Florida Senate - 2008 SB 2414
By Senator Rich
34-03005A-08 20082414__
1
A bill to be entitled
2
An act relating to anti-epileptic drugs; amending s.
3
440.13, F.S., relating to medical services and supplies;
4
conforming a cross-reference; amending s. 465.025, F.S.;
5
providing definitions; prohibiting a pharmacist from
6
interchanging an anti-epileptic drug without prior
7
notification and consent from the prescribing practitioner
8
and the patient or the patient's parent, guardian, or
9
spouse; amending s. 465.0251, F.S., relating to generic
10
drugs; conforming a cross-reference; providing an
11
effective date.
12
13
Be It Enacted by the Legislature of the State of Florida:
14
15
Section 1. Paragraph (m) of subsection (1) of section
16
440.13, Florida Statutes, is amended to read:
17
440.13 Medical services and supplies; penalty for
18
violations; limitations.--
19
(1) DEFINITIONS.--As used in this section, the term:
20
(m) "Medicine" means a drug prescribed by an authorized
21
health care provider and includes only generic drugs or single-
22
source patented drugs for which there is no generic equivalent,
23
unless the authorized health care provider writes or states that
24
the brand-name drug as defined in s. 465.025 is medically
25
necessary, or is a drug appearing on the schedule of drugs
27
at a cost lower than its generic equivalent.
28
Section 2. Section 465.025, Florida Statutes, is amended to
29
read:
30
465.025 Substitution of drugs.--
31
(1) As used in this section:
32
(a) "Anti-epileptic drug" means any drug prescribed for the
33
treatment of epilepsy or any drug used to treat or prevent
34
seizures.
35
(b)(a) "Brand name" means the registered trademark name
36
given to a drug product by its manufacturer, labeler, or
37
distributor.
38
(c) "Epilepsy" means a neurological condition characterized
39
by recurrent seizures.
40
(d)(b) "Generically equivalent drug product" means a drug
41
product having with the same active ingredient, finished dosage
42
form, and strength.
43
(e) "Interchange" means the substitution of one version of
44
the same anti-epileptic therapeutic product, including a generic
45
version for the prescribed brand, a brand version for the
46
prescribed generic version, a generic version by a manufacturer
47
for a generic version by a different manufacturer, a different
48
formulation of the prescribed anti-epileptic drug, or a different
49
anti-epileptic therapeutic drug product for the anti-epileptic
50
product originally prescribed.
51
(f)(c) "Prescriber" means any practitioner licensed to
52
prescribe medicinal drugs.
53
(g) "Seizure" means an acute clinical change that is
54
secondary to a brief disturbance in the electrical activity of
55
the brain.
56
(2) A pharmacist who receives a prescription for a brand
57
name drug, except an anti-epileptic drug, shall, unless requested
58
otherwise by the purchaser, substitute a less expensive,
59
generically equivalent drug product that is:
60
(a) Distributed by a business entity doing business, and
61
subject to suit and service of legal process, in the United
62
States; and
63
(b) Listed in the formulary of generic and brand name drug
64
products as provided in subsection (5) for the brand name drug
65
prescribed,
66
67
unless the prescriber writes the words "MEDICALLY NECESSARY," in
68
her or his own handwriting, on the face of a written
69
prescription; unless, in the case of an oral prescription, the
70
prescriber expressly indicates to the pharmacist that the brand
71
name drug prescribed is medically necessary; or unless, in the
72
case of a prescription that is electronically generated and
73
transmitted, the prescriber makes an overt act when transmitting
74
the prescription to indicate that the brand name drug prescribed
75
is medically necessary. When done in conjunction with the
76
electronic transmission of the prescription, the prescriber's
77
overt act indicates to the pharmacist that the brand name drug
78
prescribed is medically necessary.
79
(3)(a) Any pharmacist who substitutes any drug as provided
80
in subsection (2) shall notify the person presenting the
81
prescription of such substitution, together with the existence
82
and amount of the retail price difference between the brand name
83
drug and the drug substituted for it, and shall inform the person
84
presenting the prescription that such person may refuse the
85
substitution as provided in subsection (2).
86
(b) Any pharmacist substituting a less expensive drug
87
product shall pass on to the consumer the full amount of the
88
savings realized by such substitution.
