CR_14-003 Revises Chapter Phar 18, relating to operation of prescription drug monitoring program

A school of nursing will submit annual self-evaluation reports, all documents submitted to or received from nursing accreditation agencies and notify the board if there is a change in accreditation status. Failure to maintain nursing accreditation will result in loss of school approval. The board may review the school of nursing to determine whether the standards are being met in the following situations:

•   Change in accreditation status

•   Nursing accreditation reports indicate accreditation standards are not being met

•   Complaints received regarding the school

•   Failure to meet NCLEX pass rate standard for more than 2 consecutive years

•   Violation of any rules under this chapter.

The review of the school may include a site survey, self-study report or a progress report. If standards are not being met, the school of nursing shall submit a plan and progress reports as requested. The board may withdraw board approval if the school continues to not meet standards.

Closure of a school of nursing involves providing a placement for students and indicating where the academic records and transcripts will be stored and how access to those records will be maintained.

Nurse refresher courses are designed for nurses who have been out of practice for more than five years. The course will contain theory, skills labs and clinical experience. The board will review nurse the curriculum for inclusion on a listing of approved courses. The student who participates in a non-approved course may submit curriculum for approval.

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

None

Comparison with rules in adjacent states

Illinois: Illinois program approval process includes: a letter of intent, a feasibility study, hiring of a nurse administrator, submission of a curriculum proposal, and a site survey. Continued approval is based upon annual evaluation reports, full routine site visits and maintaining a NCLEX pass rate of 75% of first time test takers. Major and minor curricular changes are reported to the board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications (allows for variances to faculty standards) and student standards.

Iowa: Iowa program approval process includes: first step involves an application with information regarding the controlling institution and needs assessment; second step involves verification of employment of the head of program, submission of program's philosophy and objectives, curriculum plan, letter of intent from clinical facilities, evidence of provision of faculty, proposed budget and timeframe for implementation; next step is interim approval based upon program proposal and site visit; final approval is upon graduation of first class and NCLEX pass rate results. Provisional approval may be granted to program until standards are met. Change of controlling institution and changes in administrative personnel in the program. The program shall submit annual reports. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications, student standards and evaluation of the program. NCLEX pass rate standard is a minimum of 95% of the national passing percentage based upon first time test takers within 6 months of graduation.

Michigan: Michigan program approval process includes: the first step requires submission of a letter of intent, evidence of funding and other support, copy of Michigan Department of Career Development approval (if necessary), evidence of availability of clinical experiences, proposed number of students, proposed first date of admission, plans for recruiting director of the program and faculty and a site visit; initial approval involves a self-student report and annual progress reports; full approval is after the graduation of the 2 nd class, but no later than graduation of the 4 th class (a class for each 12 month period) and requires submission of a self-study report and a site visit. Every 4 years the school shall submit a self-study report and accredited schools shall follow the schedule of the accrediting agency. Program changes shall be submitted to the board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications (allows for variances to faculty standards), student standards, and evaluation of the program. NCLEX pass rate standard is 75% of first time test takers.

Minnesota: Minnesota program approval process includes: Phase 1 requires letter of intent including institution information, timetable for development and implementation, documentation of availability of academic facilities, impact on nursing programs in the area; Phase II involves a site visit and documentation of compliance with educational standards in order to be granted initial approval; Phase III is full approval and continual approval based upon meeting the minimum first time NCLEX success rate and acquiring national nursing education accreditation. Minnesota requires surveys of all schools on a periodic basis to maintain approval. NCLEX pass rate standard is 75% of first time test takers. All schools must be accredited by 2016. Annual reports shall be submitted to the Board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, clinical standards, nurse administrator and faculty qualifications, student standards, and evaluation of the program. The curriculum standard is the program must provide diverse learning activities that are consistent with program outcomes. Minnesota has an approval process for schools applying for innovative approaches which may require exemption from certain rules.

Summary of factual data and analytical methodologies

The Board considered the National Council of State Boards of Nursing's model practice rules and the rules and processes of our neighboring states.

