NOTE:   The following Minutes are provided for informational purposes only.

If you would like to obtain an official copy of these Minutes, please contact

the State Board of Pharmacy at 614/466-4143 for instructions and fee.

 

 

 

STATE BOARD OF PHARMACY; 77 SOUTH HIGH STREET, ROOM 1702; COLUMBUS, OHIO 43215-6126

Tel:  614/466-4143                         Fax:  614/752-4836                        Eml:  exec@bop.state.oh.us

 

 

 

Minutes Of The Meeting

Ohio State Board of Pharmacy

March 3, 4, 5, 2003

 

MONDAY, MARCH 3, 2003

 

10:00 a.m.

ROLL CALL

 

 

The State Board of Pharmacy convened in Room East-B, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Diane C. Adelman, R.Ph. (President); Robert P. Giacalone, R.Ph. (Vice-President); Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, R.Ph.; Lawrence J. Kost, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Mem­ber; and James E. Turner, R.Ph.

 

 

Also present were William T. Winsley, Executive Director; Timothy Benedict, Assistant Executive Director; William McMillen, Licensing Administrator; Mark Keeley, Legislative Affairs Administrator; Robert Cole, Compliance Supervisor; David Rowland, Legal Affairs Administrator; and Sally Ann Steuk, Assistant Attorney General.

10:05 a.m.

 

Mrs. Gregg moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code.  The motion was seconded by Mr. Turner and a roll call vote was conducted by President Adelman as follows: Eastman-Yes, Giacalone-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

10:11 a.m.

 

Gregory Braylock, R.Ph., Board member, arrived and joined the Executive Session in progress.

11:24 a.m.

 

The Executive Session ended and the meeting was opened to the public.  The Board took a brief recess.

11:35 a.m.

R-2003-117

The meeting resumed.  Mr. Turner moved that the Board accept the settlement offer presented in the matter of Leo Igwebuike, R.Ph.  The motion was seconded by Mrs. Gregg and approved (Aye-7/Nay-0/Abstain-1[Braylock]).

 

R-2003-118

Mrs. Gregg moved that the Board accept the settlement offer presented in the matter of David White, R.Ph.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-6/Nay-2).

 

R-2003-119

Mr. Lipsyc then moved that the Board accept the settlement offers in the matters of Donald Bennett, R.Ph. and Mary Ann (Tallarico) Janning as amended by the Board if both respondents agreed to the Board’s changes.  The motion was seconded by Mrs. Teater.  Mr. Braylock then moved to amend Mr. Lipsyc’s motion by revising the sug­gested changes to the original proposal.  Mr. Braylock’s motion to amend was seconded by Mrs. Gregg and approved by the Board (Aye-5/Nay-4).  The Board then voted on the motion to accept the settlement proposal with the revised Board changes.  The motion passed (Aye-5/Nay-3).

 

 

Mr. Rowland announced that the following settlement agreements previously approved by the Board had been signed by all parties and were now effective as of the date of the Board President’s signature:

 

R-2003-120

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-021119-035)

 

In the Matter of:

 

BIG BEAR PHARMACY #208

c/o William Joseph Gongola, R.Ph.)

1171 Hill Road North

Pickerington, Ohio 43147

(Terminal Distributor No. 02-0599100)

 

 

This Settlement Agreement is entered into by and between Big Bear Pharmacy #208 and the Ohio State Board of Pharmacy, a state agency charged with enforcing the Pharmacy Practice Act and Dangerous Drug Distribution Act, Chapter 4729. of the Ohio Revised Code.

 

 

Big Bear Pharmacy #208 enters into this Agreement being fully informed of its rights afforded under Chapter 119. of the Ohio Revised Code, including the right to representation by counsel, the right to a formal adjudication hearing on the issues contained herein.

 

Whereas, the State Board of Pharmacy is empowered by Section 4729.57 of the Ohio Re­vised Code to suspend, revoke, refuse to renew any license issued to a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code, or may impose a monetary penalty on the license holder, for violation of any of the enumerated grounds of Section 4729.57 of the Ohio Revised Code.

 

WHEREAS, Big Bear Pharmacy #208 is a licensed terminal distributor of dangerous drugs in the State of Ohio.

 

WHEREAS, on or about November 19, 2002, pursuant to Chapter 119. of the Ohio Revised Code, Big Bear Pharmacy #208 was notified of the allegations or charges against it, its right to a hearing, its rights in such hearing, and its right to submit contentions in writing.  Big Bear Pharmacy #208 requested a hearing; it was scheduled and continued.  The November 19, 2002, Notice of Opportunity for Hearing contains the following allegations or charges:

 

 

(1)

Records of the Board of Pharmacy indicate that Big Bear Pharmacy #208 is licensed with the State Board of Pharmacy as a Terminal Distributor of Dangerous Drugs and William J. Gongola is the Responsible Pharmacist pursuant to Rule 4729-5-11 of the Ohio Administrative Code and Sections 4729.27 and 4729.55 of the Ohio Revised Code.

