SENATE AMENDMENT

    Bill No. CS for CS for SB 370

    Amendment No. ___   Barcode 761516

                            CHAMBER ACTION
              Senate                               House
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11  Senator Campbell moved the following amendment:

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13         Senate Amendment (with title amendment) 

14         On page 40, between lines 22 and 23,

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16  insert:

17         Section 42.  (1)  This section may be cited as the

18  "Ernest Belles Act."

19         (2)  As used in this section, the term "pharmaceutical

20  adverse incident" means the dispensing of a different

21  medication, a different dose, or the correct medication in a

22  container with different instructions than those specified in

23  the prescription, which dispensation results in actual harm to

24  a patient, but does not include the dispensing of a generic

25  equivalent medication with the patient's consent.

26         (3)  A pharmacist licensed under chapter 465, Florida

27  Statutes, or other health care practitioner as defined in

28  section 456.001, Florida Statutes, who becomes aware of a

29  patient's allegation that a pharmaceutical adverse incident

30  has occurred which was caused by a health care practitioner,

31  must report such allegation to the Department of Health on

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                                                  SENATE AMENDMENT

    Bill No. CS for CS for SB 370

    Amendment No. ___   Barcode 761516





  1  forms provided by the department. This section does not apply

  2  to:

  3         (a)  Pharmacists employed by pharmacies that

  4  participate in the program provided by Rule 64B16-27.300,

  5  Florida Administrative Code or health care practitioners

  6  working in facilities that administer medications dispensed

  7  from those pharmacies; or

  8         (b)  Pharmacists employed by pharmacies that have

  9  notified the Board of Pharmacy that they will establish a

10  continuous quality-improvement program consistent with the

11  requirements of Rule 64B16-27.300, Florida Administrative

12  Code.

13         (4)  The required notification to the department must

14  be submitted in writing by certified mail and postmarked

15  within 15 days after the pharmacist or health care

16  practitioner became aware of the patient's allegation that a

17  pharmaceutical adverse incident has occurred.

18         (5)  Effective July 1, 2004, subject to subsequent act

19  of the Legislature and a specific appropriation sufficient to

20  cover the actual costs, the department shall review each

21  incident and determine whether it potentially involved conduct

22  by a pharmacist or health care practitioner who is subject to

23  disciplinary action, in which case section 465.073, Florida

24  Statutes, applies.  Disciplinary action, if any, shall be

25  taken by the board under which the pharmacist or health care

26  practitioner is licensed.

27         (6)  The Department of Health shall adopt forms and

28  rules for administering this section.

29         Section 43.  Section 42 of this act shall take effect

30  only upon the effective date of legislation that makes any

31  such information provided to the Department of Health

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                                                  SENATE AMENDMENT

    Bill No. CS for CS for SB 370

    Amendment No. ___   Barcode 761516





  1  confidential and exempt from section 119.07(1), Florida

  2  Statutes, and Section 24(a) of Article I of the State

  3  Constitution, until 10 days after probable cause is found that

  4  a violation of law occurred. Such legislation must also

  5  provide that information may be used by the department or the

  6  Board of Pharmacy only in a disciplinary proceeding brought

  7  against the pharmacist or by the department in any study of

  8  adverse incidents without identifying the patient, pharmacist,

  9  pharmacy, office, or entity by name, location, or other

10  identifier.

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12  (Redesignate subsequent sections.)

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15  ================ T I T L E   A M E N D M E N T ===============

16  And the title is amended as follows:

17         On page 4, line 5, after the semicolon

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19  insert:

20         creating the "Ernest Belles Act"; defining the

21         term "pharmaceutical adverse incident" and

22         requiring that such incidents be reported to

23         the Department of Health; providing exceptions;

24         requiring the department to review reported

25         incidents to determine whether the incidents

26         potentially involve conduct by a health care

27         practitioner that is subject to disciplinary

28         action; specifying that any disciplinary action

29         shall be taken by the appropriate board;

30         providing for the adoption of rules and forms;

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