Phone: 614/466-4143 E-mail:
exec@bop.state.oh.us
Fax: 614/752-4836
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
Minutes
Of The Meeting
June
12, 13, 14, 2000
MONDAY, JUNE 12, 2000
8:07 a.m. ROLL CALL
The
State Board of Pharmacy convened in Room 1914,
Robert B. Cavendish, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Ann D. Abele, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Suzanne L. Neuber, R.Ph.; and Nicholas R. Repke, Public Member.
Also
present were
8:08 a.m.
Ms.
Abele moved that the Board go into Executive Session for the purpose of the
investigation of complaints regarding licensees and registrants pursuant to
Section 121.22(G)(1) of the Revised Code 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
8:50 a.m.
RES. 2000-178 The
Executive Session ended and the Board meeting resumed in Public Session.
8:52 a.m.
RES. 2000-179
SETTLEMENT AGREEMENT WITH THE
STATE BOARD OF PHARMACY
(Docket No. D-000211-046)
In the Matter of:
c/o
(Terminal Distributor No.
02-0980900)
THIS SETTLEMENT AGREEMENT IS ENTERED INTO BY AND
BETWEEN
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, Newtown Fire and Rescue is a licensed
terminal distributor of dangerous drugs in the state of
WHEREAS, on or about February 11, 2000, pursuant to
Chapter 119. of the Ohio Revised Code, Newtown Fire and Rescue 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. The February 11, 2000, Notice of Opportunity
for Hearing contains the following allegations or charges:
(1) Records of the State Board of Pharmacy indicate that
(2) Newtown Fire and Rescue allowed its terminal distributor
license to lapse from January 1, 1998, to November 4, 1999. Such conduct is in violation of Section
4729.54(I) of the Ohio Revised Code.
WHEREAS, Newtown Fire and Rescue admits to the
allegations or charges, and the Board hereby adjudicates the same.
WHEREAS, Newtown Fire and Rescue admits and
acknowledges that it is not a “prevailing eligible party” for purposes of
Revised Code Sections 119.092 and 2335.39.
Further, Newtown Fire and Rescue waives any rights it may have under
Sections 119.09 and 2335.39 of the Ohio Revised Code.
WHEREAS, Newtown Fire and Rescue, with intention of
binding itself and its successors in interest and assigns, hereby releases, and
holds harmless from liability and forever discharges the State of Ohio, the
Board, the Ohio Attorney General, and any and all of their present and former
members, officers, attorneys, agents and employees, personally and in their
official capacities, from any and all claims, demands, causes of actions, judgments,
or executions that Newtown Fire and Rescue ever had, or now has or may have,
known or unknown, or that anyone claiming through or under it may have or
claims to have, created by or arising out of the allegations or charges filed
by the Board against Newtown Fire and Rescue, set forth in the Notice of Opportunity
for Hearing.
WHEREAS, Newtown Fire and Rescue 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.
The parties, in consideration of the mutual
covenants and promises contained herein, and in lieu of any further formal
proceedings at this time, and intending to be bound by said covenants, agree as
follows:
(A) Pursuant to Sections 4729.25(B) and 4729.57 of the Ohio Revised
Code, Newtown Fire and Rescue is hereby reprimanded.
(B) Newtown Fire and Rescue agrees to pay licensing and late fees
for the 1998 through 2000 renewal periods in the amount of $447.50. (Paid on November 4, 1999.)
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.
THE PARTIES HERETO ACKNOWLEDGE THAT THIS 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/
/s/ R.
R.
/s/
/s/
8:55 a.m.
The Board took a brief recess and toured the Pharmacy Board office to review the progress of the construction.
9:27 a.m.
The
meeting resumed. The Board discussed the
meeting schedule for FY 2001. There was
a conflict between the May, 2001 Board meeting and the Annual Meeting of the
National Association of Boards of Pharmacy.
9:35 a.m.
RES. 2000-180
9:45 a.m.
RES. 2000-181
10:01 a.m.
RES. 2000-182 The Board then discussed the appointment of
the two pharmacists to the Nursing Board’s Committee on Prescriptive
Governance. Under the terms of HB 241,
it was necessary for the appointments to be made by this month’s meeting.
10:10 a.m.
10:35 a.m.
10:40 a.m.
The Board took a brief recess.
11:00 a.m.
RES. 2000-183
11:25 a.m.
The Board recessed for lunch.
1:00 p.m.
The
meeting resumed with all members present.
1:30 p.m.
The Executive Session ended and the Board meeting was opened to the public.
1:33 p.m.
2:24 p.m.
The presentation concluded and the record was closed. The Board took a brief recess.
2:33 p.m.
Ms.
Abele moved that the Board go into Executive Session for the purpose of the
investigation of complaints regarding licensees and registrants pursuant to
Section 121.22(G)(1) of the Revised Code.
The motion was seconded by
3:10 p.m.
RES. 2000-184 The
Executive Session ended and the meeting was opened to the public.
RES. 2000-185 The Board then considered the request for an
expedited hearing in the matter of
3:19 p.m.
RES. 2000-186
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-000330-051)
In
The Matter Of:
NICK
(R.Ph. No. 03-2-07171)
INTRODUCTION
THE MATTER OF NICK C. STROVILAS CAME FOR
CONSIDERATION ON JUNE 12, 2000, BEFORE THE FOLLOWING MEMBERS OF THE BOARD:
ROBERT B. CAVENDISH, R.Ph. (presiding); ANN D. ABELE, R.Ph.; DIANE C. ADELMAN,
R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST,
R.Ph.; AMONTE B. LITTLEJOHN, R.Ph.; SUZANNE L. NEUBER, R.Ph.; AND NICHOLAS R.
REPKE, PUBLIC MEMBER.
SUMMARY
OF EVIDENCE
(A) Testimony
State's Witnesses:
(1)
Respondent's Witnesses:
(1) None
(B) Exhibits
State's Exhibits:
(1) Exhibit
1--Copy of twelve-page Notice of Opportunity for Hearing letter dated March 30,
2000.
(2) Exhibit
1A--Hearing Request letter dated April 28, 2000, from Attorney Frank M. Moore received
in the Board office on May 8, 2000, with envelope displaying two stamped dates
as follows: April 28, 2000, made by. Pittsburgh PA Meter No. 5004822, and May
4, 2000, made by the Pittsburgh PA 152 Post Office for cancellation.
(3) Exhibit
1B--Copy of letter from
(4) Exhibit
1C--Copy of Pharmacist File Front Sheet of Nick G. Strovilas showing original
date of registration as March 8, 1960; and copy of Ohio Board of Pharmacy,
Pharmacists/Interns licensing information report for R.Ph. No. 03-2-07171 of
(5) Exhibit
2--Copy of Dangerous Drug Distributor Inspection Reports of Mike’s Rexall
Pharmacy, Terminal Distributor No. 02-05-2847 and/or 02-0123650, as follows:
report dated March 22, 1982; report dated March 28, 1983; report dated August
8, 1984; report dated August 17, 1989; three-page report dated December 12,
1991; report dated November 2, 1992; and two-page report dated May 3, 1994; and
copy of letter from Michael Popovich dated May 18, 1994.
(6) Exhibit
3--Copy of six-page Dangerous Drug Distributor Inspection Report of Mike’s
Rexal (sic) Pharmacy, Terminal Distributor No. 02-0123650, dated March
30, 1998.
