COMMONWEALTH OF PENNSYLVANIA...Dec 10, 2019 · sargent's court reporting service, inc. (814)...

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COMMONWEALTH OF PENNSYLVANIA 1

DEPARTMENT OF STATE 2

BUREAU OF PROFESSIONAL AND OCCUPATIONAL AFFAIRS 3

4

F I N A L M I N U T E S 5

6

MEETING OF: 7

8

STATE BOARD OF PHARMACY 9

10

TIME: 9:00 A.M. 11

12

PENNSYLVANIA DEPARTMENT OF STATE 13

Board Room C 14

One Penn Center 15

2601 North Third Street 16

Harrisburg, Pennsylvania 17110 17

18

19

December 10, 2019 20

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2

State Board of Pharmacy 1 December 10, 2019 2

3 BOARD MEMBERS: 4 5 Terry M. Talbott, R.Ph., Chairperson 6 K. Kalonji Johnson, Acting Commissioner, Bureau of 7 Professional and Occupational Affairs 8 Robert B. Frankil, R.Ph., Vice Chairman 9 Janet Getzey Hart, R.Ph., Secretary 10 Patrick M. Greene, Esquire, Office of Attorney 11 General 12

Thomas P. Carey, Ed.D. 13 14

15 BUREAU PERSONNEL: 16 17 Juan A. Ruiz, Esquire, Board Counsel 18 Nicole VanOrder, Esquire, Senior Counsel in Charge 19 Glenn P. Masser, Esquire, Board Prosecutor 20 Alice Glasser, Esquire, Board Prosecutor 21 Melanie Zimmerman, R.Ph., Executive Secretary 22 Ray Michalowski, Esq., Liaison for Prosecution 23 Marc Farrell, Deputy Policy Director, Department of 24 State 25 26

27 ALSO PRESENT: 28 29 Kimberly Adams, Chief, Fiscal Management, Bureau of 30 Finance and Operations 31 Shannon Boop, Fiscal Management Specialist 1 32 Barbara Knightly, Executive Vice President of 33 Pharmacy, Pentec Health & International Academy 34 of Compounding Pharmacists 35 Angela Zaydon, Pennsylvania Pharmacists Association 36 Vincent A. Lacroce, Pharm.D., Pennsylvania Society 37 Of Health-Systems Pharmacists 38 Lisa Scannapieco, Director of Pharmacy Education and 39 Clinical Integration, Pentec Health 40

Jenna L. McCarthy, Malady & Wooten 41 Julie Ference, AHN Neighborhood Hospitals Emerus 42 Deirdre Morbitzer, AHN Neighborhood Hospitals Emerus 43 David Stillwell, AHN Neighborhood Hospitals Emerus 44 Kelley Wasicek, AHN Pharmacy Department 45 Tamarah Walker, AHN Neighborhood Hospitals Emerus 46 Cindy Dorendo, AHN Neighborhood Hospitals Emerus 47 Dave Klinger, Geisinger Health 48 Frank Trollo, Central Admixture Pharmacy Services 49 50


3

1 State Board of Pharmacy 2

December 10, 2019 3 (Continued) 4

5 Tejal J. Patel, MBA, PharmMD, RPH, Geisinger, 6 National Association of Boards of Pharmacy (NABP) 7 Charles Hartwell, Esquire, Dethlefs Pykosh Law Group 8 Jennifer Welch, ACME Markets 9 Robert Grobinski, Cardinal Health 10 Betsy Taylor, Highmark Health 11 Jim Reed, Area Healthcare Supervisor, Walgreens 12

John Sisto, Express Scripts 13 Jeenu Phillip, Walgreens 14 Andrew C. Harvan, Esquire, Pennsylvania Medical 15 Society 16 John Kriak 17 Rachel Kriak 18 Joanne Megon 19 20 21 22 23 24 25 26

