State of Iowa Board of Pharmacy - Iowa Board Pharmacy...Rebecca Seabrooke, IMP3 Case Manager At 9:05 a.m., Sharon Meyer, Chair, called the meeting of the Iowa Board of Pharmacy to

State of Iowa

Board of Pharmacy

400 S.W. Eighth Street, Suite E, Des Moines, IA 50309-4688 https://pharmacy.iowa.gov/

Telephone: (515)281-5944 Facsimile: (515)281-4609

BOARD MEMBERS SHARON MEYER BOARD MEMBERS LADONNA GRATIAS Board Chair JASON HANSEL

EDWARD McKENNA BRETT BARKER

GAYLE MAYER ANDREW FUNK JOAN SKOGSTROM Executive Director

M I N U T E S

September 18-19, 2018

The Iowa Board of Pharmacy met on September 18-19, 2018, in the conference room at 400 S.W.

Eighth Street, Des Moines, Iowa.

TUESDAY, SEPTEMBER 18, 2018

MEMBERS PRESENT

Sharon K. Meyer, Chair

Edward J. McKenna, Vice-Chair

Brett Barker

LaDonna Gratias

Jason Hansel

Gayle Mayer

Joan Skogstrom

STAFF PRESENT

Andrew Funk, Executive Director

Laura Steffensmeier, Esq., Assistant Attorney General

Therese Witkowski, Executive Officer

Amanda Woltz, Administrative Assistant

Christie Carlson, Compliance Officer

Curtis Gerhold, Compliance Officer

Mark Mather, Compliance Officer

Sue Mears, Compliance Officer

Jennifer O’Toole, Compliance Officer

Jean Rhodes, Compliance Officer

Daniel Sedlacek, Compliance Officer

James Wolfe, Compliance Officer

Tessa Register, Assistant Attorney General

Rebecca Seabrooke, IMP3 Case Manager

At 9:05 a.m., Sharon Meyer, Chair, called the meeting of the Iowa Board of Pharmacy to order on

Tuesday, September 18, 2018.

Administrative Hearing

2017-146, Christopher Betts, Pharmacist license No. 19918, Urbandale.

https://pharmacy.iowa.gov/


At 9:06 a.m., Laura Lockard, Administrative Law Judge, Department of Inspections and Appeals

opened the record. Assistant Attorney General Laura Steffensmeier represented the State. Mr.

Betts did appear and was not represented by counsel. The session was conducted in the presence

of the Board and was open to the public.

The Board examined exhibits and heard testimony of two witnesses.

At 10:04 a.m., the record was closed.

At 10:05 a.m., on a motion by Brett Barker, second by Edward McKenna, the Board voted

unanimously by roll call vote to move into closed session in accordance with Iowa Code Section

21.5(1)(f) to discuss the decision to be rendered in a contested case conducted according to the

provisions of Iowa Code Chapter 17A.

Laura Steffensmeier, Tessa Register, Rebecca Seabrooke, and Board compliance officers left the

room.

At 10:29 a.m., while still in closed session, Edward McKenna moved that the Board go into open

session, seconded by LaDonna Gratias. Motion approved unanimously.

Motion by Jason Hansel, second by Gayle Mayer, to direct Administrative Law Judge Lockard to

draft the Order consistent with the Board’s deliberation in the case 2017-146, Christopher Betts.

Motion approved unanimously.

At 10:30 a.m., Laura Steffensmeier, Tessa Register, Rebecca Seabrooke, and compliance officers

returned to the meeting.

At 10:40 a.m., Joan Skogstrom left the meeting.

Closed session

At 10:44 a.m., on a motion by Brett Barker, second by Jason Hansel, the Board voted unanimously

by roll call vote to move into closed session pursuant to Iowa Code Section 21.5(1)(a), to review

or discuss records which are required or authorized by state or federal law to be kept confidential;

pursuant to Iowa Code Section 21.5(1)(d), to discuss whether to initiate licensee disciplinary

investigations or proceedings; and pursuant to Iowa Code Section 21.5(1)(f), to discuss the

decision to be rendered in a contested case conducted according to the provisions of Iowa Code

Chapter 17A.

At 2:41 p.m., while still in closed session, Jason Hansel moved that the Board go into open session,

seconded by Edward McKenna. Motion approved unanimously.

In open session, the following actions were taken:

1. Closed Session Minutes

Motion by Edward McKenna, second by Gayle Mayer, to approve the Closed Session

Minutes of the July 24, 2018, meeting. Motion approved unanimously.

2. Close With No Further Action

Motion by Gayle Mayer, second by LaDonna Gratias, to close with no further action the

following investigative file in complaint number: 2018-22. Motion approved (Hansel

abstained).


Motion by Jason Hansel, second by Edward McKenna, to close with no further action the

following investigative file in complaint number: 2018-75. Motion approved (Barker

abstained).

Motion by Jason Hansel, second by Edward McKenna, to close with no further action the

following investigative files in complaint numbers: 2017-99, 2018-45, 2018-63, 2018-71,

2018-99, 2018-98, and 2018-59. Motion approved unanimously.

3. Administrative Warning

Motion by Edward McKenna, second by LaDonna Gratias, to issue an administrative

warning to the pharmacy support person and pharmacist in charge in 2018-70; to the

pharmacy and pharmacist in charge in 2018-62; to the pharmacy and pharmacist in charge

in 2018-63; and to the pharmacist in 2018-90. Motion approved unanimously.

4. Request for Termination of Probation

Motion by Edward McKenna, second by LaDonna Gratias, to deny the request to terminate

probation and to modify the terms of probation to reduce the frequency of inventory to

quarterly and the frequency of self-inspections to biannually. Motion approved

unanimously.

5. Notice of Hearing and Statement of Charges

Motion by Gayle Mayer, second by Edward McKenna, to approve the Notice of Hearing

and Statement of Charges in the following case. Motion approved unanimously.

A. 2018-82, Sheila Schleeper, Pharmacist License No. 23200, Burlington. A copy of the

Notice of Hearing and Statement of Charges is attached as Addendum A.

6. Settlement Agreement and Final Order

Motion by Jason Hansel, second by Edward McKenna, to approve the Settlement

Agreement and Final Order in the following cases. Motion approved unanimously.

A. 2018-24, Alan Bollinger, CSA Registration No. 1304787, Des Moines. A copy of the

Settlement Agreement and Final Order is attached as Addendum B.

B. 2018-8, David Sinnwell, Pharmacist License No. 15813, Johnston. A copy of the

Settlement Agreement and Final Order is attached as Addendum C.

