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.

 

 

 

Minutes Of The Meeting

Ohio State Board of Pharmacy

Columbus, Ohio

October 2, 3, 4, 2000

 

MONDAY, OCTOBER 2, 2000

 

8:10 a.m.     ROLL CALL

 

The State Board of Pharmacy convened in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Suzanne L. Neuber, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Ann D. Abele, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Dorothy Teater, Public Member; and James E. Turner, R.Ph.

 

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

8:53 a.m.

After discussion of items not requiring any official action by the Board, Ms. Abele 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. Giacalone and a roll call vote was conducted by President Neuber as follows: Abele-Yes, Adelman-Yes, Giacalone-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.

8:56 a.m.

Mr. Littlejohn arrived and joined the Executive Session in progress.

10:07 a.m.

RES. 2001-039   The Executive Session ended and the meeting was opened to the public.Ms. Abele moved that, pursuant to Section 3719.121 of the Revised Code, the Board summarily suspend the license to practice pharmacy belonging to Deborah Lynne Cooper, R.Ph. (03-3-21795) due to the fact that a continuation of her professional practice presents a danger of immediate and serious harm to others.The motion was seconded by Mr. Littlejohn and approved by the Board (Aye-7/Nay-0).

10:09 a.m.

RES. 2001-040   Ms. Abele then moved that, pursuant to Section 3719.121 of the Revised Code, the Board summarily suspend the license to practice pharmacy belonging to Steven Martin Sales, R.Ph. (03-3-14337) 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 Mr. Turner and approved by the Board (Aye-7/Nay-0).

10:17 a.m.

RES. 2001-041   Mr. Benedict, Mr. Keeley, and Mr. Winsley reviewed pending legislation with the Board.The discussion centered around Senate Bill 172 which had been voted out by the Legislature and was awaiting the Governorís signature and Senate Bill 248 which was due to be voted on by the House on November 8, 2000.It was the consensus of the Board that it would be necessary to form two special rules committees to develop rules as a result of these bills.It was decided that the Board would appoint a special committee to look at the rules needed for S.B. 172 at the November 2000 meeting.The discussion of the committee needed as a result of S.B. 248 would continue at the November meeting.

11:28 a.m.

The Board took a recess for lunch.

1:18 p.m.

The Board meeting resumed in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with all members present except Ms. Eastman and Mrs. Teater.

 

Mr. Kost reported on the activities of the Nursing Boardís Advanced Practice Nurse Committee.

 

Mr. Benedict had no report on the Medical Board Prescribing Committee's activities.

1:22 p.m.

RES. 2001-042   After a brief discussion, Ms. Abele moved that the Board approve the signing of the State Letters of Agreement between the National Association of Boards of Pharmacy (NABP) and the Ohio Board of Pharmacy for both the NAPLEX and MPJE examinations covering the next year.The motion was seconded by Mr. Giacalone and approved by the Board (Aye-6/Nay-0).

1:25 p.m.

Mrs. Teater arrived and joined the meeting in progress.

1:26 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 Patty J. Baxter, R.Ph., Rome.

2:25 p.m.

After reviewing the documents presented by Ms. Baxter in support of her reinstatement petition, the Board members had several questions of Ms. Baxter about apparent deficiencies in her documentation.After the Board members questioned Ms. Baxter about these deficiencies and listened to her responses, President Neuber declared that Ms. Baxter did not have the documentation required by her Board Order, that she had not complied with the terms of her Board Order, and, therefore, the hearing would be terminated.Ms. Baxter was told that the Board would issue a letter reiterating the steps she would have to take prior to any petition to the Board for reinstatement.The Board took a brief recess.

2:39 p.m.

Ms. Abele 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. Littlejohn and a roll call vote was conducted by President Neuber as follows: Abele-Yes, Adelman-Yes, Giacalone-Yes, Kost-Yes, Littlejohn-Yes, Teater-Yes, and Turner-Yes.

5:15 p.m.

RES. 2001-043   The Executive Session ended and the meeting was opened to the public.Mrs. Teater moved that the Board issue the following letter to Patty J. Baxter regarding the compliance issues with her Board Order:

 

Patty J. Baxter, R.Ph.

4900 Oakridge Drive

Rome, Ohio 44085-9650

Re: R.Ph. License No. 03-1-17642

Dear Ms. Baxter:

 

Upon examination of the documentation you submitted at your hearing on October 2, 2000, in support of your application for reinstatement to practice pharmacy, it is clear that you have not complied with the Settlement Agreement with the State Board of Pharmacy, Docket No. D-980911-014, made effective March 3, 1999.A copy of said Agreement is enclosed herewith.

 

Please pay particular attention to the terms of the Agreement.From this date forward, you need to be prepared, at your next hearing, to present substantive evidence that you have given the urine sample within 12 hours of notification.However, note that the Board removed part of Section (D)(1)(a)(ii) requiring that the lab test be conducted within 48 hours of the collection of the sample.

To restate the requirements for your reinstatement succinctly, you need to submit evidence as to the following:

(D)   September 11, 2000, or thereafter, the Board will reinstate her license to practice pharmacy only if the following conditions have been met:

(1)   Patty Jane Baxter must enter into a contract with a limited treatment provider acceptable to the Board for a period of not less than five (5) years from the effective date of this Agreement and, upon signing, submit a copy of the contract to the Board office.The contract must provide:

(a)   Random, observed urine drug screens shall be conducted at least once a month.

