Chapter CSB 4

CSB 4.11(7)(c) (c) Makes a request for the monitored prescription drug history report through its PDMP system account.

CSB 4.11(8) (8) The board shall disclose the minimum necessary amount of information in a monitored prescription drug history report about a patient to a coroner, deputy coroner, medical examiner, or medical examiner’s assistant following the death of a patient in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss. 146.82 and 961.385, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records if the person does all of the following:

CSB 4.11(8)(a) (a) Creates an account with the PDMP system.

CSB 4.11(8)(b) (b) Provides proof sufficient to the board that the person is entitled to the information under s. 146.82 (2) (a) 18., Stats.

CSB 4.11(8)(c) (c) Makes a request for the monitored prescription drug history report through its PDMP system account with the board.

CSB 4.11(9) (9) The board may disclose PDMP data without personally identifiable information that could be reasonably used to identify any patient, healthcare professional, practitioner delegate, pharmacist delegate, or dispenser for public health and scientific research purposes. The board may require evidence of institutional review board approval.

CSB 4.11(10) (10) The board shall disclose the minimum necessary amount of information in a monitored prescription drug history report about a patient, patient address, practitioner, or dispenser to designated staff of a law enforcement agency or prosecutorial unit if the designated staff does all of the following:

CSB 4.11(10)(a) (a) Creates an account with the PDMP system.

CSB 4.11(10)(b) (b) Provides documentation demonstrating the law enforcement agency or prosecutorial unit is engaged in one of the following activities:

CSB 4.11(10)(b)1. 1. An active and specific investigation or prosecution of a violation of any state or federal law involving a monitored prescription drug and that the information being requested is reasonably related to that investigation or prosecution.

CSB 4.11(10)(b)2. 2. The monitoring of a patient as part of a drug court, as defined in s. 165.955 (1).

CSB 4.11(10)(c) (c) Makes a request for the monitored prescription drug history report through its account with the PDMP system.

CSB 4.11 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: r. (3), (4), am. (6) (intro.), renum. (9) (intro.) to (9) and am., r. (9) (a) to (c) Register August 2014 No. 704, eff. 9-1-14; correction in (5) (intro.), (6) (intro.), (7) (intro.), (8) (intro.), (10) (intro.) Register September 2015 No. 717; CR 15-101: am. (1) (intro.), (b), (2) (intro.), (c), (7) (intro.), (c), (8) (intro.), (c) Register June 2016 No. 726, eff. 7-1-16; EmR1706: emerg. am (Title), (1), (2) (intro.), (c), (5) (intro.), (a), (c), cr. (d), am. (6) (intro.), (a), (c), (7) (intro.), (a), (c), (8) (intro.), (a), (c), (9), (10) eff. 4-1-17; CR 17-028: (Title), (1), (2) (intro.), (c), (5) (intro.), (a), (c), cr. (d), am. (6) (intro.), (a), (c), (7) (intro.), (a), (c), (8) (intro.), (a), (c), (9), (10) Register December 2017 No. 744, eff. 1-1-18; CR 19-156: am. (9) Register August 2020 No. 776, eff. 9-1-20.

CSB 4.12 CSB 4.12 Use of PDMP data by the board and department.

CSB 4.12(1) (1) The board shall develop and maintain a PDMP database to store dispensing data and PDMP data in a secure environment and an encrypted format.

CSB 4.12(2m) (2m) The board shall develop and maintain a PDMP system to facilitate all of the following:

CSB 4.12(2m)(a) (a) The submission of dispensing data to the PDMP database.

CSB 4.12(2m)(b) (b) The creation of monitored prescription drug history reports about specific patients, practitioners, and dispensers.

CSB 4.12(2m)(c) (c) The access to and the obtaining of monitored prescription drug history reports, prescribing metrics reports, and audit trails.

CSB 4.12(3) (3) The board shall maintain audit trails that contain all of the following information:

CSB 4.12(3)(a) (a) A log of dispensing data submitted to the PDMP database by each dispenser.

CSB 4.12(3)(b) (b) A log of persons to whom the Board has granted direct access to the PDMP system under ss. CSB 4.09 or 4.093 and a log of each time a person attempts to access PDMP data or a monitored prescription drug history report.

CSB 4.12(3)(c) (c) A log of prescription monitoring programs operated by a relevant agency in another jurisdiction with which the board exchanges PDMP data pursuant to s. CSB 4.14 and a log of each time a person from another jurisdiction attempts to access PDMP data.

CSB 4.12(3)(d) (d) A log of pharmacies or other entities at which pharmacists dispense or administer monitored prescription drugs in the course of professional practice with which the board has determined to have at least equivalent capability to maintain the confidentiality of monitored prescription drug history reports and a log of each time a person from a pharmacy or other entity attempts to access PDMP data or a monitored prescription drug history report.

