Senate Bill sb1836
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Florida Senate - 2007 SB 1836
By Senator Jones
13-725A-07
1 A bill to be entitled
2 An act relating to antiepilepsy drugs; amending
3 s. 440.13, F.S.; conforming a cross-reference;
4 amending s. 465.025, F.S.; providing
5 definitions; prohibiting a pharmacist from
6 interchanging an antiepileptic drug without
7 prior notification and consent; amending s.
8 465.0251, F.S.; conforming a cross-reference
9 from the prescribing physician and the patient
10 or the patient's parent, guardian, or spouse;
11 providing an 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
21 authorized health care provider and includes only generic
22 drugs or single-source patented drugs for which there is no
23 generic equivalent, unless the authorized health care provider
24 writes or states that the brand-name drug as defined in s.
25 465.025 is medically necessary, or is a drug appearing on the
26 schedule of drugs created pursuant to s. 465.025(7) s.
27 465.025(6), or is available at a cost lower than its generic
28 equivalent.
29 Section 2. Section 465.025, Florida Statutes, is
30 amended to read:
31 465.025 Substitution of drugs.--
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Florida Senate - 2007 SB 1836
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1 (1) As used in this section:
2 (a) "Antiepileptic drug" means any drug prescribed for
3 the treatment of epilepsy or any drug used to treat or prevent
4 seizures.
5 (b)(a) "Brand name" means the registered trademark
6 name given to a drug product by its manufacturer, labeler, or
7 distributor.
8 (c) "Epilepsy" means a neurological condition
9 characterized by recurrent seizures.
10 (d)(b) "Generically equivalent drug product" means a
11 drug product with the same active ingredient, finished dosage
12 form, and strength.
13 (e) "Interchange" means the substitution of one
14 version of the same antiepileptic therapeutic product,
15 including a generic version for the prescribed brand, a brand
16 version for the prescribed generic version, a generic version
17 by a manufacturer for a generic version by a different
18 manufacturer, a different formulation of the prescribed
19 antiepileptic drug, or a different antiepileptic therapeutic
20 drug product for the antiepileptic product originally
21 prescribed.
22 (f)(c) "Prescriber" means any practitioner licensed to
23 prescribe medicinal drugs.
24 (g) "Seizure" means an acute clinical change that is
25 secondary to a brief disturbance in the electrical activity of
26 the brain.
27 (2) A pharmacist who receives a prescription for a
28 brand name drug, except an antiepileptic drug, shall, unless
29 requested otherwise by the purchaser, substitute a less
30 expensive, generically equivalent drug product that is:
31
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Florida Senate - 2007 SB 1836
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1 (a) Distributed by a business entity doing business,
2 and subject to suit and service of legal process, in the
3 United States; and
4 (b) Listed in the formulary of generic and brand name
5 drug products as provided in subsection (5) for the brand name
6 drug prescribed,
7
8 unless the prescriber writes the words "MEDICALLY NECESSARY,"
9 in her or his own handwriting, on the face of a written
10 prescription; unless, in the case of an oral prescription, the
11 prescriber expressly indicates to the pharmacist that the
12 brand name drug prescribed is medically necessary; or unless,
13 in the case of a prescription that is electronically generated
14 and transmitted, the prescriber makes an overt act when
15 transmitting the prescription to indicate that the brand name
16 drug prescribed is medically necessary. When done in
17 conjunction with the electronic transmission of the
18 prescription, the prescriber's overt act indicates to the
19 pharmacist that the brand name drug prescribed is medically
20 necessary.
21 (3)(a) Any pharmacist who substitutes any drug as
22 provided in subsection (2) shall notify the person presenting
23 the prescription of such substitution, together with the
24 existence and amount of the retail price difference between
25 the brand name drug and the drug substituted for it, and shall
26 inform the person presenting the prescription that such person
27 may refuse the substitution as provided in subsection (2).
28 (b) Any pharmacist substituting a less expensive drug
29 product shall pass on to the consumer the full amount of the
30 savings realized by such substitution.
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Florida Senate - 2007 SB 1836
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1 (4) Each pharmacist shall maintain a record of any
2 substitution of a generically equivalent drug product for a
3 prescribed brand name drug as provided in this section.
