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

February 2, 3, 4, 2004

 

MONDAY, FEBRUARY 2, 2004

 

10:30 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); Diane C. Adelman, 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; William McMillen, Licensing Administrator; David Rowland, Legal Affairs Administrator; Robert Cole, Compli­ance Supervisor; and Sally Ann Steuk, Assistant Attorney General.

 

Mr. Rowland announced that the following settlement agreements had been signed by all parties and were effective upon the signature of the Board President:

 

R-2004-127                                  SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-030417-067)

 

In The Matter Of:

 

KELLY NICOLE LUTZ, R.Ph.

7906 Cheriton Circle

Reynoldsburg, Ohio 43068

(R.Ph. No. 03-2-23148)

 

This Settlement Agreement is entered into by and between Kelly Nicole Lutz 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.

 

Kelly Nicole Lutz voluntarily enters into this Agreement being fully informed of her 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.  Kelly Nicole Lutz acknowledges that by entering into this agreement she has waived her 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, Kelly Nicole Lutz is licensed to practice pharmacy in the State of Ohio.

 

Whereas, on or about October 17, 2003, pursuant to Chapter 119. of the Ohio Revised Code, Kelly Nicole Lutz was notified of the allegations or charges against her, her right to a hearing, her rights in such hearing, and her right to submit contentions in writing.  Kelly Nicole Lutz requested a hear­ing; it was scheduled and continued.  The October 17, 2003, Notice of Opportunity for Hearing con­tains the following allegations or charges:

 

(1)  Records of the Board of Pharmacy indicate that Kelly Nicole Lutz was originally licensed in the State of Ohio on August 11, 1998, pursuant to examination, and is currently licensed to practice pharmacy in the State of Ohio.  Records further reflect during the relevant time periods stated herein, Kelly Nicole Lutz was the Respon­sible Pharmacist at Kroger Phar­macy #290 pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule 4729-5-11 of the Ohio Administrative Code.

 

(2)  Kelly Nicole Lutz did, on or about August 15, 2001, misbrand a drug, to wit: when Kelly Nicole Lutz received a prescription for 90 dosage units of propylthiouracil 50 mg, to be taken one tablet three times per day, with two refills, she dispensed Rx# 6956310 Purinethol 50 mg, which had not been prescribed by the physician.  The patient was subsequently harmed.  Such conduct is in violation of Section 3715.52(A)(2) of the Ohio Revised Code.

 

(3)  Kelly Nicole Lutz did, on or about August 15, 2001, when dispensing Rx# 6956310, fail to offer to counsel the patient or caregiver, to wit: neither Kelly Nicole Lutz nor her designee personally offered to counsel the patient.   Such conduct is in violation of Rule 4729-5-22 of the Ohio Administrative Code.

 

Kelly Nicole Lutz neither admits nor denies the allegations stated in the Notice of Oppor­tunity for Hearing letter dated October 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, Kelly Nicole Lutz knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

 

(A)  Kelly Nicole Lutz agrees to the imposition of a monetary penalty of two hundred fifty dollars ($250.00) due and owing within thirty 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 43266-0320.

 

(B)  In addition to any and all other continuing pharmacy education requirements, Kelly Nicole Lutz agrees to attend, within one year of the effective date of this agreement, 2.0 CEU hours of continuing education, for preventing prescription errors in a retail pharmacy.

 

If, in the judgment of the Board, Kelly Nicole Lutz appears to have violated or breached any terms or conditions of this Agreement, the Ohio State Board of Pharmacy reserves the right to, at any time, revoke probation, modify the conditions of probation, and reduce or extend the period of probation, and/or the Board may institute formal disciplinary proceedings for any and all possible violations or breaches, including but not limited to, alleged violation of the laws of Ohio occurring before the effective date of this Agreement.

 

Kelly Nicole Lutz acknowledges that she 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.

 

Kelly Nicole Lutz waives any and all claims or causes of action she 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.  Kelly Nicole Lutz waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code.

 

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.  Kelly Nicole Lutz agrees that should the Board reject this Agreement and if this case proceeds to hearing, she 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.

 

 

R-2004-128                                  SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-030910-009)

 

In The Matter Of:

 

DAVID MARK OINOS, R.Ph.

