NOTE:   The following Minutes are provided for informational purposes only.

If you would like to obtain an official copy of these Minutes, please contact

the State Board of Pharmacy at 614/466-4143 for instructions and fee.

 

 

 

STATE BOARD OF PHARMACY; 77 SOUTH HIGH STREET, ROOM 1702; COLUMBUS, OHIO 43215-6126

Tel:  614/466-4143                         Fax:  614/752-4836                      Email:  exec@bop.state.oh.us

 

 

Minutes Of The Meeting

Ohio State Board of Pharmacy

July 12 & 13, 2004

 

MONDAY, JULY 12, 2004

 

  9:05 a.m.     ROLL CALL

 

The State Board of Pharmacy convened in Room West-B&C, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Lawrence J. Kost, R.Ph. (President); Suzanne R. Eastman, R.Ph. (Vice-President); Gregory Braylock, R.Ph.; Robert P. Giacalone, R.Ph.; Elizabeth I. Gregg, R.Ph.; Nathan S. Lipsyc, R.Ph.; Kevin J. Mitchell, R.Ph.; Dorothy S. Teater, Public Mem­ber; and James E. Turner, R.Ph.

 

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.

 

R-2005-001    President Kost administered the following Oath of Office to newly-appointed member Kevin J. Mitchell:

 

I, Kevin J. Mitchell, as a Member of the Ohio Board of Pharmacy do solemnly swear to uphold the Constitution of the United States and the state of Ohio; to impartially enforce the laws governing the profession of pharmacy and the legal distribution of drugs in the state of Ohio; and carry out the responsibilities of the Board as mandated by the laws of the state of Ohio without bias or prejudice, so help me God.

  9:14 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.  The motion was seconded by Mrs. Teater and a roll call vote was conducted by President Kost as follows: Braylock-Yes, Eastman-Yes, Giacalone-Yes, Gregg-Yes, Lipsyc-Yes, Mitchell-Yes, Teater-Yes, and Turner-Yes.

  9:46 a.m.

R-2005-002    The Executive Session ended and the meeting was opened to the public.  Mrs. Gregg moved that the Board grant the continuance request received from Christopher Hart, R.Ph. and that his hearing be scheduled at the next available time.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).  The Board took a brief recess.

10:10 a.m.

The meeting resumed.  Mr. Winsley distributed copies of a notice received from the Council of Ohio Colleges of Pharmacy (COCP) regarding their accreditation as a provider of continuing pharmacy education by the Accreditation Council For Pharmacy Education (ACPE).  As this was only an information item, no further action by the Board was re­quired.

 

Mr. Benedict distributed copies of the report from the Compassionate Care Task Force that had been created by the Legislature and of which he was a participating member.  Mr. Benedict then discussed the report with the Board, pointing out several areas where Board action was recommended by the Task Force.

 

Mr. McMillen presented his Licensing Report to the Board.

 

R-2005-003    Mr. Keeley presented a request for Board approvable status from eClinical Works elec­tronic prescribing system.  After discussion of the system, Mr. Braylock moved that the Board find the eClinical Works electronic prescribing system approvable pending final inspection of the installed product.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-8/­Nay-0).

 

R-2005-004    Mr. Keeley then presented a request for Board approvable status from RxNT electronic pre­scrib­ing system.  After discussion of the system, Mr. Giacalone moved that the Board find the RxNT electronic prescribing system approvable pending final inspection of the installed product.  The motion was seconded by Mr. Lipsyc and approved by the Board (Aye-8/Nay-0).

 

R-2005-005    The Board next considered the draft minutes from the June 21-23, 2004 meeting.  After discus­sion, Mrs. Gregg moved that the minutes be approved as amended.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-7/Nay-0/Abstain-1[Mitchell]).

11:33 a.m.

The Board recessed for lunch.

  1:20 p.m.

The Board reconvened in Room West-B&C, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with all members present.

 

Mr. Winsley presented requests from Children’s Hospital of Cincinnati and Children’s Hospital of Columbus for Board approval to use the IntelliFill I.V. robot.  After discussion of the system and the viewing of an informational video provided by the company, the Board members agreed that Board staff should continue their review of the system to ensure that it can be brought into compliance with current laws and rules.

 

The Board next discussed a proposal from Medco Health Solutions, Inc. for a work-at-home program they would like to implement.  After discussion, the Board members agreed that they would like to discuss this program with a representative from Medco, so the issue was tabled until the August Board meeting so that a representative could attend.

  2:57 p.m.

Mrs. Gregg moved that the Board go into Executive Session for the purpose of the investi­gation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Re­vised Code.  The motion was seconded by Mr. Turner and a roll call vote was conducted by Presi­dent Kost as follows: Braylock-Yes, Eastman-Yes, Giacalone-Yes, Gregg-Yes, Lipsyc-Yes, Mitchell-Yes, Teater-Yes, and Turner-Yes.

  3:40 p.m.

The Executive Session ended.  The Board meeting was recessed until Tuesday, July 13, 2004.

 

 

TUESDAY, JULY 13, 2004

 

  9:00 a.m.     ROLL CALL

 

The State Board of Pharmacy convened in Room West-B&C, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Lawrence J. Kost, R.Ph. (President); Suzanne R. Eastman, R.Ph. (Vice-President); Gregory Braylock, R.Ph.; Robert P. Giacalone, R.Ph.; Elizabeth I. Gregg, R.Ph.; Nathan S. Lipsyc, R.Ph.; Kevin J. Mitchell, R.Ph.; Dorothy S. Teater, Public Mem­ber; and James E. Turner, R.Ph.

 

R-2005-006    Mr. McMillen presented a request from Sukhdeep S. Mann, Pharmacy Intern, for Board recog­nition of intern hours received in Indiana prior to completion of all of his Foreign Phar­macy Gradu­ate Equivalency Certification (FPGEC) requirements.  After discussion, Mr. Giacalone moved that the Board accept the hours certified by Indiana that were actually worked in Indiana.  The motion was seconded by Mr. Lipsyc and approved by the Board (Aye-8/Nay-0).

 

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

 

R-2005-007

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-040113-052)

 

In the Matter of:

 

MEDIC DISCOUNT DRUG

c/o Nathan S. Lipsyc

4507 Clark Avenue

Cleveland, Ohio 44102

(Terminal Distributor No. 02-166800)

 

This settlement agreement is entered into by and between Medic Discount Drug 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.

 

Medic Discount Drug enters into this agreement being fully informed of its rights afforded under Chapter 119. of the Ohio Revised Code, including the right to representation by counsel, the right to a formal adjudication hearing on the issues contained herein, and the right to appeal.  Medic Discount Drug acknowledges that by entering into this agreement it has waived its rights under Chapter 119. of the Revised Code.

 

Whereas, the State Board of Pharmacy is empowered by Section 4729.57 of the Ohio Re­vised Code to suspend, revoke, refuse to renew any license issued to a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code, or may impose a monetary penalty on the license holder, for violation of any of the enumerated grounds of Section 4729.57 of the Ohio Revised Code.

 

WHEREAS, Medic Discount Drug is a licensed terminal distributor of dangerous drugs in the State of Ohio.

 

WHEREAS, on or about January 13, 2004, pursuant to Chapter 119. of the Ohio Revised Code, Medic Discount Drug was notified of the allegations or charges against it, its right to a hearing, its rights in such hearing, and its right to submit contentions in writing.  Medic Discount Drug re­quested a hearing.  The January 13, 2004, Notice of Opportunity for Hear­ing contains the fol­low­ing allegations or charges:

 

(1)     Records of the Board of Pharmacy indicate that Medic Discount Drug is licensed with the State Board of Pharmacy as a Terminal Distributor of Dangerous Drug and Allen Weaver is the Responsible Pharmacist pursuant to Rule 4729-5-11 of the Ohio Administrative Code and Sections 4729.27 and 4729.55 of the Ohio Revised Code.

