Florida Senate - 2020 SENATOR AMENDMENT Bill No. CS for HB 389 Ì8505641Î850564 LEGISLATIVE ACTION Senate . House . . . Floor: 1/AD/2R . Floor: C 03/10/2020 04:35 PM . 03/11/2020 12:36 PM ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— Senator Hutson moved the following: 1 Senate Amendment (with title amendment) 2 3 Delete lines 104 - 400 4 and insert: 5 465.189, the testing or screening for and treatment of minor, 6 nonchronic health conditions pursuant to s. 465.1895, and the 7 preparation of prepackaged drug products in facilities holding 8 Class III institutional pharmacy permits. 9 Section 3. Section 465.1865, Florida Statutes, is created 10 to read: 11 465.1865 Collaborative pharmacy practice for chronic health 12 conditions.— 13 (1) For purposes of this section, the term: 14 (a) “Collaborative pharmacy practice agreement” means a 15 written agreement between a pharmacist who meets the 16 qualifications of this section and a physician licensed under 17 chapter 458 or chapter 459 in which a collaborating physician 18 authorizes a pharmacist to provide specified patient care 19 services to the collaborating physician’s patients. 20 (b) “Chronic health condition” means: 21 1. Arthritis; 22 2. Asthma; 23 3. Chronic obstructive pulmonary diseases; 24 4. Type 2 diabetes; 25 5. Human immunodeficiency virus or acquired immune 26 deficiency syndrome; 27 6. Obesity; or 28 7. Any other chronic condition adopted in rule by the 29 board, in consultation with the Board of Medicine and Board of 30 Osteopathic Medicine. 31 (2) To provide services under a collaborative pharmacy 32 practice agreement, a pharmacist must be certified by the board, 33 according to the rules adopted by the board in consultation with 34 the Board of Medicine and the Board of Osteopathic Medicine. To 35 be certified, a pharmacist must, at a minimum: 36 (a) Hold an active and unencumbered license to practice 37 pharmacy in this state. 38 (b) Have earned a degree of doctor of pharmacy or have 39 completed 5 years of experience as a licensed pharmacist. 40 (c) Have completed an initial 20-hour course approved by 41 the board, in consultation with the Board of Medicine and Board 42 of Osteopathic Medicine, that includes, at a minimum, 43 instruction on the following: 44 1. Performance of patient assessments. 45 2. Ordering, performing, and interpreting clinical and 46 laboratory tests related to collaborative pharmacy practice. 47 3. Evaluating and managing diseases and health conditions 48 in collaboration with other health care practitioners. 49 4. Any other area required by board. 50 (d) Maintain at least $250,000 of professional liability 51 insurance coverage. However, a pharmacist who maintains 52 professional liability insurance coverage pursuant to s. 53 465.1895 satisfies this requirement. 54 (e) Have established a system to maintain records of all 55 patients receiving services under a collaborative pharmacy 56 practice agreement for a period of 5 years from each patient’s 57 most recent provision of service. 58 (3) The terms and conditions of the collaborative pharmacy 59 practice agreement must be appropriate to the pharmacist’s 60 training and the services delegated to the pharmacist must be 61 within the collaborating physician’s scope of practice. A copy 62 of the certification issued under subsection (2) must be 63 included as an attachment to the collaborative pharmacy practice 64 agreement. 65 (a) A collaborative pharmacy practice agreement must 66 include the following: 67 1. Name of the collaborating physician’s patient or 68 patients for whom a pharmacist may provide services. 69 2. Each chronic health condition to be collaboratively 70 managed. 71 3. Specific medicinal drug or drugs to be managed by the 72 pharmacist for each patient. 73 4. Circumstances under which the pharmacist may order or 74 perform and evaluate laboratory or clinical tests. 75 5. Conditions and events upon which the pharmacist must 76 notify the collaborating physician and the manner and timeframe 77 in which such notification must occur. 78 6. Beginning and ending dates for the collaborative 79 pharmacy practice agreement and termination procedures, 80 including procedures for patient notification and medical 81 records transfers. 82 7. A statement that the collaborative pharmacy practice 83 agreement may be terminated, in writing, by either party at any 84 time. 85 (b) A collaborative pharmacy practice agreement shall 86 automatically terminate 2 years after execution if not renewed. 87 (c) The pharmacist, along with the collaborating physician, 88 must maintain on file the collaborative pharmacy practice 89 agreement at his or her practice location, and must make such 90 agreements available to the department or board upon request or 91 inspection. 