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March 20, 2020 - Introduced by Representatives Vining, Spreitzer, Anderson,
Brostoff, Cabrera, Fields, Hebl, Kolste, Neubauer, Ohnstad, Shankland,
Sinicki, Stubbs, Subeck and Zamarripa, cosponsored by Senators Hansen,
Jacque, Larson, Ringhand, Schachtner, Smith, L. Taylor and Wirch.
Referred to Committee on Health.
AB1011,1,5 1An Act to renumber and amend 450.13 (1e); to amend 102.425 (1) (c), 450.11
2(4g) (a) 2. and 450.13 (title); and to create 20.435 (1) (ck), 256.158, 450.13 (1e)
3(b) and 450.13 (5m) of the statutes; relating to: epinephrine for ambulances,
4therapeutic interchange for drug products prescribed to counteract
5anaphylaxis, and making an appropriation.
Analysis by the Legislative Reference Bureau
This bill requires that the Department of Health Services purchase and provide
to ambulance service providers without charge a set of two epinephrine
auto-injectors or a set of two draw-up epinephrine kits for each ambulance
operating in the state. Under the bill, an ambulance service provider means an
ambulance service provider that is a public agency, volunteer fire department, or
nonprofit corporation. The bill also requires that, on an ongoing basis, DHS must,
upon request, provide replacement sets to ambulance service providers.
Also, for drug products prescribed to counteract anaphylaxis, this bill allows,
if certain conditions are met, a pharmacist to substitute a drug product with another
drug product in the same therapeutic class that would, in the opinion of the
pharmacist, have a substantially equivalent therapeutic effect even though the
substitute drug product is not a drug product equivalent. The bill also provides that
a pharmacist who dispenses a drug product for a patient in a hospital may, for a drug
product prescribed to counteract anaphylaxis, under the same conditions applicable
for drug product equivalents under current law, substitute a drug product with

another drug product in the same therapeutic class that would in the opinion of the
pharmacist, have a substantially equivalent therapeutic effect even though the
substitute drug product is not a drug product equivalent. Current law defines a
“drug product equivalent” as a drug product that is designated the therapeutic
equivalent of another drug product by the federal Food and Drug Administration as
set forth in the latest edition of or supplement to the federal Food and Drug
Administration's Approved Drug Products with Therapeutic Equivalence
Evaluations
, commonly known as the Orange Book. As with substitution of drug
product equivalents under current law, the therapeutic class substitutions allowed
under the bill do not apply to biological products.
For further information see the state and local fiscal estimate, which will be
printed as an appendix to this bill.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
AB1011,1 1Section 1 . 20.435 (1) (ck) of the statutes is created to read:
AB1011,2,42 20.435 (1) (ck) Epinephrine for ambulances. A sum sufficient for the
3department of health services to purchase and provide epinephrine for ambulances
4under s. 256.158.
AB1011,2 5Section 2 . 102.425 (1) (c) of the statutes is amended to read:
AB1011,2,76 102.425 (1) (c) “Drug product equivalent" has the meaning given in s. 450.13
7(1e) (a).
AB1011,3 8Section 3. 256.158 of the statutes is created to read:
AB1011,2,9 9256.158 Epinephrine for ambulances. (1) In this section:
AB1011,2,1110 (a) “Ambulance service provider” means an ambulance service provider that is
11a public agency, volunteer fire department, or nonprofit corporation.
AB1011,2,1312 (b) “Draw-up epinephrine” means epinephrine that is administered
13intramuscularly using a needle and syringe and drawn up from a vial or ampule.
AB1011,2,1514 (c) “Draw-up epinephrine kit” means a single-use vial or ampule of draw-up
15epinephrine and a syringe for administration to a patient.
AB1011,3,8
1(2) From the appropriation under s. 20.435 (1) (ck), the department shall
2purchase and provide to ambulance service providers without charge a set of 2
3epinephrine auto-injectors or a set of 2 draw-up epinephrine kits for each
4ambulance operating in the state. On an ongoing basis, the department shall, upon
5request from an ambulance service provider, provide to the ambulance service
6provider a replacement set of 2 epinephrine auto-injectors or a set of 2 draw-up
7epinephrine kits. The department shall allow the ambulance service provider to
8choose between epinephrine auto-injectors and draw-up epinephrine kits.
AB1011,4 9Section 4 . 450.11 (4g) (a) 2. of the statutes is amended to read:
AB1011,3,1110 450.11 (4g) (a) 2. “Drug product equivalent" has the meaning given in s. 450.13
11(1e) (a).