(7) Exhibit
4--Copy of six-page list of adulterated drugs, sample drugs, and outdated drugs
removed from
(8) Exhibit
5--Prescription vial with Mike’s Pharmacy label containing 24 sample tablets of
Monopril 10mg with the word “Sample” crudely scraped off the tablets;
prescription vial containing 94 sample tablets of Monopril 10mg with the word
“Sample” crudely scraped off the tablets; and prescription vial containing
small piece of paper labeled “Soma Compound” and 80 sample tablets of Soma
Compound 200/325 with the word “Sample” crudely scraped off the tablets.
(9) Exhibit
6--Two starter sample vials of SYN-Rx DM tablets with physician label.
(10) Exhibit
7--Copy of fourteen-page Dangerous Drug Distributor Inspection Report of Mikes
Rexall Pharmacy, Terminal Distributor No. 02-0123650, dated April 1, 1998.
(11) Exhibit
8--Copy of twelve-page response to the “Pink Sheet” violations recorded on the
April 1, 1998, Dangerous Drug Distributor Inspection Report of Mikes Rexall
Pharmacy signed by Michael Popovich and Nick Strovilas on April 1, 1998.
(12) Exhibit
9--Copies of twenty-seven Accountability Statements of Mikes Rexall Pharmacy,
Terminal Distributor No. 02-0123650, for the audit period of April 30, 1996,
through March 30, 1998, dated January 10, 1999, for the following drugs: Ultram
50mg; Soma-Carisoprodol; Oxycontin 40mg; Oxycontin 20mg; Oxycontin 10mg; Tylox
and Roxilox 5/500; Percodan and Oxycodone/APAP; Percocet, Roxicet, and
Oxycodone/APAP; Valium 10mg (Diazepam); Valium 5mg (Diazepam); Valium 2mg
(Diazepam); Ativan 2mg (Lorazepam); Ativan 1mg (Lorazepam); Ativan .5mg
(Lorazepam); Xanax 1mg (Alprazolam); Xanax 0.5mg (Alprazolam); Xanax 0.25mg
(Alprazolam); Lorcet 10/650 (Hydrocodone Bitartrate); Lorcet Plus 7.5/650
(Hydrocodone Bitartrate/APAP); Lortab 7.5/500 (Hydrocodone Bitartrate); Vicodin
ES 7.5/750 (Hydrocodone Bitartrate); MS Contin 15mg (Morphine Sulfate); MS
Contin 30mg (Morphine Sulfate); Ritalin 10mg (Methylphenidate); Ritalin SR 20mg
(Methylphenidate); Vicodin and Lortab 5/500 (Hydrocodone Bitartrate); and
Darvocet N/100 (Propoxyphene Napsylate).
(13) Exhibit
10--Copies of two pages of patient profile records of Richard Shimmel dated
from January 18, 1996, through February 1, 1998; and, copies of the following
prescriptions 380208, 379409, 382985, 382842, 379962, 379665, 384247, 380207,
382938, 383018, 378928, 379591, 379636, and 378650.
(14) Exhibit
11--Three-page copy of Ohio State Board of Pharmacy Report of Investigation,
Case No. 98-1192, Statement of Richard Shimmel, signed and notarized on
November 15, 1999.
(15) Exhibit
12--Copy of prescription number 384886.
(16) Exhibit
13--Copies of eleven pages of Lathem family profiles (
(17) Exhibit
14--Copies of nineteen prescriptions numbered as follows: 382290, 379322,
379119, 383711, 384377, 384884, 384885, 383710, 383890, 384535, 381047, 381869,
376653, 375422, 378397, 378822, 378543, 378823, and 379120.
(18) Exhibit
15--Copy of two-page Ohio State Board of Pharmacy Report of Investigation,
Case No. 98-1192, by Agent David Gallagher dated April 8, 1998.
(19) Exhibit 16--Copies of five pages of patient profile records of
(20) Exhibit
17--Copy of five spreadsheets regarding
(21) Exhibit
18--Copy of eleven-page Ohio State Board of Pharmacy Report of Investigation,
Case No. 98-1192, Statement of Robert Swiger, Sr. signed and notarized on
December 22, 1999.
(22) Exhibit
19--Copy of nine-page Ohio State Board of Pharmacy Report of Investigation,
Case No. 98-1192, Statement of Crist Strovilas, M.D. signed and notarized on
December 6, 1999.
(23) Exhibit
20--Twenty-page copy of Ohio State Board of Pharmacy Report of Investigation
regarding the Statement of Michael Popovich, signed and notarized on November
15, 1999.
(24) Exhibit
21--Copy of thirty-four-page Ohio State Board of Pharmacy Report of
Investigation, Case No. 98-1192, Statement of Nick Strovilas, R.Ph. signed and
notarized December 6, 1999.
(25) Exhibit
22--Copy of prescription number 381877.
(26) Exhibit
23--Copy of prescription number 384889.
(27) Exhibit
24--Copy of prescription number 385222.
(28) Exhibit
25--Copy of prescription number 383877.
(29) Exhibit
26--Copy of prescription number 384255.
(30) Exhibit
27--Copy of prescription number 378864.
(31) Exhibit
28--Copy of prescription number 379981.
(32) Exhibit
29--Copy of prescription number 382349.
(33) Exhibit
30--Copy of fourteen-page, thirty-eight-count Indictment, in the Jefferson
County Court of Common Pleas, State of
Respondent's
Exhibits:
(1) 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 March 30, 2000,
(2) As demonstrated by return receipt, not dated,
(3) Nick C. Strovilas did not request a hearing in a timely manner
pursuant to Chapter 119. of the
(4) Records of the State Board of Pharmacy indicate that
(5) Nick C. Strovilas did,
from on or about April 30, 1996, through September 15, 1998, being employed by,
or associated with, an enterprise and conducted or participated in, directly or
indirectly, the affairs of the enterprise through a pattern of corrupt activity
or the collection of an unlawful debt when the conduct was not in accordance
with Chapters 3719. and 4729. of the Ohio Revised Code, to wit:
(6) Nick C. Strovilas did, from on or about April 30, 1996, through
April 1, 1998, knowingly furnish another a sample drug, to wit: Nick C.