27 28 29 30 31 32 33 34 35 36 37 38 39 40

41 42 43 44 45 46 47 48 49 50


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*** 1

State Board of Pharmacy 2

December 10, 2019 3

*** 4

Thomas P. Carey, Ed.D., was sworn in as a new 5

Board Member prior to the commencement of the meeting. 6

The regularly scheduled meeting of the State 7

Board of Pharmacy was held on Tuesday, December 10, 8

2019. Terry M. Talbott, R.Ph., Chairperson, called 9

the meeting to order at 9:00 a.m. K. Kalonji Johnson, 10

Acting Commissioner, Bureau of Professional and 11

Occupational Affairs, was not present at the 12

commencement of the meeting. 13

The Pledge of Allegiance was recited. 14

*** 15

Evacuation Announcement 16

[Melanie Zimmerman, R.Ph., Executive Secretary, 17

reviewed the emergency evacuation procedures for One 18

Penn Center.] 19

*** 20

[Chairperson Talbott requested that all electronic 21

devices be turned off or silenced.] 22

*** 23

[Chairperson Talbott requested the introduction of 24

Board members, Board staff, and audience members. 25


5

Thomas P. Carey, Ed.D., provided a summary of his 1

professional background.] 2

*** 3

Approval of Agenda 4

CHAIRPERSON TALBOTT: 5

I will entertain a motion to accept the 6

agenda as written. Are there any 7

additions? 8

MS. HART: 9

So moved. 10


Second? 12

MR. FRANKIL: 13

Second. 14


All in favor? Any opposed? 16

[The motion carried unanimously.] 17

*** 18

Approval of minutes of the October 22, 2019 meeting 19


I will entertain a motion to approve the 21

October 22nd meeting minutes. 22

Are there any corrections, deletions, 23

additions? 24

MR. FRANKIL: 25


6

Motion to approve. 1


Thank you. Second? 3

MR. GREENE: 4

Second. 5


Any discussion? All in favor? Any 7

opposed? 8


*** 10

Report of Prosecutorial Division 11

[Glenn P. Masser, Esquire, Board Prosecutor, presented 12

the Consent Agreement for File No. 17-54-06187. 13

Patrick M. Greene, Esquire, recused from the 14

presentation and discussion on the matter.] 15

*** 16

Appointment – Annual Board Budget Presentation 17

[Kimberly Adams, Chief, Fiscal Manager, Bureau of 18

Finance and Operations, introduced herself and Shannon 19

Boop, Fiscal Management Specialist 1, to the Board. 20

Ms. Adams referred the Board to the FY 2019-20 21

Pharmacy Complete Budget in their agenda packet. Ms. 22

Adams reviewed information regarding the Board’s 23

licensee population. Ms. Adams noted 39,654 renewable 24

licensees for FY19-20. 25


7

Ms. Adams referred to sources of revenue, noting 1

the actual total for FY17-18 and FY18-19. She noted 2

the majority of revenue was from renewals and 3

applications. She stated the last fee increase was in 4

2005. The current biennial total was noted. 5

Ms. Adams discussed the cost categories for 6

expenses, which can be incurred from direct charges, 7

timesheet charges, and license-based charges. She 8

referred to administrative and legal expenses. She 9

noted the expenses for FY17-18, FY18-19, as well as 10

the budget for FY19-20 and the expenses as of 11

11/27/2019. 12

Ms. Adams reviewed the revenue and expenses 13

together. She reviewed the balances for FY17-18, 14

FY18-19, and FY19-20, and the anticipated balance at 15

the end of this fiscal year, noting a very healthy 16

projected balance through FY22-23. 17

Ms. Adams addressed the Board's budget and Board 18

member expense categories. She reviewed FY17-18 and 19

FY18-19 expenses with the FY19-20 budget. She noted 20

FY19-20 expenses as of 11/27/19, noting the Board was 21

within budget. She noted the budgeted amount for 22

FY20-21. She mentioned that any money left over at 23

