Florida Senate - 2020 COMMITTEE AMENDMENT
Bill No. CS for SB 1094
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LEGISLATIVE ACTION
Senate . House
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The Committee on Appropriations (Diaz) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsection (2) of section 381.0031, Florida
6 Statutes, is amended to read:
7 381.0031 Epidemiological research; report of diseases of
8 public health significance to department.—
9 (2) Any practitioner licensed in this state to practice
10 medicine, osteopathic medicine, chiropractic medicine,
11 naturopathy, or veterinary medicine; any licensed pharmacist
12 authorized under a collaborative pharmacy practice agreement, as
13 defined in s. 465.1865, to perform or order and evaluate
14 laboratory and clinical tests; any hospital licensed under part
15 I of chapter 395; or any laboratory appropriately certified by
16 the Centers for Medicare and Medicaid Services under the federal
17 Clinical Laboratory Improvement Amendments and the federal rules
18 adopted thereunder which diagnoses or suspects the existence of
19 a disease of public health significance shall immediately report
20 the fact to the Department of Health.
21 Section 2. Subsection (13) of section 465.003, Florida
22 Statutes, is amended to read:
23 465.003 Definitions.—As used in this chapter, the term:
24 (13) “Practice of the profession of pharmacy” includes
25 compounding, dispensing, and consulting concerning contents,
26 therapeutic values, and uses of any medicinal drug; consulting
27 concerning therapeutic values and interactions of patent or
28 proprietary preparations, whether pursuant to prescriptions or
29 in the absence and entirely independent of such prescriptions or
30 orders; and conducting other pharmaceutical services. For
31 purposes of this subsection, the term “other pharmaceutical
32 services” means the monitoring of the patient’s drug therapy and
33 assisting the patient in the management of his or her drug
34 therapy; reviewing and making recommendations regarding, and
35 includes review of the patient’s drug therapy and health care
36 status in communication with the patient’s prescribing health
37 care provider as licensed under chapter 458, chapter 459,
38 chapter 461, or chapter 466, or a similar statutory provision in
39 another jurisdiction, or such provider’s agent or such other
40 persons as specifically authorized by the patient; and
41 initiating, modifying, or discontinuing drug therapy for a
42 chronic health condition under a collaborative pharmacy practice
43 agreement, regarding the drug therapy. However, Nothing in this
44 subsection may be interpreted to permit an alteration of a
45 prescriber’s directions, the diagnosis or treatment of any
46 disease, the initiation of any drug therapy, the practice of
47 medicine, or the practice of osteopathic medicine, unless
48 otherwise permitted by law or specifically authorized by s.
49 465.1865. The term “Practice of the profession of pharmacy” also
50 includes any other act, service, operation, research, or
51 transaction incidental to, or forming a part of, any of the
52 foregoing acts, requiring, involving, or employing the science
53 or art of any branch of the pharmaceutical profession, study, or
54 training, and shall expressly permit a pharmacist to transmit
55 information from persons authorized to prescribe medicinal drugs
56 to their patients. The practice of the profession of pharmacy
57 also includes the administration of vaccines to adults pursuant
58 to s. 465.189 and the preparation of prepackaged drug products
59 in facilities holding Class III institutional pharmacy permits.
60 The term also includes ordering and evaluating any laboratory or
61 clinical testing; conducting patient assessments; and modifying,
62 discontinuing, or administering medicinal drugs pursuant to s.
63 465.0125 by a consultant pharmacist.
64 Section 3. Section 465.0125, Florida Statutes, is amended
65 to read:
66 465.0125 Consultant pharmacist license; application,
67 renewal, fees; responsibilities; rules.—
68 (1) The department shall issue or renew a consultant
69 pharmacist license upon receipt of an initial or renewal
70 application that which conforms to the requirements for
71 consultant pharmacist initial licensure or renewal as adopted
72 promulgated by the board by rule and a fee set by the board not
73 to exceed $250. To be licensed as a consultant pharmacist, a
74 pharmacist must complete additional training as required by the
75 board.
76 (a) A consultant pharmacist may provide medication
77 management services in a health care facility within the
78 framework of a written collaborative practice agreement between
79 the pharmacist and a health care facility medical director or a
80 physician licensed under chapter 458 or chapter 459, a podiatric
81 physician licensed under chapter 461, or a dentist licensed
82 under chapter 466 who is authorized to prescribe medicinal
83 drugs. A consultant pharmacist may provide medication management
84 services, conduct patient assessments, and order and evaluate
85 laboratory or clinical testing only for patients of the health
86 care practitioner with whom the consultant pharmacist has a
87 written collaborative practice agreement.
88 (b) A written collaborative practice agreement must outline
89 the circumstances under which the consultant pharmacist may:
90 1. Order and evaluate any laboratory or clinical tests to
91 promote and evaluate patient health and wellness, and monitor
92 drug therapy and treatment outcomes.
93 2. Conduct patient assessments as appropriate to evaluate
94 and monitor drug therapy.
