Wisconsin 2023-2024 Regular Session

Wisconsin Senate Bill SB783 Compare Versions

Only one version of the bill is available at this time.

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3	3	2023 - 2024 LEGISLATURE
4	4	2023 SENATE BILL 783
5	5	December 8, 2023 - Introduced by Senators SPREITZER, SMITH, TAYLOR and WIRCH,
6	6	cosponsored by Representatives VINING, C. ANDERSON, J. ANDERSON, CLANCY,
7	7	CONLEY, CONSIDINE, DRAKE, EMERSON, JOERS, MADISON, OHNSTAD, ORTIZ-VELEZ,
8	8	RATCLIFF, SHANKLAND and SINICKI. Referred to Committee on Health.
9	9	AN ACT to amend 450.13 (title); and to create 450.13 (5n) of the statutes;
10	10	relating to: therapeutic interchange for drug products prescribed to
11	11	counteract anaphylaxis.
12	12	Analysis by the Legislative Reference Bureau
13	13	This bill allows a pharmacist to substitute a drug product prescribed to
14	14	counteract anaphylaxis with another drug product that would, in the opinion of the
15	15	pharmacist, have a substantially equivalent therapeutic effect even though the
16	16	substitute drug product is not a drug product equivalent if certain conditions are met.
17	17	The bill also provides that a pharmacist who dispenses a drug product for a patient
18	18	in a hospital may, for a drug product prescribed to counteract anaphylaxis, under the
19	19	same conditions applicable for drug product equivalents under current law,
20	20	substitute a drug product with another drug product that would, in the opinion of the
21	21	pharmacist, have a substantially equivalent therapeutic effect even though the
22	22	substitute drug product is not a drug product equivalent. Current law defines a
23	23	“drug product equivalent” as a drug product that is designated the therapeutic
24	24	equivalent of another drug product by the federal Food and Drug Administration as
25	25	set forth in the latest edition of the supplement to the federal Food and Drug
26	26	Administration's Approved Drug Products with Therapeutic Equivalence
27	27	Evaluations, commonly known as the Orange Book. As with substitution of drug
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32	32	SENATE BILL 783
33	33	product equivalents under current law, the therapeutic substitutions allowed under
34	34	the bill do not apply to biological products.
35	35	The people of the state of Wisconsin, represented in senate and assembly, do
36	36	enact as follows:
37	37	SECTION 1. 450.13 (title) of the statutes is amended to read:
38	38	450.13 (title) Using drug product equivalent in dispensing
39	39	prescriptions; therapeutic exchange for drug products prescribed to
40	40	counteract anaphylaxis.
41	41	SECTION 2. 450.13 (5n) of the statutes is created to read:
42	42	450.13 (5n) THERAPEUTIC INTERCHANGE FOR DRUGS COUNTERACTING ANAPHYLAXIS.
43	43	(a) Notwithstanding subs. (1s) to (4), for a drug product prescribed to counteract
44	44	anaphylaxis, a pharmacist may substitute a drug product with another drug product
45	45	that would, in the opinion of the pharmacist, have a substantially equivalent
46	46	therapeutic effect even though the substitute drug product is not a drug product
47	47	equivalent, provided all of the following conditions are met:
48	48	1. A prescribing practitioner has not indicated, by writing on the face of the
49	49	prescription order or, with respect to a prescription order transmitted electronically,
50	50	by designating in electronic format that a substitution of the drug product prescribed
51	51	may not be made under this subsection. If such indication is made, the pharmacist
52	52	shall dispense the prescription with the specific drug product prescribed.
53	53	2. The drug product substitution is intended to ensure formulary compliance
54	54	with the consumer's health insurance plan or, in the case of a consumer without
55	55	insurance, to lower the cost to the patient while maintaining safety.
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77	77	SECTION 2
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79	79	3. The consumer opts in to the drug product substitution, and the pharmacist
80	80	clearly informs the consumer of the differences in the drug products and specifies
81	81	that the consumer may refuse the substitution.
82	82	(b) If a pharmacist substitutes a drug product prescribed to counteract
83	83	anaphylaxis under this subsection, the pharmacist must ensure that the prescriber's
84	84	directions and quantity are modified to allow for equivalent dispensing to what was
85	85	originally prescribed.
86	86	(c) Within 5 business days after the dispensing of a drug product substitute
87	87	under this subsection, the dispensing pharmacist or the pharmacist's designee shall
88	88	do one of the following:
89	89	1. Make an entry of the specific drug product provided to the patient, including
90	90	the name of the product and the manufacturer. Entry into an electronic records
91	91	system as described in this paragraph is presumed to provide notice to the
92	92	prescribing practitioner. The communication shall be conveyed by making an entry
93	93	that is electronically accessible to the prescribing practitioner through one of the
94	94	following:
95	95	a. An interoperable electronic medical records system.
96	96	b. An electronic prescribing technology.
97	97	c. A pharmacist benefit management system.
98	98	d. A pharmacy record.
99	99	2. If a pharmacist is unable to make an entry as provided in subd. 1.,
100	100	communicate the drug product substitute dispensed to the prescribing practitioner
101	101	using facsimile, telephone, electronic transmission, or another prevailing means,
102	102	except that communication under this paragraph is not required if a refill of the drug
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128	128	SECTION 2 SENATE BILL 783
129	129	product is not changed from the product dispensed on the prior filling of the
130	130	prescription.
131	131	(d) Notwithstanding pars. (a) to (c), a pharmacist who dispenses a drug product
132	132	prescribed for a patient in a hospital may, for a drug product prescribed to counteract
133	133	anaphylaxis, substitute a drug product with another drug product that would, in the
134	134	opinion of the pharmacist, have a substantially equivalent therapeutic effect even
135	135	though the substitute drug product is not a drug product equivalent, if the
136	136	pharmacist dispenses the drug product substitute in accordance with written
137	137	guidelines or procedures previously established by a pharmacy and therapeutics
138	138	committee of the hospital and approved by the hospital's medical staff and use of the
139	139	drug product substitute has been approved for a patient during the period of the
140	140	patient's stay within the hospital by any of the following:
141	141	1. The patient's individual physician.
142	142	2. The patient's advanced practice nurse prescriber, if the advanced practice
143	143	nurse prescriber has entered into a written agreement to collaborate with a
144	144	physician.
145	145	3. The patient's physician assistant.
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