FR Doc E7-25342 [Federal Register: January 2, 2008 (Volume
73, Number 1)] [Notices] [Page 363-388] From the Federal
Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ja08-100]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 03-21]
Medicine Shoppe--Jonesborough; Revocation of Registration
On March 14, 2003, the Deputy Assistant Administrator, Office
of Diversion Control, issued an Order to Show Cause to the
Medicine Shoppe--Jonesborough (Respondent) of Jonesborough,
Tennessee. The Show Cause Order proposed the revocation of
Respondent's DEA Certificate of Registration, BM3913781, as a
retail pharmacy, and the denial of any pending application for
renewal of its registration, on the ground that its continued
registration would be "inconsistent with the public
interest.'' Show Cause Order at 1 (citing 21
U.S.C. 823(f)).
The Show Cause Order specifically alleged that a DEA
investigation had determined that between 1990 and 1995, Royce
E. Blackmon, Jr., a physician located in Butler, Tennessee, had
"issued numerous controlled substance prescriptions for no
legitimate medical reason.'' Id. The Show Cause Order alleged
that in December 1995, DEA investigators visited Respondent and
determined that it had filled 947 of the controlled-substance
prescriptions issued by Dr. Blackmon. Id. at 1-2. The Show Cause
Order further alleged that on October 29, 1997, DEA
investigators returned to Respondent and subsequently determined
that Respondent had filled an additional 3,100
controlled-substance prescriptions issued by Dr. Blackmon. Id.
at 2. Relatedly, the Show Cause Order alleged that on October 6,
1997, Blackmon entered into an Agreed Order with the Tennessee
Board of Medical Examiners which revoked his state medical
license. Id. at 2.
The Show Cause Order next alleged that between May 1996 and
December 1997, Respondent filled 124 prescriptions issued by
Edmond Watts, a veterinarian practicing in Johnson City,
Tennessee, notwithstanding that Watts' DEA registration and
state veterinary license had expired on May 31, 1996, and
February 29, 1996, respectively. Id. at 2. The Show Cause Order
further alleged that "[m]any of these prescriptions were
issued to persons using several aliases and false addresses,''
and that Watts was ultimately indicted and pled guilty to two
state-law counts of obtaining prescription drugs by fraud. Id.
at 2-3.
The Show Cause Order next alleged that on March 9, 1998, DEA
investigators returned to Respondent to review its
controlled-substance records and to conduct an accountability
audit. Id. at 3. The Show Cause Order alleged that Mr. Jeff
Street, Respondent's owner and pharmacist, told DEA
investigators that "the pharmacy's computer could not
process prescription information at that time,'' and that the
investigators "would have to wait until the following
morning'' to obtain the information. Id. The Show Cause Order
further alleged "[t]hat the following morning, Mr. Street
informed investigators that the pharmacy's computer [had]
'crashed' and its data had been lost.'' Id. at 3. The Show Cause
Order thus alleged that Respondent violated 21
U.S.C. 827(a)(3), as well as 21
CFR 1304.04 and 1304.21.
Id.
Next, the Show Cause Order alleged that on December 14, 1999,
DEA audited Respondent's handling of twenty-nine controlled
substances during the period of January 11, 1999, to December
14, 1999. Id. The Show Cause Order alleged that the audit found
that Respondent had an overage of 29,656 dosage units of
diazepam, a schedule IV controlled substance, and a shortage of
3,453 dosage units of combination hydrocodone drugs, which are
schedule III controlled substances. Id.
Relatedly, the Show Cause Order alleged that on April 10,
2001, and April 2, 2002, DEA had performed additional audits of
Respondent's handling of various controlled substances and that
each audit had found both overages and shortages. Id. at 3-4.
More specifically, the Show Cause Order alleged that the April
2002 audit found that Respondent was short 4,505 tablets of some
higher-strength combination hydrocodone/ acetaminophen products
and had overages of 2,273 lower-strength hydrocodone/acetaminophen
products. Id. at 4. The Show Cause Order further alleged that
the April 2002 audit found both "shortages and overages of
between 500 and 1,000 tablets.'' Id.
Finally, the Show Cause Order alleged that in analyzing
Respondent's records for the period 2001 through 2002, DEA had
determined that "many patients received in excess of 2,000
dosage units of hydrocodone, often from several physicians.''
Id. The Show Cause Order thus alleged that "[u]nder
regulation, a pharmacy has a corresponding liability to ensure
that every prescription [it] dispense[s] is for a legitimate
medical purpose,'' and that "[t]here is no indication that
[Respondent] took steps to corroborate the necessity of these
large amounts of controlled substances.'' Id. at 4- 5.
Respondent, through its counsel, timely requested a hearing
on the allegations. The matter was assigned to Administrative
Law Judge (ALJ) Gail Randall, who conducted a hearing in
Knoxville, Tennessee, on July 27-29, 2004, and in Greenville,
Tennessee, on May 24, 2005. At the hearing, both the Government
and Respondent called witnesses to testify and introduced both
testimonial and documentary evidence into the record. Following
the hearing, both parties filed briefs containing their proposed
findings of fact and conclusions of law.
On June 9, 2006, the ALJ filed her recommended decision. In
her decision, the ALJ found that while there was a factual
"dispute regarding the exact numbers involved in the three
DEA audits, the record clearly shows that [the] audits and
inventories of * * * Respondent revealed substantial shortages
and overages of the controlled substances investigated.'' ALJ at
69. The ALJ rejected, however, the Government's contention that
Respondent had failed "on multiple occasions'' to comply
with "its corresponding responsibility to ensure that
dispensed prescriptions for controlled substances were issued by
the physician for a legitimate medical purpose and in the usual
course of professional practice.'' Gov. Proposed Findings at 10;
see also ALJ at 72.
While noting that "the patient profiles did not contain
any documents demonstrating that Respondent's pharmacists made
any telephone calls to verify suspect prescriptions,'' the ALJ
credited the testimony of Respondent's owner that he had called
the doctors whose prescriptions were suspicious "on many
occasions'' to "verify the prescriptions prior to filling
them.'' ALJ at 72; see also id. at 75 (noting that "Mr.
Street's credible testimony concerning his personal knowledge of
his customers [and] the actions he took to coordinate his
dispensing with the patients' health care providers * * *
dispelled many of [the] concerns'' expressed by the Government's
expert witnesses). While the ALJ also found Respondent's filling
of prescriptions issued by a veterinarian during 1996 and 1997
"bothersome,'' she further reasoned that the datedness of
the conduct and "the lack of any more recent evidence of
similar carelessness'' did not support the revocation of
Respondent's registration. Id. at 78. The ALJ thus recommended
that Respondent be allowed to maintain its registration subject
to the condition that it undergo an annual audit by an
independent auditor at its own expense for a period of three
years from the date of the issuance of this Final Order. Id. at
78.
[[Page 365]]
The Government filed exceptions to the ALJ's recommended
decision. While asserting that it was not arguing "the
minutiae of the specific findings, or the issue of the
credibility * * * of seriatim statements of Respondent's
pharmacist owner,'' the Government's principal exception was
that "Respondent's entire defense consistently produced
explanations for every fact that the Government proved,'' and
that "for every patient that the Government showed * * *
was receiving excessive amounts of controlled substances,
Respondent had a recitation as to the medical condition . . .
which would . . . justify [the] dispensing'' and the avoidance
of liability under 21
CFR 1306.04. Gov. Exceptions at 1-2. The Government further
argued that Respondent's owner "had months . . . to prepare
a self-serving testimonial defense by acquiring and reviewing
medical records after [the] presentation of the Government's
case,'' and that Respondent did not have access to these records
"at the time the prescriptions were presented.'' Id. at 2.
The Government thus contended that "by accepting'' the
testimony of Respondent's owner, "the ALJ effectively
negated the expert testimony of the two health care
professionals who testified on behalf of the Government.'' Id.
The Government also argued that Respondent's lack of
accountability in its handling of controlled substances
warranted the revocation of its registration.\1\ Id.
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\1\ I also note Respondent's response to the Government's
exceptions and have considered the arguments raised therein.
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Thereafter, the record was forwarded to me for final agency
action. In her decision, the ALJ decision found that Respondent
had "last renewed [its] registration on January 3, 2000,
and [that] the registration was due to expire on January 31,
2003.'' ALJ at 3. Under DEA precedent, "[i]f a registrant
has not submitted a timely renewal application prior to the
expiration date, then the registration number expires and there
is nothing to revoke.'' Ronald J. Riegel, 63 FR 67132, 67133
(1998). Because "it appear[ed] that Respondent's
registration had expired before the . . . proceeding was even
initiated,'' the case was remanded to the ALJ to determine
whether Respondent had submitted a timely renewal application in
accordance with DEA's regulations and the Administrative
Procedure Act (APA). See Order Remanding for Further Proceedings
at 1-2; see also 5 U.S.C. 558(c) ("[w]hen [a] licensee has
made timely and sufficient application for a renewal or a new
license in accordance with agency rules, a license with
reference to an activity of a continuing nature does not expire
until the application has been finally determined by the
agency'').
Thereafter, the ALJ conducted further proceedings in
accordance with my remand order. Those proceedings determined
that Respondent had submitted a renewal application prior to the
January 31, 2003 expiration of its registration and had paid the
appropriate fee. However, Respondent's owner was told that its
registration had not been renewed pending "administrative
review.'' Affidavit of Jeffrey Street at 1. According to the
Government, Respondent's registration was renewed, but "for
unknown reasons,'' the Agency's Registrant Information
Consolidated System "did not record the renewal timely
submitted for the 2003-2006 period,'' Gov. Resp. to the
Registration Issue on Remand at 2, and "did not advance the
expiration date from January 31, 2003 to January 31, 2006.''
Affidavit of Richard Boyd, Chief of Registration and Program
Support Section, at 1. Apparently, the new registration which
was issued to Respondent in January 2003, simply used the same
January 31, 2003 expiration date of the previous registration.
