CR 15-101 Rule Text

Illinois: Illinois’ prescription monitoring program does not address proactive disclosure of suspicious or critically dangerous conduct or practices.

Iowa: Iowa does not have rules which allow for disclosure to regulatory agencies or law enforcement without an order, subpoena or other means of legal compulsion relating to a specific investigation of a specific individual and supported by a determination of probable cause.

Michigan: Michigan’s prescription monitoring program does not address proactive disclosure of suspicious or critically dangerous conduct or practices to entities.

Minnesota: The Minnesota Board of Pharmacy is required by statute to review the data submitted to the prescription monitoring program on at least a quarterly basis to determine if a patient meets criteria defined by the Board in consultation with an advisory task force. If the Board determines that a patient meets the criteria, the Board may disclose information about the patient to prescribers and pharmacists who have treated the patient. The prescription monitoring program may be used by permissible users for the identification of individuals receiving prescriptions for controlled substances from prescribers who subsequently obtain controlled substances from dispensers in quantities or with a frequency inconsistent with generally recognized standards of use for those controlled substances and individuals presenting forged or otherwise false or altered prescriptions for controlled substances to dispensers. Minnesota does not allow accessing the database for the sole purpose of identifying prescribers of controlled substances for unusual or excessive prescribing patterns without a valid search warrant or court order. No licensing board or agency may access the database for the purpose of obtaining information to be used to initiate or substantiate a disciplinary action against a prescriber.

Summary of factual data and analytical methodologies:

In order to define what factors to evaluate to determine what constitutes suspicious or critically dangerous conduct or practices the Board consulted the following sources:

Prescription Drug Monitoring Program Center of Excellence at Brandeis University, Using PDMP Data to Guide Interventions with Possible At-Risk Prescribers, Oct. 2014.

Prescription Drug Monitoring Program Center of Excellence at Brandeis University, Guidance on PDMP Best Practices: Options for Unsolicited Reporting, Jan. 2014.

Johns Hopkins Bloomberg School of Public Health, The Prescription Opioid Epidemic: An Evidence-Based Approach, Nov. 2015.

Haegerich, et al., What We Know, and Don’t Know, About the Impact of State Policy and Systems-Level Interventions on Prescriptions Drug Overdose, Drug and Alcohol Dependence: An International Journal on Biomedical and Psychosocial Approaches, Oct. 2014.

WCMR 14-118-011 Rules Governing The Controlled Substances Prescription Monitoring Program.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:

This rule was posted for 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 [e-mail], or by calling [phone].

Agency contact person:

Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail].

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 Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8366, or by email to [e-mail]. Comments must be received at or before the public hearing at 9:30 a.m. on February 5, 2016 to be included in the record of rule-making proceedings.

---------------------------------------------------------------------------------------------------------------------

TEXT OF RULE

Section 1. CSB 4.02 (4) is amended to read:

CSB 4.02 (4) “Board” has the meaning given in s. 450.01 (2), Stats. means Controlled Substances Board.

Section 2. CSB 4.03 (3) is repealed.

Section 3. CSB 4.08 (1) is amended to read:

CSB 4.08 (1) The board shall exempt a dispenser from compiling and submitting dispensing data and from submitting a zero report as required under this chapter until the dispenser is required to renew his or her its license, or until the dispenser dispenses a monitored prescription drug, if the dispenser satisfies all of the following conditions:

Section 4. CSB 4.10 (1) (c) is amended to read:

CSB 4.10 (1) (c) The denial, suspension, revocation or other restriction or limitation imposed on the dispenser’s, dispenser pharmacist’s, pharmacist delegate’s, practitioner’s, or practitioner delegate’s account pursuant to s. CSB 18.09 (3).

Section 5. CSB 4.10 (2) (a) is amended to read:

CSB 4.10 (2) (a) The dispenser’s, dispenser pharmacist’s, pharmacist delegate’s, practitioner’s, or practitioner delegate’s name and address, including street address, city, state and ZIP code.

Section 6. CSB 4.11 (1) is amended to read:

CSB 4.11 (1) The board shall disclose PDMP information dispensing data about a patient to the patient if he or she does all of the following:

Section 7. CSB 4.11 (1) (b) is amended to read:

CSB 4.11 (1) (b) Makes a request for the PDMP information dispensing data on a form provided by the board.

Section 8. CSB 4.11 (2) is amended to read:

CSB 4.11 (2) The board shall disclose PDMP information dispensing data about a patient to a person authorized by the patient if the person authorized by the patient does all of the following:

Section 9. CSB 4.11 (2) (c) is amended to read:

CSB 4.11 (2) (c) Makes a request for the PDMP information dispensing data on a form provided by the board.

Section 10. CSB 4.11 (7) is amended to read:

CSB 4.11 (7) The board shall disclose the minimum amount of PDMP information dispensing data necessary to a prisoner’s health care provider, the medical staff of a prison or jail in which a prisoner is confined, the receiving institution intake staff at a prison or jail to which a prisoner is being transferred or a person designated by a jailer to maintain prisoner medical records or designated staff of the department of corrections 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:

Section 11. CSB 4.11 (7) (c) is amended to read:

CSB 4.11 (7) (c) Makes a request for the PDMP information dispensing data through its account with the board.

Section 12. CSB 4.11 (8) is amended to read: