Bill Text: FL S1094 | 2020 | Regular Session | Comm Sub
Bill Title: Practice of Pharmacy
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Introduced - Dead) 2020-03-10 - Laid on Table, refer to CS/CS/HB 599 [S1094 Detail]
Download: Florida-2020-S1094-Comm_Sub.html
Florida Senate - 2020 CS for CS for SB 1094
By the Committees on Appropriations; and Health Policy; and
Senator Diaz
576-04564-20 20201094c2
1 A bill to be entitled
2 An act relating to the practice of pharmacy; amending
3 s. 381.0031, F.S.; requiring certain licensed
4 pharmacists to report specified information relating
5 to public health to the Department of Health; amending
6 s. 465.003, F.S.; revising the definition of the term
7 “practice of the profession of pharmacy”; amending s.
8 465.0125, F.S.; requiring a pharmacist to complete
9 additional training to be licensed as a consultant
10 pharmacist; authorizing a consultant pharmacist to
11 perform specified services under certain circumstances
12 and within the scope of a written collaborative
13 practice agreement with certain health care
14 practitioners; providing requirements for the
15 agreement; prohibiting a consultant pharmacist from
16 modifying or discontinuing medicinal drugs prescribed
17 by a health care practitioner without a written
18 collaborative practice agreement; revising the
19 responsibilities of a consultant pharmacist; requiring
20 written collaborative practice agreements to be made
21 available upon request from or upon inspection by the
22 Department of Health; prohibiting a consultant
23 pharmacist from diagnosing any disease or condition;
24 defining the term “health care facility”; creating s.
25 465.1865, F.S.; defining the terms “collaborative
26 pharmacy practice agreement” and “chronic health
27 condition”; specifying criteria a pharmacist must meet
28 to provide services under a collaborative pharmacy
29 practice agreement; providing requirements for
30 collaborative pharmacy practice agreements; providing
31 for the renewal of such agreements; requiring
32 collaborating pharmacists and physicians to maintain a
33 copy of the collaborative pharmacy practice agreements
34 at their practices and make such agreements available
35 upon request or inspection; requiring pharmacists to
36 submit a copy of the signed collaborative pharmacy
37 practice agreement to the Board of Pharmacy before
38 implementing it; prohibiting pharmacists from engaging
39 in specified activities without a collaborative
40 pharmacy practice agreement; prohibiting pharmacists
41 from entering into collaborative pharmacy practice
42 agreements under certain circumstances; prohibiting
43 collaborating physicians from delegating to
44 pharmacists the authority to initiate or prescribe a
45 controlled substance; providing continuing education
46 requirements for pharmacists practicing under
47 collaborative pharmacy practice agreements; requiring
48 the Board of Medicine in consultation with the Board
49 of Osteopathic Medicine and the Board of Pharmacy to
50 adopt rules; providing an effective date.
51
52 Be It Enacted by the Legislature of the State of Florida:
53
54 Section 1. Subsection (2) of section 381.0031, Florida
55 Statutes, is amended to read:
56 381.0031 Epidemiological research; report of diseases of
57 public health significance to department.—
58 (2) Any practitioner licensed in this state to practice
59 medicine, osteopathic medicine, chiropractic medicine,
60 naturopathy, or veterinary medicine; any licensed pharmacist
61 authorized under a collaborative pharmacy practice agreement, as
62 defined in s. 465.1865, to perform or order and evaluate
63 laboratory and clinical tests; any hospital licensed under part
64 I of chapter 395; or any laboratory appropriately certified by
65 the Centers for Medicare and Medicaid Services under the federal
66 Clinical Laboratory Improvement Amendments and the federal rules
67 adopted thereunder which diagnoses or suspects the existence of
68 a disease of public health significance shall immediately report
69 the fact to the Department of Health.