See id.
I therefore find that in January 2003, Respondent made a
timely and sufficient application for a new registration. I
further hold that because the registration which the Agency
issued in January 2003 did not extend the expiration date of the
registration, but rather, only re-instituted the January 31,
2003 expiration date of the existing registration, the Agency
did not make a final determination on the application and
Respondent therefore has maintained a valid registration
throughout these proceedings.\2\ See 5 U.S.C. 558(c).
Accordingly, there is jurisdiction to determine whether
Respondent's registration should be revoked and its pending
application should be denied.
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\2\ The Government contends that
Respondent's "registration actually expired on January
31, 2006,'' and that "Respondent was obligated to
continue to file renewal applications during the duration of
the show cause process.'' Gov. Resp. to the Registration Issue
(ALJ Ex. 14) at 2. While I reject the Government's contention,
even if Respondent's registration had, in fact, been renewed
with a new expiration date of January 31, 2006, there is no
evidence that the Agency ever notified it of this fact.
Respondent cannot be faulted for failing to file an
application to renew a registration when the Government never
informed it of the new expiration date.
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Having considered the record as a whole including the ALJ's
recommended decision, I hereby issue this Decision and Final
Order. As explained below, I adopt in part and reject in part
the ALJ's findings of fact and conclusions of law. More
specifically, while the ALJ rejected the entirety of the
Government's allegations that Respondent dispensed controlled
substances to numerous patients in violation of its
corresponding responsibility under federal law, as ultimate
factfinder, I conclude that the Government has proved by a
preponderance of the evidence that Respondent unlawfully
dispensed controlled substances to numerous persons. I also
conclude that Respondent violated federal law and DEA
regulations by failing to maintain complete and accurate
records. Based on my findings and Respondent's (and its owner's)
failure to acknowledge their misconduct, I concluded that
revocation of its registration is necessary to protect the
public interest. I make the following findings.
Findings of Fact
Respondent is a pharmacy which is located in Jonesborough,
Tennessee. Respondent has been registered as a retail pharmacy
since February 1994, and as found above, currently holds DEA
Certificate of Registration, BM3913781, which remains valid
pending the issuance of this Final Order. See Gov. Ex. 1.
Respondent is owned by Mr. Jeffrey Street, who has been a
licensed pharmacist since 1984. Tr. May 24, 2005 at 75.\3\
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\3\ All citations to the transcript which do
not include a date refer to the testimony taken on July 27-29,
2004.
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The Investigation of Respondent
Sometime in 1995, DEA investigators received information from
the Tennessee Bureau of Investigation and the First Judicial
District Drug Task Force that Dr. Royce Blackmon, a Butler,
Tennessee based physician, was writing prescriptions for drugs
containing hydrocodone, a schedule III controlled substance, see
21
CFR 1308.13(e), and for Dilaudid (hydromorphone), a schedule
II controlled substance, id. 1308.12(b),
without a legitimate medical purpose. Tr. 22. As part of the
investigation, DEA investigators interviewed some of Dr.
Blackmon's "patients'' and determined that Blackmon would
frequently write prescriptions "without even seeing the
patient.'' Id. at 24.\4\ Dr. Blackmon's staff would then tell
the "patients'' to bring the prescriptions to Respondent
for filling. Id. Moreover, the investigation determined that
both Dr. Blackmon's
[[Page 366]]
wife and his daughter were drug addicts, that Dr. Blackmon
prescribed both Dilaudid and hydrocodone drugs for his daughter,
and that Mr. Street filled some of the daughter's prescriptions.
Id. at 53 & 86.
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\4\ DEA investigators were, however, unable
to obtain Blackmon's medical records. Tr. 56.
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As part of the investigation, DEA conducted a prescription
review of approximately 15 to 20 pharmacies including
Respondent, which were located in the areas of Johnson City,
Bristol, Kingsport and Jonesborough. Id. at 26. In either
November or December 1995, DEA investigators visited Respondent
and found that it had dispensed approximately 950 prescriptions
which had been issued by Dr. Blackmon. Id. at 27; see also id.
at 181. Most of the other area pharmacies had stopped filling
Blackmon's prescriptions, id. at 26, but some continued to do
so. May 24, 2005 Tr. at 9-10.
In October 1997, DEA investigators returned to Respondent to
determine whether Respondent had continued to fill Blackmon's
prescriptions since the previous visit. Tr. at 182. The
investigators found that Respondent had filled more than 3,000
of Blackmon's prescriptions, all of which were for controlled
substances. Id. at 183.
Mr. Richards, a private investigator retained by Respondent,
testified, however, that he had interviewed Mr. James Backers, a
pharmacist who had worked as a relief pharmacist for Respondent
during the last three months of 1996, as well as in 1997 and
1998. May 24, 2005 Tr. at 69. According to Mr. Richards, Mr.
Backers told him that "because he had heard rumors that
some . . . drugstores weren't filling Dr. Blackmon's
prescriptions anymore'' he visited Blackmon at his office. Id.
at 11. Mr. Richards testified that Mr. Backers stated that
Blackmon "was very nice to him, showed him his records,
showed him that he was making referrals to specialists, [and]
doing tests.'' Id. Moreover, Dr. Blackmon "was writing not
only pain medication, but other maintenance drugs, as well.''
Id. Mr. Backers told Mr. Street about his visit. Id. He also
continued to fill Blackmon's prescriptions although he would
call his office if one did not "look right.'' Id.\5\
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\5\ It is questionable whether Mr. Backers'
hearsay statements are reliable because Mr. Richards obtained
them in anticipation of this litigation. I assume without
deciding that the statements meet the APA's standard that
evidence must be "reliable'' and "substantial,'' 5
U.S.C. 556(d), because I conclude that the appropriate
analysis of whether Respondent dispensed controlled substances
in violation of federal law should focus on the actual
prescriptions it filled.
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The Audits
In March 1998, a DI returned to Respondent with the intention
of auditing its handling of controlled substances and presented
an Administrative Inspection Warrant to Mr. Street. Tr. at
185-87. The DI asked Mr. Street to provide the pharmacy's
purchase, dispensing and distribution records,\6\ id. at 187-88;
these are records which a pharmacy is required under regulation
to maintain for two years. Id. at 189. Mr. Street assisted in
conducting a closing inventory and provided the pharmacy's
invoices for the drugs being audited. Because preparing the drug
usage reports required accessing data in Respondent's computer
and Mr. Street was to teach a class that night, Mr. Street
printed out only two drug usage reports (one for Dilaudid and
one for Lortab 5) and requested that he be allowed to print out
the remaining reports in the morning. Tr. 192; May 5, 2005 Tr.
at 117.\7\ When the DI arrived at the pharmacy the next morning,
Mr. Street reported that "his computer had crashed and he'd
lost all [of] his prescription data.'' Tr. 192. Mr. Street
further told the DI that his computer's hard drive had failed.
May 24, 2005 Tr. at 121.
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\6\ Under DEA regulations, a pharmacy is
required to maintain records for a minimum of two years and
the records must document the purchase and receipt,
dispensing, and distribution through destruction, loss, theft
or a transfer between registrants of controlled substances.
Tr. 190-91; see also 21
CFR 1304.22(c). Moreover, records pertaining to schedule
II controlled substances must be "maintained separately
from all other records of the pharmacy,'' with the
prescriptions "maintained in a separate prescription
file.'' 21
CFR 1304.04(h)(1). With respect to schedule III through V
controlled substances, a pharmacy's records must be
"maintained separately from all other records of the
pharmacy or in such form that the information required is
readily retrievable from [the] ordinary business records of
the pharmacy'' with prescription records "maintained
either in a separate prescription file for controlled
substances in Schedules III, IV, and V only or in such form
that they are readily retrievable from the other records of
the pharmacy.'' See also 21 CFR 1304; Tr. 193.
\7\ There is conflicting evidence as to when
the DI obtained Respondent's backup tape. The DI testified
that Mr. Street gave him the backup tape (which was stored in
his files and not the pharmacy's computer) before leaving on
the day that he showed up to conduct the audit. Tr. 192. Mr.
Street testified that upon the DI's arrival the next morning,
he assured the DI that "everything's going to be okay
because I've got a good backup tape,'' to which the DI
responded "Show it to me.'' May 24, 2005 Tr. at 121.
According to Mr. Street, he then pulled the tape out of the
computer's "external drive'' and the DI took possession
of it. Id. at 121.
I also note that Mr. Street testified that
he ran a backup tape "every night.'' May 24, 2005 Tr. at
120. Mr. Street did not testify that the backup tapes were
re-used, and given the absence of such testimony, it is
perplexing that Mr. Street did not have a more current backup
tape available. The ALJ did not, however, reconcile her
findings with this testimony.
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According to Mr. Street, several days later the DI returned
to the pharmacy with the backup tape. Upon loading the tape into
the computer, there were no records on it. Respondent then
loaded another backup tape, which he had last used in either
October or November and the tape loaded up right away. Id. at
122. Because several months of records were missing, the DI
determined that an audit could not be conducted. Tr. 193. The
ALJ specifically credited the DI's testimony that while he had
inspected fifty to seventy-five pharmacies, this was the only
time a pharmacy had been unable to produce the required records.
ALJ at 10 (citing Tr. 194).
In December 1999, the DI obtained another administrative
warrant and returned to Respondent to conduct an audit.\8\ GX 6,
Tr. 195. Mr. Street provided the DI with a copy of Respondent's
biennial inventory which had been taken on January 11, 1999. GX
5. According to Mr. Street, under the rules of the Tennessee
Board of Pharmacy, a pharmacist is allowed to estimate the
number of pills in an open bottle in conducting an inventory of
schedule III through V controlled substances. May 24, 2005 Tr.
149.
