First Substitute H.B. 440

This document includes House Floor Amendments incorporated into the bill on Mon, Feb 26, 2007 at 9:12 AM by ddonat. -->

Representative Eric K. Hutchings proposes the following substitute bill:

1 DRUG PRODUCT EQUIVALENT AMENDMENTS
2 2007 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor: Eric K. Hutchings
5 Senate Sponsor: Sheldon L. Killpack
6
7 LONG TITLE
8 General Description:
9 This bill amends Pharmacy Practice Act provisions governing the substitution of a drug
10 product equivalent for a drug specified in a prescription order.
11 Highlighted Provisions:
12 This bill:
13 . amends the Pharmacy Practice Act;
14 . except as specified, prohibits substitution of a drug product equivalent for a drug
15 prescribed to treat or prevent seizures without the prescribing practitioner's
16 authorization; and
17 . clarifies that the preferred drug list and the generic requirements of the state
18 Medicaid program supercede provisions related to substitutions for seizure
19 medications.
20 Monies Appropriated in this Bill:
21 None
22 Other Special Clauses:
23 None
24 Utah Code Sections Affected:
25 AMENDS:

26 58-17b-605, as enacted by Chapter 280, Laws of Utah 2004
27
28 Be it enacted by the Legislature of the state of Utah:
29 Section 1. Section 58-17b-605 is amended to read:
30 58-17b-605. Drug product equivalents.
31 (1) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
32 by brand or proprietary name may substitute another drug product equivalent as defined in
33 Section 58-17b-102 for the prescribed drug only if:
34 (a) the purchaser specifically requests or consents to the substitution of a drug product
35 equivalent;
36 (b) the substituted drug product equivalent is of the same generic type and is
37 designated the therapeutic equivalent in the approved drug products with therapeutic
38 equivalence evaluations prepared by the Center for Drug Evaluation and Research of the
39 Federal Food and Drug Administration;
40 (c) the substituted drug product is permitted to move in interstate commerce;
41 (d) the pharmacist or pharmacy intern counsels the patient on the use and the expected
42 response to the prescribed drug, whether a substitute or not, and the substitution is not
43 otherwise prohibited by this chapter;
44 (e) the prescribing practitioner has not indicated that [an equivalent] a drug product [is]
45 equivalent may not [to] be substituted for the drug, as provided in Subsection (5); [and]
46 (f) except when the prescription drug is paid for in whole or in part by Medicaid, if the
47 prescribed drug H. is an epileptic drug that .H has been prescribed in this instance to treat or
47a prevent seizures, the pharmacist
48 or pharmacy intern obtains the authorization of the prescribing practitioner; and
49 [(f)] (g) the substitution is not otherwise prohibited by law, including any restrictions
50 imposed by the Medicaid program.
51 (2) (a) Each out-of-state mail service pharmacy dispensing a substituted drug product
52 equivalent as a substitute for another drug into this state shall notify the patient of the
53 substitution either by telephone or in writing.
54 (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
55 chapter with respect to [drugs which may be] a drug product equivalent substituted for another
56 drug, including labeling [and], record keeping[, when dispensing substituted drug products],

57 and in accordance with Subsection (1)(f), prescribing practitioner authorization.
58 (3) Pharmacists or pharmacy interns may not substitute without the prescriber's
59 authorization on trade name drug product prescriptions unless the product is currently
60 categorized in the approved drug products with therapeutic equivalence evaluations prepared
61 by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration
62 as a drug product considered to be therapeutically equivalent to another drug product.
63 (4) A pharmacist or pharmacy intern who dispenses a prescription with a drug product
64 equivalent under this section assumes no greater liability than would be incurred had the
65 pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
66 (5) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
67 patient that [an equivalent] a drug product equivalent not be substituted for another drug, the
68 practitioner may indicate a prohibition on substitution either by writing "dispense as written" or
69 may sign in the appropriate space where two lines have been preprinted on a prescription order
70 and captioned "dispense as written" or "substitution permitted".
71 (b) If the prescription is communicated orally by the prescribing practitioner to the
72 pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
73 and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
74 name of the practitioner and the words "orally by" and the initials of the pharmacist or
75 pharmacy [practitioner] intern written after it.
76 (6) The substitution, if any, shall be communicated to the purchaser. The container
77 shall be labeled with the name of the drug product equivalent dispensed and the pharmacist,
78 pharmacy intern, or pharmacy technician shall indicate on the file copy of the prescription both
79 the name of the prescribed drug and the name of the drug product equivalent dispensed in its
80 place.
81 (7) Failure of a licensed medical practitioner to specify that no substitution is
82 authorized does not constitute evidence of negligence.