CODING: Words stricken are deletions; words underlined are additions.





                                                  SENATE AMENDMENT

    Bill No. SB 370

    Amendment No.    

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

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13         Senate Amendment (with title amendment) 

14         On page 1, between lines 25 and 26,

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16  insert:

17         Section 2.  Subsection (6) of section 465.025, Florida

18  Statutes, is amended to read:

19         465.025  Substitution of drugs.--

20         (6)  The Board of Pharmacy and the Board of Medicine

21  shall establish by rule a formulary of generic drug type and

22  brand name drug products as defined in 21 C.F.R. section

23  320.33 which meet all of the following criteria: the drug

24  product requires careful patient titration under the

25  supervision of a physician to establish the proper patient

26  dose; the drug product requires routine laboratory monitoring

27  of the patient to maintain the proper patient dose; improper

28  patient dosing can lead to life-threatening adverse events;

29  and the drug is a chronic-care medication involving therapy

30  beyond 30 days which are determined by the boards to

31  demonstrate clinically significant biological or therapeutic

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                                                  SENATE AMENDMENT

    Bill No. SB 370

    Amendment No.    





 1  inequivalence and which, if substituted, would pose a threat

 2  to the health and safety of patients receiving prescription

 3  medication.

 4         (a)  The formulary may be added to or deleted from as

 5  the Board of Pharmacy and the Board of Medicine deem

 6  appropriate; however, the Board of Pharmacy and the Board of

 7  Medicine shall jointly review the formulary not less than once

 8  every 2 years to determine whether each of the individual drug

 9  products on the formulary continues to meet the criteria

10  established in this subsection.  Any person who requests any

11  inclusion, addition, or deletion of a generic drug type or

12  brand name drug product to the formulary shall have the burden

13  of proof to show cause why such inclusion, addition, or

14  deletion should be made.

15         (b)  Upon adoption of the formulary required by this

16  subsection, and upon each addition, deletion, or modification

17  to the formulary, the Board of Pharmacy shall mail a copy to

18  each manager of the prescription department of each community

19  pharmacy licensed by the state, each nonresident pharmacy

20  registered in the state, and each board regulating

21  practitioners licensed by the laws of the state to prescribe

22  drugs shall incorporate such formulary into its rules.  No

23  pharmacist shall substitute a generically equivalent drug

24  product for a prescribed brand name drug product if the brand

25  name drug product or the generic drug type drug product is

26  included in the the said formulary, unless the prescriber

27  authorizes substitution in advance of dispensing such

28  substitute drug product.

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30  (Redesignate subsequent sections.)

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                                                  SENATE AMENDMENT

    Bill No. SB 370

    Amendment No.    





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

 2  And the title is amended as follows:

 3         On page 1, line 6, after the semicolon,

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 5  insert:

 6         amending s. 465.025, F,S.; prescribing criteria

 7         for inclusion of drugs on the formulary;

 8         requiring periodic review of drugs on the

 9         formulary; requiring prior physician

10         authorization for substitution of drugs;

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