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\8\ The DI was accompanied by another DI and
an investigator from the Tennessee Board. Tr. 198.
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Another DI and a state investigator conducted a closing
inventory of Respondent's controlled substances. Tr. 198. Mr.
Street signed the closing inventory thereby attesting to its
accuracy. Id. at 199. According to the DI, the audit "look[ed]
. . . at all the records of purchase, all records of
distribution'' including the prescription records, as well as
various DEA forms for reporting theft, loss and destruction of
controlled substances, and other forms that document the
movement of controlled substances between the beginning and end
dates of the audit. Id. at 201. For each audited drug, the DI
added up the amount of Respondent's purchases during the audit
period and added them to the opening inventory; the DI then
added the total amount of each drug dispensed (and or
distributed) to the ending inventory and compared the two
figures. Id.
While the two numbers should equal each other, the DEA audit
found that there were both numerous shortages and overages. GX
8. Some of the discrepancies involved substantial quantities in
absolute terms. The ALJ found credible Mr. Street's testimony
that the Government's audit contained eleven errors because four
drug usages reports had been left out,\9\ that one of
[[Page 367]]
the five diazepam drug usage reports provided to DEA
overlapped with another report resulting in an overage of 30,000
tablets of diazepam,\10\ that the DI had used "some
inaccurate beginning counts . . . off of our inventory,'' and
that the DI had failed to include drugs Respondent had reported
stolen. May 24, 2005 Tr. 125.\11\
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\9\ In his testimony, Mr. Street did not
specifically identify which drug usage reports had been left
out. Respondent also did not submit the DEA-106s into
evidence.
To make clear for
future cases, to successfully challenge an audit, a registrant
must specifically identify the error which it claims was made.
For example, if it claims that the Government left out a drug
usage report, it must specifically identify the report and
show how its exclusion affected the results. The generalized
testimony which Mr. Street typically gave is wholly
insufficient to demonstrate that the audit results were
erroneous. I conclude, however, that there is no need for a
remand on this issue because even Mr. Street's audits found
numerous discrepancies.
\10\ As discussed
below, it is a registrant's responsibility to maintain
accurate records. The fact that the audit may have showed an
overage of diazepam because the dispensings were recorded on
multiple drug usage reports is therefore further evidence of
Respondent's poor recordkeeping practices.
\11\ At the hearing, the DI acknowledged
that he erred when he recorded the beginning inventory figure
for hydrocodone/ acetaminophen 10/650 from Respondent's
January 11, 1999 inventory onto his spreadsheet. More
specifically, the DI wrote that the pharmacy had on hand 330
tablets rather than 33. Tr. 219.
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There is, however, no dispute that Respondent was short 800
tablets of hydrocodone/acetaminophen \12\ (5/500) and more than
380 tablets of Lortab (7.5/500), a brand name drug which also
contains hydrocodone and acetaminophen. Compare ALJ Attachments
A and B. Respondent was also short 200 tablets of Dilaudid (hydromorphone)
4 mg. and 193 tablets of generic hydromorphone 4 mg. Id.
Respondent was also short 485 tablets of acetaminophen/codeine
(300/60). Id.
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\12\ Through out this decision, the term
"apap'' is used as an abbreviation for acetaminophen.
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Furthermore, according to Respondent's audit, the pharmacy
was short 589 tablets of hydrocodone/apap (7.5/500) and 704
tablets of Diazepam 10 mg. Id. at Attachment B. Moreover,
Respondent's audit found substantial overages in multiple drugs
include hydrocodone/apap 7.5/750 (740 tablets), hydrocodone/apap
10/650 (438 tablets), Lortab 5/500 (189 tablets), and apap/codeine
300/30 (369 tablets). Id. While it is not uncommon that a
pharmacy will have small shortages or overages (of less than
fifty dosage units), Tr. 72-73, the shortages and overages found
during the 1999 audit are not trifling amounts. On April 10,
2001, DEA investigators returned to Respondent to conduct
another audit. For the closing counts, the DIs took an inventory
of the drugs being audited which Mr. Street verified. GX 10. For
most of the drugs being audited, the DIs used the inventory
taken during the December 14, 1999 audit for the beginning
counts.\13\ Here again, the Government found several substantial
shortages of hydrocodone/apap drugs and numerous overages. See
GX 11.
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\13\ For several schedule II drugs (Oxycontin
and Methadone) which had not been previously audited, the DIs
used for the beginning count the inventory which Respondent
took on May 10, 2000. GX 11.
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Mr. Street also disputed the accuracy of this audit and
testified that he found that it had eight errors. May 24, 2005
Tr 128. More specifically, Mr. Street testified that the several
drug usage reports and purchase invoices were left out. Id. He
also asserted that the diazepam was again over-accounted for.
Id.
Mr. Street again conducted his own audit and found that
Respondent had substantial shortages in numerous drugs. See ALJ
15, Resp. Ex. 3. With respect to generic hydrocodone/apap drugs,
Respondent was short 171 tablets of 5/500 strength, 656 tablets
of 7.5/500, and 657 tablets of 10/500; Respondent was also short
196 tablets of Lortab 10. Resp. Ex. 3. As for diazepam,
Respondent was short 312 tablets of 5 mg. strength and 554
tablets of 10 mg. strength. See id. Respondent was also short
152 tablets of methadone 40 mg. (a schedule II drug, 21
CFR 1308.12(c)), and 166 tablets of acetaminophen and
codeine 4. See Resp. Ex. 3 at 2.
On April 30, 2002, the DIs returned to Respondent and
conducted an audit which covered the period between the April
10, 2001 and the date of their visit. GX 13. The DIs used the
closing inventory counts from the 2001 audit for the beginning
count and took an inventory of the drugs on hand for the closing
count, which Mr. Street verified. See id.
Even though the DIs audited only twelve drugs, they again
found several substantial shortages and overages, see GX 14, and
Mr. Street disputed the accuracy of the audit. May 24, 2005 Tr.
at 129 & 137. More specifically, Mr. Street testified that
the DEA audit did not include three drug usage reports and that
apparently, the amounts from some invoices were not properly
counted. Id. at 129.
Once again, Mr. Street's audit found substantial shortages
and overages. See Resp. Ex. 4. Specifically, Respondent was
short 498 tablets of diazepam 10mg., 754 tablets of hydrocodone/apap
7.5/500, and 910 tablets of hydrocodone/apap 10/500. Resp. Ex.
4. Respondent also had overages of 442 units of hydrocodone/apap
7.5/650 and 364 units of hydrocodone/apap 10/650.
With respect to the 2001 audit, the ALJ found that Mr. Street
"credibly stated that he attributed such discrepancies to
human error.'' ALJ 15. More specifically, Mr. Street testified
that "it could have been simply [that] the person was
supposed to have gotten the generic and we accidentally pulled
the name brand off the shelf.'' May 24, 2005 Tr. at 142-43. Mr.
Street further testified that there were "four different''
strengths of combination hydrocodone drugs "all on the
shelf together[,] and it could have been just simply the fact
that we just pulled the wrong one off the shelf.'' Id. at 143.
The ALJ also credited Mr. Street's testimony that "there
was no deliberate diversion of drugs.'' ALJ at 15 (May 24, 2005
Tr. at 143).
As for Mr. Street's contention that his pharmacy may have
confused branded and generic drugs when it filled prescriptions,
it would have been easy enough to prove this by showing the
existence of corresponding overages and shortages in the
respective drugs. Mr. Street did not, however, offer any
evidence from his own audits to this effect.\14\
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\14\ For example, even if DEA did not audit
a branded drug of the same strength as a generic drug that it
audited, Mr. Street could have done so.
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Mr. Street's contention that he and other pharmacy personnel
may have mistakenly filled a prescription with a drug of a
different strength than that prescribed by his customers'
physicians is alarming. Under federal regulations, drug
manufacturers and distributors are required to label the
containers that they use to distribute their drugs. 21 CFR Pt.
201. Manufacturers are also required to imprint each dosage unit
"with a code imprint that, in conjunction with the
product's size, shape and color, permits the unique
identification of the drug product and the manufacturer * * * of
the product.'' 21 CFR 206.10(a). Moreover, "[i]dentification
of the drug product requires identification of its active
ingredients and its dosage strength.'' Id. In short, a
pharmacist should know the strength of a drug he is dispensing
based on both the container's labeling and the imprint on the
dosage unit and make sure that he has dispensed the correct
strength of a drug. Indeed, dispensing controlled substances of
the wrong strength can have serious consequences for the health
of patients.
As for Mr. Street's testimony that "there was no
deliberate diversion'' of the drugs his pharmacy was short of,
this is pure speculation. Respondent offered no evidence that it
had
[[Page 368]]
investigated its employees to determine whether any of them
could be diverting the missing drugs. In short, Mr. Street does
not know whether or not his pharmacy's employees could have been
diverting drugs.
Respondent also introduced into evidence the affidavit of Mr.
Timothy Mitchell Pierce, a lawyer and registered pharmacist.
Resp. Ex. 6. Mr. Pierce reviewed various documents in the case,
medical records, and interviewed Mr. Street. Mr. Pierce, who was
presumably testifying as an expert, opined that "the
alleged overages and shortages of controlled substances as
described in the Order to Show Cause are not due to deliberate
diversion,'' and "are more likely due to DEA audit errors,
acceptable human error by [Respondent's] personnel and theft by
person(s) not associated with'' Respondent. Id. at 4.
I reject the conclusions of Mr. Pierce for several reasons.
First, while Mr. Pierce has been a registered pharmacist and
stated that he has practiced in retail pharmacy settings, his
affidavit does not establish how many years of actual pharmacy
practice he has, that he has remained active in pharmacy
practice,\15\ and that he has any experience in conducting
audits.
---------------------------------------------------------------------------
\15\ Indeed, it appears that Mr. Pierce has
not practiced as a pharmacist in a substantial time because he
graduated from a Tennessee law school in 1992, is licensed as
a lawyer in Tennessee, but holds a Louisiana pharmacy license.