Strovilas obtained the following drug samples from Jefferson County physicians
and furnished them to Mike’s Pharmacy to sell to patients:
Contents of
Evidence
|
Sample
Drug/Strength/Form |
Type of container |
Qty found in the vial |
Qty noted on the vial |
|
Altace cap |
mfg. pkg. |
191 |
192 |
|
Altace cap |
mfg. pkg. |
175 |
176 |
|
Amaryl 2mg |
mfg. pkg. |
49 |
48 |
|
Amaryl 4mg |
mfg. pkg. |
47 |
48 |
|
Capozide 25mg |
mfg. pkg. |
266 |
270 |
|
Capozide tab |
mfg. pkg. |
106 |
72 |
|
Corgard |
mfg. pkg. |
95 |
112 |
|
Corzide 5mg tablet |
vial |
305 |
no # |
|
Covera-HS tab |
vial |
100 |
180 |
|
Covera-HS tab 240mg |
mfg. pkg. |
75 |
75 |
|
Diovan 80mg |
mfg. pkg. |
107 |
108 |
|
Lotensin 10mg |
mfg. pkg. |
416 |
70 |
|
Lotrel 10/2.5 cap |
mfg. pkg. |
95 |
no # |
|
Monopril 10mg tab |
vial |
126 |
no # |
|
Monopril 10mg tab |
mfg. pkg. |
236 |
105 |
|
Monopril tablet |
mfg. vial |
670 |
no # |
|
Mykrox tablet |
vial |
60 |
60 |
|
Nizoral tablet |
vial |
34 |
20 |
|
Pravachol tab |
mfg. pkg. |
44 |
4 |
|
Rynatan tab |
vial |
66 |
88 |
|
Rynatan tab |
vial |
60 |
108 |
|
Rynatuss tab |
vial |
8 |
8 |
|
Serzone tablets |
vial |
27 |
no # |
|
Serzone tablets |
mfg. pkg. |
178 |
167 |
|
Suprax 400mg tab |
mfg. pkg. |
25 |
no # |
|
Suprax 400mg tab |
vial |
36 |
36 |
|
Suprax tab |
vial |
18 |
25 |
|
Synthroid tabs |
vial |
32 |
no # |
|
Synthroid 175mg |
mfg. pkg. |
42 |
42 |
|
Tegretol 200mg tab |
mfg. pkg. |
95 |
8 |
|
Trandate 200mg tabs (split in half) |
vial |
30 |
no # |
|
Vaseretic 10/25 tabs |
mfg. pkg. |
113 |
4 |
|
Vaseretic 5/12.5 tabs |
mfg. pkg. |
111 |
4 |
|
Verelan 180mg cap |
mfg. pkg. |
105 |
no # |
|
Verelan 360mg caps |
vial |
50 |
no # |
|
Verelan 120mg tab |
mfg. pkg. |
19 |
20 |
|
Zocor 40mg tablet |
vial |
113 |
112 |
|
Zoloft tab |
mfg. pkg. |
164 |
168 |
Contents of Evidence
|
Sample
Drug/Strength/Form |
Type of container |
Qty found in the vial |
Qty noted on the vial |
|
Altace cap |
mfg. pkg. |
191 |
192 |
|
Anaprox DS tabs |
mfg. bottle |
170 |
no # |
|
Avapro 150mg |
vial |
91 |
91 |
|
Coreg 6.25 |
vial |
140 |
140 |
|
|
vial |
25 |
50 |
|
Effexor 75mg |
vial |
12 |
12 |
|
Effexor 37.5 tabs |
vial |
120 |
120 |
|
Fosamax 10mg tab |
vial |
18 |
18 |
|
Fosamax 5mg tab |
vial |
35 |
36 |
|
Fumadine tabs |
vial |
29 |
30 |
|
Lodine 500mg tabs |
mfg. bottle |
78 |
108 |
|
Loterl 5/20 cap |
vial |
48 |
48 |
|
Lotrel 2.5/10 |
vial |
95 |
96 |
|
Mavik 1mg tabs |
vial |
97 |
91 |
|
Mavik 1mg tabs |
vial |
420 |
420 |
|
Microzide 12.5mg caps |
vial |
56 |
56 |
|
Microzide 12.5mg caps |
vial |
220 |
240 |
|
Nu-Iron tabs |
vial |
11 |
11 |
|
Slow Fe tabs |
vial |
120 |
no # |
|
Tarka 1/240 tab |
vial |
35 |
35 |
|
Tarka 2/180 tab |
vial |
105 |
105 |
|
Tarka 2/240 tab |
vial |
70 |
70 |
|
Tarka 2/240 tab |
vial |
35 |
35 |
|
Tarka 4/240 |
vial |
35 |
35 |
|
Tarka 4/240 |
vial |
69 |
70 |
|
Tiazac 360mg caps |
vial |
34 |
35 |
|
Tritec 400mg |
vial |
139 |
140 |
|
Valtrex 500mg tab |
vial |
65 |
61 |
Contents of Evidence
|
Sample
Drug/Strength/Form |
Type of container |
Qty found in the vial |
Qty noted on the vial |
|
Altace cap |
mfg. pkg. |
191 |
192 |
|
Anatuss LA tabs |
mfg. bottle |
232 |
221 |
|
Covera-HS 180mg tabs |
mfg. bottle |
174 |
175 |
|
Duratuss 1200mg |
mfg. bottle |
50 |
54 |
|
Lodine 500mg |
mfg. bottle |
252 |
230 |
|
Phrenilin
50mg |
mfg. bottle |
166 |
168 |
|
Phrenilin Forte 50mg caps |
vial |
54 |
54 |
|
Precose
50mg |
mfg. bottle |
374 |
470 |
|
Sedapap 50 / 650 |
mfg. bottle |
99 |
236 |
|
Semprex caps |
mfg. bottle |
239 |
348 |
|
Valtrex 500mg |
mfg. bottle |
156 |
156 |
|
Zephrex LA tabs |
mfg. bottle |
76 |
96 |
|
Zyflo 600mg |
mfg. bottle |
95 |
96 |
Contents of Evidence
|
Sample
Drug/Strength/Form |
Type of container |
Qty found in the vial |
Qty noted on the vial |
|
Cardizem 240mg CD tabs |
vial |
56 |
no # |
|
EC -Naprosyn 500mg tab |
vial |
59 |
no # |
|
EC-Naprosyn 375mg tabs |
vial |
69 |
70 |
|
Lorabid
200mg caps |
vial |
6 |
72 |
|
Lorabid 200mg caps |
vial |
60 |
60 |
|
Lorabid 400mg caps |
vial |
20 |
20 |
|
Lotensin 10mg tabs |
mfg. vial |
180 |
100 |
|
Lotrel 5 / 10 (sample
handwritten on the label) |
vial |
45 |
48 |
|
Paxil
30mg tabs |
vial |
30 |
no # |
|
Precose 50mg tabs |
mfg. vial |
204 |
100 |
|
Prilosec 10mg caps |
vial |
44 |
70 |
|
Prozac
30mg caps |
vial |
52 |
no # |
|
Prozac 20mg caps |
mfg. vial |
129 |
100 |
|
Prozac 20mg caps |
mfg. vial |
79 |
30 |
|
Prozac 20mg caps |
mfg. vial |
143 |
100 |
|
Prozac 30mg caps |
vial |
80 |
no # |
|
Seldane 60mg tabs |
mfg. vial |
157 |
100 |
|
Syn-Rx DM tabs (two vials
banded together w/sample pkt) |
vials / pkt |
78 |
|
Contents of
Evidence
|
Sample
Drug/Strength/Form |
Type of container |
Qty found in the vial |
Qty noted on the vial |
|
Arthrotec 75mg tabs
(with patient name |
vial |
11 |
14 |
|
Cefzil
500mg |
vial |
14 |
24 |
|
Cipro 750 tabs |
vial |
3 |
no # |
|
Cipro Cystitis 100mg tabs |
vial |
18 |
18 |
|
Cystospaz .375mcg caps |
sample vial |
21 |
12 |
|
Deconsal Sprinkle cap |
sample vial |
25 |
4 |
|
Dulcolax 5mg tab |
sample vial |
17 |
5 |
|
Famvir 125mg tabs |
vial |
127 |
95 |
|
Famvir 250mg tab |
vial |
15 |
15 |
|
Generic Elavil 100mg |
vial |
183 |
no # |
|
Hemaspan tab |
vial |
24 |
24 |
|
Lamisil Tabs |
vial |
12 |
12 |
|
Levaquin 250mg tab |
vial |
14 |
12 |
|
Maxaquin
400mg tabs |
vial |
8 |
8 |
|
Mevacor 10mg |
vial |
96 |
96 |
|
Naprosyn
375mg tabs |
vial |
5 |
20 |
|
Normodyne
100mg tabs |
mfg vial |
194 |
100 |
|
Pink |
vial |
44 |
no # |
|
Posicor 100mg tab |
vial |
28 |
28 |
|
Posicor 50mg tab |
vial |
28 |
no # |
|
Posicor 50mg tab |
vial |
139 |
140 |
|
Premphase .625mg / 5mg |
vial |
140 |
140 |
|
Prozac 10mg caps |
vial |
7 |
no # |
|
Seldane tablets (National Rx
vial w/label for |
patient vial |
38 |
60 |
|
Synthroid 112mcg tabs |
vial |
42 |
42 |
|
Synthroid tab |
vial |
42 |
42 |
|
|
vial |
18 |
no # |
|
Tolectin 600mg |
sample vial |
42 |
6 |
|
Toprol XL
200mg tab |
sample vial |
26 |
7 |
|
Uni-Dur 400mg tabs
(in a 600 mg sample bottle) |
sample vial |
21 |
7 |
|
Uro-Mag caps |
sample vial |
119 |
60 |
|
Ziac 10 / 6.25mg tabs |
vial |
5 |
no # |
|
Zocor 40mg |
vial |
86 |
136 |
|
Zocor 5mg tabs |
sample vial |
8 |
4 |
|
Zoloft 50mg tabs |
mfg vial |
301 |
100 |
|
Zoloft 50mg tabs |
vial |
278 |
no # |
|
Zovirax
400mg |
vial |
10 |
10 |
Contents of
Evidence
|
Sample
