Florida Senate - 2012 COMMITTEE AMENDMENT
Bill No. SB 850
Barcode 741504
LEGISLATIVE ACTION
Senate . House
Comm: FAV .
01/26/2012 .
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The Committee on Health Regulation (Jones) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 465.189, Florida Statutes, is amended to
6 read:
7 465.189 Administration of vaccines and epinephrine
8 autoinjection influenza virus immunizations.—
9 (1) A pharmacist Pharmacists may administer, pursuant to a
10 written or electronic prescription issued to the patient by a
11 physician licensed under chapter 458 or chapter 459, the
12 following influenza virus immunizations to adults within the
13 framework of an established protocol under a supervising
14 supervisory practitioner who is a physician licensed under
15 chapter 458 or chapter 459:
16 (a) Influenza vaccine to an adult 18 years of age or older.
17 (b) Shingles vaccine to an adult 60 years of age or older.
18 (c) Pneumococcal vaccine to an adult 65 years of age or
19 older.
20 (d) Epinephrine using an autoinjector delivery system to an
21 adult 18 years of age or older who is suffering an anaphylactic
22 reaction.
23
24 The Each protocol must shall contain specific procedures for
25 addressing any unforeseen adverse allergic reaction to the
26 vaccine or epinephrine autoinjection influenza virus
27 immunizations.
28 (2) A pharmacist may not enter into a protocol unless he or
29 she maintains at least $200,000 of professional liability
30 insurance and has completed training on administration of the
31 vaccines and epinephrine autoinjection in influenza virus
32 immunizations as provided in this section.
33 (3) A pharmacist who administers a vaccine or epinephrine
34 autoinjection must administering influenza virus immunizations
35 shall maintain and make available patient records using the same
36 standards for confidentiality and maintenance of such records as
37 those that are imposed on health care practitioners under s.
38 456.057. These records must shall be maintained for a minimum of
39 5 years.
40 (4) The decision by a supervising physician supervisory
41 practitioner to enter into a protocol under this section is a
42 professional decision on the part of the physician practitioner,
43 and a person may not interfere with a supervising physician’s
44 supervisory practitioner’s decision to enter as to entering into
45 such a protocol. A pharmacist may not enter into a protocol that
46 is to be performed while acting as an employee without the
47 written approval of the owner of the pharmacy. Pharmacists shall
48 forward immunization records to the department for inclusion in
49 the state registry of immunization information.
50 (5) Any pharmacist seeking to administer a vaccine or
51 epinephrine autoinjection influenza virus immunizations to
52 adults under this section must first complete a 10-hour
53 certification program on the administration of vaccines and
54 epinephrine autoinjection offered by a statewide professional
55 association of physicians in this state which is accredited to
56 provide educational activities designated for AMA PRA Category 1
57 credit be certified to administer influenza virus immunizations
58 pursuant to a certification program approved by the Board of
59 Pharmacy in consultation with the Board of Medicine and the
60 Board of Osteopathic Medicine. The certification program must
61 shall, at a minimum, require that the pharmacist attend at least
62 20 hours of continuing education classes approved by the board.
63 The program shall have a curriculum of instruction concerning
64 the safe and effective administration of the vaccines and
65 epinephrine autoinjection listed in subsection (1) influenza
66 virus immunizations, including, but not limited to, potential
67 adverse allergic reactions to the vaccines or epinephrine
68 autoinjection influenza virus immunizations.
69 (6) The written protocol between the pharmacist and
70 supervising physician must include particular terms and
71 conditions imposed by the supervising physician upon the
72 pharmacist relating to the administration of a vaccine or
73 epinephrine autoinjection influenza virus immunizations by the
74 pharmacist. The written protocol must shall include, at a
75 minimum, specific categories and conditions among patients for
76 whom the supervising physician authorizes the pharmacist to
77 administer a vaccine or epinephrine autoinjection influenza
78 virus immunizations. The terms, scope, and conditions set forth
79 in the written protocol between the pharmacist and the
80 supervising physician must be appropriate to the pharmacist’s
81 training and certification for the vaccine or epinephrine
82 autoinjection immunization. A pharmacist Pharmacists who is have
83 been delegated the authority to administer a vaccine or
84 epinephrine autoinjection influenza virus immunizations by the
85 supervising physician must shall provide evidence of current
86 certification by the Board of Pharmacy to the supervising
87 physician. A supervising physician must physicians shall review
88 the administration of the vaccine or epinephrine autoinjection
89 influenza virus immunizations by the pharmacist pharmacists
90 under such physician’s supervision pursuant to the written
91 protocol, and this review shall take place as outlined in the
92 written protocol. The process and schedule for the review shall
93 be outlined in the written protocol between the pharmacist and
94 the supervising physician.
95 (7) The pharmacist shall submit to the Board of Pharmacy a
96 copy of his or her protocol or written agreement to administer
97 the vaccine or epinephrine autoinjection influenza virus
98 immunizations.
99 Section 2. Subsection (13) of section 465.003, Florida
100 Statutes, is amended to read:
101 465.003 Definitions.—As used in this chapter, the term:
102 (13) “Practice of the profession of pharmacy” includes
103 compounding, dispensing, and consulting concerning contents,
104 therapeutic values, and uses of any medicinal drug; consulting
105 concerning therapeutic values and interactions of patent or
106 proprietary preparations, whether pursuant to prescriptions or
107 in the absence and entirely independent of such prescriptions or
108 orders; and other pharmaceutical services. For purposes of this
109 subsection, “other pharmaceutical services” means the monitoring
110 of the patient’s drug therapy and assisting the patient in the
111 management of his or her drug therapy, and includes review of
112 the patient’s drug therapy and communication with the patient’s
113 prescribing health care provider as licensed under chapter 458,
114 chapter 459, chapter 461, or chapter 466, or similar statutory
115 provision in another jurisdiction, or such provider’s agent or
116 such other persons as specifically authorized by the patient,
117 regarding the drug therapy. However, nothing in this subsection
118 does not may be interpreted to permit an alteration of a
119 prescriber’s directions, the diagnosis or treatment of any
120 disease, the initiation of any drug therapy, the practice of
121 medicine, or the practice of osteopathic medicine, unless
122 otherwise permitted by law. The term “practice of the profession
123 of pharmacy” also includes any other act, service, operation,
124 research, or transaction incidental to, or forming a part of,
125 any of the foregoing acts, requiring, involving, or employing
126 the science or art of any branch of the pharmaceutical
127 profession, study, or training, and shall expressly permit a
128 pharmacist to transmit information from persons authorized to
129 prescribe medicinal drugs to their patients. The term practice
130 of the profession of pharmacy also includes the administration
131 of certain vaccines and epinephrine autoinjection influenza
132 virus immunizations to adults pursuant to s. 465.189.
133 Section 3. This act shall take effect July 1, 2012.
134
135 ================= T I T L E A M E N D M E N T ================
136 And the title is amended as follows:
137 Delete everything before the enacting clause
138 and insert:
139 A bill to be entitled
140 An act relating to pharmacy; amending s. 465.189,
141 F.S.; allowing pharmacists to administer certain
142 vaccines or an epinephrine autoinjection pursuant to a
143 prescription from a licensed physician; revising the
144 types of vaccines that pharmacists may administer;
145 authorizing pharmacists to administer an epinephrine
146 autoinjection under certain circumstances; revising
147 protocol requirements for vaccine administration and
148 the duties of supervising physicians under such
149 protocols; revising requirements for training
150 programs, certifications, and patient records related
151 to vaccine administration; amending s. 465.003, F.S.;
152 conforming terminology; providing an effective date.