pharmacy and the Board of Osteopathic 36 Medicine, to adopt rules within a specified timeframe; 37 requiring pharmacists to notify a patient’s primary 38 care provider and follow up with the treated patient 39 within specified timeframes; prohibiting a pharmacist 40 from testing or treating patients under certain 41 circumstances; specifying circumstances under which a 42 physician may supervise a pharmacist under a written 43 protocol; providing a contingency on implementation; 44 providing an effective date. 45 46 Be It Enacted by the Legislature of the State of Florida: 47 48 Section 1. Subsection (2) of section 381.0031, Florida 49 Statutes, is amended to read: 50 381.0031 Epidemiological research; report of diseases of 51 public health significance to department.— 52 (2) Any practitioner licensed in this state to practice 53 medicine, osteopathic medicine, chiropractic medicine, 54 naturopathy, or veterinary medicine; any licensed pharmacist 55 authorized pursuant to a written protocol to order and evaluate 56 laboratory and clinical tests; any hospital licensed under part 57 I of chapter 395; or any laboratory appropriately certified by 58 the Centers for Medicare and Medicaid Services under the federal 59 Clinical Laboratory Improvement Amendments, and the federal 60 rules adopted thereunder, which diagnoses or suspects the 61 existence of a disease of public health significance shall 62 immediately report the fact to the Department of Health. 63 Section 2. Subsection (13) of section 465.003, Florida 64 Statutes, is amended to read: 65 465.003 Definitions.—As used in this chapter, the term: 66 (13) “Practice of the profession of pharmacy” includes 67 compounding, dispensing, and consulting concerning contents, 68 therapeutic values, and uses of any medicinal drug; consulting 69 concerning therapeutic values and interactions of patent or 70 proprietary preparations, whether pursuant to prescriptions or 71 in the absence and entirely independent of such prescriptions or 72 orders; and conducting other pharmaceutical services. For 73 purposes of this subsection, “other pharmaceutical services” 74 means the monitoring of the patient’s drug therapy and assisting 75 the patient in the management of his or her drug therapy, and 76 includes review of the patient’s drug therapy and communication 77 with the patient’s prescribing health care provider as licensed 78 under chapter 458, chapter 459, chapter 461, or chapter 466, or 79 similar statutory provision in another jurisdiction, or such 80 provider’s agent or such other persons as specifically 81 authorized by the patient, regarding the drug therapy. However, 82 nothing in this subsection may be interpreted to permit an 83 alteration of a prescriber’s directions, the diagnosis or 84 treatment of any disease, the initiation of any drug therapy, 85 the practice of medicine, or the practice of osteopathic 86 medicine, unless otherwise permitted by law. “Practice of the 87 profession of pharmacy” also includes any other act, service, 88 operation, research, or transaction incidental to, or forming a 89 part of, any of the foregoing acts, requiring, involving, or 90 employing the science or art of any branch of the pharmaceutical 91 profession, study, or training, and shall expressly permit a 92 pharmacist to transmit information from persons authorized to 93 prescribe medicinal drugs to their patients. The practice of the 94 profession of pharmacy also includes the administration of 95 vaccines to adults pursuant to s. 465.189, the testing for and 96 treatment of influenza pursuant to s. 465.1895, and the 97 preparation of prepackaged drug products in facilities holding 98 Class III institutional pharmacy permits. 99 Section 3. Section 465.1895, Florida Statutes, is created 100 to read: 101 465.1895 Testing for and treatment of influenza.— 102 (1) A pharmacist may test for and treat influenza if all of 103 the following criteria are met: 104 (a) The pharmacist has entered into a written protocol with 105 a supervising physician licensed under chapter 458 or chapter 106 459, and such protocol complies with the requirements in 107 subsection (5) and the Board of Medicine’s rules. 108 (b) The pharmacist uses an instrument and a waived test, as 109 that term is defined in 42 C.F.R. s. 493.2. 110 (c) The pharmacist uses a testing system that: 111 1. Provides automated readings in order to reduce user 112 subjectivity or interpretation of results. 113 2. Is capable of directly or indirectly interfacing with 114 electronic medical records systems. 115 3. Is capable of electronically reporting daily 116 deidentified test results to the appropriate agencies. 117 4. Uses an instrument that incorporates both internal and 118 external controls and external calibration that show the reagent 119 and assay procedure is performing properly. External controls 120 must be used in accordance with local, state, and federal 121 regulations and accreditation requirements. 122 (d) The pharmacist is certified to test for and treat 123 influenza pursuant to a certification program approved by the 124 Board of Medicine, in consultation with the board and the Board 125 of Osteopathic Medicine. The certification program must be 126 developed and implemented within 90 days after the date upon 127 which this section becomes effective and must require that the 128 pharmacist attend, on a one-time basis, 8 hours of continuing 129 education courses approved by the Board of Medicine. The 130 continuing education curriculum must be provided by an 131 organization that is approved by the Accreditation Council for 132 Pharmacy Education to provide instructional services and must 133 include, at a minimum, point-of-care testing for influenza and 134 the safe and effective treatment of influenza. 135 (e) The pharmacist collects from the patient a full history 136 of the patient’s past and present medical conditions on a form 137 adopted by the Board of Medicine by rule which allows the 138 patient to check off medical conditions from a list and add 139 other conditions that are not listed. The history must be 140 maintained as part of the patient’s records in accordance with 141 subsection (3). 