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

September 8, 9, 10, 2003

 

MONDAY, September 8, 2003

 

  8:00 a.m.

ROLL CALL

 

 

The State Board of Pharmacy convened in Room East-B, 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.; Nathan S. Lipsyc, 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.

 

Mr. Rowland announced that the following settlement agreements had been signed by all parties and were now effective:

 

R-2004-037

 

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-030109-053)

 

In The Matter Of:

 

DAVID L. RIEDER, R.Ph.

333 Belleview Avenue

Chillicothe, Ohio 45601-3701

(R.Ph. No. 03-3-09634)

 

 

 

This Settlement Agreement is entered into by and between David L. Rieder 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 L. Rieder 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 L. Rieder 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 L. Rieder is licensed to practice pharmacy in the State of Ohio.

 

Whereas, on or about January 9, 2003, pursuant to Chapter 119. of the Ohio Revised Code, David L. Rieder 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 L. Rieder re­quested a hearing; it was scheduled and continued.  The January 9, 2003, Notice of Opportunity for Hearing contains the following allegations or charges:

 

 

(1)

Records of the Board of Pharmacy indicate that David L. Rieder was originally licensed in the State of Ohio on July 27, 1970, pursuant to examination, and is currently licensed to practice pharmacy in the State of Ohio.

 

 

(2)

David L. Rieder did, from January 13, 2001, to September 23, 2001, by deception, procure the administration of, a prescription for, or the dispensing of a dangerous drug, to wit: David L. Rieder did, while working as a pharmacist at Kroger’s Phar­macy, fill the following unauthorized prescriptions for himself:

 

Rx No.

Date

Drug Type

Strength

Qty

6606574

01/13/01

Guaifen/PSE 600

60 mg

36

6607438

02/04/01

amoxicillin

500 mg

60

6607439

02/04/01

Guaifen/PSE 600

60 mg

115

6607937

02/17/01

amoxicillin

500 mg

30

6608200

02/24/01

naproxen

375 mg

57

6609199

03/28/01

loperamide

2 mg

60

6610133

05/08/01

naproxen

250 mg

60

6610683

06/04/01

naproxen

375 mg

60

6611110

06/23/01

Elimite Cream 5%

 

60

6611387

07/05/01

Methylprednisln DSPK

4 mg

21

6611387

07/30/01

Methylprednisln DSPK

4 mg

21

6612177

08/12/01

piroxicam

20 mg

18

6612891

09/04/01

Nalfon

300 mg

37

6613477

09/23/01

Ansaid

100 mg

100

 

 

 

Such conduct is in violation of Section 2925.22 of the Ohio Revised Code.

 

 

(3)

David L. Rieder did, from July 1, 2000, through December 31, 2001, did knowingly sell a controlled substance in an amount less than the bulk amount when the con­duct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: without a prescription and without a legitimate medical pur­pose, David L. Rieder sold the following drugs to his mother:

 

Rx No.

Date

Drug Type

Strength

Qty

4400188

07/01/00

Darvocet

100/650 mg

100

4400188-refill

08/03/00

Darvocet

100/650 mg

100

4401046

01/20/01

Darvocet

100/650 mg

100

4402196

09/29/01

Darvocet

100/650 mg

100

 

 

 

Such conduct is in violation of Section 2925.03 of the Ohio Revised Code.

 

 

(4)

David L. Rieder did, from July 1, 2000, through December 31, 2001, sell at retail dan­gerous drugs when the conduct was not in accordance with Chapters 4729. and 4731. of the Ohio Revised Code, to wit: without a prescription and without a legiti­mate medical purpose, David L. Rieder sold the following drugs to his mother:

 

Rx No.

Date

Drug Type

Strength

Qty

4400188

07/01/00

Darvocet

100/650 mg

100

4400188-refill

08/03/00

Darvocet

100/650 mg

100

4401046

01/20/01

Darvocet

100/650 mg

100

4402196

09/29/01

Darvocet

100/650 mg

100

6600404

05/27/00

spironlactone

25 mg

60

6600404-refill

07/01/00

spironlactone

25 mg

60

6600404-refill

09/08/00

spironlactone

25 mg

60

6600404-refill

10/06/00

spironlactone

25 mg

60

6600404-refill

11/02/00

spironlactone

25 mg

60

6600404-refill

12/07/00

spironlactone

25 mg

60

6600404-refill

01/27/01

spironlactone

25 mg

60

6600404-refill

02/23/01

spironlactone

25 mg

60

6600404-refill

03/22/01

spironlactone

25 mg

60

6600404-refill

04/20/01

spironlactone

25 mg

60

6601781

07/01/00

Evista

60 mg

30

6602576

08/07/00

furosemide

40 mg

30

6602576-refill

09/20/00

furosemide

40 mg

30

6602576-refill

10/20/00

furosemide

40 mg

30

6602576-refill

10/26/00

furosemide

40 mg

30

6602576-refill

12/28/00

furosemide

40 mg

30

6602576-refill

02/23/01

furosemide

40 mg

30

6602576-refill

04/20/01

furosemide

40 mg

30

6602604

08/24/00

Zoloft

50 mg

30

6602604-refill

09/20/00

Zoloft

50 mg

30

6602604-refill

10/20/00

Zoloft

50 mg

30

6602604-refill

11/23/00

Zoloft

50 mg

30

6602604-refill

12/28/00

Zoloft

50 mg

30

6602604-refill

01/27/01

Zoloft

50 mg

30

6602604-refill

03/01/01

Zoloft

50 mg

30

6602604-refill

03/30/01

Zoloft

50 mg

30

6603507

09/17/00

Evista

60 mg

30

6603507-refill

10/12/00

Evista

60 mg

30

6603507-refill

11/09/00

Evista

60 mg

30

6603507-refill

02/01/01

Evista

60 mg

30

6603507-refill

03/01/01

Evista

60 mg

30

6603507-refill

03/30/01

Evista

60 mg

30

6603507-refill

06/04/01

Evista

60 mg

30

6603507-refill

07/05/01

Evista

60 mg

30

6603507-refill

08/06/01

Evista

60 mg

30

6603507-refill

09/01/01

Evista

60 mg

30

6604421

10/22/00

loperamide

2 mg

30

6604421-refill

12/28/00

loperamide

2 mg

30

6604421-refill

03/01/01

loperamide

2 mg

30

6611010

06/19/01

Aricept

5 mg

34

6611806

07/24/01

Zoloft

50 mg

30

6611806-refill

08/18/01

Zoloft

50 mg

30

6611806-refill

09/23/01

Zoloft

50 mg

30

6611806-refill

10/22/01

Zoloft

50 mg

30

6611806-refill

11/16/01

Zoloft

50 mg

30

6611806-refill

12/31/01

Zoloft

50 mg

30

6613656

09/29/01

potassium

10 mg

180

6613656-refill

12/31/01

potassium

10 mg

180

6613657

09/29/01

Evista

60 mg

30

6613657-refill

11/04/01

Evista

60 mg

30

6613657-refill

11/30/01

Evista

60 mg

30

6613657-refill

12/31/01

Evista

60 mg

30

 

 

 

Such conduct is in violation of Section 4729.51(C)(1) of the Ohio Revised Code.

 

 

 

David L. Rieder neither admits nor denies the allegations stated in the Notice of Opportunity for Hearing letter dated January 9, 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 L. Rieder knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

 

 

(A)

David L. Rieder's license to practice pharmacy in the State of Ohio is on probation for a period of two (2) years commencing with the date of this Agreement.  Terms of probation are as follows:

 

 

(1)

The State Board of Pharmacy hereby declares that David L. Rieder's 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)

David L. Rieder may not serve as a responsible pharmacist.

 

 

(3)

David L. Rieder may not destroy, assist in, or witness the destruction of con­trolled substances.

 

 

(4)

David L. Rieder must not violate the drug laws of Ohio, any other state, or the federal government.