the end of the fiscal year would go into a restricted 24

account. 25


8

Mr. Frankil suggested the Board discuss having 1

meetings on the road.] 2

*** 3

Report of Prosecutorial Division – (Continued) 4

[Ray Michalowski, Esquire, Prosecution Liaison, 5

presented the VRP Consent Agreements for File No. 19-6

54-011118, File No. 19-54-011513, File No. 19-54-7

014494, and File No. 19-54-014512. 8

Chairperson Talbott inquired as to any updates 9

regarding the inspectors. Mr. Michalowski discussed 10

the pharmacy inspectors adapting to the PALS system. 11

Mr. Michalowski discussed promulgating 12

regulations that would reference the Prescription Drug 13

Monitoring Program (PDMP) reporting requirements. 14

Mr. Michalowski noted the need to develop Act 48 15

citations related to the PDMP. 16

He reported on minimal consumer complaints 17

related to the establishment of electronic prescribing 18

requirements. 19

Mr. Michalowski discussed non-resident pharmacy 20

issues with reporting to the PDMP but indicated that 21

some of these pharmacies are found to be out of 22

business. 23

Mr. Frankil reported on pharmacy inspectors 24

discussing compounding issues and promoting compliance 25


9

with the regulations. 1

The Board discussed the enforcement of USP 800, 2

relating to hazardous drug handling in healthcare 3

settings. Mr. Michalowski discussed adding questions 4

to the inspection reports related to the Board’s new 5

compounding regulations. 6

Mr. Frankil referred to a statement in a memo 7

from the New Jersey Board of Pharmacy pertaining to 8

compounding and compliance with USP 800. Mr. Ruiz 9

advised as to proceeding with enforcement of the 10

compounding regulations, as well as adding language in 11

the regulations and on the Board’s website similar to 12

the statement in the New Jersey memo - USP 800 applies 13

only to pharmacies engaged in compounding.] 14

*** 15


Rob, make the motion to add language 17

similar to the New Jersey statement 18

regarding USP 800? 19

MR. FRANKIL: 20

I will make that motion. 21


Second? 23

MS. HART: 24

Second. 25


10


Any discussion? All in favor? Any 2

opposed? 3


*** 5

[Chairperson Talbott questioned Tejal J. Patel, MBA, 6

Pharm.D., R.Ph., Geisinger and National Association of 7

Boards of Pharmacy (NABP), as to the Board’s alignment 8

on USP from NABP’s perspective. Dr. Patel discussed 9

the enforcement of USP 800 by the Delaware Board and 10

using an educational focus with pharmacists. 11

Mr. Michalowski requested updated information on 12

the pharmacy technician bill. Angela Zaydon, 13

Pennsylvania Pharmacists Association, reported the 14

bill could move in the Senate. Chairperson Talbott 15

suggested the Board should consider promulgating 16

regulations so as to be prepared when the pharmacy 17

technician bill is signed into law.] 18

*** 19

Report of Board Counsel 20

[Juan A. Ruiz, Esquire, Board Counsel, noted a 21

reinstatement hearing scheduled for 10:00 a.m. He 22

also noted a proposed Adjudication and Order and a 23

citation appeal for discussion during Executive 24

Session. 25


11

Mr. Ruiz discussed receipt of newsletter articles 1

which he will review for acceptability. 2

Mr. Ruiz next referred to the two regulatory 3

packages being drafted by the Board. Comments were 4

received on the Pharmacy Intern package and he will be 5

editing the regulations. He had no update on the 6

status of the General Revisions package. 7

Mr. Ruiz stated the Board would discuss drafting 8

the Act 41 regulations after today’s Board Meeting. 9

Chairperson Talbott suggested including PDMP language 10

