Wisconsin 2023-2024 Regular Session

Wisconsin Assembly Bill AB849 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 ASSEMBLY BILL 849
5	5	December 22, 2023 - Introduced by Representatives VINING, C. ANDERSON, J.
6	6	ANDERSON, CLANCY, CONLEY, CONSIDINE, DRAKE, EMERSON, JOERS, MADISON,
7	7	OHNSTAD, ORTIZ-VELEZ, RATCLIFF, SHANKLAND and SINICKI, cosponsored by
8	8	Senators SPREITZER, SMITH, TAYLOR, WIRCH and AGARD. Referred to Committee
9	9	on Health, Aging and Long-Term Care.
10	10	*AUTHORS SUBJECT TO CHANGE*
11	11	AN ACT to amend 450.13 (title); and to create 450.13 (5n) of the statutes;
12	12	relating to: therapeutic interchange for drug products prescribed to
13	13	counteract anaphylaxis.
14	14	Analysis by the Legislative Reference Bureau
15	15	This bill allows a pharmacist to substitute a drug product prescribed to
16	16	counteract anaphylaxis with another drug product that would, in the opinion of the
17	17	pharmacist, have a substantially equivalent therapeutic effect even though the
18	18	substitute drug product is not a drug product equivalent if certain conditions are met.
19	19	The bill also provides that a pharmacist who dispenses a drug product for a patient
20	20	in a hospital may, for a drug product prescribed to counteract anaphylaxis, under the
21	21	same conditions applicable for drug product equivalents under current law,
22	22	substitute a drug product with another drug product that would, in the opinion of the
23	23	pharmacist, have a substantially equivalent therapeutic effect even though the
24	24	substitute drug product is not a drug product equivalent. Current law defines a
25	25	“drug product equivalent” as a drug product that is designated the therapeutic
26	26	equivalent of another drug product by the federal Food and Drug Administration as
27	27	set forth in the latest edition of the supplement to the federal Food and Drug
28	28	Administration's Approved Drug Products with Therapeutic Equivalence
29	29	Evaluations, commonly known as the Orange Book. As with substitution of drug
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34	34	ASSEMBLY BILL 849
35	35	product equivalents under current law, the therapeutic substitutions allowed under
36	36	the bill do not apply to biological products.
37	37	The people of the state of Wisconsin, represented in senate and assembly, do
38	38	enact as follows:
39	39	SECTION 1. 450.13 (title) of the statutes is amended to read:
40	40	450.13 (title) Using drug product equivalent in dispensing
41	41	prescriptions; therapeutic exchange for drug products prescribed to
42	42	counteract anaphylaxis.
43	43	SECTION 2. 450.13 (5n) of the statutes is created to read:
44	44	450.13 (5n) THERAPEUTIC INTERCHANGE FOR DRUGS COUNTERACTING ANAPHYLAXIS.
45	45	(a) Notwithstanding subs. (1s) to (4), for a drug product prescribed to counteract
46	46	anaphylaxis, a pharmacist may substitute a drug product with another drug product
47	47	that would, in the opinion of the pharmacist, have a substantially equivalent
48	48	therapeutic effect even though the substitute drug product is not a drug product
49	49	equivalent, provided all of the following conditions are met:
50	50	1. A prescribing practitioner has not indicated, by writing on the face of the
51	51	prescription order or, with respect to a prescription order transmitted electronically,
52	52	by designating in electronic format that a substitution of the drug product prescribed
53	53	may not be made under this subsection. If such indication is made, the pharmacist
54	54	shall dispense the prescription with the specific drug product prescribed.
55	55	2. The drug product substitution is intended to ensure formulary compliance
56	56	with the consumer's health insurance plan or, in the case of a consumer without
57	57	insurance, to lower the cost to the patient while maintaining safety.
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79	79	SECTION 2
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81	81	3. The consumer opts in to the drug product substitution, and the pharmacist
82	82	clearly informs the consumer of the differences in the drug products and specifies
83	83	that the consumer may refuse the substitution.
84	84	(b) If a pharmacist substitutes a drug product prescribed to counteract
85	85	anaphylaxis under this subsection, the pharmacist must ensure that the prescriber's
86	86	directions and quantity are modified to allow for equivalent dispensing to what was
87	87	originally prescribed.
88	88	(c) Within 5 business days after the dispensing of a drug product substitute
89	89	under this subsection, the dispensing pharmacist or the pharmacist's designee shall
90	90	do one of the following:
91	91	1. Make an entry of the specific drug product provided to the patient, including
92	92	the name of the product and the manufacturer. Entry into an electronic records
93	93	system as described in this paragraph is presumed to provide notice to the
94	94	prescribing practitioner. The communication shall be conveyed by making an entry
95	95	that is electronically accessible to the prescribing practitioner through one of the
96	96	following:
97	97	a. An interoperable electronic medical records system.
98	98	b. An electronic prescribing technology.
99	99	c. A pharmacist benefit management system.
100	100	d. A pharmacy record.
101	101	2. If a pharmacist is unable to make an entry as provided in subd. 1.,
102	102	communicate the drug product substitute dispensed to the prescribing practitioner
103	103	using facsimile, telephone, electronic transmission, or another prevailing means,
104	104	except that communication under this paragraph is not required if a refill of the drug
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131	131	product is not changed from the product dispensed on the prior filling of the
132	132	prescription.
133	133	(d) Notwithstanding pars. (a) to (c), a pharmacist who dispenses a drug product
134	134	prescribed for a patient in a hospital may, for a drug product prescribed to counteract
135	135	anaphylaxis, substitute a drug product with another drug product that would, in the
136	136	opinion of the pharmacist, have a substantially equivalent therapeutic effect even
137	137	though the substitute drug product is not a drug product equivalent, if the
138	138	pharmacist dispenses the drug product substitute in accordance with written
139	139	guidelines or procedures previously established by a pharmacy and therapeutics
140	140	committee of the hospital and approved by the hospital's medical staff and use of the
141	141	drug product substitute has been approved for a patient during the period of the
142	142	patient's stay within the hospital by any of the following:
143	143	1. The patient's individual physician.
144	144	2. The patient's advanced practice nurse prescriber, if the advanced practice
145	145	nurse prescriber has entered into a written agreement to collaborate with a
146	146	physician.
147	147	3. The patient's physician assistant.
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