Drug/Strength/Form |
Type of container |
Qty found in the vial |
Qty noted on the vial |
|
Axocet |
mfg. vial |
66 |
72 |
|
Covera-HS 240mg tab |
mfg. vial |
198 |
200 |
|
|
mfg. vial |
90 |
160 |
|
Lotrel 2.5mg |
vial |
48 |
48 |
|
Midrin 65/100/325 |
vial |
60 |
no # |
|
Naprelan 500mg tabs |
mfg. vial |
169 |
216 |
|
Pink Tab P/F no label on vial |
mfg. vial |
269 |
no # |
|
Pink Tab P/F no label on vial |
mfg. vial |
261 |
no # |
|
Premphase .625 |
vial |
42 |
42 |
|
Premphase .625 |
vial |
42 |
42 |
|
Sporonax |
mfg. vial |
61 |
no # |
|
Sular 20mg |
mfg. vial |
185 |
416 |
|
Sular 20mg |
mfg. vial |
151 |
252 |
|
Tarka 1/240 |
mfg. vial |
104 |
70 |
|
Theo-24 200mg caps |
mfg. vial |
203 |
223 |
|
Tiazac 180mg caps |
mfg. vial |
247 |
379 |
|
Tiazac 300mg caps |
mfg. vial |
135 |
285 |
|
Trinalin
3.72 tabs |
mfg. vial |
668 |
no # |
|
Trinalin 3.72 tabs |
mfg. vial |
140 |
no # |
|
Uniphyl
600mg |
Smuckers Jar |
298 |
298 |
|
Univasc 15mg |
|
|
|
|
(
pills are split in the bottle ) |
vial |
29 |
no # |
|
Univasc 15mg |
|
|
|
|
(
pills are split in the bottle ) |
vial |
32 |
no # |
|
Univasc 15mg tabs |
mfg. vial |
708 |
770 |
|
Zyflo 600mg |
mfg. vial |
64 |
64 |
Such
conduct is in violation of Section 2925.36 of the Ohio Revised Code.
(7) Nick
C. Strovilas did, on or about April 30, 1996, through September 15, 1998,
adulterate, mutilate, destroy, obliterate or remove of the whole or any part of
the labeling of a drug, while the article was held for sale, resulting in the
article being misbranded, to wit: agents of the Board discovered that the word
“sample” was crudely scrapped off medications in an attempt to alter their
distribution appearance prior to sale; the following are examples of Nick C.
Strovilas’ conduct:
|
Drug |
Quantity |
|
Monopril
10mg |
24 |
|
Monopril
10mg |
94 |
|
Soma
Compound 200/325 |
80 |
Such
conduct is in violation of Section 3715.52(A) of the Ohio Revised Code.
(8) Nick
C. Strovilas did, on or about January 26, 1998, knowingly make a false
statement in a prescription order, report or record required by Chapter 3719.
or 4729. of the Revised Code, to wit: Nick C. Strovilas created prescription
number 384886 for 40 unit doses of Vicodin ES, a Schedule III controlled substance,
when not authorized by a practitioner in violation of Section 2925.23(A) of the
Ohio Revised Code.
(9) Nick
C. Strovilas did, on or about January 26, 1998, sell a controlled substance in
an amount exceeding the bulk amount but not exceeding five times the bulk
amount when the conduct was not in accordance with Chapters 3719. and 4729. of
the Ohio Revised Code, to wit: Nick C. Strovilas sold 40 unit doses of Vicodin
ES, a Schedule III controlled substance, without a legitimate prescription and
without legitimate medical purpose pursuant to prescription number 384886. Such conduct is in violation of Section
2925.03(A) of the Ohio Revised Code.
(10) Nick C.
Strovilas did, on or about February 1, 1998, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 384886
for 40 unit doses of Vicodin ES, a Schedule III controlled substance, when not
authorized by a practitioner in violation of Section 2925.23(A) of the Ohio
Revised Code.
(11) Nick C.
Strovilas did, on or about February 1, 1998, sell a controlled substance in an
amount exceeding the bulk amount but not exceeding five times the bulk amount
when the conduct was not in accordance with Chapters 3719. and 4729. of the
Ohio Revised Code, to wit: Nick C. Strovilas sold 40 unit doses of Vicodin ES,
a Schedule III controlled substance, without a legitimate prescription and
without a legitimate medical purpose pursuant to prescription number
384886. Such conduct is in violation of
Section 2925.03(A) of the Ohio Revised Code.
(12) Nick C.
Strovilas did, on or about April 15, 1997, knowingly make a false statement in
a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 381877
for 30 unit doses of Rynatan 30mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
(13) Nick C.
Strovilas did, on or about January 27, 1998, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 384889
for 20 unit doses of Biaxin 500mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
(14) Nick C.
Strovilas did, on or about February 20, 1998, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 385222
for 60 unit doses of Ultram 50mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
(15) Nick C.
Strovilas did, on or about October 20, 1997, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 383877
for 90 unit doses of Soma 350mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
(16) Nick C.
Strovilas did, on or about November 21, 1997, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 384255
for 90 unit doses of Soma 350mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
(17) Nick C.
Strovilas did, on or about December 22, 1997, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 384255
for 90 unit doses of Soma 350mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
(18) Nick C.
Strovilas did, on or about January 19, 1998, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 384255
for 90 unit doses of Soma 350mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
(19) Nick C.
Strovilas did, on or about February 16, 1998, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 384255
for 90 unit doses of Soma 350mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
(20) Nick C.
Strovilas did, on or about March 16, 1998, knowingly make a false statement in
a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 384255
for 90 unit doses of Soma 350mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
(21) Nick C. Strovilas did, on or about July 18, 1996, knowingly make
a false statement in a prescription order, report or record required by Chapter
3719. or 4729. of the Revised Code, to wit: Nick C. Strovilas created
prescription number 378864 for 60 unit doses of Xanax .5mg, a Schedule IV
controlled substance, when not authorized by a practitioner in violation of
Section 2925.23(A) of the Ohio Revised Code.
(22) Nick C.
Strovilas did, on or about October 31, 1996, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 379961
for 30 unit doses of Xanax .5mg, a Schedule IV controlled substance, when not
authorized by a practitioner in violation of Section 2925.23(A) of the Ohio
Revised Code.
(23) Nick C.
