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                      Email:  exec@bop.state.oh.us

 

 

Minutes Of The Meeting

Ohio State Board of Pharmacy

April 5, 6, 7, 2004

 

MONDAY, APRIL 5, 2004

 

10:00 a.m.     ROLL CALL

 

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

 

Robert P. Giacalone, R.Ph. (President); Lawrence J. Kost, R.Ph. (Vice-President); Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, R.Ph.; and James E. Turner, R.Ph.

 

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

10:11 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 and for the purpose of conferring with an attorney for the Board regarding pending or imminent court action pursuant to Section 121.22(G)(3) of the Re­vised Code.  The motion was seconded by Mr. Kost and a roll call vote was conducted by President Giacalone as follows: Braylock-Yes, Eastman-Yes, Gregg-Yes,  Kost-Yes, and Turner-Yes.

10:49 a.m.

Mrs. Teater arrived and joined the Executive Session in progress.

11:15 a.m.

R-2004-166    The Executive Session ended and the meeting was opened to the public.  Mrs. Gregg moved that the Board deny the request for a continuance in the matter of SAKS Distri­buting.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-5/­Nay-0/Abstain-1[Teater]).

 

R-2004-167    Mr. Turner then moved that SAKS Distributing be allowed to withdraw their Application for Registration as a Wholesale Distributor of Dangerous Drugs.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-5/Nay-0/Abstain-1[Teater]).

 

R-2004-168    Mrs. Gregg moved that the hearing in the joint matters of Teregen Labs and Christopher Kiel, R.Ph. be continued.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-5/Nay-0/Abstain-1[Teater]).

 

R-2004-169    Ms. Eastman moved that the Board approve the request by DeLinda McDaniel, R.Ph. for an extension of time to pay the fine levied by the Board in her Board Order with the modification that the fine is to be paid in full by the end of the probation period.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-5/Nay-0/Abstain-1[Teater]).

 

R-2004-170    Mr. Turner moved that the Board deny the requested adjustment to the settlement offer under discussion in the matter of Stephen Summers R.Ph. and that the only settlement acceptable to the Board would be the terms previously discussed.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-5/Nay-0/Abstain-1[Teater]).

 

R-2004-171    Mr. Braylock moved that the Board deny the requested adjustment to the settlement offer under discussion in the matter of Elaine Woll R.Ph. and that the only settlement acceptable to the Board would be the terms previously discussed.  The motion was seconded by Mr. Turner and approved by the Board (Aye-5/Nay-0/Abstain-1[Teater]).

 

R-2004-172    Mr. Kost moved that the Board deny the settlement offer received in the matter of Jeffrey Allen Iserman, R.Ph. and that the hearing be held as scheduled.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-6/Nay-0).

 

R-2004-173    Mr. Turner moved that the Board deny the settlement offer received in the matter of Richard Berning and that the hearing be held as scheduled.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-6/Nay-0).

 

R-2004-174    Mrs. Gregg moved that the Board deny the request for reconsideration of the Board’s Order in the matter of PSS World Medical, but that the Board, making note of the fact that PSS World Medical had filed a new application, would allow that new application to proceed through the normal licensing process.  The motion was seconded by Mrs. Teater and approved by the Board (Aye-6/Nay-0).

 

Mr. Winsley announced that the settlement agreement in the matters of B. Elise Miller, R.Ph., Miller Pharmacy, and Three Rivers O.P.T.I.O.N. Care, Inc. had been signed by all parties and became effective as of the date of the signature of the Board President:

 

R-2004-175                                   SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-030917-013, D-030917-014 and D-030917-015)

 

In The Matter Of:

 

B. ELISE MILLER, R.Ph.

MILLER PHARMACY

and

THREE RIVERS O.P.T.I.O.N. CARE, INC.

2171 Forest Hill

Coshocton, Ohio 43812

(R.Ph. No. 03-1-12257)

(TDDD No. 02-0084550 and 02-0517450)

 

This Settlement Agreement is entered into by and between B. Elise Miller, Miller Pharmacy and Three Rivers O.P.T.I.O.N. Care, Inc. (hereinafter referred to as “Respondents”) 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.

 

Respondents voluntarily enter into this Agreement being fully informed of all their 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.  Respondents each acknowledge that by entering into this agreement each has waived all rights under Chapter 119. of the Revised Code.

 

Whereas, the Board is empowered by Sections 4729.16 and 4729.57 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, B. Elise Miller is licensed to practice pharmacy in the State of Ohio.

 

Whereas, Miller Pharmacy and Three Rivers O.P.T.I.O.N. Care, Inc. are licensed as Terminal Distributors of Dangerous Drugs in the State of Ohio.