 

(2)     Medic Discount Drug did, on or about May 1, 2001 through May 6, 2003, cease to satisfy the qualifications of a terminal distributor of dangerous drugs set forth in Section 4729.55 of the Ohio Revised Code, to wit: Medic Discount Drug 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.  Persons other than pharmacists and pharmacy interns have stolen thousands of controlled substances undetected for a period of years.  Audit results have revealed the following shortages:

 

Drug

Strength

Shortage

% Short

acetaminophen w/Codeine # 3

30 mg

922

1.24%

acetaminophen w/Codeine # 4

60 mg

1,519

8.33%

acetaminophen w/Codeine # 2

15 mg

12

3.80%

alprazolam

.25 mg

1,063

5.09%

alprazolam

2 mg

35

2.60%

diazepam

10 mg

26,816

27.85%

diazepam

2 mg

1,741

17.91%

diazepam

5 mg

6,180

9.87%

Duragesic

100 ug/h

36

5.63%

Duragesic 

25 ug/h

52

4.38%

Duragesic

50 ug/h

26

2.99%

Duragesic

75 ug/h

39

11.17%

Endocet

10/650 mg

1,105

18.58%

Endocet

7.5/500 mg

199

1.69%

hydrocodone w/acetaminophen

10/325 mg

98

2.78%

hydrocodone w/acetaminophen

10/500 mg

3,617

33.88%

hydrocodone w/acetaminophen

10/650 mg

4,138

25.01%

hydrocodone w/acetaminophen

10/660 mg

568

6.59%

hydrocodone w/acetaminophen

5/500 mg

2,556

1.82%

hydrocodone w/acetaminophen

7.5/325 mg

140

46.67%

hydrocodone w/acetaminophen

7.5/500 mg

80

2.20%

hydrocodone w/acetaminophen

7.5/750 mg

740

1.07%

Lorcet

10/650 mg

790

31.70%

Lortab

5/500

100

100%

OxyContin

10 mg

47

0.56%

OxyContin

20 mg

403

1.02%

OxyContin

40 mg

1,204

5.96%

OxyContin

80 mg

170

5.80%

Percocet

10/325 mg

299

14.95%

Percocet

10/650 mg

307

35.90%

Percocet

2.5/325 mg

355

34.59%

Percocet

5/325 mg

89

1.88%

Percocet

7.5/325 mg

15

0.64%

Percocet

7.5/500 mg

304

15.73%

Roxicet

5/325 mg

960

0.56%

Tylenol w/Codeine No. 3

30 mg

121

7.88%

Tylenol w/Codeine No. 4

60 mg

32

4.57%

Valium

10 mg

2,783

60.90%

Valium

2 mg

55

55%

Viagra

100 mg

171

5.94%

Vicodin

5 mg

364

4.01%

Vicodin ES

7.5/750

6,186

45.69%

Vicodin HP

10/660

96

20.87%

Xanax

.25 mg

119

5.30%

Xanax

.5 mg

94

3.60%

Xanax

1 mg

190

100.00%

 

Such lack of security and controls indicates that the pharmacy ceased to satisfy the qualifications of a terminal distributor within the meaning of Section 4729.57 of the Ohio Revised Code.

 

(3)     Medic Discount Drug did, on or about May 6, 2003, and dates previous, violate a Rule of the Board, to wit: adequate safeguards were not assured 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.  One employee who admitted stealing controlled substances indicated to Board agents that "stealing drugs was easy because of poor security and recordkeeping."  Such lack of safeguards is in violation of Rule 4729-9-11 of the Ohio Administrative Code.

 

(4)     Medic Discount Drug did, from May 1, 2001, through May 6, 2003, using a com­puterized recordkeeping system, fail in the capability of providing immediate re­trieval (via CRT display and hard-copy printout or other mutually agreeable transfer medium) of patient profile information for all prescriptions filled within the previous twelve months and retrieval within three working days, excluding weekends and holidays, of all pre­scrip­tions dispensed within the previous thirty-six months which included the name of the prescriber, to wit: of 17,700 computer records generated during this time period, 3,369 prescriptions (19% of the records) did not have the name of the pre­scriber included therein.  Such conduct is in violation of Rule 4729-5-28(A)(5) of the of the Ohio Admini­stra­tive Code.

 

(5)     Medic Discount Drug did, from May 1, 2001, through May 6, 2003, dispense drugs pur­su­ant to prescriptions with labels affixed thereto when the labels did not indicate the name of the prescriber, to wit: of 17,700 computer records gen­erated during this time period, 3,369 prescriptions (19% of the records) did not have the name of the prescriber indicated on the label.  Such conduct is in viola­tion of Rule 4729-5-16(A)(3) of the Ohio Administrative Code.

