SENATE AMENDMENT

    Bill No. CS for CS for SB 370

    Amendment No. ___   Barcode 742614

                            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 742614





  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

  6         (b)  Pharmacists employed by pharmacies that have

  7  notified the Board of Pharmacy that they will establish a

  8  continuous quality-improvement program consistent with the

  9  requirements of Rule 64B16-27.300, Florida Administrative

10  Code.

11         (4)  The required notification to the department must

12  be submitted in writing by certified mail and postmarked

13  within 15 days after the pharmacist or health care

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

15  pharmaceutical adverse incident has occurred.

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

17  of the Legislature and a specific appropriation sufficient to

18  cover the actual costs, the department shall review each

19  incident and determine whether it potentially involved conduct

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

21  disciplinary action, in which case section 465.073, Florida

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

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

24  practitioner is licensed.

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

26  rules for administering this section.

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

28  only upon the effective date of legislation that makes any

29  such information provided to the Department of Health

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

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

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                                                  SENATE AMENDMENT

    Bill No. CS for CS for SB 370

    Amendment No. ___   Barcode 742614





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

  2  a violation of law occurred. Such legislation must also

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

  4  Board of Pharmacy only in a disciplinary proceeding brought

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

  6  adverse incidents without identifying the patient, pharmacist,

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

  8  identifier.

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10  (Redesignate subsequent sections.)

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

14  And the title is amended as follows:

15         On page 4, line 5, after the semicolon

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17  insert:

18         creating the "Ernest Belles Act"; defining the

19         term "pharmaceutical adverse incident" and

20         requiring that such incidents be reported to

21         the Department of Health; providing exceptions;

22         requiring the department to review reported

23         incidents to determine whether the incidents

24         potentially involve conduct by a health care

25         practitioner that is subject to disciplinary

26         action; specifying that any disciplinary action

27         shall be taken by the appropriate board;

28         providing for the adoption of rules and forms;

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