Strovilas did, on or about November 18, 1996, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 379961
for 30 unit doses of Xanax .5mg, a Schedule IV controlled substance, when not
authorized by a practitioner in violation of Section 2925.23(A) of the Ohio
Revised Code.
(24) Nick C.
Strovilas did, on or about December 9, 1996, knowingly make a false statement
in a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 379961
for 30 unit doses of Xanax .5mg, a Schedule IV controlled substance, when not
authorized by a practitioner in violation of Section 2925.23(A) of the Ohio
Revised Code.
(25) Nick C.
Strovilas did, on or about January 7, 1997, knowingly make a false statement in
a prescription order, report or record required by Chapter 3719. or 4729. of
the Revised Code, to wit: Nick C. Strovilas created prescription number 379961
for 30 unit doses of Xanax .5mg, a Schedule IV controlled substance, when not
authorized by a practitioner in violation of Section 2925.23(A) of the Ohio
Revised Code.
(26) Nick C.
Strovilas did, on or about May 27, 1997, knowingly make a false statement in a
prescription order, report or record required by Chapter 3719. or 4729. of the
Revised Code, to wit: Nick C. Strovilas created prescription number 382349 for
30 unit doses of Ultram 350mg when not authorized by a practitioner in
violation of Section 2925.23(A) of the Ohio Revised Code.
CONCLUSIONS
OF LAW
(1) Upon
consideration of the record as a whole, the State Board of Pharmacy concludes
that paragraphs (5) through (26) of the Findings of Fact constitute being
guilty of a felony or gross immorality as provided in Division (A)(1) of
Section 4729.16 of the Ohio Revised Code.
(2) Upon
consideration of the record as a whole, the State Board of Pharmacy concludes
that paragraphs (5) through (26) 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.
(3) Upon consideration
of the record as a whole, the State Board of Pharmacy concludes that
paragraphs (5) through (26) 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 Sections 3715.52 to 3715.72 or
Chapter 2925. of the Revised Code as provided in Division (A)(5) of Section
4729.16 of the
ACTION
OF THE BOARD
Pursuant to Section 4729.16 of the Ohio Revised
Code, the State Board of Pharmacy takes the following actions in the matter of
(A) On the
basis of the Findings of Fact and paragraph (1) of the Conclusions of Law set
forth above, the State Board of Pharmacy hereby revokes the pharmacist
identification card, No. 03-2-07171, held by
(B) On the
basis of the Findings of Fact and paragraph (2) of the Conclusions of Law set
forth above, the State Board of Pharmacy hereby revokes the pharmacist
identification card, No. 03-2-07171, held by
(C) On the
basis of the Findings of Fact and paragraph (3) of the Conclusions of Law set
forth above, the State Board of Pharmacy hereby revokes the pharmacist
identification card, No. 03-2-07171, held by
Pursuant to Section 4729.16(B) 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
3:23 p.m.
The Board meeting recessed until Tuesday, June 13, 2000.
TUESDAY, june 13, 2000
8:05 a.m. ROLL CALL
The
State Board of Pharmacy convened in Room 1914,
Robert B. Cavendish, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Ann D. Abele, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; and Nicholas R. Repke, Public Member.
8:14 a.m.
Ms.
Abele moved that the Board go into Executive Session for the purpose of the
investigation of complaints regarding licensees and registrants pursuant to
Section 121.22(G)(1) of the Revised Code.
The motion was seconded by
8:18 a.m.
8:21 a.m.
RES. 2000-187 The
Executive Session ended and the meeting was opened to the public.
8:25 a.m.
RES. 2000-188
8:35 a.m.
RES. 2000-189
8:44 a.m.
After
a discussion of the proposed Minutes for the May 1, 2, 3, 2000 Board meeting,
8:45 a.m.
The Board took a brief recess.
9:19 a.m.
The
Board was joined by
11:16 a.m.
The hearing concluded and the record was closed.
11:25 a.m.
Ms.
Abele moved that the Board go into Executive Session for the purpose of the
investigation of complaints regarding licensees and registrants pursuant to
Section 121.22(G)(1) of the Revised Code.
The motion was seconded by
11:35 a.m.
RES. 2000-190 The
Executive Session ended and the meeting was opened to the public.
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-990908-018)
In
The Matter Of:
(R.Ph. No. 03-3-10368)
INTRODUCTION
THE MATTER OF JAMES MURRAY BAYLESS CAME FOR HEARING
ON JUNE 13, 2000, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT B.
CAVENDISH, R.Ph. (presiding); ANN D. ABELE, R.Ph.; DIANE C. ADELMAN, R.Ph.;
ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; AMONTE B. LITTLEJOHN,
R.Ph.; SUZANNE L. NEUBER, R.Ph.; AND NICHOLAS R. REPKE, PUBLIC MEMBER.
SUMMARY
OF EVIDENCE
(A) Testimony
State's Witnesses:
(1)
Respondent's Witnesses:
(1)
(2)
(B) Exhibits
State's Exhibits:
(1) Exhibit
1--Copy of four-page Summary Suspension Order/Notice of
(2) Exhibit
1A--Hearing Request letter dated October 5, 1999.
(3) Exhibit
1B--Copy of Hearing Schedule letter dated October 8, 1999.
(4) Exhibit
1C--Hearing Representation and Continuance Request letter dated January 13,
2000.
(5) Exhibit
1D--Copy of Hearing Schedule letter dated January 14, 2000.
(6) Exhibit
1E--Copy of Pharmacist File Front Sheet of James Murray Bayless showing
original date of registration as March 6, 1973, and copy of Renewal Application
for Pharmacist License No. 03-3-10368 for a license to practice pharmacy in
(7) Exhibit
2
(8) Exhibit
3
(9) Exhibit
4
(10) Exhibit
5
.
(11) Exhibit
6
(12) Exhibit 7
Respondent's Exhibits:
(1) Respondent’s
Exhibit List dated June 13, 2000.
(2) Exhibit
A--Medical Records Release form of
(3) Exhibit
B1--Letter from
(4) Exhibit
B2
(5) Exhibit
B3--Letter from
(6) Exhibit
B4--Copy of letter from
(7) Exhibit
B5--Letter from
(8) Exhibit
C1--Copies of fifteen 12-Step Reaction Sheets dated from January 11, 1999,
through February 4, 2000.
(9) Exhibit
C2--Copies of three pages of Record of Meeting Attendance of Client No. 144
dated from February 6, 2000, through May 28, 2000.
(10) Exhibit
D--Copies of thirteen pages consisting of twelve urine drug screen reports of
(11) Exhibit
E1--Two-page copy of Pharmacists Rehabilitation Organization, Inc. Pharmacist’s
Recovery Contract of James M. Bayless dated January 18, 2000.
(12) Exhibit
E2--Letter from
(13) Exhibit
E3--Letter from
(14) Exhibit
E4--Copy of Airborne Express Airbill, No. 3458045360, from
(15) Exhibit
F--Copies of ten Continuing Pharmacy Education Certificates of
(16) Exhibit
G
FINDINGS
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 the following to be fact:
(1) Records
of the State Board of Pharmacy indicate that James Murray Bayless was
originally licensed in the state of
(2) James
Murray Bayless is addicted to and/or abusing liquor or drugs or impaired
physically or mentally to such a degree as to render him unfit to practice
pharmacy, to wit:
James Murray Bayless has admitted that he has a “drinking problem”;
James Murray Bayless has admitted consuming a fifth of Vodka on a daily basis,
at times with controlled substances; and James Murray Bayless has admitted
practicing pharmacy while impaired. Such
conduct indicates that James Murray Bayless falls within the ambit of Sections
3719.121(B) and 4729.16(A)(3) of the Ohio Revised Code.