in the General Revisions package.] 11

*** 12

Report of Board Chairperson 13

[Terry M. Talbott, R.Ph., Chairperson, proceeded with 14

the election of officers.] 15


So we will entertain a motion for Board 17

Chair. 18

MR. FRANKIL: 19

I would like to make a motion to nominate 20

Terry Talbott as Chair. 21

MS. HART: 22

Second. 23


Are there any other nominations? 25


12

Motion to close the nominations? 1

MR. FRANKIL: 2

So moved. 3




*** 7


Motion for Vice Chair. 9

MS. HART: 10

I would like to make a motion for Rob 11

Frankil for Vice Chair. 12

MR. GREENE: 13

Second. 14




MS. HART: 18

Motion to close. 19


Can we vote on the nomination of Mr. 21

Frankil as Vice Chair? 22



*** 25


13


Finally, we need a nomination for the 2

position of secretary. 3

MR. FRANKIL: 4

I would like to make a motion to make 5

Janet Getzey Hart Board Secretary. 6

MR. GREENE: 7

Second. 8




MR. FRANKIL: 12

Move to close. 13




*** 17


Moving onto our Committee assignments. 19

ADA Committee was me as Board Chair and 20

Janet was alternate. Are we good with 21

that? So we’ll leave that as it is.22

Probable Cause was Pat as Chair and 23

Gayle as alternate. So Pat, do you want 24

to keep it? 25


14

MR. GREENE: 1

Sure. I’ll keep it. 2


Who wants to be alternate? Tom, do you 4

want to be alternate? 5

DR. CAREY: 6

Okay. 7


Application Review, I think we should 9

have the three of us. Rob, do you want 10

to take Chair? 11

MR. GREENE: 12

Sure. 13


Okay. Rob will be Chair. Janet. We 15

really need somebody else, because I 16

should be the alternate only; right? 17

MR. RUIZ: 18

Yes. Usually the Chair is the alternate. 19


We can do the two, and I’ll just be the 21

alternate. If Rob and Janet don’t agree, 22

I can be the tie-breaker. 23

MR. RUIZ: 24

That’s fine. And if you have to recuse, 25


15

that would be fine. 1


CPR. Rob, you were the Chairman of that 3

one. Gayle was on that one, too. So I 4

can be on that one. 5

And the Act 41, which we have yet to 6

have a meeting. Janet, you chair that. 7

Okay. We’re good. 8

Can we just have one motion to accept the 9

Committee assignments as we just read 10

them off? 11

MR. FRANKIL: 12

So moved. 13

MS. HART: 14

Second. 15



[The motion carried unanimously. It was noted that 18

the full Act 41 Committee will consist of Chairperson 19

Janet Hart along with Terry Talbott and Robert 20

Frankil.] 21

*** 22


Janet. Medical Marijuana. 24

I notice nobody else has a burning 25


16

desire to be on the Medical Marijuana 1

Board. Hearing none, Janet, you’re 2

hereby designated. 3

*** 4

Report of Probable Cause Screening Committee 5

[Patrick M. Greene, Esquire, Office of Attorney 6

General, signed an order on a Petition for Appropriate 7

Relief.] 8

*** 9

Report of Executive Secretary 10

[Melanie Zimmerman, R.Ph., Executive Secretary, had no 11

additional information regarding the Board’s 12

newsletter. She noted the applications would be 13

reviewed in Executive Session.] 14

*** 15

New Business 16

[Melanie Zimmerman, R.Ph., Executive Secretary, stated 17

the Board wanted to discuss holding its meetings twice 18

a year at pharmacy schools. Mr. Ruiz discussed the 19

traveling of other boards to cities like Pittsburgh 20

and Philadelphia. He did not anticipate a problem 21

with approval for this Board’s traveling. Chairperson 22

Talbott suggested contacting schools willing to host 23

the Board’s meetings. It was suggested to hold travel 24

meetings in March and October of 2020. 25


17

Ms. Zimmerman offered to reach out to schools 1

regarding interest in serving as a Board meeting site. 2

She also noted the Board would have to use paper 3

