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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. |
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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
September 13, 14, 15, 2004
MONDAY, SEPTEMBER 13, 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:
Lawrence J. Kost, R.Ph. (President); Suzanne R. Eastman, R.Ph. (Vice-President); Gregory Braylock, R.Ph.; Elizabeth I. Gregg, R.Ph.; Nathan S. Lipsyc, R.Ph.; Kevin J. Mitchell, 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.
Mr. Rowland announced that the following settlement agreement in the matter of Tricare Network Pharmacy had been signed by all parties and was now effective:
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R-2005-027 |
SETTLEMENT AGREEMENT WITH THE STATE BOARD OF
PHARMACY |
(Docket
No. 031119-036)
In
the Matter of:
TRICARE PHARMACY NETWORK, LLC
c/o
Gary Harris, R.Ph.
1517
Nicholasville Road, Suite 404
Lexington,
Kentucky 40503
(Terminal Distributor No.
02-1309100)
This settlement agreement is
entered into by and between Tricare Pharmacy Network, LLC 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.
Tricare Pharmacy Network, LLC
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, the right to appeal. Tricare Pharmacy Network, LLC acknowledges that by
entering into this agreement it has waived its rights under Chapter 119. of the
Revised Code.
Whereas, the Ohio 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, Tricare Pharmacy
Network, LLC is a licensed terminal distributor of dangerous drugs in the State
of Ohio.
WHEREAS, on or about November 19, 2003, pursuant to Chapter 119. of the
Ohio Revised Code, Tricare Pharmacy Network, LLC 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. A hearing was scheduled. The November 19, 2003, Notice of Opportunity
for Hearing contains the following allegations or charges:
(1) Records of the
Board of Pharmacy indicate that Tricare Pharmacy Network, LLC is licensed by
the State of Ohio as a Terminal Distributor of Dangerous Drugs and Gary Harris,
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) Tricare
Pharmacy Network, LLC did, on or about the following dates, sell a new drug
without having an application with respect to the drug effective under Section
505 of the Federal Food, Drug, and Cosmetic Act, to wit: the pharmacy sold the
following dangerous drugs into the State of Ohio without obtaining
patient-specific orders for the products:
|
Drug |
Qty |
Date Order Placed |
Date Received |
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sincalide
5 mcg sincalide 3 mcg methylprednisolone acetate 10 ml 80 mg/ml betamethasone acetate sodium phosphate 10 ml 6 mg Nicotine Lollipops 2 mg Nicotine Lollipops 2 mg methylprednisolone acetate 5 ml 40 mg/ml Depo-Testosterone 10 ml 200 mg/ml albuterol/ipratropium 3.2 ml .249%/0.05% Nicotine Lollipops 2 mg sincalide 5 mcg Nicotine Lollipops 2 mg sincalide 5 mcg Nicotine Lollipops 2 mg |
70 10 5 5 12 4 5 2 50 18 10 18 5 12 |
07/30/02 09/04/02 09/09/02 09/09/02 09/09/02 10/07/02 10/15/02 10/15/02 10/15/02 10/15/02 10/16/02 10/16/02 01/07/03 01/07/03 |
07/31/02 09/05/02 09/10/02 09/10/02 09/10/02 10/10/02 10/17/02 10/17/02 10/17/02 10/17/02 10/17/02 10/17/02 01/08/03 01/08/03 |
Such conduct is in violation
of Section 3715.65 of the Ohio Revised Code.
(3) Tricare Pharmacy
Network, LLC did, on or about the following dates, knowingly make or affix a
false or forged label to a receptacle containing dangerous drugs, to wit: the
pharmacy sold dangerous drugs in containers having labels containing names of
fictitious patients attached thereto:
|
Drug |
Qty |
Date Order Placed |
Date Received |
|
|
sincalide
5 mcg sincalide 3 mcg methylprednisolone acetate 10 ml 80 mg/ml betamethasone acetate sodium phosphate 10 ml 6 mg Nicotine Lollipops 2 mg Nicotine Lollipops 2 mg methylprednisolone acetate 5 ml 40 mg/ml Depo-Testosterone 10 ml 200 mg/ml albuterol/ipratropium 3.2 ml .249%/0.05% Nicotine Lollipops 2 mg sincalide 5 mcg Nicotine Lollipops 2 mg sincalide 5 mcg Nicotine Lollipops 2 mg |
70 10 5 5 12 4 5 2 50 18 10 18 5 12 |
07/30/02 09/04/02 09/09/02 09/09/02 09/09/02 10/07/02 10/15/02 10/15/02 10/15/02 10/15/02 10/16/02 10/16/02 01/07/03 01/07/03 |
07/31/02 09/05/02 09/10/02 09/10/02 09/10/02 10/10/02 10/17/02 10/17/02 10/17/02 10/17/02 10/17/02 10/17/02 01/08/03 01/08/03 |
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A Tricare Pharmacy Network,
LLC pharmacist indicated to an agent of the Board that the pharmacy would
"make up names" if such were not provided and such conduct is in
violation of Section 2925.23 (D) of the Ohio Revised Code.