---------------------------------------------------------------------------
Second, Mr. Pierce's affidavit typically did not address the
shortages which Mr. Street's own audits found. For example, in
discussing the December 1999 audit, Mr. Pierce discussed only
the shortage of one drug (hydrocodone/apap 7.5/500). RX 6, at
4-5. Mr. Pierce's affidavit ignores that Respondent was short
800 tablets of hydrocodone/apap 5/500, 380 tablets of Lortab
(7.5/500), 200 tablets of Dilaudid 4 mg., 193 tablets of generic
hydromorphone 4 mg., 485 tablets of acetaminophen/codeine
(300/60), and 704 tablets of diazepam 10 mg. See id. Similarly,
with respect to the April 2001 audits, Mr. Pierce's affidavit
ignores the shortages of 312 tablets of diazepam 5 mg. and 554
tablets of diazepam 10 mg. See id. at 5-6. The affidavit also
offers nothing but speculation regarding the shortages of
hydrocodone/ apap.\16\
---------------------------------------------------------------------------
\16\ With respect to the April 2002 audits
and the diazepam shortages, Mr. Pierce's affidavit responds to
the allegations of the Show Cause Order. The Show Cause Order,
however, only sets the parameters of the proceeding and does
not constitute evidence.
---------------------------------------------------------------------------
Finally, with respect to the April 2002 audits, Mr. Pierce's
affidavit does not even acknowledge the figures for the
hydrocodone shortages per Mr. Street's own audit (754 tablets of
hydrocodone/apap 7.5/500 and 910 tablets of hydrocodone/apap
10/500). See id. at 8. Mr. Pierce then opined that the shortages
and overages "were probably due'' to "inadvertently''
dispensing the wrong strength of drug. Id. Mr. Pierce also
opined that a name brand drug could have been "dispensed
for a generic brand drug or vice versa,'' and noted that "[t]he
name brand drugs were not audited and thus cannot be compared.''
Id. Again, Mr. Pierce's opinion amounts to pure speculation. His
testimony is therefore rejected.
The Evidence Regarding Respondent's Dispensings
The ALJ found that during 1997, Respondent "filled over
124 controlled substance prescriptions written by Edmond
Watts,'' a veterinarian who had allowed both his DEA
registration and state veterinary license to expire without
renewing them, ALJ at 17 (citing Tr. 37-38, 41-42), and was
therefore without authority to prescribe controlled substances.
According to the credited testimony of a DEA supervisory
diversion investigator, a pharmacist is required to periodically
check with the appropriate state licensing authority to ensure
that a practitioner holds a current license. Id. (citing Tr.
61).
Normally, veterinarians purchase the controlled substances
they dispense directly from wholesale distributors and dispense
the drugs directly to the owner of the animal. Tr. 88. Indeed,
under DEA regulations, "[a] prescription may not be issued
in order for an individual practitioner to obtain controlled
substances for supplying the individual practitioner for the
purpose of general dispensing to patients.'' 21 CFR 1306.04(b).
Watts wrote the prescriptions, which were for drugs
containing hydrocodone, in the names of fictitious patients,\17\
Tr. 40, and had his brother present them to Respondent for
filling. Id. at 62-63. Moreover, Watts' brother was presenting
the prescriptions "almost every day [or] every other day.''
Id. at 62. The drugs were then personally used by Veterinarian
Watts. Id. at 40. Eventually, Watts was convicted of a
controlled-substances related felony. Id. at 42.
---------------------------------------------------------------------------
\17\ Watts also wrote prescriptions "in
the name of his sister- in-law.'' Tr. 41. Watt's sister-in-law
"was interviewed and indicated [that] she never received
that medication.'' Id.
---------------------------------------------------------------------------
With respect to the prescriptions issued by Watts, Respondent
put on the testimony of Mr. Richards, a private investigator it
had retained. Mr. Richards testified that Watts told him that he
had "deceived'' Street, and "didn't tell him
[Street]'' about his licensure status. May 24, 2005 Tr. at 14.
There is, however, no evidence that Mr. Street had asked Watts
whether he had a valid DEA registration and state license prior
to the incident in summer of 1997 when state investigators
showed up at Respondent and inquired about Watts' prescriptions.
Id.
Moreover, Mr. Richards testified that "all of the
prescriptions that Dr. Watts wrote that Jeff filled for any kind
of pain drugs contained acetaminophen. And that would alert a
pharmacist to the fact that it was probably for an animal,
because acetaminophen is toxic to certain animals.'' Id. at 16.
Contrary to Mr. Richard's testimony, the fact that
"acetaminophen is toxic to certain animals'' points to the
exact opposite conclusion--that the drugs were not being
prescribed to treat animals for a "legitimate medical
purpose'' and that Watts was not acting in the "usual
course of his professional practice.'' 21
CFR 1306.04(a).
DEA investigators also found that Respondent was filling
large amounts of prescriptions for schedule III drugs containing
hydrocodone that were written by a dentist, J. Michael Haws. ALJ
at 19 (citing Tr. 34-35, GX 15I). According to a DEA diversion
group supervisor, Dr. Haws "was prescribing to almost all
of his patients, and even though the amounts weren't that large,
the frequency was. [The patients] were going to him almost every
other day and requiring additional prescriptions.'' Tr. 35.
Ultimately, the state dental board placed Dr. Haws on probation
for three years, and following the issuance of an Order to Show
Cause, Haws voluntarily agreed to restrictions on his DEA
registration. Id. at 37.
On cross-examination, the DEA investigator acknowledged that
Haws did a lot of extractions and that it would not be unusual
for a dentist to prescribe pain medication after doing this
procedure. Id. at 59. However, on re-direct examination, the
investigator testified that in his experience, dentists who
performed extractions treat acute pain which "lasts for a
short period of time'' and that dentists do not "normally''
treat chronic pain. Id. at 87-88. The investigator further
explained that the frequency of the prescriptions issued by Haws
and filled by Respondent was not consistent with the treatment
of acute pain, but rather, with the treatment of chronic pain.
Id. at 87-88.
DEA investigators also determined that Respondent was filling
a large number of prescriptions issued by Dr. Frank Varney for
benzodiazepines (such as Valium or diazepam), which are
[[Page 369]]
schedule IV controlled substances. Tr. 28, 31-33, see 21
CFR 1308.14(c)). According to the supervisory investigator,
in 1994, the state board put Dr. Varney on probation and
required that he attend a course on prescribing controlled
substances. Tr. 33. Before the state board action, Dr. Varney
was writing prescriptions for schedule II narcotic
prescriptions; after the board action, he turned to writing the
benzodiazepine prescriptions. Id. at 33-34. Respondent filled
"over 7000'' prescriptions written by Dr. Varney, most of
which were for benzodiazepines. Id.\18\
---------------------------------------------------------------------------
\18\ Mr. Richards testified that between
1997 to 1999, a competitor pharmacy "filled 1,886
controlled substance prescriptions for Dr. Varney'' and
"Jonesborough Drug filled 25,861 hard copies during the
same period.'' May 24, 2005 Tr. 32. Even if Mr. Richard's
testimony regarding the prescriptions filled by Jonesborough
Drug was meant to refer to controlled-substance prescriptions,
the testimony is not relevant to the issue of whether
Respondent filled unlawful prescriptions.
---------------------------------------------------------------------------
The Prescription Traces
The Government introduced into evidence prescriptions traces
for twenty-five customers of Respondent. See Gov. Ex. 15 (A-Y).
For each customer, the traces indicated the name and strength of
the controlled substance, the quantity dispensed, the
prescription number, the date of the original prescription, and
the name of the prescribing practitioners. The Government also
put on two expert witnesses, Dr. John Mulder, a physician with a
specialty in family practice who is board certified in hospice
and palliative medicine, GX 16, and Dr. James Ferrell, a
pharmacist with forty-one years of experience and the former
director of the Tennessee State Board of Pharmacy. Tr. 271, GX
17.
With respect to several of the traces, either one or both of
the Government's experts testified that Respondent's dispensings
were not improper. With respect to Customer M.B. (GX 15-A), Dr.
Mulder opined that his review found "no significant
deviation from what could be expected to be a standard of care
for prescribing these medications. In other words, the
quantities over a period of time could be consistent with an
acceptable medical reason.'' Tr. 499.
With respect to patient D.C. 2 (GX 15-C), Dr. Mulder
"found nothing that would be outside of a legitimate
medical reason for the dispensing of these particular amounts
and types of medications.'' Id. at 507. As for Government
Exhibit 15-E, a trace which listed a male (D.E.) and female (J.E.)
who used the same address, Dr. Mulder stated that "[t]he
amounts of medicine prescribed began to skirt the upper limit of
acceptable, but [they] never actually surpassed it in terms of
the number of pills dispensed within a given month.'' Id. at
509. Dr. Mulder further explained that "it is conceivable
that someone with a particular pain problem could be dispensed
this amount of medication longitudinally, so I did not have a
particular problem with this particular chart.'' Id. at 509-10.
Dr. Mulder also found that the prescriptions for patient B.R.
(GX 15-O) "could have been . . . for legitimate medical
purposes,'' Tr. 528, that Respondent had properly dispensed to
patient W.B. (GX 15-P), Tr. 530, and that Respondent
"probably met'' the standard in dispensing to patient R.S.
(GX 15-S). Tr. 533. Finally, with respect to patient W.T. (GX
15-W), Dr. Ferrell noted that while "[t]he dosages are
really high . . . [w]hen your patients have cancer and they're
dying, we do see . . . dosages of controlled substances [that]
are really high.'' Tr. 359. Dr. Ferrell thus concluded that the
prescriptions "could be legitimate.'' Id. at 359-60.
