Florida Senate - 2020 SB 714 By Senator Hutson 7-00934-20 2020714__ 1 A bill to be entitled 2 An act relating to the testing for and treatment of 3 influenza and streptococcus; amending s. 381.0031, 4 F.S.; requiring specified licensed pharmacists to 5 report certain information to the Department of 6 Health; amending s. 465.003, F.S.; revising the 7 definition of the term “practice of the profession of 8 pharmacy”; creating s. 465.1895, F.S.; authorizing 9 pharmacists to test for and treat influenza and 10 streptococcus and providing requirements relating 11 thereto; requiring that the written protocol between a 12 pharmacist and supervising physician contain certain 13 information, terms, and conditions; requiring the 14 Board of Pharmacy to adopt rules within a specified 15 time period; requiring that a pharmacist notify a 16 patient’s primary care provider within a specified 17 time period after providing any such testing or 18 treatment; providing an effective date. 19 20 Be It Enacted by the Legislature of the State of Florida: 21 22 Section 1. Subsection (2) of section 381.0031, Florida 23 Statutes, is amended to read: 24 381.0031 Epidemiological research; report of diseases of 25 public health significance to department.— 26 (2) Any practitioner licensed in this state to practice 27 medicine, osteopathic medicine, chiropractic medicine, 28 naturopathy, or veterinary medicine; any licensed pharmacist 29 authorized pursuant to a written protocol to order and evaluate 30 laboratory and clinical tests; any hospital licensed under part 31 I of chapter 395; or any laboratory appropriately certified by 32 the Centers for Medicare and Medicaid Services under the federal 33 Clinical Laboratory Improvement Amendments, and the federal 34 rules adopted thereunder, which diagnoses or suspects the 35 existence of a disease of public health significance shall 36 immediately report the fact to the Department of Health. 37 Section 2. Subsection (13) of section 465.003, Florida 38 Statutes, is amended to read: 39 465.003 Definitions.—As used in this chapter, the term: 40 (13) “Practice of the profession of pharmacy” includes 41 compounding, dispensing, and consulting concerning contents, 42 therapeutic values, and uses of any medicinal drug; consulting 43 concerning therapeutic values and interactions of patent or 44 proprietary preparations, whether pursuant to prescriptions or 45 in the absence and entirely independent of such prescriptions or 46 orders; and conducting other pharmaceutical services. For 47 purposes of this subsection, “other pharmaceutical services” 48 means the monitoring of the patient’s drug therapy and assisting 49 the patient in the management of his or her drug therapy, and 50 includes review of the patient’s drug therapy and communication 51 with the patient’s prescribing health care provider as licensed 52 under chapter 458, chapter 459, chapter 461, or chapter 466, or 53 similar statutory provision in another jurisdiction, or such 54 provider’s agent or such other persons as specifically 55 authorized by the patient, regarding the drug therapy. However, 56 nothing in this subsection may be interpreted to permit an 57 alteration of a prescriber’s directions, the diagnosis or 58 treatment of any disease, the initiation of any drug therapy, 59 the practice of medicine, or the practice of osteopathic 60 medicine, unless otherwise permitted by law. “Practice of the 61 profession of pharmacy” also includes any other act, service, 62 operation, research, or transaction incidental to, or forming a 63 part of, any of the foregoing acts, requiring, involving, or 64 employing the science or art of any branch of the pharmaceutical 65 profession, study, or training, and shall expressly permit a 66 pharmacist to transmit information from persons authorized to 67 prescribe medicinal drugs to their patients. The practice of the 68 profession of pharmacy also includes the administration of 69 vaccines to adults pursuant to s. 465.189, the testing for and 70 treatment of influenza and streptococcus pursuant to s. 71 465.1895, and the preparation of prepackaged drug products in 72 facilities holding Class III institutional pharmacy permits. 73 Section 3. Section 465.1895, Florida Statutes, is created 74 to read: 75 465.1895 Testing for and treatment of influenza and 76 streptococcus.— 77 (1) A pharmacist may test for and treat influenza and 78 streptococcus if all of the following criteria are met: 79 (a) The pharmacist has entered into a written protocol with 80 a supervising physician licensed under chapter 458 or chapter 81 459, and such protocol complies with the requirements in 82 subsection (5) and board rules. 83 (b) The pharmacist uses an instrument and a waived test, as 84 that term is defined in 42 C.F.R. s. 493.2. 85 (c) The pharmacist uses a testing system that: 86 1. Provides automated readings in order to reduce user 87 subjectivity or interpretation of results. 88 2. Is capable of directly or indirectly interfacing with 89 electronic medical records systems. 90 3. Is capable of electronically reporting daily 91 deidentified test results to the appropriate agencies. 92 4. Uses an instrument that incorporates both internal and 93 external controls and external calibration that show the reagent 94 and assay procedure is performing properly. External controls 95 must be used in accordance with local, state, and federal 96 regulations and accreditation requirements. 97 (d) The pharmacist is certified to test for and treat 98 influenza and streptococcus pursuant to a certification program 99 approved by the board, in consultation with the Board of 100 Medicine and the Board of Osteopathic Medicine, within 90 days 101 after the date upon which this section becomes effective. The 102 certification program must require that the pharmacist attend, 103 on a one-time basis, 8 hours of continuing education courses 104 approved by the board. The continuing education curriculum must 105 be provided by an organization of instruction approved by the 106 Accreditation Council for Pharmacy Education and must include, 107 at a minimum, point-of-care testing for influenza and 108 streptococcus and the safe and effective treatment of influenza 109 and streptococcus. 110 (2) A pharmacist may not enter into a written protocol 111 under this section unless he or she maintains at least $200,000 112 of professional liability insurance and is certified as required 113 in paragraph (1)(d). 114 (3) A pharmacist who tests for and treats influenza and 115 streptococcus shall maintain and make available patient records 116 using the same standards for confidentiality and maintenance of 117 such records as those that are imposed on health care 118 practitioners under s. 456.057. Such records shall be maintained 119 for at least 5 years. 120 (4) The decision by a supervising physician licensed under 121 chapter 458 or chapter 459 to enter into a written protocol 122 under this section is a professional decision on the part of the 123 physician and a person may not interfere with a physician’s 124 decision regarding entering into such a protocol. A pharmacist 125 may not enter into a written protocol that is to be performed 126 while acting as an employee without the written approval of the 127 owner of the pharmacy. 128 (5) The board shall adopt rules establishing requirements 129 for the written protocol within 90 days after the date upon 130 which this section becomes effective. At a minimum, the written 131 protocol shall include: 132 (a) The terms and conditions required in s. 465.189(7). 133 (b) Specific categories of patients for whom the 134 supervising physician authorizes the pharmacist to test for and 135 treat influenza and streptococcus. 136 (c) The supervising physician’s instructions for the 137 treatment of influenza and streptococcus based on the patient’s 138 age, symptoms, and test results, including negative results. 139 (d) A process and schedule for the supervising physician to 140 review the pharmacist’s actions under the written protocol. 141 (e) A process and schedule for the pharmacist to notify the 142 supervising physician of the patient’s condition, tests 143 administered, test results, and course of treatment. 144 (6) When the patient has a primary care provider, a 145 pharmacist who provides testing for or treatment of influenza 146 and streptococcus under this section shall notify the patient’s 147 primary care provider within 2 business days after providing any 148 such testing or treatment. 149 Section 4. This act shall take effect upon becoming a law.