 

Whereas, on or about September 17, 2003, pursuant to Chapter 119. of the Ohio Revised Code, Respondents were notified of the allegations or charges against them, their rights to hearings, their rights in such hearings, and their rights to submit contentions in writing. Respondents requested hearings; they were scheduled, consolidated and continued.  The September 17, 2003, Notice of Opportunity for Hearing letters contain the following allega­tions or charges:

 

B. Elise Miller:

 

(1)    Records of the Board of Pharmacy indicate that B. Elise Miller was originally licensed in the State of Ohio as a pharmacist on March 6, 1978, pursuant to ex­amination and that her license expired on September 15, 2001.  Records further reflect during the relevant time periods stated herein, B. Elise Miller was indicated as the Responsible Pharmacist at Miller Pharmacy.

 

(2)    B. Elise Miller did, from September 15, 2001, through March 24, 2003, while not a reg­is­tered pharmacist or pharmacy intern under the supervision of a registered phar­ma­cist, practice pharmacy, to wit: after B. Elise Miller’s license to practice pharmacy lapsed, she admittedly continued to practice pharmacy and dispense dangerous drugs.  Such con­duct is in violation of Section 4729.28 of the Ohio Re­vised Code.

 

(3)    B. Elise Miller did, on or about March 24, 2003, and on occasions previous there­to, knowingly make false statements when the statements were made with pur­pose to mislead a public official in performing the public official's official func­tion, to wit: B. Elise Miller repeatedly lied to Board of Pharmacy specialists and agents as follows:

 

(a)    B. Elise Miller twice stated that she was not practicing pharmacy during the period of her pharmacist's license lapse;

 

(b)    B. Elise Miller lied to agents of the Board about the status of the Re­sponsible Pharmacist at facilities that she owns and that are licensed with the Board as terminal distributors;

 

(c)    B. Elise Miller lied to an agent of the Board when she indicated that she sub­mit­ted her renewal application during the week of March 17, 2003;

 

(d)    B. Elise Miller lied to an agent of the Board when she indicated that a Board specialist had approved her system of managing Synagis dispens­ings.

 

Such conduct is in violation of Section 2921.13 of the Ohio Revised Code.

 

(4)    B. Elise Miller did, on or about dates immediately preceding March 24, 2003, allow access to the physical confines of the pharmacy when not under the per­sonal supervision of a pharmacist, to wit: in Three Rivers O.P.T.I.O.N. Care, Inc. she allowed the lone pharmacist to leave for lunch breaks or to work elsewhere without coverage by another pharmacist and without physically securing the pharmacy and its dangerous drug stocks.  Such conduct is in violation of Rule 4729-9-11 of the Ohio Administrative Code.

 

(5)    B. Elise Miller did, on or about the following dates, knowingly make false state­ments when the statements were made with purpose to secure the issuance by a governmental agency of a license, to wit: B. Elise Miller submitted applications to the Board for renewal of the following terminal distributor of dangerous drugs licenses, where B. Elise Miller listed herself as a registered pharmacist in the posi­tion of Responsible Pharmacist:

02-0084550

date signed: 10-01-01

02-0517450

date signed: 10-04-01

02-0084550

date signed: 09-20-02

02-0517450

date signed: 01-02-03

 

Such conduct is in violation of Section 2921.13 of the Ohio Revised Code.

 

Miller Pharmacy:

 

(1)    Records of the Board of Pharmacy indicate that Miller Pharmacy is licensed with the State Board of Pharmacy as a Terminal Distributor of Dangerous Drugs and James H. Sycks, R.Ph. 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)    Miller Pharmacy did, from September 15, 2001, through March 24, 2003, cease to satisfy the qualifications of a terminal distributor of dangerous drugs as set forth in Section 4729.55 of the Ohio Revised Code, to wit: the pharmacy did not have a registered pharmacist in full and actual charge of the pharmacy during this time period, and adequate safeguards were not assured to prevent the sale or distri­bution of dangerous drugs by persons other than a pharmacist or licensed pre­scriber.  Such conduct is in violation of Section 4729.27 of the Ohio Revised Code.

 

Three Rivers O.P.T.I.O.N. Care, Inc.:

 

(1)    Records of the Board of Pharmacy indicate that Three Rivers O.P.T.I.O.N. Care, Inc. is licensed with the State Board of Pharmacy as a Terminal Distributor of Danger­ous Drugs and B. Elise Miller is  the owner of Three Rivers O.P.T.I.O.N. Care, Inc.

 

(2)    Three Rivers O.P.T.I.O.N. Care, Inc. did, from September 15, 2001, through March 24, 2003, while not a pharmacist or pharmacy intern under the personal supervi­sion of a pharmacist, compound, dispense, or sell dangerous drugs or otherwise engage in the practice of pharmacy, to wit: the pharmacy, through its owner, B. Elise Miller, whose pharmacist license had lapsed, dispensed dangerous drugs and/or practiced pharmacy.  Such conduct is in violation of Section 4729.28 of the Ohio Revised Code.

