Florida Senate - 2021 SB 768
By Senator Baxley
12-00562A-21 2021768__
1 A bill to be entitled
2 An act relating to immunizations; amending s. 381.003,
3 F.S.; requiring certain persons licensed to practice
4 pharmacy to report specified vaccination data to the
5 Department of Health’s immunization registry, with
6 exceptions; amending s. 465.189, F.S.; authorizing
7 certain pharmacists and registered interns to
8 administer specified immunizations and vaccines to
9 children within a specified age range under certain
10 circumstances; revising the specified immunizations or
11 vaccines that such pharmacists and registered interns
12 may administer; requiring authorized pharmacists and
13 registered interns to obtain a certain medical consent
14 form before administering a vaccine to a child younger
15 than 18 years of age; specifying requirements for the
16 consent form; requiring the parent or guardian of such
17 child to provide a certain opt-out form to the
18 pharmacist or registered intern to exclude the minor
19 from the department’s immunization registry; requiring
20 the pharmacist or registered intern to submit the opt
21 out form to the department; requiring authorized
22 pharmacists and registered interns to submit
23 vaccination data to the department if an opt-out form
24 is not provided; amending s. 465.003, F.S.; conforming
25 a provision to changes made by the act; providing an
26 effective date.
27
28 Be It Enacted by the Legislature of the State of Florida:
29
30 Section 1. Paragraph (e) of subsection (1) of section
31 381.003, Florida Statutes, is amended to read:
32 381.003 Communicable disease and AIDS prevention and
33 control.—
34 (1) The department shall conduct a communicable disease
35 prevention and control program as part of fulfilling its public
36 health mission. A communicable disease is any disease caused by
37 transmission of a specific infectious agent, or its toxic
38 products, from an infected person, an infected animal, or the
39 environment to a susceptible host, either directly or
40 indirectly. The communicable disease program must include, but
41 need not be limited to:
42 (e) Programs for the prevention and control of vaccine
43 preventable diseases, including programs to immunize school
44 children as required by s. 1003.22(3)-(11) and the development
45 of an automated, electronic, and centralized database and
46 registry of immunizations. The department shall ensure that all
47 children in this state are immunized against vaccine-preventable
48 diseases. The immunization registry must allow the department to
49 enhance current immunization activities for the purpose of
50 improving the immunization of all children in this state.
51 1. Except as provided in subparagraph 2., the department
52 shall include all children born in this state in the
53 immunization registry by using the birth records from the Office
54 of Vital Statistics. The department shall add other children to
55 the registry as immunization services are provided.
56 2. The parent or guardian of a child may refuse to have the
57 child included in the immunization registry by signing a form
58 obtained from the department, or from the health care
59 practitioner or entity that provides the immunization, which
60 indicates that the parent or guardian does not wish to have the
61 child included in the immunization registry. Each consent to
62 treatment form provided by a health care practitioner or by an
63 entity that administers vaccinations or causes vaccinations to
64 be administered to children from birth through 17 years of age
65 must contain a notice stating that the parent or guardian of a
66 child may refuse to have his or her child included in the
67 immunization registry. The parent or guardian must provide such
68 opt-out form to the health care practitioner or entity upon
69 administration of the vaccination. Such health care practitioner
70 or entity shall submit the form to the department. A parent or
71 guardian may submit the opt-out form directly to the department.
72 Any records or identifying information pertaining to the child
73 shall be removed from the registry, if the parent or guardian
74 has refused to have his or her child included in the
75 immunization registry.
76 3. A college or university student, from 18 years of age to
77 23 years of age, who obtains a vaccination from a college or
78 university student health center or clinic in the state may
79 refuse to be included in the immunization registry by signing a
80 form obtained from the department, health center, or clinic
81 which indicates that the student does not wish to be included in
82 the immunization registry. The student must provide such opt-out
83 form to the health center or clinic upon administration of the
84 vaccination. Such health center or clinic shall submit the form
85 to the department. A student may submit the opt-out form
86 directly to the department. Any records or identifying
87 information pertaining to the student shall be removed from the
88 registry if the student has refused to be included in the
89 immunization registry.
