REPORT TITLE:
Drug Formulary


DESCRIPTION:
Permitting the Board of Health to designate the Orange Book,
published by the FDA, as the state generic drug formulary.
(SB1018 HD2)

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                        1018
THE SENATE                              S.B. NO.           S.D. 1
TWENTIETH LEGISLATURE, 1999                                H.D. 2
STATE OF HAWAII                                            
                                                             
________________________________________________________________
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                   A  BILL  FOR  AN  ACT

RELATING TO THE DRUG FORMULARY.



BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 1      SECTION 1.  Section 328-91, Hawaii Revised Statutes, is
 
 2 amended by adding two new definitions to be appropriately
 
 3 inserted and to read as follows:
 
 4      ""Hawaii additions and deletions list" means:
 
 5      (1)  A list of drug products that the board has determined
 
 6           to be safe, effective, and therapeutically equivalent
 
 7           generic drug products but are not in the Orange Book;
 
 8           and
 
 9      (2)  A list of drug products that are included in the Orange
 
10           Book, but the board has determined not to be safe,
 
11           effective, therapeutically equivalent, or bioequivalent
 
12           generic drug products.
 
13      "Orange Book" means the United States Food and Drug
 
14 Administration's "Approved Drug Products with Therapeutic
 
15 Equivalence Evaluations" publication and its cumulative
 
16 supplements, which include a list of approved prescription drug
 
17 products with therapeutic equivalence evaluations."
 
18      SECTION 2.  Section 328-96, Hawaii Revised Statutes, is
 
19 amended to read as follows:
 

 
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 1      "328-96  Drug formulary.(a)  The board [shall] may adopt
 
 2 rules, pursuant to chapter 91, [for the establishment and
 
 3 maintenance of a state drug formulary of equivalent drug
 
 4 products, and] to effectuate the purpose of this part[; except
 
 5 that the board may, without].  Without regard to chapter 91, 
 
 6 [establish in the formulary equivalent drug products that] the
 
 7 board may adopt as rules the Orange Book and its cumulative
 
 8 supplements once they are issued by the Commissioner of Food and
 
 9 Drugs, United States Food and Drug Administration, [has approved
 
10 as safe and effective and has determined to be therapeutically
 
11 equivalent.  The formulary shall list all drug products that the
 
12 Commissioner of Food and Drugs, United States Food and Drug
 
13 Administration, has approved as safe and effective and has
 
14 determined to be therapeutically equivalent.] as the state drug
 
15 formulary of equivalent drug products.  The board shall update
 
16 the formulary as often as necessary by meeting no less than every
 
17 six months, resources permitting, to adopt the Orange Book or its
 
18 cumulative supplements.  Upon the adoption of the Orange Book or
 
19 its cumulative supplements, the board shall notify all pharmacies
 
20 in the state and other interested individuals, within thirty
 
21 working days, that the formulary has been updated.  Pursuant to
 
22 chapter 91, the board may establish and maintain as rules a
 
23 Hawaii additions and deletions list; provided that, as required
 

 
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 1 by subsection 328-92(d), the pharmacist shall not substitute an
 
 2 equivalent drug product for any prescription for an anti-
 
 3 epileptic drug, except upon the consent of the practitioner and
 
 4 the patient or the patient's parent or guardian.  The [formulary]
 
 5 Hawaii additions and deletions list may list additional
 
 6 substitutable drug products that are determined by the board to
 
 7 [meet requirements adequate to assure product quality and
 
 8 therapeutic equivalence.] be safe, effective, and therapeutically
 
 9 equivalent.  The [formulary] Hawaii additions and deletions list
 
10 may delete [approved drugs] drug products listed in the Orange
 
11 Book upon [a] the board's finding that product quality or
 
12 therapeutic equivalency or bioequivalency, as appropriate, is not
 
13 adequately assured.
 
14      (b)  [The formulary] Pursuant to chapter 91, the Hawaii
 
15 additions and deletions list may be changed, added to, or deleted
 
16 from as the board deems appropriate.  Any person who requests
 
17 that any change be made or that a generic name or brand name drug
 
18 be included or added to or deleted from the [formulary] Hawaii
 
19 additions and deletions list shall have the burden of proof to
 
20 show cause why the change, inclusion, addition, or deletion
 
21 should be made.
 
22      (c)  The board shall [provide for revision or
 
23 supplementation of the formulary] revise or supplement the Hawaii
 

 
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 1 additions and deletions list as necessary [but not less than
 
 2 annually].
 
 3      (d)  The department [of health] shall provide for
 
 4 distribution of the [formulary,] Hawaii additions and deletions
 
 5 list and its revisions[,] and supplements to all pharmacies in
 
 6 the State and to any other interested individuals.  The
 
 7 department [of health] may establish fees to be charged to
 
 8 persons who receive the [formulary,] Hawaii additions and
 
 9 deletions list and its revisions[,] and supplements.  The amounts
 
10 of the fees charged for the [formulary,] Hawaii additions and
 
11 deletions list and its revisions[,] and supplements shall be
 
12 approximately the same as the costs of producing and distributing
 
13 the [formulary,] Hawaii additions and deletions list and its
 
14 revisions[,] and supplements.
 
15      [(e)  The department of health shall provide for public
 
16 education regarding the provisions of this part and shall monitor
 
17 the effects of this part.]
 
18      (e)  Each pharmacy in the state shall:
 
19      (1)  Obtain, maintain, and update the Orange Book and its
 
20           cumulative supplements; and
 
21      (2)  Obtain the Hawaii additions and deletions list.
 
22      (f)  The department shall provide for public education
 
23 regarding the provisions of this part and shall monitor the
 
24 effects of this part."
 

 
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 1      SECTION 3.  Statutory material to be repealed is bracketed.
 
 2 New statutory material is underscored.
 
 3      SECTION 4.  This Act shall take effect upon its approval.