agendas at the meetings held outside of Harrisburg, 4

PA. Mr. Ruiz explained issues with utilizing Wi-Fi in 5

remote locations.] 6

*** 7


Let’s have a motion to take the show on 9

the road for two meetings, preferably 10

spring and fall. We will put the dates 11

in. And direct Melanie to ask Kalonji 12

for approval. 13

MS. HART: 14

I’ll make that motion. 15

MR. FRANKIL: 16

Second. 17




*** 21

[K. Kalonji Johnson, Acting Commissioner, entered the 22

meeting at 9:49 a.m.] 23

*** 24

[Chairperson Talbott informed Acting Commissioner 25


18

Johnson of the Board’s decision to take its meetings 1

on the road twice a year.] 2

*** 3

Report of Commissioner 4

[K. Kalonji Johnson, Acting Commissioner, welcomed Dr. 5

Carey to the Board. He wished everyone Happy 6

Holidays. 7

Acting Commissioner Johnson discussed the 8

expansion of the voicemail functionality to the phone 9

system in order to improve customer service. He 10

reviewed the website licensure navigator system which 11

was designed to improve awareness of the licensure 12

process and provide education on the three phases of 13

the application process. Acting Commissioner Johnson 14

encouraged the Board members to provide feedback on 15

the process. The Board of Pharmacy is scheduled to 16

have pharmacist application information added to the 17

navigator later in December or in January. 18

Chairperson Talbott and Ms. Hart commended the 19

staff on the prompt processing of applications as 20

reported from applicants. 21

Acting Commissioner Johnson applauded the Board’s 22

staff for their excellent work over the past year. 23

Chairperson Talbott questioned the reappointment 24

of Ms. Hart and the filling of the vacancies on the 25


19

Board. Acting Commissioner Johnson stated the 1

appointments are under review by the Senate and on 2

hold until the Senate is back in session.] 3

*** 4

[The Board recessed from 9:57 a.m. until 10:02 a.m. 5

Acting Commissioner Johnson exited the meeting during 6

this time.] 7

*** 8

[A Formal Hearing was held from 10:05 a.m. until 10:50 9

a.m. In The Matter of the Petition for Reinstatement 10

of the Pharmacist License of John Kriak, Case No. 19-11

54-013954.] 12

*** 13

[Pursuant to Section 708(a)(5) of the Sunshine Act, at 14

10:53 a.m., the Board entered into Executive Session 15

with Juan A. Ruiz, Esquire, Board Counsel, to receive 16

legal advice and engage in quasi-judicial 17

deliberations. The Board returned to open session at 18

11:50 a.m.] 19

*** 20

MOTIONS 21


The Board of Pharmacy met in Executive 23

Session to discuss and review consent 24

orders and other legal documents. 25


20

Are there any motions regarding these 1

discussions? 2

MR. FRANKIL: 3

Yes, Madam Chair. I move to adopt the 4

Consent Agreement for File No. 17-54-5

06187. 6


Do we have a second? 8

MS. HART: 9

Second. 10


Any discussion? Call the vote. 12

13

Frankil, aye; Greene, recuse; Talbott, 14

aye; Hart, aye; Carey, aye. 15

[The motion carried unanimously. Mr. Greene recused 16

from deliberations and voting on the motion. The 17

pharmacist’s name is Joel Anthony Gonzalo, R.Ph.] 18

*** 19

MR. GREENE: 20

I move that we approve the following VRP 21

Consent Agreements: File No. 19-54-22

011118, File No. 19-54-011513, File No. 23

19-54-014494, and File No. 19-54-014512. 24



21

Do we have a second? 1

MR. FRANKIL: 2

Second. 3



6

Frankil, aye; Greene, aye; Talbott, aye; 7

Hart, aye; Carey, aye. 8


*** 10

MR. GREENE: 11

In the matter of Commonwealth of 12

Pennsylvania, BPOA v. Trevor B. 13

Strenchock, R.Ph., File No. 17-54-07192, 14

I move that we direct Board Counsel to 15