(i)   The urine sample must be given within twelve (12) hours of notification.The urine drug screen must include testing for creatinine or specific gravity of the sample as the dilutional standard.

(ii)   Alcohol and butorphynol (Stadol) must be added to the standard urine drug screen.Testing for alcohol must be conducted within forty-eight hours from the time the sample is given.A breathalyzer may be used to test for alcohol, but the test must be conducted by an appropriately certified individual within twelve hours of notification.

(iii)   Results of urine screens must be negative.Any positive results, including those which may have resulted from ingestion of food, but excluding false positives which resulted from medication legitimately prescribed, indicates a violation of the contract and probation.

(b)   regular attendance, at least three (3) times per week, at an Alcoholics Anonymous, Narcotics Anonymous, and/or similar support group meetings, and at meetings of a professional support group, is required during outpatient treatment and/or during aftercare; and

(c)   the program shall immediately report to the Board of Pharmacy any positive urine screens and/or other violations of the contract.

(E)   Patty Jane Baxter must provide a report from her physician that outlines her treatment for headaches.

(F)   This Agreement, when signed by Patty Jane Baxter, shall constitute her full consent to any and all health care providers, licensed health professionals, treatment programs, or other entities or individuals, to release directly to the Board her medical and/or drug and alcohol treatment records.This release shall be in effect until such time as Patty Jane Baxter has completed the terms of this Agreement.

Assuming you will be prepared to submit this information to the Board, your hearing will be scheduled for Monday, March 5, 2001, at 3:00 p.m.If you wish to request a continuance or have any questions or comments, please call Tim Benedict or David Rowland at the Board office.

Sincerely,

 

William T. Winsley, M.S., R.Ph.

Executive Director

 

cc: Sally Ann Steuk, Assistant Attorney General

 

The motion was seconded by Mrs. Adelman and approved by the Board (Aye-7/Nay-0).

5:20 p.m.

Mr. Winsley distributed a letter to the Board members that had been received in the Board office.The letter addressed a patientís concerns about the workload and stress faced by pharmacists.The Board members took note of the issues raised in the letter, but did not feel that any official action was possible at this time.

5:28 p.m.

The Board recessed until Tuesday, October 3, 2000.

 

 

tuesday, october 3, 2000

 

9:00 a.m.     ROLL CALL

 

The State Board of Pharmacy convened in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Suzanne L. Neuber, R.Ph. (President); Ann D. Abele, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Amonte B. Littlejohn, R.Ph.; and James E. Turner, R.Ph.

9:08 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 Garnet V. Anderson, Pharmacy Intern, Zanesville.

11:19 a.m.

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

11:32 a.m.

The meeting resumed.Ms. Abele 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 Neuber as follows: Abele-Yes, Eastman-Yes, Giacalone-Yes, Kost-Yes, Littlejohn-Yes, and Turner-Yes.

11:55 a.m.

RES. 2001-044   The Executive Session ended and the meeting was opened to the Public.Mr. Giacalone moved that the Board adopt the following Order in the matter of Garnet V. Anderson:

 

(A)     Testimony

 

State's Witnesses:

 

(1)     William Padgett, Ohio State Board of Pharmacy

 

Respondent's Witnesses:

 

(1)     Garnet Valentine Anderson, Respondent

 

(B)     Exhibits

 

State's Exhibits:

 

(1)     Exhibit 1--Copy of four-page Notice of Opportunity for Hearing letter dated May 31, 2000.

(2)     Exhibit 1A--Hearing Request letter dated June 7, 2000.

(3)     Exhibit 1B--Copy of Hearing Schedule letter dated June 15, 2000.

(4)     Exhibit 1C--Copy of four-page Proposal to Deny Exam Application/Notice of Opportunity for Hearing letter dated July 10, 2000.

(5)     Exhibit 1D--Letter of Representation from Daniel D. Connor dated September 8, 2000.

(6)     Exhibit 1E--Intern Registration Record of Garnet Valentine Anderson showing original date of registration as April 28, 1997.

(7)     Exhibit 1F--Renewal Application for Intern License, No. 06-0-00949, for a license to practice pharmacy as an intern in Ohio from September 15, 2000, to September 15, 2001, of Garnet Valentine Anderson dated July 7, 2000.

(8)     Exhibit 1G--Application for Examination as a Pharmacist of Garnet Valentine Anderson signed and notarized on June 29, 2000, with the following attachments: Zanesville Police Department Authorization to Release Information form of Garnet V. Anderson, Zanesville Police Department Record Certification form signed by Jerri Newell, and copy of Criminal Docket report for Garnet V. Anderson, all dated May 12, 2000.

(9)     Exhibit 2--Renewal Application for Intern License, No. 06-0-00949, for a license to practice pharmacy as an Intern in Ohio from September 15, 1999, to September 15, 2000, of Garnet Valentine Anderson dated January 31, 2000.

(10)   Exhibit 3--Zanesville Municipal Court Traffic/Criminal Docket of Garnet V. Anderson regarding case number 99CRB01181.