 

 

(2)

Big Bear Pharmacy #208 did, on or about July 18, 2000 to March 5, 2002, fail to provide “supervision and control” of dangerous drugs as required in Section 4729.55(B) of the Revised Code, and “adequate safeguards” to assure that danger­ous drug are being distributed in accordance with all state and federal laws as required in Section 4729.55(C) of the Revised Code, to wit: a technician was given authority to order all medications from wholesalers, checked the orders when received, and stocked the shelves with the medications, without any supervision.  Such conduct is in violation of Rule 4729-9-11 of the Ohio Administrative Code and is not in accordance with Section 4729.55 of the Ohio Revised Code.

 

 

(3)

Big Bear Pharmacy #208 did, on or about July 18, 2000 to March 5, 2002, fail to provide effective and approved controls and procedures to deter and detect theft and diversion of dangerous drugs, to wit: the following drugs were diverted from the pharmacy without adequate detection and/or prevention:

 

Drug Type

Strength

Shortage

% Short

diazepam

10 mg

3,613

60%

diazepam

2 mg

177

15%

diazepam

5 mg

3,681

34%

hydrocodone/APAP

5/500

6,253

16%

hydrocodone/APAP

10/325

5,199

40%

hydrocodone/APAP

10/500

2,894

36%

hydrocodone/APAP

10/660

1,589

40%

hydrocodone/APAP

5/325

18

2%

hydrocodone/APAP

7.5/325

100

50%

OxyContin

10 mg

41

41%

OxyContin

20 mg

236

3%

OxyContin

40 mg

120

0.4%

OxyContin

80 mg

201

0.6%

OxyContin

160 mg

100

50%

carisoprodol / soma

350 mg

11,143

49%

Vicoprofin  (sic)

200/7.5

470

27%

phentermine

37.5 mg

5,548

76%

 

 

 

Such conduct is in violation of Rule 4729-9-05 of the Ohio Administrative Code.

 

 

Wherefore, in consideration of the foregoing and mutual promises hereinafter set forth, and in lieu of a formal hearing at this time, Big Bear Pharmacy #208 knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

 

 

(1)

Big Bear Pharmacy #208 agrees to the imposition of a monetary penalty of Two Thousand Dollars ($2000.00) due and owing within 30 days of the effective date of this Agreement.  The monetary penalty should be made payable to the “Treasurer, State of Ohio” and mailed with the enclosed form to the State Board of Pharmacy, 77 S. High Street, 17th Floor, Columbus, Ohio 43215-6126.

 

 

(2)

Big Bear Pharmacy #208 agrees to adopt and implement the policies as submitted to the Ohio State Board of Pharmacy in its letter dated January 2, 2003, and amended by the Board’s letter dated January 8, 2003, so as to include “drugs of abuse” as well as controlled substances in said policies.  These policies are incor­porated into this agreement as if fully rewritten herein.

 

 

Big Bear Pharmacy #208 acknowledges that it has had an opportunity to ask questions concerning the terms of this agreement and that all questions asked have been answered in a satisfactory manner.  Any action initiated by the Board based on alleged violation of this Agreement shall comply with the Administrative Procedure Act, Chapter 119. of the Ohio Revised Code.

 

Big Bear Pharmacy #208 waives any and all claims or causes of action it may have against the State of Ohio or the Board, and members, officers, employees, and/or agents of either, arising out of matters which are the subject of this Agreement. Big Bear Pharmacy #208 waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code.

 

This agreement embodies the entire agreement between and of the parties.  There are no express or implied promises, guarantees, terms, covenants, conditions, or obligations other than those contained herein; and this agreement supersedes all previous com­munications, representations or agreements, either verbal or written, between the parties.

 

In the event the Board, in its discretion, does not adopt this Agreement as its Adjudication, this settlement offer is withdrawn and shall be of no evidentiary value and shall not be relied upon or introduced in any disciplinary action or appeal by either party. Big Bear Phar­macy #208 agrees that should the Board reject this Agreement and if this case proceeds to hearing, Big Bear Pharmacy #208 will assert no claim that the Board was prejudiced by its review and discussion of this Agreement or of any information relating thereto.

 

This Settlement Agreement shall be considered a public record, as that term is used in Section 149.43 of the Ohio Revised Code, and shall become effective upon the date of the Board President’s signature below.

 

/s/          William J. Gongola

 

/d/     2–24–03

Big Bear Pharmacy #208, Respondent

 

Date of Signature

 

 

 

/s/          Mary Barley-McBride

 

/d/      2/20/03

Mary Barley-McBride, Attorney for Respondent

 

Date of Signature

 

 

 

/s/          Diane C. Adelman

 

/d/      3/3/03

Diane C. Adelman, President, Ohio State Board of Pharmacy

 

Date of Signature

 

 

 

/s/          Sally Ann Steuk

 

/d/      3–3–03

Sally Ann Steuk, Ohio Assistant Attorney General

 

Date of Signature

 

R-2003-121

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-021119-036)

 

In The Matter Of:

 

WILLIAM JOSEPH GONGOLA, R.Ph.

