961.385 Prescription drug monitoring program.

(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 (1b) (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 (1) (b), or an individual licensed under s. 457.08 (4), 457.10, 457.11, 457.12, 457.13, or 457.14 (1) (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 (1) (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.

(cs)

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, 2020.

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 (1) (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.

e. It is not possible to review the patient's records under the program because the digital platform for the program is not operational or due to other technological failure if that failure is reported to the board.

(d) Specify a secure electronic format for submittal of a record generated under the program and authorize the board to grant a pharmacy or practitioner a waiver of the specified format.

(e) Specify a deadline for the submittal of a record to the board.

(f) Permit the board to refer to the appropriate licensing or regulatory board for discipline a pharmacist, pharmacy, or practitioner that fails to comply with rules promulgated under this subsection, including by failure to generate a record that is required by the program.

(fm) Permit the board to refer a pharmacist, pharmacy, or practitioner to the appropriate law enforcement agency for investigation and possible prosecution when the board has determined that a criminal violation may have occurred.

(g) Maximize the potential for funding the operation of the program with available federal funding sources.

(h) Ensure that the program complies with s. 146.82, except as otherwise provided in this section, and 45 CFR part 164, subpart E.

(i) Disclose information submitted to the program by a law enforcement agency under s. 961.37 (3) (a) to relevant practitioners, pharmacists, and others to whom the board may make disclosures under par. (c).

(2m)

(a) The rules promulgated under sub. (2) may not require that a record submitted to the board before 2 years after April 9, 2014, contain the name recorded under s. 450.11 (1b) (bm).

(b) After consultation with representatives of licensed pharmacists and pharmacies, and subject to the approval of the secretary of safety and professional services, the board may delay the requirement that a record submitted to the board contain the name recorded under s. 450.11 (1b) (bm) for an additional period beyond the date specified in par. (a).

(3)

(a) A pharmacy, pharmacist, or practitioner is immune from civil or criminal liability or professional discipline arising from the pharmacy's, pharmacist's, or practitioner's compliance in good faith with this section or with rules promulgated under this section.

(b) Nothing in this section may be construed to require a pharmacy or pharmacist to obtain, before dispensing a monitored prescription drug to a patient, information about the patient that has been collected pursuant to the program established under sub. (2).

(4) Records generated under the program under this section are not subject to inspection or copying under s. 19.35.

(5)

(a) Beginning with the 3rd calendar quarter of 2016, no later than 30 days after the end of each calendar quarter, the board shall conduct a review of the program under this section to evaluate the actual outcomes of the program compared with projected outcomes, as determined by the board. The board's review shall include an evaluation of all of the following:

1. The satisfaction with the program of pharmacists, pharmacies, practitioners, and other users of the program.

2. The program's impact on referrals of pharmacists, pharmacies, and practitioners to licensing or regulatory boards for discipline and to law enforcement agencies for investigation and possible prosecution.

(b) This subsection does not apply after October 30, 2020.

(6) Beginning with the 3rd calendar quarter of 2016, no later than 30 days after the end of each calendar quarter, the board shall provide a report to the department of safety and professional services that includes all of the following:

(a) The results of the board's review under sub. (5). This paragraph does not apply after October 30, 2020.

(b) An assessment of the trends and changes in the use of monitored prescription drugs in this state.

(c) The number of practitioners, by profession, and pharmacies submitting records to the board under the program in the previous quarter.

(d) A description of the number, frequency, and nature of submissions by law enforcement agencies under s. 961.37 (3) (a) in the previous quarter.

(e) A description of the number, frequency, and nature of requests made in the previous quarter for disclosure of records generated under the program.

(f) The number of individuals receiving prescription orders from 5 or more practitioners or having monitored prescription drugs dispensed by 5 or more pharmacies within the same 90-day period at any time over the course of the program.

(g) The number of individuals receiving daily morphine milligram equivalents of 1 to 19 milligrams, 20 to 49 milligrams, 50 to 99 milligrams, and 100 or more milligrams in the previous quarter.

(h) The number of individuals to whom both opioids and benzodiazepines were dispensed within the same 90-day period at any time over the course of the program.

(7s)

(a) The board may contract with an analytics firm to augment the program under this section with an analytics platform that provides data integration, advanced analytics, and alert management capabilities to detect problematic behaviors of practitioners, pharmacies, pharmacists, and patients.

(b) If the board augments the program under this section as specified in par. (a), the goals of that augmentation shall include all of the following:

1. Allowing the board, with the assistance of the analytics firm, to identify past patterns of abuse, addiction, or criminal activity.

2. Proactively improving painkiller prescribing, informing clinical practice, and protecting patients at risk.

3. Measuring program outcomes at an individual level to minimize the abuse of monitored prescription drugs in this state.

(c) For purposes of this subsection, the board may disclose records generated under the program to an analytics firm with which the board contracts.

History: 2009 a. 362; 2011 a. 260 s. 81; 2013 a. 3, 20, 124, 199; 2015 a. 55 ss. 4477, 4737f to 4731k; Stats. 2015 s. 961.385; 2015 a. 195, 266, 267, 268; 2017 a. 59, 262.