142 (f) The pharmacy in which a pharmacist tests for and treats 143 influenza prominently displays signage indicating that any 144 patient tested and treated at the pharmacy is advised to seek 145 followup care from his or her primary care physician or, if the 146 patient has no primary care physician, from the pharmacist’s 147 supervising physician. 148 (g) The pharmacist who tests for or treats influenza 149 provides the patient with the name and contact information for 150 the pharmacist’s supervising physician and a pamphlet or 151 brochure that meets criteria established by the Board of 152 Medicine by rule informing the patient that: 153 1. If the test indicates that the patient has influenza, 154 the patient is advised to seek followup care from the patient’s 155 primary care physician or, if the patient has no primary care 156 physician, from the pharmacist’s supervising physician; and 157 2. If the pharmacist treats the patient for influenza, the 158 pharmacist and the pharmacy where the testing and treating 159 occurred are liable for damages the patient suffers as a result 160 of an adverse reaction to the treatment. 161 (h) The pharmacist’s treatment is limited to medications 162 designed to treat influenza which are approved by the Board of 163 Medicine and which the Board of Medicine shall review annually. 164 (i) The pharmacist, prior to treating the patient, reviews 165 the patient’s current prescriptions and recent prescription 166 history to check for relative contraindications involving the 167 pharmacist’s intended treatment. 168 (2) A pharmacist may not enter into a written protocol 169 under this section unless he or she maintains at least $250,000 170 of professional liability insurance and is certified as required 171 in paragraph (1)(d). 172 (3) A pharmacist who tests for and treats influenza shall 173 maintain and make available patient records using the same 174 standards for confidentiality and maintenance of such records as 175 those that are imposed on health care practitioners under s. 176 456.057. Each patient’s records maintained under this subsection 177 must include confirmation that the requirements of paragraphs 178 (1)(e) and (1)(g) were fulfilled. Such records shall be 179 maintained for at least 5 years. 180 (4) The decision by a supervising physician licensed under 181 chapter 458 or chapter 459 to enter into a written protocol 182 under this section is a professional decision on the part of the 183 physician and a person may not interfere with a physician’s 184 decision regarding entering into such a protocol. A pharmacist 185 may not enter into a written protocol that is to be performed 186 while acting as an employee without the written approval of the 187 owner of the pharmacy. 188 (5) The Board of Medicine, in consultation with the board 189 and the Board of Osteopathic Medicine, shall adopt rules 190 establishing requirements for the written protocol within 90 191 days after the date upon which this section becomes effective. 192 At a minimum, the written protocol shall include: 193 (a) The terms and conditions required in s. 465.189(7). 194 (b) Specific categories of patients for whom the 195 supervising physician authorizes the pharmacist to test for and 196 treat influenza. 197 (c) The supervising physician’s instructions for the 198 treatment of influenza based on the patient’s age, symptoms, and 199 test results, including negative results. 200 (d) A process and schedule for the supervising physician to 201 review the pharmacist’s actions under the written protocol. 202 (e) A process and schedule for the pharmacist to notify the 203 supervising physician of the patient’s condition, tests 204 administered, test results, and course of treatment. 205 (6) When the patient has a primary care provider, a 206 pharmacist who provides testing for or treatment of influenza 207 under this section shall notify the patient’s primary care 208 provider within 2 business days after providing any such testing 209 or treatment. 210 (7) If a pharmacist tests for and treats influenza for a 211 patient under this section, the pharmacist or his or her 212 designee must follow up with the patient 3 days later to 213 determine whether the patient’s condition has improved, and if 214 the patient informs the pharmacist that his or her condition has 215 not improved, the pharmacist shall do all of the following: 216 (a) Recommend that the patient seek treatment from the 217 patient’s primary care physician or, if the patient has no 218 primary care physician, from the pharmacist’s supervising 219 physician. 220 (b) Inform the patient’s primary care physician that the 221 patient’s condition failed to improve 3 days after treatment or, 222 if the patient has no primary care physician, the pharmacist 223 shall so inform the pharmacist’s supervising physician. 224 (c) Document in the patient’s record maintained under 225 subsection (3) whether the followup required under this 226 subsection occurred or whether attempts to contact the patient 227 were unsuccessful. 228 (8) A pharmacist may not test for or treat influenza under 229 this section for a patient who: 230 (a) Is younger than 18 years of age; 231 (b) Is older than 75 years of age; 232 (c) Refuses to provide a medical history under paragraph 233 (1)(e); or 234 (d) Provides a medical history under paragraph (1)(e) 235 indicating a history of conditions relating to heart disease, 236 bronchial disorders, pneumonia, chronic obstructive pulmonary 237 disease, asthma, or any other medical conditions as determined 238 by the Board of Medicine by rule on an annual basis. 239 (9) A supervising physician who enters into a written 240 protocol with a pharmacist under this section must be a primary 241 care physician who is actively practicing in the community in 242 which the pharmacist tests and treats under this section 243 according to Board of Medicine rule. A supervising physician may 244 not enter into such a protocol with pharmacists employed at more 245 than four pharmacy locations. 246 (10) Implementation of this section is contingent upon the 247 enactment of an appropriation within the General Appropriations 248 Act which is sufficient to fund the Board of Medicine’s efforts 249 to carry out its duties as required under this section. 250 Section 4. This act shall take effect upon becoming a law.