7. Combined Statement of Charges, Settlement Agreement, and Final Order

Motion by Gayle Mayer, second by Edward McKenna, to approve the Combined Statement

of Charges, Settlement Agreement, and Final Order in the following case. Motion approved

unanimously.

A. 2018-31, Stacy Cook, Pharmacy Technician Registration No. 23514, Carroll. A copy

of the Combined Statement of Charges, Settlement Agreement, and Final Order is

attached as Addendum D.

At 2:49 p.m., motion by Gayle Mayer, second by Jason Hansel, to adjourn. Motion approved

unanimously.


WEDNESDAY, SEPTEMBER 19, 2018

MEMBERS PRESENT

Sharon K. Meyer, Chair

Edward J. McKenna, Vice-Chair

Brett Barker

LaDonna Gratias

Jason Hansel

Gayle Mayer

Joan Skogstrom

SPEAKERS

Jon Fransen, Hy-Vee

Dennis McAllister, Express Scripts

Laura Manatt, Poweshiek County

Trevor White, Poweshiek County

Pamela Wiltfang, NuCara Pharmacy

Heidi Price-Eastman, Primary Health Care

Casey Ficek, IPA

Brian Wegmann, NuCara Pharmacy

Cheri Schmit, GRx Holdings/Medicap

STAFF PRESENT

Andrew Funk, Executive Director

Laura Steffensmeier, Esq., Assistant Attorney General

Therese Witkowski, Executive Officer

Amanda Woltz, Administrative Assistant

Christie Carlson, Compliance Officer

Curtis Gerhold, Compliance Officer

Mark Mather, Compliance Officer

Sue Mears, Compliance Officer

Jean Rhodes, Compliance Officer

Daniel Sedlacek, Compliance Officer

James Wolfe, Compliance Officer

Rebecca Seabrooke, IMP3 Case Manager

Call to Order and Announcements

At 9:01 a.m. on Wednesday, September 19, 2018, Sharon Meyer, Chair, called the meeting of the

Iowa Board of Pharmacy to order.

Public Comments

There were no comments from the public.

Approval of Open Session Minutes

The open session minutes of the July 24, 2018, Open Session Meeting were reviewed.

Motion by Brett Barker, second by Gayle Mayer, to approve the Open Session Minutes of the July

24, 2018, meeting as presented. Motion approved unanimously.

Requests

1. Request for Internship hours – Mariam Amir Fahmy Wanis, Intern License No. 7169,

Coralville.

Motion by Jason Hansel, second by Brett Barker, to allow Ms. Wanis’s life experience to

satisfy 300 hours of the 1,500 hour internship requirement. Motion passed unanimously.

2. Request for Variance of delivery requirements – Primary Health Care Pharmacy, Pharmacy

license No. 1237, Des Moines.


Motion by Jason Hansel, second by Gayle Mayer, to table the request and ask the pharmacy

to provide additional information in a future request. Motion passed unanimously.

3. Request to approve Telepharmacy application and possible waiver of distance requirement

– NuCara Pharmacy, Telepharmacy applicant.

Motion by Jason Hansel, second by Joan Skogstrom, to approve the waiver request for

distance from the nearest pharmacy that dispenses prescription drugs to outpatients, subject

to mandatory review by Department of Public Health Director Claybaugh. Motion passed

5-1-1 (Barker abstain, McKenna voted no).

Licensure/Registration Application Review

1. Request for license transfer approval – Timothy Schirm, RPh, Fishershville, VA.

Motion by Brett Barker, second by Jason Hansel, to approve Mr. Schirm’s request for

license transfer to Iowa. Motion passed unanimously.

2. Review of Pharmacist in Charge Registration application – Brandon Wayne Blake, Hicare

Pharmacy, Texas.

Motion by Jason Hansel, second by Edward McKenna, to approve the registration. Motion

passed unanimously.

Reports

1. Executive Director’s Report

A. Appointments

The governor’s office is seeking applicants for the open Board member position for a

Certified Pharmacy Technician. To maintain gender and geographical balance on the

board, the governor is seeking a male technician from western/southwestern or northern

Iowa.

Jason Hansel was appointed to represent NABP District V on the NABP Resolution

Committee.

Andrew Funk was appointed to chair the NABP Task Force to Develop Regulations Based

on Standards of Care, a resolution which passed during this year’s Annual Meeting.

B. Staffing

Rebecca Seabrooke has joined Board staff as IMP3 Case Manager.

Two additional temporary clerk specialists will be hired to assist with fall renewals.

The four health boards are considering seeking a full-time human resources professional

to provide on-site human resources support.

C. Licensing.


Andrew Funk has developed a mechanism to award one hour of non-ACPE continuing

education credit for pharmacists in attendance at the board meetings which will be reported

to the pharmacist’s CPE monitor.

Since implementation of the new licensing database, 3,742 licenses/registrations have been

renewed online, representing 53% of all renewal transactions.

D. Database project

Online renewals for wholesalers, outsourcing facilities, pharmacies, and pharmacy support

persons will be available November 1, 2018.

Online new applications will be implemented in the spring of 2019.

The project’s scope and budget remains constant, while the full implementation has been

extended at least three months.

E. USP

The comment period for proposed revisions to USP General Chapter 797 is between July

27, 2018 and November 30, 2018. The proposed revisions will be reviewed and draft

comments will be reviewed at the Board’s November meeting.

The official / enforceable date for USP General Chapter 800 is currently set for December

1, 2019. Board rules require compliance with USP Chapters 795 and 797, which by

reference will include USP 800, unless the board seeks changes to rules.

USP has two on-demand webinars available for anyone interested.

The Board will be hosting a live training session on USP 800 on October 2, 2018 to be held

at the Johnston-Grimes Fire Department in Johnston, Iowa. The training will be provided

by The Accreditation Commission for Health Care (ACHC). Registration is full and staff

is assessing the need for a second session in early 2019.

F. Implementation of 2018 legislation

Rules to implement the Board’s bill have been published for Notice and have been

presented to the Administrative Rules Review Committee (ARRC). A public hearing is

scheduled for Tuesday, September 25, 2018 to receive additional public comments relating

to the proposed rules for wholesalers, limited distributors, and third-party logistics

providers. Any comments received through the open comment period and hearing will be

reviewed by the rules committee in October and the board in November.

Chapter 37, “Prescription Monitoring Program,” will be completely revised to include the

applicable provisions of House File 2377. The PMP Advisory Council and the rules

committee will review and finalize proposed amendments for the Board’s consideration at

its November meeting.

The rules committee held extensive discussion on rules relating to Technician Product

Verification (TPV) and statewide protocols to implement SF 2322. The committee wishes

to continue discussion on TPV at its October meeting and intends to have proposed rules

for the Board’s consideration at its November meeting. The committee approved proposed

rules relating to statewide protocols which will be presented to the Board later on this

agenda.