(11)   Exhibit 4--Two-page letter from Garnet Andersonreceived in the Board office on March 3, 2000.

(12)   Exhibit 5--Copy of page one of Zanesville Police Department Supplementary Report, Inc. # 9906270, dated August 7, 1999.

(13)   Exhibit 6--Letter from Cindy Cash dated March 21, 2000, and attached report of a meeting held on August 16, 1999 between Bruce Umbleby, Cindy Cash, Scott Kimmins, and Garnet Valley Anderson dated March 16, 2000.

(14)   Exhibit 7--Three-page handwritten statement of Garnet V. Anderson signed and notarized on March 15, 2000.

(15)   Exhibit 8--Application for Intern Registration of Garnet Valentine Anderson signed and notarized on April 15, 1997.

 

Respondent's Exhibits:

 

(1)     Exhibit A--Copy of two-page letter from Linda Kirkbride dated September 13, 2000; copy of letter from Paul D. Mumma dated September 26, 2000; letter from Martin Winland, not dated; and letter from Scott A. Kimmins dated September 1, 2000.

 

(1)     Records of the State Board of Pharmacy indicate that Garnet Valentine Anderson was originally licensed to practice pharmacy as an intern in the State of Ohio on April 28, 1997, and is currently licensed as an intern.Records further indicate that Garnet Valentine Anderson submitted an application for examination as a pharmacist on or about July 6, 2000.

 

(2)     Garnet Valentine Anderson did, on or about January 31, 2000, knowingly make a false statement, or knowingly swear or affirm the truth of a false statement previously made, when the statement was made with purpose to secure the issuance by a governmental agency of a license, permit, authorization, certificate, or registration, to wit: Garnet Valentine Anderson falsified her renewal application for pharmacy intern license number 06-0-00949 by indicating that she had never been charged with or convicted of a felony or misdemeanor when she had in fact been criminally charged with and convicted of Disorderly Conduct and Criminal Trespassing on August 9, 1999.Such conduct is in violation of Section 2921.13 of the Ohio Revised Code.

 

(3)     Garnet Valentine Anderson is addicted to and/or abusing liquor or drugs or impaired physically or mentally to such a degree as to render her unfit to practice pharmacy, to wit: Garnet Valentine Anderson admitted that she has no recollection of the events that took place from 2:00 a.m. to 5:00 a.m. on August 7, 1999, after leaving a local bar in Zanesville, Ohio, where she became intoxicated.Garnet Valentine Anderson was found, passed out, lying in the front yard of the residence at 1635 Linden Avenue, Zanesville, Ohio.Officers were unable to wake Garnet Valentine Anderson; they transported Garnet Valentine Anderson to the city jail where she awoke.While being interviewed, Garnet Valentine Anderson stated that she was not really passed out, that she was faking it and only wanted to have a good time.

 

(4)     Garnet Valentine Anderson was, on or about August 9, 1999, convicted of Criminal Trespassing in violation of Section 2911.21 of the Ohio Revised Code and Disorderly Conduct in violation of Section 2917.11 of the Ohio Revised Code, Fourth Degree Misdemeanors, in the Zanesville Municipal Court, State of Ohio v. Garnet V. Anderson, Case No. 99CRB01181.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (2) and (3) of the Findings of Fact constitute being guilty of dishonesty as provided in Division (A)(2) of Section 4729.16 of the Ohio Revised Code.

 

(A)     Pursuant to Section 4729.16 of the Ohio Revised Code, and on the basis of the Findings of Fact and Conclusion of Law set forth above, the State Board of Pharmacy hereby suspends the pharmacy intern license, No. 06-0-00949, of Garnet Valentine Anderson for two years and such suspension is effective as of the date of the mailing of this Order.

 

(B)     Further, the Board suspends the two-year suspension and places Garnet Valentine Andersonís pharmacy intern identification card on probation for two years, effective as of the date of the mailing of this Order.The terms of probation are as follows:

 

(1)     Garnet Valentine Anderson must not violate the drug laws of the state of Ohio, any other state, or the federal government.

 

(2)     Garnet Valentine Anderson must abide by the rules of the Ohio State Board of Pharmacy.

 

(3)     Garnet Valentine Anderson must comply with the terms of this Order.

 

(C)     Pursuant to Section 4729.08 of the Ohio Revised Code, and the foregoing Findings of Fact and Conclusion of Law, the State Board of Pharmacy hereby accepts the Application for Examination as a Pharmacist submitted by Garnet V. Anderson, and will provisionally allow her to sit for the examination with the stipulation that, if Garnet Valentine Anderson successfully completes the examination, her pharmacist license will be placed on probation effective as of the issuance of the pharmacist identification card through October 6, 2002.The terms of probation are as follows:

 

(1)     The State Board of Pharmacy hereby declares that Garnet V. Andersonís pharmacist identification card is not in good standing and thereby denies the privilege of being a preceptor and training pharmacy interns pursuant to paragraph (D)(1) of Rule 4729-3-01 of the Ohio Administrative Code.

 

(2)     Garnet V. Anderson may not serve as a responsible pharmacist.

 

(3)     Garnet V. Anderson must not violate the drug laws of the state of Ohio, any other state, or the federal government.

 

(4)     Garnet V. Anderson must abide by the rules of the Ohio State Board of Pharmacy.

 

(5)     Garnet V. Anderson must comply with the terms of this Order.

 

(D)     The Board may at any time revoke probation for cause, modify the conditions of probation, and reduce or extend the period of probation.At any time during this period of probation, the Board may revoke probation for a violation occurring during the probation period.

 

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-6/Nay-0).

12:00 p.m.

The Board recessed for lunch.

1:00 p.m.

The Board convened in Room 1919, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio, for the purpose of meeting with the candidates for licensure by reciprocity with the following members present:

 

Suzanne L. Neuber, R.Ph. (President); Ann D. Abele, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Amonte B. Littlejohn, R.Ph.; Dorothy Teater, Public Member; and James E. Turner, R.Ph.

 

RES. 2001-045   Following presentations by Board members and self-introductions by the candidates for licensure by reciprocity, Mr. Littlejohn moved that the Board approve the following candidates for licensure.The motion was seconded by Mrs. Teater and approved by the Board (Aye-7/Nay-0).

 

SHERRY LYNN BOYD

 

03-1-24424

 

MICHIGAN

RONALD JOSEPH CLERICO

 

03-1-24407

 

PENNSYLVANIA

AMANDA DAWN DAILEY

 

03-1-24400

 

WEST VIRGINIA

ANTHONY JAMES MANSON

 

03-1-24404

 

UTAH

MARIA SCHOLASTICA NAMATA

 

03-1-24409

 

INDIANA

JENNIFER TROFE

 

03-1-24417

 

PENNSYLVANIA

ALAN BRUCE WHITE

 

03-1-24381

 

ILLINOIS

TARA LEIGH ZEMSKI

 

03-1-24415

 

MICHIGAN

1:30 p.m.

The Board reconvened in Room 1914 to continue the regular business of the Board.The Board continued their discussion of the Continuing Pharmacy Education (C.P.E.) requirements contained in Chapter 4729-7 of the Administrative Code.

2:50 p.m.

The discussion on the continuing education requirement ended.The consensus of the Board was that a compliance bulletin should be sent out to all licensed pharmacists that reminds the pharmacists about the increases in the C.P.E. requirements.The Board recessed until Wednesday, October 4, 2000.

 

 

wednesday, october 4, 2000

 

8:45 a.m.     ROLL CALL

 

The State Board of Pharmacy convened in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Suzanne L. Neuber, R.Ph. (President); Ann D. Abele, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; and James E. Turner, R.Ph.

8:55 a.m.

Ms. Abele moved that the Minutes of the September 5, 6, 7, 2000 Board meeting be approved as written.The motion was seconded by Ms. Eastman and approved by the Board (Aye-5/Nay-0).

9:08 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 matters of Bethesda Hospital-North, Terminal Distributor, Cincinnati and Good Samaritan Hospital Pharmacy, Terminal Distributor, Cincinnati.

9:11 a.m.

Mr. Littlejohn arrived and joined the hearing in progress.All parties agreed that he would participate in the hearing and its deliberations.

12:08 p.m.

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

1:03 p.m.

The Board meeting resumed in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with all members present except Ms. Eastman and Mrs. Adelman.

 

RES. 2001-046   Mr. Benedict presented a request from Mercy Health Partners (Toledo) for an exemption from the requirements of Rule 4729-5-10 (Pick-up station) in preparation for a pending bargaining unit action that would affect the systemís outpatient areas.Mr. Giacalone moved that the Board approve the request on a provisional basis.The authorization to serve as a pick-up station would only take effect if a job action occurred and would last only until the end of such job action.The motion was seconded by Mr. Turner and approved by the Board (Aye-6/Nay-0).

1:05 p.m.

The Board was joined by the following individuals representing the four colleges of pharmacy in Ohio for a discussion about items of common interest:

 

Alan Escovitz, Robert Lee, Dean John Cassidy, Dean Johnnie Early, Dean Bobby Bryant, Wayne Hoss, and Sylvan Frank.

 

Discussion with this group focused on the following areas:

 

1.     Exam Report

2.     Legislation/Rules Review

3.     Licensing Statistics

4.     State Funding for Professional Licensing Programs

5.     Increasing Board & Student Interaction

1:25 p.m.

Ms. Eastman arrived and joined the meeting in progress.

2:50 p.m.

The meeting with the representatives from the Ohio colleges of pharmacy ended and the Board took a brief recess.

3:05 p.m.

Ms. Abele 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. Kost and a roll call vote was conducted by President Neuber as follows: Abele-Yes, Eastman-Yes, Giacalone-Yes, Kost-Yes, Littlejohn-Yes, Teater-Yes, Turner-Yes.

4:15 p.m.