draft an Adjudication and Order 16

consistent with the discussions in 17

Executive Session. 18

MR. FRANKIL: 19

Second. 20



23




22


*** 2

MR. GREENE: 3

In the matter of Petition for 4

Reinstatement of the Pharmacist License 5

of John Kriak, File No. 19-54-013954, I 6

move that we direct Board Counsel to 7

draft an Adjudication and Order 8

consistent with the terms discussed 9

during Executive Session. 10

MR. FRANKIL: 11

Second. 12



15


Hart, recuse; Carey, aye. 17

[The motion carried. Ms. Hart recused from 18

deliberations and voting on the motion based on 19

evidence presented during the hearing.] 20

*** 21

MR. GREENE: 22

In the matter of Just Here II Pharmacy, 23

File No. 19-54-006273, I move that we 24

direct Board Counsel to draft and issue 25


23

an order consistent with the discussions 1

in Executive Session. 2

MR. FRANKIL: 3

Second. 4



7




*** 11

MR. GREENE: 12

I move that we approve the Application of 13

AHN Hempfield Neighborhood Hospital. 14

MR. FRANKIL: 15

Second. 16



19




*** 23

MR. GREENE: 24

I move that we provisionally deny the 25


24

Non-Resident Application of Pharmcare USA 1

of Edison Dept. 2

MR. FRANKIL: 3

Second. 4



7




*** 11

MR. GREENE: 12

I move that we approve the Application of 13

Nancy Mekhail for a reduction of 250 14

hours of the intern hours required. 15

MR. FRANKIL: 16

Second. 17



20


Hart, recuse; Carey, aye. 22

[The motion carried. Ms. Hart recused from 23

deliberations and voting on the motion. Ms. Mekhail 24

must complete at least 1,250 acceptable intern hours 25


25

for licensure as a pharmacist.] 1

*** 2

Adjournment 3


Is there any other business to be brought 5

before the Board? 6

Hearing none, we are adjourned. 7

*** 8

[There being no further business, the State Board of 9

Pharmacy Meeting adjourned at 11:54 a.m.] 10

*** 11

[A regulation work session was held after the Board 12

Meeting.] 13

*** 14

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CERTIFICATE 3

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I hereby certify that the foregoing summary 5

minutes of the State Board of Pharmacy meeting, was 6

reduced to writing by me or under my supervision, and 7

that the minutes accurately summarize the substance of 8

the State Board of Pharmacy meeting. 9

10

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12

Alicia R. Gascoigne, 13

Minute Clerk 14

Sargent’s Court Reporting 15

Service, Inc. 16

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STATE BOARD OF PHARMACY 1 REFERENCE INDEX 2

December 10, 2019 3 4

5 TIME AGENDA 6 7 9:00 Official Call to Order 8 9 9:00 Pledge of Allegiance and Emergency 10 Announcement 11 12

9:01 Introduction of Board Members, Board 13 Staff, and Audience Members 14 15 9:04 Approval of Agenda and Minutes 16 17 9:05 Report of Prosecutorial Division 18 19 9:06 Appointment – Annual Board Budget 20 Presentation and Fee Changes 21 22 9:14 Report of Prosecutorial Division 23 24 9:37 Report of Board Counsel 25 26

9:40 Report of Board Chairperson 27 28 9:44 Report of Committees 29 30 9:45 Report of Executive Secretary 31 32 9:46 New Business 33 34 9:51 Report of Commissioner 35 36 9:57 Recess 37 38 10:02 Return to Open Session 39 40

10:05 Appointment - Hearing – John Kriak 41 42 10:53 Executive Session 43 44 11:50 Return to Open Session 45 46 11:50 Motions 47 48 11:54 Adjournment 49 50

COMMONWEALTH OF PENNSYLVANIA...Dec 10, 2019 · sargent's court reporting service, inc. (814)...

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Transcript of COMMONWEALTH OF PENNSYLVANIA...Dec 10, 2019 · sargent's court reporting service, inc. (814)...