Florida Senate - 2019 SB 706
By Senator Bean
4-00744A-19 2019706__
1 A bill to be entitled
2 An act relating to institutional pharmacies; amending
3 s. 465.003, F.S.; revising the definition of the term
4 “institutional formulary system”; amending s. 465.019,
5 F.S.; authorizing the use of an institutional
6 formulary system in a Class I institutional pharmacy;
7 specifying requirements for the policies and
8 procedures of an institutional formulary system in a
9 Class I institutional pharmacy; providing an effective
10 date.
11
12 Be It Enacted by the Legislature of the State of Florida:
13
14 Section 1. Subsection (7) of section 465.003, Florida
15 Statutes, is amended to read:
16 465.003 Definitions.—As used in this chapter, the term:
17 (7) “Institutional formulary system” means a method whereby
18 the medical staff evaluates, appraises, and selects those
19 medicinal drugs or proprietary preparations that, which in the
20 clinical judgment of the medical staff, staff’s clinical
21 judgment are most useful in patient care, and which are
22 available for dispensing by a practicing pharmacist for a Class
23 I institutional pharmacy, or a practicing pharmacist in a Class
24 II institutional pharmacy or a Class III institutional pharmacy,
25 as those terms are defined in s. 465.019(2).
26 Section 2. Subsection (6) of section 465.019, Florida
27 Statutes, is amended, subsection (7) is added to that section,
28 and paragraph (a) of subsection (2) of that section is
29 republished, to read:
30 465.019 Institutional pharmacies; permits.—
31 (2) The following classes of institutional pharmacies are
32 established:
33 (a) “Class I institutional pharmacies” are those
34 institutional pharmacies in which all medicinal drugs are
35 administered from individual prescription containers to the
36 individual patient and in which medicinal drugs are not
37 dispensed on the premises, except that nursing homes licensed
38 under part II of chapter 400 may purchase medical oxygen for
39 administration to residents. No medicinal drugs may be dispensed
40 in a Class I institutional pharmacy.
41 (6) In a Class I institutional pharmacy, a Class II
42 institutional pharmacy, or a Class III institutional pharmacy,
43 an institutional formulary system may be adopted with approval
44 of the medical staff for the purpose of identifying those
45 medicinal drugs, proprietary preparations, biologics,
46 biosimilars, and biosimilar interchangeables that may be
47 dispensed by a practicing pharmacist for a Class I institutional
48 pharmacy, or dispensed by a practicing pharmacist in a Class II
49 institutional pharmacy or a Class III institutional pharmacy,
50 who is employed by the institutional pharmacy the pharmacists
51 employed in such institution. A facility that has with a Class I
52 institutional pharmacy permit, a Class II institutional pharmacy
53 permit, or a Class III institutional pharmacy permit which is
54 operating under the formulary system shall establish policies
55 and procedures for the development of the system, in accordance
56 with the joint standards of the American Hospital Association
57 and American Society of Hospital Pharmacists, for the use
58 utilization of an institutional a hospital formulary system,
59 which must formulary shall be approved by the medical staff.
60 (7) The policies and procedures for an institutional
61 formulary system in a Class I institutional pharmacy must:
62 (a) Be approved by the medical staff.
63 (b) Openly provide detailed methods and criteria for the
64 selection and objective evaluation of all available
65 pharmaceuticals.
66 (c) Include policies for the development, maintenance,
67 approval, dissemination, and notification to prescribers of the
68 drug formulary and for continuous and comprehensive review of
69 formulary drugs.
70 (d) Provide for regular monitoring of compliance with the
71 policies and procedures and of clinical outcomes in
72 circumstances in which a substitution of drugs has occurred.
73 (e) Provide a mechanism to inform the prescriber prior to
74 any substitution of drugs by using a method of communication
75 designated by the prescriber for such purpose. The method of
76 communication designated by the prescriber must be noted in the
77 patient’s chart.
78 (f) Establish a process that allows any individual
79 prescriber to opt out of the formulary system.
80 (g) Establish a process that allows any individual
81 prescriber to opt out of the formulary system only with respect
82 to a particular patient.
83 (h) Include policies stating that practitioners will not be
84 penalized for prescribing nonformulary drug products that are
85 medically necessary.
86 (i) Be consistent with applicable state and federal laws
87 and with rules of the department and board.
88 Section 3. This act shall take effect July 1, 2019.