 

 

(5)

David L. Rieder must abide by the rules of the State Board of Pharmacy.

 

 

(B)

David L. Rieder agrees to the imposition of a monetary penalty of two thousand five hundred dollars ($2,500.00) due and owing within sixty (60) 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.

 

 

 

If, in the judgment of the Board, David L. Rieder 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 L. Rieder 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 L. Rieder 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 L. Rieder 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.  David L. Rieder 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.

 

 

R-2004-038

 

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-020910-007)

 

In The Matter Of:

 

MAYNARD D. TURNER, R.Ph.

Rural Route 1

6912 White Oak N.E.

Bloomingburg, Ohio 43106

(R.Ph. No. 03-2-09730)

 

This Settlement Agreement is entered into by and between Maynard D. Turner 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.

 

Maynard D. Turner 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.  Maynard D. Turner 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, on or about September 10, 2002, pursuant to Chapter 119. of the Ohio Revised Code, Maynard D. Turner 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. Maynard D. Turner requested a hearing; it was scheduled and continued.  The September 10, 2002 Summary Suspension and July 22, 2003 Addendum Notice contain the following allegations or charges:

 

 

(1)

Records of the Board of Pharmacy indicate that Maynard D. Turner was originally licensed in the State of Ohio on February 8, 1971, pursuant to examination, and was Summarily Suspended on September 10, 2002.  Records further reflect during the relevant time periods stated herein, Maynard D. Turner was the Responsible Pharma­cist at CVS/Pharmacy #3408 pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Section 4729-5-11 of the Ohio Administrative Code.

 

 

(2)

Maynard D. Turner is addicted to liquor or drugs or impaired physically or mentally to such a degree as to render him unfit to practice pharmacy, to wit: on or about August 22, 2002, Maynard D. Turner admitted to an agent of the Board of Pharmacy that he believes he has been addicted to Xanax and Fioricet for the past two years; and, that his addiction has reached its peak within the past few weeks at six (6) to eight (8) Xanax a day and four (4) to five (5) Fioricet a day.  Maynard D. Turner admit­ted to stealing Xanax to cope with the stress of working at CVS/Pharmacy #3408, and he admitted stealing Fioricet for headaches.  Such conduct indicates that Maynard D. Turner is addicted to the use of controlled substances within the mean­ing of Sections 3719.121 and 4729.16 of the Ohio Revised Code.

 

 

(3)

Maynard D. Turner did, on or about unknown dates prior to August 22, 2002, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of CVS/Pharmacy #3408, by deception, to wit: Maynard D. Turner stole the following drugs over the past two years.  Maynard D. Turner also stole various other types of maintenance medications for the treatment of colds and allergies.

 

Drug

Qty.

Vicodin 5/500 mg

200

Ambien

200

Valium

200

hydrocodone/apap 5/500 mg

1.5

alprazolam 0.25 mg

8

alprazolam 0.5 mg

3

alprazolam 1 mg

14

diazepam 5 mg

3

butalbital/apap/caffeine

3

flurbiprofen 100 mg

3

Levbid Extended-Release 0.375 mg

3

Claritin-D

1

sulfamethoxazole/trimethoprim

1

Guaifenex PSE 120 mg

4.5

Mycelex Troche 10 mg

3

Cetirizine HCI

3

butalbital/apap/Caffeine

5

Acetaminophen/Codeine #4

4

atropine sulfate/diphenoxylate HCL

19

Concerta 36 mg

27

 

 

 

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

 

 

(4)

Maynard D. Turner did, on or about unknown dates prior to August 22, 2002, know­ingly possess or use controlled substances when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: agents of the Board of Pharmacy removed the following drugs, obtained without valid prescriptions, from Maynard D. Turner’s residence:

 

Drug

Qty.

hydrocodone/apap 5/500 mg

1.5

alprazolam 0.25 mg

8

alprazolam 0.5 mg

3

alprazolam 1 mg

14

diazepam 5 mg

3

Acetaminophen/Codeine #4

4

atropine sulfate/diphenoxylate HCL

19

Concerta 36 mg

27

 

 

 

Such conduct is in violation of Section 2925.11 of the Ohio Revised Code.

 

 

(5)

Maynard D. Turner did, on or about unknown dates prior to August 22, 2002, know­ingly possess or use dangerous drugs when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: agents of the Board of Pharmacy removed the following dangerous drugs, obtained without valid prescriptions, from Maynard D. Turner’s residence:

 

Drug

Qty.

butalbital/apap/caffeine

3

flurbiprofen 100 mg

3

Levbid Extended-Release 0.375 mg

3

Claritin-D

1

sulfamethoxazole/trimethoprim

1

Guaifenex PSE 120 mg

4.5

Mycelex Troches 10 mg

3

cetirizine HCI

3

butalbital/apap/caffeine

5

 

 

 

Such conduct is in violation of Section 4729.51(C)(3) of the Ohio Revised Code.

 

 

(6)

Maynard D. Turner did, on or about unknown dates prior to August 22, 2002, intention­ally make and/or knowingly possess a false or forged prescription, to wit: Maynard D. Turner compounded prescriptions #342026, #342027, #342028, #342029 and #342032, labeled “Fluffo Cream” for various patients having skin problems.  Such conduct violates Section 2925.23(B) of the Ohio Revised Code.

 

 

(7)

Maynard D. Turner did, on or about unknown dates prior to August 22, 2002, know­ingly sell a dangerous drug when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit:  Maynard D. Turner gave a customer a 100 lot bottle of Viagra in exchange for spring mushrooms, stating, “This should cover it.”  Such conduct violates Section 4729.51(C)(2) of the Ohio Revised Code.

 

 

(8)

On June 17, 2003, Maynard D. Turner pled guilty to two (2) counts of Theft of Drugs, felonies of the fourth degree under Section 2913.02 of the Ohio Revised Code; one (1) count of Aggravated Possession of Drugs, a felony of the fifth degree under Sec­tion 2925.11 of the Ohio Revised Code; and two (2) counts of Illegal Processing of Drug Documents, felonies of the fifth degree under Section 2913.02 of the Ohio Revised Code.  On the same date you requested Intervention in Lieu of Conviction.  State of Ohio vs M. Dwight Turner, Case No. 20030116 CRI, Fayette County Common Pleas Court.  Such conduct indicates that Maynard D. Turner is guilty of a felony or gross immorality, dishonesty or unprofessional conduct in the practice of pharmacy, and/or addicted to or abusing drugs to render him unfit to practice pharmacy within the meaning of Section 4729.16 of the Ohio Revised Code.

 

 

 

Maynard D. Turner neither admits nor denies the allegations stated in the Summary Suspen­sion/Notice of Opportunity for Hearing letter dated September 10, 2002 and Addendum Notice dated July 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, Maynard D. Turner knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

 

Maynard D. Turner's license to practice pharmacy in the State of Ohio is hereby INDEFINITE­LY SUSPENDED.  Pursuant to Rule 4729-9-01(F) of the Ohio Administrative Code, Maynard D. Turner may not be employed by or work in a facility licensed by the State Board of Pharmacy to possess or distribute dangerous drugs during the suspension.

 

Further, Maynard D. Turner agrees to the imposition of a monetary penalty of Six Thousand Dollars ($6,000.00) pursuant to an approved payment plan as follows: One Hundred Dollars ($100.00) per month, due on or before the last day of each month, until the balance is paid in full.  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.  At any future 119. hearing pursuant to a petition for rein­statement, the payment plan will be revised and/or adjusted in the discretion of the Board, if Maynard D. Turner's license to practice pharmacy is reinstated.

 

After a period two (2) years following the date of the Summary Suspension Order of Septem­ber 10, 2002, the Board will consider any petition filed by Maynard D. Turner for a hearing, pursuant to Ohio Revised Code Chapter 119., for reinstatement.  The Board will only con­sider reinstatement of Maynard D. Turner's license to practice pharmacy if the following conditions have been met:

 

 

 

(A)  Maynard D. Turner must enter into a contract, signed within thirty days after the effective date of this Order, with an Ohio Department of Alcohol and Drug Addiction Services (ODADAS) treatment provider or a treatment provider acceptable to the Board for a period of not less than five years and submit a copy of the signed contract to the Board office before his pharmacist identification card is issued.  The contract must provide that:

 

 

 

(1)  Random, observed urine drug screens shall be conducted at least once each month for the first year and then at least once every three months for the remain­ing four years.

 

 

 

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

 

(b)  Results of all drug screens must be negative.  Any positive re­sults, in­cluding those that may have resulted from ingestion of food, but excluding false positives that resulted from medication legitimately pre­scribed, indi­cate a violation of probation.

 

(c)  Refusals of urine screens or diluted urine screens are equivalent to a positive result and indicate a violation of probation.

 

 

 

(2)  The intervener/sponsor shall provide copies of all drug screen reports to the Board in a timely fashion.

 

(3)  Attendance is required a minimum of three times per week at an Alco­holics Anonymous, Narcotics Anonymous, and/or similar support group meeting.

 

(4)  The program shall immediately report to the Board any violations of the contract and/or lack of cooperation.

 

 

 

If, in the judgment of the Board, Maynard D. Turner 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.

 

Maynard D. Turner 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.

 

Maynard D. Turner 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.  Maynard D. Turner 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.  Maynard D. Turner 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.

 

10:16 a.m.

 

Board Member Gregory Braylock arrived and joined the meeting in progress.

10:16 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.

11:30 a.m.

R-2004-039

The Executive Session ended and the meeting was opened to the public.  Mrs. Teater moved that the Board accept the settlement offer as amended by the Board in the matter of Tarra Lynn Bryant, R.Ph.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-6/Nay-1/Abstain-1[Lipsyc]).  The agreement will become final upon the signature of all parties.

 

R-2004-040

Mr. Braylock moved that the Board summarily suspend the license to practice pharmacy belonging to John J. Sholtis, R.Ph. (03-1-17295) 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).

11:38 a.m.

 

The Board recessed for lunch.

  1:00 p.m.

 

The meeting resumed with all members present.

 

Mr. Winsley began to discuss several requests for exemptions to OAC Rule 4729-5-10 (Pick-up station) involving the drug Synagis.  Due to the need to obtain answers to sev­eral questions, this matter was continued until later.

 

R-2004-041

The Board considered a request from Tri-State Urgent Care to withdraw the application for the West Chester location and for a continuance of their scheduled Board hearing.  After discussion, Mrs. Gregg moved that the Board accept the withdrawal of the applica­tion and grant the continuance request.  The motion was seconded by Mrs. Adelman and approved by the Board (Aye-8/Nay-0).

  1:35 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 James W. Smetana, R.Ph., Russells Point.

  2:19 p.m.

 

Mr. Kost 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. Gregg and a roll call vote was conducted by President Giacalone as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Gregg-Yes, Lipsyc-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.

  2:30 p.m.

 

The Executive Session ended, the meeting was opened to the public, and the hearing resumed.

  3:55 p.m.

 

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

  4:10 p.m.

R-2004-042

The meeting resumed.  Mr. Winsley continued the discussion of the Pick-up station requests that had been received for the drug Synagis.  After discussion, Mrs. Gregg moved that Board staff be delegated the ability to grant waivers to OAC Rule 4729-5-10 (Pick-up station) involving this drug as long as the requests show compliance with all of the requirements of the rule.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).

 

Mr. Keeley discussed his Legislative Report with the Board.

  4:30 p.m.

 

Mr. Kost 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, Braylock-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

  5:05 p.m.

R-2004-043

The Executive Session ended and the meeting was opened to the public.  Mr. Braylock moved that the Board adopt the following Order in the matter of James W. Smetana, R.Ph.:

 

 

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-030228-002)

 

In The Matter Of:

 

JAMES W. SMETANA, R.Ph.

9481 Orchard Drive #23

Russells Point, Ohio 43348

(R.Ph. No. 03-3-11602)

 

 

 

INTRODUCTION

 

THE MATTER OF JAMES W. SMETANA CAME FOR HEARING ON SEPTEMBER 8, 2003, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.

 

JAMES W. SMETANA WAS REPRESENTED BY KEVIN P. BYERS AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

 

 

SUMMARY OF EVIDENCE

State’s Witnesses

 

None

 

Respondent's Witnesses

 

1.  James W. Smetana, R.Ph., Respondent

 

 

 

State's Exhibits

 

1. Reinstatement Hearing Request letter from James W. Smetana  [02-19-03]

1A-1D.  Procedurals

2.  Copy of State Board of Pharmacy Order in re James W. Smetana, R.Ph.  [11-07-01]

2A.  Copy of State Board of Pharmacy Order in re James W. Smetana, R.Ph.  [10-30-95]

3.  Copy of State Board of Pharmacy Order in re James W. Smetana, R.Ph.  [09-09-99]

4.  Copy of Controlled Drug Inventory Records for Cocaine Flakes at Children's Medical Center, Dayton  [11-08-93 to 07-18-95]

5.  Copy of Pharmacy Service Manufacturing Control Records for TAC Topical Solution  [03-04-95 to 06-23-95]

6.  Prepackaged Pharmaceutical Item Control Records for TAC Topical Solution  [06-23-92 to 07-18-95]

7.  Toxicology Associates, Inc. Reports for Substance Identification and Quantification  [07-05-95 to 07-17-95]

8.  Summary Chart of Controlled Drug Inventory Logs, Manufacturing Records, and Prepack­aged Pharmacy item Control Records  [07-18-94 to 07-18-95]

9.  Children's Medical Center Pharmacy Department Policy and Procedure for Manufacturing TAC Topical Solution  [revised 5/94]

10.  Indictment, State of Ohio vs. James W. Smetana, Case No. 95-CR-3065, Montgomery County Common Plea Court  [01-02-96]

11.  Decision and Entry, Treatment in Lieu of Conviction  [02-29-96]

12.  Termination Entry  [03-01-99]

13.  Indictment, State of Ohio vs. James W. Smetana, Case No. 97-CR-1596, Montgomery County Common Pleas Court  [11-10-97)

14.  Entry of Waivers and Plea(s) on Indictment, Entry and Order  [02-17-98]

15.  Order of Probation  [02-26-99]

16.  Termination Entry - Community Control  [04-06-98]

17.  Copy of Notarized Statement of Sheryl Vickers  [10-06-99]

18.  List of Credit Card Charges by James Smetana  [04-96 to 06-97]

19.  Copy of Notarized Statement of Sheryl Vickers  [08-21-01]

20.  In re: James W. Smetana, Case No. 99-32150, United States Bankruptcy Court, Southern District of Ohio, Western Division at Dayton  [08-05-99]

21.  Copy of letter from David W. Baker  [10-15-97]

 

 

 

Respondent's Exhibits

 

A.  Support Group Attendance Records  [09-12-01 TO 09-05-03]

B.  Urine Drug Screen Reports  [09-17-01 to 08-21-03]

C.  Letters from D. Scott Coffman MSEd, CCDC III-E  [07-24-03]; Robert D. Bolte CCDC III E  [07-28-03]; Tammie L. Bendixen-Dusoe LSAC  [06-30-02]

D.  Continuing Pharmaceutical Education Credits and Certificates  [01-05-01 to 07-02-03]

E.  Termination of Probation Entry (Incomplete), State of Ohio vs. James W. Smetana, Case No. 97-CR-1596, Montgomery County Common Pleas Court  [05-30-02]; Two Adult Probation Department Restitution Payment Receipts  [07-16-03 and 08-05-03]

F.   Four Letters of Support  [07-14-03 to 08-15-03]

G.  Contract Reinstatement letter from D. Scott Coffman BA, CCDC III-E and James W. Smetana  [07-11-02]

 

 

 

FINDING OF FACT

 

 

 

 

DECISION OF THE BOARD

 

Further, after one year from the effective date of this Order, the Board will consider any peti­tion filed by James W. Smetana for a hearing, pursuant to Ohio Revised Code Chapter 119., for reinstatement.  The Board will only consider reinstatement of the license to practice pharmacy in Ohio if James W. Smetana provides documentation of continuous compliance with the Board's September 9, 1999 Order and demonstrates satisfactory proof that he is no longer addicted to or abusing liquor or drugs or impaired physically or mentally to such a degree as to render him unfit to practice pharmacy.

 

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

MOTION CARRIED.

SO ORDERED.

 

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).

  5:10 p.m.

 

The Board meeting recessed until Tuesday, September 9, 2003.

 

 

TUESDAY, September 9, 2003

 

  8:39 a.m.

ROLL CALL

 

 

The State Board of Pharmacy convened in Room East-B, 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.; 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.

 

Mr. McMillen presented a request for approval as a provider of continuing pharmacy education received from the Ohio Association for Alcohol/Drug Abuse Counselors (OAADAC).  After significant discussion by the Board, this issue was tabled until further information can be received.

 

After a review of the minutes of the special telephone conference call held on August 25, 2003, Mrs. Gregg moved that the minutes be approved as written.  The motion was seconded by Mr. Turner and approved by the Board (Aye-7/Nay-0/Abstain-1[Adelman]).

 

The Board next discussed the draft minutes from the August, 2003 Board meeting.  Mrs. Adelman moved that the minutes of the August 4, 5, 6, 2003 meeting be approved as amended.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).

  9:13 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 Michael M. Fraulini, R.Ph., Portsmouth.

10:35 a.m.

 

The hearing was recessed so the Board could receive a presentation from Alteer Electronic Transmission Systems that had been scheduled for 10:45 a.m.

10:40 a.m.

 

The Board was joined by David Francis of Alteer Electronic Transmission Systems.  Mr. Francis presented information regarding his company’s electronic prescription system in response to concerns that the Board had expressed at a prior meeting.

11:13 a.m.

 

The hearing in the matter of Michael M. Fraulini, R.Ph. resumed.

12:25 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 Mr. Turner 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.

12:41 p.m.

 

The Executive Session ended, the meeting was opened to the public, and the hearing resumed.

12:47 p.m.

 

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

12:55 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 Giacalone as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

  1:15 p.m.

R-2004-044

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 Michael M. Fraulini, R.Ph.:

 

 

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-030716-003)

 

In The Matter Of:

 

(R.Ph. No. 03-2-19444

 

 

 

INTRODUCTION

 

THE MATTER OF MICHAEL M. FRAULINI CAME FOR HEARING ON SEPTEMBER 9, 2003, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph., GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.

 

MICHAEL M. FRAULINI WAS REPRESENTED BY JACK D. YOUNG AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

 

 

SUMMARY OF EVIDENCE

State’s Witnesses

 

None

 

Respondent's Witnesses

 

1.  Michel M. Fraulini, R.Ph., Respondent

2.  Dina Fraulini

3.  Juanita Fraulini

4.  John J. Gill

5.  Ann Shepherd, D.D.S.

6.  Steven Griffith

7.  James Reneau

8.  Jason Bentley

9.  Thomas A. Scott, R.Ph.

 

 

 

State's Exhibits

 

1.  Reinstatement Hearing Request letter from Jack D. Young  [07-11-03]

1A-1D.  Procedurals

2.  Portsmouth Police Department Incident Report, CFS No. 2002-002862  [02-08-02]

2A.  Copy of State Board of Pharmacy Order in re Michael M. Fraulini, R.Ph.  [07-11-02]

3.  Portsmouth Police Department Traffic Crash Report  [01-11-02]

4.  Indictment, State of Ohio vs. Michael M. Fraulini, Case No. 02-CR-157, Scioto County Common Pleas Court  [03-07-02]

5.  Drug Screen Report  [02-08-02]

6.  Six Drug Audit reports for accountability of Percocet and Hydrocodone/APAP at Sciotoville Pharmacy  [02-14-02]

7.  Copy of Statement of Jane Stephenson  [02-08-02]

8.  Copy of Statement of Debbie Delabar  [02-08-02]

9.  Copy of Statement of Laura A. Estep  [02-08-02]

10.  Copy of Statement of Marianne Osborne  [02-08-02]

11.  Copy of Statement of Jennifer Lewis  [02-08-02]

12.  Copy of Statement of Lisa Hoskins  [02-08-02]

 

 

 

Respondent's Exhibits

 

August 1, 2002 to January 31, 2003

 

A.  Copy of Letter from Michael M. Fraulini  [02-05-03]

B.  Copy of Progress Report from Melanie Sauls, LICSW and Jay Hughes, MD [01-29-03]; copy of Progress Report from Melanie Sauls, LICSW  [01/29/03]

C.  Two New Hope Christian Counseling Center Client Monitoring Sheets  [09-01-02 to 01-26-03]

D.  Copy of letter from Jay Hughes, M.D.  [08-25-03]; Drug screen reports  [08-29-02 to 02-05-03]

E.  Two Lists of Sponsors and Witnesses  [08-01-02 to 01-31-03]; Schedule of Alcoholics Anonymous Meetings  [02/05/03]; List of A.A. meetings chaired by Michael Fraulini  [08-01-02 to 01-31-03]

F.  Support Group Attendance Records  [09-02-02 to 01-31-03]

G.  Copy of New Hope Christian Counseling Center Contract for Michael M. Fraulini  [08-29-02]

H.  Copy of Counseling Resume  [not dated]

 

February 1, 2003 to July 31, 2003

 

A.  Copy of letter from Michael M. Fraulini  [05-27-03]

B.  Copy of Progress Report from Jay Hughes, M.D.  [08-25-03]; copy of Progress Report from Melanie Sauls, LICSW  [not dated]

C.  Two New Hope Christian Counseling Center Client Monitoring Sheets [02-01-03 to 07-27-03]

D.  Copy of letter from Jay Hughes, M.D.  [08-25-03]; Drug screen reports  [02-05-03 to 07-16-03]

E.  Two Lists of Sponsors and Witnesses  [02-01-03 to 07-31-03]; Schedule of Alcoholics Anonymous Meetings  [08-25-03]; List of A.A. meetings chaired by Michael Fraulini  [02-01-03 to 07-31-03]

F.  Support Group Attendance Records  [02-01-03 to 09-08-03]

G.  C.P.E. Requirements Information Sheet  [08-04-03; C.P.E. Report Form of Michael M. Fraulini  [08-26-03]; Continuing Pharmaceutical Education Statements of Credit and  Official Transcript of Credit  [03-12-99 to 08-26-03]

H.  Nine Letters of Support  [08-23-03 to 09-09-03]

I.   Copy of Calendar Pages  [01-20-03 and 01-26-03]

 

 

 

FINDING OF FACT

 

After having heard the testimony, observed the demeanor of the witnesses, considered the evidence, and weighed the credibility of each, the State Board of Pharmacy finds that Michael M. Fraulini has complied with the terms set forth in the Order of the State Board of Pharmacy, Docket No. D-020307-046, effective July 11, 2002.

 

DECISION OF THE BOARD

 

On the basis of the Finding of Fact set forth above, and after consideration of the record as a whole, the State Board of Pharmacy hereby approves the reinstatement of the pharmacist identification card, No. 03-2-19444, held by Michael M. Fraulini to practice pharmacy in Ohio and places Michael M. Fraulini on probation for five years beginning on the effective date of this Order, with the following conditions:

 

 

 

(A)  Michael M. Fraulini must enter into a contract, signed within thirty days after the effective date of this Order, with an Ohio Department of Alcohol and Drug Addiction Services (ODADAS) treatment provider or a treatment provider acceptable to the Board for a period of not less than five years and submit a copy of the signed contract to the Board office before his pharmacist identification card is issued.  The contract must provide that:

 

 

 

(1)  Random, observed urine drug screens shall be conducted at least once each month for the first year and then at least once every three months for the remaining four years.