 

(3)    Three Rivers O.P.T.I.O.N. Care, Inc. did, from September 15, 2001, through March 24, 2003, allow access to the physical confines of the pharmacy when not under the personal supervision of a pharmacist, to wit: when the lone pharmacist on duty was permitted to leave to cover for lunch breaks of the pharmacist at Miller Pharmacy, the pharmacy was left without coverage by another pharmacist and the pharmacy and its dangerous drug stocks were not physically secured.  Such con­duct is in violation of Rule 4729-9-11 of the Ohio Administrative Code.

 

(4)    Three Rivers O.P.T.I.O.N. Care, Inc. did, from September 15, 2001, through March 24, 2003, cease to satisfy the qualifications of a terminal distributor of dangerous drugs as set forth in Section 4729.55 of the Ohio Revised Code, to wit: the phar­macy did not have a registered pharmacist in full and actual charge of the phar­macy during this time period, and adequate safeguards were not assured to pre­vent the sale or distribution of dangerous drugs by persons other than a pharma­cist or licensed prescriber.  Such conduct is in violation of Section 4729.27 of the Ohio Revised Code.

 

(5)    Three Rivers O.P.T.I.O.N. Care, Inc. did, on or about May 3, 2003, and dates sub­sequent, cease to satisfy the qualifications of a terminal distributor of dangerous drugs as set forth in Section 4729.55 of the Ohio Revised Code, to wit: the phar­macy's Responsible Pharmacist resigned, and was not replaced with another Responsible Pharmacist.  As such, the pharmacy did not have a registered phar­macist in full and actual charge of the pharmacy during this time period, and adequate safeguards were not assured to prevent the sale or distribution of dan­gerous drugs by persons other than a pharmacist or licensed prescriber.  Such conduct is in violation of Section 4729.27 of the Ohio Revised Code.

 

(6)    Three Rivers O.P.T.I.O.N. Care, Inc. did, on or about April 23, 2003, and on dates subsequent, fail to keep records of the practice of pharmacy subject to inspection by the Board, and it did fail to make records readily available and/or promptly produce such records upon the request of a Board of Pharmacy agent, to wit: though an agent of the Board requested records of drugs dispensed, the phar­macy has failed to produce the records as requested.  Such conduct is in violation of Section 4729.37 of the Ohio Revised Code and/or Rules 4729-5-27 and 4729-5-28 of the Ohio Revised Code.

 

Respondents neither admit nor deny the allegations stated in the Notice of Opportunity for Hearing letters dated September 17, 2003; however, the Board has evidence sufficient to sustain the allegations and hereby adjudicates the same.

 

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

 

(A)    B. Elise Millers’ pharmacist identification card, No. 03-1-12257, will be suspended for six months from the effective date of this Agreement.

 

(B)    B. Elise Miller agrees to the imposition of a monetary penalty of three thousand dollars ($3,000.00), due and owing within thirty (30) days from the effective date of this Agreement.

 

(C)    Miller Pharmacy agrees to the imposition of a monetary penalty of three thousand dollars ($3,000.00), due and owing within thirty (30) days from the effective date of this Agreement.

 

(D)    Three Rivers O.P.T.I.O.N. Care, Inc. agrees to the imposition of a monetary penalty of seventeen thousand five hundred dollars ($17,500), due and owing within thirty (30) days from the effective date of this agreement. 

 

Checks should be made payable to the “Treasurer, State of Ohio” and mailed with the enclosed forms to the State Board of Pharmacy, 77 South High Street, 17th Floor, Columbus, Ohio 43215-6126.

 

Respondents acknowledge that they have 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.

 

Respondents waive any and all claims or causes of action they 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.  Respondents waive any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code.

 

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.

 

11:35 a.m.

The Board recessed for lunch.

  1:10 p.m.

The Board reconvened in Room West-B&C, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

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

  1:12 p.m.

The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Johari Jamille Bradshaw, Pharmacy Intern, Cincinnati.  Mr. Braylock recused himself from the hearing and the resulting deliberations.

  3:10 p.m.

The hearing ended and the record was closed.  The Board took a brief recess.

  3:16 p.m.

The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of creating a record in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of James Joseph Parsley, R.Ph., Wheelersburg.

  3:52 p.m.

The record was closed.

  3:55 p.m.

The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of creating a record in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Tim Ivan Miller, R.Ph., West Lafayette.

  4:14 p.m.

The record was closed.  The Board took a brief recess.

  4:19 p.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. Braylock and a roll call vote was conducted by President Giacalone as follows: Braylock-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.

 4:43 p.m.

