Rule-Making Notices (Hearing Notices)

Section 18 clarifies that the dispenser shall submit a zero report for each 7 day period which the dispenser did not dispense a monitored prescription drug.

Section 22 clarifies if incorrect dispensing data had been submitted, the dispenser shall submit the correct information within 7 days.

Section 23 removes the “he or she" reference and inserts “dispenser".

Sections 25, 26, 27, 29, and 30 remove “dispenser" and “dispenser delegate" throughout ss. Phar 18.09 and 18.10 (1) (intro), (2) (b), (3), (6), and (7) and replace with the terms “pharmacist" and “pharmacist delegate".

Section 28 requires a specific statute or rule to be given when requesting a review.

Section 31 repeals the requirement for board to disclose PDMP information to staff of a relevant agency in another state who are authorized to access confidential patient health care records under ss. 146.82 and 450.19, Stats. It also repeals the requirement to disclose minimum amount of PDMP information necessary to health care facility staff committees or accreditation or health care services review organizations.

Section 32 adds that the board will disclose the minimum amount of PDMP information necessary to staff who are investigating pharmacists and pharmacist delegates.

Section 33 clarifies that the board may disclose de-identified PDMP information which does not identify any patient upon request.

Section 34 repeals the requirements for a researcher to obtain PDMP information.

Section 36 adds pharmacist and pharmacist delegate to the list of people which the board maintains a log for their access to PDMP information.

Section 37 clarifies relevant agencies in other jurisdictions with prescription drug monitoring programs by adding the word “state."

Summary of, and comparison with, existing or proposed federal regulation

None. Prescription drug monitoring programs are operated by the state jurisdictions.

Comparison with rules in adjacent states

Illinois: The statutes and administrative rules governing the Illinois Prescription Monitoring Program require dispensers to submit to a database similar information regarding the prescribing and dispensing of controlled substances. Dispensers are required to submit the method of payment the patient used for a prescription. See 720 Illinois Compiled Statutes 570/316-21 and Illinois Administrative Code Title 77, Chapter X, Subchapter e, Part 2080. Dispensers are not required to submit refill information.

Iowa: The statutes and administrative rules governing the Iowa Prescription Monitoring Program require dispensers to submit to a database similar information regarding the prescribing and dispensing of controlled substances. Dispensers are required to submit refill information and the method of payment the patient used for a prescription. See Iowa Code § 124.551-58 and Iowa Administrative Code Title 657, Chapter 37.

Michigan: The statutes, administrative rules, and requirements for the Michigan Automated Prescription System require dispensers to submit to a database similar information regarding the prescribing and dispensing of controlled substances. Dispensers are required to submit refill information and the method of payment the patient used for a prescription. See Michigan Public Health Code § 333.7333and Michigan Administrative Code R. 338.471, and “List of Required Fields," Michigan Automated Prescription System (MAPS). See also http://www.michigan.gov/documents/lara/lara_MAPS_ASAP2009_ListofRequiredFields_365562_7.pdf, accessed on Dec. 17, 2013.

Minnesota: The statutes governing the Minnesota Prescription Monitoring Program require dispensers to submit to a database similar information regarding the prescribing and dispensing of controlled substances on a daily basis. Dispensers are not required to submit refill information or the method of payment the patient used for a prescription. See Minnesota Statute 152.126.

Summary of factual data and analytical methodologies

The Board received feedback while developing and deploying the prescription drug monitoring program and gained considerable expertise in ways to improve it once it became fully operational.

The Board is aware that currently there are some provisions which create inefficiencies and ambiguities that the PDMP has to overcome to be as effective of a tool to combat prescription drug misuse and abuse as it can be. This proposed rule corrects and updates those provisions.

All the modifications are based on feedback from stakeholders and the prescription drug monitoring program uses as well as other information obtained while developing and deploying the prescription drug 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 impact comments for 14 days and none were received.

Fiscal Estimate and Economic Impact Analysis

The Fiscal Estimate and Economic Impact Analysis is attached.

Initial Regulatory Flexibility Analysis or Summary

These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats.

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].

STATE OF WISCONSIN DEPARTMENT OF ADMINISTRATION DOA-2049 (R03/2012)	Division of Executive Budget and Finance 101 East Wilson Street, 10th Floor P.O. Box 7864 Madison, WI 53707-7864 FAX: [phone]
ADMINISTRATIVE RULES Fiscal Estimate & Economic Impact Analysis

1. Type of Estimate and Analysis
X Original   ⍽ Updated   ⍽ Corrected
2. Administrative Rule Chapter, Title and Number
Phar 18
3. Subject
Prescription Drug Monitoring Program updates
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   ⍽ FED   X PRO   ⍽ PRS   ⍽ SEG   ⍽ SEG-S			20.165(1)(g) and 20.165(1)(hg)
6. Fiscal Effect of Implementing the Rule
⍽ No Fiscal Effect ⍽ Indeterminate	⍽ Increase Existing Revenues ⍽ Decrease Existing Revenues		X Increase Costs X Could Absorb Within Agency's Budget ⍽ Decrease Cost
7. The Rule Will Impact the Following (Check All That Apply)
⍽ State's Economy ⍽ Local Government Units		⍽ Specific Businesses/Sectors ⍽ Public Utility Rate Payers ⍽ Small Businesses (if checked, complete Attachment A)
8. Would Implementation and Compliance Costs Be Greater Than $20 million? ⍽ Yes   X No
9. Policy Problem Addressed by the Rule
The Board is aware that currently there are provisions which create inefficiencies and ambiguities that the prescription drug monitoring program has to overcome to be as effective of a tool to combat prescription drug misuse and abuse as it can be. This proposed rule corrects and updates those provisions.
10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
Economic impact comments were solicited by posting on Department and Administrative Rules websites for 14 days and no comments were received. Stakeholders had provided feedback during the implementation of changes which should be made to the current rules.
11. Identify the local governmental units that participated in the development of this EIA.
None
12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
This rule will not have an economic or fiscal impact on specific businesses, business sectors, public utility rate payers, local governmental units or the state's economy as a whole.
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
The Board received feedback while developing and deploying the prescription drug monitoring program (PDMP) and gained considerable expertise in ways to improve it once it became fully operational. The benefit to implementing the rule is to make those changes. The alternative is to not make the modifications, which would not enable the Board to improve the PDMP based on information obtained while developing and deploying the PDMP and the feedback of stakeholders and PDMP users.
14. Long Range Implications of Implementing the Rule
The long range benefit is to have an effective prescription drug monitoring program.
15. Compare With Approaches Being Used by Federal Government
None
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota)
Our neighboring states require dispensers to submit to a database similar information regarding the prescribing and dispensing of controlled substances.
17. Contact Name				18. Contact Phone Number
Sharon Henes				[phone]

This document can be made available in alternate formats to individuals with disabilities upon request.