Florida Senate - 2012 CS for SB 850
By the Committee on Budget Subcommittee on Health and Human
Services Appropriations; and Senator Oelrich
603-03209-12 2012850c1
1 A bill to be entitled
2 An act relating to pharmacy; amending s. 465.189,
3 F.S.; revising the types of vaccines that pharmacists
4 may administer under certain circumstances;
5 authorizing pharmacists to administer an influenza
6 vaccine, an epinephrine autoinjection, or a shingles
7 vaccine within the framework of an established
8 protocol under certain circumstances; amending s.
9 465.003, F.S.; revising the definition of the term
10 “practice of the profession of pharmacy” to conform to
11 changes made by the act; amending s. 465.009, F.S.;
12 revising continuing professional pharmaceutical
13 educational requirements with respect to administering
14 such vaccines or autoinjection; providing effective
15 dates.
16
17 Be It Enacted by the Legislature of the State of Florida:
18
19 Section 1. Subsections (2) through (7) of section 465.189,
20 Florida Statutes, are renumbered as subsections (4) through (9),
21 respectively, and new subsections (1), (2), and (3) are added to
22 that section, to read:
23 465.189 Administration of vaccines and epinephrine
24 autoinjection influenza virus immunizations.—
25 (1) In accordance with guidelines of the Centers for
26 Disease Control and Prevention for each recommended immunization
27 or vaccine, a pharmacist may administer the following vaccines
28 to an adult within the framework of an established protocol
29 under a supervising physician licensed under chapter 458 or
30 chapter 459:
31 (a) Influenza vaccine.
32 (b) Pneumococcal vaccine.
33 (2) In accordance with guidelines of the Centers for
34 Disease Control and Prevention, a pharmacist may administer the
35 shingles vaccine within the framework of an established protocol
36 and pursuant to a written or electronic prescription issued to
37 the patient by a physician licensed under chapter 458 or chapter
38 459.
39 (3) In order to address any unforeseen allergic reaction, a
40 pharmacist may administer epinephrine using an autoinjector
41 delivery system within the framework of an established protocol
42 under a supervising physician licensed under chapter 458 or
43 chapter 459.
44 (1) Pharmacists may administer influenza virus
45 immunizations to adults within the framework of an established
46 protocol under a supervisory practitioner who is a physician
47 licensed under chapter 458 or chapter 459. Each protocol shall
48 contain specific procedures for addressing any unforeseen
49 allergic reaction to influenza virus immunizations.
50 (4)(2) A pharmacist may not enter into a protocol unless he
51 or she maintains at least $200,000 of professional liability
52 insurance and has completed training in administering vaccines
53 authorized under influenza virus immunizations as provided in
54 this section.
55 (5)(3) A pharmacist administering vaccines under this
56 section influenza virus immunizations shall maintain and make
57 available patient records using the same standards for
58 confidentiality and maintenance of such records as those that
59 are imposed on health care practitioners under s. 456.057. These
60 records shall be maintained for a minimum of 5 years.
61 (6)(4) The decision by a supervising physician licensed
62 under chapter 458 or chapter 459 supervisory practitioner to
63 enter into a protocol under this section is a professional
64 decision on the part of the practitioner, and a person may not
65 interfere with a physician’s supervisory practitioner’s decision
66 as to entering into such a protocol. A pharmacist may not enter
67 into a protocol that is to be performed while acting as an
68 employee without the written approval of the owner of the
69 pharmacy. Pharmacists shall forward vaccination immunization
70 records to the department for inclusion in the state registry of
71 immunization information.
72 (7)(5) Any pharmacist seeking to administer vaccines
73 influenza virus immunizations to adults under this section must
74 be certified to administer such vaccines influenza virus
75 immunizations pursuant to a certification program approved by
76 the Board of Pharmacy in consultation with the Board of Medicine
77 and the Board of Osteopathic Medicine. The certification program
78 shall, at a minimum, require that the pharmacist attend at least
79 20 hours of continuing education classes approved by the board.
80 The program shall have a curriculum of instruction concerning
81 the safe and effective administration of such vaccines influenza
82 virus immunizations, including, but not limited to, potential
83 allergic reactions to such vaccines influenza virus
84 immunizations.
85 (8)(6) The written protocol between the pharmacist and
86 supervising physician under this section must include particular
87 terms and conditions imposed by the supervising physician upon
88 the pharmacist relating to the administration of vaccines
89 influenza virus immunizations by the pharmacist pursuant to this
90 section. The written protocol shall include, at a minimum,
91 specific categories and conditions among patients for whom the
92 supervising physician authorizes the pharmacist to administer
93 such vaccines influenza virus immunizations. The terms, scope,
94 and conditions set forth in the written protocol between the
95 pharmacist and the supervising physician must be appropriate to
96 the pharmacist’s training and certification for administering
97 such vaccines immunization. Pharmacists who have been delegated
98 the authority to administer vaccines under this section
99 influenza virus immunizations by the supervising physician under
100 the protocol shall provide evidence of current certification by
101 the Board of Pharmacy to the supervising physician. A
102 supervising physician physicians shall review the administration
103 of such vaccines influenza virus immunizations by the pharmacist
104 pharmacists under such physician’s supervision pursuant to the
105 written protocol between them, and this review shall take place
106 as outlined in the written protocol. The process and schedule
107 for the review shall be outlined in the written protocol between
108 the pharmacist and the supervising physician.
109 (9)(7) The pharmacist shall submit to the Board of Pharmacy
110 a copy of his or her protocol or written agreement to administer
111 vaccines under this section influenza virus immunizations.
112 Section 2. Subsection (13) of section 465.003, Florida
113 Statutes, is amended to read:
114 465.003 Definitions.—As used in this chapter, the term:
115 (13) “Practice of the profession of pharmacy” includes
116 compounding, dispensing, and consulting concerning contents,
117 therapeutic values, and uses of any medicinal drug; consulting
118 concerning therapeutic values and interactions of patent or
119 proprietary preparations, whether pursuant to prescriptions or
120 in the absence and entirely independent of such prescriptions or
121 orders; and other pharmaceutical services. For purposes of this
122 subsection, “other pharmaceutical services” means the monitoring
123 of the patient’s drug therapy and assisting the patient in the
124 management of his or her drug therapy, and includes review of
125 the patient’s drug therapy and communication with the patient’s
126 prescribing health care provider as licensed under chapter 458,
127 chapter 459, chapter 461, or chapter 466, or similar statutory
128 provision in another jurisdiction, or such provider’s agent or
129 such other persons as specifically authorized by the patient,
130 regarding the drug therapy. However, nothing in this subsection
131 may be interpreted to permit an alteration of a prescriber’s
132 directions, the diagnosis or treatment of any disease, the
133 initiation of any drug therapy, the practice of medicine, or the
134 practice of osteopathic medicine, unless otherwise permitted by
135 law. “Practice of the profession of pharmacy” also includes any
136 other act, service, operation, research, or transaction
137 incidental to, or forming a part of, any of the foregoing acts,
138 requiring, involving, or employing the science or art of any
139 branch of the pharmaceutical profession, study, or training, and
140 shall expressly permit a pharmacist to transmit information from
141 persons authorized to prescribe medicinal drugs to their
142 patients. The practice of the profession of pharmacy also
143 includes the administration of vaccines influenza virus
144 immunizations to adults pursuant to s. 465.189.
145 Section 3. Effective October 1, 2012, subsection (6) is
146 added to section 465.009, Florida Statutes, to read:
147 465.009 Continuing professional pharmaceutical education.—
148 (6) Notwithstanding subsections (1)-(5):
149 (a) Each pharmacist certified to administer a vaccine or
150 epinephrine autoinjection under s. 465.189 must complete a 3
151 hour continuing education course, which shall be offered by a
152 statewide professional association of physicians in this state
153 accredited to provide educational activities designated for the
154 American Medical Association Physician’s Recognition Award (AMA
155 PRA) Category 1 credit, on the safe and effective administration
156 of vaccines and epinephrine autoinjection as part of biennial
157 relicensure or recertification. This course may be offered in a
158 distance-learning format and must be included in the 30 hours of
159 continuing professional pharmaceutical education specified in
160 subsection (1).
161 (b) Each pharmacist must submit confirmation of having
162 completed the course specified in paragraph (a) on a form
163 provided by the board when submitting fees for license renewal.
164 (c) Failure to comply with paragraphs (a) and (b) results
165 in the revocation of the authorization for a pharmacist to
166 administer a vaccine or epinephrine autoinjection under s.
167 465.189. Such authorization may be restored upon completion of
168 such requirements.
169 Section 4. Except as otherwise expressly provided in this
170 act, this act shall take effect July 1, 2012.