95 3. Modify or discontinue medicinal drugs as outlined in the
96 agreed-upon patient-specific order or preapproved treatment
97 protocol under the direction of a physician. However, a
98 consultant pharmacist may not modify or discontinue medicinal
99 drugs prescribed by a health care practitioner who does not have
100 a written collaborative practice agreement with the consultant
101 pharmacist.
102 4. Administer medicinal drugs.
103 (c) A The consultant pharmacist shall maintain be
104 responsible for maintaining all drug, patient care, and quality
105 assurance records as required by law and, with the collaborating
106 practitioner, maintain written collaborative practice agreements
107 that must be available upon request from or upon inspection by
108 the department.
109 (d) This subsection does not authorize a consultant
110 pharmacist to diagnose any disease or condition.
111 (e) For purposes of this subsection, the term “health care
112 facility” means an ambulatory surgical center or hospital
113 licensed under chapter 395, an alcohol or chemical dependency
114 treatment center licensed under chapter 397, an inpatient
115 hospice licensed under part IV of chapter 400, a nursing home
116 licensed under part II of chapter 400, an ambulatory care center
117 as defined in s. 408.07, or a nursing home component licensed
118 under chapter 400 within a continuing care facility licensed
119 under chapter 651 for establishing drug handling procedures for
120 the safe handling and storage of drugs. The consultant
121 pharmacist may also be responsible for ordering and evaluating
122 any laboratory or clinical testing when, in the judgment of the
123 consultant pharmacist, such activity is necessary for the proper
124 performance of the consultant pharmacist’s responsibilities.
125 Such laboratory or clinical testing may be ordered only with
126 regard to patients residing in a nursing home facility, and then
127 only when authorized by the medical director of the nursing home
128 facility. The consultant pharmacist must have completed such
129 additional training and demonstrate such additional
130 qualifications in the practice of institutional pharmacy as
131 shall be required by the board in addition to licensure as a
132 registered pharmacist.
133 (2) Notwithstanding the provisions of subsection (1), a
134 consultant pharmacist or a doctor of pharmacy licensed in this
135 state may also be responsible for ordering and evaluating any
136 laboratory or clinical testing for persons under the care of a
137 licensed home health agency when, in the judgment of the
138 consultant pharmacist or doctor of pharmacy, such activity is
139 necessary for the proper performance of his or her
140 responsibilities and only when authorized by a practitioner
141 licensed under chapter 458, chapter 459, chapter 461, or chapter
142 466. In order for the consultant pharmacist or doctor of
143 pharmacy to qualify and accept this authority, he or she must
144 receive 3 hours of continuing education relating to laboratory
145 and clinical testing as established by the board.
146 (3) The board shall adopt promulgate rules necessary to
147 implement and administer this section.
148 Section 4. Section 465.1865, Florida Statutes, is created
149 to read:
150 465.1865 Collaborative pharmacy practice for chronic health
151 conditions.—
152 (1) For purposes of this section, the term:
153 (a) “Collaborative pharmacy practice agreement” means a
154 written agreement between a pharmacist who meets the
155 qualifications of this section and a physician licensed under
156 chapter 458 or chapter 459 in which a collaborating physician
157 authorizes a pharmacist to provide specified patient care
158 services to the collaborating physician′s patients.
159 (b) “Chronic health condition” means:
160 1. Arthritis;
161 2. Asthma;
162 3. Chronic obstructive pulmonary diseases;
163 4. Type 2 diabetes;
164 5. Human immunodeficiency virus or acquired immune
165 deficiency syndrome; or
166 6. Obesity.
167 (2) To provide services under a collaborative pharmacy
168 practice agreement, a pharmacist must be certified according to
169 rules of the Board of Medicine that he or she:
170 (a) Holds an active and unencumbered license to practice
171 pharmacy in the state.
172 (b) Has earned a degree of doctor of pharmacy or has
173 completed 5 years of experience as a licensed pharmacist.
174 (c) Has completed an initial 20-hour course approved by the
175 Board of Medicine in consultation with the Board of Osteopathic
176 Medicine and the Board of Pharmacy which includes, at a minimum,
177 instruction on all of the following:
178 1. Performance of patient assessments.
179 2. Ordering, performing, and interpreting clinical and
180 laboratory tests related to collaborative pharmacy practice.
181 3. Evaluating and managing diseases and health conditions
182 in collaboration with other health care practitioners.
183 4. Any other area required by Board of Medicine rule,
184 adopted in consultation with the Board of Osteopathic Medicine
185 and the Board of Pharmacy.
186 (d) Maintains at least $250,000 of professional liability
187 insurance coverage. However, a pharmacist who maintains
188 professional liability insurance coverage of at least $250,000
189 under a written protocol with a supervising physician for the
190 testing for and treatment of minor nonchronic health conditions
191 satisfies this requirement.
192 (e) Has established a system to maintain records of all
193 patients receiving services under a collaborative pharmacy
194 practice agreement for a period of 5 years.
195 (3) The terms and conditions of the collaborative pharmacy
196 practice agreement must be appropriate to the pharmacist′s
197 education and training and the services delegated to the
198 pharmacist must be within the collaborating physician′s scope of
199 practice. A copy of the certification issued under subsection
200 (2) must be included as an attachment to the collaborative
201 pharmacy practice agreement.