70 Section 2. Subsection (13) of section 465.003, Florida
71 Statutes, is amended to read:
72 465.003 Definitions.—As used in this chapter, the term:
73 (13) “Practice of the profession of pharmacy” includes
74 compounding, dispensing, and consulting concerning contents,
75 therapeutic values, and uses of any medicinal drug; consulting
76 concerning therapeutic values and interactions of patent or
77 proprietary preparations, whether pursuant to prescriptions or
78 in the absence and entirely independent of such prescriptions or
79 orders; and conducting other pharmaceutical services. For
80 purposes of this subsection, the term “other pharmaceutical
81 services” means the monitoring of the patient’s drug therapy and
82 assisting the patient in the management of his or her drug
83 therapy; reviewing and making recommendations regarding, and
84 includes review of the patient’s drug therapy and health care
85 status in communication with the patient’s prescribing health
86 care provider as licensed under chapter 458, chapter 459,
87 chapter 461, or chapter 466, or a similar statutory provision in
88 another jurisdiction, or such provider’s agent or such other
89 persons as specifically authorized by the patient; and
90 initiating, modifying, or discontinuing drug therapy for a
91 chronic health condition under a collaborative pharmacy practice
92 agreement, regarding the drug therapy. However, Nothing in this
93 subsection may be interpreted to permit an alteration of a
94 prescriber’s directions, the diagnosis or treatment of any
95 disease, the initiation of any drug therapy, the practice of
96 medicine, or the practice of osteopathic medicine, unless
97 otherwise permitted by law or specifically authorized by s.
98 465.1865. The term “Practice of the profession of pharmacy” also
99 includes any other act, service, operation, research, or
100 transaction incidental to, or forming a part of, any of the
101 foregoing acts, requiring, involving, or employing the science
102 or art of any branch of the pharmaceutical profession, study, or
103 training, and shall expressly permit a pharmacist to transmit
104 information from persons authorized to prescribe medicinal drugs
105 to their patients. The practice of the profession of pharmacy
106 also includes the administration of vaccines to adults pursuant
107 to s. 465.189 and the preparation of prepackaged drug products
108 in facilities holding Class III institutional pharmacy permits.
109 The term also includes ordering and evaluating any laboratory or
110 clinical testing; conducting patient assessments; and modifying,
111 discontinuing, or administering medicinal drugs pursuant to s.
112 465.0125 by a consultant pharmacist.
113 Section 3. Section 465.0125, Florida Statutes, is amended
114 to read:
115 465.0125 Consultant pharmacist license; application,
116 renewal, fees; responsibilities; rules.—
117 (1) The department shall issue or renew a consultant
118 pharmacist license upon receipt of an initial or renewal
119 application that which conforms to the requirements for
120 consultant pharmacist initial licensure or renewal as adopted
121 promulgated by the board by rule and a fee set by the board not
122 to exceed $250. To be licensed as a consultant pharmacist, a
123 pharmacist must complete additional training as required by the
124 board.
125 (a) A consultant pharmacist may provide medication
126 management services in a health care facility within the
127 framework of a written collaborative practice agreement between
128 the pharmacist and a health care facility medical director or a
129 physician licensed under chapter 458 or chapter 459, a podiatric
130 physician licensed under chapter 461, or a dentist licensed
131 under chapter 466 who is authorized to prescribe medicinal
132 drugs. A consultant pharmacist may provide medication management
133 services, conduct patient assessments, and order and evaluate
134 laboratory or clinical testing only for patients of the health
135 care practitioner with whom the consultant pharmacist has a
136 written collaborative practice agreement.
137 (b) A written collaborative practice agreement must outline
138 the circumstances under which the consultant pharmacist may:
139 1. Order and evaluate any laboratory or clinical tests to
140 promote and evaluate patient health and wellness, and monitor
141 drug therapy and treatment outcomes.
142 2. Conduct patient assessments as appropriate to evaluate
143 and monitor drug therapy.