92 (d) A pharmacist who enters into a collaborative pharmacy 93 practice agreement must submit a copy of the signed agreement to 94 the board before the agreement may be implemented. 95 (4) A pharmacist may not: 96 (a) Modify or discontinue medicinal drugs prescribed by a 97 health care practitioner with whom he or she does not have a 98 collaborative pharmacy practice agreement. 99 (b) Enter into a collaborative pharmacy practice agreement 100 while acting as an employee without the written approval of the 101 owner of the pharmacy. 102 (5) A physician may not delegate the authority to initiate 103 or prescribe a controlled substance as described in s. 893.03 or 104 21 U.S.C. s. 812 to a pharmacist. 105 (6) A pharmacist who practices under a collaborative 106 pharmacy practice agreement must complete an 8-hour continuing 107 education course approved by the board that addresses issues 108 related to collaborative pharmacy practice each biennial 109 licensure renewal in addition to the continuing education 110 requirements under s. 465.009. A pharmacist must submit 111 confirmation of having completed such course when applying for 112 licensure renewal. A pharmacist who fails to comply with this 113 subsection shall be prohibited from practicing under a 114 collaborative pharmacy practice agreement under this section. 115 (7) The board, in consultation with the Board of Medicine 116 and the Board of Osteopathic Medicine, shall adopt rules 117 pursuant to ss. 120.536(1) and 120.54 to implement this section. 118 Section 4. Section 465.1895, Florida Statutes, is created 119 to read: 120 465.1895 Testing or screening for and treatment of minor, 121 nonchronic health conditions.— 122 (1) A pharmacist may test or screen for and treat minor, 123 nonchronic health conditions within the framework of an 124 established written protocol with a supervising physician 125 licensed under chapter 458 or chapter 459. For purposes of this 126 section, a minor, nonchronic health condition is typically a 127 short-term condition that is generally managed with minimal 128 treatment or self-care, and includes: 129 (a) Influenza. 130 (b) Streptococcus. 131 (c) Lice. 132 (d) Skin conditions, such as ringworm and athlete’s foot. 133 (e) Minor, uncomplicated infections. 134 (2) A pharmacist who tests or screens for and treats minor, 135 nonchronic health conditions under this section must: 136 (a) Hold an active and unencumbered license to practice 137 pharmacy in the state. 138 (b) Hold a certification issued by the board to test and 139 screen for and treat minor, nonchronic health conditions, in 140 accordance with requirements established by the board in rule in 141 consultation with the Board of Medicine and Board of Osteopathic 142 Medicine. The certification must require a pharmacist to 143 complete, on a one-time basis, a 20-hour education course 144 approved by the board in consultation with the Board of Medicine 145 and the Board of Osteopathic Medicine. The course, at a minimum, 146 must address patient assessments; point-of-care testing 147 procedures; safe and effective treatment of minor, nonchronic 148 health conditions; and identification of contraindications. 149 (c) Maintain at least $250,000 of liability coverage. A 150 pharmacist who maintains liability coverage pursuant to s. 151 465.1865 satisfies this requirement. 152 (d) Report a diagnosis or suspected existence of a disease 153 of public health significance to the department pursuant to s. 154 381.0031. 155 (e) Upon request of a patient, furnish patient records to a 156 health care practitioner designated by the patient. 157 (f) Maintain records of all patients receiving services 158 under this section for a period of 5 years from each patient’s 159 most recent provision of service. 160 (3) The board shall adopt, by rule, a formulary of 161 medicinal drugs that a pharmacist may prescribe for the minor, 162 nonchronic health conditions approved under subsection (1). The 163 formulary must include medicinal drugs approved by the United 164 States Food and Drug Administration which are indicated for 165 treatment of the minor, nonchronic health condition. The 166 formulary may not include any controlled substance as described 167 in s. 893.03 or 21 U.S.C. s. 812. 168 (4) A pharmacist who tests or screens for and treats minor, 169 nonchronic health conditions under this section may use any 170 tests that may guide diagnosis or clinical decisionmaking which 171 the Centers for Medicare and Medicaid Services has determined 172 qualifies for a waiver under the federal Clinical Laboratory 173 Improvement Amendments of 1988, or the federal rules adopted 174 thereunder, or any established screening procedures that can 175 safely be performed by a pharmacist. 