Chapter CSB 4

Chapter CSB 4

PRESCRIPTION DRUG MONITORING PROGRAM

CSB 4.01   Authority and scope.

CSB 4.02   Definitions.

CSB 4.03   Drugs that have a substantial potential for abuse.

CSB 4.04   Compilation of dispensing data.

CSB 4.05   Electronic submission of dispensing data.

CSB 4.06   Frequency of submissions.

CSB 4.07   Correction of dispensing data.

CSB 4.08   Exemptions from compiling and submitting dispensing data.

CSB 4.09   Access to monitored prescription drug history reports and PDMP data about a patient.

CSB 4.093   Monitored prescription drug history reports and audit trails about healthcare professionals.

CSB 4.097   Deny, suspend, revoke or otherwise restrict or limit access.

CSB 4.10   Requests for review.

CSB 4.105   Practitioners’ requirement to review monitored prescription drug history reports.

CSB 4.11   Methods of obtaining monitored prescription drug history reports.

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

CSB 4.13   Confidentiality of PDMP records.

CSB 4.14   Exchange of PDMP data.

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

Ch. CSB 4 Note Note: Chapter Phar 18 was renumbered chapter CSB 4 under s. 13.92 (4) (b) 1., Stats., Register September 2015 No. 717.

CSB 4.01 CSB 4.01 Authority and scope. The rules in this chapter are adopted under authority in ss. 227.11 (2) (a) and 961.385, Stats., for the purpose of creating a prescription drug monitoring program to collect and disclose information relating to the prescribing and dispensing of monitored prescription drugs.

CSB 4.01 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; correction 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 4.02 CSB 4.02 Definitions. As used in this chapter:

CSB 4.02(1) (1) “Access” means to have the ability to view monitored prescription drug history reports, audit trails, and PDMP data as authorized by s. CSB 4.09.

CSB 4.02(2) (2) “Administer” has the meaning given in s. 961.385 (1) (a), Stats.

CSB 4.02(2m) (2m) “Agent” has the meaning given in s. 961.385 (1) (ab), Stats.

CSB 4.02(3) (3) “Animal” has the meaning given in s. 89.02 (1m), Stats.

CSB 4.02(3m) (3m) “ASAP” means the American Society for Automation in Pharmacy.

CSB 4.02 Note Note: Contact: American Society for Automation in Pharmacy, 492 Norristown Road, Suite 160; Blue Bell, PA 19422; phone: [phone]; fax: [phone]; webpage: http://asapnet.org/index.html.

CSB 4.02(3s) (3s) “Audit trail” means the log that contains information about each time the PDMP system discloses PDMP data, monitored prescription drug history reports, and prescribing metrics reports.

CSB 4.02(4) (4) “Board” means the Controlled Substances Board.

CSB 4.02(4m) (4m) “Business day” has the meaning given in s. 961.385 (1) (ad), Stats.

CSB 4.02(5) (5) “Controlled substance” means a drug, substance, analog, or precursor described in any of the following:

CSB 4.02(5)(a) (a) Schedule I, II, III, IV, or V in the federal controlled substances act, 21 USC 812 (b) (1) to (b) (5) and (c), as changed and updated by 21 CFR 1308.

CSB 4.02(5)(b) (b) Schedule I, II, III, IV, or V in subch. II of ch. 961, Stats., as amended by ch. CSB 2.

CSB 4.02(5k) (5k) “DEA registration number” means the registration number issued to a dispenser or practitioner by the federal department of justice, drug enforcement administration.

CSB 4.02(5m) (5m) “Deliver” or “delivery” has the meaning in s. 961.385 (1) (ae), Stats.

CSB 4.02(6) (6) “Department” means the department of safety and professional services.

CSB 4.02(7) (7) “Dispense” has the meaning given in s. 961.385 (1) (af), Stats.

CSB 4.02(8) (8) “Dispenser” means all of the following:

CSB 4.02(8)(a) (a) A pharmacy.

CSB 4.02 Note Note: A site of remote dispensing authorized under s. 450.062, Stats., is under the supervision of a pharmacy.

CSB 4.02(8)(b) (b) A practitioner who dispenses a monitored prescription drug.

CSB 4.02(9) (9) “Dispenser delegate” means any of the following:

CSB 4.02(9)(a) (a) A managing pharmacist of a pharmacy.

CSB 4.02(9)(b) (b) An agent or employee of a practitioner who has been delegated the task of satisfying the data compilation and submission requirements of ss. CSB 4.04 and 4.05.

CSB 4.02(10) (10) “Dispensing data” means data compiled pursuant to s. CSB 4.04.

CSB 4.02(11) (11) “Drug” has the meaning given in s. 450.01 (10), Stats.

CSB 4.02(11c) (11c) “Healthcare Professional” means a pharmacist, practitioner, registered nurse licensed under s. 441.06, Stats., substance abuse counselor, as defined in s. 440.88 (1) (b), Stats., or individual authorized under s. 457.02 (5m), Stats., to treat alcohol or substance dependency or abuse as a specialty.

CSB 4.02(11g) (11g) “Hospital” has the meaning given in s. 50.33 (2), Stats.

CSB 4.02(11n) (11n) “Law enforcement agency” has the meaning given in s. 165.77 (1) (b), Stats.

CSB 4.02(11r) (11r) “Managing pharmacist” means a pharmacist designated by the pharmacy owner to have responsibility for and direct control of pharmaceutical operations in a pharmacy.

CSB 4.02(11w) (11w) “Medical coordinator” means a person who medically coordinates, directs, supervises, or establishes standard operating procedures for a healthcare professional.

CSB 4.02(12) (12) 

CSB 4.02(12)(a) (a) “Monitored prescription drug” means all of the following:

CSB 4.02(12)(a)1. 1. A controlled substance included in s. 961.385 (1) (ag), Stats.

CSB 4.02(12)(a)2. 2. A drug identified by the board as having a substantial potential for abuse in s. CSB 4.03.

CSB 4.02(12)(b) (b) “Monitored prescription drug” does not mean a controlled substance that by law may be dispensed without a prescription order.

CSB 4.02(12m) (12m) “Monitored prescription drug history report” means all of the following information about a patient, patient address, practitioner, or dispenser compiled by the PDMP system and disclosed as authorized in ss. CSB 4.09 and 4.11:

CSB 4.02(12m)(a) (a) PDMP data.

CSB 4.02(12m)(b) (b) Reports submitted to the program pursuant to s. 961.37, Stats.

CSB 4.02(12m)(c) (c) Information submitted to the program by a healthcare professional.

CSB 4.02(12m)(d) (d) Information from the analytics platform.

CSB 4.02(13) (13) “Patient” has the meaning given in s. 961.385 (1) (aj), Stats.

CSB 4.02(14e) (14e) “PDMP” means the Wisconsin prescription drug monitoring program.