(3)
(4)
CONCLUSIONS
OF LAW
(1)
(2) Upon
consideration of the record as a whole, the State Board of Pharmacy concludes
that paragraphs (2) 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.
(3) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraph (2) of the Findings of Fact constitutes
being addicted to or abusing liquor or drugs or impaired physically or mentally
to such a degree as to render him unfit to practice pharmacy as provided in
Division (A)(3) of Section 4729.16 of the Ohio Revised Code.
(4) Upon
consideration of the record as a whole, the State Board of Pharmacy concludes
that paragraph (2) of the Findings of Fact constitutes being guilty of
willfully violating, conspiring to violate, attempting to violate, or aiding
and abetting the violation of provisions of Chapters 3719. and 4729. of the
Revised Code as provided in Division (A)(5) of Section 4729.16 of the
ACTION
OF THE BOARD
Pursuant to Section 3719.121 of the Ohio Revised
Code, the State Board of Pharmacy hereby removes the Summary Suspension Order
issued to James Murray Bayless on September 8, 1999.
Pursuant to Section 4729.16 of the Ohio Revised
Code, the State Board of Pharmacy takes the following actions in the matter of
James Murray Bayless:
(A) On the
basis of the Findings of Fact and Conclusions of Law, the State Board of
Pharmacy hereby indefinitely suspends the pharmacist identification card, No.
03-3-10368, held by James Murray Bayless and such suspension is effective as of
the date of the mailing of this Order.
(1) James
Murray Bayless, pursuant to Rule 4729-9-01(F) of the Ohio Administrative Code,
may not be employed by or work in a facility licensed by the Board of Pharmacy
to possess or distribute dangerous drugs during such period of suspension.
(2) James
Murray Bayless, pursuant to Section 4729.16(B) of the Ohio Revised Code, must
return the identification card and license (wall certificate) to the office of
the State Board of Pharmacy within ten days after receipt of this Order. The certificate and identification card
should be sent by certified mail, return receipt requested.
(B) Further,
two years from the effective date of this Order or thereafter, the Board will
consider any petition filed by James Murray Bayless 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
(1) James
Murray Bayless must obtain, within 90 days after the effective date of this
Order, a full psychiatric or psychological evaluation by a licensed
psychiatrist or psychologist that includes a recommended treatment plan. James Murray Bayless must abide by the
treatment plan as designed by that psychiatrist or psychologist.
(2) James
Murray Bayless must enter into a contract, signed within 90 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. The contract must provide that:
(a) Random, observed urine drug screens
shall be conducted at least once each month.
(i) The urine sample must be given within twelve hours of
notification. The urine screen must
include testing for creatinine or specific gravity of the sample as the dilutional
standard.
(ii) Alcohol must be added to the standard urine drug screen. A Breathalyzer may be used to test for
alcohol, but the test must be conducted by an appropriately certified
individual within twelve hours of notification.
(iii) Results
of 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, indicates a violation of the
contract.
(b) Regular
attendance, a minimum of three times per week, at an Alcoholics Anonymous,
Narcotics Anonymous, and/or similar support group meeting is required.
(c) The
program shall immediately report to the Ohio Board of Pharmacy any violations
of the contract and/or lack of cooperation.
(3) James
Murray Bayless must provide, at the reinstatement petition hearing,
documentation of the following:
(a) Compliance
with the licensed psychiatrist’s or psychologist’s recommended treatment plan.
(b) A
report by the licensed psychiatrist or psychologist regarding James Murray
Bayless’ fitness for readmission into the practice of pharmacy.
(c) Compliance
with the contract required in paragraph (B)(2) above (e.g.-proof of giving the
urine sample within 12 hours of notification, copies of all urine screen
reports, meeting attendance records, treatment program reports, etc.).
(d) Compliance
with the continuing pharmacy education requirements as set forth in Chapter
4729-7 of the Ohio Administrative Code in effect on the date of petitioning the
Board for reinstatement.
(e) Compliance
with the terms of this Order.
(D) If reinstatement is not accomplished within three years after
the effective date of this Order, James Murray Bayless must successfully
complete the NAPLEX examination or an equivalent examination approved by the
Board.
THIS
ORDER WAS APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION
CARRIED.
SO ORDERED.
The
motion was seconded by
The Board recessed for lunch.
1:00 p.m.
RES. 2000-191 The
Board reconvened in Room 1948 of the
|
CAMPO, |
03-3-24203 |
|
|
DELEO, |
03-3-24146 |
|
|
DOWD, |
03-3-24263 |
|
|
FRANCIONI, |
03-3-24226 |
|
|
FRY, |
03-3-24145 |
|
|
HOSCHAR, |
03-3-24193 |
|
|
|
03-3-24202 |
|
|
KOONTZ, |
03-3-24148 |
|
|
KOSOWSKI, |
03-3-24007 |
|
|
KRUEGER, TYSHA |
03-3-24073 |
|
|
|
03-3-24147 |
|
|
LONGSTRETH, |
03-3-24091 |
|
|
MAMAKOS, |
03-3-24125 |
|
|
|
03-3-24128 |
|
|
MESHANSKI, |
03-3-24237 |
|
|
|
03-3-24157 |
NEW |
|
PANDELADIS, |
03-3-24170 |
|
|
POLZIN, |
03-3-24134 |
|
|
|
03-3-24165 |
|
|
VAIDYA, |
03-3-24035 |
|
|
WEINSTEIN, |
03-3-24267 |
|
|
WHETSELL HUNT, |
03-3-24211 |
|
|
WIECZOREK, |
03-3-24204 |
|
1:43 p.m.
The
Board was joined by
3:30 p.m.
The hearing concluded and the record was closed. The Board took a brief recess.
3:49 p.m.
The
Board was joined by
5:29 p.m.
The hearing concluded and the record was closed.
5:35 p.m.
Mrs.
Adelman 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
6:15 p.m.
RES. 2000-192 The
Executive Session ended and the meeting was opened to the public.
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-991112-030)
In
The Matter Of:
THE MEDICINE SHOPPE PHARMACY
c/o
(Terminal Distributor No.
02-0681600)
INTRODUCTION
THE MATTER OF THE MEDICINE SHOPPE PHARMACY CAME FOR
HEARING ON JUNE 13, 2000, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT B.
CAVENDISH, R.Ph. (presiding); ANN D. ABELE, R.Ph.; DIANE C. ADELMAN, R.Ph.; SUZANNE
R. EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; AMONTE
B. LITTLEJOHN, R.Ph.; SUZANNE L. NEUBER, R.Ph.; AND NICHOLAS R. REPKE, PUBLIC
MEMBER.
THE MEDICINE SHOPPE PHARMACY WAS REPRESENTED BY
SUMMARY
OF EVIDENCE
(A) Testimony
State's Witnesses:
(1)
Respondent's Witnesses:
(1)
(2)
(B) Exhibits
State's Exhibits:
(1) Exhibit
1--Copy of nine-page Notice of Opportunity for Hearing letter in the matter of
(2) Exhibit
1A--Copy of nine-page Notice of Opportunity for Hearing letter in the matter of
The Medicine Shoppe Pharmacy,
(3) Exhibit
1B--Hearing Request letter dated November 15, 1999.
(4) Exhibit
1C--Copy of Hearing Schedule letter dated November 23, 1999.
(5) Exhibit
1D--Letter of Representation and Continuance Request letter dated January 17,
2000.