144 3. Modify or discontinue medicinal drugs as outlined in the
145 agreed-upon patient-specific order or preapproved treatment
146 protocol under the direction of a physician. However, a
147 consultant pharmacist may not modify or discontinue medicinal
148 drugs prescribed by a health care practitioner who does not have
149 a written collaborative practice agreement with the consultant
150 pharmacist.
151 4. Administer medicinal drugs.
152 (c) A The consultant pharmacist shall maintain be
153 responsible for maintaining all drug, patient care, and quality
154 assurance records as required by law and, with the collaborating
155 practitioner, maintain written collaborative practice agreements
156 that must be available upon request from or upon inspection by
157 the department.
158 (d) This subsection does not authorize a consultant
159 pharmacist to diagnose any disease or condition.
160 (e) For purposes of this subsection, the term “health care
161 facility” means an ambulatory surgical center or hospital
162 licensed under chapter 395, an alcohol or chemical dependency
163 treatment center licensed under chapter 397, an inpatient
164 hospice licensed under part IV of chapter 400, a nursing home
165 licensed under part II of chapter 400, an ambulatory care center
166 as defined in s. 408.07, or a nursing home component licensed
167 under chapter 400 within a continuing care facility licensed
168 under chapter 651 for establishing drug handling procedures for
169 the safe handling and storage of drugs. The consultant
170 pharmacist may also be responsible for ordering and evaluating
171 any laboratory or clinical testing when, in the judgment of the
172 consultant pharmacist, such activity is necessary for the proper
173 performance of the consultant pharmacist’s responsibilities.
174 Such laboratory or clinical testing may be ordered only with
175 regard to patients residing in a nursing home facility, and then
176 only when authorized by the medical director of the nursing home
177 facility. The consultant pharmacist must have completed such
178 additional training and demonstrate such additional
179 qualifications in the practice of institutional pharmacy as
180 shall be required by the board in addition to licensure as a
181 registered pharmacist.
182 (2) Notwithstanding the provisions of subsection (1), a
183 consultant pharmacist or a doctor of pharmacy licensed in this
184 state may also be responsible for ordering and evaluating any
185 laboratory or clinical testing for persons under the care of a
186 licensed home health agency when, in the judgment of the
187 consultant pharmacist or doctor of pharmacy, such activity is
188 necessary for the proper performance of his or her
189 responsibilities and only when authorized by a practitioner
190 licensed under chapter 458, chapter 459, chapter 461, or chapter
191 466. In order for the consultant pharmacist or doctor of
192 pharmacy to qualify and accept this authority, he or she must
193 receive 3 hours of continuing education relating to laboratory
194 and clinical testing as established by the board.
195 (3) The board shall adopt promulgate rules necessary to
196 implement and administer this section.
197 Section 4. Section 465.1865, Florida Statutes, is created
198 to read:
199 465.1865 Collaborative pharmacy practice for chronic health
200 conditions.—
201 (1) For purposes of this section, the term:
202 (a) “Collaborative pharmacy practice agreement” means a
203 written agreement between a pharmacist who meets the
204 qualifications of this section and a physician licensed under
205 chapter 458 or chapter 459 in which a collaborating physician
206 authorizes a pharmacist to provide specified patient care
207 services to the collaborating physician′s patients.
208 (b) “Chronic health condition” means:
209 1. Arthritis;
210 2. Asthma;
211 3. Chronic obstructive pulmonary diseases;
212 4. Type 2 diabetes;
213 5. Human immunodeficiency virus or acquired immune
214 deficiency syndrome; or
215 6. Obesity.
216 (2) To provide services under a collaborative pharmacy
217 practice agreement, a pharmacist must be certified according to
218 rules of the Board of Medicine that he or she:
219 (a) Holds an active and unencumbered license to practice
220 pharmacy in the state.
221 (b) Has earned a degree of doctor of pharmacy or has
222 completed 5 years of experience as a licensed pharmacist.
223 (c) Has completed an initial 20-hour course approved by the
224 Board of Medicine in consultation with the Board of Osteopathic
225 Medicine and the Board of Pharmacy which includes, at a minimum,
226 instruction on all of the following:
227 1. Performance of patient assessments.
