Wisconsin Department of Safety and Professional Services Division of Policy Development 1400 E. Washington Ave PO Box 8366 Madison WI 53708-8366

Phone: 608-266-2112 Web: http://dsps.wi.gov

Email: dsps@wisconsin.gov

Scott Walker, Governor Dave Ross, Secretary

PHARMACY EXAMINING BOARD Contact: Dan Williams (608) 266-2112

Room 121A, 1400 East Washington Avenue, Madison, WI 53703 April 7, 2016

Notice: The following agenda describes the issues that the Board plans to consider at the meeting. At the time of the meeting, items may be removed from the agenda. Please consult the meeting minutes for

a description of the action and deliberation of the Board.

AGENDA

11:00 A.M. (Or immediately following the pharmacy rules committee meeting.)

OPEN SESSION – CALL TO ORDER – ROLL CALL

A. Adoption of Agenda (1-4)

B. Approval of Minutes of February 24, 2016 (5-8)

C. Administrative Updates – Discussion and Consideration 1) Staff Updates 2) Board Member – Term Expiration Date

a. Franklin LaDien – 7/1/2016 b. Terry Maves – 7/1/2018 c. Thaddeus Schumacher – 7/1/2019 d. Kristi Sullivan – 7/1/2016 e. Philip Trapskin – 7/1/2017 f. Cathy Winters – 7/1/2017 g. Public Member – Vacancy

D. Legislation/Administrative Rule Matters – Discussion and Consideration (9-11) 1) Act 290 Relating to Administration by Injection of Prescribed Drugs by Pharmacists 2) Act 291 Relating to Prescription Fills and Refills 3) Update on Legislation and Pending or Possible Rulemaking Projects

E. Discussion and Consideration of Pilot Program Related to Act 313

F. Informational Overview of Tech-Check-Tech (TCT) Opportunities in Community Pharmacy Settings Presentation by Pharmacy Society of Wisconsin (PSW) (12-13)

G. Informational Items

H. Items Received After Preparation of the Agenda 1) Introductions, Announcements and Recognition 2) Election of Board Officers 3) Appointment of Board Liaisons 4) Administrative Updates

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5) Education and Examination Matters 6) Credentialing Matters 7) Practice Matters 8) Legislation/Administrative Rule Matters 9) Informational Items 10) Disciplinary Matters 11) Presentations of Petitions for Summary Suspension 12) Petitions for Designation of Hearing Examiner 13) Presentation of Proposed Stipulations, Final Decisions and Orders 14) Presentation of Proposed Final Decision and Orders 15) Presentation of Interim Orders 16) Petitions for Re-Hearing 17) Petitions for Assessments 18) Petitions to Vacate Orders 19) Requests for Disciplinary Proceeding Presentations 20) Motions 21) Petitions 22) Appearances from Requests Received or Renewed 23) Speaking Engagement(s), Travel, or Public Relations Request(s) 24) Division of Legal Services and Compliance (DLSC) Matters 25) Prescription Drug Monitoring Program Information 26) Consulting with Legal Counsel 27) Liaison Report(s)

a. Appointed to Controlled Substances Board per Wis. Stats. §15.405(5g): Franklin LaDien

b. Continuing Education (CE) and Education and Examinations Liaison: Terry Maves c. Credentialing Liaison(s): Terry Maves, Cathy Winters d. Digest Liaison: Philip Trapskin e. DLSC Liaison: Thaddeus Schumacher, Cathy Winters f. Legislative Liaison: Philip Trapskin, Thaddeus Schumacher, Terry Maves g. Monitoring Liaison(s): Franklin LaDien, Cathy Winters h. PHARM Rep to State Council on Alcohol and Other Drug Abuse (SCAODA): Kristi

Sullivan i. Pharmacy Rules Committee: Thaddeus Schumacher, Franklin LaDien, Philip

Trapskin, Kristi Sullivan j. Professional Assistance Procedure (PAP) Liaison: Franklin LaDien k. Screening Panel: Cathy Winters, Kristi Sullivan, Philip Trapskin l. Variance Report Liaison: Philip Trapskin, Cathy Winters