2. Meetings and Travel

A. IMP3 will meet on Friday, September 21, 2018.

B. FDA will hold its seventh Intergovernmental Working Group on Pharmacy

Compounding in Silver Spring, MD on September 25-26, 2018. Sue Mears, Christie

Carlson, and Dr. Caitlin Pedati (IDPH medical director and state epidemiologist) will

attend.

C. The National Opioid Crisis Management Conference will be held in Washington, DC

on September 27-28, 2018. Andrew Funk will be a presenter.

D. ACHC Compliance Workshop (USP 800) will be held in Johnston on October 2, 2018.

Sharon Meyer, Joan Skogstrom, Gayle Mayer, Brett Barker, and all the compliance staff

plan to attend.

E. The NABP Executive Officer Form will be held in Chicago, IL on October 2-3, 2018.

Andrew Funk will attend.

F. Andrew Funk will give a presentation on the PMP to dentists/social workers/nurses at

Iowa Western Community College in Council Bluffs on October 5, 2018.

G. Critical Point’s Sterile Compounding Inspector Training Certification will be held in

Totowa, New Jersey on October 7-11, 2018. Christie Carslon, Dan Sedlacek, and Jennifer

O’Toole will attend.

H. The NABP Task Force to Develop Regulations Based on Standards of Care will be held

in Chicago, IL on October 9-10, 2018. Andrew Funk will attend.

I. The PMP Advisory Council will meet in Des Moines, Iowa on October 8, 2018.

J. The National Association of State Controlled Substance Authorities (NASCSA) Annual

Conference will be held in Scottsdale, AZ on October 30-November 2, 2018. Sue Mears

will attend.

K. The American Society for Pharmacy Law Annual Meeting will be held in Hilton Head,

South Carolina on November 1-4, 2018. Andrew Funk will attend and present on Iowa’s

drug repository.

L. The Board will next meet on November 13-14, 2018 in Des Moines.

M. NABP Interactive Member Forum will be held in Chicago, IL on November 28-29,

2018. Jason Hansel will attend.

N. ASHP Clinical Midyear meeting will be held in Anaheim, CA on December 2-6, 2018.

Sharon Meyer will attend.

3. Budget Report - Terry Witkowski.

Terry Witkowski reported that FY18 ended September 17, 2018 with the Board carrying

over approximately $1,220,000 to begin FY19. Carryover amounts for IMP3 and PMP are

approximately $32,600 and $95,500, respectively. As these amounts are not sufficient for

these programs, amounts of approximately $60,550 (IMP3) and $140,000 (PMP) will be

transferred to those accounts, leaving the Board with approximately $1,019,000 to carry

over, which is approximately $10,000 more than anticipated, and will be sufficient to

ensure the Board can meet its obligations until receipts come in from renewals.


4. PMP and MedDrop Update – Andrew Funk.

PMP administrators continue to work with Appriss on its new platform.

IDPH has been awarded grant funds, part of which will be used to develop a web-based

system for reporting naloxone administration by first responders and emergency

departments.

PMP report cards will be initiated in February, 2019.

The PMP Advisory Council will establish threshold criteria to implement proactive

notifications as authorized in HF 2377.

Mandatory registration with the PMP has been implemented with CSA registration, with

the exception of veterinarians.

The PMP Advisory Council has fulfilled all remaining vacancies and will next meet on

October 8, 2018.

Information on the MedDrop program was provided in Board materials.

5. Iowa Monitoring Program for Pharmacy Professionals (IMP3) – Rebecca Seabrooke.

The IMP3 committee will next meet on September 21, 2018. The program has 11

participants (5 pharmacists, 1 intern, and 5 technicians).

6. Legal update – Laura Steffensmeier.

The Board’s administrative denial of a request for a legislative recommendation related to

marijuana is being appealed to district court for judicial review. AAG Steffensmeier has

filed an order to dismiss.

7. IPA Medication Disposal Report – Quarter 2 – Casey Ficek

Information provided for the Board’s review.

8. Hy-Vee Iowa Error Report – Quarter 1 and 2 – Jon Fransen

Information provided for the Board’s review.

9. FDA Statement – New steps to help ensure the quality of and preserve access to

compounded drugs.

Informational item.

10. Board meeting calendar

Proposed meeting dates for 2019 were provided to the Board. As two Board members have

terms which end April 30, 2019, the meeting scheduled for April 30 – May 1, 2019 may

need to be rescheduled.

Rules and Legislation

1. 2019 Legislative Agenda.


The Board discussed potential legislative initiatives for consideration during the 2019

legislative session. Proposed draft language will be reviewed by the rules committee and

brought back to the Board at its November meeting.

2. Proposed for Adoption and Filing Amendments to Chapter 15, “Correctional Pharmacy

Practice.”

Motion by Brett Barker, second by Edward McKenna, to adopt. Motion approved

unanimously. A copy is attached as Addendum E.

4. Proposed for Notice of Intended Action to amend Chapter 4, “Pharmacist-Interns.”

Motion by Brett Barker, second by Jason Hansel, to file for Notice of Intended Action.

Motion approved unanimously. A copy is attached as Addendum F.

5. Proposed for Notice of Intended Action to Amend Chapter 8, “Universal Practice

Standards,” and Chapter 13, “Telepharmacy Practice.”

Motion by Jason Hansel, second by Brett Barker, to file for Notice of Intended Action.

Motion approved unanimously. A copy is attached as Addendum G.

6. Proposed for Notice of Intended Action to Amend Chapter 39, “Expanded Practice

Standards.”

Motion by Brett Barker, second by Gayle Mayer, to file for Notice of Intended Action.

Motion approved unanimously. A copy is attached as Addendum H.

The Board recessed at 11:43 a.m. for lunch.

The Board reconvened at 12:49 p.m. in Open Session.

Closed Session

At 12:49 p.m., on a motion by Jason Hansel, second by Brett Barker, the Board voted unanimously

by roll call vote to move into closed session pursuant to Iowa Code Section 21.5(1)(d), to discuss

whether to initiate licensee disciplinary investigations or proceedings.

At 1:40 p.m., while still in closed session, Brett Barker moved that the Board go into open session,

seconded by Gayle Mayer. Motion approved unanimously.

In open session, the following actions were taken:

1. Close with No Further Action

Motion by Brett Barker, second by Gayle Mayer, to close with no further action the following

investigative file in complaint number: 2018-42. Motion approved unanimously.


The Board adjourned at 1:42 p.m. on September 19, 2018.

_______

Sue Mears

Recording Secretary

Andrew Funk Sharon K. Meyer

Executive Director Board Chair

APPROVED THIS 14th DAY OF NOVEMBER, 2018

ADDENDUM A

NOTICE OF HEARING AND STATEMENT OF CHARGES

SHEILA SCHLEEPER

PHARMACIST LICENSE NO. 23200

BURLINGTON, IOWA

Page 1 of 3

BEFORE THE IOWA BOARD OF PHARMACY

RE: Pharmacist License of SHEILA SCHLEEPER License No. 23200 Respondent

CASE NO. 2018-82 NOTICE OF HEARING AND STATEMENT OF CHARGES

COMES NOW the Iowa Board of Pharmacy (“Board”) and files this Notice of Hearing and Statement of Charges against Sheila Schleeper (“Respondent”), 1704 Parkway Dr, Burlington IA 52601, pursuant to Iowa Code sections 17A.12(2), 17A.18(3), and 272C.3(1)"e", and 657 IAC 35.6 and 35.7. Respondent’s Iowa pharmacist license number 23200 is currently active through June 30, 2019.

A. TIME, PLACE, AND NATURE OF HEARING

Hearing. A disciplinary contested case hearing shall be held on November 13, 2018, before the Board. The hearing shall begin at 1:00 p.m. and shall be located in the Board conference room located at the Iowa Board of Pharmacy Office, 400 SW 8th St, Ste E, Des Moines IA 50309.

Answer. Within twenty (20) days of the date you are served this Notice of Hearing and Statement of Charges, you may file an Answer pursuant to 657 IAC 35.16. The Answer should specifically admit, deny, or otherwise answer all allegations contained in sections C and D of this Notice of Hearing and Statement of Charges.

Filing of Pleadings. Pleadings shall be filed with the Board either by e-mail, if done in compliance with 657 IAC 35.17(2), to [email protected], or by mail/delivery to the following address: Iowa Board of Pharmacy, 400 SW 8th St, Ste E, Des Moines IA 50309.

Presiding Officer. The Board shall serve as presiding officer, but the Board may request an Administrative Law Judge from the Department of Inspections and Appeals make initial rulings on prehearing matters, and be present to assist and advise the Board at hearing.

Hearing Procedures. The procedural rules governing the conduct of the contested case hearing, including prehearing matters, are found at 657 IAC chapter 35. At the hearing, you may appear personally or be represented by counsel at your own expense. You will be allowed the opportunity to respond to the charges against you, to produce evidence on your behalf on issues of material fact, cross-examine witnesses present at the hearing, and examine and respond to any documents introduced at the hearing. The hearing may be open to the public or closed to the public at your discretion, pursuant to Iowa Code section 272C.6(1) and 657 IAC 35.25(10).

mailto:[email protected]

Page 2 of 3

Prosecution. The Office of Attorney General of Iowa is responsible for representing the public interest (the State) in this proceeding. Counsel for the State in this matter is Assistant Attorney General Laura Steffensmeier. Ms. Steffensmeier can be reached by phone at (515) 281-6690. Copies of pleadings should be provided to counsel for the State either by email to [email protected], or by mail/delivery to the following address:

Laura Steffensmeier Assistant Attorney General Hoover State Office Building—2nd Floor 1305 E Walnut St Des Moines IA 50319

Communications. You may not contact individual Board members in any manner, including by phone, letter, or e-mail, regarding this Notice of Hearing and Statement of Charges. Board members may only receive information about the case when all parties have notice and the opportunity to participate, such as at the hearing or in pleadings you file and serve upon all parties in the case.

B. LEGAL AUTHORITY AND JURISDICTION

Jurisdiction. The Board has jurisdiction in this matter pursuant to Iowa Code chapters 17A, 147, 155A, and 272C (2018).

Legal Authority. If any of the allegations against you are founded, the Board has authority to take disciplinary action against you under Iowa Code chapters 147, 155A, and 272C, and 657 IAC chapter 36.

Default. If you fail to appear at the hearing, the Board may enter a default decision or proceed with the hearing and render a decision in your absence, in accordance with Iowa Code section 17A.12(3) and 657 IAC 35.27.

C. STATEMENT OF CHARGES

COUNT I OUT-OF-STATE DISCIPLINE

Respondent is charged with having a license revoked or suspended or having other disciplinary action taken by a licensing authority of this state or of another state, territory, or country for conduct substantially equivalent to any of the grounds for disciplinary action in Iowa, pursuant to Iowa Code sections 147.55(9) and 155A.12(1) and 657 IAC 36.6(31).

D. FACTUAL CIRCUMSTANCES

On June 27, 2018, the Illinois Department of Financial and Professional Regulation approved a Consent Order that placed Respondent’s Illinois pharmacist license on indefinite probation for filling fraudulent prescriptions for self-use.


Page 3 of 3

E. SETTLEMENT

This matter may be resolved by settlement agreement. The procedural rules governing the Board’s settlement process are found at 657 IAC 35.24. To cancel a scheduled hearing, an executed settlement agreement must be received by the Board at least three (3) business days prior to the scheduled hearing. If you are interested in pursuing settlement in this matter, please contact the Assistant Attorney General identified above.

F. FINDING OF PROBABLE CAUSE

On this 18th day of September, 2018, the Iowa Board of Pharmacy found probable cause to file this Notice of Hearing and Statement of Charges.

_____________________________________

Chairperson Iowa Board of Pharmacy

Copy to: Laura Steffensmeier Assistant Attorney General Hoover State Office Building—2nd Floor 1305 E Walnut St Des Moines IA 50319 ATTORNEY FOR THE STATE

PLEASE NOTE: If you require the assistance of auxiliary aids or services to participate in this matter because of a disability, immediately call 515-281-5944. (If you are hearing impaired, call Relay Iowa TTY at 1-800-735-2942).

ADDENDUM B

SETTLEMENT AGREEMENT AND FINAL ORDER

ALAN BOLLINGER

CSA REGISTRATION NO. 1304787

DES MOINES, IOWA

ADDENDUM C

SETTLEMENT AGREEMENT AND FINAL ORDER

DAVID SINNWELL

PHARMACIST LICENSE NO. 15813

JOHNSTON, IOWA

ADDENDUM D

COMBINED STATEMENT OF CHARGES, SETTLEMENT

AGREEMENT, AND FINAL ORDER

STACY COOK

TECHNICIAN REGISTRATION NO. 23514

CARROLL, IOWA

ADDENDUM E

ADOPTION AND FILING

AMENDING CHAPTER 15, “CORRECTIONAL

PHARMACY PRACTICE”

SEPTEMBER 19, 2018

ARC 3848CPHARMACY BOARD[657]

Notice of Intended Action

Proposing rule making related to review of correctional pharmacy practice rules andproviding an opportunity for public comment

The Board of Pharmacy hereby proposes to amend Chapter 15, “Correctional Pharmacy Practice,”Iowa Administrative Code.

