1     
PRESCRIPTION NOTIFICATION AMENDMENTS

2     
2015 GENERAL SESSION

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STATE OF UTAH

4     
Chief Sponsor: Francis D. Gibson

5     
Senate Sponsor: J. Stuart Adams

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7     LONG TITLE
8     General Description:
9          This bill amends provisions related to biosimilar products in the Pharmacy Practice Act.
10     Highlighted Provisions:
11          This bill:
12          ▸     deletes the definition of biosimilar;
13          ▸     defines interchangeable biological product;
14          ▸     requires a pharmacist to notify the prescriber when a biological product is dispensed
15     if an interchangeable biological product is available;
16          ▸     establishes the methods of notifying a prescriber; and
17          ▸     amends repealer language.
18     Money Appropriated in this Bill:
19          None
20     Other Special Clauses:
21          None
22     Utah Code Sections Affected:
23     AMENDS:
24          58-17b-605.5, as enacted by Laws of Utah 2013, Chapter 423
25          63I-2-258, as last amended by Laws of Utah 2013, Chapter 423
26     

27     Be it enacted by the Legislature of the state of Utah:
28          Section 1. Section 58-17b-605.5 is amended to read:
29          58-17b-605.5. Interchangeable biological products.
30          (1) For the purposes of this section:
31          (a) "Biological product" [is as] means the same as that term is defined in 42 U.S.C.
32     Sec. 262[;].
33          [(b) "biosimilar" is as defined in 42 U.S.C. Sec. 262; and]
34          [(c) "interchangeable" is as defined in 42 U.S.C. Sec. 262.]
35          (b) "Interchangeable biological product" means a biological product that the federal
36     Food and Drug Administration:
37          (i) has:
38          (A) licensed; and
39          (B) determined meets the standards for interchangeability pursuant to 42 U.S.C. Sec.
40     262(k)(4); or
41          (ii) has determined is therapeutically equivalent as set forth in the latest edition of or
42     supplement to the federal Food and Drug Administration's Approved Drug Products with
43     Therapeutic Equivalence Evaluations.
44          (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific
45     biological product by brand or proprietary name may substitute [a biosimilar] an
46     interchangeable biological product for the prescribed biological product only if:
47          (a) the purchaser specifically requests or consents to the substitute of an
48     interchangeable [biosimilar] biological product;
49          [(b) the biosimilar product has been determined by the United States Food and Drug
50     Administration to be interchangeable with the prescribed biological product;]
51          [(c)] (b) the interchangeable [biosimilar] biological product is permitted to move in
52     interstate commerce;
53          [(d)] (c) the pharmacist or pharmacy intern counsels the patient on the use and the
54     expected response to the prescribed biological product, whether a substitute or not, and the
55     substitution is not otherwise prohibited by this chapter;
56          [(e)] (d) the prescribing practitioner has not prohibited the substitution of an
57     interchangeable [biosimilar] biological product for the prescribed biological product, as
58     provided in Subsection (6); and
59          [(f)] (e) the substitution is not otherwise prohibited by law.
60          (3) [(a)] Each out-of-state mail service pharmacy dispensing an interchangeable
61     [biosimilar] biological product as a substitute for another biological product into this state
62     shall:
63          (a) notify the patient of the substitution either by telephone or in writing[.]; and
64          (b) [Each out-of-state mail service pharmacy shall] comply with the requirements of
65     this chapter with respect to an interchangeable [biosimilar] biological product substituted for
66     another biological product, including labeling and record keeping.
67          (4) Pharmacists or pharmacy interns may not substitute without the prescriber's
68     authorization biological product prescriptions unless the product has been determined by the
69     United States Food and Drug Administration to be interchangeable with the prescribed
70     biological product.
71          (5) A pharmacist or pharmacy intern who dispenses a prescription with an
72     interchangeable [biosimilar] biological product under this section assumes no greater liability
73     than would be incurred had the pharmacist or pharmacy intern dispensed the prescription with
74     the biological product prescribed.
75          (6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
76     patient that an interchangeable [biosimilar] biological product not be substituted for a
77     prescribed biological product, the practitioner may prohibit a substitution either by writing
78     "dispense as written" or by signing in the appropriate space where two lines have been
79     preprinted on a prescription order and captioned "dispense as written" or "substitution
80     permitted."
81          (b) (i) If the prescription is communicated orally by the prescribing practitioner to the
82     pharmacist or pharmacy intern, the practitioner shall direct the prohibition or substitution.
83          (ii) The pharmacist or pharmacy intern shall make a written note of the practioner's
84     direction by writing the name of the practitioner and the words "orally by" and the initials of
85     the pharmacist or pharmacy intern written after it.
86          (7) A pharmacist or pharmacy intern who substitutes an interchangeable [biosimilar]
87     biological product for a prescribed biological product shall communicate the substitution to the
88     purchaser. The interchangeable [biosimilar] biological product container shall be labeled with
89     the name of the interchangeable [biosimilar] biological product dispensed, and the pharmacist,
90     pharmacy intern, or pharmacy technician shall indicate on the file copy of the prescription both
91     the name of the prescribed biological product and the name of the interchangeable [biosimilar]
92     biological product dispensed in its place.
93          [(8) (a) A pharmacist or pharmacy intern who substitutes an interchangeable biosimilar
94     product for a prescribed biological product shall:]
95          [(i) notify the prescriber in writing, by fax, telephone, or electronic transmission of the
96     substitution, as soon as practicable, but not later than three business days after dispensing the
97     interchangeable biosimilar product in place of the prescribed biological product; and]
98          [(ii) include the name and manufacturer of the interchangeable biosimilar product
99     substituted.]
100          [(b) This subsection is repealed on May 15, 2015.]
101          (8) Within five business days following the dispensing of a biological product, the
102     dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product
103     provided to the patient, including the name of the product and the manufacturer. The
104     communication shall be conveyed by making an entry into an interoperable electronic medical
105     records system, through an electronic prescribing technology, a pharmacy benefit management
106     system, or a pharmacy record that is electronically accessible by the prescriber. Entry into an
107     electronic records system as described in this Subsection (8) is presumed to provide notice to
108     the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed
109     to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means,
110     provided that communication shall not be required where:
111          (a) there is no FDA-approved interchangeable biological product for the product
112     prescribed;
113          (b) a refill prescription is not changed from the product dispensed on the prior filling of
114     the prescription; or
115          (c) the product is paid for using cash or cash equivalent.
116          Section 2. Section 63I-2-258 is amended to read:
117          63I-2-258. Repeal dates -- Title 58.
118          [(1) Subsection 58-72-201(1)(b) is repealed July 1, 2014.]
119          [(2) Subsection 58-17b-605.5(8) is repealed on May 15, 2015.]