RES. 2001-047   The Executive Session ended and the meeting was opened to the Public.Mr. Littlejohn moved that the Board adopt the following Order in the matter of Bethesda Hospital-North:

 

(A)     Testimony

 

State's Witnesses:

 

(1)     William F. McMillen, R.Ph., Ohio State Board of Pharmacy

(2)     Elaine Jones, R.Ph., Ohio State Board of Pharmacy

 

Respondent's Witnesses:

 

(1)     Steve Porowski, Responsible Pharmacist, Bethesda Hospital-North

(2)     Susan McBeth, R.Ph., Responsible Pharmacist, Good Samaritan Hospital

 

(B)     Exhibits

 

State's Exhibits:

 

(1)     Exhibit 1--Copy of four-page Notice of Opportunity for Hearing letter dated May 30, 2000.

(2)     Exhibit 1A--Hearing Request letter dated June 27, 2000.

(3)     Exhibit 1B--Copy of Hearing Schedule letter dated June 30, 2000.

(4)     Exhibit 1C--Copy of Renewal Application for DDD License, No. 02-0032100, for a terminal distributor of dangerous drugs license from January 1, 2000, to December 31, 2000, of Bethesda Hospital-North signed and dated by Stephen Porowski on September 13, 1999.

(5)     Exhibit 2--Copy of four-page Settlement Agreement with the State Board of Pharmacy, Docket No. D-970121-028, in the matter of Bethesda Hospital-North effective June 16, 1997.

(6)     Exhibit 3--Copy of Incident Form of Bethesda North Hospital, Complaint No. 17327, dated December 20, 1999.

(7)     Exhibit 4--Copy of Ohio State Board of Pharmacy Report of Investigation regarding Theft of Drugs from Bethesda North Hospital, Case No. 99-2261, by Specialist Elaine Jones dated February 24, 2000.

(8)     Exhibit 5--Copy of ten-page Dangerous Drug Distributor Inspection Report of Bethesda North Hospital dated December 16, 1999, and attached copy of Seniority List - North Pharmacy R.Ph.ís dated November, 1999.

(9)     Exhibit 6--Copy of page one of ten-page Dangerous Drug Distributor Inspection Report of Bethesda North Hospital dated December 16, 1999, and copy of four pages of response to pink sheet dated January 3, 2000.

(10)   Exhibit 7--Copy of five-page Dangerous Drug Distributor Inspection Report of Bethesda Hospital-North dated February 7, 1996.

(11)   Exhibit 8--Copy of Memorandum regarding Procedure for Signing in Narcotics on the Floors dated February 23, 1996; copy of blank Narcotic Checklist log sheet; copy of blank Drug Disposition and Controlled Substance Audit Record form; copy of front side of DEA Form 106 of Bethesda North Hospital dated January 1, 1995, through December 31, 1995; and copy of front side of DEA Form 106 of Bethesda North Hospital dated January 1, 1996, through February 29, 1996.

(12)   Exhibit 9--Copy of four-page Dangerous Drug Distributor Inspection Report of Bethesda Hospital-North dated November 5, 1986.

(13)   Exhibit 10--Copy of four-page response to pink sheet items with the following attachments: copy of letter from Peter D. Reeme dated November 18, 1986; copy of memo from David Day regarding retention of fill lists and chart check records dated November 5, 1986; and copy of memo from David Day regarding clarification of documentation requirements on cart fill lists dated November 6, 1986.

(14)   Exhibit 11--Copy of eight-page Dangerous Drug Distributor Inspection Report of Bethesda Hospital-North dated October 1, 1998; and attached copy of Licensure Information Form of Bethesda North, not dated.

(15)   Exhibit 12--Copy of three-page Dangerous Drug Distributor Inspection Report of Bethesda Hospital-North dated August 26, 1997, and attached page titled ďChanges Made to Increase Security and Recordkeeping at Bethesda North Hospital,Ē not dated.

(16)   Exhibit 13--Copy of two-page Dangerous Drug Distributor Inspection Report of Bethesda Hospital-North dated August 2, 1994.

 

Respondent's Exhibits:

 

(1)     Exhibit A--Copy of four-page Notice of Opportunity for Hearing letter dated May 30, 2000.

(2)     Exhibit B--Copy of two-page Response to Opportunity for Hearing, not dated.

(3)     Exhibits C1 and C2--Copy of two-page Controlled Drug Update, not dated.

(4)     Exhibit C3--Copy of Changes Made to Increase Security and Recordkeeping at Bethesda North Hospital, not dated.

(5)     Exhibits C4 through C6--Copy of three-page Dangerous Drug Distributor Inspection Report of Bethesda Hospital-North dated August 26, 1997.

(6)     Exhibits C7 through C14--Copy of eight-page Dangerous Drug Distributor Inspection Report of Bethesda Hospital-North dated October 1, 1998.

(7)     Exhibit C15--Copy of notes regarding the State Board of Pharmacy Visit of September 29, 1998.

(8)     Exhibit C16--Copy of memo from Steve Porowski regarding controlled substance storage dated June 17, 1999.

(9)     Exhibit C17--Copy of procedure for common controlled substances floor-stocking, not dated.

(10)   Exhibit C18--Copy of procedure for placing ties on returned anesthesia kits, not dated.

(11)   Exhibits C19 through C28--Copy of ten-page Dangerous Drug Distributor Inspection Report of Bethesda North Hospital dated December 16, 1999.

(12)   Exhibit C29--Copy of response to the State Board Inspection of December 16, 1999, not dated.