CSB 4.12(3)(e) (e) A log of hospitals or other entities at which practitioners prescribe, dispense, or administer monitored prescription drugs in the course of professional practice with which the board has determined to have at least equivalent capability to maintain the confidentiality of monitored prescription drug history reports and a log of each time a person from a hospital or other entity attempts to access PDMP data or a monitored prescription drug history report.

CSB 4.12(3)(f) (f) A log of monitored prescription drug history reports and PDMP data disclosed pursuant to s. CSB 4.11, including the name of the person to whom the information was disclosed.

CSB 4.12(3)(g) (g) A log of requests for PDMP data or monitored prescription drug history reports even when no information was disclosed.

CSB 4.12(6) (6) Staff assigned administrative duties over the PDMP, vendors, contractors, and other agents of the board shall only have access to the minimum amount of PDMP data necessary for all of the following purposes:

CSB 4.12(6)(a) (a) The design, implementation, operation, and maintenance of the program, including the PDMP database, PDMP system, the disclosure of information via other entities pursuant to s. CSB 4.09 (4), and the exchange of information pursuant to s. CSB 4.15 as part of the assigned duties and responsibilities of their employment.

CSB 4.12(6)(am) (am) The operation of an analytics platform that provides data cleansing and standardization, data integration, advanced analytics, and alert management capabilities as part of the PDMP database and PDMP system.

CSB 4.12(6)(b) (b) The collection of dispensing data as part of the assigned duties and responsibilities under s. 961.385, Stats., and this chapter.

CSB 4.12(6)(c) (c) Evaluating and responding to legitimate requests for monitored prescription drug history reports, audit trails, and PDMP data.

CSB 4.12(6)(cg) (cg) Preparing monitored prescription drug history reports, audit trails, and PDMP data for the board to determine whether suspicious or critically dangerous conduct or practices has occurred or is occurring pursuant to s. CSB 4.15.

CSB 4.12(6)(cr) (cr) Conducting a review of the program as required by s. 961.385 (5), Stats.

CSB 4.12(6)(d) (d) Other legally authorized purposes.

CSB 4.12 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: am. (4), cr. (4g), (4r) Register August 2014 No. 704, eff. 9-1-14; correction in (6) (b) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; EmR1706: emerg. am. (title), (1), r. (2), cr. (2m), r. and recr. (3), r. (4), (4g), (4r), (5), am. (6) (intro.), (a), cr. (6) (am), am. (6) (c), cr. (6) (cg), (cr), eff. 4-1-17; CR 17-028: am. (title), (1), r. (2), cr. (2m), r. and recr. (3), r. (4), (4g), (4r), (5), am. (6) (intro.), (a), cr. (6) (am), am. (6) (c), cr. (6) (cg), (cr), Register December 2017 No. 744, eff. 1-1-18; ; correction in (3) (b) made under s. 13.92 (4) (b) 7., Stats., December 2017 No. 744.

CSB 4.13 CSB 4.13 Confidentiality of PDMP records.

CSB 4.13(1) (1) The dispensing data, PDMP data, audit trails, monitored prescription drug history reports, and prescribing metrics reports maintained, created, or stored as a part of the program are not subject to inspection or copying under s. 19.35, Stats.

CSB 4.13(2) (2) A person who discloses or a person whose delegate discloses dispensing data, PDMP data, audit trails, monitored prescription drug history reports, or prescribing metrics reports in violation of s. 146.82 or 961.385, Stats., this chapter, or other state or federal laws or regulations relating to the privacy of patient health care records, may be referred to the appropriate licensing or regulatory board for discipline, or the appropriate law enforcement agency for investigation and possible prosecution if the board determines that a criminal violation may have occurred.

CSB 4.13 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; correction in (2) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; EmR1706: emerg. am., eff. 4-1-17; CR 17-028: am. Register December 2017 No. 744, eff. 1-1-18.

CSB 4.14 CSB 4.14 Exchange of PDMP data.

CSB 4.14(1) (1) The board may exchange monitored prescription drug history reports and PDMP data with a prescription monitoring program operated by a relevant agency in another state or jurisdiction if the prescription monitoring program satisfies all of the following conditions:

CSB 4.14(1)(a) (a) The prescription monitoring program is compatible with the program.

CSB 4.14(1)(b) (b) The relevant agency operating the prescription monitoring program agrees to exchange similar information with the program.

CSB 4.14(2) (2) In determining the compatibility of a prescription monitoring program to the program, the board may consider any of the following:

CSB 4.14(2)(a) (a) The safeguards for privacy of patient records and the prescription monitoring program’s success in protecting patient privacy.

CSB 4.14(2)(b) (b) The persons authorized to access the information stored by the prescription monitoring program.

CSB 4.14(2)(c) (c) The schedules of controlled substances monitored by the prescription monitoring program.

CSB 4.14(2)(d) (d) The information required by the agency to be submitted regarding the dispensing of a prescription drug.

CSB 4.14(2)(e) (e) The costs and benefits to the board of sharing information.

CSB 4.14(3) (3) The board may assess a prescription monitoring program’s continued compatibility with the program at any time.