Legal Authority for Rule Making

This rule making is proposed under the authority provided in Iowa Code sections 124.301 and 147.76.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code sections 124.303, 124.306, 124.308,126.10, 126.11, 155A.6A, 155A.6B, 155A.10, 155A.13, 155A.27, 155A.28, 155A.31 to 155A.36 and155A.41.

Purpose and Summary

Pursuant to Iowa Code section 17.7(2), the Board has completed a review of this chapter ofadministrative rules. The proposed amendments update the required references to be maintained in areference library in order to be consistent with recent Board action for other practice settings, removethe requirement that the policies and procedures identify the hours of operation of the pharmacy, clarifythe record retention requirements for training documentation, and add the option of an electronicsignature on prescription drug orders.

Fiscal Impact

This rule making has no fiscal impact to the State of Iowa.

Jobs Impact

After analysis and review of this rule making, no impact on jobs has been found.

Waivers

Any person who believes that the application of the discretionary provisions of this rule making wouldresult in hardship or injustice to that person may petition the Board for a waiver of the discretionaryprovisions, if any, pursuant to 657—Chapter 34.

Public Comment

Any interested person may submit written comments concerning this proposed rule making. Writtencomments in response to this rule making must be received by the Board no later than 4:30 p.m. on July10, 2018. Comments should be directed to:

Sue MearsBoard of Pharmacy400 S.W. 8th Street, Suite EDes Moines, Iowa 50309Email: [email protected]

1


Public Hearing

No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)“b,” an oralpresentation regarding this rule making may be demanded by 25 interested persons, a governmentalsubdivision, the Administrative Rules Review Committee, an agency, or an association having 25 ormore members.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rulemaking by executive branch agencies, may, on its own motion or on written request by any individual orgroup, review this rule making at its regular monthly meeting or at a special meeting. The Committee’smeetings are open to the public, and interested persons may be heard as provided in Iowa Code section17A.8(6).

The following rule-making actions are proposed:ITEM 1. Amend rule 657—15.4(155A) as follows:

657—15.4(155A) Reference library. References may be printed or computer-accessed. Eachcorrectional pharmacy shall have on site, at a minimum, one current maintain a reference from each ofthe following categories, including access to current periodic updates library, which is either printed orcomputer-accessed and which adequately meets the needs of the services provided and patients served.Examples of references include:

1. A reference including all pertinent Iowa laws, rules, and regulations that impact the pharmacy’spractice.

2. A patient information reference that includes or provides patient information in compliancewith rule 657—6.14(155A).

3. A reference on drug interactions.4. A general drug information reference.5. A drug equivalency reference.6. A reference on natural or herbal medicines.7. The readily accessible telephone number of a poison control center that serves the area.8. Additional references as may be necessary for the pharmacist to adequately meet the needs of

the patients served relating to specific patient populations served.ITEM 2. Amend subrule 15.5(3) as follows:15.5(3) Pharmacist responsibility. Each pharmacist, while on duty, shall be responsible for the

security of the correctional pharmacy. This responsibility includes provisions for effective controlagainst theft of, diversion of, or unauthorized access to prescription drugs or devices, controlledsubstances, records for such drugs and devices, and patient records as provided in 657—Chapter 21and rule 657—8.16(124,155A). Policies and procedures shall identify the days and hours the pharmacyshall be open. A pharmacist shall be on site during all times that the pharmacy is open.

ITEM 3. Amend rule 657—15.7(124,126,155A) as follows:

657—15.7(124,126,155A) Training and utilization of pharmacy technicians or pharmacy supportpersons. Pharmacy technician and pharmacy support person training shall be documented andmaintained by the pharmacy for the duration of at least two years from the last date of employment.Policies and procedures and documentation of pharmacy technician and pharmacy support persontraining shall be available for inspection by the board or an agent of the board.

ITEM 4. Amend subrule 15.8(1) as follows:15.8(1) Required information. Prescription drug orders written in patient health records shall include

the following information:a. Patient name, identification number, and correctional facility location;

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https://www.legis.iowa.gov/committees/meetings/meetingsListComm?groupID=705&ga=87

https://www.legis.iowa.gov/docs/iac/chapter/657.21.pdf

https://www.legis.iowa.gov/docs/iac/rule/657.8.16.pdf

b. Drug name, strength, dosage form, and quantity or duration;c. Directions for use of the drug;d. Date the prescription drug order is authorized;e. Prescriber’s name, signature or electronic signature, and office address;f. Prescriber’s DEA number for controlled substances.

3

ADDENDUM F

NOTICE OF INTENDED ACTION

AMENDING CHAPTER 4, “PHARMACIST-INTERNS”

SEPTEMBER 19, 2018

1

PHARMACY BOARD [657]


The Board of Pharmacy hereby proposes to amend Chapter 4, “Pharmacist-Interns,” Iowa

Administrative Code.


This rule making is proposed under the authority provided in Iowa Code sections 147.76

and 155A.6.


This rule making implements, in whole or in part, Iowa Code section 155A.6.

Purpose and Summary

This proposed amendment removes the limitation of a pharmacist to supervise no more

than two pharmacist-interns concurrently.

Fiscal Impact

This rule making has no fiscal impact to the state of Iowa.

Jobs Impact


Waivers

Any person who believes that the application of the discretionary provisions of this rule

making would result in hardship or injustice to that person may petition the Board for a waiver of

the discretionary provisions, if any, pursuant to 657—Chapter 34.

Public Comment

2

Any interested person may submit comments concerning this proposed rule making.

Written comments in response to this rule making must be received by the Board no later than

4:30 p.m. on ________, 2018. Comments should be directed to:

Sue Mears

Iowa Board of Pharmacy

400 S.W. 8th Street, Suite E

Des Moines, Iowa 50309

E-mail: [email protected]

Public Hearing

No public hearing is scheduled at this time. As provided in Iowa Code section

17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested

persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or

an association having 25 or more members.


The Administrative Rules Review Committee, a bipartisan legislative committee which

oversees rule making by executive branch agencies, may, on its own motion or on written request

by any individual or group, review this rule making at its regular monthly meeting or at a special

meeting. The Committee’s meetings are open to the public, and interested persons may be heard

as provided in Iowa Code section 17A.8(6).

The following rule-making action is proposed:

Amend rule 657—4.9(155A) as follows:

657—4.9 (155A) Preceptor requirements.