(13)   Exhibit D1--Copy of TriHealth Hospitals Pharmacy Department Control Drug Discrepancy Report of Bethesda Hospital-North dated December 3, 1999.

(14)   Exhibits D2 and D3--Two-page copy of DEA Form 106, Report of Theft or Loss of Controlled Substances, of Bethesda North Hospital dated December 14, 1999.

(15)   Exhibit D4--Copy of two-page letter from Diana L. Housman dated October 1, 2000.

(16)   Exhibit E1--Copy of TriHealth Records Center Transfer List of North Pharmacy dated September, 1999.

(17)   Exhibit E2--Copy of TriHealth Records Center Transfer List of Rx-Pharmacy dated January 18, 2000.

(18)   Exhibit F1--Copy of Bethesda Hospital Controlled Drug Record of Administration/-Destruction, Anesthesia Department, for Kit A, Number 186, dated September, 2000.

(19)   Exhibit F2--Copy of table for drug records of anesthesia kits dated September 20, 2000.

(20)   Exhibit F3--Copy of Pharmacy Narcotic Record of Fentanyl 2ml Amp dated from September 14, 2000, through September 25, 2000.

(21)   Exhibit G1--Copy of Surgery North Anesthesia Kit Sign-Out Sheet dated September 19, 2000.

(22)   Exhibit G2--Copy of Pyxis Corporation Supplement to Purchase and Customer Support Agreement sold to Bethesda North Hospital, not dated.

(23)   Exhibit H--Copy of letter from G. Keith Bullock dated May 28, 1999.

 

(1)     Records of the State Board of Pharmacy indicate that Steve Porowski is the Responsible Pharmacist at Bethesda Hospital-North pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule 4729-17-02 of the Ohio Administrative Code; and, Mr. Porowski has held that position since June 18, 1988.

 

(2)     Records further indicate that Bethesda Hospital-North entered into a Settlement Agreement with the State Board of Pharmacy, Docket No. D-970121-028, effective June 16, 1997.The terms of the Settlement Agreement included:a monetary penalty of ten thousand dollars ($10,000.00); and proof of compliance with Ohio and federal laws, rules, and regulations.Contrary to the terms of the Settlement Agreement, Bethesda Hospital-North has failed to show compliance with Ohio and federal laws, rules, and regulations.Such conduct is in violation of the terms of its Settlement Agreement with the Board.

 

(3)     Bethesda Hospital-North, an institutional pharmacy, did, on or about July 1999, through December 16, 1999, fail to maintain records of all drug orders and records relating to the practice of pharmacy, to wit: the Responsible Pharmacist at Bethesda Hospital-North, Steve Porowski, failed to maintain physician drug orders and/or other adequate system of recordkeeping.Such conduct is in violation of Rule 4729-17-04(B) of the Ohio Administrative Code.

 

(4)     Bethesda Hospital-North, on or about December 16, 1999, and dates preceding, failed to provide controls adequate to prevent diversion of drugs; failed to institute recordkeeping procedures to account adequately for the drugs when used and who obtained the drugs from the drug supply; failed to ensure that such drugs are properly labeled and packaged in sufficient quantities to provide drug therapy during the period when the institutional pharmacy is not open; and failed to provide procedures for the inspection of the contingency drug inventory to assure proper utilization and replacement of the drug supply, to wit: Bethesda Hospital-North technicians obtained, restocked, and returned contingency drugs or anesthesia trays and, at no time during this process, were the trays checked by a pharmacist.Further, Bethesda Hospital-North did not maintain documentation for accountability of such procedures.Such conduct is in violation of Rule 4729-17-03(A)(2) of the Ohio Administrative Code.

 

(5)     Bethesda Hospital-North, on or about December 16, 1999, and dates immediately preceding, failed to provide storage of its contingency trays in a secure area and/or in containers with tamper-evident seals; failed to provide adequate recordkeeping procedures to document the disposition of the drugs in supply; and failed to maintain security, to wit: the surgery unit's anesthesia cabinet at Bethesda Hospital-North was left unlocked during the day and unused drugs on the anesthesiologist's drug trays were left unsecured, allowing anyone in the surgery area to gain access to controlled substances.Such conduct is in violation of paragraphs (B) and (C) of Rule 4729-17-03 of the Ohio Administrative Code.

 

(6)     Bethesda Hospital-North did, prior to December 16, 1999, cease to satisfy the qualifications of a terminal distributor of dangerous drugs set forth in Section 4729.55 of the Revised Code, to wit: Bethesda Hospital-North failed to provide adequate safeguards to prevent the sale or other distribution of dangerous drugs by any person other than a pharmacist or licensed health professional authorized to prescribe drugs.Further, Bethesda Hospital-North has not instituted proper policies and procedures to maintain supervision and control of the possession and custody of all dangerous drugs acquired by the institutional facility.Such conduct is in violation of Rule 4729-17-02(A) of the Ohio Administrative Code, and not in accordance with Section 4729.55(C) of the Ohio Revised Code.