89
(4) Each pharmacist shall maintain a record of any
90
substitution of a generically equivalent drug product for a
91
prescribed brand name drug as provided in this section.
92
(5) A pharmacist may not interchange an anti-epileptic drug
93
or formulation of an anti-epileptic drug, brand, or generic for
94
the treatment of seizures or epilepsy without prior notification
95
of, and the signed, informed consent to, such interchange from
96
the prescribing practitioner and the patient or the patient's
97
parent, legal guardian, or spouse.
98
(6)(5) Each community pharmacy shall establish a formulary
99
of generic and brand name drug products which, if selected as the
100
drug product of choice, would not pose a threat to the health and
101
safety of patients receiving prescription medication. In
102
compiling the list of generic and brand name drug products for
103
inclusion in the formulary, the pharmacist shall rely on drug
104
product research, testing, information, and formularies compiled
105
by other pharmacies, by states, by the United States Department
106
of Health, Education, and Welfare, by the United States
107
Department of Health and Human Services, or by any other source
108
which the pharmacist deems reliable. Each community pharmacy
109
shall make such formulary available to the public, the Board of
110
Pharmacy, or any physician requesting same. This formulary shall
111
be revised following each addition, deletion, or modification of
112
said formulary.
113
(7)(6) The Board of Pharmacy and the Board of Medicine
114
shall establish by rule a formulary of generic drug type and
115
brand name drug products which are determined by the boards to
116
demonstrate clinically significant biological or therapeutic
117
inequivalence and which, if substituted, would pose a threat to
118
the health and safety of patients receiving prescription
119
medication.
120
(a) The formulary may be added to or deleted from as the
121
Board of Pharmacy and the Board of Medicine deem appropriate. Any
122
person who requests any inclusion, addition, or deletion of a
123
generic drug type or brand name drug product to the formulary
124
shall have the burden of proof to show cause why such inclusion,
125
addition, or deletion should be made.
126
(b) Upon adoption of the formulary required by this
127
subsection, and upon each addition, deletion, or modification to
128
the formulary, the Board of Pharmacy shall mail a copy to each
129
manager of the prescription department of each community pharmacy
130
licensed by the state, each nonresident pharmacy registered in
131
the state, and each board regulating practitioners licensed by
132
the laws of the state to prescribe drugs shall incorporate such
133
formulary into its rules. No pharmacist shall substitute a
134
generically equivalent drug product for a prescribed brand name
135
drug product if the brand name drug product or the generic drug
136
type drug product is included in the said formulary.
137
(8)(7) Every community pharmacy shall display in a
138
prominent place that is in clear and unobstructed public view, at
139
or near the place where prescriptions are dispensed, a sign in
140
block letters not less than 1 inch in height which shall read:
141
"CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS
142
EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF
143
FLORIDA LAW."
144
(9)(8) The standard of care to be applied to the acts of
145
any pharmacist performing professional services in compliance
146
with this section when a substitution is made by said pharmacist
147
shall be that which would apply to the performance of
148
professional services in the dispensing of a prescription order
149
prescribing a drug by generic name. In no event when a pharmacist
150
substitutes a drug shall the prescriber be liable in any action
151
for loss, damage, injury, or death to any person occasioned by or
152
arising from the use or nonuse of the substituted drug, unless
153
the original drug was incorrectly prescribed.
154
Section 3. Section 465.0251, Florida Statutes, is amended
155
to read:
156
465.0251 Generic drugs; removal from formulary under
157
specified circumstances.--
158
(1) The Board of Pharmacy and the Board of Medicine shall
159
remove any generic named drug product from the formulary
161
marketed equivalent of that drug product is "A" rated as
162
therapeutically equivalent to a reference listed drug or is a
163
reference listed drug as referred to in "Approved Drug Products
164
with Therapeutic Equivalence Evaluations" (Orange Book) published
165
by the United States Food and Drug Administration.
166
(2) Nothing in This section does not act shall alter or
167
amend s. 465.025 as to existing law providing for the authority
168
of physicians to prohibit generic drug substitution by writing
169
"medically necessary" on the prescription.
170
Section 4. This act shall take effect upon becoming a law.
CODING: Words stricken are deletions; words underlined are additions.