176 (5) The written protocol between a pharmacist and 177 supervising physician under this subsection must include 178 particular terms and conditions imposed by the supervising 179 physician relating to the testing and screening for and 180 treatment of minor, nonchronic health conditions under this 181 section. The terms and conditions must be appropriate to the 182 pharmacist’s training. A pharmacist who enters into such a 183 protocol with a supervising physician must submit the protocol 184 to the board. 185 (a) At a minimum, the protocol shall include: 186 1. Specific categories of patients who the pharmacist is 187 authorized to test or screen for and treat minor, nonchronic 188 health conditions. 189 2. The physician’s instructions for obtaining relevant 190 patient medical history for the purpose of identifying 191 disqualifying health conditions, adverse reactions, and 192 contraindications to the approved course of treatment. 193 3. The physician’s instructions for the treatment of minor, 194 nonchronic health conditions based on the patient’s age, 195 symptoms, and test results, including negative results. 196 4. A process and schedule for the physician to review the 197 pharmacist’s actions under the protocol. 198 5. A process and schedule for the pharmacist to notify the 199 physician of the patient’s condition, tests administered, test 200 results, and course of treatment. 201 6. Any other requirements as established by the board in 202 consultation with the Board of Medicine and the Board of 203 Osteopathic Medicine. 204 (b) A pharmacist authorized to test and screen for and 205 treat minor, nonchronic conditions under a protocol shall 206 provide evidence of current certification by the board to the 207 supervising physician. A supervising physician shall review the 208 pharmacist’s actions in accordance with the protocol. 209 (6) A pharmacist providing services under this section may 210 not perform such services while acting as an employee without 211 the written approval of the owner of the pharmacy. 212 (7) A pharmacist providing services under this section must 213 complete a 3-hour continuing education course approved by the 214 board addressing issues related to minor, nonchronic health 215 conditions each biennial licensure renewal in addition to the 216 continuing education requirements under s. 465.009. Each 217 pharmacist must submit confirmation of having completed the 218 course when applying for licensure renewal. A pharmacist who 219 fails to comply with this subsection may not provide testing, 220 screening, or treatment services. 221 (8) A pharmacist providing services under this section must 222 provide a patient with written information to advise the patient 223 to seek followup care from his or her primary care physician. 224 The board, by rule, shall adopt guidelines for the circumstances 225 under which the information required under this subsection shall 226 be provided. 227 (9) The pharmacy in which a pharmacist tests and screens 228 for and treats minor, nonchronic health conditions must 229 prominently display signage indicating that any patient 230 receiving testing, screening, or treatment services under this 231 section is advised to seek followup care from his or her primary 232 care physician. 233 (10) A pharmacist providing services under this section 234 must comply with applicable state and federal laws and 235 regulations. 236 (11) The requirements of the section do not apply with 237 respect to minor, nonchronic health conditions when treated with 238 over-the-counter products. 239 Section 5. This act shall take effect July 1, 2020. 240 241 ================= T I T L E A M E N D M E N T ================ 242 And the title is amended as follows: 243 Delete lines 27 - 47 244 and insert: 245 the Board of Pharmacy to adopt rules in consultation 246 with the Board of Medicine and the Board of 247 Osteopathic Medicine; creating s. 465.1895, F.S.; 248 requiring the Board of Pharmacy to identify minor, 249 nonchronic health conditions that a pharmacist may 250 test or screen for and treat; providing requirements 251 for a pharmacist to test or screen for and treat 252 minor, nonchronic health conditions; requiring the 253 board to develop a formulary of medicinal drugs that a 254 pharmacist may prescribe; providing requirements for 255 the written protocol between a pharmacist and a 256 supervising physician; prohibiting a pharmacist from 257 providing certain services under certain 258 circumstances; requiring a pharmacist to complete a 259 specified amount of continuing education; providing 260 additional requirements for pharmacists and pharmacies 261 providing testing and screening services; providing 262 for applicability; providing an effective date.