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Section 43 creates provision regarding the operation of the analytics platform.
Section 44 updates terminology from PDMP information to monitored prescription drug history reports, audit trails and PDMP data.
Section 45 creates the requirement for preparing monitored prescription drug history reports, audit trails and PDMP data for the board to review in determining whether suspicious or critically dangerous conduct or practices took place.
Section 46 updates terminology regarding the confidentiality of PDMP records. It clarifies that a person who discloses PDMP data may be referred for discipline or prosecution.
Section 47 updates terminology from information to monitored prescription drug history reports and data.
Section 48 amends the information being reviewed and disclosed by the board when determining suspicious or critically dangerous conduct to include dispensing data, monitored prescription drug history reports, and PDMP data.
Section 49 creates the provision to allow the board to refer a pharmacist, pharmacy, or practitioner to law enforcement agency for investigation and possible prosecution if the board determines tat a criminal violation may have occurred. As part of the referral, the board may disclose monitored prescription drug history reports, audit trails and PDMP data.
Summary of, and comparison with, existing or proposed federal regulation: None
Comparison with rules in adjacent states:
Illinois: Illinois requires reporting to the drug monitoring program within one day. Illinois does not require mandatory use of the drug monitoring program. Illinois does not provide access to mental health, substance abuse professionals or law enforcement.
Iowa: Iowa requires reporting to the drug monitoring program within one week. Iowa does not require mandatory use of the drug monitoring program. Iowa does not provide access to mental health, substance abuse professionals or law enforcement.
Michigan: Michigan requires reporting to the drug monitoring program within one day if reporting online and within one week if reporting by mail. Michigan does not require mandatory use of the drug monitoring program. Michigan does not provide access to mental health, substance abuse professionals or law enforcement.
Minnesota: Minnesota requires reporting to the drug monitoring program within one day. Minnesota does require mandatory use of the drug monitoring program. Minnesota does provide access to mental health and substance abuse professionals. Minnesota does not provide access to law enforcement.
Summary of factual data and analytical methodologies:
This rule updates terminology and requirements resulting from 2015 Wisconsin Acts 266, 267 and 268.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
This rule was posted on website for the solicitation of economic comments and none were received.
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis is attached.
Effect on small business:
These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at Kirsten.Reader@wisconsin.gov, or by calling (608) 267-2435.
Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov.
Place where comments are to be submitted and deadline for submission:
Comments may be submitted to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received at or before the public hearing to be held on May 12, 2017 to be included in the record of rule-making proceedings.
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TEXT OF RULE
Section 1. CSB 4.01 is amended to read:
CSB 4.01Authority 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 maintain disclose information relating to the prescribing and dispensing of monitored prescription drugs.
Section 2. CSB 4.02 (1) and (2) are amended to read:
CSB 4.02 (1)“Access” means to have the ability to view PDMP information through an account established with the board monitored prescription drug history reports, audit trails, and PDMP data as authorized by s. CSB 4.09.
(2)“Administer” has the meaning given in s. 450.01 (1) 961.385 (1) (a), Stats.
Section 3. CSB 4.02 (2m), (3s), (4m) and (5m) are created to read:
CSB 4.02 (2m) “Agent” has the meaning given in s. 961.385 (1) (ab), Stats.
(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.
(4m)Business day” has the meaning given in s. 961.385 (1) (ad), Stats.
(5m)Deliver” or “delivery” has the meaning in s. 961.385 (1) (ae), Stats.
Section 4. CSB 4.02 (7) is amended to read:
CSB 4.02 (7)“Dispense” has the meaning given in s. 450.01 (7) 961.385 (1) (af), Stats.
Section 5. CSB 4.02 (11c) and (11n) are created to read:
CSB 4.02 (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.
(11n) “Law enforcement agency” has the meaning given in s. 165.77 (1) (b), Stats.
Section 6. CSB 4.02 (11r) and (12) (a) 1. are amended to read:
CSB 4.02 (11r) “Managing pharmacist” has the meaning given in s. Phar 1.02 (6) means a pharmacist designated by the pharmacy owner to have responsibility for and direct control of pharmaceutical operations in a pharmacy.
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