228 2. Ordering, performing, and interpreting clinical and
229 laboratory tests related to collaborative pharmacy practice.
230 3. Evaluating and managing diseases and health conditions
231 in collaboration with other health care practitioners.
232 4. Any other area required by Board of Medicine rule,
233 adopted in consultation with the Board of Osteopathic Medicine
234 and the Board of Pharmacy.
235 (d) Maintains at least $250,000 of professional liability
236 insurance coverage. However, a pharmacist who maintains
237 professional liability insurance coverage of at least $250,000
238 under a written protocol with a supervising physician for the
239 testing for and treatment of minor nonchronic health conditions
240 satisfies this requirement.
241 (e) Has established a system to maintain records of all
242 patients receiving services under a collaborative pharmacy
243 practice agreement for a period of 5 years.
244 (3) The terms and conditions of the collaborative pharmacy
245 practice agreement must be appropriate to the pharmacist′s
246 education and training and the services delegated to the
247 pharmacist must be within the collaborating physician′s scope of
248 practice. A copy of the certification issued under subsection
249 (2) must be included as an attachment to the collaborative
250 pharmacy practice agreement.
251 (a) A collaborative pharmacy practice agreement must
252 include the following:
253 1. Name of the collaborating physician′s patient or
254 patients for whom a pharmacist may provide services.
255 2. Each chronic health condition to be collaboratively
256 managed.
257 3. Specific medicinal drug or drugs to be managed by the
258 pharmacist.
259 4. Circumstances under which the pharmacist may order or
260 perform and evaluate laboratory or clinical tests.
261 5. Conditions and events upon which the pharmacist must
262 notify the collaborating physician and the manner and timeframe
263 in which such notification must occur.
264 6. Beginning and ending dates for the collaborative
265 pharmacy practice agreement and termination procedures,
266 including procedures for patient notification and medical
267 records transfers.
268 7. A statement that the collaborative pharmacy practice
269 agreement may be terminated, in writing, by either party at any
270 time.
271 (b) A collaborative pharmacy practice agreement must be
272 renewed at least every 2 years.
273 (c) The pharmacist, along with the collaborating physician,
274 must maintain on file the collaborative pharmacy practice
275 agreement at his or her practice location and must make such
276 agreements available upon request or inspection.
277 (d) A pharmacist who enters into a collaborative pharmacy
278 practice agreement must submit a copy of the signed agreement to
279 the Board of Pharmacy before the agreement may be implemented.
280 (4) A pharmacist may not:
281 (a) Modify or discontinue medicinal drugs prescribed by a
282 health care practitioner with whom he or she does not have a
283 collaborative pharmacy practice agreement.
284 (b) Enter into a collaborative pharmacy practice agreement
285 while acting as an employee without the written approval of the
286 owner of the pharmacy.
287 (5) A physician may not delegate to a pharmacist the
288 authority to initiate or prescribe a controlled substance as
289 described in s. 893.03 or 21 U.S.C. s. 812.
290 (6) In addition to the continuing education requirements
291 under s. 465.009, a pharmacist who practices under a
292 collaborative pharmacy practice agreement must, for each
293 biennial licensure renewal, complete an 8-hour continuing
294 education course approved by the Board of Medicine in
295 consultation with the Board of Osteopathic Medicine and the
296 Board of Pharmacy which addresses issues related to the chronic
297 conditions to be collaboratively managed. Such pharmacist must
298 submit confirmation of having completed such course when
299 applying for licensure renewal. A pharmacist who fails to comply
300 with this subsection shall be prohibited from practicing under a
301 collaborative pharmacy practice agreement under this section.
302 (7) The Board of Medicine in consultation with the Board of
303 Osteopathic Medicine and the Board of Pharmacy shall adopt rules
304 pursuant to ss. 120.536(1) and 120.54 to implement this section.
305 Section 5. This act shall take effect July 1, 2020.