The remaining traces did, however, raise substantial
questions regarding the legitimacy of the prescriptions
Respondent filled. Set forth below is a discussion of the
evidence regarding Respondent's dispensings to those patients
which the Government's experts concluded (at least initially)
did not satisfy the "corresponding responsibility'' under
Federal law.
Patient D.C. 1.
This trace showed that Respondent dispensed to D.C. numerous
prescriptions for Lorcet, a branded drug combining hydrocodone
and acetaminophen, which were issued by J. Michael Haws, a
dentist. See GX 15-B, at 1-2. Between June 24, 1997, and
September 29, 1997, Respondent filled twenty-nine controlled
substance prescriptions for narcotics; twenty-eight of the
prescriptions were for hydrocodone and acetaminophen, and one of
the prescriptions was for Percodan, a schedule II controlled
substance which contains oxycodone and aspirin. See 21
CFR 1308.12(b). The prescriptions were typically issued
every three to four days. See GX 15-B, at 1-2. Furthermore,
during both July and August, the controlled substances dispensed
by Respondent contained 140,400 mg. of acetaminophen or
approximately 4529 mg. per day. Moreover, on July 8, 1997, one
day after Respondent filled a prescription for twenty-four
Vicodin ES tablets, which was issued by Dentist Haws, it filled
a prescription for sixty Lorcet 10/650 tablets issued by another
practitioner, Dr. Caudle. Id. at 2.
With respect to the prescriptions Dentist Haws issued to
D.C., Dr. Ferrrell observed: "that's a lot of times, a lot
of dental problems right there. At some point in time, you've
got to wonder * * * why he's seeing the dentist so often and why
he's having so much dental problems.'' Tr. 289. Dr. Ferrell
further explained that dentists usually treat acute pain and
that "after maybe a month or two and I continued to see
those things * * * I would ask the dentist to supply me some
type of reason for why the prescriptions kept going on for such
a long period of time.'' Id. at 290.
Relatedly, Dr. Mulder opined "that the prescriptions
over a longitudinal basis for this narcotic in this dose were
being prescribed by a dentist who is not a physician which
heightens the level of concern about this particular
prescription.'' Id. at 504. Dr. Mulder also testified that the
drugs Respondent dispensed contained acetaminophen, and that
there is a "safe limit'' as to the amount of acetaminophen
an individual can take during a day without "developing a
toxic state,'' which is "four grams a day.'' Id. at 500.
Dr. Mulder further testified that "[t]he number of pills
dispensed to this individual were above the acceptable limit''
and could lead to serious illness if the patient was actually
taking the drugs. Id. at 500-01.
In his testimony, Mr. Street acknowledged that the
prescriptions "slightly exceed[ed]'' the safe limit for
acetaminophen "on two separate months.'' May 25, 2005 Tr.
at 79. Mr. Street testified that D.C. "required a lot of
dental work,'' and that because he was a patient "that Dr.
Haws [was] treating over a long period of time, we kept in touch
with the dentist office. And it was easy to do, because the
dentist office is right there in town. And kept in touch with
either Dr. Haws or his receptionist * * * Ms. Williams, to
verify that they were, you know, requiring ongoing treatment.''
Id. The ALJ credited this testimony, see ALJ at 35, and many of
the prescriptions issued by Dentist Haws appear to have been
called in to Respondent.\19\ See GX 15-B.
[[Page 370]]
None of the prescriptions, however, include a notation that
the dispensing pharmacist had questioned Dentist Haws about
D.C.'s continuing need for the drugs. See Id.
---------------------------------------------------------------------------
\19\ The ALJ also found that "Mr.
Street had counseled [D.C. 1] not to take additional
over-the-counter acetaminophen during this time.'' ALJ at 35
(citing Resp. Ex. 1, at 1). Mr. Street did not, however,
testify to this under oath and the document which contains
this statement was not sworn. It is also notable that Mr.
Street and his counsel had approximately ten months from the
time the Government rested until the hearing reconvened and
thus they had ample time to prepare for his testimony. ALJ at
2. Because Mr. Street could have testified to this but chose
not to, I give no weight to this statement.
---------------------------------------------------------------------------
Patient E.C.
Government Exhibit 15-D shows that on several occasions,
Respondent dispensed to E.C. prescriptions for combination
hydrocodone and acetaminophen products issued by different
doctors within a short period of other similar prescriptions.
For example, on October 24, 1997, Respondent dispensed a
prescription for 20 Lortab 7.5/500 issued by Dr. Hussain; the
next day, it dispensed a prescription for 25 hydrocodone/apap
5/500 issued by Dr. Wiles. See GX 15-D at 1. Three days later
(on October 28), Respondent dispensed another 30 tablets of
Lortab 5/500 issued by Dr. Wiles. Id. Dr. Ferrell specifically
noted that upon receiving such prescriptions, a pharmacist
should call the prescriber and ask if he was "aware that
the patient had gotten Lortab the day before.'' Tr. 296.
The trace also showed that Respondent had filled multiple
prescriptions for sixty tablets of alprazolam 5 mg. issued by
Dr. Hussain, as well as multiple prescriptions for diazepam 5
mg. issued by Dr. Slonaker. GX 15-D. In several instances,
Respondent filled the prescriptions only days apart. See Id. at
1 (10/26/99 Rx for 60 alprazolam and 10/27/99 Rx for 60
diazepam; 11/20/99 Rx for 60 alprazolam and 11/23/99 Rx for 60
diazepam). Id. at 1. Both drugs are schedule IV depressants, see
21
CFR 1308.14(c), and according to Dr. Ferrell "have a
synergistic effect'' when taken together. Tr. 297. Dr. Ferrell
further noted that the trace showed that the patient was
simultaneously receiving multiple controlled substances for pain
(from Dr. Slonaker) such as hydrocodone/apap 7.5/500 and
hydrocodone/apap 10/ 500, Id. at 298, and that the pharmacy
should have questioned this. Id. at 300; GX 15-D at 2. Relatedly,
Dr. Mulder testified that "[it] is generally considered not
appropriate to be mixing different short- acting analgesic
medications at the same time'' such as E.C. was receiving, and
that the pharmacist should have contacted the physician. Tr.
508. None of the prescriptions indicated that Respondent had
contacted the prescriber. See GX 15-D.
Mr. Street testified that "I'd talk to Dr. Slonaker
about this before, because he does this for many of his
patients'' and that "he likes to prescribe a stronger pain
med for severe pain, and a weaker pain med * * * for mild to
moderate pain.'' May 24, 2005 Tr. 81-82. Mr. Street also
testified that E.C. had been a patient since Respondent opened,
that he had "chronic back problems'' and "has
seizures'' related to a fall he had in November 1997. Id. at 81.
Mr. Street, however, offered no testimony regarding Respondent's
frequent (and sometimes nearly simultaneous) dispensings of the
alprazolam and diazepam prescriptions which were written by
different doctors.
Respondent also introduced into evidence the affidavit of
Joseph Montgomery, a physician with thirty years of experience.
See RX 5. Dr. Montgomery reviewed the medical records of most of
the patients identified in the traces. Dr. Montgomery opined
that it was "probably * * * medically justified'' for E.C.
"to receive the degree of pain medications prescribed.'' RX
5, Ex. A. at 2. Dr. Montgomery offered no opinion, however, as
to whether the prescriptions Respondent repeatedly filled for
alprazolam and diazepam were issued for a legitimate medical
purpose. See Id.
Patient S.F.
The prescription trace for S.F. shows that beginning in
January 1996 and ending in April 1997, Respondent filled
approximately 126 prescriptions issued by Dr. Blackmon which
were primarily for Dilaudid (schedule II) and Lorcet 10/650
(schedule III). GX 15-F. Dr. Ferrell noted that in 1996,
Respondent filled approximately 47 hydrocodone/apap
prescriptions for a total of 3,915 dosage units and 35 Dilaudid
prescriptions for 3,090 dosage units. Tr. 306. Dr. Ferrell
further explained that this amounted to ten tablets a day of
hydrocodone and eight tablets a day of Dilaudid, "which is
real heavy usage of * * * the two opioids.'' Id. Moreover, in
the first three-and-a-half months of 1997, Respondent filled 23
prescriptions totaling 2,070 dosage units of hydrocodone and 16
prescriptions totaling 1,454 dosage units of Dilaudid. Id. This
amounted to approximately 17 tablets a day of hydrocodone and 12
tablets a day of Dilaudid. Id. Dr. Ferrell also noted that
Respondent had filled a prescription for Buprenex, a narcotic
agonist-antagonist which can cause acute withdrawal symptoms in
patients taking Dilaudid, an opioid agonist. Id. at 307.
Dr. Ferrell further noted that the Buprenex prescriptions
contained no notation that Respondent had contacted the
prescriber. Id. at 308. Dr. Ferrell added that based upon the
dosages being prescribed, S.F. was "at least physically
dependent'' on the opioids and that he would have "probably
refuse[d] to fill his prescriptions.'' Id.
Dr. Mulder added that the quantities of dosage units of
hydrocodone/acetaminophen drugs "were twice the acceptable
limits'' and "would be potentially toxic.'' Id. at 511. He
further testified that a pharmacist has an obligation "not
to dispense medication knowingly harmful to the patient'' and
"to contact the physician to let him know that the
prescriptions were exceeding acceptable norms.'' Id. Dr. Mulder
also noted that Respondent was dispensing "two different
narcotics simultaneously in relatively large quantities.'' Id.
The ALJ found credible Mr. Street's testimony that S.F. had
"three major back surgeries'' and had difficulty walking.
ALJ 40. The ALJ also found credible Mr. Street's testimony that
he "had to make frequent phone calls about him, because he
was always wanting his medications early, or he would * * *
bring a prescription in that was * * * too frequent, too close
to the other one he brought in.'' May 24, 2005 Tr. 85. Mr.
