CS/CS/CS/HB 433

1	A bill to be entitled
2	An act relating to prescribed drugs; amending s. 456.42,
3	F.S.; revising provisions specifying the information
4	required to be included in written prescriptions for
5	medicinal drugs; amending ss. 465.003 and 465.019, F.S.;
6	authorizing the use of an institutional formulary system
7	for a Class I institutional pharmacy at which, with
8	certain exceptions, all medicinal drugs are administered
9	from individual prescription containers to the patient and
10	medicinal drugs are not dispensed on the premises;
11	specifying requirements for the policies and procedures of
12	such an institutional formulary system; amending s.
13	627.4239, F.S.; revising the definition of the term
14	"standard reference compendium" for purposes of regulating
15	the insurance coverage of drugs used in the treatment of
16	cancer; amending s. 893.04, F.S.; authorizing a pharmacist
17	to dispense a controlled substance and require
18	photographic identification without documenting certain
19	information; authorizing a pharmacist to dispense a
20	controlled substance without verification of certain
21	information by the prescriber under certain circumstances;
22	providing an effective date.
23
24	Be It Enacted by the Legislature of the State of Florida:
25
26	Section 1.  Section 456.42, Florida Statutes, is amended to
27	read:
28	456.42  Written prescriptions for medicinal drugs.--A
29	written prescription for a medicinal drug issued by a health
30	care practitioner licensed by law to prescribe such drug must be
31	legibly printed or typed so as to be capable of being understood
32	by the pharmacist filling the prescription; must contain the
33	name of the prescribing practitioner, the name and strength of
34	the drug prescribed, the quantity of the drug prescribed in both
35	textual and numerical formats, and the directions for use of the
36	drug; must be dated with the month written out in textual
37	letters; and must be signed by the prescribing practitioner on
38	the day when issued. A written prescription for a controlled
39	substance listed in chapter 893 must have the quantity of the
40	drug prescribed in both textual and numerical formats and must
41	be dated with the abbreviated month written out on the face of
42	the prescription. However, a prescription that is electronically
43	generated and transmitted must contain the name of the
44	prescribing practitioner, the name and strength of the drug
45	prescribed, the quantity of the drug prescribed in numerical
46	format, and the directions for use of the drug and must be dated
47	and signed by the prescribing practitioner only on the day
48	issued, which signature may be in an electronic format as
49	defined in s. 668.003(4).
50	Section 2.  Subsection (7) of section 465.003, Florida
51	Statutes, is amended to read:
52	465.003  Definitions.--As used in this chapter, the term:
53	(7)  "Institutional formulary system" means a method
54	whereby the medical staff evaluates, appraises, and selects
55	those medicinal drugs or proprietary preparations which in the
56	medical staff's clinical judgment are most useful in patient
57	care, and which are available for dispensing by a practicing
58	pharmacist for a Class I or in a Class II institutional
59	pharmacy.
60	Section 3.  Subsection (6) of section 465.019, Florida
61	Statutes, is amended, and subsection (7) is added to that
62	section, to read:
63	465.019  Institutional pharmacies; permits.--
64	(6)  In a Class I or Class II institutional pharmacy, an
65	institutional formulary system may be adopted with approval of
66	the medical staff for the purpose of identifying those medicinal
67	drugs and proprietary preparations that may be dispensed by a
68	practicing pharmacist for a Class I or in a Class II
69	institutional pharmacy the pharmacists employed in such
70	institution. A facility that has with a Class I or Class II
71	institutional permit which is operating under the formulary
72	system shall establish policies and procedures for the
73	development of the system, in accordance with the joint
74	standards of the American Hospital Association and American
75	Society of Hospital Pharmacists, for the use utilization of an
76	institutional a hospital formulary system, which formulary shall
77	be approved by the medical staff.
78	(7)  The policies and procedures for an institutional
79	formulary system in a Class I institutional pharmacy shall:
80	(a)  Be approved by the medical staff.
81	(b)  Openly provide detailed methods and criteria for the
82	selection and objective evaluation of all available
83	pharmaceuticals.
84	(c)  Include policies for the development, maintenance,
85	approval, and dissemination of the drug formulary and for
86	continuous and comprehensive review of formulary drugs.
87	(d)  Provide for regular monitoring of compliance with the
88	policies and procedures and of clinical outcomes in
89	circumstances in which a substitution of drugs has occurred.
90	(e)  Provide a mechanism to obtain the prescriber's consent
91	before dispensing any substitution of drugs using a method of
92	communication designated by the prescriber on the prescription
93	for such purposes. The method of communication designated by the
94	prescriber shall be noted in the patient's chart.
95	(f)  Establish a process that allows any individual
96	prescriber to opt out of the formulary system entirely.
97	(g)  Establish a process that allows any individual
98	prescriber to opt out of the formulary system with respect to a
99	particular patient.
100	(h)  Provide a mechanism to ensure that patients or
101	guardians are informed of any change of an existing prescription
102	to a formulary substitute.
103	(i)  Include policies that state that practitioners are not
104	penalized for prescribing nonformulary drug products that are
105	medically necessary.
106	(j)  Be consistent with applicable state and federal laws
107	and with rules of the department and board.
108	Section 4.  Paragraph (b) of subsection (1) of section
109	627.4239, Florida Statutes, is amended to read:
110	627.4239  Coverage for use of drugs in treatment of
111	cancer.--
112	(1)  DEFINITIONS.--As used in this section, the term:
113	(b)  "Standard reference compendium" means an authoritative
114	compendium identified by the Secretary of the United States
115	Department of Health and Human Services and recognized by the
116	federal Centers for Medicare and Medicaid Services:
117	1.  The United States Pharmacopeia Drug Information;
118	2.  The American Medical Association Drug Evaluations; or
119	3.  The American Hospital Formulary Service Drug
120	Information.
121	Section 5.  Paragraph (d) of subsection (2) of section
122	893.04, Florida Statutes, is amended to read:
123	893.04  Pharmacist and practitioner.--
124	(2)
125	(d)  Each written prescription prescribed by a practitioner
126	in this state for a controlled substance listed in Schedule II,
127	Schedule III, or Schedule IV must include both a written and a
128	numerical notation of the quantity of the controlled substance
129	prescribed on the face of the prescription and a notation of the
130	date, with the abbreviated month written out on the face of the
131	prescription. A pharmacist may, upon verification by the
132	prescriber, document any information required by this paragraph.
133	If the prescriber is not available to verify a prescription, the
134	pharmacist may dispense the controlled substance but may insist
135	that the person to whom the controlled substance is dispensed
136	provide valid photographic identification. If a prescription
137	includes a numerical notation of the quantity of the controlled
138	substance or date but does not include the quantity or date
139	written out in textual format, the pharmacist may dispense the
140	controlled substance without verification by the prescriber of
141	the quantity or date if the pharmacy previously dispensed
142	another prescription for the person to whom the prescription was
143	written.
144	Section 6.  This act shall take effect July 1, 2009.

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