c2585264
Senate
s0300-98
s0370
2002
AA
104940
Senator Campbell moved the following amendment to amendment
(104940):
On page 97, between lines 23 and 24,
On page 107, line 21,




                                                  SENATE AMENDMENT

    Bill No. CS for CS for SB 370

    Amendment No. ___   Barcode 585264

                            CHAMBER ACTION
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10  ______________________________________________________________

11  Senator Campbell moved the following amendment to amendment

12  (104940):

13

14         Senate Amendment (with title amendment) 

15         On page 97, between lines 23 and 24,

16

17  insert:

18         Section 80.  (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 for CS for SB 370

    Amendment No. ___   Barcode 585264





  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 81.  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 for CS for SB 370

    Amendment No. ___   Barcode 585264





  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.

12

13  (Redesignate subsequent sections.)

14

15

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 107, line 21, after the semicolon

19

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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