Street maintained, however, that Dr. Blackmon "was
monitoring him closely,'' and that while Dr. Blackmon
acknowledged that "he was giving [S.F.] a high amount of
narcotics, he felt [S.F.] needed these just so * * * he could
function in every day life.'' Id.
The ALJ also found credible Mr. Street's testimony that while
he provided early refills of S.F.'s prescription, he never did
so without verifying it with Dr. Blackmon and then "document[ed]
the transaction in the computer.'' ALJ at 40 (citing May 24,
2005 Tr. at 85-86). Respondent did not, however, produce any
printouts of this documentation (or for any other instance in
which he claimed to have contacted a prescriber) and testified
on cross-examination that he did not know if the "specific
notes for each specific patient'' could even be printed out. May
24, 2005 Tr. at 154.
As for the filling of the Buprenex, the ALJ credited Mr.
Street's testimony that the drug's package insert "gives no
interactions or contraindications to ingestion with hydrocodone.''
ALJ at 40. The ALJ also credited Mr. Street's testimony that
"[t]he only precaution regarding Buprenex and hydrocodone
is that the combination may 'increase * * * drowsiness.''' Id.
at 40-41 (citing May 24, 2005 Tr. 87).
Respondent, however, offered no testimony in response to Dr.
Mulder's testimony that Respondent was filling prescriptions for
combination hydrocodone/acetaminophen at quantities that
exceeded acceptable safe
[[Page 371]]
limits.\20\ Furthermore, I take official notice of the
package insert for Buprenex.\21\ Under the section captioned
"Use in Narcotic- Dependent Patients,'' the insert states:
"Because of the narcotic antagonist activity of Buprenex,
use in the physically dependent individual may result in
withdrawal effects.'' Buprenex Injectable Package Insert, at 1.
I therefore reject the ALJ's finding crediting Mr. Street's
testimony on the issue. I further find that at the time
Respondent filled the Buprenex prescription, it had filled more
than sixty prescriptions issued to S.F. for both Dilaudid (hydromorphone)
and combination hydrocodone drugs, both of which are narcotics.
See GX 15-F, at 1 & 3; see also 21
CFR 1300.01(b)(30); Id. 1308.12(b)(1);
Id. 1308.13(e).
---------------------------------------------------------------------------
\20\ Neither Mr. Street nor his expert
witness, Dr. Montgomery, offered any evidence to refute this
testimony. See RX 5, at 3-4. Moreover, while Dr. Montgomery
stated that "the records showed that Jeff Street called
Dr. Blackmon's office regarding the quantity of pain medicine
and Soma that [S.F.] received,'' RX 5, at 5, Dr. Montgomery
offered no opinion as to why it was appropriate to dispense
either quantities of drugs that are potentially toxic or
multiple opiates. See id. at 4-5.
\21\ In accordance with the Administrative
Procedure Act (APA), an agency "may take official notice
of facts at any stage in a proceeding--even in the final
decision.'' U.S. Dept. of Justice, Attorney General's Manual
on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt
& Sons, Inc., Reprint 1979). In accordance with the APA
and DEA's regulations, Respondent is "entitled on timely
request to an opportunity to show to the contrary.'' 5 U.S.C.
Sec. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the opportunity to
refute the facts of which I take official notice, Respondent
may file a motion for reconsideration within fifteen days of
service of this order which shall commence with the mailing of
the order.
---------------------------------------------------------------------------
Patient B.J.
This trace showed that twenty-one different physicians had
prescribed controlled substances to B.J. The prescriptions were
for multiple schedule IV benzodiazepines including alprazolam,
lorazepam, clonazepam, temazepam, and triazolam; multiple
schedule III narcotics including combination hydrocodone/apap,
Fiorinal with Codeine,\22\ and propoxyphene/apap, some schedule
II endocet (oxycodone with acetaminophen), and four
prescriptions for Stadol (butorphanol), a schedule IV drug (21
CFR 1308.14(f)), which is a mixed agonist/ antagonist but which
has opioid antagonist properties. Tr. 548.
---------------------------------------------------------------------------
\22\ A branded drug containing butalbital,
aspirin, caffeine and codeine phosphate.
---------------------------------------------------------------------------
The trace showed that Respondent repeatedly filled alprazolam
and lorazepam prescriptions which were issued by different
physicians for B.J. and that in multiple instances the
prescriptions were filled within several days of each other. See
GX 15-G at 1 (Compare Dr. Greenwood Rx for 60 alprazolam on
5/24/99 with Dr. Varney Rx for 90 lorazepam on 5/25/99;
Greenwood Rx for 45 alprazolam on 6/23/99 with Varney Rx for 90
lorazepam on 6/21/99; Greenwood Rx for 60 alprazolam on 10/26/99
with Varney Rx for 90 lorazepam on 11/1/99; Greenwood Rx for 60
alprazolam on 11/30/99 with Varney Rx for 90 lorazepam on 11/29/
99).\23\ The trace also showed multiple instances in which
Respondent filled prescriptions for schedule III narcotics such
as generic Fiorinal with Codeine and propoxyphene--which again
were issued by different doctors--within a short time of each
dispensing. Moreover, the trace showed numerous instances in
which Respondent filled prescriptions for hydrocodone/apap
issued by six practitioners. Id. at 8.
---------------------------------------------------------------------------
\23\ There were also similar instances on
February 9 and 15, 1999; March 6 and 11, 1999; April 27, 29,
30 and May 1, 1999, in which Respondent filled prescriptions
for these drugs which were issued by these two doctors for B.J.
See GX 15-G, at 2. There were also many instances in which the
prescriptions were presented within a week to two weeks of
each other but were for large quantities.
---------------------------------------------------------------------------
Finally, the trace showed that Respondent filled
prescriptions for Stadol on April 19 and 24, 1999, September 30,
1999, and November 6, 1999. Id. at 1-2. Respondent, however, was
also filling prescriptions for narcotics contemporaneously with
its Stadol dispensings. See Id.
In his testimony, Dr. Ferrell explained that "[a]
pharmacist is basically the gatekeeper of the medical delivery
system.'' Tr. 310. After noting the numerous instances in which
Respondent filled prescriptions for different benzodiazepines
which were issued by different doctors and the large quantities
of these drugs it dispensed, Id. at 312, Dr. Ferrell explained
that a pharmacist must contact the prescriber, ask him if he is
"familiar with the fact [that] the patient'' is on another
drug of the same class, and ask if he really wants the patient
to receive the drug. Id. at 313. Dr. Ferrell also found
problematic Respondent's filling of the prescriptions for
hydrocodone/apap which were written by six different
practitioners. Id. at 315.
Dr. Mulder found problematic Respondent's filling of
"simultaneous prescription[s] of narcotic analgesics'' and
noted that "there were six different narcotics being * * *
dispensed simultaneously by a number of different physicians.''
Id. at 512-13. Dr. Mulder further found that "[t]he number
of pills dispensed * * * exceeded the acceptable safe limits and
would have been toxic to the patient.'' Id. at 513.
Dr. Mulder also explained that prescribing an
agonist/antagonist such as Stadol "at the same time that
you're giving an agonist * * * precipitate[s] a withdrawal
reaction [in] the patients.'' Id. Dr. Mulder further explained
that Stadol and narcotic agonist drugs "cannot be given
simultaneously and they were given simultaneously in this
particular patient.'' Id. at 513-514. According to Dr. Mulder,
Respondent "should not have filled'' the Stadol
prescriptions. Id. at 514. Respondent also should have notified
the physician that "he cannot fill'' the prescription
because of the "potential medical problems'' that can occur
"by dispensing these two medications together'' and also
that the "numbers of pills are too much.'' Id.
Finally, with respect to Respondent's dispensing of multiple
benzodiazepines, Dr. Mulder opined that "the patient was
receiving as many as three different benzodiazepines as the same
time [and] [t]here [is] no medical indication for it
whatsoever.'' Tr. 515. Dr. Mulder further explained that
"to dispense'' these prescriptions was "problematic,''
because "the combined effect'' of the drugs "could be
devastating for the patient.'' Id.
Mr. Street testified that B.J. had "a lot of medical
problems'' including chronic pain, chronic headaches, chronic
kidney problems and numerous hospital stays. May 24, 2005 Tr.
87. Mr. Street also testified that B.J. had seen four different
primary care physicians because the first two she saw had closed
their practices or Tenncare had required her to change doctors.
Id. at 88. Mr. Street further stated that B.J. "didn't see
[the physicians] at the same time.'' Id.
Mr. Street also testified that B.J. "is a mental health
patient,'' and that she went to a mental health group practice
which had "five or six doctors.'' Id. Mr. Street maintained
that B.J. would not necessarily see the same doctor at each
appointment. Id.
As for the three different benzodiazepines, Mr. Street
testified that Dr. Varney was her primary care physician and was
prescribing her one benzodiazepine for tension because she had
headaches and another for sleep. Id. at 89. Moreover, a
physician at the mental health group was prescribing alprazolam
to her for anxiety. Id. The ALJ further credited Mr. Street's
testimony that he had called both Dr. Varney and the mental
health group and that "[t]hey were both aware they were
both prescribing at the same time.'' Id. See also ALJ at 43. The
ALJ also credited Mr. Street's testimony that he documented this
in his computer. Id. Mr. Street did not, however, testify as to
[[Page 372]]
when he first called the respective physicians.
Moreover, Mr. Street did not address why Respondent, between
March and October 1999, repeatedly filled prescriptions for
propoxyphene/apap and butalbital with codeine, which were
continually issued by Drs. Gastineau and Varney
respectively.\24\ See GX 15-G, at 1-2. Nor did he offer any
testimony as to why Respondent filled the four Stadol
prescriptions when it was also dispensing narcotics to B.J.\25\
Moreover, while Dr. Montgomery's affidavit concluded that B.J.
"is an unfortunate patient who has multiple medical/dental
producing pain syndromes which were appropriately treated,'' the
affidavit does not address the prescribings of narcotics by Drs.
