CS for CS for SB 1868 First Engrossed (ntc)
20091868e1
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; amending s. 456.42, F.S.;
15 revising provisions specifying the information
16 required to be included in written prescriptions for
17 medicinal drugs; amending s. 893.04, F.S.; authorizing
18 a pharmacist to dispense a controlled substance and
19 require photographic identification without
20 documenting certain information; authorizing a
21 pharmacist to dispense a controlled substance without
22 verification of certain information by the prescriber
23 under certain circumstances; providing an effective
24 date.
25
26 Be It Enacted by the Legislature of the State of Florida:
27
28 Section 1. Subsection (7) of section 465.003, Florida
29 Statutes, is amended to read:
30 465.003 Definitions.—As used in this chapter, the term:
31 (7) “Institutional formulary system” means a method whereby
32 the medical staff evaluates, appraises, and selects those
33 medicinal drugs or proprietary preparations which in the medical
34 staff’s clinical judgment are most useful in patient care, and
35 which are available for dispensing by a practicing pharmacist
36 for in a Class I or in a Class II institutional pharmacy.
37 Section 2. Subsection (6) of section 465.019, Florida
38 Statutes, is amended, and subsection (7) is added to that
39 section, to read:
40 465.019 Institutional pharmacies; permits.—
41 (6) In a Class I or Class II institutional pharmacy, an
42 institutional formulary system may be adopted with approval of
43 the medical staff for the purpose of identifying those medicinal
44 drugs and proprietary preparations that may be dispensed by a
45 practicing pharmacist for a Class I or in a Class II
46 institutional pharmacy the pharmacists employed in such
47 institution. A facility that has with a Class I or Class II
48 institutional permit which is operating under the formulary
49 system shall establish policies and procedures for the
50 development of the system, in accordance with the joint
51 standards of the American Hospital Association and American
52 Society of Hospital Pharmacists, for the use utilization of an
53 institutional a hospital formulary system, which formulary shall
54 be approved by the medical staff.
55 (7) The policies and procedures for an institutional
56 formulary system in a Class I institutional pharmacy shall:
57 (a) Be approved by the medical staff.
58 (b) Openly provide detailed methods and criteria for the
59 selection and objective evaluation of all available
60 pharmaceuticals.
61 (c) Include policies for the development, maintenance,
62 approval, dissemination, and notification to prescribers of the
63 drug formulary and for continuous and comprehensive review of
64 formulary drugs.
65 (d) Provide for regular monitoring of compliance with the
66 policies and procedures and of clinical outcomes in
67 circumstances in which a substitution of drugs has occurred.
68 (e) Provide a mechanism to obtain consent from the
69 prescriber prior to dispensing any substitution of drugs by
70 using a method of communication designated by the prescriber on
71 the prescription for such purposes. The method of communication
72 designated by the prescriber shall be noted in the patient’s
73 chart.
74 (f) Establish a process that allows any individual
75 prescriber to opt out of the formulary system entirely.
76 (g) Establish a process that allows any individual
77 prescriber to opt out of the formulary system with respect to a
78 particular patient.
79 (h) Provide a mechanism to ensure that patients or
80 guardians are informed of any change of an existing prescription
81 to a formulary substitute.
82 (i) Include policies stating that practitioners are not
83 penalized for prescribing nonformulary drug products that are
84 medically necessary.
85 (j) Be consistent with applicable state and federal laws
86 and with rules of the department and board.
87 Section 3. Paragraph (b) of subsection (1) of section
88 627.4239, Florida Statutes, is amended to read:
89 627.4239 Coverage for use of drugs in treatment of cancer.—
90 (1) DEFINITIONS.—As used in this section, the term:
91 (b) “Standard reference compendium” means an authoritative
92 compendium identified by the Secretary of the United States
93 Department of Health and Human Services and recognized by the
94 federal Centers for Medicare and Medicaid Services:
95 1. The United States Pharmacopeia Drug Information;
96 2. The American Medical Association Drug Evaluations; or
97 3. The American Hospital Formulary Service Drug
98 Information.
99 Section 4. Section 456.42, Florida Statutes, is amended to
100 read:
101 456.42 Written prescriptions for medicinal drugs.—A written
102 prescription for a medicinal drug issued by a health care
103 practitioner licensed by law to prescribe such drug must be
104 legibly printed or typed so as to be capable of being understood
105 by the pharmacist filling the prescription; must contain the
106 name of the prescribing practitioner, the name and strength of
107 the drug prescribed, the quantity of the drug prescribed in both
108 textual and numerical formats, and the directions for use of the
109 drug; must be dated with the month written out in textual
110 letters; and must be signed by the prescribing practitioner on
111 the day when issued. A written prescription for a controlled
112 substance listed in chapter 893 must have the quantity of the
113 drug prescribed in both textual and numerical formats and must
114 be dated with the abbreviated month written out on the face of
115 the prescription. However, a prescription that is electronically
116 generated and transmitted must contain the name of the
117 prescribing practitioner, the name and strength of the drug
118 prescribed, the quantity of the drug prescribed in numerical
119 format, and the directions for use of the drug and must be dated
120 and signed by the prescribing practitioner only on the day
121 issued, which signature may be in an electronic format as
122 defined in s. 668.003(4).
123 Section 5. Paragraph (d) of subsection (2) of section
124 893.04, Florida Statutes, is amended to read:
125 893.04 Pharmacist and practitioner.—
126 (2)
127 (d) Each written prescription prescribed by a practitioner
128 in this state for a controlled substance listed in Schedule II,
129 Schedule III, or Schedule IV must include both a written and a
130 numerical notation of the quantity of the controlled substance
131 prescribed on the face of the prescription and a notation of the
132 date, with the abbreviated month written out on the face of the
133 prescription. A pharmacist may, upon verification by the
134 prescriber, document any information required by this paragraph.
135 If the prescriber is not available to verify a prescription, the
136 pharmacist may dispense the controlled substance but may insist
137 that the person to whom the controlled substance is dispensed
138 provide valid photographic identification. If a prescription
139 includes a numerical notation of the quantity of the controlled
140 substance or date, but does not include the quantity or date
141 written out in textual format, the pharmacist may dispense the
142 controlled substance without verification by the prescriber of
143 the quantity or date if the pharmacy previously dispensed
144 another prescription for the person to whom the prescription was
145 written.
146 Section 6. This act shall take effect July 1, 2009.