961.385 Prescription drug monitoring program.

1,321 words·~6 min read·/wi/chapter-961/961-385-5

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(1)In this section:

(a)“Administer” means the direct application of a monitored prescription drug, whether by injection, ingestion, or any other means, to the body of a patient by any of the following:

1. A practitioner or his or her agent.

2. A patient at the direction of a practitioner.

3. A pharmacist.

(ab)“Agent” means an authorized person who acts on behalf of or at the direction of another person.

(ac)“Board” means the controlled substances board.

(ad)“Business day” means any day on which the offices of the department of safety and professional services are open.

(ae)“Deliver” or “delivery” means the actual, constructive, or attempted transfer of a monitored prescription drug from one person to another.

(af)“Dispense” means to deliver a monitored prescription drug pursuant to the lawful prescription order of a practitioner, including the compounding, packaging, or labeling necessary to prepare the monitored prescription drug for delivery.

(ag)“Monitored prescription drug” means a substance identified in s. 961.16 , 961.18 , 961.20 , or 961.22 or a drug identified by the board by rule as having a substantial potential for abuse.

(aj)“Patient” means an individual or animal for whom a monitored prescription drug is prescribed or to whom a monitored prescription drug is dispensed or administered.

(aL)“Pharmacist” means a person licensed by the pharmacy examining board under s. 450.03 or 450.05 or licensed in another state and recognized by this state as a person authorized to engage in the practice of pharmacy in the state in which the person is licensed.

(an)“Pharmacy” means a place of practice licensed under s. 450.06 or 450.065 .

(ar)“Practitioner” has the meaning given in s. 450.01

(17)but does not include a veterinarian licensed under ch. 89 .

(b)“Prescription order” means an order transmitted orally, electronically, or in writing by a practitioner or a veterinarian licensed under ch. 89 for a monitored prescription drug for a particular patient.

(2)The board shall establish by rule a program for monitoring the dispensing of monitored prescription drugs. The program shall do all of the following:

(a)Require a pharmacy or a practitioner to generate a record documenting each dispensing of a monitored prescription drug at the pharmacy or, if the monitored prescription drug is not dispensed at a pharmacy, by the practitioner and to submit the record to the board no later than 11:59 p.m. of the next business day after the monitored prescription drug is dispensed, except that the program may not require the generation of a record in any of the following circumstances:

1. A monitored prescription drug is administered directly to a patient.

2. A monitored prescription drug is compounded, packaged, or labeled in preparation for delivery but is not delivered.

3. The prescription order is for a monitored prescription drug that is a substance listed in the schedule in s. 961.22 and is not a narcotic drug, and the prescription order is for a number of doses that is intended to last the patient 7 days or less.

(b)Identify specific data elements to be contained in a record documenting the dispensing of a monitored prescription drug, including the method of payment and, subject to sub.

(2m), the name recorded under s. 450.11

(bm). In identifying specific data elements, the board shall consider data elements identified by similar programs in other states and shall ensure, to the extent possible, that records generated by the program are easily shared with other states.

(c)Specify the persons to whom a record may be disclosed and the circumstances under which the disclosure may occur. Except as otherwise provided under this section, the rule promulgated under this paragraph shall comply with s. 146.82 .

(cm)Permit the board to disclose a record generated by the program to any of the following:

1. A practitioner, pharmacist, registered nurse licensed under s. 441.06 , or substance abuse counselor, as defined in s. 440.88

(b), or an individual holding a credential under s. 457.08

(2),

(3), or

(4), 457.10 , 457.11 , 457.12 , 457.13 , or 457.14

(d)to

(f)who treats alcohol or substance dependency or abuse as a specialty, if any of the following is applicable:

a. The practitioner, pharmacist, registered nurse, substance abuse counselor, or individual is directly treating or rendering assistance to the patient.

b. The practitioner, pharmacist, registered nurse, substance abuse counselor, or individual is being consulted regarding the health of the patient by an individual who is directly treating or rendering assistance to the patient.

2. A person who medically coordinates, directs, or supervises, or establishes standard operating procedures for, a practitioner, pharmacist, registered nurse, substance abuse counselor, or individual to whom records may be disclosed under subd. 1. , if the person is evaluating the job performance of the practitioner, pharmacist, registered nurse, substance abuse counselor, or individual, or is performing quality assessment and improvement activities, including outcomes evaluation or development of clinical guidelines, and if the disclosure does not contain personally identifiable information, as defined in s. 19.62

(5), of a patient and is limited to only those records about the practitioner, pharmacist, registered nurse, substance abuse counselor, or individual the person medically coordinates, directs, or supervises, or for whom the person establishes standard operating procedures.

3. Relevant state boards and agencies, relevant agencies of other states, relevant law enforcement agencies, as defined in s. 165.77

(b), and relevant prosecutorial units, as defined in s. 978.001

(2), if any of the following is true:

a. The state board or agency, agency of another state, law enforcement agency, or prosecutorial unit makes a written request for the record and is engaged in an active and specific investigation or prosecution of a violation of any state or federal law involving a monitored prescription drug, and the record being requested is reasonably related to that investigation or prosecution.

b. The state board or agency, agency of another state, law enforcement agency, or prosecutorial unit makes a written request for the record and is monitoring the patient as part of a drug court, as defined in s. 165.955

(1).

c. The circumstances indicate suspicious or critically dangerous conduct or practices of a pharmacy, pharmacist, practitioner, or patient. The board shall define what constitutes suspicious or critically dangerous conduct or practices for purposes of this subd. 3. c.

4. An agent of a practitioner or pharmacist if disclosure to the practitioner or pharmacist is authorized subject to subd. 1.

5. An overdose fatality review team, a suicide review team, or a maternal mortality review team under s. 250.22

961.385 Note NOTE: The correct cross-reference is shown in brackets. Corrective legislation is pending.

Effective date note NOTE: Subd. 5. is created eff. 5-1-27 by 2025 Wis. Act 148 .

1. Require that a patient’s records under the program be reviewed before the practitioner issues a prescription order for the patient. The review required under this subdivision may be performed by the practitioner or by the practitioner’s agent in accordance with applicable standards of practice. This subdivision does not apply after April 1, 2030.

2. The requirement under subd. 1. that a patient’s records under the program be reviewed before the practitioner issues a prescription order for the patient does not apply if any of the following is true:

a. The patient is receiving hospice care, as defined in s. 50.94

(a).

b. The prescription order is for a number of doses that is intended to last the patient 3 days or less and is not subject to refill.

c. The monitored prescription drug is lawfully administered to the patient.

d. Due to emergency, it is not possible to review the patient’s records under the program before the practitioner issues a prescription order for the patient.