Varney and Gastineau. RX 5, at 11. Nor did it address the
medical appropriateness of the simultaneous prescribing of
alprazolam and lorazepam by Drs. Greenwood and Varney. See Id.
---------------------------------------------------------------------------
\24\ Dr. Gastineau was also a family and
internal medicine practitioner and practiced in Elizabethon,
Tennessee; Dr. Varney was not a member of Dr. Gastineau's
group and practiced in Jonesborough. See GX 15-G, at 38 &
71.
\25\ As explained at footnote 19, Respondent
submitted an exhibit entitled "Comparison/Analysis of
Patients in Exhibit 15.'' RX 1. With respect to B.J., the
documents states that "MD OK'd Stadol, but not with other
meds. Drug literature says can be given with a narcotic, and
to use caution when doing so.'' RX 1, at 3. The ALJ did not
rely on this statement and the exhibit was not sworn. As
stated above, because Mr. Street could have testified to this
(and been subject to cross-examination) but did not, I
conclude that the statements in this document are entitled to
no weight.
---------------------------------------------------------------------------
Patient W.L.
The prescriptions for W.L. indicate that between December 21,
1995, and February 15, 1997, Respondent filled 239 controlled
substances prescriptions (including refills) issued by Dr.
Blackmon for such drugs as Buprenex, Diazepam, Lortab 7.5/500,
generic hydrocodone/apap 10/650, and Tussionex Pennkinetic
Suspension (hydrocodone with chlorpheniramine) oral solution.
See GX 15-H. In 1996, Respondent made 163 dispensings of
Buprenex totaling 5,380 dosage units for "approximately 14
units a day,'' thirty-one dispensings of hydrocodone/apap
totaling 2550 dosage units, and twenty-two dispensings of
diazepam totaling 1530 dosage units. Tr. 317; see also GX 15-H,
at 1-4.\26\
---------------------------------------------------------------------------
\26\ Some of the refills may have dispensed
in the first week of January of the next year.
---------------------------------------------------------------------------
Dr. Ferrell re-iterated that "Buprenex is a narcotic
antagonist'' and "has many drug interactions'' including
"respiratory and cardiovascular bouts * * * in patients
receiving therapeutic doses of diazepam.'' Id. Dr. Ferrrell
stated that he "probably would not have filled the
prescription.'' Id. at 318.
Relatedly, Dr. Mulder testified that Respondent did not
comply with its corresponding responsibility under federal law
for three reasons. Tr. 515-16. Specifically, Dr. Mulder noted:
(1) That "the number [of] pills dispensed * * * would have
been toxic if taken as prescribed''; (2) "the simultaneous
prescription of two or more analgesic medications''; and (3)
"the combination of * * * agonist and the antagonist,
agonist medications which are contraindicated to be given
together.'' Id. at 516. Dr. Mulder concluded that Respondent
should have notified the physician that the medications
prescribed were contraindicated and that it should not have
filled the prescriptions. Id.
The ALJ credited Mr. Street's testimony that W.L. was
disabled and had chronic back pain. ALJ at 43. (citing May 24,
2005 Tr. at 90). On the issue of the interaction of Buprenex and
diazepam, Mr. Street testified that "the only thing the
package insert says about combining the two drugs is that there
have been reports of respiratory problems when Diazepam is given
with Buprenex.'' May 24, 2005 Tr. at 90. Mr. Street further
added that the insert then "tells the physician to proceed
with caution if you're going to administer the two drugs.'' Id.
The ALJ also credited Mr. Street's testimony that while W.L. was
receiving "a pretty heavy dose of narcotics, * * * we
stayed [in] contact with Dr. Blackmon's office; and Dr. Blackmon
* * * said he was monitoring him close,'' and needed the high
doses "for his medical condition.'' Id. at 90-91; ALJ at
44.
According to the Buprenex package insert (which I have taken
official notice of), "[t]here have been reports of
respiratory and cardiovascular collapse in patients who receive
therapeutic dose of diazepam and Buprenex,'' and "[p]articular
care should be taken when Buprenex is used in combination with
central nervous system depressant drugs.'' Buprenex Package
Insert at 1. The package insert further states, however, that
"[p]atients receiving Buprenex in the presence of other
narcotic analgesics [and] benzodiazepines * * * may exhibit
increased CNS depression. When such combined therapy is
contemplated, it is particularly important that the dose of one
or both agents be reduced.'' Id. (emphasis added).
The prescription traces indicate, however, that Dr.
Blackmon's prescriptions did not reduce the dosing of the
Buprenex, the diazepam, or the hydrocodone/apap and Tussionex.
For example, while in January 1996, Blackmon twice prescribed
only thirty Lortab, on February 7, he issued a prescription for
sixty Lortab (7.5/500) with one refill, and on February 21, he
issued a prescription for ninety hydrocodone/apap (10/650) with
two refills. Blackmon proceeded to prescribe ninety Lortab in
various strengths with refills until February 1997. See GX 15-H,
at 1. Moreover, while Blackmon initially prescribed only thirty
tablets of diazepam, approximately two weeks later, he issued a
prescription for sixty tablets with one refill. See Id. Two
weeks later, Blackmon issued another prescription for sixty
diazepam with one refill. See Id. Three weeks later, Blackmon
increased the diazepam prescriptions to ninety tablets with one
refill, and similar prescriptions were issued on approximately a
monthly basis until Blackmon's prescription writing ended. See
Id.
Moreover, the trace indicates that Blackmon increased the
quantity and number of refills of Buprenex notwithstanding that
he was also prescribing the other drugs. See id. Thus, the
evidence indicates that Blackmon did not reduce the dosing of
either the Buprenex or the other drugs as called for in the
Buprenex warnings but actually increased them.\27\ Respondent
nonetheless filled the prescriptions.
---------------------------------------------------------------------------
\27\ Dr. Montgomery's affidavit does not
discuss W.L. See RX 5.
---------------------------------------------------------------------------
Patient A.L.
This trace indicated that between August 23, 1997, and
January 12, 1998, Respondent filled twenty-four prescriptions
for Angela L. (who was married to Rex L., GX 15-J) which were
issued by Dentist Haws. Most of the prescriptions were for
either Lorcet 10/650 or Lortab 10/500. See GX 15-I. Respondent
also filled three prescriptions Dentist Haws issued for
Tussionex Pennkinetic Suspension, a combination of hydrocodone
and chlorpheniramine which is prescribed for cough and upper
respiratory symptoms. The original prescription was dated 9/11/
97, and the trace indicates that Respondent also dispensed two
re- fills. GX 15-I. The trace also showed that Respondent filled
other prescriptions for Lortab which were issued by a Dr.
Caudle/Caudill.
Based on the stickers that had been attached to the original
prescriptions, Dr. Ferrell noted that some of the prescriptions
were issued to Rex L. but were apparently dispensed to Angela L.
See id. at 4; Tr. 320-21. Dr. Ferrell
[[Page 373]]
stated that this should not have occurred. Id. at 321. Dr.
Mulder testified that the number of pills dispensed would have
been "toxic if taken the way they were prescribed and
dispensed.'' Id. at 517. He further explained that the
pharmacist should have "[a]dvised the patient as to the * *
* problem * * * and notified the physician that an excess amount
of pills were prescribed.'' Id. at 518.
Mr. Street testified that Angela L. was a typical patient of
Dentist Haws because she had a "low income,'' "no
insurance'' and "needed a lot of work.'' May 24, 2005, Tr.
91. He also testified that "as with all his patients that
he was treating over a long period of time, we stayed in
contact'' with Dr. Haws and "verified that they were still
getting treatment.'' Id. The ALJ credited this testimony. ALJ at
45. Mr. Street further testified that while Angela L.'s
prescriptions may have exceeded the acetaminophen limits
"slightly,'' this happened in only one month and she was
getting "lots of dental work done.'' May 24, 2005 Tr. 91.
In discussing Respondent's dispensings to Rex L., Mr. Street
testified that he had discovered that a "relief
pharmacist'' had filled a prescription for Tussionex, which Mr.
Street caught "when [he] came back to work.'' May 24, 2005,
Tr. 93. Mr. Street then testified:
And I alerted Dr. Haws to the fact that * * * it's not within
your usual course of practice to prescribe Tussionex. And so * *
* I explained to him why. I said, "That's--basically,
that's not a pain syrup, that's a cough syrup, and that's not
within your usual course of practice.'' And after that, he
ceased doing that. I've never seen him do it again.
Id. According to the trace for Rex L., Respondent filled or
refilled Tussionex prescriptions issued by Dr. Haws on August 1,
4, and 29, 1997. See GX 15-J, at 2, 5 & 13.
The trace for Angela L. shows, however, that Respondent
filled a Tussionex prescription which Dr. Haws issued on
September 11, 1997, after Mr. Street claimed to have called
Haws. See GX 15-I, at 1. Moreover, Respondent refilled this
prescription twice. See id. Mr. Street offered no explanation as
to why these prescriptions and the refills were also not outside
the usual course of Dr. Haws' professional practice. See May 24,
2005 Tr. at 91. Nor did he explain why Respondent filled the
prescriptions. See id.
Patient R.L.
This trace showed that Respondent dispensed numerous
prescriptions for diazepam and combination hydrocodone products
(primarily Lorcet 10/ 650) between February 27, 1996, and April
15, 1997. See GX 15-J. According to Dr. Ferrell, in 1996,
Respondent filled 53 prescriptions (with refills) written by Dr.
Blackmon totaling 3,180 dosage units of combination hydrocodone/apap,
and twenty-one prescriptions totaling 1,200 dosage units of
diazepam. Tr. 323.