AB1011,5 12Section 5. 450.13 (title) of the statutes is amended to read:
AB1011,3,15 13450.13 (title) Using drug product equivalent in dispensing
14prescriptions
; therapeutic exchange for drug products prescribed to
15counteract anaphylaxis
.
AB1011,6 16Section 6. 450.13 (1e) of the statutes is renumbered 450.13 (1e) (intro.) and
17amended to read:
AB1011,3,1818 450.13 (1e) Definition Definitions. (intro.) In this section, “drug:
AB1011,3,23 19(a) “Drug product equivalent" means a drug product that is designated the
20therapeutic equivalent of another drug product by the federal food and drug
21administration as set forth in the latest edition of or supplement to the federal food
22and drug administration's Approved Drug Products with Therapeutic Equivalence
23Evaluations.
AB1011,7 24Section 7. 450.13 (1e) (b) of the statutes is created to read:
AB1011,4,2
1450.13 (1e) (b) “Therapeutic class” means a group of similar drug products that
2are used to treat a specific condition.
AB1011,8 3Section 8. 450.13 (5m) of the statutes is created to read:
AB1011,4,94 450.13 (5m) Therapeutic interchange for drugs counteracting anaphylaxis.
5(a) Notwithstanding subs. (1s) to (4), for a drug product prescribed to counteract
6anaphylaxis, a pharmacist may substitute a drug product with another drug product
7in the same therapeutic class that would, in the opinion of the pharmacist, have a
8substantially equivalent therapeutic effect even though the substitute drug product
9is not a drug product equivalent, provided all of the following conditions are met:
AB1011,4,1410 1. A prescribing practitioner has not indicated, by writing on the face of the
11prescription order or, with respect to a prescription order transmitted electronically,
12by designating in electronic format that a substitution of the drug product prescribed
13may not be made under this subsection. If such indication is made, the pharmacist
14shall dispense the prescription with the specific drug product prescribed.
AB1011,4,1715 2. The drug product substitution is intended to ensure formulary compliance
16with the consumer's health insurance plan or, in the case of a consumer without
17insurance, to lower the cost to the patient while maintaining safety.
AB1011,4,2018 3. The consumer opts in to the drug product substitution, and the pharmacist
19clearly informs the consumer of the differences in the drug products and specifies
20that the consumer may refuse the substitution.
AB1011,4,2421 (b) If a pharmacist substitutes a drug product prescribed to counteract
22anaphylaxis under this subsection, the pharmacist must ensure that the prescriber's
23directions and quantity are modified to allow for equivalent dispensing to what was
24originally prescribed.
AB1011,5,3
1(c) Within 5 business days after the dispensing of a drug product substitute
2under this subsection, the dispensing pharmacist or the pharmacist's designee shall
3do one of the following:
AB1011,5,94 1. Make an entry of the specific drug product provided to the patient, including
5the name of the product and the manufacturer. Entry into an electronic records
6system as described in this paragraph is presumed to provide notice to the
7prescribing practitioner. The communication shall be conveyed by making an entry
8that is electronically accessible to the prescribing practitioner through one of the
9following:
AB1011,5,1010 a. An interoperable electronic medical records system.
AB1011,5,1111 b. An electronic prescribing technology.
AB1011,5,1212 c. A pharmacist benefit management system.
AB1011,5,1313 d. A pharmacy record.
AB1011,5,1914 2. If a pharmacist is unable to make an entry as provided in subd. 1.,
15communicate the drug product substitute dispensed to the prescribing practitioner
16using facsimile, telephone, electronic transmission, or another prevailing means,
17except that communication under this paragraph is not required if a refill of the drug
18product is not changed from the product dispensed on the prior filling of the
19prescription.
AB1011,6,420 (d) Notwithstanding pars. (a) to (c), a pharmacist who dispenses a drug product
21prescribed for a patient in a hospital may, for a drug product prescribed to counteract
22anaphylaxis, substitute a drug product with another drug product in the same
23therapeutic class that would in the opinion of the pharmacist, have a substantially
24equivalent therapeutic effect even though the substitute drug product is not a drug
25product equivalent, if the pharmacist dispenses the drug product substitute in

1accordance with written guidelines or procedures previously established by a
2pharmacy and therapeutics committee of the hospital and approved by the hospital's
3medical staff and use of the drug product substitute has been approved for a patient
4during the period of the patient's stay within the hospital by any of the following:
AB1011,6,55 1. The patient's individual physician.
AB1011,6,86 2. The patient's advanced practice nurse prescriber, if the advanced practice
7nurse prescriber has entered into a written agreement to collaborate with a
8physician.
AB1011,6,99 3. The patient's physician assistant.
AB1011,6,1010 (End)
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