I. Public Comments

CONVENE TO CLOSED SESSION to deliberate on cases following hearing (s. 19.85(1)(a), Stats.); to consider licensure or certification of individuals (s. 19.85(1)(b), Stats.); to consider closing disciplinary investigations with administrative warnings (ss. 19.85 (1)(b), and 440.205, Stats.); to consider individual histories or disciplinary data (s. 19.85 (1)(f), Stats.); and to confer with legal counsel (s. 19.85(1)(g), Stats.).

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J. Deliberation on Division of Legal Services and Compliance (DLSC) Matters 1) Administrative Warnings

a. 15 PHM 019 (R.J.D.) (14-15) b. 15 PHM 140 (L.P.) (16-17) c. 15 PHM 188 (T.H.E.) (18-19) d. 15 PHM 198 (B.P.) (20-21)

2) Proposed Stipulations, Final Decision and Orders a. 14 PHM 093 (B.P.I.) (22-27) b. 15 PHM 010 (M.C.H.S.) (28-33) c. 15 PHM 069 (C.M.I.) (34-39)

3) Case Closings a. 14 PHM 146 (J.A.Z.) (40-42) b. 15 PHM 001 (M.H.) (43-46) c. 15 PHM 010 (T.W.G.) (47-51) d. 15 PHM 118 (Z.P.) (52-53) e. 15 PHM 151 (P.H.) (54-55) f. 15 PHM 162 (R.K. and S.D., Inc.) (56-58) g. 15 PHM 186 (B.T., LLC.) (59-60) h. 15 PHM 188 (H.P.) (61-64) i. 15 PHM 197 (M.S.) (65-66) j. 16 PHM 005 (C.P.) (67-69)

K. Deliberation on Credentialing Matters

L. Deliberation of Items Received After Preparation of Agenda 1) Education and Examination Matters 2) Credentialing Matters 3) Disciplinary Matters 4) Monitoring Matters 5) Professional Assistance Procedure (PAP) Matters 6) Petitions for Summary Suspension 7) Petitions for Designation of Hearing Examiner 8) Proposed Stipulations, Final Decisions and Orders 9) Administrative Warnings 10) Review of Administrative Warnings 11) Proposed Final Decisions and Orders 12) Orders Fixing Costs/Matters Related to Costs 13) Case Closings 14) Proposed Interim Orders 15) Petitions for Assessments and Evaluations 16) Petitions to Vacate Orders 17) Remedial Education Cases 18) Motions 19) Petitions for Re-Hearing 20) Appearances from Requests Received or Renewed

M. Consult with Legal Counsel

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RECONVENE INTO OPEN SESSION IMMEDIATELY FOLLOWING CLOSED SESSION

N. Voting on Items Considered or Deliberated upon in Closed Session, if Voting is Appropriate

O. Board Meeting Process (Time Allocation, Agenda Items) – Discussion and Consideration

ADJOURNMENT

The Next Scheduled Meeting is May 25, 2016.

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Pharmacy Examining Board

Meeting Minutes

February 24, 2016

PHARMACY EXAMINING BOARD

MEETING MINUTES

FEBRUARY 24, 2016

PRESENT: Franklin LaDien, Terry Maves (via GoToMeeting), Thaddeus Schumacher, Kristi Sullivan,

Philip Trapskin, Cathy Winters (via GoToMeeting, was excused from the meeting at 1:33 p.m.)

STAFF: Dan Williams – Executive Director, Nilajah Hardin – Bureau Assistant, Sharon Henes –

Administrative Rules Coordinator, and other Department staff

CALL TO ORDER

Thaddeus Schumacher, Chair, called the meeting to order at 11:15 a.m. A quorum of six (6) members was

confirmed.

ADOPTION OF AGENDA

MOTION: Philip Trapskin moved, seconded by Franklin LaDien, to adopt the agenda as

published. Motion carried unanimously.