7189 Crestway Road

Clayton, Ohio 45315

R.Ph. No. 03-3-14305

 

This Settlement Agreement is entered into by and between David Mark Oinos 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.

 

David Mark Oinos 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. David Mark Oinos 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, David Mark Oinos is licensed to practice pharmacy in the State of Ohio.

 

Whereas, on or about September 10, 2003, pursuant to Chapter 119. of the Ohio Revised Code, David Mark Oinos 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.  David Mark Oinos requested a hearing; it was scheduled and continued.  The September 10, 2003 Notice of Opportunity for Hearing contains the following allegations or charges:

 

(1)  Records of the Board of Pharmacy indicate that David Mark Oinos was originally licensed in the State of Ohio on July 31, 1981, pursuant to examination, and is cur­rently licensed to practice pharmacy in the State of Ohio.  Records further reflect during the relevant time periods stated herein, David Mark Oinos was the Respon­sible Pharmacist at Ray’s Phar­macy Inc.

 

(2)  David Mark Oinos did, on or about March 20, 2003, misbrand a drug, to wit: when David Mark Oinos received Rx #969175 for Seroquel 300 mg, he dispensed Serzone 200 mg, which had not been prescribed by the physician.  The patient was subse­quently hos­pi­tal­ized.  Such conduct is in violation of Section 3715.52(A)(2) of the Ohio Revised Code.

 

David Mark Oinos neither admits nor denies the allegations stated in the Notice of Oppor­tunity for Hearing letter dated September 10, 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, David Mark Oinos knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

 

(A)  David Mark Oinos agrees to the imposition of a monetary penalty of two hundred fifty dollars ($250.00) due and owing within thirty 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 43266-0320.

 

(B)  In addition to any and all other continuing education requirements, David Mark Oinos agrees to attend, within one year of the effective date of this agreement, two hours (0.2 CEUs) additional hours of Board-approved continuing pharmacy educa­tion for pediatric dosing and patient consultation in a retail pharmacy.

 

If, in the judgment of the Board, David Mark Oinos appears to have violated or breached any terms or conditions of this Agreement, the Ohio State Board of Pharmacy reserves the right to, at any time, revoke probation, modify the conditions of probation, and reduce or extend the period of probation, and/or the Board may institute formal disciplinary proceedings for any and all possible violations or breaches, including but not limited to, alleged violation of the laws of Ohio occurring before the effective date of this Agreement.

 

David Mark Oinos acknowledges that he 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.

 

David Mark Oinos waives any and all claims or causes of action he 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. David Mark Oinos waives 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.

 

10:32 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 Mrs. Adelman and a roll call vote was conducted by President Giacalone as follows: Adelman-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, and Turner-Yes.

11:35 a.m.

R-2004-129    The Executive Session ended and the meeting was opened to the public.  Mr. Turner moved that the Board deny the request for a continuance in the matter of Lauren Smith R.Ph.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-5/Nay-0).

 

R-2004-130    Mrs. Gregg moved that the Board deny the settlement offer presented in the matter of Kevon Armstrong, R.Ph.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-5/­Nay-0).

 

R-2004-131    Ms. Eastman moved that the Board deny the settlement offer presented in the matter of Richard Sweet, R.Ph.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-5/Nay-0).

 

R-2004-132    Mrs. Gregg moved that the Board deny the request received from Walter Hubish, R.Ph. for a re­vi­sion in the terms of his probation to allow him to participate in the destruction of controlled sub­stances.  The motion was seconded by Mrs. Adelman and approved by the Board (Aye-5/Nay-0).

 

R-2004-133    Mr. Kost moved that the Board summarily suspend the license to practice pharmacy belonging to Donald Christopher Hart, R.Ph. (03-1-12131) due to the fact that a con­tinuation of his pro­fes­sional practice presents a danger of immediate and serious harm to others.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-5/­Nay-0).

11:50 a.m.

The Board recessed for lunch.

  1:05 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); Diane C. Adelman, R.Ph.; Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, R.Ph.; and James E. Turner, R.Ph.

 

R-2004-134    Mr. Winsley discussed the Optometry Board’s proposed changes to Rule 4725-16-02 (Additional oral therapeutic pharmaceutical agents) prior to leaving for the meeting of the Joint Committee on Agency Rule Review (JCARR) scheduled to begin at 1:30 p.m.  After the discussion, the consensus of the Board was that the antiviral agents proposed as additions to the formulary (acyclovir, valacyclovir, and famciclovir) were necessary for patient care.  However, the Board members indicated that, because these are oral drugs used to treat the ocular manifestations of a systemic disease, they would be more comfortable with the addition of these drugs if the optometrist would be required to refer the patient to a physician after starting the patient on the therapy.

  1:26 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 PSS World Medical, Inc., Cincinnati.

  1:56 p.m.

The record was closed.

  2:03 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 Michael J. Esber, R.Ph., Louisville.

  3:07 p.m.

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

  3:16 p.m.

Mr. McMillen discussed his Licensing Report with the Board members.

  3:22 p.m.

R-2004-135    Mr. McMillen next presented a request for an exemption to Rule 4729-5-11 (Responsible person) received from Nagy Ramzy, R.Ph. for the following Terminal Distributor of Dan­gerous Drugs licenses:

 

Aultman Hospital (02-0029050)

Aultman RX (application pending)

 

After discussion, Ms. Eastman moved that the Board approve this request through June 1, 2004.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-5/­Nay-0).

 

R-2004-136    The Board then considered a request for an exemption to Rule 4729-5-11 (Responsible person) received from Richard Dawson, R.Ph. for the following Terminal Distributor of Dangerous Drugs licenses:

 

Cuyahoga Falls General Hospital (02-0039150)

Cuyahoga Falls General Hospital Retail Pharmacy (application pending)

 

After discussion, Mr. Turner moved that the Board approve this request through June 1, 2004.  The motion was seconded by Mrs. Adelman and approved by the Board (Aye-5/­Nay-0).

 

R-2004-137    Mr. Benedict then presented a system for paperless recordkeeping that Dayton Heart Hospital would like to utilize.  Copies of the physician order sheets would be initialed by the pharmacist and then scanned into the computer as a read-only file.  The images would also be burned onto a compact disk for storage purposes.  After discussion, Mrs. Gregg moved that the Board consider this to be an acceptable method of recordkeeping.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-5/Nay-0).

 

R-2004-138    Mr. Benedict then presented a proposal from Omnicare of Wadsworth for a bar code checking system.  After discussion, Mrs. Gregg moved that the Board approve the system as described by the Omnicare documents received and by the Board’s agents who had viewed the system.  The motion was seconded by Mr. Kost and approved by the Board (Aye-5/Nay-0).

  3:56 p.m.

Ms. Eastman 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 Mrs. Adelman and a roll call vote was conducted by President Giacalone as follows: Adelman-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, and Turner-Yes.

  4:05 p.m.

R-2004-139    The Executive Session ended and the meeting was opened to the public.  Mr. Kost moved that the Board adopt the following Order in the matter of PSS World Medical, Inc.:

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-031208-040)

 

In The Matter Of:

 

PSS WORLD MEDICAL, INC.

c/o Mary M. Jennings, Vice President

11121 Kenwood Road

Cincinnati, Ohio 45242

(Wholesale Distributor No. 01-0964200)

 

INTRODUCTION

 

THE MATTER OF PSS WORLD MEDICAL, INC. CAME FOR CONSIDERATION ON FEBRUARY 2, 2004, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; AND JAMES E. TURNER, R.Ph.

 

PSS WORLD MEDICAL, INC. WAS NOT PRESENT NOR WAS IT REPRESENTED BY COUNSEL, AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GEN­ERAL.

 

SUMMARY OF EVIDENCE

State’s Witnesses

 

1.  Richard Haun, Ohio State Board of Pharmacy

2.  William McMillen, R.Ph., Ohio State Board of Pharmacy

 

Respondent's Witnesses

 

None

 

State's Exhibits

 

1.  Copy of Proposal to Deny/Notice of Opportunity for Hearing letter  [12-09-03]

1A.  Procedural

2.  PSS World Medical, Inc. Renewal Application for a Wholesale Distributor of Dangerous Drugs license for 07/01/03 to 06/30/04  [05-28-03]

3.  Copy of Ohio State Board of Pharmacy Licensing Procedure letter to PSS World Medical, Inc.  [06/17/03]

 

Respondent's Exhibits

 

None

 

FINDINGS OF FACT

 

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

 

(1)  On December 9, 2003, PSS World Medical, Inc. was notified by letter of its right to a hearing, its rights in such hearing, and its right to submit any contentions in writing.

 

(2)  As demonstrated by return receipt dated December 11, 2003, PSS World Medi­cal, Inc. received the letter of December 9, 2003, informing it of the Board's reasons for proposing to deny its renewal application, and its rights.

 

(3)  PSS World Medical, Inc. has not responded in any manner to the letter of Decem­ber 9, 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 on or about June 30, 2003, Mary M. Jennings served as Vice President of PSS World Medical, Inc., 10848 Ken­wood Road, Cincinnati, Ohio 45242, and that on or about May 28, 2003, PSS World Medical, Inc. applied for renewal of its registration as a Wholesale Distributor of Dangerous Drugs, on which the box indicating a change of address was marked.

 

(5)  PSS World Medical, Inc. is not equipped as to land, buildings, equipment, and personnel to properly carry on the business of a wholesale distributor of dangerous drugs, including providing adequate security for and proper storage conditions and handling of dangerous drugs within the meaning of Section 4729.53 of the Ohio Re­vised Code, to wit: the facility is primarily a drop-shipper having inadequate facili­ties and/or paraphernalia in which to store dangerous drugs.

 

CONCLUSION OF LAW

 

Upon consideration of the record as a whole, the State Board of Pharmacy con­cludes that paragraph (5) of the Findings of Fact constitutes failure to meet the qualifications for regis­tration as a Wholesale Distributor of Dangerous Drugs set forth in Division (A) of Section 4729.53 of the Ohio Revised Code.

 

ACTION OF THE BOARD

 

Pursuant to Division (A) of Section 4729.52 of the Ohio Revised Code, and after considera­tion of the record as a whole, the State Board of Pharmacy hereby refuses to register PSS World Medical, Inc. and, therefore, denies the Wholesale Distributor of Dangerous Drugs Renewal Application submitted by Mary M. Jennings on May 28, 2003.

 

THIS ORDER WAS APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.

MOTION CARRIED.

SO ORDERED.

 

The motion was seconded by Mrs. Gregg and approved by the Board (Aye-5/Nay-0).

 

R-2004-140    Mrs. Adelman moved that the Board adopt the following Order in the matter of Michael J. Esber, R.Ph:

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-030910-012)

 

In The Matter Of:

 

MICHAEL J. ESBER, R.Ph.

1807 California Avenue

Louisville, Ohio 44641

(R.Ph. No. 03-1-13497)

 

INTRODUCTION

 

THE MATTER OF MICHAEL J. ESBER CAME FOR HEARING ON FEBRUARY 2, 2004, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; AND JAMES E. TURNER, R.Ph.

 

MICHAEL J. ESBER WAS REPRESENTED BY DAVID W. GRAUER AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

SUMMARY OF EVIDENCE

State’s Witnesses

 

1.  Louis Robert Mandi, R.Ph., Ohio State Board of Pharmacy

 

Respondent's Witnesses

 

1.  Michael J. Esber, R.Ph., Respondent

 

State's Exhibits

 

1.  Copy of Notice of Opportunity For Hearing letter  [09-10-03]

1A-1D.  Procedurals

2.  Copy of State Board of Pharmacy Order in re Michael J. Esber, R.Ph.  [07-16-01]

3.  Copy of Children’s Hospital Medical Center of Akron HEM/ONC Outpatient Visit Form for (redacted)  [02-13-03]

4.  Copy of Rx #02387 275870  [02-14-03]

5.  Copy of Rite Aid Pharmacy bottle label for Rx #275870  [02-14-03]

6.  Copy of Children’s Hospital Medical Center of Akron Adverse Drug Reaction Reporting Form for I(redacted)  [not dated]

7.  Rite Aid - E. Tuscarawas Customer History Report for (redacted)