202 (a) A collaborative pharmacy practice agreement must
203 include the following:
204 1. Name of the collaborating physician′s patient or
205 patients for whom a pharmacist may provide services.
206 2. Each chronic health condition to be collaboratively
207 managed.
208 3. Specific medicinal drug or drugs to be managed by the
209 pharmacist.
210 4. Circumstances under which the pharmacist may order or
211 perform and evaluate laboratory or clinical tests.
212 5. Conditions and events upon which the pharmacist must
213 notify the collaborating physician and the manner and timeframe
214 in which such notification must occur.
215 6. Beginning and ending dates for the collaborative
216 pharmacy practice agreement and termination procedures,
217 including procedures for patient notification and medical
218 records transfers.
219 7. A statement that the collaborative pharmacy practice
220 agreement may be terminated, in writing, by either party at any
221 time.
222 (b) A collaborative pharmacy practice agreement must be
223 renewed at least every 2 years.
224 (c) The pharmacist, along with the collaborating physician,
225 must maintain on file the collaborative pharmacy practice
226 agreement at his or her practice location and must make such
227 agreements available upon request or inspection.
228 (d) A pharmacist who enters into a collaborative pharmacy
229 practice agreement must submit a copy of the signed agreement to
230 the Board of Pharmacy before the agreement may be implemented.
231 (4) A pharmacist may not:
232 (a) Modify or discontinue medicinal drugs prescribed by a
233 health care practitioner with whom he or she does not have a
234 collaborative pharmacy practice agreement.
235 (b) Enter into a collaborative pharmacy practice agreement
236 while acting as an employee without the written approval of the
237 owner of the pharmacy.
238 (5) A physician may not delegate to a pharmacist the
239 authority to initiate or prescribe a controlled substance as
240 described in s. 893.03 or 21 U.S.C. s. 812.
241 (6) In addition to the continuing education requirements
242 under s. 465.009, a pharmacist who practices under a
243 collaborative pharmacy practice agreement must, for each
244 biennial licensure renewal, complete an 8-hour continuing
245 education course approved by the Board of Medicine in
246 consultation with the Board of Osteopathic Medicine and the
247 Board of Pharmacy which addresses issues related to the chronic
248 conditions to be collaboratively managed. Such pharmacist must
249 submit confirmation of having completed such course when
250 applying for licensure renewal. A pharmacist who fails to comply
251 with this subsection shall be prohibited from practicing under a
252 collaborative pharmacy practice agreement under this section.
253 (7) The Board of Medicine in consultation with the Board of
254 Osteopathic Medicine and the Board of Pharmacy shall adopt rules
255 pursuant to ss. 120.536(1) and 120.54 to implement this section.
256 Section 5. This act shall take effect July 1, 2020.
257
258 ================= T I T L E A M E N D M E N T ================
259 And the title is amended as follows:
260 Delete everything before the enacting clause
261 and insert:
262 A bill to be entitled
263 An act relating to the practice of pharmacy; amending
264 s. 381.0031, F.S.; requiring specified licensed
265 pharmacists to report certain information relating to
266 public health to the Department of Health; amending s.
267 465.003, F.S.; revising the definition of the term
268 “practice of the profession of pharmacy”; amending s.
269 465.0125, F.S.; requiring a pharmacist to complete
270 additional training to be licensed as a consultant
271 pharmacist; authorizing a consultant pharmacist to
272 perform specified services under certain conditions;
273 prohibiting a consultant pharmacist from modifying or
274 discontinuing medicinal drugs prescribed by a health
275 care practitioner under certain conditions; revising
276 the responsibilities of a consultant pharmacist;
277 requiring a consultant pharmacist and a collaborating
278 practitioner to maintain collaborative practice
279 agreements; requiring collaborative practice
280 agreements to be made available upon request from or
281 upon inspection by the Department of Health;
282 prohibiting a consultant pharmacist from diagnosing
283 any disease or condition; defining the term “health
284 care facility”; creating s. 465.1865, F.S.; defining
285 terms; providing requirements for pharmacists to
286 provide services under a collaborative pharmacy
287 practice agreement; requiring the terms and conditions
288 of such agreement to be appropriate to the training of
289 the pharmacist and the scope of practice of the
290 physician; requiring notification to the Board of
291 Pharmacy upon practicing under a collaborative
292 pharmacy practice agreement; requiring pharmacists to
293 submit a copy of the signed collaborative pharmacy
294 practice agreement to the Board of Pharmacy; providing
295 for the maintenance of patient records for a certain
296 timeframe; providing for renewal of such agreement;
297 requiring a pharmacist and the collaborating physician
298 to maintain on file and make available the
299 collaborative pharmacy practice agreement; prohibiting
300 certain actions relating to such agreement; requiring
301 specified continuing education for a pharmacist who
302 practices under a collaborative pharmacy practice
303 agreement; requiring the Board of Medicine in
304 consultation with the Board of Osteopathic Medicine
305 and the Board of Pharmacy to adopt rules; providing an
306 effective date.