APPROVAL OF MINUTES OF JANUARY 12, 2016

MOTION: Philip Trapskin moved, seconded by Franklin LaDien, to approve the minutes of January

12, 2016 as published. Motion carried unanimously.

PUBLIC HEARING ON CLEARINGHOUSE RULE 16-017 RELATING TO APPLICATION AND

EXAMINATION

Review and Respond to Clearinghouse Report and Public Hearing Comments

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to accept Clearinghouse comments

for Clearinghouse Rule 16-017 Relating to Application and Examination. Motion carried

unanimously.

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to authorize the Chair to approve the

Legislative Report and Draft for Clearinghouse Rule 16-017 Relating to Application and

Examination for submission to the Governor’s Office and the Legislature. Motion

carried unanimously.

PUBLIC HEARING ON CLEARINGHOUSE RULE 16-018 RELATING TO IDENTIFICATION

CARD REQUIRED FOR CERTAIN CONTROLLED SUBSTANCES (ACT 199)

Review and Respond to Clearinghouse Report and Public Hearing Comments

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to reject Clearinghouse comment

number(s) 2(a) and accept all remaining Clearinghouse comments for Clearinghouse 16-

018 Relating to Identification Card Required for Certain Controlled Substances (Act

199). Motion carried unanimously.

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Pharmacy Examining Board

Meeting Minutes

February 24, 2016

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to authorize the Chair to approve the

Legislative Report and Draft for Clearinghouse Rule 16-018 Relating to Identification

Card Required for Certain Controlled Substances (Act 199) for submission to the

Governor’s Office and the Legislature. Motion carried unanimously.

SPEAKING ENGAGEMENT(S), TRAVEL, OR PUBLIC RELATIONS REQUEST(S)

2016 NABP Annual Meeting – May 14-17, 2016

MOTION: Kristi Sullivan moved, seconded by Terry Maves, to designate Cathy Winters as the

board’s delegate to attend the 2016 NABP Annual Meeting on May 14-17, 2016 in San

Diego, CA and to authorize travel. Motion carried unanimously.

NABP MPJE Item-Development Workshop – March 15-16, 2016

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to designate the Chair to develop a

proposal for a MPJE Test Question Committee for consideration at a future Board

meeting. Motion carried unanimously.

Cathy Winters was excused from the meeting at 1:33 p.m.

CLOSED SESSION

MOTION: Franklin LaDien moved, seconded by Kristi Sullivan, to convene to closed session to

deliberate on cases following hearing (s. 19.85(1)(a), Stats.); to consider licensure or

certification of individuals (s. 19.85(1)(b), Stats.); to consider closing disciplinary

investigations with administrative warnings (ss. 19.85 (1)(b), and 440.205, Stats.); to

consider individual histories or disciplinary data (s. 19.85 (1)(f), Stats.); and to confer

with legal counsel (s. 19.85(1)(g), Stats.). Thaddeus Schumacher, Chair, read the

language of the motion. The vote of each member was ascertained by voice vote. Roll

Call Vote: Franklin LaDien –yes; Terry Maves-yes; Thaddeus Schumacher-yes; Kristi

Sullivan- yes; Philip Trapskin-yes. Motion carried unanimously.

The Board convened into Closed Session at 1:49 p.m.

RECONVENE TO OPEN SESSION

MOTION: Franklin LaDien moved, seconded by Kristi Sullivan, to reconvene into open session.

Motion carried unanimously.

The Board reconvened into Open Session at 3:52 p.m.

VOTING ON ITEMS CONSIDERED OR DELIBERATED ON IN CLOSED SESSION

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to affirm all motions made in closed

session. Motion carried unanimously.

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Pharmacy Examining Board

Meeting Minutes

February 24, 2016

CREDENTIALING MATTERS

M.K. – Application Review (NABP License Transfer)

MOTION: Philip Trapskin moved, seconded by Terry Maves, to approve the Pharmacist

endorsement application of Matthew Kolb, once all requirements are met. Motion

carried.