 

 

 

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

 

(b)  Alcohol must be added to the standard urine drug screen.  A Breath­alyzer may be used to test for alcohol, but an appropriately certified individual must conduct the test within twelve hours of notification.

 

(c)  Results of all drug and alcohol screens must be negative.  Any positive results, including those that may have resulted from inges­tion of food, but excluding false positives that resulted from medi­cation legitimately prescribed, indicate a violation of probation.

 

(d)  Refusals of urine screens or diluted urine screens are equiva­lent to a positive result and indicate a violation of probation.

 

 

 

(2)  The intervener/sponsor shall provide copies of all drug and alcohol screen reports to the Board in a timely fashion.

 

(3)  Attendance is required a minimum of three times per week at an Alco­holics Anonymous, Narcotics Anonymous, and/or similar support group meeting.

 

(4)  The program shall immediately report to the Board any violations of the contract and/or lack of cooperation.

 

 

 

(B)  Michael M. Fraulini must submit quarterly progress reports to the Board (due January 10, April 10, July 10, and October 10 of each year of probation) that include:

 

 

 

(1)  The written report and documentation provided by the treatment pro­gram pursuant to the contract, and

 

(2)  A written description of Michael M. Fraulini's progress towards recovery and what Mr. Fraulini has been doing during the previous three months.

 

 

 

(C)  Other terms of probation are as follows:

 

 

 

(1)  The State Board of Pharmacy hereby declares that Michael M. Fraulini's 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)  Michael M. Fraulini may not serve as a responsible pharmacist.

 

(3)  Michael M. Fraulini may not destroy, assist in, or witness the destruc­tion of controlled substances.

 

(4)  Michael M. Fraulini must abide by the contract with his treatment provider and must immediately report any violation of the contract to the Board.

 

(5)  Michael M. Fraulini must not violate the drug laws of Ohio, any other state, or the federal government.

 

(6)  Michael M. Fraulini must abide by the rules of the Ohio Board of Phar­macy.

 

(7)  Michael M. Fraulini must comply with the terms of this Order.

 

 

 

(D)  Any violation of probation may result in a Board hearing to consider alternative or additional sanctions under Section 4729.16 of the Ohio Revised Code.

 

 

 

Michael M. Fraulini is hereby advised that 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.

 

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

MOTION CARRIED.

SO ORDERED.

 

 

The motion was seconded by Mrs. Adelman and approved by the Board (Aye-8/Nay-0).

 

R-2004-045

After further discussion of the information presented regarding the Alteer Electronic Transmission System, Mrs. Gregg moved that the Board find the system to be approvable pending a final inspection of the installed product.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).

 

R-2004-046

Mr. Keeley distributed some proposed changes to OAC Rule 4729-5-11 (Responsible pharmacist) to the Board.  After discussing the proposed revisions, Mrs. Teater moved that the Board approve the proposed amendments to Rule 4729-5-11 and that the rule be filed for Public Hearing with the rules previously approved by the Board, as follows:

 

 

 

Rule 4729-5-11  Responsible pharmacist person.

 

 

(A)

For a pharmacy licensed as a terminal distributor of dangerous drugs:

 

 

(A)    (1)

Only a pharmacist may be the responsible person whose name appears on the terminal distributor of dangerous drugs license for a pharmacy as defined in division (A) of section 4729.01 of the Revised Code.  A pharmacist shall be the responsible person for no more than one such pharmacy except with writ­ten permission from the state board of phar­macy.  A written request shall be sub­mitted outlining the circumstances requiring a pharmacist to be respon­sible for more than one pharmacy and the period of time during which the circum­stances will exist.  A pharmacist shall not be designated the respon­sible pharmacist person for a pharmacy unless he/she will be physically pre­sent in the phar­macy a sufficient amount of time to provide supervision and control.

 

 

(B)    (2)

The responsible pharmacist person shall be responsible for the practice of the profession of pharmacy, including but not limited to "supervision and control" of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, "adequate safeguards" as required in divi­sion (C) of section 4729.55 of the Revised Code, and maintaining all drug records otherwise required.

 

 

(C)

If there is a change in the responsible pharmacist, the state board of pharmacy shall be notified on a board approved form within thirty days thereof of the effective date of the change and the name of the new responsible pharmacist.

 

 

(1)

This notice to the state board of pharmacy shall be by certified mail, return receipt requested, or by verified facsimile transmission.

 

 

(2)

A complete inventory, pursuant to federal regulations and rule 4729-9-14 of the Admini­strative Code, shall be taken of the controlled sub­stances on hand at the pharmacy with the new responsible pharmacist.  The new responsible pharma­cist shall be responsible for completing and maintaining this inven­tory record at the site of the terminal distri­butor of dangerous drugs.

 

 

(D)    (3)

The person to whom the terminal distributor of dangerous drug drugs license has been issued and all pharma­cists on duty are responsible for compliance with all state and fed­eral laws, regulations, and rules regulat­ing the distri­bution of drugs and the practice of pharmacy.

 

 

(B)

For all locations licensed as a terminal distributor of dangerous drugs:

 

 

(1)

A location licensed as a terminal distributor of dangerous drugs must have a respon­sible person at all times.

 

 

(2)

When there is a change of responsible person, the state board of phar­macy shall be notified by the new responsible person within thirty days on a board-approved form.  This notice to the state board of pharmacy shall be sent by certified mail, return receipt requested, or by verified facsimile transmission.

 

 

(3)

A complete inventory, pursuant to federal regulations and rule 4729-9-14 of the Administrative Code, shall be taken of the controlled sub­stances on hand with the new responsible person on the effective date of the change of re­sponsible person.  The new responsible person shall be responsible for com­pleting and main­taining this inventory record at the site of the terminal dis­tributor of dangerous drugs.

 

 

(4)

The responsible person to whom the terminal distributor of dangerous drugs license has been issued is responsible for compliance with all state and fed­eral laws, regula­tions, and rules regulating the distribution of drugs.

 

 

The motion was seconded by Mr. Lipsyc and approved by the Board (Aye-8/Nay-0).

  1:30 p.m.

 

With all members present, the Board moved to Room South-A, 31st Floor, 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.

 

R-2004-047

Following presentations by Board members and 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.

 

PENNY D. ADAM

03-1-25951

ARIZONA

KRISTEN RENEE CARL

03-1-25947

INDIANA

LANE MYLES CHERAMIE

03-1-25938

LOUISIANA

SHARON YVONNE COLLINS

03-1-25995

TEXAS

JENNIE CORA-PABON

03-1-25924

VIRGINIA

JASON ANDREW CORCORAN

03-1-25968

MARYLAND

ELIZABETH ANN DOBBS

03-1-25970

PENNSYLVANIA

MARY L. GLAVAN

03-3-14646

WASHINGTON DC

BARBARA JANE GROFF

03-1-25959

NEW YORK

JENNIFER BANKS HARRIS

03-1-25963

NORTH CAROLINA

SHARON SUE HUDDLESTON

03-1-25953

ARIZONA

BRADLEY SHERWOOD JENNINGS

03-1-25944

COLORADO

CHRISTOPHER JOHN LOWE

03-1-25969

MARYLAND

CORRIE ANN MARTIN

03-1-25967

KENTUCKY

ERIK JOSEPH RACHWALSKI

03-1-25966

KENTUCKY

TOMMY DALE ROBERTS

03-1-25965

NEVADA

SANDRA LOUISE SHEPHERD

03-1-25932

NEW YORK

CORBETT L. SORRELL

03-1-25941

ARIZONA

LISA ANN SORRELL

03-1-15940

ARIZONA

JARETT SZCZEPANSKI

03-1-25971

WEST VIRGINIA

  1:40 p.m.