535 Cherry Hill Drive

Pickerington, Ohio 43147

(R.Ph. No. 03-1-18875)

 

 

This Settlement Agreement is entered into by and between William Joseph Gongola and the Ohio State Board of Pharmacy, a state agency charged with enforcing the Pharmacy Practice Act and Dangerous Drug Distribution Act, Chapter 4729. of the Ohio Revised Code.

 

William Joseph Gongola voluntarily enters into this Agreement being fully informed of his rights afforded under Chapter 119. of the Ohio Revised Code, including the right to repre­sentation by counsel, the right to a formal adjudication hearing on the issues contained herein, and the right to appeal. William Joseph Gongola acknowledges that by entering into this agreement he has waived his rights under Chapter 119. of the Revised Code.

 

Whereas, the Board is empowered by Section 4729.16 of the Ohio Revised Code to suspend, revoke, place on probation, refuse to grant or renew an identification card or enforce a monetary penalty on the license holder for violation of any of the enumerated grounds therein.

 

Whereas, William Joseph Gongola is licensed to practice pharmacy in the State of Ohio.

 

Whereas, on or about November 19, 2002, pursuant to Chapter 119. of the Ohio Revised Code, William Joseph Gongola was notified of the allegations or charges against him, his right to a hearing, his rights in such hearing, and his right to submit contentions in writing. William Joseph Gongola requested a hearing; it was scheduled and continued.  The Novem­ber 19, 2002, Notice of Opportunity for Hearing contains the following allegations or charges:

 

 

(1)

Records of the Board of Pharmacy indicate that William Joseph Gongola was origi­nally licensed in the State of Ohio on July 29, 1991, pursuant to examination, and is cur­rently licensed to practice pharmacy in the State of Ohio.  Records further reflect that as of July 11, 2000, William Joseph Gongola was the Responsible Phar­macist at Big Bear Pharmacy #208 pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule 4729-5-11 of the Ohio Admini­strative Code.

 

 

(2)

William Joseph Gongola as Responsible Pharmacist did, on or about July 18, 2000, to March 5, 2002, fail to provide “supervision and control” of dangerous drugs as required in Section 4729.55(B) of the Revised Code, and “adequate safeguards” to assure that dangerous drug are being distributed in accordance with all state and federal laws as required in Section 4729.55(C) of the Revised Code, to wit: a tech­nician was given authority to order all medications from wholesalers, checked the orders when received, and stocked the shelves with the medications without any supervision.  Such conduct is in violation of Rule 4729-9-11 of the Ohio Admini­strative Code and is not in accordance with Section 4729.55 of the Ohio Revised Code.

 

 

(3)

William Joseph Gongola as Responsible Pharmacist did, on or about July 18, 2000 to March 5, 2002, fail to provide effective and approved controls and procedures to deter and detect theft and diversion of dangerous drugs, to wit: the following drugs were diverted from the pharmacy without adequate detection and/or pre­vention:

 

Drug Type

Strength

Shortage

% Short

diazepam

10 mg

3,613

60 %

diazepam

2 mg

177

15%

diazepam

5 mg

3,681

34%

hydrocodone/APAP

5/500

6,253

16%

hydrocodone/APAP

10/325

5,199

40%

hydrocodone/APAP

10/500

2,894

36%

hydrocodone/APAP

10/660

1,589

40%

hydrocodone/APAP

5/325

18

2%

hydrocodone/APAP

7.5/325

100

50%

OxyContin

10 mg

41

41%

OxyContin

20 mg

236

3%

OxyContin

40 mg

120

0.4%

OxyContin

80 mg

201

0.6%

OxyContin

160 mg

100

50%

carisoprodol / soma

350 mg

11,143

49%

Vicoprofin  (sic)

200/7.5

470

27%

phentermine

37.5 mg

5,548

76%

 

 

 

Such conduct is in violation of Rule 4729-9-05 of the Ohio Administrative Code and is not in accordance with Section 4729.55 of the Ohio Revised Code.

 

 

Wherefore, the parties, in consideration of the mutual covenants and promises contained herein, and in lieu of any further formal proceedings at this time, and intending to be bound by said covenants, agree as follows:

 

 

(A)

William Joseph Gongola’s pharmacist identification card, No. 03-1-18875, will be placed on probation for one year from the effective date of this Agreement, with the following conditions:

 

 

 

(1)  William Joseph Gongola must obtain within one year from the effective date of this agreement, completion of 0.3 CEUs (three hours) of continuing pharmacy education focused on pharmacy management and/or diversion issues.  These hours are in addition to those required for renewal.  If proof of completion is not submitted to the Board office before the end of his probation period, William Joseph Gongola’s pharmacist identification card  will be suspended until this con­dition is achieved.

 

(2)  The State Board of Pharmacy hereby declares that William Joseph Gongola’s phar­ma­cist identification card is not in good standing.