90 4. The immunization registry shall allow for immunization
91 records to be electronically available to entities that are
92 required by law to have such records, including, but not limited
93 to, schools and licensed child care facilities.
94 5. A health care practitioner licensed under chapter 458,
95 chapter 459, or chapter 464, or chapter 465 in this state who
96 administers vaccinations or causes vaccinations to be
97 administered to children from birth through 17 years of age is
98 required to report vaccination data to the immunization
99 registry, unless a parent or guardian of a child has refused to
100 have the child included in the immunization registry by meeting
101 the requirements of subparagraph 2. A health care practitioner
102 licensed under chapter 458, chapter 459, or chapter 464, or
103 chapter 465 in this state who administers vaccinations or causes
104 vaccinations to be administered to college or university
105 students from 18 years of age to 23 years of age at a college or
106 university student health center or clinic is required to report
107 vaccination data to the immunization registry, unless the
108 student has refused to be included in the immunization registry
109 by meeting the requirements of subparagraph 3. Vaccination data
110 for students in other age ranges may be submitted to the
111 immunization registry only if the student consents to inclusion
112 in the immunization registry. The upload of data from existing
113 automated systems is an acceptable method for updating
114 immunization information in the immunization registry. The
115 information in the immunization registry must include the
116 child’s name, date of birth, address, and any other unique
117 identifier necessary to correctly identify the child; the
118 immunization record, including the date, type of administered
119 vaccine, and vaccine lot number; and the presence or absence of
120 any adverse reaction or contraindication related to the
121 immunization. Information received by the department for the
122 immunization registry retains its status as confidential medical
123 information and the department must maintain the confidentiality
124 of that information as otherwise required by law. A health care
125 practitioner or other agency that obtains information from the
126 immunization registry must maintain the confidentiality of any
127 medical records in accordance with s. 456.057 or as otherwise
128 required by law.
129 Section 2. Present subsections (2) through (8) of section
130 465.189, Florida Statutes, are redesignated as subsections (3)
131 through (9), respectively, a new subsection (2) is added to that
132 section, and subsection (1) and present subsection (6) are
133 amended, to read:
134 465.189 Administration of vaccines and epinephrine
135 autoinjection.—
136 (1) In accordance with guidelines of the United States
137 Centers for Disease Control and Prevention for each recommended
138 immunization or vaccine, a pharmacist, or a registered intern
139 under the supervision of a pharmacist who is certified under
140 subsection (7)(6), may administer the following immunizations or
141 vaccines to a person 6 years of age or older an adult within the
142 framework of an established protocol under a supervising
143 physician licensed under chapter 458 or chapter 459:
144 (a) Immunizations or vaccines listed in the Adult
145 Immunization Schedule as of February 1, 2015, by the United
146 States Centers for Disease Control and Prevention. The board may
147 authorize, by rule, additional immunizations or vaccines as they
148 are added to the Adult Immunization Schedule.
149 (b) Immunizations or vaccines listed in the Child and
150 Adolescent Immunization Schedule by the United States Centers
151 for Disease Control and Prevention.
152 (c) Immunizations or vaccines recommended by the United
153 States Centers for Disease Control and Prevention for
154 international travel as of July 1, 2015. The board may
155 authorize, by rule, additional immunizations or vaccines as they
156 are recommended by the United States Centers for Disease Control
157 and Prevention for international travel.
158 (d)(c) Immunizations or vaccines approved by the board in
159 response to a state of emergency declared by the Governor
160 pursuant to s. 252.36.
161
162 A registered intern who administers an immunization or vaccine
163 under this subsection must be supervised by a certified
164 pharmacist at a ratio of one pharmacist to one registered
165 intern.