(6) Exhibit
1E--Copy of Hearing Schedule letter dated January 19, 2000.
(7) Exhibit 1F--Copy of Pharmacist File Front Sheet of Martin
Barron showing original date of registration as August 4, 1953.
(8) Exhibit
1G--Copy of Renewal Application for Pharmacist License No. 03-2-05416 for a
license to practice pharmacy in
(9) Exhibit
1H--Copy of Renewal Application for DDD License No. 02-0681600 for a Terminal
Distributor of Dangerous Drugs License from January 1, 1999, to December 31,
1999, of The Medicine Shoppe Pharmacy dated October 8, 1998.
(10) Exhibit
1I--Copy of fax cover-page to Robert Cole from Robert Koeth dated May 1, 2000;
letter from Robert J. Koeth dated April 28, 2000; three-page Memorandum in
Support regarding Martin Barron by Robert J. Koeth and Clark D. Rice, not
dated; copy of letter from Alma Davis dated April 21, 0000; copy of letter from
Peter S. Kibbe dated April 24, 2000; copy of letter from Bartholomew M.
Caterino dated April 20, 2000; copy of letter from Daniel R. Wendt dated April
23, 2000; copy of letter from Steven H. Newman dated April 29, 2000; and copy
of letter from David J. Ruzicka dated February 7, 2000.
(11) Exhibit
1J--Copy of letter from
(12) Exhibit
2--Copy of six-page Order of the State Board of Pharmacy, Docket No.
D-971024-015, in the matter of
(13) Exhibit
3, 3A, 3B, and 3C--Copy of four-page Accountability Report of The Medicine
Shoppe,
(14) Exhibit
4A--Audit work paper for Ritalin 5mg for the period of April 30, 1996, through
November 17, 1998.
(15) Exhibit
4B--Audit work paper for Tylox.
(16) Exhibit
4C--Audit work paper for MS Contin 30mg.
(17) Exhibit
4D--Audit work paper for Demerol 50mg.
(18) Exhibit
4E--Audit work paper for Roxicodone.
(19) Exhibit
4F--Audit work paper for Dexedrine 10mg spansules.
(20) Exhibit
4G--Audit work paper for Adderal 30mg.
(21) Exhibit
4H--Audit work paper for Dexedrine 5mg spansules.
(22) Exhibit
4I--Audit work paper for Oxycontin 80mg.
(23) Exhibit
4J--Audit work paper for Ritalin 5mg.
(24) Exhibit
4K--Audit work paper for Ritalin SR 20mg.
(25) Exhibit
4L--Audit work paper for Morphine Sulfate 15mg.
(26) Exhibit
4M--Audit work paper for Methylphenidate 20mg.
(27) Exhibit
4N--Audit work paper for MS Contin 15mg.
(28) Exhibit
4O--Audit work paper for MS Contin 60mg.
(29) Exhibit
4P--Audit work paper for Adderall 5mg.
(30) Exhibit
4Q--Audit work paper for Duragesic 75mcg.
(31) Exhibit
4R--Audit work paper for Duragesic patch 50mcg.
(32) Exhibit
4S--Audit work paper for Duragesic 25mcg.
(33) Exhibit
4T--Audit work paper for Percocet.
(34) Exhibit
4U--Audit work paper for Duragesic 100mcg/hr.
(35) Exhibit
4V--Audit work paper for Seconal 100mg.
(36) Exhibit
4W--Audit work paper for Ritalin 20mg
(37) Exhibit
4X--Audit work paper for Dilaudid 2mg.
(38) Exhibit
4Y--List Drug Utilization report of The Medicine Shoppe Pharmacy for Dilaudid
2mg for the time period of April 30, 1996, to November 7, 1998.
(39) Exhibit
4Z--Product Activity Report of The Medicine Shoppe Pharmacy for Dilaudid 4mg
for the time period of April 30, 1996, to November 7, 1998.
(40) Exhibit
4AA--Audit work paper for Dilaudid 4mg.
(41) Exhibit
4BB--Audit work paper for MS Contin 100mg and Meperidine 100mg.
(42) Exhibit
4CC--Copy of letter from Marty Barron dated June 11, 1999, faxed on May 15,
1999, at 4:37 p.m.
(43) Exhibit
4DD through 4VV--Nineteen pages of prescription reports of The Medicine Shoppe
Pharmacy dated from March 20, 1995, through March 5, 1998.
(44) Exhibit
4WW--Copy of letter from Marty Barron dated June 11, 1999, faxed on May 15,
1999, at 7:49 p.m.
(45) Exhibit
4XX--Letter from Marty Barron dated June 11, 1999.
(46) Exhibit
4YY--Original of letter faxed on May 15, 1999, at 7:49 p.m. from Marty Barron.
(47) Exhibits
5, 5A, and 5B--Three-page handwritten closing drug inventory of The Medicine
Shoppe Pharmacy dated April 12, 1999.
(48) Exhibits
6, and 6A through 6F--Copy of seven-page Dangerous Drug Distributor Inspection
Report of Medicine Shoppe Pharmacy (02-0681600) dated June 27, 1997.
(49) Exhibits
7, and 7A through 7C--Copy of letter from Marty Barron dated July 3, 1997, and
attached three-page response to “pink sheet”, not dated.
(50) Exhibit
8--Two-page Dangerous Drug Distributor Inspection Report of The Medicine Shoppe
Pharmacy (02-0681600) dated April 14, 1999.
(51) Exhibit
9 and 9A--“Pink Sheet” copy of Dangerous Drug Distributor Inspection Report of
The Medicine Shoppe Pharmacy (02-0681600) dated April 14, 1999, and attached
copy of “pink sheet” response, not dated.
(52) Exhibit
10--Copy of DEA Form 222 of Shaker Professional Pharmacy D.B.A.: Medicine
Shoppe Pharmacy, Order No. 952977678, received on February 10, 1997.
(53) Exhibit
11--Copy of page one of two-page Shaker Professional Pharmacy D.B.A.: Medicine
Shoppe Customer Controlled Item Report
dated February 28, 1997.
(54) Exhibit
12--Copy of DEA Form 222 of Shaker Professional Pharmacy D.B.A.: Medicine
Shoppe Pharmacy, Order No. 982006506, received on December 7, 1998.
(55) Exhibit
13--Independent Drug Company Invoice No. 969727 dated December 7, 1998.
(56) Exhibit
13A--Copy of page two of two-page Shaker Professional Pharmacy D.B.A.: Medicine
Shoppe Customer Controlled Item Report dated February 28, 1997.
Respondent's
Exhibits:
(1) Table
of Contents and three-page Memorandum in Support, not dated.
(2) Exhibit
A--Copy of letter from
(3) Exhibit
B--Copy of letter from
(4) Exhibit
C--Copy of letter from
(5) Exhibit
D--Copy of letter from
(6) Exhibit
E--Copy of letter from
(7) Exhibit
F--Copy of letter from
(8) Exhibit
G--Copy of letter from
(9) Exhibit
H--Copy of letter from
(10) Exhibit
I--Copy of The Medicine Shoppe Income and Expense Statement for the month
ending December 31, 1998.
FINDINGS
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 the following to be fact:
(1) Records
of the State Board of Pharmacy indicate that during the relevant time periods
stated herein,
(2) The Medicine Shoppe Pharmacy did, from May 1, 1996, through
April 11, 1999, fail to provide effective and approved controls and procedures
to deter and detect theft and diversion of dangerous drugs, to wit: during this
time period, the following drugs were diverted from The Medicine Shoppe
Pharmacy without adequate detection and/or prevention:
|
Drug Name/Strength |
Amount of
Shortage |
% of Drug
Supply |
|
Adderall
5mg |
99 |
5.0% |
|
Adderall
10mg |
523 |
6.0% |
|
Codeine
SO4 30mg |
9 |
1.3% |
|
Hydromorphone
2mg |
111 |
2.9% |
|
Hydromorphone
4mg |
3,594 |
8.6% |
|
Duragesic
25mcg/hr |
2 |
.1% |
|
Duragesic
50mcg/hr |
17 |
7.9% |
|
Duragesic
75mcg/hr |
10 |
2.9% |
|
Duragesic
100mcg/hr |
11 |
1.9% |
|
Methadone
10mg |
626 |
6.4% |
|
MS
Contin 15mg |
65 |
7.4% |
|
MS
Contin 30mg |
102 |
3.1% |
|
MS
Contin 60mg |
47 |
3.5% |
|
Oxycontin
10mg |
408 |
15.7% |
|
Oxycontin
20mg |
1,672 |
16.6% |
|
Oxycontin
40mg |
1,467 |
13.5% |
|
Oxycontin
80mg |
29 |
3.6% |
|
OxyIR
5mg |
65 |
3.1% |
|
Percodan |
463 |
3.5% |
|
Roxicet |
433 |
5.2% |
|
Roxicodone |
61 |
3.6% |
|
Diazepam
10mg |
14,234 |
19.1% |
|
Phentermine
8mg |
17 |
>0.1% |
|
Ionamin
15mg |
33 |
8.3% |
|
Ionamin
30mg |
79 |
9.3% |
|
Fastin
30mg |
30 |
6.9% |
|
Propoxyphene
N-100 |
9,475 |
4.7% |
Such
conduct is in violation of Rule 4729-9-05 of the Ohio Administrative Code.
(3) The
Medicine Shoppe Pharmacy did, from May 1, 1996, through April 11, 1999,
knowingly sell a controlled substance in an amount greater than one hundred
times the bulk amount when the conduct was not in accordance with Chapters
3719., 4729., and 4731. of the Ohio Revised Code, to wit: the following
Schedule II controlled substances were diverted from The Medicine Shoppe
Pharmacy without prescriptions:
|
Drug Name/Strength |
Amount of
Shortage |
% of Drug
Supply |
|
Dilaudid 4mg |
3,303 |
13.1% |
|
Hydromorphone 4mg |
291 |
1.9% |
|
Oxycontin
20mg |
1,672 |
16.6% |
|
Oxycontin
40mg |
1,467 |
13.5% |
Such
conduct is in violation of Section 2925.03 of the Ohio Revised Code.
(4) The
Medicine Shoppe Pharmacy did, from May 1, 1996, through April 11, 1999,
knowingly sell a controlled substance in an amount greater than five times the
bulk amount but in an amount less than fifty times the bulk amount when the
conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio
Revised Code, to wit: the following Schedule II controlled substances were
diverted from The Medicine Shoppe Pharmacy without prescriptions:
|
Drug Name/Strength |
Amount of
Shortage |
% of Drug
Supply |
|
Adderall
10mg |
523 |
5.0% |
|
Duragesic
100mcg/hr |
11 |
1.9% |
|
Methadone
10mg |
626 |
6.4% |
|
Oxycontin
10mg |
408 |
15.7% |
|
Oxycontin
80mg |
29 |
3.6% |
|
Percodan |
463 |
3.5% |
|
Roxicet |
433 |
5.2% |
Such
conduct is in violation of Section 2925.03 of the Ohio Revised Code.
(5) The
Medicine Shoppe Pharmacy did, from May 1, 1996, through April 11, 1999,
knowingly sell a controlled substance in an amount greater than the bulk amount
but less than five times the bulk amount when the conduct was not in accordance
with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: the
following Schedule II controlled substances were diverted from The Medicine
Shoppe Pharmacy without prescriptions:
|
Drug Name/Strength |
Amount of
Shortage |
% of Drug
Supply |
|
Dilaudid
2mg |
81 |
3.1% |
|
Hydromorphone
2mg |
30 |
2.7% |
|
Duragesic
50mcg/hr |
17 |
7.9% |
|
Duragesic
75mcg/hr |
10 |
2.9% |
|
MS
Contin 15mg |
65 |
7.4% |
|
MS
Contin 30mg |
102 |
3.1% |
|
MS
Contin 60mg |
47 |
3.5% |
|
OxyIR
5mg |
65 |
3.1% |
|
Roxicodone |
61 |
3.6% |
Such
conduct is in violation of Section 2925.03 of the Ohio Revised Code.
(6) The
Medicine Shoppe Pharmacy did, from May 1, 1996, through April 11, 1999,
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: the following Schedule II controlled substances
were diverted from The Medicine Shoppe Pharmacy without prescriptions:
|
Drug Name/Strength |
Amount of
Shortage |
% of Drug
Supply |
|
Adderall
5mg |
99 |
5.0% |
|
Codeine
SO4 30mg |
9 |
1.3% |
|
Duragesic
25mcg/hr |
2 |
0.1% |
Such
conduct is in violation of Section 2925.03 of the Ohio Revised Code.
(7) The
Medicine Shoppe Pharmacy did, from May 1, 1996, through April 11, 1999,
knowingly sell a controlled substance in an amount greater than fifty times the
bulk amount but in an amount less than one hundred times that amount when the
conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio
Revised Code, to wit: the following Schedule III, IV, or V controlled substances
were diverted from The Medicine Shoppe Pharmacy without prescriptions:
|
Drug Name/Strength |
Amount of
Shortage |
% of Drug
Supply |
|
Diazepam 10mg |
14,234 |
19.1% |
|
Propoxyphene
N-100 |
9,475 |
4.7% |
Such
conduct is in violation of Section 2925.03 of the Ohio Revised Code.
(8) The
Medicine Shoppe Pharmacy did, from May 1, 1996, through April 11, 1999,
knowingly sell a controlled substance in an amount greater than the bulk amount
but less than five times the bulk amount when the conduct was not in accordance
with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: the
following Schedule III, IV, or V controlled substances were diverted from The
Medicine Shoppe Pharmacy without prescriptions:
|
Drug Name/Strength |
Amount of
Shortage |
% of Drug
Supply |
|
Ionamin 30mg |
79 |
9.3% |
|
Fastin
30mg |
30 |
6.9% |
Such
conduct is in violation of Section 2925.03 of the Ohio Revised Code.
(9) The
Medicine Shoppe Pharmacy did, from May 1, 1996, through April 11, 1999,
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: the
following Schedule III, IV, or V controlled substances were diverted from The
Medicine Shoppe Pharmacy without prescriptions:
|
Drug Name/Strength |
Amount of
Shortage |
% of Drug
Supply |
|
Phentermine 8mg |
17 |
>0.1% |
|
Ionamin
15mg |
33 |
8.3% |
Such
conduct is in violation of Section 2925.03 of the Ohio Revised Code.
(10) The
Medicine Shoppe Pharmacy did, on or about November of 1998 and/or June of 1999,
knowingly make a false statement when the statement was made with purpose to
mislead a public official in performing his duties, to wit: Mr. Barron, the
Responsible Pharmacist for The Medicine Shoppe Pharmacy, reported a loss of
controlled substances to the Ohio State Board of Pharmacy.
(11) The
Medicine Shoppe Pharmacy did, on or about April 12, 1999, possess for sale
misbranded drugs, to wit: The Medicine Shoppe Pharmacy possessed the following
drugs which had been "consolidated for accountability purposes:"