4.9(1) to 4.9(2) No change.

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4.9(3) Number of interns. A preceptor may supervise no more than two pharmacist-

interns concurrently.

4.9(4) Responsibility. A preceptor shall be responsible for all functions performed by a

pharmacist-intern.

ADDENDUM G


AMENDING CHAPTER 8, “UNIVERSAL PRACTICE

STANDARDS,” AND CHAPTER 13, “TELEPHARMACY

PRACTICE”

SEPTEMBER 19, 2018

1



The Board of Pharmacy hereby proposes to amend Chapter 8, “Universal Practice

Standards,” and Chapter 13, “Telepharmacy Practice,” Iowa Administrative Code.


This rule making is proposed under the authority provided in Iowa Code sections 147.76,

147.80, and 155A.13.


This rule making implements, in whole or in part, Iowa Code sections 147.80, 155A.13,

and 155A.26.

Purpose and Summary

These proposed amendments provide more clear language relating to the distance

requirement between a proposed telepharmacy site and a currently licensed pharmacy that

provides prescription drugs to outpatients, consistent with language found in Iowa Code, which

pharmacy may be another licensed telepharmacy; require a pharmacy which intends to change

license type to submit an application and may be subject to an inspection by a board compliance

officer prior to issuance of the new license; implement a late penalty fee for late submission of

license change application; and authorize the board to collect a fee for a written verification of a

pharmacy license.

Fiscal Impact

This rule making is not anticipated to have a fiscal impact to the state of Iowa.

Jobs Impact


2

Waivers




Public Comment




Sue Mears

Iowa Board of Pharmacy




Public Hearing









3




ITEM 1. Amend subrule 8.35(4) as follows:

8.35(4) Inspection of new pharmacy location.

a. A new pharmacy location in Iowa shall require an on-site inspection by an authorized

agent of the board. Application for a pharmacy license and other required registrations shall be

submitted to the board at least 14 days prior to the anticipated inspection. Any deficiencies

identified during the inspection shall be corrected and verified by an authorized agent of the

board prior to the issuance of the pharmacy license. Prescription drugs, including controlled

substances, may not be delivered to a new pharmacy location prior to the delivery of the

pharmacy license and registration certificates.

b. A pharmacy location in Iowa which is applying for a different license type than

previously held may be subject to an inspection prior to the issuance of the new license.

ITEM 2. Amend subrule 8.35(6) as follows:

8.35(6) Pharmacy license changes. When a pharmacy changes its name, location,

ownership, or pharmacist in charge, or license type, a completed pharmacy license application

with a nonrefundable $135 fee shall be submitted to the board pursuant to subrule 8.35(2). Upon

receipt of the completed application and fee, the board shall issue an updated pharmacy license

certificate, pending any necessary inspection pursuant to subrule 8.35(4), paragraph “b”, unless

the board identifies any ground for denial of the license. Any restrictions or disciplinary history

associated with the previous pharmacy shall remain unchanged. A pharmacy wishing to

disassociate itself from the previously licensed pharmacy restrictions or disciplinary history may

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petition the board for such disassociation. The burden is on the pharmacy to demonstrate that the

current pharmacy is not associated with or responsible for the pharmacy as it previously existed.

The old license certificate shall be returned to the board within ten days of receiving the updated

license certificate.

a. through d. No change.

e. License type. A change in pharmacy license type shall require submission of a

pharmacy license application and appropriate fee prior to the change. A pharmacy changing

licensure type shall notify the pharmacist in charge and patients of the change in accordance with

subrule 8.35(7).

f. License change application submission. Applications for license changes shall be

timely submitted pursuant to this subrule. A licensed pharmacy that has timely submitted a

license change application and fee may continue to service Iowa patients while the license

change is pending final approval. An applicant that has submitted an application for license

changes after the required date of submission pursuant to this subrule but within 30 days of the

required date of submission shall be assessed a nonrefundable late penalty fee of $135 in

addition to the license fee. An applicant that has submitted an application for license changes 31

days or later following the required date of submission pursuant to this subrule shall be assessed

a nonrefundable late penalty fee of $540.

ITEM 3. Adopt the following new subrule 8.35(9):

8.35(9) License verification fee. The board may require a nonrefundable fee of $15 to

complete a request for written license verification of any pharmacy license.

ITEM 4. Amend rule 657—13.16(124,155A) as follows:

657—13.16(124,155A) Telepharmacy site—initial application.

5

13.16(1) License application. A telepharmacy site shall complete and submit to the board

a limited use/telepharmacy license application and nonrefundable fee as provided in rule 657—

8.35(155A). In addition to the application and fee, the telepharmacy site shall include the

additional information identified in this rule.

13.16(2) CSA registration application. If controlled substances will be dispensed from

the telepharmacy site, the telepharmacy site shall complete and submit, with the limited

use/telepharmacy license application and fee, the CSA registration application and

nonrefundable fee as provided in rule 657—10.1(124) 657—10.5(124).

13.16(3) No change.

13.16(4) Distance to nearest general pharmacy that dispenses prescription drugs to

outpatients. The telepharmacy site application shall identify the nearest licensed pharmacy that

dispenses prescription drugs to outpatients and shall provide evidence identifying the total

driving distance between the proposed telepharmacy site and the nearest currently licensed

general pharmacy that dispenses prescription drugs to outpatients.

a. If the distance between the proposed telepharmacy site and the nearest currently

licensed general pharmacy that dispenses prescription drugs to outpatients is less than ten miles,

the telepharmacy site shall submit a request for waiver of the distance requirement. The process

and requirements for a request for waiver are identified in subrule 13.16(8).

b. No change.

13.16(5) through 13.16(7) No change.

13.16(8) Request for distance waiver. The board shall consider a request for waiver of the

distance requirement between the proposed telepharmacy site and the nearest currently licensed

pharmacy that dispenses prescription drugs to outpatients if the petitioner can demonstrate to the

6

board that the proposed telepharmacy site is located in an area where there is limited access to

pharmacy services and that there exist compelling circumstances that justify waiving the distance

requirement.

a. No change.

b. In addition to the requirements of 657—Chapter 34, the request for waiver shall

include evidence and specific information regarding each of the following, if applicable. If an

item identified below does not apply to the proposed telepharmacy site, the request for waiver

shall specifically state that the item does not apply.

(1) to (2) No change.

(3) That access to the nearest currently licensed general pharmacy that dispenses

prescription drugs to outpatients is limited. A description of how the proposed telepharmacy site

will improve patient access to pharmacy services shall be included.