PROPOSED FINAL DECISION AND ORDER(S)

Khushboo S. Modi, R.Ph., Respondent (DHA Case # SPS-15-0042)(DLSC Case # 14 PHM 062)

MOTION: Kristi Sullivan moved, seconded by Franklin LaDien, to adopt the Findings of Fact

within the Proposed Final Decision and Order in the matter of disciplinary proceedings

against Khushboo S. Modi, R.Ph., Respondent (DHA Case # SPS-15-0042)(DLSC Case

# 14 PHM 062) but varies the remaining portions of the Order to reflect the Boards

decision. Motion carried. Recused: Philip Trapskin

MOTION: Terry Maves moved, seconded by Kristi Sullivan, to designate the Chair to review and

approve the Order with Variance Khushboo S. Modi, R.Ph., Respondent (DHA Case #

SPS-15-0042)(DLSC Case # 14 PHM 062). Motion carried. Recused: Philip Trapskin

(Philip Trapskin recused himself and left the room for deliberation, and voting in the matter concerning

Khushboo S. Modi, R.Ph., Respondent (DHA Case # SPS-15-0042)(DLSC Case # 14 PHM 062).)

DIVISION OF LEGAL SERVICES AND COMPLIANCE (DLSC) MATTERS

15 PHM 007 – R.S.

MOTION: Franklin LaDien moved, seconded by Kristi Sullivan, to table the Administrative

Warning in the matter of 15 PHM 007 (R.S.). Motion carried unanimously.

15 PHM 038 – B.T.P.

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to issue an Administrative Warning

in the matter of 15 PHM 038 (B.T.P.). Motion carried unanimously.

15 PHM 047 – S.P.S.

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to issue an Administrative Warning

in the matter of 15 PHM 047 (S.P.S.). Motion carried unanimously.

Proposed Stipulations, Final Decisions and Orders

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to adopt the Findings of Fact,

Conclusions of Law and Order in the matter of disciplinary proceedings against:

1. 14 PHM 129 (A.L.H.)

2. 15 PHM 161 (M.L.)

3. 15 PHM 193 (S.P.)

Motion carried unanimously.

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Pharmacy Examining Board

Meeting Minutes

February 24, 2016

15 PHM 004 – S.V.H.

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to reject the Findings of Fact,

Conclusions of Law and Order in the matter of disciplinary proceedings against Steven

V. Henningfield, R.Ph., DLSC case number 15 PHM 004. Motion carried unanimously.

Case Closings

MOTION: Franklin LaDien moved, seconded by Kristi Sullivan, to close the DLSC cases for the

reasons outlined below:

1. 14 PHM 061 (I.A. and A.P.) – Prosecutorial Discretion (P2)

2. 15 PHM 052 (W.L.) - Prosecutorial Discretion (P5 - Flag)

3. 15 PHM 123 (P.G.M.) - Prosecutorial Discretion (P5 - Flag)

Motion carried unanimously.

15 PHM 007

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to table DLSC case number 15

PHM 007, against Walgreens # 02927. Motion carried unanimously.

MOTION: Philip Trapskin moved, seconded by Terry Maves, to deny the request of John Bosnjak,

R.Ph. for a reduction in AA/NA attendance. The Board grants the request of John

Bosnjak, R.Ph. for a reduction in drug and alcohol screens to 24 per year and one annual

hair test. Reason for Denial: Insufficient time of compliance under the terms of the

Order (12/11/2013). Motion carried unanimously.

Erin Orth, R. Ph. – Requesting Full Licensure

MOTION: Philip Trapskin moved, seconded by Kristi Sullivan, to deny the request of Erin Orth,

R.Ph. for full licensure. The Board instead grants a reduction in drug and alcohol screens

to 24 and one annual hair test and 24 PIC hours. Reason for Denial: Insufficient time of

compliance under the terms of the Order (09/23/2009). Motion carried unanimously.

ADJOURNMENT

MOTION: Kristi Sullivan moved, seconded by Franklin LaDien, to adjourn the meeting. Motion

carried unanimously.

