Florida Senate - 2020 SB 1020
By Senator Bean
4-01221-20 20201020__
1 A bill to be entitled
2 An act relating to institutional formularies
3 established by nursing home facilities; creating s.
4 400.143, F.S.; defining terms; authorizing a nursing
5 home facility to establish and implement an
6 institutional formulary; requiring such formulary to
7 be developed by a committee established by the nursing
8 home facility; providing for committee membership;
9 providing requirements for the development and
10 implementation of the institutional formulary;
11 requiring a nursing home facility to maintain written
12 policies and procedures for the institutional
13 formulary; requiring a nursing home facility to make
14 available such policies and procedures to the Agency
15 for Health Care Administration, upon request;
16 requiring a prescriber to annually authorize the use
17 of the institutional formulary for certain patients;
18 requiring the prescriber to opt into any changes made
19 to the institutional formulary; authorizing a
20 prescriber to opt out of use of the institutional
21 formulary or to prevent a therapeutic substitution,
22 under certain circumstances; prohibiting a nursing
23 home facility from taking adverse action against a
24 prescriber for refusing to agree to the use of the
25 institutional formulary; amending s. 465.025, F.S.;
26 authorizing a pharmacist to therapeutically substitute
27 medicinal drugs under an institutional formulary
28 established by a nursing home facility, under certain
29 circumstances; prohibiting a pharmacist from
30 therapeutically substituting a medicinal drug, under
31 certain circumstances; providing an effective date.
32
33 Be It Enacted by the Legislature of the State of Florida:
34
35 Section 1. Section 400.143, Florida Statutes, is created to
36 read:
37 400.143 Institutional formularies established by nursing
38 home facilities.—
39 (1) For purposes of this section, the term:
40 (a) “Institutional formulary” means a list of medicinal
41 drugs established by a nursing home facility under this section
42 for which a pharmacist may use a therapeutic substitution for a
43 medicinal drug prescribed to a resident of the facility.
44 (b) “Medicinal drug” has the same meaning as provided in s.
45 465.003(8).
46 (c) “Prescriber” has the same meaning as provided in s.
47 465.025(1).
48 (d) “Therapeutic substitution” means the practice of
49 replacing a nursing home facility resident’s prescribed
50 medicinal drug with another chemically different medicinal drug
51 that is expected to have the same clinical effect.
52 (2) A nursing home facility may establish and implement an
53 institutional formulary in accordance with the requirements of
54 this section.
55 (3) A nursing home facility that implements an
56 institutional formulary under this section shall:
57 (a) Establish a committee to develop the institutional
58 formulary and written guidelines or procedures for such
59 institutional formulary. The committee must consist of, at a
60 minimum, all of the following:
61 1. The facility’s medical director.
62 2. The facility’s director of nursing services.
63 3. A consultant pharmacist licensed by the Department of
64 Health and certified under s. 465.0125.
65 (b) Establish methods and criteria for selecting and
66 objectively evaluating all available pharmaceutical products
67 that may be used as therapeutic substitutes.
68 (c) Establish policies and procedures for developing and
69 maintaining the institutional formulary and for approving,
70 disseminating, and notifying prescribers of the institutional
71 formulary.
72 (d) Perform quarterly monitoring to ensure compliance with
73 the policies and procedures established under paragraph (c) and
74 monitor the clinical outcomes in circumstances in which a
75 therapeutic substitution has occurred.
76 (4) The nursing home facility shall maintain all written
77 policies and procedures for the institutional formulary
78 established under this section. Each nursing home facility shall
79 make available such policies and procedures to the agency, upon
80 request.
81 (5)(a) A prescriber shall annually authorize the
82 institutional formulary for his or her patients and shall opt
83 into any subsequent changes made to a nursing home facility’s
84 institutional formulary.
85 (b) A prescriber may opt out of the nursing home facility’s
86 institutional formulary with respect to a particular patient,
87 medicinal drug, or class of medicinal drugs.
88 (c) A prescriber may prevent a therapeutic substitution for
89 a specific medication order if such order is provided verbally
90 or generated and transmitted electronically by indicating “NO
91 THERAPEUTIC SUBSTITUTION” on the prescription.
92 (d) A nursing home facility may not take adverse action
93 against a prescriber for refusing to agree to the use of the
94 facility’s institutional formulary.
95 Section 2. Subsection (9) is added to section 465.025,
96 Florida Statutes, to read:
97 465.025 Substitution of drugs.—
98 (9) A pharmacist may therapeutically substitute medicinal
99 drugs in accordance with an institutional formulary established
100 under s. 400.143 for the resident of a nursing home facility if
101 the prescriber has agreed to the use of such institutional
102 formulary. The pharmacist may not therapeutically substitute a
103 medicinal drug pursuant to the facility’s institutional
104 formulary if the prescriber indicates verbally or electronically
105 on the prescription “NO THERAPEUTIC SUBSTITUTION,” as authorized
106 under s. 400.143(5)(c).
107 Section 3. This act shall take effect July 1, 2020.