 

(6)     Medic Discount Drug did, from May 1, 2001, through May 6, 2003, fail to main­tain records of drugs dispensed, to wit: after having received a request from a Board agent, Medic Discount Drug was unable to produce eight prescriptions for OxyContin, one prescription for alprazolam, and one prescription for acetamino­phen with codeine as the prescriptions were not maintained in the pharmacy files.  Such conduct is in violation of Section 3719.07 and 4729.37 of the Ohio Revised Code.

 

Medic Discount Drug neither admits nor denies the allegations stated in the Notice of Oppor­tunity for Hearing letter dated January 13, 2004; 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, Medic Discount Drug knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

 

(1)     Medic Discount Drug agrees to the imposition of a monetary penalty of two thousand dollars ($2,000.00) due and owing within 30 days of the effective date of this Agree­ment.  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 S. High Street, 17th Floor, Columbus, Ohio 43215-6126.

 

(2)     Medic Discount Drug agrees to adopt and implement the policies and procedures as submitted to the Ohio State Board of Pharmacy in its letter dated April 27, 2004.  These policies are incorporated into this agreement as if fully rewritten herein.

 

Medic Discount Drug acknowledges that it has had an opportunity to ask questions concern­ing the terms of this agreement and that all questions asked have been answered in a satis­factory man­ner.  Any action initiated by the Board based on alleged violation of this Agree­ment shall comply with the Administrative Procedure Act, Chapter 119. of the Ohio Revised Code.

 

Medic Discount Drug waives any and all claims or causes of action it may have against the State of Ohio or the Board, and members, officers, employees, and/or agents of either, arising out of mat­ters which are the subject of this Agreement.  Medic Discount Drug waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code.

 

This agreement embodies the entire agreement between and of the parties.  There are no express or implied promises, guarantees, terms, covenants, conditions, or obligations other than those contained herein; and this agreement supersedes all previous communications, representations or agreements, either verbal or written, between the parties.

 

This Settlement Agreement shall be considered a public record, as that term is used in Sec­tion 149.43 of the Ohio Revised Code, and shall become effective upon the date of the Board Presi­dent’s signature below.

 

/s/         Nathan S. Lipsyc

 

/d/    7–2–04

 

Nathan S. Lipsyc, President

 

Date of Signature

 

/s/         Robert P. Giacalone

 

/d/    7/13/04

 

Robert P. Giacalone, President, Ohio State Board of Pharmacy

 

Date of Signature

 

/s/         Sally Ann Steuk

 

/d/    7–13–04

 

Sally Ann Steuk, Ohio Assistant Attorney General

 

Date of Signature

 

 

R-2005-008

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-040113-053)

 

In The Matter Of:

 

ALLEN BRUCE WEAVER, R.Ph.

15753 Balmoral Court

Strongsville, Ohio 44136

(R.Ph. No. 03-1-12438)

 

This Settlement Agreement is entered into by and between Allen Bruce Weaver 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.

 

Allen Bruce Weaver 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. Allen Bruce Weaver 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, Allen Bruce Weaver is licensed to practice pharmacy in the State of Ohio.

 

Whereas, on or about January 13, 2004, pursuant to Chapter 119. of the Ohio Revised Code, Allen Bruce Weaver 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. Allen Bruce Weaver requested a hearing.  The January 13, 2004, Notice of Opportunity for Hearing contains the following alle­ga­tions or charges:

 

(1)     Records of the State Board of Pharmacy indicate that Allen Bruce Weaver was originally licensed by the State of Ohio as a pharmacist on August 10, 1977, pur­suant to examination, and is currently licensed to practice pharmacy in Ohio.  Records further reflect during the relevant time periods stated herein, Allen Bruce Weaver was the Responsible Pharmacist at Medic Discount Drug, 4507 Clark Ave­nue, Cleveland, Ohio, pursuant to Rule 4729-5-11 of the Ohio Administrative Code and Sections 4729.27 and 4729.55 of the Ohio Revised Code.

 

(2)     Allen Bruce Weaver as the Responsible Pharmacist did, on or about May 1, 2001 through May 6, 2003, violate a rule of the Board, to wit: Allen Bruce Weaver failed to assure 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.  One employee who admitted stealing controlled substances indicated to Board agents that "stealing drugs was easy because of poor security and recordkeeping." Audit results have revealed the following short­ages: