Representative Raymond P. Ward proposes the following substitute bill:


1     
PHARMACY AMENDMENTS

2     
2024 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: Raymond P. Ward

5     
Senate Sponsor: Evan J. Vickers

6     

7     LONG TITLE
8     General Description:
9          This bill allows pharmacists and pharmacy interns to substitute prescribed drugs under
10     certain circumstances.
11     Highlighted Provisions:
12          This bill:
13          ▸     defines terms;
14          ▸     allows pharmacists and pharmacy interns to substitute prescribed drugs under
15     certain circumstances;
16          ▸     requires the Division of Professional Licensing, in consultation with certain
17     licensing boards, to develop a therapeutically similar drug list; and
18          ▸     provides rulemaking authority.
19     Money Appropriated in this Bill:
20          None
21     Other Special Clauses:
22          None
23     Utah Code Sections Affected:
24     AMENDS:
25          58-17b-605, as last amended by Laws of Utah 2020, Chapter 372
26     

27     Be it enacted by the Legislature of the state of Utah:
28          Section 1. Section 58-17b-605 is amended to read:
29          58-17b-605. Drug product equivalents and similar drug products.
30          (1) For the purposes of this section:
31          (a) (i) "Drug" is as defined in Section 58-17b-102.
32          (ii) "Drug" [does not mean] includes a "biological product" as defined in Section
33     58-17b-605.5.
34          (b) "Drug product equivalent" means[: (i)] a drug product that is designated as the
35     therapeutic equivalent of another drug product in the Approved Drug Products with
36     Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
37     of the United States Food and Drug Administration[; and].
38          [(ii) notwithstanding Subsection (1)(b)(i), an appropriate substitute for albuterol
39     designated by division rule made under Subsection (9).]
40          (c) "Osteopathic Physician and Surgeon's Licensing Board" means the board created in
41     Section 58-68-201.
42          (d) "Physicians Licensing Board" means the board created in Section 58-67-201.
43          (e) "Therapeutically similar drug product" means a drug product that:
44          (i) provides a similar level of therapeutic benefit and risk to a patient as another drug
45     product; and
46          (ii) is on the list of therapeutically similar drugs created by the division in accordance
47     with Subsection (9).
48          (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
49     by brand or proprietary name may substitute:
50          (a) a drug product equivalent for the prescribed drug [only] if:
51          [(a)] (i) the purchaser specifically requests or consents to the substitution of a drug
52     product equivalent;
53          [(b)] (ii) the drug product equivalent is of the same generic type and is designated the
54     therapeutic equivalent in the approved drug products with therapeutic equivalence evaluations
55     prepared by the Center for Drug Evaluation and Research of the Federal Food and Drug
56     Administration;
57          [(c)] (iii) the drug product equivalent is permitted to move in interstate commerce;
58          [(d)] (iv) the pharmacist or pharmacy intern counsels the patient on the use and the
59     expected response to the prescribed drug, whether a substitute or not[, and];
60          (v) the substitution is not otherwise prohibited by [this chapter;] law; and
61          [(e)] (vi) the prescribing practitioner has not indicated that a drug product equivalent
62     may not be substituted for the drug, as provided in Subsection (6); [and] or
63          [(f) the substitution is not otherwise prohibited by law.]
64          (b) a therapeutically similar drug product if:
65          (i) the prescriber has written "similar substitution authorized" on the prescription for
66     the prescribed drug;
67          (ii) the therapeutically similar drug product is listed on the therapeutically similar drug
68     list described in Subsection (9) as a drug that can be substituted for the prescribed drug;
69          (iii) the purchaser specifically requests or consents to the substitution of the
70     therapeutically similar drug;
71          (iv) the dispensed therapeutically similar drug product is permitted to move in
72     interstate commerce;
73          (v) the pharmacist or pharmacy intern counsels the patient on the use and the expected
74     response to the therapeutically similar drug product;
75          (vi) the substitution is not otherwise prohibited by law; and
76          (vii) the substitution:
77          (A) results in a decreased cost to the patient;
78          (B) is covered on the patient's health benefit plan formulary as a preferred drug or at
79     the same or lower payment tier;
80          (C) is necessary because the pharmacist does not have the originally prescribed
81     medication available to dispense to the patient; or
82          (D) would be beneficial to the patient for any reason if the patient and pharmacist
83     mutually agree that the substitution would benefit the patient.
84          (3) (a) Each out-of-state mail service pharmacy dispensing a drug product equivalent or
85     a therapeutically similar drug product as a substitute for another drug into this state shall notify
86     the patient of the substitution either by telephone or in writing.
87          (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
88     chapter with respect to a drug product equivalent or a therapeutically similar drug product
89     substituted for another drug, including labeling and record keeping.
90          (4) (a) Pharmacists or pharmacy interns may not substitute without the prescriber's
91     authorization on trade name drug product prescriptions unless the product is currently