CSB 4.14 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: am. (1) (intro.) Register August 2014 No. 704, eff. 9-1-14; EmR1706: emerg. am. (title), (1) (intro.), eff. 4-1-17; CR 17-028: am. (title), (1) (intro.) Register December 2017 No. 744, eff. 1-1-18.

CSB 4.15 CSB 4.15 Disclosure of suspicious or critically dangerous conduct or practices.

CSB 4.15(1) (1) The board may review dispensing data, monitored prescription drug history reports, PDMP data, and data compiled pursuant to s. CSB 4.12 to determine whether circumstances indicate suspicious or critically dangerous conduct or practices of a pharmacist, pharmacy, practitioner, or patient.

CSB 4.15(2) (2) The board may include any of the following factors when determining whether circumstances indicate suspicious or critically dangerous conduct or practices of a pharmacist or pharmacy:

CSB 4.15(2)(a) (a) The pharmacist or pharmacy’s monitored prescription drug dispensing practices deviate from accepted pharmacist or pharmacy practices.

CSB 4.15(2)(b) (b) There are unusual patterns in the payment methodology used by patients to whom monitored prescription drugs are dispensed by the pharmacist or pharmacy.

CSB 4.15(2)(c) (c) The history of actions taken against the pharmacist or pharmacy by other state agencies, agencies of another state, or law enforcement.

CSB 4.15(2)(d) (d) The type and number of monitored prescription drugs dispensed by the pharmacist or at the pharmacy.

CSB 4.15(2)(e) (e) The pharmacist or pharmacy has dispensed forged prescription orders for a monitored prescription drug.

CSB 4.15(2)(f) (f) The distance patients travel to have monitored prescription drugs dispensed at the pharmacy.

CSB 4.15(2)(g) (g) The number of patients dispensed monitored prescription drugs at the pharmacy or by the pharmacist who satisfy any of the criteria identified in sub. (4).

CSB 4.15(3) (3) The board may include any of the following factors when determining whether circumstances indicate suspicious or critically dangerous conduct or practices of a practitioner:

CSB 4.15(3)(a) (a) The practitioner’s monitored prescription drug prescribing practices deviate from accepted prescribing practices.

CSB 4.15(3)(b) (b) The practitioner prescribes potentially dangerous combinations of monitored prescription drugs to the same patient.

CSB 4.15(3)(c) (c) The type and number of monitored prescription drugs prescribed by the practitioner.

CSB 4.15(3)(d) (d) The history of actions taken against the practitioner by other state agencies, agencies of another state, or law enforcement.

CSB 4.15(3)(e) (e) The distance patients travel to obtain monitored prescription drug prescriptions from the practitioner.

CSB 4.15(3)(f) (f) The number of patients to whom the practitioner prescribed a monitored prescription who satisfy any of the criteria identified in sub. (4).

CSB 4.15(4) (4) The board may include any of the following factors when determining whether circumstances indicate suspicious or critically dangerous conduct or practices of a patient:

CSB 4.15(4)(a) (a) The number of practitioners from whom the patient has obtained a prescription for a monitored prescription drug.

CSB 4.15(4)(b) (b) The number of pharmacies from where the patient was dispensed a monitored prescription drug.

CSB 4.15(4)(c) (c) The number of prescriptions for a monitored prescription drug obtained by the patient.

CSB 4.15(4)(d) (d) The number of monitored prescription drug doses dispensed to the patient.

CSB 4.15(4)(e) (e) Whether the monitored prescription drugs dispensed to the patient include dangerous levels of any drug.

CSB 4.15(4)(f) (f) The number of times the patient is prescribed or dispensed a monitored prescription drug before the previously dispensed amount of the same or a similar monitored prescription drug would be expected to end.

CSB 4.15(4)(g) (g) The payment methodology used by the patient to obtain controlled substances at a pharmacy.

CSB 4.15(5) (5) Upon determining that circumstances indicate suspicious or critically dangerous conduct or practices of a pharmacy, practitioner, or patient, the Board may disclose monitored prescription drug history reports, audit trails, and PDMP data to any of the following:

CSB 4.15(5)(a) (a) A relevant patient.

CSB 4.15(5)(b) (b) A relevant pharmacist or practitioner.

CSB 4.15(5)(c) (c) A relevant state board or agency.

CSB 4.15(5)(d) (d) A relevant agency of another state.

CSB 4.15(5)(e) (e) A relevant law enforcement agency.

CSB 4.15(6) (6) Upon determining that a criminal violation may have occurred, the board may refer a pharmacist, pharmacy, or practitioner to the appropriate law enforcement agency for investigation and possible prosecution. The board may disclose monitored prescription drug history reports, audit trails, and PDMP data to the law enforcement agency as part of the referral.

CSB 4.15 History History: CR 15-101: cr. Register June 2016 No. 726, eff. 7-1-16; CR 17-028: am. (1), (5) (intro.), cr. (6) Register December 2017 No. 744, eff. 1-1-18.