The meeting adjourned at 3:54 p.m.

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State of Wisconsin Department of Safety & Professional Services

Revised 8/13

AGENDA REQUEST FORM

1) Name and Title of Person Submitting the Request: Sharon Henes Administrative Rules Coordinator

2) Date When Request Submitted: 28 March 2016 Items will be considered late if submitted after 12:00 p.m. on the deadline date:

8 business days before the meeting 3) Name of Board, Committee, Council, Sections: Pharmacy Examining Board 4) Meeting Date: 7 April 2016

5) Attachments: Yes No

6) How should the item be titled on the agenda page? Legislation and Rule Matters – Discussion and Consideration 1. Act Relating to a Pilot Program Authorized by the Pharmacy Examining Board. 2. Act Relating to Administration by Injection of Prescribed Drugs by Pharmacists 3. Act Relating to Prescription Fills and Refills 4. Update on Pending and Possible Rulemaking Projects

7) Place Item in: Open Session Closed Session Both

8) Is an appearance before the Board being scheduled? Yes (Fill out Board Appearance Request) No

9) Name of Case Advisor(s), if required:

10) Describe the issue and action that should be addressed:

11) Authorization Sharon Henes 28 March 2016 Signature of person making this request Date Supervisor (if required) Date Executive Director signature (indicates approval to add post agenda deadline item to agenda) Date Directions for including supporting documents: 1. This form should be attached to any documents submitted to the agenda. 2. Post Agenda Deadline items must be authorized by a Supervisor and the Policy Development Executive Director. 3. If necessary, Provide original documents needing Board Chairperson signature to the Bureau Assistant prior to the start of a meeting.

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Rev. 3/6/2012

STATEMENT OF SCOPE

PHARMACY EXAMINING BOARD Rule No.: Phar 7.10 Relating to: Administration of Drug Products and Devices Other Than Vaccines Rule Type: Both Permanent and Emergency 1. Finding/nature of emergency (Emergency Rule only): 2015 Act 290 creates the ability for a person engaged in the practice of pharmacy to administer by injection a prescribed drug product or device pursuant to requirements and procedures established in the rules promulgated. Act 290 went into effect on March 31, 2016. A final rule submitted to the legislature in the remaining months of 2016 will not be considered received until the first day of the next regular session of the legislature. Due to the timing of the Act’s effective date, this creates a delay in the implementation of Act 290. Rules promulgated to implement Act 290 will create increased patient access and adherence to medications by allowing pharmacists to assist patients in the community with self-injectable medications or in the institutional setting as part of the multidisciplinary care team. Preservation of the public health, safety and welfare necessitates putting the rule into effect prior to 2017. 2. Detailed description of the objective of the proposed rule: The objective of the proposed rule is to establish requirements and procedures for a pharmacist or pharmacist intern to administer a prescribed drug product or device in order to implement 2015 Act 290. 3. Description of the existing policies relevant to the rule, new policies proposed to be included in the rule, and an analysis of policy alternatives: Prior to Act 290, a pharmacist or pharmacist intern could only administer an injectable prescribed drug product or device in the course of teaching self-administration techniques to a patient. Act 290 removes the restriction for the purposes of patient teaching only. The proposed rule would update the requirements and procedures to reflect the statutory change. 4. Detailed explanation of statutory authority for the rule (including the statutory citation and language): s. 15.08(5)(b), Stats. Each examining board: shall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession. s. 450.02(2g)(b), Stats. The board shall promulgate rules that establish requirements and procedures for the administration of a drug product or device, as defined in s. 450.035(1g), by a pharmacist under s. 450.035(1r). 5. Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule: 75 hours

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6. List with description of all entities that may be affected by the proposed rule: Pharmacists, pharmacist interns, and patients. 7. Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule: None 8. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses): None to minimal. It is not likely to have a significant economic impact on small businesses. Contact Person: Sharon Henes, Administrative Rules Coordinator, (608) 261-2377 Authorized Signature Date Submitted