92     categorized in the approved drug products with therapeutic equivalence evaluations prepared
93     by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration
94     as a drug product considered to be therapeutically equivalent to another drug product.
95          (b) A pharmacist or pharmacy intern that substitutes a drug product for a
96     therapeutically similar drug product under Subsection (2)(b), for any prescription intended to
97     last longer than 30 days, shall notify the prescriber that the pharmacist or pharmacy intern
98     substituted the drug.
99          (5) A pharmacist or pharmacy intern who dispenses a prescription with a drug product
100     equivalent or a therapeutically similar drug product under this section assumes no greater
101     liability than would be incurred had the pharmacist or pharmacy intern dispensed the
102     prescription with the drug product prescribed.
103          (6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
104     patient that a drug product equivalent not be substituted for a prescribed drug, the practitioner
105     may indicate a prohibition on substitution either by writing "dispense as written" or signing in
106     the appropriate space where two lines have been preprinted on a prescription order and
107     captioned "dispense as written" or "substitution permitted".
108          (b) If the prescription is communicated orally by the prescribing practitioner to the
109     pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
110     and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
111     name of the practitioner and the words "orally by" and the initials of the pharmacist or
112     pharmacy intern written after it.
113          (7) (a) A pharmacist or pharmacy intern who substitutes a drug product equivalent or
114     therapeutically similar drug product for a prescribed drug shall communicate the substitution to
115     the purchaser.
116          (b) The drug product equivalent or therapeutically similar drug product container shall
117     be labeled with the name of the drug dispensed[, and the].
118          (c) The pharmacist, pharmacy intern, or pharmacy technician shall indicate on the file
119     copy of the prescription both the name of the prescribed drug and the name of the drug product
120     equivalent or the therapeutically similar drug product dispensed in [its] place of the prescribed
121     drug.
122          (8) (a) For purposes of this Subsection (8), "substitutes" means to substitute:
123          (i) a generic drug for another generic drug;
124          (ii) a generic drug for a nongeneric drug;
125          (iii) a nongeneric drug for another nongeneric drug; or
126          (iv) a nongeneric drug for a generic drug.
127          (b) A prescribing practitioner who makes a finding under Subsection (6)(a) for a
128     patient with a seizure disorder shall indicate a prohibition on substitution of a drug product
129     equivalent in the manner provided in Subsection (6)(a) or (b).
130          (c) Except as provided in Subsection (8)(d), a pharmacist or pharmacy intern who
131     cannot dispense the prescribed drug as written, and who needs to substitute a drug product
132     equivalent for the drug prescribed to the patient to treat or prevent seizures shall notify the
133     prescribing practitioner prior to the substitution.
134          (d) Notification under Subsection (8)(c) is not required if the drug product equivalent is
135     paid for in whole or in part by Medicaid.
136          (9) (a) [The division shall designate by rule made in] In accordance with Title 63G,
137     Chapter 3, Utah Administrative Rulemaking Act, and in consultation with the board, the
138     Physicians Licensing Board [created in Section 58-67-201], and the Osteopathic Physician and
139     Surgeon's Licensing Board [created in Section 58-68-201, appropriate substitutes for
140     albuterol.], the division shall create a therapeutically similar drug product list that contains lists
141     of drug products that are therapeutically similar to each other.
142          (b) [Subsections (2)(b) and (4) do not apply to the substitution of a drug product
143     equivalent for albuterol.] The division may not add a drug product to the therapeutically similar
144     drug product list if the addition is opposed by:
145          (i) the board;
146          (ii) the Physicians Licensing Board; or
147          (iii) the Osteopathic Physician and Surgeon's Licensing Board.
148          (c) When considering a drug to be added to the therapeutically similar drug product
149     list, the division shall consult with each board described in Subsection (9)(b).
150          (d) When consulting with the division under Subsection (9)(c), a board described in
151     Subsection (9)(b) may:
152          (i) review clinical practice guidelines;
153          (ii) review peer-review studies; and
154          (iii) consult with medical specialists who are familiar with the drug under
155     consideration.
156          (e) When creating the therapeutically similar drug product list, before considering any
157     other types of drugs, the division shall consider:
158          (i) albuterol inhalers;
159          (ii) injectable forms of insulin; and
160          (iii) diabetic test strips.
161          (f) The division may, in consultation with each board described in Subsection (9)(b),
162     create standards in rule for considering drug products that should be added to the
163     therapeutically similar drug product list.
164          (10) Failure of a licensed medical practitioner to specify that no substitution is
165     authorized does not constitute evidence of negligence.
166          Section 2. Effective date.
167          This bill takes effect on May 1, 2024.