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

The rule was posted for 14 days for economic impact comments 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 Sharon.Henes@wisconsin .gov.

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
N 1
3. Subject
School of Nursing Approval
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   ⍽ FED   ⍽ PRO   ⍽ PRS   ⍽ SEG   ⍽ SEG-S			20.165(1)(g)
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   ⍽ No
9. Policy Problem Addressed by the Rule
This rule updates the school of nursing approval process. The current rules have been in place since 1985 and are not adequately addressing the changes in education.
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.
This rule was posted for economic comments for a period of 14 days and no comments were received.
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 benefit is to provide clarity and updates to the school of nursing approval process. The proposed rules also decrease the duplication between approval and national nursing school accreditation.
14. Long Range Implications of Implementing the Rule
The benefit is to provide clarity and updates to the school of nursing approval process. The proposed rules also decrease the duplication between approval and national nursing school accreditation.
15. Compare With Approaches Being Used by Federal Government
None
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
Illinois: Illinois program approval process includes: a letter of intent, a feasibility study, hiring of a nurse administrator, submission of a curriculum proposal, and a site survey. Continued approval is based upon annual evaluation reports, full routine site visits and maintaining a NCLEX pass rate of 75% of first time test takers. Major and minor curricular changes are reported to the board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications (allows for variances to faculty standards) and student standards.
Iowa: Iowa program approval process includes: first step involves an application with information regarding the controlling institution and needs assessment; second step involves verification of employment of the head of program, submission of program's philosophy and objectives, curriculum plan, letter of intent from clinical facilities, evidence of provision of faculty, proposed budget and timeframe for implementation; next step is interim approval based upon program proposal and site visit; final approval is upon graduation of first class and NCLEX pass rate results. Provisional approval may be granted to program until standards are met. Change of controlling institution and changes in administrative personnel in the program. The program shall submit annual reports. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications, student standards and evaluation of the program. NCLEX pass rate standard is a minimum of 95% of the national passing percentage based upon first time test takers within 6 months of graduation. Michigan: Michigan program approval process includes: the first step requires submission of a letter of intent, evidence of funding and other support, copy of Michigan Department of Career Development approval (if necessary), evidence of availability of clinical experiences, proposed number of students, proposed first date of admission, plans for recruiting director of the program and faculty and a site visit; initial approval involves a self-student report and annual progress reports; full approval is after the graduation of the 2 nd class, but no later than graduation of the 4 th class (a class for each 12 month period) and requires submission of a self-study report and a site visit. Every 4 years the school shall submit a self-study report and accredited schools shall follow the schedule of the accrediting agency. Program changes shall be submitted to the board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications (allows for variances to faculty standards), student standards, and evaluation of the program. NCLEX pass rate standard is 75% of first time test takers Minnesota: Minnesota program approval process includes: Phase 1 requires letter of intent including institution information, timetable for development and implementation, documentation of availability of academic facilities, impact on nursing programs in the area; Phase II involves a site visit and documentation of compliance with educational standards in order to be granted initial approval; Phase III is full approval and continual approval based upon meeting the minimum first time NCLEX success rate and acquiring national nursing education accreditation. Minnesota requires surveys of all schools on a periodic basis to maintain approval. NCLEX pass rate standard is 75% of first time test takers. All schools must be accredited by 2016. Annual reports shall be submitted to the Board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, clinical standards, nurse administrator and faculty qualifications, student standards, and evaluation of the program. The curriculum standard is the program must provide diverse learning activities that are consistent with program outcomes. Minnesota has an approval process for schools applying for innovative approaches which may require exemption from certain rules.
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.