 

(7)     Bethesda Hospital-North, an institutional pharmacy, did, on or about December 16, 1999, and dates immediately preceding, fail to maintain records of positive identification of the pharmacist responsible for performing all activities relating to the practice of pharmacy when entering prescription information into the recordkeeping system, to wit: Bethesda Hospital-North pharmacists used a password without a second means to meet positive identification requirements.Such conduct is in violation of Rule 4729-5-27(A) of the Ohio Administrative Code.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (3) through (7) of the Findings of Fact constitute violating rules of the Board as provided in Division (A)(2) of Section 4729.57 of the Ohio Revised Code.

 

(A)     The State Board of Pharmacy hereby imposes a monetary penalty of six thousand dollars.

 

(B)     Further, the Board will suspend three thousand dollars of the six thousand dollar monetary penalty provided that Bethesda Hospital-North comply with the terms of this Order.The monetary penalty of three thousand dollars ($3,000.00) is due and owing within thirty days of the issuance of this Order.The monetary penalty should be made payable to the "Treasurer, State of Ohio" and mailed with the enclosed form to the State Board of Pharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126.Other terms of this Order are as follows:

 

(1)     Bethesda Hospital-North must correct the violations noted in the Findings of Fact stated herein within ninety days of the effective date of this Order and notify the Ohio State Board of Pharmacy Compliance Specialist in its area that the corrections have been made.The specialist will conduct an inspection within the ninety-day period.The inspection must show compliance with Ohio and federal laws, rules and regulations.

 

(2)     Bethesda Hospital-North Pharmacy will be subject to inspection annually for three years.

 

(3)     Bethesda Hospital-North Pharmacy must notify the Board of any proposed changes to its policies and procedures before implementation.

 

 

The motion was seconded by Ms. Abele and approved by the Board (Aye-5/Nay-1/Abstain-1[Teater]).

4:20 p.m.

RES. 2001-048   Ms. Abele then moved that the Board adopt the following Order in the matter of Good Samaritan Hospital Pharmacy:

 

(A)     Testimony

 

State's Witnesses:

 

(1)     William F. McMillen, Ohio State Board of Pharmacy

(2)     Elaine Jones, R.Ph., Ohio State Board of Pharmacy

 

Respondent's Witnesses:

 

(1)     Steve Porowski, Responsible Pharmacist, Bethesda Hospital-North

(2)     Susan McBeth, R.Ph., Responsible Pharmacist, Good Samaritan Hospital

 

(B)     Exhibits

 

State's Exhibits:

 

(1)     Exhibit 1--Copy of four-page Notice of Opportunity for Hearing letter dated May 30, 2000.

(2)     Exhibit 1A--Hearing Request Letter dated June 26, 2000.

(3)     Exhibit 1B--Copy of Hearing Schedule letter dated July 6, 2000.

(4)     Exhibit 1C--Copy of Renewal Application for DDD License, No. 02-0030650, for a terminal distributor of dangerous drugs license from January 1, 2000, to December 31, 2000, of Good Samaritan Hospital signed by Susan K. McBeth dated October 20, 1999.

(5)     Exhibit 2--Copy of four-page Settlement Agreement with the State Board of Pharmacy, Docket No. D-970121-029, in the matter of Good Samaritan Hospital effective June 16, 1997.

(6)     Exhibit 3--Copy of ten-page Dangerous Drug Distributor Inspection Report of Good Samaritan Hospital dated December 21, 1999.

(7)     Exhibit 4--Two-page copy of response to pink sheet signed by Susan McBeth, not dated.

(8)     Exhibit 5--Copy of three-page Dangerous Drug Distributor Inspection Report of Good Samaritan Hospital dated February 8, 1996.

(9)     Exhibit 6--Two-page copy of response to pink sheet, not dated.

(10)   Exhibit 7--Copy of six-page Dangerous Drug Distributor Inspection Report of Good Samaritan Hospital dated September 30, 1998; and copy of Licensure Information for the Pharmacy Department dated from 1998through 1999.

(11)   Exhibit 8--Copy of Dangerous Drug Distributor Inspection Report of Good Samaritan Hospital dated August 27, 1997.

 

Respondent's Exhibits:

 

(1)     Exhibit A--Copy of four-page Notice of Opportunity for Hearing letter dated May 30, 2000.

(2)     Exhibit B--Copy of response to the allegations sent to Good Samaritan Hospital on May 30, 2000, not dated.

(3)     Exhibit C--Copy of letter from G. Keith Bullock dated May 28, 1999.

 

(1)     Records of the State Board of Pharmacy indicate that Susan McBeth is the Responsible Pharmacist at Good Samaritan Hospital pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule 4729-17-02 of the Ohio Administrative Code.

 

(2)     Records further indicate that Good Samaritan Hospital entered into a Settlement Agreement with the State Board of Pharmacy, Docket No. D-970121-029, dated June 16, 1997.The terms of the Settlement Agreement include: a monetary penalty of six thousand dollars ($6,000.00) and proof of compliance with Ohio and federal laws, rules, and regulations.Contrary to the terms of the Settlement Agreement, Good Samaritan Hospital has failed to show compliance with Ohio and federal laws, rules, and regulations.

 

(3)     Good Samaritan Hospital, an institutional pharmacy, on or about December 21, 1999, and dates immediately preceding, failed to maintain records of positive identification of the pharmacist responsible for performing all activities relating to the practice of pharmacy when entering prescription information into the recordkeeping system, to wit: Good Samaritan Hospital pharmacists use a password without a second means to meet positive identification requirements.Such conduct is in violation of Rule 4729-5-27(A) of the Ohio Administrative Code.

