Section 24 creates provisions for correcting dispensing data within 5 business days of discovering the error. The board may refer a dispenser or delegate that fails to correct data to the licensing board for discipline or to law enforcement for possible prosecution.
Section 25 creates a provision that a dispenser is not required to submit dispensing data when a drug is prepared for delivery but not yet delivered.
Section 26 repeals and recreates the provisions relating to access to monitored prescription drug history reports and PDMP data to reflect updated terminology and requirements as a result of Acts 266, 267 and 268. Monitored prescription drug history reports may be accessed by healthcare professionals, pharmacists and pharmacist delegates if the individual is treating or rendering assistance to the patient or the individual is being consulted regarding the health of the patient. Healthcare professionals, pharmacists and pharmacist delegates may only disclose monitored prescription drug history reports to the patient, to another healthcare professional or medical coordinator for consultation, to the pharmacist or practitioner who is directly treating or rendering assistance or to a law enforcement agency.
Section 27 creates a section regarding monitored prescription drug history reports and audit rails about healthcare professions. Healthcare professionals may access audit trails about themselves and their delegates. A practitioner may access the audit trails accessible to healthcare professionals and a prescribing metrics report about themselves. Medical coordinators may access prescribing metrics reports and audit trails about individuals they direct or supervise or if they are evaluating the job performance or performing quality assessment and improvement activities.
Section 28 provides grounds for denying, suspending, revoking or restricting or limiting access to the PDMP.
Section 29 updates to include healthcare professional and medical coordinator.
Section 30 repeals a no longer valid cross reference.
Section 31 updates the section to include healthcare professional and medical coordinator.
Section 32 creates the provision that the practitioner review PDMP before prescribing unless the patient is receiving hospice care, the prescription is for 3 days or less, the drug is administered to the patient, the practitioner is unable to review the PDMP due to an emergency or because the PDMP is not operation or other technological failure that is reported to the board. The board may refer a practitioner that fails to review the PDMP to the licensing board for discipline or to law enforcement for possible prosecution.
Section 33 updates terminology. It also clarifies if a patient is requesting data by mail that copies of two forms of identity must be included with the request.
Section 34 creates a provision the board may disclose the minimum necessary amount of information to designated staff of a federal or state governmental agency that cites the agency’s authorization to similar confidential patient care records.
Section 35 updates terminology.
Section 36 repeals an obsolete note.
Section 37 updates that the PDMP database is to store dispensing data and is in a secure environment and encrypted format.
Section 38 repeals the separate provision that is unnecessary due to the update in section 37.
Section 39 creates a requirement for the board to develop and maintain PDMP to facilitate the submission of dispensing data, creation of monitored prescription drug history reports about patients, practitioners and dispensers and access to the monitored prescription drug history reports, prescribing metrics reports and audit trails.
Section 40 creates the description of audit trails which includes logs of dispensing data, persons who have access to the PDMP, prescription monitoring programs in other states which shares data, pharmacies and hospitals which are determined to have the equivalent capability to maintain the confidentiality of monitored prescription drug history reports and a log of each time a person accesses PDMP, monitored prescription drug history reports and PDMP data disclosed pursuant to CSB 4.11 and requests for PDMP data or monitored prescription drug history reports even when no information was disclosed.
Section 41 repeals the separate provisions regarding logs which must be maintained due to the creation of section 40.
Section 42 updates terminology.
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.
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:
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
Fiscal Estimate and Economic Impact Analysis:
There is no fiscal impact.
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. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