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    Tuesday, March 22, 2016  Thaddeus Schumacher, Chair  Wisconsin Pharmacy Examining Board  P.O. Box 8935  Madison, Wisconsin 53708‐8935   Dear Dr. Schumacher,   RE: Pharmacy Examining Board April 7, 2016 Meeting Agenda Request  We request time at the April 7, 2016 Pharmacy Examining Board meeting to provide an informational overview of tech‐check‐tech (TCT) opportunities in community pharmacy settings.  Community pharmacy‐based TCT programs are being evalulated for the potential to afford pharmacists more time to provide clinical services such as immunization administration and medication therapy management.    In the future, the Pharmacy Society of Wisconsin seeks to conduct and advance research entitled “Advancing Community Pharmacy Quality – A Wisconsin Statewide Research Pilot Project.”  The intent of the project is to implement tech‐check‐tech programs in a variety of community pharmacy practice settings across the state and assess the impact of the program on patient safety measures and pharmacist patient care service expansion.  This research pilot project is similar to efforts in Iowa to evaluate a new practice model for community pharmacy designed to facilitate community pharmacists delivery of patient care services.  Pharmacy practices intended for inclusion in that project includes independent, chain, and health‐system pharmacies.  We believe the outcomes data from this pilot project will assist the Pharmacy Examining Board in future revisions to the Phar 7 Administrative Code related to tech‐check‐tech in community pharmacy settings.  Thank you for your consideration of our request for this informational overview.   Sincerely, 

 Anna Legreid Dopp, PharmD Vice President of Public Affairs Pharmacy Society of Wisconsin  Enclosure: Advancing Community Pharmacy Quality – A Wisconsin Statewide Research Pilot Project Description 

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Advancing Community Pharmacy Quality A Wisconsin Statewide Research Pilot Project 

Leveraging Tech‐Check‐Tech to Expand Patient Care Services in Community Pharmacies 

  

Background Numerous studies have shown pharmacists can improve patients’ clinical outcomes from medication therapy, but ongoing research outlines the barriers to pharmacists’ ability to provide expanded care services. According to the 2013 MTM Digest, the greatest challenge, following reimbursement, was pharmacists having inadequate time to provide clinical services. Additionally, workflow and time limitations were the most  prevelant barrier to WPQC service provision in the 3‐year PSW led research project.  For years, the Wisconsin Pharmacy Examining Board (PEB) has recognized the role of hospital pharmacy technicians in assisting with product verification when technology, training, and quality assurance programs can be leveraged – tech‐check‐tech (TCT). This expanded role for pharmacy technicians has resulted in the ability of pharmacy departments to deploy pharmacists’ time for clinical services, enabling them to address clinical outcome improvement for patients.  Proposed Pilot Project Goals Building upon the track record of successful TCT programs in Wisconsin and based upon the findings from a recently completed, 2‐year pilot research project in the state of Iowa, PSW would like to propose expansion of Wisconsin TCT programs to community pharmacies and intends to submit a pilot project proposal for PEB review at a future meeting.  This PSW led 2‐year research pilot would aim to implement TCT programs in community pharmacies and assess: 

Aim 1: Impact of a TCT program in community pharmacies in Wisconsin on patient safety measures.  

Aim 2: Impact of a TCT program in community pharmacies in Wisconsin in facilitating community 

pharmacist‐provided patient care (expanded immunization services, coordination with other health care 

providers, collaborative practice agreement implementation, medication therapy management including 

comprehensive medication reviews, medication adherence counciling, etc.) 

Key Pilot Components 

Creation of policies, procedures, and training materials to ensure the program’s adherence to legislative statute, regulatory allowances, and best practice standards 

Identification of 15‐20 pilot sites having capabilities to expand clinical services 

In cooperation with a university research partner and with IRB approval, collection and analysis of data assessing achievement of program’s aims with regular reporting to PEB 

Compile and report data to inform future PEB rule‐making  Funding This project is supported, in part, by a grant from the National Association of Chain Drug Stores (NACDS). 

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