166 (2) To administer an immunization or vaccine to a child
167 younger than 18 years of age, a pharmacist or registered intern
168 certified under subsection (7) must first obtain a medical
169 consent form signed by a person who has the power to consent to
170 medical care or treatment on behalf of the child in accordance
171 with s. 743.0645. The medical consent form must contain a notice
172 stating that the parent or guardian of such child may refuse to
173 have the child included in the immunization registry under s.
174 381.003. If a parent or guardian does not want the child
175 included in the immunization registry, he or she must provide to
176 the pharmacist or registered intern a completed opt-out form
177 approved by the department upon administration of the vaccine.
178 The pharmacist or registered intern shall submit the opt-out
179 form to the department. If a parent or guardian of a child
180 younger than 18 years of age does not provide an opt-out form,
181 the pharmacist or registered intern must report the vaccination
182 data for such child to the department in accordance with s.
183 381.003.
184 (7)(6) Any pharmacist or registered intern seeking to
185 administer vaccines to adults under this section must be
186 certified to administer such vaccines pursuant to a
187 certification program approved by the Board of Pharmacy in
188 consultation with the Board of Medicine and the Board of
189 Osteopathic Medicine. The certification program shall, at a
190 minimum, require that the pharmacist attend at least 20 hours of
191 continuing education classes approved by the board and the
192 registered intern complete at least 20 hours of coursework
193 approved by the board. The program shall have a curriculum of
194 instruction concerning the safe and effective administration of
195 such vaccines, including, but not limited to, potential allergic
196 reactions to such vaccines.
197 Section 3. Subsection (13) of section 465.003, Florida
198 Statutes, is amended to read:
199 465.003 Definitions.—As used in this chapter, the term:
200 (13) “Practice of the profession of pharmacy” includes
201 compounding, dispensing, and consulting concerning contents,
202 therapeutic values, and uses of any medicinal drug; consulting
203 concerning therapeutic values and interactions of patent or
204 proprietary preparations, whether pursuant to prescriptions or
205 in the absence and entirely independent of such prescriptions or
206 orders; and conducting other pharmaceutical services. For
207 purposes of this subsection, the term “other pharmaceutical
208 services” means monitoring the patient’s drug therapy and
209 assisting the patient in the management of his or her drug
210 therapy, and includes reviewing, and making recommendations
211 regarding, the patient’s drug therapy and health care status in
212 communication with the patient’s prescribing health care
213 provider as licensed under chapter 458, chapter 459, chapter
214 461, or chapter 466, or a similar statutory provision in another
215 jurisdiction, or such provider’s agent or such other persons as
216 specifically authorized by the patient; and initiating,
217 modifying, or discontinuing drug therapy for a chronic health
218 condition under a collaborative pharmacy practice agreement.
219 This subsection may not be interpreted to permit an alteration
220 of a prescriber’s directions, the diagnosis or treatment of any
221 disease, the initiation of any drug therapy, the practice of
222 medicine, or the practice of osteopathic medicine, unless
223 otherwise permitted by law or specifically authorized by s.
224 465.1865 or s. 465.1895. The term “practice of the profession of
225 pharmacy” also includes any other act, service, operation,
226 research, or transaction incidental to, or forming a part of,
227 any of the foregoing acts, requiring, involving, or employing
228 the science or art of any branch of the pharmaceutical
229 profession, study, or training, and shall expressly permit a
230 pharmacist to transmit information from persons authorized to
231 prescribe medicinal drugs to their patients. The practice of the
232 profession of pharmacy also includes the administration of
233 vaccines to persons 6 years of age or older adults pursuant to
234 s. 465.189, the testing or screening for and treatment of minor,
235 nonchronic health conditions pursuant to s. 465.1895, and the
236 preparation of prepackaged drug products in facilities holding
237 Class III institutional pharmacy permits. The term also includes
238 the ordering and evaluating of any laboratory or clinical
239 testing; conducting patient assessments; and modifying,
240 discontinuing, or administering medicinal drugs pursuant to s.
241 465.0125 by a consultant pharmacist.
242 Section 4. This act shall take effect July 1, 2021.