 

(4)     Good Samaritan Hospital, an institutional pharmacy, on or about December 21, 1999, and dates immediately preceding, failed to make all records relating to the practice of pharmacy readily available and promptly produced upon request for inspection by State Board of Pharmacy officers, agents, and/or inspectors during regular business hours, to wit: Good Samaritan Hospital discarded physiciansí orders after thirty days from the time they were entered into the computer system and were not produced when requested.Such conduct is in violation of Rule 4729-5-27(H) of the Ohio Administrative Code.

 

(5)     Good Samaritan Hospital, an institutional pharmacy, on or about December 21, 1999, and dates immediately preceding, failed to store adulterated drugs in a separate and secure area apart from the storage of drugs used for dispensing and administration, to wit: State Board of Pharmacy Specialists observed expired drugs on the shelves with non-expired drugs.Such conduct is in violation of Rule 4729-9-17 of the Ohio Administrative Code.

 

(6)     Good Samaritan Hospital, an institutional pharmacy, on or about December 21, 1999, and dates immediately preceding, failed to have the Responsible Pharmacist ensure adherence to Rule 4729-17-02 of the Ohio Administrative Code, to wit: Good Samaritan Hospitalís Responsible Pharmacist, Susan McBeth, did not properly assure adherence to policies and procedures for the safe and efficient distribution of drugs in all areas of the institution; ensure responsibility for the security and control of all drugs within the institution; maintain all records, required by state or federal law to be kept at the licensed location, of the acquisition, use, distribution, and disposition of all drugs; and implement written policies and procedures which were to be consistent with Chapter 4729-17 of the Ohio Administrative Code and other applicable federal and state laws and rules governing the legal distribution of drugs. Such conduct is in violation of Rule 4729-17-02(C) of the Ohio Administrative Code.

 

(7)     Good Samaritan Hospital, an institutional pharmacy, on or about December 21, 1999, and dates immediately preceding, failed to maintain records of all drug orders and records relating to the practice of pharmacy, to wit: though such orders and records may be microfilmed or retained by any process providing an exact duplicate of the original order, Good Samaritan Hospital did not maintain any such records.In addition, there was no alternate system of recordkeeping utilized, allowing such records to be stored on any storage medium that meets industry standards for quality having stability, for a period of at least three years.Records on an automated data processing system, or subsequent storage of such records, were not readily retrievable (via CRT display or hard-copy printout) within seventy-two hours.Such conduct is in violation of Rule 4729-17-04(B) of the Ohio Administrative Code.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (3) through (7) of the Findings of Fact constitute violating rules of the Board as provided in Division (A)(2) of Section 4729.57 of the Ohio Revised Code.

 

(A)     The State Board of Pharmacy hereby imposes a monetary penalty of five thousand dollars.

 

(B)     Further, the Board will suspend two thousand five hundred dollars of the five thousand-dollar monetary penalty provided that Good Samaritan Hospital comply with the terms of this Order.The monetary penalty of two thousand five hundred dollars ($2,500.00) is due and owing within thirty days of the issuance of this Order.The monetary penalty should be made payable to the "Treasurer, State of Ohio" and mailed with the enclosed form to the State Board of Pharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126.Other terms of this Order are as follows:

 

(1)     Good Samaritan Hospital must correct the violations noted in the Findings of Fact stated herein within ninety days of the effective date of this Order and notify the State Board of Pharmacy Compliance Specialist in its area that the corrections have been made.The specialist will conduct an inspection within the ninety-day period.The inspection must show compliance with Ohio and federal laws, rules and regulations.

 

(2)     Good Samaritan Hospital will be subject to inspection annually for three years.

 

(3)     Good Samaritan Hospital must notify the Board of any proposed changes to its policies and procedures before implementation.

 

 

The motion was seconded by Ms. Eastman and approved by the Board (Aye-5/Nay-1/Abstain-1[Teater]).

4:22 p.m.

RES. 2001-049   Mr. Winsley distributed a proposed patient notification form from RxMadeSimple.com.The Board had tabled a decision on this electronic prescription transmission system at the September, 2000 meeting pending receipt of this document.After review and discussion, the consensus of the Board members was that this would make the system approvable pending an inspection by Board staff before the programís implementation.

4:24 p.m.

Mr. Littlejohn moved that the Board receive Per Diem as follows:

 

PER DIEM

09/13

10/02

10/03

10/04

Total

Abele

1

1

1

1

4

Adelman

1

1

-

-

2

Eastman

1

-

1

1

3

Giacalone

-

1

1

1

3

Littlejohn

1

1

1

1

4

Kost

1

1

1

1

4

Neuber

1

1

1

1

4

Teater

-

1

1

1

3

Turner

1

1

1

1

4

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0).

4:25 p.m.

Mr. Littlejohn moved that the meeting be adjourned.The motion was seconded by Mr. Kost and approved (Aye-7/Nay-0).

 

 

 

 

THE BOARD APPROVED THESE MINUTES ON NOVEMBER 8, 2000.