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

July 14 & 15, 2003

MONDAY, JULY 14, 2003

8:07 a.m.

ROLL CALL

The State Board of Pharmacy convened in the Starboard Room at Maumee Bay Conference Center, 1750 Park Road #2, Oregon, Ohio with the following members present:

Robert P. Giacalone, R.Ph. (President); Lawrence J. Kost, R.Ph. (Vice-President); Diane C. Adelman, R.Ph.; Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, 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; William McMillen, Licensing Administrator; Mark Keeley, Legislative Affairs Administrator; David Rowland, Legal Affairs Administrator; Robert Cole, Compliance Supervisor; and Sally Ann Steuk, Assistant Attorney General.

8:10 a.m.

	As the first order of business, Immediate Past President Diane C. Adelman, R.Ph. administered the following oaths of office to President Robert P. Giacalone, R.Ph. and Vice-President Lawrence J. Kost, R.Ph.:
	OATH OF PRESIDENT I, ROBERT P. GIACALONE, as President of the Ohio Board of Pharmacy do solemnly swear to uphold the Constitution of the United States and the state of Ohio; to impartially enforce the laws governing the profession of pharmacy and the legal distribution of drugs in the state of Ohio; and carry out the responsibilities of the Board as mandated by the laws of the state of Ohio without bias or prejudice, so help me God.
	OATH OF VICE-PRESIDENT I, LAWRENCE J. KOST, as Vice-President of the Ohio Board of Pharmacy do solemnly swear to uphold the Constitution of the United States and the state of Ohio; to impartially enforce the laws governing the profession of pharmacy and the legal distribution of drugs in the state of Ohio; and carry out the responsibilities of the Board as mandated by the laws of the state of Ohio without bias or prejudice, so help me God.
R-2004-001	Mr. McMillen distributed the following list of reciprocity candidates who participated in a discussion of pharmacy laws and rules with Mr. McMillen on July 10, 2003 and were then presented with their pharmacist identification cards:

AMANDA JO COLLINGSWORTH	03-3-25884	ILLINOIS
JEFFREY ALAN FENERTY	03-3-25825	PENNSYLVANIA
DINA R. GIRGIS	03-3-25847	NEW YORK
TRAMY THUY LENGUYEN	03-3-25826	TEXAS
MICHAEL DAVID MARTIN, JR.	03-3-25719	ARIZONA
KENNETH JAY MAXIK	03-3-25757	NEW YORK
BRADLEY EDWARD McCRORY	03-3-25894	INDIANA
CHRISTINE MYERS HARRIS	03-3-25860	WEST VIRGINIA
JAY WESLEY MYERS	03-3-25861	WEST VIRGINIA
DAVID JUDE PAVLIK	03-3-25908	PENNSYLVANIA
SABRINA JOY RAYBON	03-3-25917	MARYLAND
SHELBY MARIE SCRABIS	03-3-25864	NORTH CAROLINA
CHRISTOPHER JAMES SUGG	03-3-25875	NORTH CAROLINA

R-2004-002	President Giacalone then distributed the following list of committee assignments to the Board members along with a revised seating chart for Fiscal Year 2004:
	Adelman Exams/Internship/Reciprocity Braylock Administration/Probationary Reports Eastman Personnel Giacalone Compliance/Enforcement Gregg Continuing Education Kost Legislation/Rules Lipsyc Licensure/Registration Teater Budget/Finance Turner Consumer Affairs/Public Relations
	Mr. Rowland announced that the following settlement agreements had been signed by all parties and were now effective:
R-2004-003	SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY (Docket No. D-030422-069) In The Matter Of: RAYNER B. LOTTON, R.Ph. 505 Sycamore Drive Circleville, Ohio 43113 (R.Ph. No. 03-3-22200)
	This Settlement Agreement is entered into by and between Rayner B. Lotton 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. Rayner B. Lotton 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. Rayner B. Lotton 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, Rayner B. Lotton is licensed to practice pharmacy in the State of Ohio.
	Whereas, on or about April 22, 2003, pursuant to Chapter 119. of the Ohio Revised Code, Rayner B. Lotton 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. Rayner B. Lotton requested a hearing; it was scheduled. The April 22, 2003, Notice of Opportunity for Hearing contains the following allegations or charges:

(1)	Records of the Board of Pharmacy indicate that Rayner B. Lotton was originally licensed in the State of Ohio on March 4, 1997, pursuant to reciprocity, and is currently licensed to practice pharmacy in the State of Ohio. Records further reflect during the relevant time periods stated herein, Rayner B. Lotton was the Responsible Pharmacist at Berger Hospital pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Section 4729-5-11 of the Ohio Administrative Code.
(2)	Rayner B. Lotton did, as the Responsible Pharmacist-in-charge, on or about August 26, 2001, (prior to dispensing a drug order to patient #1) upon review of the patient profile in order to conduct prospective drug utilization review, Rayner B. Lotton recognized over-utilization yet he failed to take appropriate steps to avoid or resolve the problem. Rayner B. Lotton received a drug order for “Librium 300 mg one qid,” yet he dispensed the drug in spite of the over dosage and the patient suffered severe harm. Such conduct is in violation of Rule 4729-5-20 of the Ohio Administrative Code.
(3)	Rayner B. Lotton did, as the Responsible Pharmacist-in-charge, on or about August 26, 2001, fail to implement policies and procedures consistent with federal and state laws and rules, and/or adhere to such policies and procedures, so as to provide for the safe and effective distribution of drugs, to wit: hospital and pharmacy policy provided that, when a pharmacist questioned the validity or propriety of a drug order, the pharmacist would contact the patient’s responsible nurse, who would then contact the physician. Alternatively, a pharmacist must directly contact the prescribing physician when questions or problems would arise to ensure the safe and effective distribution of drugs. When dispensing a drug order on this date, due to adherence to this improper policy, a patient was harmed as indicated in paragraph 2 above. Such conduct is in violation of Rule 4729-17-02(C)(3) of the Ohio Administrative Code.

Rayner B. Lotton neither admits nor denies the allegations stated in the Notice of Opportunity for Hearing letter dated April 22, 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, Rayner B. Lotton knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

(A)	Pursuant to Sections 4729.16 and 4729.25(B), Rayner B. Lotton is hereby reprimanded for the aforementioned violations of rules and/or laws.
(B)	In addition to any and all other Continuing Education requirements, Rayner B. Lotton agrees to attend 2.0 hours of continuing education within one year of the effective date of this agreement in the area of policies and procedures and other measures to prevent dispensing errors in hospital pharmacy practice.

Rayner B. Lotton 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.

Rayner B. Lotton 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. Rayner B. Lotton 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. Rayner B. Lotton agrees that should the Board reject this Agreement and if this case proceeds to hearing, he 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/          Rayner B. Lotton	7–08–03
Rayner B. Lotton, R.Ph., Respondent	Date of Signature
/s/          David W. Grauer	7–8–03
David W. Grauer, Attorney for Respondent	Date of Signature
/s/          Robert P. Giacalone	7/14/03
Robert P. Giacalone, President, Ohio State Board of Pharmacy	Date of Signature
/s/          Sally Ann Steuk	7–14–03
Sally Ann Steuk, Ohio Assistant Attorney General	Date of Signature

R-2004-004

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY (Docket No. D-030701-001) In The Matter Of: DEBORAH S. MCCRAY, R.Ph. 3823 Behrwald Avenue Cleveland, Ohio 44109 (R.Ph. No. 03-3-21891)

This Settlement Agreement is entered into by and between Deborah S. McCray 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. Deborah S. McCray 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. Deborah S. McCray 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, Deborah S. McCray is licensed to practice pharmacy in the State of Ohio. Whereas, Deborah S. McCray has no prior history of disciplinary proceedings of any kind. Whereas, Deborah S. McCray, by and through her attorney, self-reported the conduct at issue herein to the Ohio State Board of Pharmacy and has been fully cooperative with the investigation of this matter. Deborah S. McCray neither admits nor denies the allegations stated in this Settlement Agreement, however, the Board has evidence sufficient to sustain the allegations and hereby adjudicates the same:

(1)

Records of the Board of Pharmacy indicate that Deborah S. McCray was originally licensed in the State Of Ohio on July 30, 1996, pursuant to examination, and is currently licensed to practice pharmacy in the State of Ohio.

(2)

Deborah S. McCray did, on or about April, 2002, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of the Cleveland Department of Veterans Affairs Medical Center, beyond the express or implied consent of the owner, to wit: Deborah S. McCray has admitted to a Board of Pharmacy agent that she stole 25 unit doses of Ultram, a dangerous drug. Though Deborah S. McCray had previously had valid prescriptions for the medication, such was not the case for the doses in April of 2002. Such conduct constitutes dishonesty or unprofessional conduct in the practice of pharmacy within the meaning of Section 4729.16 of the Ohio Revised Code

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

(A) Deborah S. McCray’s pharmacist identification card, No. 03-3-21891, will be placed on probation for two years from April 17, 2002, with the following conditions:

(1) Pursuant to Deborah S. McCrays drug and alcohol assessment, she is not addicted. However, Ms. McCray has voluntarily completed rehabilitation, and shall continue with her aftercare program.

(2) The State Board of Pharmacy hereby declares that Deborah S. McCray’s pharmacist identification card is not in good standing.

(3) Deborah S. McCray is not barred from practicing pharmacy during the period of her probation and/or while her pharmacist identification card is not in good standing.

(4) Deborah S. McCray must not violate the drug laws of the State of Ohio, any other state, or the federal government.

(5) Deborah S. McCray must abide by the rules of the State Board of Pharmacy.

(6) Deborah S. McCray must comply with the terms of this Agreement.

If, in the judgment of the Board, Deborah S. McCray 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.

Deborah S. McCray 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.

Deborah S. McCray 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. Deborah S. McCray 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. Deborah S. McCray 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.

/s/          Deborah S. McCray	9 Jul 2003
Deborah S. McCray, Respondent	Date of Signature
/s/          John A. Fatica	7/9/03
John A. Fatica, Attorney for Respondent	Date of Signature
/s/          Robert P. Giacalone	7/14/03
Robert P. Giacalone, President, Ohio State Board of Pharmacy	Date of Signature
/s/          Sally Ann Steuk	7–14–03
Sally Ann Steuk, Ohio Assistant Attorney General	Date of Signature

8:25 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, Braylock-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

11:00 a.m.

The meeting was recessed for lunch.

12:57 p.m.

The Executive Session resumed with all members present.

1:00 p.m.

	The Executive Session ended and the meeting was opened to the public. The Board members reviewed requests for reconsideration of Board Orders from William Ringle and Abdullah Abukhalil. No action was taken on either request.
R-2004-005	Mr. Braylock moved that the Board reject the request for withdrawal of an application for a Terminal Distributor of Dangerous Drugs received from Ghassan Haj-Hamed, M.D. and that a hearing be scheduled. The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).
R-2004-006	Mrs. Gregg then moved that the Board refuse the settlement offer issued in the matter of Alan Patrick Horvath, R.Ph. and that a hearing be scheduled. The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).
R-2004-007	Mr. Braylock moved that the Board refuse the settlement offer issued in the matter of Tarra Bryant, R.Ph. and that a hearing be scheduled. The motion was seconded by Ms. Eastman and approved by the Board (Aye-8/Nay-0).
R-2004-008	Mrs. Gregg then moved that the Board refuse the settlement offer issued in the matter of Maynard D. Turner, R.Ph. and that a hearing be scheduled. The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).
R-2004-009	Mr. Braylock moved that the Board refuse the settlement offer issued in the matter of David L. Rieder, R.Ph. and that a hearing be scheduled. The motion was seconded by Mrs. Teater and approved by the Board (Aye-5/Nay-3).
R-2004-010	Mr. McMillen presented a request from Nick Femia, R.Ph. asking for a waiver from the requirements of Rule 4729-5-11(A) to allow him to serve as responsible pharmacist at more than one location. After discussion, Mrs. Gregg moved that the request be approved until October 1, 2003 at the following two locations: Mahoning Valley Hospital – Youngstown Campus (Application Pending) [Formerly Specialty Hospital of Mahoning Valley (02-1141750)] Mahoning Valley Hospital – Trumbull Campus (Application Pending) The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).
R-2004-011	Mr. Winsley presented a request from Timothy R. Tannert, R.Ph. asking for a waiver from the requirements of Rule 4729-5-11(A) to allow him to serve as responsible pharmacist at more than one location. After discussion, Mr. Lipsyc moved that the request be approved until October 1, 2003 at the following two locations: NCS Hilliard (02-0564600) Omnicare of Columbus (02-1194500) The motion was seconded by Mrs. Adelman and approved by the Board (Aye-8/Nay-0).
R-2004-012	Mr. Winsley then presented a request from Michael Pellek, R.Ph. asking for a waiver from the requirements of Rule 4729-5-11(A) to allow him to serve as responsible pharmacist for four Terminal Distributor licenses all located at one location. After discussion, Mrs. Gregg moved that the request be approved for one year for the following licenses: HCS At Home (02-1383800) HCS Lancaster (02-1304400) Conemaugh Home Medical Equipment (02-1349750) Caring Services DME (02-1331700) The motion was seconded by Mrs. Teater and approved by the Board (Aye-8/Nay-0).
R-2004-013	Mr. Winsley next presented a request from University Health Services (UHS) at the University of Cincinnati for an exemption to Rule 4729-5-10 (Pick-up station) so that patient-specific prescriptions could be prepared at the UHS Scioto Campus Pharmacy (02-1087400) and delivered to the UHS Holmes Clinic (Application Pending) for distribution to patients who are students at the University. After discussion, Mr. Braylock moved that the Board approve the request due to the need for involvement by a health care professional in the patient’s drug therapy [OAC Rule 4729-5-10(B)(5)(b)]. The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-1).
R-2004-014	Mr. McMillen presented information received regarding a request for approval as a provider of continuing pharmacy education (CPE) from University Home Care/Pammi Farren, R.Ph. The request for approval had been tabled at a previous meeting pending receipt of this information. After discussion, Ms. Eastman moved that University Home Care be approved as a provider of CPE. The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0). The Board next reviewed a brochure received from the Ohio Hospice & Palliative Care Organization regarding various rules and regulations pertinent to hospice care. Before the Board would allow the Board’s name to be added to the brochure, Board staff was instructed to review the document carefully. No action was taken on this issue until such a review could be accomplished.
R-2004-015	Mr. Winsley presented a request for reconsideration of the sanctions contained in his Board order from Bradley J. Heim, R.Ph. After discussion, Mrs. Adelman moved that the Board deny the request for reconsideration. The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).
R-2004-016	After discussion, Ms. Eastman moved that the Board continue their membership in the National Association of State Controlled Substance Authorities (NASCSA) and that the payment of dues for the following year be authorized. The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0). Mr. Braylock announced that the July meeting of the Nursing Board’s Committee on Prescriptive Governance had been cancelled. Mr. Keeley then discussed his legislative report with the Board.

2:29 p.m.

The Board took a brief recess.

2:45 p.m.

R-2004-017

The meeting resumed. Mr. Keeley discussed the rules proposed by the special committee appointed to prepare rules regarding the Drug Repository program. After discussion of the proposed rules, Mrs. Gregg moved that the following rules be approved for filing at the appropriate time:

PROPOSED NEW RULES

DRUG REPOSITORY PROGRAM

4729-35-01 Definitions.

As used in Chapter 4729-35 of the Administrative Code:

(A)	“Dangerous drug” has the same meaning as in section 4729.01 of the Revised Code and in rule 4729-9-01 of the Administrative Code.
(B)	“Drug repository program” has the same meaning as in sections 3715.87 to 3715.873 of the Revised Code.
(C)	“Hospital” has the same meaning as in section 3715.87 of the Revised Code.
(D)	“Institutional facility” has the same meaning as in rule 4729-17-01 of the Administrative Code.
(E)	“Licensed health care professional” has the same meaning as in section 3715.872 of the Revised Code.
(F)	“Nonprofit clinic” has the same meaning as in section 3715.87 of the Revised Code.
(G)	“Original sealed and tamper-evident unit dose packaging” includes single unit dose packaging of oral medications from a manufacturer or a repackager licensed with the Federal Food and Drug Administration, and injectables, topicals, and aerosols in the manufacturer’s or repackager’s unopened original tamper-evident packaging.

4729-35-02 Eligibility requirements for a pharmacy, hospital, or nonprofit clinic.

A pharmacy, hospital, or nonprofit clinic may elect to participate in the drug repository program, pursuant to sections 3715.87 to 3715.873 of the Revised Code, if all of the following requirements are met:

(A)	Must be licensed as a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code.
(B)	Must comply with all federal and state laws, rules, and regulations.

4729-35-03 Donating drugs.

(A)	The following may donate a dangerous drug, pursuant to the eligibility requirements of rule 4729-35-04 of the Administrative Code, to a pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository program:

(1)	A licensed terminal distributor of dangerous drugs.
(2)	A licensed wholesale distributor of dangerous drugs.