(4) Tricare
Pharmacy Network, LLC did, on or about the following dates, compound and sell
prescription drugs when not pursuant to specific orders for individual patients
issued by prescribers and not in limited quantities in anticipation of prescription
drug orders based on routine, regularly observed prescribing patterns, to wit:
the pharmacy compounded and dispensed the following prescriptions:
|
Drug |
Qty |
Date Order Placed |
Date Received |
|
sincalide
5 mcg sincalide 3 mcg methylprednisolone acetate 10 ml 80 mg/ml betamethasone acetate sodium phosphate 10 ml 6 mg Nicotine Lollipops 2 mg Nicotine Lollipops 2 mg methylprednisolone acetate 5 ml 40 mg/ml Depo-Testosterone 10 ml 200 mg/ml albuterol/ipratropium 3.2 ml .249%/0.05% Nicotine Lollipops 2 mg sincalide 5 mcg Nicotine Lollipops 2 mg sincalide 5 mcg Nicotine Lollipops 2 mg |
70 10 5 5 12 4 5 2 50 18 10 18 5 12 |
07/30/02 09/04/02 09/09/02 09/09/02 09/09/02 10/07/02 10/15/02 10/15/02 10/15/02 10/15/02 10/16/02 10/16/02 01/07/03 01/07/03 |
07/31/02 09/05/02 09/10/02 09/10/02 09/10/02 10/10/02 10/17/02 10/17/02 10/17/02 10/17/02 10/17/02 10/17/02 01/08/03 01/08/03 |
Such conduct is in violation
of Rule 4729-9-21 of the Ohio Revised Code.
Tricare Pharmacy Network, LLC denies the allegations
stated in the Notice of Opportunity for Hearing letter dated November 19, 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, Tricare Pharmacy Network, LLC knowingly and voluntarily agrees with the
State Board of Pharmacy to the following:
(A) Tricare
Pharmacy Network, LLC agrees to the imposition of a monetary penalty of four
thousand dollars ($4,000.00) 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.
(B) Tricare
Pharmacy Network, LLC’s Ohio Terminal Distributor license, No. 02-1309100, is
hereby suspended for one (1) month and such suspension is effective as of the
date of the mailing of this Agreement.
Tricare Pharmacy Network, LLC 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.
Tricare Pharmacy Network, LLC 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.
Tricare Pharmacy Network, LLC 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.
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.
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/s/ Gary Harris |
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/d/ 8/3/04 |
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Gary Harris, R.Ph. for
Tricare Pharmacy Network, LLC |
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Date of
Signature |
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/s/ K P Byers |
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/d/ 8/6/04 |
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Kevin P. Byers, Attorney
for Respondent |
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Date of
Signature |
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/s/ Lawrence J. Kost |
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/d/ 9/13/04 |
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Lawrence J. Kost,
President, Ohio State Board of Pharmacy |
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Date of
Signature |
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/s/ Sally Ann Steuk |
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/d/ 9–14–04 |
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Sally Ann Steuk, Ohio
Assistant Attorney General |
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Date of Signature |
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10:06 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. Braylock and a roll call vote was conducted by President Kost as follows: Braylock-Yes, Eastman-Yes, Gregg-Yes, Lipsyc-Yes, Mitchell-Yes, Teater-Yes, and Turner-Yes.
10:12 a.m.
Board member Robert Giacalone arrived and joined the Executive Session in progress.
11:06 a.m.
R-2005-028 The Executive Session ended and the meeting opened to the public. Mr. Turner moved that the Board approve the settlement offer presented in the matter of Delbert Brown as amended by the Board. The motion was seconded by Mrs. Gregg and approved by the Board (Aye-7/Nay-0/Abstain-1[Giacalone]).
R-2005-029 Mrs. Gregg then moved that the Board deny the request for a continuance in the matter of Jason Reip and that the hearing be held as scheduled. The motion was seconded by Mrs. Teater and approved by the Board (Aye-8/Nay-0).
After considering a letter received from the attorney representing Dennis White, R.Ph., the Board members determined that no settlement had been offered and, therefore, no official action by the Board was required.
R-2005-030 Mr. Turner moved that the Board refuse the settlement offer submitted in the matter of Richard Sweet, R.Ph. and that the hearing be held as scheduled. The motion was seconded by Mrs. Gregg and approved by the Board (Aye-8/Nay-0).
A request from Robert Berkowitz, R.Ph. that the Board clarify an issue relating to his Board Order was discussed and then tabled until the October meeting to allow Board staff to research the matter in greater detail.
R-2005-031 Mr. Braylock then moved that the Board summarily suspend the license to practice pharmacy belonging to Gary Nicholas Sass, R.Ph. (03-1-18015) 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-8/Nay-0).
11:10 a.m.
The Board took a brief recess.
11:16 a.m.
R-2005-032 The meeting resumed. The Board reviewed a policy statement issued by the Ohio Department of Job and Family Services (ODJFS) regarding the issue of mandated tablet splitting for Ohio Medicaid recipients. After discussion, Mr. Turner moved that the Board indicate their opposition to such a policy as it would create a potential patient safety hazard. The motion was seconded by Mrs. Gregg and approved by the Board (Aye-8/Nay-0). Board staff was instructed to prepare a letter to be sent to ODJFS informing them of the Board’s deep concern for the patient safety hazards such a policy would present.
R-2005-033 The Board considered a request for an exemption from Rule 4729-5-10 (Pick-up station) received from the following sites:
Summa Health Systems/Akron City Campus (02-0726250)
Central Admixture Pharmacy Services (02-1312700)
After discussion, Mr. Giacalone moved that the Board approve the request. The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).
R-2005-034 The Board next considered a request for an exemption from Rule 4729-5-10 (Pick-up station) received from the following sites:
Summa Health Systems/St. Thomas Campus (02-0726300)
Central Admixture Pharmacy Services (02-1312700)
After discussion, Mrs. Gregg moved that the Board approve the request. The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).
R-2005-035 The Board then considered a request for an exemption from Rule 4729-5-10 (Pick-up station) received from the following sites:
Teregen Labs (02-1235150)
Numerous Physician Offices noted on the letter of request
After discussion, Mr. Turner moved that the Board approve the request. The motion was seconded by Ms. Eastman and approved by the Board (Aye-6/Nay-2).
R-2005-036 Mr. McMillen presented a request for approval as a provider of continuing pharmacy education (CPE) from the Ohio State Health Network/Columbus. After discussion, Mr. Braylock moved that the Board approve the Ohio State Health Network as a Board Approved In-State Provider of CPE. The motion was seconded by Mr. Mitchell and approved by the Board (Aye-8/Nay-0).
Mr. Winsley distributed the NABP Task Force and Committee list of appointments to the Board members for their information. No official action of the Board was required.
12:01 p.m.
The Board recessed for lunch.
1:38 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 all members present.
1:39 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 Thomas Allen Scott, R.Ph., Portsmouth.
3:04 p.m.
The hearing ended and the record was closed. The Board took a brief recess.
3:18 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 Todd C. LaTour, R.Ph., Cincinnati.
6:37 p.m.
The hearing ended and the record was closed.
6:39 p.m.
The Board meeting was recessed until Tuesday, September 14, 2004.
TUESDAY, SEPTEMBER 14, 2004
8:00 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:
Lawrence J. Kost, R.Ph. (President); Suzanne R. Eastman, R.Ph. (Vice-President); Gregory Braylock, R.Ph.; Robert P. Giacalone, R.Ph.; Elizabeth I. Gregg, R.Ph.; Nathan S. Lipsyc, R.Ph.; Kevin J. Mitchell, R.Ph.; Dorothy S. Teater, Public Member; and James E. Turner, R.Ph.
R-2005-037 Mr. Winsley distributed the letter that was to be sent to ODJFS regarding the tablet splitting issue to the Board members for their review prior to its mailing. There were no changes suggested by the Board members and the members agreed that it should be mailed as soon as possible.
Mr. Keeley distributed a set of recommendations from the Ad Hoc Committee on Rule Review for the Board to review prior to the October meeting. Several proposed rule changes were discussed. The Board will need to take final action on these rules at the October meeting.
R-2005-038 Mr. Keeley then presented a request from the American Pharmaceutical Association (APhA) for approval of their revised immunization program. After discussion, Mrs. Gregg moved that the program be approved as of its revision date of October 1, 2003. The motion was seconded by Mr. Giacalone and approved by the Board (Aye-8/Nay-0).
8:55 a.m.
The Board took a brief recess.
9:07 a.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 John David Campbell, R.Ph., Nashport. Mr. Mitchell recused himself from the hearing and the resulting deliberations by the Board.
11:40 a.m.
The hearing ended and the record was closed. The Board took a brief recess.
11:54 a.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 Jason Matthew Reip, Pharmacy Intern, Westlake. President Kost recused himself from the hearing and Vice-President Eastman assumed the chair.
12:25 p.m.
The hearing ended and the record was closed. President Kost returned to chair the meeting.
12:30 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. Turner and a roll call vote was conducted by President Kost as follows: Braylock-Yes, Eastman-Yes, Giacalone-Yes, Gregg-Yes, Lipsyc-Yes, Mitchell-Yes, Teater-Yes, and Turner-Yes.
1:30 p.m.
While the Executive Session continued, Mr. McMillen met with the candidates for licensure by reciprocity in Room South-A, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio.
R-2005-039 Following self-introductions by the candidates for licensure by reciprocity, the following candidates participated in a discussion of pharmacy laws and rules with Mr. McMillen and were then presented with their pharmacist identification cards.
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JACQUELINE MARIE ARGENZIANO |
03-2-26521 |
PENNSYLVANIA |
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CHARLES JAY BEYER |
03-2-26510 |
INDIANA |
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CHARLES BOAMAH |
03-2-26498 |
MARYLAND |