Florida Senate - 2009 CS for SB 1868
By the Committee on Health Regulation; and Senator Peaden
588-04443-09 20091868c1
1 A bill to be entitled
2 An act relating to prescribed drugs; amending ss.
3 465.003 and 465.019, F.S.; authorizing the use of an
4 institutional formulary system in a Class I
5 institutional pharmacy at which, with certain
6 exceptions, all medicinal drugs are administered from
7 individual prescription containers to the patient and
8 medicinal drugs are not dispensed on the premises;
9 specifying requirements for the policies and
10 procedures of such an institutional formulary system;
11 amending s. 627.4239, F.S.; revising the definition of
12 the term “standard reference compendium” for purposes
13 of regulating the insurance coverage of drugs used in
14 the treatment of cancer; providing an effective date.
15
16 Be It Enacted by the Legislature of the State of Florida:
17
18 Section 1. Subsection (7) of section 465.003, Florida
19 Statutes, is amended to read:
20 465.003 Definitions.—As used in this chapter, the term:
21 (7) “Institutional formulary system” means a method whereby
22 the medical staff evaluates, appraises, and selects those
23 medicinal drugs or proprietary preparations which in the medical
24 staff’s clinical judgment are most useful in patient care, and
25 which are available for dispensing by a practicing pharmacist
26 for in a Class I or in a Class II institutional pharmacy.
27 Section 2. Subsection (6) of section 465.019, Florida
28 Statutes, is amended, and subsection (7) is added to that
29 section, to read:
30 465.019 Institutional pharmacies; permits.—
31 (6) In a Class I or Class II institutional pharmacy, an
32 institutional formulary system may be adopted with approval of
33 the medical staff for the purpose of identifying those medicinal
34 drugs and proprietary preparations that may be dispensed by a
35 practicing pharmacist for a Class I or in a Class II
36 institutional pharmacy the pharmacists employed in such
37 institution. A facility that has with a Class I or Class II
38 institutional permit which is operating under the formulary
39 system shall establish policies and procedures for the
40 development of the system, in accordance with the joint
41 standards of the American Hospital Association and American
42 Society of Hospital Pharmacists, for the use utilization of an
43 institutional a hospital formulary system, which formulary shall
44 be approved by the medical staff.
45 (7) The policies and procedures for an institutional
46 formulary system in a Class I institutional pharmacy shall:
47 (a) Be approved by the medical staff.
48 (b) Openly provide detailed methods and criteria for the
49 selection and objective evaluation of all available
50 pharmaceuticals.
51 (c) Include policies for the development, maintenance,
52 approval, dissemination, and notification to prescribers of the
53 drug formulary and for continuous and comprehensive review of
54 formulary drugs.
55 (d) Provide for regular monitoring of compliance with the
56 policies and procedures and of clinical outcomes in
57 circumstances in which a substitution of drugs has occurred.
58 (e) Provide a mechanism to inform the prescriber prior to
59 any substitution of drugs by using a method of communication
60 designated by the prescriber for such purpose. The method of
61 communication designated by the prescriber shall be noted in the
62 patient’s chart.
63 (f) Establish a process that allows any individual
64 prescriber to opt out of the formulary system entirely.
65 (g) Establish a process that allows any individual
66 prescriber to opt out of the formulary system with respect to a
67 particular patient.
68 (h) Provide a mechanism to ensure that patients or
69 guardians are informed of any change of an existing prescription
70 to a formulary substitute.
71 (i) Include policies stating that practitioners are not
72 penalized for prescribing nonformulary drug products that are
73 medically necessary.
74 (j) Be consistent with applicable state and federal laws
75 and with rules of the department and board.
76 Section 3. Paragraph (b) of subsection (1) of section
77 627.4239, Florida Statutes, is amended to read:
78 627.4239 Coverage for use of drugs in treatment of cancer.—
79 (1) DEFINITIONS.—As used in this section, the term:
80 (b) “Standard reference compendium” means an authoritative
81 compendium identified by the Secretary of the United States
82 Department of Health and Human Services and recognized by the
83 federal Centers for Medicare and Medicaid Services:
84 1. The United States Pharmacopeia Drug Information;
85 2. The American Medical Association Drug Evaluations; or
86 3. The American Hospital Formulary Service Drug
87 Information.
88 Section 4. This act shall take effect July 1, 2009.