HB 585

1
A bill to be entitled
2An act relating to pharmacy; amending s. 465.189, F.S.;
3revising the types of vaccines that pharmacists are
4authorized to administer; authorizing pharmacy interns to
5administer the vaccines under certain circumstances;
6authorizing pharmacists and pharmacy interns to administer
7an epinephrine autoinjection under certain circumstances;
8revising protocol requirements for vaccine administration
9and the duties of supervising physicians under such
10protocols; revising requirements for training programs,
11certifications, and patient records related to vaccine
12administration; amending s. 465.003, F.S.; revising
13terminology to conform to changes made by the act;
14providing an effective date.
15
16Be It Enacted by the Legislature of the State of Florida:
17
18     Section 1.  Section 465.189, Florida Statutes, is amended
19to read:
20     465.189  Administration of vaccines and epinephrine
21autoinjection influenza virus immunizations.-
22     (1)  A pharmacist, and a pharmacy intern having proper
23certification and working under the pharmacist's supervision,
24Pharmacists may administer, influenza virus immunizations to
25adults within the framework of an established protocol under a
26supervising supervisory practitioner who is a physician licensed
27under chapter 458 or chapter 459, the following:
28     (a)  Influenza vaccine to an adult 18 years of age or
29older.
30     (b)  Varicella zoster vaccine to an adult 60 years of age
31or older.
32     (c)  Pneumococcal vaccine to an adult 65 years of age or
33older.
34     (d)  Epinephrine using an autoinjector delivery system to
35an adult 18 years of age or older who is suffering an
36anaphylactic reaction.
37
38The Each protocol must shall contain specific procedures for
39addressing any unforeseen adverse allergic reaction to the
40vaccine or epinephrine autoinjection influenza virus
41immunizations.
42     (2)  A pharmacist may not enter into a protocol unless he
43or she maintains at least $200,000 of professional liability
44insurance and has completed training on the vaccines and
45epinephrine autoinjection in influenza virus immunizations as
46provided in this section.
47     (3)  A pharmacist who administers, or whose pharmacy intern
48administers, a vaccine or epinephrine autoinjection must
49administering influenza virus immunizations shall maintain and
50make available patient records using the same standards for
51confidentiality and maintenance of such records as those that
52are imposed on health care practitioners under s. 456.057. These
53records must shall be maintained for a minimum of 5 years.
54     (4)  The decision by a supervising physician supervisory
55practitioner to enter into a protocol under this section is a
56professional decision on the part of the physician practitioner,
57and a person may not interfere with a supervising
58supervisory practitioner's decision to enter as to entering into
59such a protocol. A pharmacist may not enter into a protocol that
60is to be performed while acting as an employee without the
61written approval of the owner of the pharmacy. Pharmacists shall
62forward immunization records to the department for inclusion in
63the state registry of immunization information.
64     (5)  Any pharmacist or pharmacy intern seeking to
65administer a vaccine or epinephrine autoinjection influenza
66virus immunizations to adults under this section must be
67certified to administer the vaccine or epinephrine autoinjection
68influenza virus immunizations pursuant to a certification
69program approved by the Board of Pharmacy in consultation with
70the Board of Medicine and the Board of Osteopathic Medicine. The
71certification program shall, at a minimum, require that the
72pharmacist or pharmacy intern attend at least 20 hours of
73continuing education classes approved by the board. The program
74shall have a curriculum of instruction concerning the safe and
75effective administration of the vaccines listed in subsection
76(1) and epinephrine autoinjection influenza virus immunizations,
77including, but not limited to, potential adverse allergic
78reactions to the vaccines or epinephrine autoinjection influenza
79virus immunizations.
80     (6)  The written protocol between the pharmacist and
81supervising physician must include particular terms and
82conditions imposed by the supervising physician upon the
83pharmacist relating to the administration of a vaccine or
84epinephrine autoinjection influenza virus immunizations by the
85pharmacist or pharmacy intern working under the pharmacist's
86supervision. The written protocol must shall include, at a
87minimum, specific categories and conditions among patients for
88whom the supervising physician authorizes the pharmacist or
89pharmacy intern to administer a vaccine or epinephrine
90autoinjection influenza virus immunizations. The terms, scope,
91and conditions set forth in the written protocol between the
92pharmacist and the supervising physician must be appropriate to
93the pharmacist's or pharmacy intern's training and certification
94for the vaccine or epinephrine autoinjection immunization. A
95pharmacist, or pharmacy intern working under the pharmacist's
96supervision, Pharmacists who is have been delegated the
97authority to administer a vaccine or epinephrine autoinjection
98influenza virus immunizations by the supervising physician must
99shall provide evidence of current certification by the Board of
100Pharmacy to the supervising physician. A supervising physician
101must physicians shall review the administration of the vaccine
102or epinephrine autoinjection influenza virus immunizations by
103the pharmacist, or a pharmacy intern working under the
104pharmacist's supervision, pharmacists under such physician's
105supervision pursuant to the written protocol, and this review
106shall take place as outlined in the written protocol. The
107process and schedule for the review shall be outlined in the
108written protocol between the pharmacist and the supervising
109physician.
110     (7)  The pharmacist shall submit to the Board of Pharmacy a
111copy of his or her protocol or written agreement to administer
112the vaccine or epinephrine autoinjection influenza virus
113immunizations.
114     Section 2.  Subsection (13) of section 465.003, Florida
115Statutes, is amended to read:
116     465.003  Definitions.-As used in this chapter, the term:
117     (13)  "Practice of the profession of pharmacy" includes
118compounding, dispensing, and consulting concerning contents,
119therapeutic values, and uses of any medicinal drug; consulting
120concerning therapeutic values and interactions of patent or
121proprietary preparations, whether pursuant to prescriptions or
122in the absence and entirely independent of such prescriptions or
123orders; and other pharmaceutical services. For purposes of this
124subsection, "other pharmaceutical services" means the monitoring
125of the patient's drug therapy and assisting the patient in the
126management of his or her drug therapy, and includes review of
127the patient's drug therapy and communication with the patient's
128prescribing health care provider as licensed under chapter 458,
129chapter 459, chapter 461, or chapter 466, or similar statutory
130provision in another jurisdiction, or such provider's agent or
131such other persons as specifically authorized by the patient,
132regarding the drug therapy. However, nothing in this subsection
133does not may be interpreted to permit an alteration of a
134prescriber's directions, the diagnosis or treatment of any
135disease, the initiation of any drug therapy, the practice of
136medicine, or the practice of osteopathic medicine, unless
137otherwise permitted by law. The term "practice of the profession
138of pharmacy" also includes any other act, service, operation,
139research, or transaction incidental to, or forming a part of,
140any of the foregoing acts, requiring, involving, or employing
141the science or art of any branch of the pharmaceutical
142profession, study, or training, and shall expressly permit a
143pharmacist to transmit information from persons authorized to
144prescribe medicinal drugs to their patients. The term practice
145of the profession of pharmacy also includes the administration
146of certain vaccines and epinephrine autoinjection influenza
147virus immunizations to adults pursuant to s. 465.189.
148     Section 3.  This act shall take effect July 1, 2011.


CODING: Words stricken are deletions; words underlined are additions.