4 (5) A pharmacist may not interchange an antiepileptic
5 drug or formulation of an antiepileptic drug, brand, or
6 generic for the treatment of seizures or epilepsy without
7 prior notification of and the signed, informed consent to such
8 interchange from the prescribing physician and the patient or
9 the patient's parent, legal guardian, or spouse.
10 (6)(5) Each community pharmacy shall establish a
11 formulary of generic and brand name drug products which, if
12 selected as the drug product of choice, would not pose a
13 threat to the health and safety of patients receiving
14 prescription medication. In compiling the list of generic and
15 brand name drug products for inclusion in the formulary, the
16 pharmacist shall rely on drug product research, testing,
17 information, and formularies compiled by other pharmacies, by
18 states, by the United States Department of Health, Education,
19 and Welfare, by the United States Department of Health and
20 Human Services, or by any other source which the pharmacist
21 deems reliable. Each community pharmacy shall make such
22 formulary available to the public, the Board of Pharmacy, or
23 any physician requesting same. This formulary shall be
24 revised following each addition, deletion, or modification of
25 said formulary.
26 (7)(6) The Board of Pharmacy and the Board of Medicine
27 shall establish by rule a formulary of generic drug type and
28 brand name drug products which are determined by the boards to
29 demonstrate clinically significant biological or therapeutic
30 inequivalence and which, if substituted, would pose a threat
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1 to the health and safety of patients receiving prescription
2 medication.
3 (a) The formulary may be added to or deleted from as
4 the Board of Pharmacy and the Board of Medicine deem
5 appropriate. Any person who requests any inclusion, addition,
6 or deletion of a generic drug type or brand name drug product
7 to the formulary shall have the burden of proof to show cause
8 why such inclusion, addition, or deletion should be made.
9 (b) Upon adoption of the formulary required by this
10 subsection, and upon each addition, deletion, or modification
11 to the formulary, the Board of Pharmacy shall mail a copy to
12 each manager of the prescription department of each community
13 pharmacy licensed by the state, each nonresident pharmacy
14 registered in the state, and each board regulating
15 practitioners licensed by the laws of the state to prescribe
16 drugs shall incorporate such formulary into its rules. No
17 pharmacist shall substitute a generically equivalent drug
18 product for a prescribed brand name drug product if the brand
19 name drug product or the generic drug type drug product is
20 included in the said formulary.
21 (8)(7) Every community pharmacy shall display in a
22 prominent place that is in clear and unobstructed public view,
23 at or near the place where prescriptions are dispensed, a sign
24 in block letters not less than 1 inch in height which shall
25 read: "CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF
26 A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE
27 REQUIREMENTS OF FLORIDA LAW."
28 (9)(8) The standard of care to be applied to the acts
29 of any pharmacist performing professional services in
30 compliance with this section when a substitution is made by
31 said pharmacist shall be that which would apply to the
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1 performance of professional services in the dispensing of a
2 prescription order prescribing a drug by generic name. In no
3 event when a pharmacist substitutes a drug shall the
4 prescriber be liable in any action for loss, damage, injury,
5 or death to any person occasioned by or arising from the use
6 or nonuse of the substituted drug, unless the original drug
7 was incorrectly prescribed.
8 Section 3. Section 465.0251, Florida Statutes, is
9 amended to read:
10 465.0251 Generic drugs; removal from formulary under
11 specified circumstances.--
12 (1) The Board of Pharmacy and the Board of Medicine
13 shall remove any generic named drug product from the formulary
14 established by s. 465.025(7) s. 465.025(6), if every
15 commercially marketed equivalent of that drug product is "A"
16 rated as therapeutically equivalent to a reference listed drug
17 or is a reference listed drug as referred to in "Approved Drug
18 Products with Therapeutic Equivalence Evaluations" (Orange
19 Book) published by the United States Food and Drug
20 Administration.
21 (2) Nothing in This section does not act shall alter
22 or amend s. 465.025 as to existing law providing for the
23 authority of physicians to prohibit generic drug substitution
24 by writing "medically necessary" on the prescription.
25 Section 4. This act shall take effect upon becoming a
26 law.
27
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29 SENATE SUMMARY
30 Prohibits a pharmacist from interchanging an
antiepileptic drug without prior notification and
31 consent.
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