Notice of Hearing

Safety and Professional Services —
Pharmacy Examining Board

CR 14-003

NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in s.15.08 (5) (b), 450.19 (2), and 961.31, Wis. Stats., and interpreting s. 450.19 , Wis. Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to repeal sections Phar 18.04 (3) (intro) , 18.04 (3) (k) , 18.11 (3) , 18.11 (4) , 18.11 (9) (a) , 18.11 (9) (b) , and 18.11 (9) (c) ; to renumber and amend section Phar 18.04 (2) ; to amend sections Phar 18.02 (8) (a) , 18.02 (9) , 18.02 (15) (intro) , 18.02 (17) , 18.04 (title), 18.04 (3) (L) , 18.04 (3) (m) , 18.04 (3) (n) , 18.04 (4) , 18.05 (1) , (1) (note) , (2) (note) , (3) (b) (note) , and (4) , 18.06 (2) , (3) (b) (note) , (6) (b) (note) , and (8) , 18.07 , 18.08 (1) (a) and (b) (note) , 18.09 , 18.10 (1) (intro) , (2) (intro.) and (b) , (3) , (6) , and (7) , 18.11 (6) (intro) and (10) (c) (note) , 18.12 (4) , and 18.14 (1) (intro) ; and to create sections Phar 18.02 (11m) , (15g) , and (15r) , 18.04 (2) (gg) and (gr) , relating to the prescription drug monitoring program.

Hearing Information

Date:   Wednesday, February 12, 2014
Time:   9:00 a.m.
Location:   1400 East Washington Avenue
  Room 121A
  Madison, Wisconsin

Appearances at the Hearing

Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708. Written comments must be received at or before the public hearing to be included in the record of rule-making proceedings.

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 53708-8935, or by email to [e-mail] . Comments must be received at or before the public hearing to be held on February 12, 2014 to be included in the record of rule-making proceedings.

Copies of Rule

Copies of this proposed rule are available upon request to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, P.O. Box 8366, Madison, Wisconsin 53708, or by email at [e-mail] .

Analysis prepared by the Department of Safety and Professional Services

Statutes interpreted

Section 450.19 , Wis. Stats.

Statutory authority

Sections 15.08 (5) (b) , 450.19 (2) , and 961.31 , Wis. Stats.

Explanation of agency authority

The board has authority to promulgate rules for the guidance of the profession and to interpret the provisions of the statutes it enforces. The board also has authority to promulgate rules relating to the manufacture, distribution and dispensing of controlled substances within Wisconsin.

Specifically, the legislature directs the board to establish to govern the prescription drug monitoring program.

Related statute or rule

Section 450.19 , Wis. Stats. and ch. Phar 18 , Wis. Admin. Code.

Plain language analysis

This proposed rule modifies the ch. Phar 18 to improve the efficiency of the Prescription Drug Monitoring Program (PDMP) by ensuring consistency between the language of the rule and how PDMP functions.

Sections 1, 2, 3, 4, 5, and 6 clarify and simplify definitions. A dispenser is a pharmacy. Dispenser delegate is a managing pharmacist or an agent or employee of a practitioner who has the delegated responsibility for data compilation and submission to PDMP. Managing pharmacist, pharmacist and practitioner definitions are identical to definitions in the statutes. Pharmacist delegate is an agent of a pharmacist who has been delegated access to PDMP information.

Section 7 clarifies the title of s. Phar 18.04 to "compilation of dispensing data".

Section 8 changes the "he or she" to dispenser. It also becomes an introduction paragraph to the items currently listed under s. Phar 18.04 (3) (intro) .

Section 9 repeals the introduction section. Therefore all of the times currently listed under it are now under new introduction paragraph created by Section 8.

Section 10, 11, 12 amends the dispensing data. The classification codes for payment type and refill number are added. The quantity prescribed is no longer required data. There is clarification of how to record an animal patient's name, address and birthdate.

Sections 13, 17, and 21 adds dispenser delegate as subject to discipline for failing to compile required dispensing data.

Section 14 clarifies the rule that unless exempt, a dispenser shall electronically submit data.

Sections 15, 16 , 19, 20, 24, and 35 update the P.O. Box number for the Department in all the notes in ch. Phar 18 which reference the Department's address.

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 § 333.7333 and 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.