 

The Board recessed for lunch.

  2:58 p.m.

 

The Board reconvened in Room East B with all members present.  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 Zachary James Blake; Castalia.

  3:12 p.m.

 

The record was closed.

  3:17 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 Patricia M. Crane, R.Ph.; Painesville.

  3:39 p.m.

 

The record was closed.

 

The Board next set the meeting schedule for Fiscal Year 2005 (July 1, 2004-June 30, 2005) as follows:

 

07/12/04

07/13/04

07/14/04

 

10/04/04

10/05/04

10/06/04

 

01/03/05

01/04/05

01/05/05

 

04/11/05

04/12/05

04/13/05

 

08/02/04

08/03/04

08/04/04

 

11/08/04

11/09/04

11/10/04

 

02/07/05

02/08/05

02/09/05

 

05/02/05

05/03/05

05/04/05

 

09/13/04

09/14/04

09/15/04

12/06/04

12/07/04

12/08/04

03/07/05

03/08/05

03/09/05

06/06/05

06/07/05

06/08/05

  3:45 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 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 Giacalone as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

  4:00 p.m.

R-2004-048

The Executive Session ended and the meeting was opened to the public.  Mr. Turner moved that the Board adopt the following Order in the matter of Zachary James Blake:

 

 

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-030606-076)

 

In The Matter Of:

 

ZACHARY JAMES BLAKE

203 Depot Street, P.O. Box 38

Castalia, Ohio 44824

(D.O.B. 08/01/78)

 

INTRODUCTION

 

THE MATTER OF ZACHARY JAMES BLAKE CAME FOR CONSIDERATION ON SEPTEMBER 9, 2003, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.

 

ZACHARY JAMES BLAKE WAS NOT PRESENT NOR WAS HE REPRESENTED BY COUNSEL AND THE  STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

SUMMARY OF EVIDENCE

State’s Witnesses

 

1.  Dale Fritz, Jr., Ohio State Board of Pharmacy

 

Respondent's Witnesses

 

None

 

 

 

State's Exhibits

 

1.  Copy of Proposal to Deny/Notice of Opportunity For Hearing letter  [06-06-03]

2.  Statement of Zachary James Blake   [07-04-98]

3.  Sandusky Police Department Complaint Report No. 9217  [07-04-98]

4.  History Information File, City of Sandusky vs. Zachary J. Blake, Case No. CRB-9803223-A, Sandusky Municipal Court  [07-06-98]

5.  History Information File, City of Sandusky vs. Zachary J. Blake, Case No. CRB-9803223-B, Sandusky Municipal Court  [07-06-98]

6.  History Information File, City of Sandusky vs. Zachary J. Blake, Case No. CRB-9803200-A, Sandusky Municipal Court  [07-06-98]

7.  History Information File, City of Sandusky vs. Zachary J. Blake, Case No. CRB-9803200-B, Sandusky Municipal Court  [07-06-98]

8.  Statement of Zachary James Blake  [01-10-99]

9.  Sandusky Police Department Complaint Report No. 331  [01-10-99]

10.  History Information File, City of Sandusky vs. Zachary J. Blake, Case No. CRB-9900084-A, Sandusky Municipal Court  [06-04-99]

11.  History Information File, City of Sandusky vs. Zachary J. Blake, Case No. CRB-9900084-B, Sandusky Municipal Court  [06-04-99]

12.  Statement of Zachary James Blake  [01-06-01]

13.  Perkins Police Department Incident Report CR# 01-000183  [01-06-01]

14.  History Information File, City of Sandusky vs. Zachary J. Blake, Case No. CRB-0100131, Sandusky Municipal Court  [01-12-01]

15.  Statement of Zachary James Blake  [05-10-02]

16.  Bowling Green Police Division Incident Report No. 02-007060  [12-18-02]

17.  Court Entry Record, Bowling Green Police Dept. vs. Zachary J. Blake, Case No. 02CRB-00783-A, Bowling Green Municipal Court  [05-10-02]

 

Respondent's Exhibits

 

None

 

 

 

FINDINGS OF FACT

 

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

 

 

 

(1)  On June 6, 2003, Zachary James Blake was notified by letter of his right to a hearing, his rights in such hearing, and his right to submit his contentions in writing.

 

(2)  As demonstrated by return receipt dated June 7, 2003, Zachary James Blake re­ceived the letter of June 6, 2003, informing him of the allegations against him, and his rights.

 

(3)  Zachary James Blake has not responded in any manner to the letter of June 6, 2003, and has not requested a hearing in this matter.

 

(4)  Records of the Ohio Board of Pharmacy indicate that Zachary James Blake applied to the Board for registration as a pharmacy intern in  Ohio on October 23, 2002.

 

(5)  Zachary James Blake was, on or about July 4, 1998, stopped by a Sandusky police officer for drinking from an open container of beer after leaving a bar.  Zachary James Blake was arrested after the officer discovered he had an altered driver’s license.  On July 6, 1998, Zachary James Blake was found guilty of Misrepre­sentation of Person Under 21, a misdemeanor of the first degree under Section 4301.634 of the Ohio Revised Code; Consuming Under Age, a misdemeanor of the first degree under Section 4301.632 of the Ohio Revised Code, and two counts of Open Flask in Public, minor misdemeanors under the City of Sandusky Ordinance No. 139.04.  Zachary James Blake received a fine, suspended jail time, and was re­quired to attend an alcohol program.  City of Sandusky vs. Zachary J. Blake, Case Nos. 9003200A, 9803200B, 98CRB03223A, and 98CRB03223B, Sandusky Municipal Court.  Such conduct constitutes not being of good moral character and habits within the meaning of Rule 4729-5-04 of the Ohio Administrative Code and thus not meeting the requirements of the Board within the meaning of Section 4729.11 of the Ohio Revised Code.

 

(6)  Zachary James Blake was, on or about January 10, 1999, observed by a San­dusky police officer walking down the street at 2:43 a.m.  Zachary James Blake was intoxicated and in possession of an altered driver’s license.  Zachary James Blake was tested to have a .182 blood alcohol content.  On June 4, 1999, Zachary James Blake was found guilty of Consuming Under Age, a misdemeanor of the first degree under Section 4301.632 of the Ohio Revised Code; and Misrepresentation of Person Under 21, a misdemeanor of the first degree under Section 4301.64 of the Ohio Revised Code.  Zachary James Blake received a fine and suspended jail time.  City of Sandusky vs. Zachary J. Blake, Case No. 9900084A and 9900084B, Sandusky Muni­cipal Court.  Such conduct constitutes not being of good moral character and habits within the meaning of Rule 4729-5-04 of the Ohio Administrative Code and thus not meeting the requirements of the Board within the meaning of Section 4729.11 of the Ohio Revised Code.

 

(7)  Zachary James Blake was, on or about January 6, 2001, arrested by a Perkins Police Department officer after being involved in a fight.  On January 12, 2001, Zachary James Blake was found guilty of and fined for Disorderly Conduct, a minor misdemeanor under Section 2917.11 of the Ohio Revised Code.  City of Sandusky vs. Zachary J. Blake, Case No. CRB 0100131, Sandusky Municipal Court.  Such con­duct constitutes not being of good moral character and habits within the meaning of Rule 4729-5-04 of the Ohio Administrative Code and thus not meeting the re­quirements of the Board within the meaning of Section 4729.11 of the Ohio Revised Code.

