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