CS/CS/HB 433

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

CODING: Words stricken are deletions; words underlined are additions.