 

(8)  Zachary James Blake was, on or about April 15, 2002, arrested by a Bowling Green police officer after being observed carrying an open container of beer on the street.  On May 10, 2002, Zachary James Blake was found guilty of and fined for having an Open Container of Alcohol, a minor misdemeanor under Section 96.03 of the Bowling Green Codified Ordinance.  Bowling Green Police Department vs. Zachary J. Blake, Case No. 02CRB00783-A, Bowling Green Municipal Court.  Such conduct constitutes not being of good moral character and habits within the mean­ing of Rule 4729-5-04 of the Ohio Administrative Code and thus not meeting the requirements of the Board within the meaning of Section 4729.11 of the Ohio Re­vised Code.

 

 

 

CONCLUSION OF LAW

 

The State Board of Pharmacy concludes that paragraphs (5) through (8) of the Findings of Fact constitutes not being of good moral character and habits as provided in paragraph (C) of Rule 4729-5-04 of the Ohio Administrative Code.

 

DECISION OF THE BOARD

 

Pursuant to Section 4729.11 of the Ohio Revised Code, and Rule 4729-5-04 of the Ohio Administrative Code, the State Board of Pharmacy hereby refuses to grant a license and, therefore, denies the Application for Pharmacy Intern Registration submitted by Zachary James Blake on October 23, 2002.

 

Further, the Board will not consider any new application submitted by Zachary James Blake until Mr. Blake appears before the Board.

 

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

MOTION CARRIED.

SO ORDERED.

 

 

The motion was seconded by Ms. Eastman and approved by the Board (Aye-8/Nay-0).

 

R-2004-049

Mr. Turner then moved that the Board adopt the following Order in the matter of Patricia M. Crane, R.Ph.:

 

 

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-030606-077)

 

In The Matter Of:

 

PATRICIA M. CRANE, R.Ph.

1651 Mentor Avenue 603

Painesville, Ohio 44077

(R.Ph. No. 03-2-11312)

 

 

 

INTRODUCTION

 

THE MATTER OF PATRICIA M. CRANE CAME FOR CONSIDERATION ON SEPTEMBER 9, 2003, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.

 

PATRICIA M. CRANE WAS NOT PRESENT NOR WAS SHE REPRESENTED BY COUNSEL AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

 

 

SUMMARY OF EVIDENCE

State’s Witnesses

 

1.  Joann Predina, R.Ph., Ohio State Board of Pharmacy

 

Respondent's Witnesses

 

None

 

State's Exhibits

 

1.  Copy of Notice of Opportunity For Hearing letter  [06-06-03]

1A.  Copy of Amendment Notice letter  [07-01-03]

1B-1C.  Procedurals

2.  C.P.E. Report Form for Patricia M. Crane  [09-05-02]

3.  C.P.E.. Audit Notice letter to Patricia M. Crane  [09-13-02]

4.  Pharmacist License Lapsed Notice letter to Patricia M. Crane  [09-25-02]

5.  C.P.E. Audit Non-Compliance letter to Patricia M. Crane  [10-18-02]

6.  C.P.E. Audit Non-Compliance letter to Patricia M. Crane  [11-07-02]

7.  Letter from Patricia M. Crane  [11-20-02]

8.  C.P.E. Report Form for Patricia M. Crane  [10-30-02]

9.  Letter from Patricia M. Crane  [01-10-03]

10A-10I.  Rx #92427-5821  [09-17-02]; Rx #93070-5821  [09-23-02]; Rx #93834-5821  [09-30-02]; Rx #94481-5821  [10-07-02]; Rx #95647-5821  [10-19-02]; Rx #95769-5821  [10-21-02]; Rx #96653-5821  [10-30-02]; Rx #97028-5821  [11-03-02]; Rx #97259-5821  [11-05-02]

 

Respondent's Exhibits

 

None

 

 

 

FINDINGS OF FACT

 

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

 

 

 

(1)  On June 6, 2003, Patricia M. Crane was notified by letter of her right to a hear­ing, her rights in such hearing, and her right to submit her contentions in writing.

 

(2)  As demonstrated by return receipt dated June 17, 2003, Patricia M. Crane re­ceived the letter of June 6, 2003, informing her of the allegations against her, and her rights.

 

(3)  Patricia M. Crane has not responded in any manner to the letter of June 6, 2003, and has not requested a hearing in this matter.

 

(4)  Records of the Ohio Board of Pharmacy indicate that Patricia M. Crane was origi­nally licensed by the State of Ohio as a pharmacist on August 4, 1975, pursuant to examination, and is currently licensed to practice pharmacy in Ohio.

 

(5)  Patricia M. Crane did, on or about September 5, 2002, with purpose to defraud, forge a writing so that it purported to be genuine when it was actually spurious, to wit: on Patricia M. Crane’s continuing pharmacy education report form to the Board, she falsified continuing education program numbers for programs which she did not complete.  Patricia M. Crane submitted the form to the Board purporting to having complied with continuing education requirements, when she had not.  Such conduct is in violation of Section 2913.31 of the Ohio Revised Code.

 

(6)  Patricia M. Crane did, on or about September 5, 2002, knowingly make a false statement to secure the issuance of her renewal identification card by the Ohio Board of Pharmacy and/or when the statement was in connection with a report re­quired by law, to wit: Patricia M. Crane submitted her continuing pharmacy edu­cation report form with false information.  Such conduct is in violation of Sections 2921.13 and 4729.12 of the Ohio Revised Code.

 

(7)  Patricia M. Crane did, from September 15, 2002, through November 6, 2002, while not a properly licensed pharmacist, practice pharmacy, to wit: while Patricia M. Crane had not properly renewed her license, and during a period when she had either not obtained her pharmacist’s identification card or after she had surrepti­tiously obtained an invalid identification card, Patricia M. Crane practiced pharmacy when not legally authorized to do so.  Such conduct is in violation of Section 4729.28 of the Ohio Revised Code.

 

 

 

CONCLUSIONS OF LAW

 

(1)  The State Board of Pharmacy concludes that paragraphs (5) through (7) of the Find­ings of Fact constitute being guilty of dishonesty and unprofessional conduct in the practice of pharmacy as provided in Division (A)(2) of Section 4729.16 of the Ohio Revised Code.

 

(2)  The State Board of Pharmacy concludes that paragraphs (6) and (7) of the Findings of Fact constitute being guilty of willfully violating, conspiring to violate, attempting to violate, or aiding and abetting the violation of provisions of Chapter 4729. of the Revised Code as provided in Division (A)(5) of Section 4729.16 of the Ohio Revised Code.

 

(3)  The State Board of Pharmacy concludes that paragraphs (5) and (6) of the Find­ings of Fact constitute having committed fraud, misrepresentation, or deception in applying for or securing a license or identification card issued by the board under Chapter 4729. of the Revised Code.

 

 

 

DECISION OF THE BOARD

 

Pursuant to Section 4729.16 of the Ohio Revised Code, and after consideration of the record as a whole, the State Board of Pharmacy hereby suspends, for one month, the pharmacist identification card, No. 03-2-11312, held by Patricia M. Crane effective as of the date of the mailing of this Order.  Further, the Board suspends the suspension and places her identifica­tion card on probation for 24 months, with the following conditions.

 

 

 

(A)  Patricia M. Crane will be audited for three continuing pharmacy education cycles.

 

(B)   Patricia M. Crane must not violate the drug laws of Ohio, any other state, or the federal government.

 

(C)  Patricia M. Crane must abide by the rules of the State Board of Pharmacy.

 

(D)  Patricia M. Crane must comply with the terms of this Order.

 

(E)  Any violation of probation may result in a Board hearing to consider alternative or additional sanctions under Section 4729.16 of the Ohio Revised Code..

 

 

 

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

MOTION CARRIED.

SO ORDERED.

 

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).

  4:05 p.m.

 

The Board recessed until Wednesday, September 10, 2003.

 

 

WEDNESDAY, September 10, 2003

 

  8:35 a.m.

ROLL CALL

 

 

The State Board of Pharmacy convened in Room East-B, 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.; 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.

 

Mr. Braylock reported that the Nursing Board’s Committee on Prescriptive Governance had not met since the last report.