(4) to (7) No change.

c. The board shall consider a request for waiver of the distance requirement during any

open session of a meeting of the board. One or more representatives of the parties to the waiver

request, including representatives of the proposed telepharmacy site, the managing pharmacy,

and the nearest currently licensed general pharmacy that dispenses prescription drugs to

outpatients, shall be invited and encouraged to attend the meeting at which the waiver request is

scheduled for consideration to be available to respond to any questions.

d. No change.

ADDENDUM H


AMENDING CHAPTER 39, “EXPANDED PRACTICE

STANDARDS”

SEPTEMBER 19, 2018

1



The Board of Pharmacy hereby proposes to amend Chapter 39, “Expanded Practice

Standards,” Iowa Administrative Code.


This rule making is proposed under the authority provided in Iowa Code 147.76 and 2018

Iowa Acts, Senate File 2322.


This rule making implements, in whole or in part, Iowa Code 155A.44 and 2018 Iowa

Acts, Senate File 2322.

Purpose and Summary

These proposed amendments establish that a pharmacist may participate in a statewide

protocol developed by the board in consultation with the department of public health; establish

the minimum requirements for participation in statewide protocols, including required

pharmacist training and education and required notification to the patient’s primary care provider

of the product dispensed pursuant to the statewide protocol; require the required continuing

education be approved by the Accreditation Council for Pharmacy Education (ACPE) with the

specific topic designator of “06” for pharmacists; and identify a repeal date for vaccine

administration by pharmacists via a physician-signed protocol in compliance with Senate File

2322, section 8.

Fiscal Impact

This rule making has no fiscal impact to the state of Iowa.

Jobs Impact

2


Waivers




Public Comment




Sue Mears

Board of Pharmacy




Public Hearing









3




ITEM 1. Adopt the following new rule 657—39.6(155A):

657—39.6(155A) Statewide protocols. A pharmacist may, pursuant to statewide protocols

developed by the board in consultation with the department of public health and available on the

board’s website at pharmacy.iowa.gov, prescribe and dispense medications pursuant to rule

657—39.8(155A), rule 657—39.9(155A), and rule 657—39.11(155A).

This rule is intended to implement 2018 Iowa Acts, Senate File 2322.


657—39.8(155A) Statewide protocol – naloxone. An authorized pharmacist may prescribe and

dispense naloxone to patients eighteen years and older pursuant to a statewide protocol

developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized

pharmacist may only delegate the dispensing of naloxone to an authorized pharmacist-intern

under the direct supervision of an authorized pharmacist.

39.8(1) Definitions. For the purposes of this rule, the following definitions shall apply:

“ACPE” means the Accreditation Council for Pharmacy Education.

“Authorized pharmacist” means an Iowa-licensed pharmacist who has completed the

training requirements of this rule. “Authorized pharmacist” also includes an Iowa-registered

pharmacist-intern who has completed the training requirements of this rule and is working under

the direct supervision of an authorized pharmacist.

“Authorized pharmacist-intern” means an Iowa-registered pharmacist-intern who has

completed the training requirements for an authorized pharmacist pursuant to this rule.

4

“Board” means the Iowa board of pharmacy.

“Patient” means an individual consulting with a pharmacist for drug therapy and may

include an individual in a position to assist someone at risk of an opioid-related overdose.

39.8(2) Authorized pharmacist training. An authorized pharmacist shall document

successful completion of an ACPE-approved continuing education program of at least one-hour

duration related to naloxone utilization prior to dispensing naloxone pursuant to the statewide

protocol.

39.8(3) Assessment. An authorized pharmacist shall assess a patient for eligibility to

receive naloxone using criteria identified in the statewide protocol.

39.8(4) Patient education. Upon assessment and determination that a patient is eligible to

receive and possess naloxone pursuant to the statewide protocol, an authorized pharmacist shall,

prior to dispensing naloxone pursuant to the statewide protocol, provide training and education to

the patient including, but not limited to, the information identified in this subrule. An authorized

pharmacist may provide to the patient written materials that include, but may not be limited to,

the information identified in this subrule, but the written materials shall not be in lieu of direct

pharmacist consultation with the patient.

a. The signs and symptoms of opioid-related overdose as described in the statewide

protocol.

b. The importance of calling 911 as soon as possible and the potential need for rescue

breathing.

c. The appropriate use and directions for administration of the naloxone to be dispensed

pursuant to the statewide protocol.

5

d. Adverse reactions of naloxone as well as reactions resulting from opioid withdrawal

following administration.

e. The proper storage conditions, including temperature excursions, of the naloxone

product being dispensed.

f. The expiration date of the naloxone product being dispensed and the appropriate

disposal of the naloxone product upon expiration.

g. Information about substance abuse or behavioral health treatment programs, if

applicable.

39.8(5) Labeling. Naloxone dispensed pursuant to this rule shall be labeled in accordance

with rule 657—6.10(126,155A) and the labeling shall not render the expiration date of the

product illegible.

39.8(6) Reporting. As soon as reasonably possible, the authorized pharmacist shall notify

the patient’s primary health care provider of the naloxone product provided to the patient. If the

patient does not have a primary health care provider, the authorized pharmacist shall provide the

patient with a written record of the naloxone product provided to the patient and shall advise the

patient to consult a physician.

39.8(7) Records. An authorized pharmacist shall maintain records of naloxone prescribed

and dispensed pursuant to the statewide protocol.



657—39.9(155A) Statewide protocol – nicotine replacement tobacco cessation products. An

authorized pharmacist may prescribe and dispense nicotine replacement tobacco cessation

products to patients eighteen years and older pursuant to a statewide protocol developed pursuant

6

to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only

delegate the dispensing of a nicotine replacement tobacco cessation product to an authorized

pharmacist-intern under the direct supervision of an authorized pharmacist.



“Authorized pharmacist” means an Iowa-licensed pharmacist who has completed the

training requirements of this rule. “Authorized pharmacist” also includes an Iowa-registered

pharmacist-intern who has completed the training requirements of this rule and is working under

the direct supervision of an authorized pharmacist.

“Authorized pharmacist-intern” means an Iowa-registered pharmacist-intern who has

completed the training requirements for an authorized pharmacist pursuant to this rule.


39.9(2) Authorized pharmacist training. An authorized pharmacist shall document

successful completion of an ACPE-approved continuing education program of at least one-hour

duration related to nicotine replacement tobacco cessation product utilization prior to dispensing

such products under the statewide protocol.

39.9(3) Assessment. An authorized pharmacist shall assess a patient for appropriateness

of receiving a nicotine replacement tobacco cessation product pursuant to the statewide protocol.

39.9(4) Patient counseling and instructions. Upon assessment and determination that

provision of the nicotine replacement tobacco cessation product is appropriate pursuant to the

statewide protocol, an authorized pharmacist shall, prior to dispensing such product, provide

counseling and instructions to the patient pursuant to rule 657—6.14(155A).