R-2004-176    The Executive Session ended and the meeting was opened to the public.  Mrs. Gregg moved that the Board deny the request for a continuance in the matter of Elsebeth Csizmadia-Baumgartner, R.Ph. and that the hearing be held as scheduled.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-6/Nay-0).

 

R-2004-177    Mr. Kost moved that the Board adopt the following Order in the matter of Tim Ivan Miller, R.Ph.:

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-031224-049)

 

In The Matter Of:

 

TIM IVAN MILLER, R.Ph.

660 East Russell Avenue

West Lafayette, Ohio 43845

(R.Ph. No. 03-3-11708)

 

INTRODUCTION

 

THE MATTER OF TIM IVAN MILLER CAME FOR CONSIDERATION ON APRIL 5, 2004, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.

 

TIM IVAN MILLER WAS NOT PRESENT NOR WAS HE REPRESENTED BY COUNSEL AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

SUMMARY OF EVIDENCE

State’s Witnesses

 

1.  David Gallagher, Ohio State Board of Pharmacy

 

Respondent's Witnesses

 

None

 

State's Exhibits

 

1.  Copy of Summary Suspension Order/Notice of Opportunity For Hearing letter  [12-24-03]

1A.  Procedural

2.  Notarized Statement of Tim I. Miller  [12-05-03]

3.  Five Drug Audit Accountability Sheets for Xanax .5 mg, alprazolam .5 mg, Norco 10/325 mg, hydrocodone/APAP 10/325, and hydrocodone/APAP 5/500 mg at Buehler’s Phar­macy  [03-02-04]

 

Respondent's Exhibits

 

None

 

FINDINGS OF FACT

 

After having heard the testimony, observed the demeanor of the witness, considered the evidence, and weighed the credibility of each, the State Board of Pharmacy finds the fol­low­ing to be fact:

 

(1)  On December 24, 2003, Tim Ivan Miller was notified by letter of his right to a hearing, his rights in such hearing, and his right to submit any contentions in writing.

 

(2)  As demonstrated by return receipt dated December 26, 2003, signed by Debbi Miller, Tim Ivan Miller received the letter of December 24, 2003, informing him of the allegations against him and his rights.

 

(3)  Tim Ivan Miller has not responded in any manner to the letter of December 24, 2003, and has not requested a hearing in this matter, therefore the matter was referred to the Board for consideration.

 

(4)  Records of the State Board of Pharmacy indicate that Tim Ivan Miller was origi­nally licensed by the State of Ohio as a pharmacist on August 4, 1976, pursuant to examination, and that his license to practice pharmacy in Ohio was summarily sus­pended effective December 24, 2003.

 

(5)  Tim Ivan Miller is abusing controlled substances and/or physically or mentally impaired to such a degree as to render him unfit to practice pharmacy, to wit: Tim Ivan Miller has admitted to stealing and abusing hydrocodone; and, Tim Ivan Miller has admitted to abusing drugs to help him deal with stress and depression.  Such conduct indicates that Tim Ivan Miller falls within the ambit of Section 4729.16(A)(3) of the Ohio Revised Code.

 

(6)  Tim Ivan Miller did, from November 26, 2003, through November 28, 2003, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Buehler's Pharmacy, beyond the express or implied consent of the owner, to wit: Tim Ivan Miller was caught leaving the store after having stolen the following drugs:

 

Drug

Qty

hydrocodone/APAP 10/325 mg

24

Anaprox DS 550 mg

10

Celebrex 200 mg

2

indomethacin ER 75 mg

1

Promethazine 25 mg

1

atenolol 50 mg

11

chlorthalidone 50 mg

3

Flexeril 10 mg

1

Xanax .5 mg

4

fenoprofen calcium 600 mg

31

Unknown

2

 

Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(7)  Tim Ivan Miller did, from June, 2003, through early August, 2003, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Buehler's Pharmacy, beyond the express or implied consent of the owner, to wit: Tim Ivan Miller admittedly stole between 3 and 8 dosage units of hydrocodone/­APAP 5/500 mg per day while working in the pharmacy.  Such conduct is in viola­tion of Section 2913.02 of the Ohio Revised Code.

 

(8)  Tim Ivan Miller did, from early August, 2003, through November, 2003, with pur­pose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Buehler's Pharmacy, beyond the express or implied consent of the owner, to wit: Tim Ivan Miller admittedly stole between 4 and 10 dosage units of hydrocodone/APAP 10/325 mg per day while working in the pharmacy.  Such con­duct is in violation of Sec­tion 2913.02 of the Ohio Revised Code.

 

CONCLUSIONS OF LAW

 

(1)  The State Board of Pharmacy concludes that paragraphs (5) through (8) of the Find­ings of Fact constitute being guilty of gross immorality as provided in Division (A)(1) of Section 4729.16 of the Ohio Revised Code.