 

R-2004-050

Mr. Keeley distributed some proposed changes to OAC Rule 4729-5-01 (Definitions) to the Board which contained proposed revisions to paragraph (L), the definition of Protocol.  After discussing the proposed revisions, Mrs. Gregg moved that the Board approve the proposed amendments to Rule 4729-5-01 and that the rule be filed for Public Hearing with the rules previously approved by the Board, as follows:

 

 

 

Rule 4729-5-01  Definitions.

 

As used in Chapter 4729. of the Revised Code:

 

 

(A)

"Practice of pharmacy" is as defined in division (B) of section 4729.01 of the Re­vised Code.

 

 

(B)

The term "dispense" means the final association of a drug with a particular patient pursuant to the prescription, drug order, or other lawful order of a prescriber and the professional judgment of and the responsibility for: interpreting, preparing, compounding, labeling, and packaging a specific drug.

 

 

(C)

The term "compounding" has the same meaning as defined in division (C) of sec­tion 4729.01 of the Revised Code.

 

 

(D)

"Interpret prescriptions" means the professional judgment of a pharmacist when reviewing a pre­scription order of a prescriber for a patient.

 

 

(E)

"To participate in drug selection" means selecting and dispensing a drug product pursuant to sections 4729.38 and 4729.381 of the Revised Code.

 

 

(F)

"To participate with prescribers in reviews of drug utilization" means monitoring the appropriate use of drugs through communication with the prescriber(s) involved.

 

 

(G)

"Pharmacist" means an individual who holds a current pharmacist identification card pursuant to section 4729.08 or 4729.09 of the Revised Code; or, pursuant to section 4729.12 of the Revised Code.

 

 

(H)

"Original prescription" means the prescription issued by the prescriber in writing, an oral or elec­tronically transmitted prescription recorded in writing by the phar­macist, a prescription transmit­ted by use of a facsimile machine, or a prescription transmit­ted by a board-approved electronic prescription transmission system, each of which is pursuant to rule 4729-5-30 of the Administra­tive Code.

 

 

(I)

"Personal supervision" means a pharmacist shall be physically present in the phar­macy and pro­vide personal review and approval of all professional phar­maceutical activities.

 

 

(J)

"Preprinted order" is defined as a patient-specific, definitive set of drug treatment directives to be administered to an individual patient who has been examined by a prescriber and for whom the prescriber has determined that the drug therapy is appropriate and safe when used pursu­ant to the conditions set forth in the pre­printed order.  Preprinted orders may be used only for inpatients in an institu­tional facility as defined in Chapter 4729‑17 of the Administrative Code.

 

 

(K)

"Standing order" will mean the same as the term "protocol".

 

 

(L)

"Protocol" is defined as:

 

 

(1)

A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been author­ized by a prescriber as defined in rule 4729-5-15 of the Administrative Code and have been approved by the state board of pharmacy to be used by certified or licensed health care professionals when providing limited medical services to individuals in an emergency situation when the services of a prescriber are not immediately available; or

 

 

(2)

A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been author­ized by a prescriber as defined in rule 4729-5-15 of the Administrative Code and have been approved by the state board of pharmacy to be used by certified or licensed health care professionals when admini­stering biologicals or vaccines to individuals for the purpose of prevent­ing diseases.; or

 

 

(3)

A definitive set of written treatment guidelines that include patient-specific and dose-specific orders for the administration of a specific drug that have been authorized by a pre­scriber to be used when the services of that prescriber are not immediately available.  The state board of pharmacy must approve the treatment guidelines prior to implementa­tion.  A list of the board-approved drugs used in the treatment guide­lines shall be dis­played on the board’s website (www.state.oh.us/pharmacy).  To be considered for approval by the board, the treatment guidelines must meet the follow­ing requirements:

 

 

(a)

The drugs shall only be administered by an individual authorized by law to administer the drugs that are listed in the treatment guidelines.

 

 

(b)

A prescriber must complete an assessment and make a diagnosis prior to order­ing a set of treatment guidelines.

 

 

(c)

The treatment guidelines:

 

 

(i)

Can only be initiated upon the order of a prescriber, and the prescriber, uti­lizing positive identification, must create an order in the patient record to acknowledge and document an adjustment made pursuant to the treatment guidelines before another dose or frequency adjustment can be made;

 

 

(ii)

Shall only apply to adjusting the dose or frequency of the admini­stration of a specific drug that has been previously ordered by a prescriber;

 

 

(iii)

Apply only to those drugs that may require calculations for specific dose and frequency adjustments which shall be based on objective measures;

 

 

(iv)

Apply only to those drugs for which the therapeutic dose is signi­ficantly lower than the dose expected to cause detrimental adverse effects;

 

 

(v)

Do not apply to those drugs for which a dosage change selected within the usual normal dose range could cause detrimental adverse effects;

 

 

(vi)

Can be performed without requiring the exercise of medical judgment;

 

 

(vii)

Will lead to results that are reasonably predictable and safe;

 

 

(viii)

Can be performed safely without repeated medical assessments;

 

 

(ix)

If performed improperly, would not present a danger of immediate and serious harm to the patient.

 

 

 

A protocol may be used only by licensed or certified individuals acting within the scope of their license or certification who have been adequately trained in the safe administration and use of the drugs and other authorized by law to admini­ster the drugs and to perform the procedures included in the protocol.

 

Protocols submitted for approval by the state board of pharmacy may be reviewed with the medi­cal and/or nursing board, as appropriate, health care related board prior to any approval by the state board of pharmacy.

 

 

(M)

"Prescriber" means any person authorized by the Revised Code to prescribe dan­gerous drugs as part of their professional practice.

 

 

(N)

"Positive identification" means a method of identifying an individual who pre­scribes, administers, or dispenses a dangerous drug.  Such method must include a physical means of identification such as, but not limited to, the following:

 

 

(1)

A manual signature on a hard-copy record;

 

(2)

A magnetic card reader;

 

(3)

A bar code reader;

 

(4)

A thumbprint reader or other biometric method; or

 

(5)

A daily printout of every transaction that is verified and manually signed within twenty-four hours by the individual who prescribed, administered, or dispensed the dangerous drug.  The printout must be maintained for three years and made available on request to those individuals authorized by law to review such records.

 

 

 

A magnetic card reader or a bar code reader system of identification must also in­clude a private personal identifier, such as a password, for entry into a mechanical or automated system.

 

 

The motion was seconded by Ms. Eastman and approved by the Board (Aye-8/Nay-0).

  9:35 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 Giacalone as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Gregg-Yes, Lipsyc-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.

10:02 a.m.

 

The Executive Session ended and the meeting was opened to the public.

10:03 a.m.

 

Mrs. Gregg moved that the Board receive Per Diem as follows:

 

PER DIEM

9/8

9/9

9/10

Total

Adelman

1

1

1

3

Braylock

1

1

1

3

Eastman

1

1

1

3

Giacalone

1

1

1

3

Gregg

1

1

1

3

Lipsyc

1

1

1

3

Kost

1

1

1

3

Teater

1

1

1

3

Turner

1

1

1

3

 

 

The motion was seconded by Mrs. Adelman and approved by the Board (Aye-8/Nay-0).

10:05 a.m.

 

The meeting was recessed so the Board members could travel to the Villa Milano restaurant for a meeting with the Executive Committee of the Ohio Pharmacists Association (OPA) and, following that meeting, the Licensure Ceremony.

10:45 a.m.

 

The Board reconvened at the Villa Milano Restaurant to meet with the Executive Committee of the OPA to discuss items of mutual interest and concern.  There were no issues requiring official action of the Board.

11:55 a.m.

 

The meeting with the OPA Executive Committee ended.  Mrs. Gregg moved that the Board meeting be adjourned so that the members could attend the Licensure Ceremony.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-8/Nay-0).

 

THE BOARD APPROVED THESE MINUTES

OCTOBER 15, 2003