7

39.9(5) Labeling. Nicotine replacement tobacco cessation products dispensed pursuant to

this rule shall be labeled in accordance with rule 657—6.10(126,155A) and the labeling shall not

render the expiration date of the product illegible.

39.9(6) Reporting. As soon as reasonably possible, the authorized pharmacist shall notify

the patient’s primary health care provider of the nicotine replacement tobacco cessation product

provided to the patient. If the patient does not have a primary health care provider, the authorized

pharmacist shall provide the patient with a written record of the nicotine replacement tobacco

cessation product provided to the patient and shall advise the patient to consult a physician.

39.9(7) Records. An authorized pharmacist shall maintain records of nicotine

replacement tobacco cessation products prescribed and dispensed pursuant to the statewide

protocol.


ITEM 4. Amend rule 657—39.10(155A) as follows:

657—39.10(155A) Vaccine administration by pharmacists – physician approved protocol.

An Through June 30, 2019, an authorized pharmacist may administer vaccines pursuant to

protocols established by the CDC in compliance with the requirements of this rule. An

authorized pharmacist may only delegate the administration of a vaccine to an authorized

pharmacist-intern under the direct supervision of the authorized pharmacist.

39.10(1) No change.

39.10(2) Authorized pharmacist training and continuing education. An authorized

pharmacist shall document successful completion of the requirements in paragraph 39.10(2)“a”

and shall maintain competency by completing and maintaining documentation of the continuing

education requirements in paragraph 39.10(2)“b.”

8

a. No change.

b. Continuing education. During any pharmacist license renewal period, an authorized

pharmacist who engages in the administration of vaccines shall complete and document at least

one hour of ACPE-approved continuing education related to vaccines with the ACPE topic

designator “06” followed by the letter “P”.

c. No change.

39.10(3) through 39.10(6) No change.

39.10(7) Verification and reporting. The requirements of this subrule do not apply to

influenza and other emergency vaccines administered via protocol pursuant to subrule 39.10(4).

An authorized pharmacist shall:

a. No change.

b. Within 30 days As soon as reasonably possible following administration of a

vaccine identified in subrule 39.10(5) or 39.10(6), report the vaccine administration to the

statewide immunization registry or health information network and to the patient’s primary

health care provider, if known.


657—39.11(155A) Vaccine administration by pharmacists – statewide protocol. An

authorized pharmacist may prescribe and administer vaccines and immunizations pursuant to a

statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule.

An authorized pharmacist may only delegate the prescribing and administration of a vaccine to

an authorized pharmacist-intern under the direct supervision of an authorized pharmacist.


“ACIP” means the CDC Advisory Committee on Immunization Practices.

9


“Authorized pharmacist” means an Iowa-licensed pharmacist who has met the

requirements identified in subrule 39.11(3).

“Authorized pharmacist-intern” means an Iowa-registered pharmacist-intern who has met

the requirements for an authorized pharmacist identified in subrule 39.11(3).


“CDC” means the United States Centers for Disease Control and Prevention.

“Immunization” shall have the same meaning as, and shall be interchangeable with, the

term “vaccine.”

“Vaccine” means a specially prepared antigen administered to a person for the purpose of

providing immunity.

39.11(2) Vaccines authorized by statewide protocol. The vaccines authorized to be

prescribed and administered pursuant to the statewide protocol shall include:

a. To patients ages eighteen years and older:

(1) An immunization or vaccination recommended by ACIP in its approved vaccination

schedule for adults.

(2) An immunization or vaccination recommended by CDC for international travel.

(3) A Tdap (tetanus, diphtheria, acellular pertussis) vaccination in a booster application.

(4) Other emergency immunizations or vaccinations in response to a public health

emergency.

b. To patients ages six months and older:

(1) A vaccine or immunization for influenza.

10

(2) Other emergency immunizations or vaccines in response to a public health

emergency.

c. To patients ages eleven years and older:

(1) The final two doses in a course of vaccinations for HPV.

39.11(3) Authorized pharmacist training and continuing education. An authorized

pharmacist shall document successful completion of the requirements in paragraph 39.11(3)”a”

and shall maintain competency by completing and maintaining documentation of the continuing

education requirements in paragraph 39.11(3)”b.”

a. Initial qualification. An authorized pharmacist shall have successfully completed an

organized course of study in a college or school of pharmacy or an ACPE-accredited continuing

education program on vaccine administration that:

(1) Requires documentation by the pharmacist of current certification in the American

Heart Association or the Red Cross Basic Cardiac Life Support Protocol for health care

providers.

(2) Is an evidence-based course that includes study material and hands-on training and

techniques for administering vaccines, requires testing with a passing score, complies with

current CDC guidelines, and provides instruction and experiential training in the following

content areas:

1. Standards for immunization practices;

2. Basic immunology and vaccine protection;

3. Vaccine-preventable diseases;

4. Recommended immunization schedules;

5. Vaccine storage and management;

11

6. Informed consent;

7. Physiology and techniques for vaccine administration;

8. Pre- and post-vaccine assessment, counseling, and identification of contraindications to

the vaccine;

9. Immunization record management; and

10. Management of adverse events, including identification, appropriate response,

documentation, and reporting.

b. Continuing education. During any pharmacist license renewal period, an authorized

pharmacist who engages in the administration of vaccines shall complete and document at least

one hour of ACPE-approved continuing education with the ACPE topic designator “06”

followed by the letter “P.”

c. Certification maintained. During any period within which the pharmacist may engage

in the administration of vaccines, the pharmacist shall maintain current certification in the

American Heart Association or the Red Cross Basic Cardiac Life Support Protocol for health

care providers.

39.11(4) Assessment. An authorized pharmacist shall assess a patient for appropriateness

of receiving a vaccine pursuant to the statewide protocol.

39.11(5) Verification and reporting. Prior to the prescribing and administration of an

immunization pursuant to the statewide protocol, the authorized pharmacist shall consult and

review the statewide immunization registry or health information network. As soon as

reasonably possible following administration of a vaccine, the pharmacist shall report such

administration to the patient’s primary health care provider, primary physician, and a statewide

immunization registry or health information network. If the patient does not have a primary

12

health care provider, the pharmacist shall provide the patient with a written record of the vaccine

administered to the patient and shall advise the patient to consult a physician.


State of Iowa Board of Pharmacy - Iowa Board Pharmacy...Rebecca Seabrooke, IMP3 Case Manager At 9:05 a.m., Sharon Meyer, Chair, called the meeting of the Iowa Board of Pharmacy to

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