CODING: Words stricken are deletions; words underlined are additions.
e2332360
House
h0900-99
h0913
2002
AA
913362
Senator Campbell moved the following amendment to amendment
(913362):
On page 79, between lines 14 and 15,
On page 85, page 26,
SENATE AMENDMENT
Bill No. CS/HB 913, 2nd Eng.
Amendment No. ___ Barcode 332360
CHAMBER ACTION
Senate House
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11 Senator Campbell moved the following amendment to amendment
12 (913362):
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14 Senate Amendment (with title amendment)
15 On page 79, between lines 14 and 15,
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17 insert:
18 Section 27. (1) This section may be cited as the
19 "Ernest Belles Act."
20 (2) As used in this section, the term "pharmaceutical
21 adverse incident" means the dispensing of a different
22 medication, a different dose, or the correct medication in a
23 container with different instructions than those specified in
24 the prescription, which dispensation results in actual harm to
25 a patient, but does not include the dispensing of a generic
26 equivalent medication with the patient's consent.
27 (3) A pharmacist licensed under chapter 465, Florida
28 Statutes, or other health care practitioner as defined in
29 section 456.001, Florida Statutes, who becomes aware of a
30 patient's allegation that a pharmaceutical adverse incident
31 has occurred which was caused by a health care practitioner,
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SENATE AMENDMENT
Bill No. CS/HB 913, 2nd Eng.
Amendment No. ___ Barcode 332360
1 must report such allegation to the Department of Health on
2 forms provided by the department. This section does not apply
3 to:
4 (a) Pharmacists employed by pharmacies that
5 participate in the program provided by Rule 64B16-27.300,
6 Florida Administrative Code or health care practitioners
7 working in facilities that administer medications dispensed
8 from those pharmacies; or
9 (b) Pharmacists employed by pharmacies that have
10 notified the Board of Pharmacy that they will establish a
11 continuous quality-improvement program consistent with the
12 requirements of Rule 64B16-27.300, Florida Administrative
13 Code.
14 (4) The required notification to the department must
15 be submitted in writing by certified mail and postmarked
16 within 15 days after the pharmacist or health care
17 practitioner became aware of the patient's allegation that a
18 pharmaceutical adverse incident has occurred.
19 (5) Effective July 1, 2004, subject to subsequent act
20 of the Legislature and a specific appropriation sufficient to
21 cover the actual costs, the department shall review each
22 incident and determine whether it potentially involved conduct
23 by a pharmacist or health care practitioner who is subject to
24 disciplinary action, in which case section 465.073, Florida
25 Statutes, applies. Disciplinary action, if any, shall be
26 taken by the board under which the pharmacist or health care
27 practitioner is licensed.
28 (6) The Department of Health shall adopt forms and
29 rules for administering this section.
30 Section 28. Section 80 of this act shall take effect
31 only upon the effective date of legislation that makes any
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SENATE AMENDMENT
Bill No. CS/HB 913, 2nd Eng.
Amendment No. ___ Barcode 332360
1 such information provided to the Department of Health
2 confidential and exempt from section 119.07(1), Florida
3 Statutes, and Section 24(a) of Article I of the State
4 Constitution, until 10 days after probable cause is found that
5 a violation of law occurred. Such legislation must also
6 provide that information may be used by the department or the
7 Board of Pharmacy only in a disciplinary proceeding brought
8 against the pharmacist or by the department in any study of
9 adverse incidents without identifying the patient, pharmacist,
10 pharmacy, office, or entity by name, location, or other
11 identifier.
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13 (Redesignate subsequent sections.)
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16 ================ T I T L E A M E N D M E N T ===============
17 And the title is amended as follows:
18 On page 85, page 26, after the semicolon
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20 insert:
21 creating the "Ernest Belles Act"; defining the
22 term "pharmaceutical adverse incident" and
23 requiring that such incidents be reported to
24 the Department of Health; providing exceptions;
25 requiring the department to review reported
26 incidents to determine whether the incidents
27 potentially involve conduct by a health care
28 practitioner that is subject to disciplinary
29 action; specifying that any disciplinary action
30 shall be taken by the appropriate board;
31 providing for the adoption of rules and forms;
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