Rex L. also received numerous prescriptions from Dentist Haws
for combination hydrocodone drugs and the two prescriptions for
720 ml. of Tussionex. Regarding the Tussionex, Dr. Ferrell
testified that not only is it "unusual to see a dentist
write for cough syrup,'' but these prescriptions were for a very
large quantity and he could not "think of any reason why a
prescription for [720 ml.] of Tussionex'' would be necessary.
Id. at 324-25. According to Dr. Ferrell, "the usual
dosage'' of Tussionex "is 5 milliliters every 12 hours,''
so that 720 ml. provides 144 dosage units. Id. at 325.\28\
---------------------------------------------------------------------------
\28\ Dr. Ferrrell testified that if a
patient took the usual dosage of five ml. twice a day, 144
dosage units would last 36 days. Id. at 326. This appears to
be a math error as 144 dosage units, if taken twice a day,
should last 72 days.
---------------------------------------------------------------------------
The stickers attached to the actual hard copy prescriptions
show that on August 1, 1997, Respondent dispensed to Rex. L. 720
ml. of Tussionex, and that three days later, it dispensed to him
an additional 360 ml. GX 15-J, at 13. Furthermore, on August 29,
1997, Respondent dispensed to Rex L. an additional prescription
for 720 ml. of Tussionex based on Dr. Haws' authorization. Id.
at 5. Dr. Ferrell further noted that Dr. Haws' Tussionex
prescriptions did not appear to include specific directions as
to how the drug should be taken. Tr. 326; see also GX 15-J, at 5
& 13.
Regarding Rex L., Dr. Mulder testified that the quantities of
pills Respondent dispensed "could have been toxic if taken
as prescribed.'' Tr. 519. Dr. Mulder further noted that there
was evidence that Rex L. was "Doctor Shopping,'' a practice
in which drug abusers and prescription drug-dealers "will
go from physician to physician to present the same story to''
each doctor so as to "amass their quantities of
medications.'' Id. at 520-21.
According to the trace, on November 10, 14, and 18, 1997,
Respondent filled prescriptions which Rex L. obtained from
Dentist Haws for 24 Lorcet (10/650). GX 15-J, at 2. Thereafter,
on November 22, Respondent filled a prescription Rex L. obtained
from Dr. Egidio for another 60 Lorcet. Next, on November 29,
Respondent filled a prescription Rex L. obtained from Dr.
Caudill for 90 Lortab 10/500; Respondent then refilled this
prescription twice. See id.
This was followed by a December 5 dispensing of a
prescription for 240 ml. of Tussionex issued by Dr. Caudell,\29\
dispensings on December 9 and 12 of prescriptions for 20 and 24
Lorcet issued by Dentist Haws, a December 17 dispensing of a
prescription for 100 tablets of MS Contin 100 mg. (a schedule II
drug containing morphine) issued by Dr. Caudle, and a December
23 dispensing of a prescription for 65 Dilaudid 4 mg. issued by
Dr. Egidio. See id. These were followed by dispensings of 24
Lorcet tablets on December 31, 1997, and January 5, 1998,
pursuant to prescriptions issued by Dentist Haws, followed by a
January 9 dispensing of a prescription for 240 ml. of Tussionex
issued by Dr. Caudill, and additional prescriptions for Lorcet
issued by Dentist Haws. See id.
---------------------------------------------------------------------------
\29\ It is not clear whether this is a
misspelling of Dr. Caudill's name.
---------------------------------------------------------------------------
The ALJ found credible Mr. Street's testimony that Rex L.
suffered from "extreme chronic pain'' and that Respondent
contacted Dr. Blackmon who informed him that "he needed
this dose for his chronic pain.'' May 24, 2005, Tr. 92; see also
ALJ at 46. The ALJ also found that Mr. Street was aware that
patients may develop a tolerance and require larger doses of
pain medication. ALJ at 46.
Regarding the Tussionex, the ALJ found credible Mr. Street's
testimony "that the prescription * * * was filled by a
relief pharmacist.'' ALJ at 46 (citing May 24, 2005 Tr. at 93.
The ALJ also found credible Mr. Street's testimony that he
called Dr. Haws and discussed that the prescriptions "would
not normally be within the usual course of a dentist's
practice,'' and "that, after the phone call, he did not see
anymore Tussionex prescriptions issued by Dr. Haws.'' Id.
(Citing May 24, 2005 at 93). For the reasons stated in the
discussion regarding Angela L., I reject the ALJ's credibility
finding regarding Mr. Street's phone call.
In his testimony, Mr. Street did not specify which of the
three Tussionex prescriptions issued by Dr. Haws for Rex L. were
filled by the relief pharmacist. Nor did he testify as to which
of these prescriptions prompted his phone call to Haws. See May
24, 2005 Tr. 93.
Moreover, Mr. Street offered no testimony responding to Dr.
Mulder's opinion that Rex L. was engaged in doctor shopping.
More specifically, Mr. Street did not testify at all as to why
his pharmacy filled the prescriptions that
[[Page 374]]
Rex L. presented from multiple practitioners between November
1997 and January 1998.\30\ See id. at 92-93.
---------------------------------------------------------------------------
\30\ Again I note that in Respondent Exhibit
1, there is a notation that "MDs (Caudill and Egidio)
were contacted to make sure both were aware patient was seeing
each. Both had agreed to see patient since Caudill was
semi-retired.'' RX 1, at 4. As explained previously, I decline
to give any weight to this document. I further note that even
if Mr. Street contacted both doctors, his statement says
nothing about whether he notified each of them as to what drug
the other doctor (as well as Dr. Haws) was prescribing.
---------------------------------------------------------------------------
Patient K.P.
This trace showed that Respondent filled prescriptions K.P.
had received from "some 22 different prescribers.'' \31\
Tr. 328. Most of the prescriptions were for combination
hydrocodone/acetaminophen in various strengths. See GX 15-K.
There were, however, also prescriptions for alprazolam,
propoxyphene/apap, Tussionex, Fiorinal with Codeine, and
phentermine. See id.
---------------------------------------------------------------------------
\31\ There actually appear to have been 26
different prescribers. See GX 15-K.
---------------------------------------------------------------------------
Dr. Ferrell noted that between April 20, 2001, and April 19,
2002, Respondent dispensed to K.P. 58 prescriptions for
combination hydrocodone/apap products totaling 2,355 dosage
units. Tr. 328. According to Dr. Ferrell, Respondent
"absolutely should have called'' the prescribers "on
each case.'' Id. at 329. Dr. Ferrell opined that K.P. was a
"doctor shopper.'' Id. at 330.
Dr. Mulder likewise identified "the number[] of
physicians for whom prescriptions were being filled over a
relatively short period of time,'' and that the "quantity
of pills * * * exceeded * * * acceptable limits.'' Tr. 522. Dr.
Mulder further testified that Respondent "[h]ad a
responsibility not to fill prescriptions for more pills than
what would be considered safe and acceptable'' and to
"notify * * * the physicians that the patient was receiving
the same prescription from multiple physicians over the same
period of time.'' Id. at 522-23.
Regarding K.P., Mr. Street testified that she had
complications from neck surgery. May 24, 2005 Tr. at 94. He
further testified that "over the course of time [K.P.] had
to see five different primary care physicians'' either because
the physician closed his/her practice or Tenncare moved her to a
different physician. Id. Mr. Street added that K.P. had
"seen neurosurgeons'' and they had "referred her to a
pain management doctor who * * * was writing her pain meds.''
Id. Mr. Street further added that "[t]hey were both aware
that they were prescribing them at the same time.'' Id. Finally,
Mr. Street added that during the April 2001 to April 2002
period, K.P. "had to see seven emergency room doctors,''
and added that this was "not surprising, considering * * *
she had the two major surgeries [and] all the complications.''
Id. While the ALJ credited this testimony, Mr. Street did not
identify the names of the doctors by their practice areas. Nor,
other than in his vague testimony that the neurosurgeons (Drs.
Wiles and Vaught) and the pain management doctor (Dr. Smyth)
were each aware of the other's prescribing, did Mr. Street
testify as to his pharmacy having contacted any of the other
prescribers, such as the orthopedic surgeons (Drs. Beaver and J.
Williams) and the emergency room physicians she was also seeing
in the same time frame. Moreover, while Dr. Mongtomery opined
that there was medical justification for K.P. to have received
"tremendous amounts of narcotics,'' his affidavit does not
address the issue of doctor shopping. RX 5, at 12.
Patient P.P.
The prescription trace indicated that Respondent filled
prescriptions for P.P. that were issued by eleven different
prescribers. See GX 15-L. Dr. Ferrell specifically noted that
during February 2002, P.P. obtained prescriptions for
hydrocodone/apap from Doctors Goulding, Smyth, Haws and
Pelletier for a total of 79 dosage units.\32\ Tr. 331. Dr.
Ferrell further concluded that "if [Respondent] was telling
the different physicians about [the] history of this patient,
[it] probably could have cancelled their prescriptions.'' Id. at
332.
---------------------------------------------------------------------------
\32\ The prescriptions were dated between
February 14, 2002, and February 25, 2002. GX 15-L, at 2.
---------------------------------------------------------------------------
There is also evidence that during the fall of 1999,
Respondent filled prescriptions for narcotics that were issued
in close proximity to other prescriptions for either the same or
similar narcotics and that P.P. was engaged in doctor shopping.
For example, on October 4, 1999, Respondent dispensed an
original prescription for 60 hydrocodone/ apap (5/500) that was
issued by Dr. Lynch; Respondent dispensed refills of the
prescription on both October 15 and 25, 1999. GX 15-L, at 1. On
October 18, 1999, Respondent dispensed two prescriptions issued
by Dr. Wyche: one for 30 hydrocodone/apap (5/500), and one for
48 propoxyphene/apap. Id. Moreover, on November 17, 1999,
Respondent dispensed a prescription for 36 propoxyphene/apap
issued by Dr. Wyche, and on November 18, Respondent dispensed a
prescription for 48 hydrocodone/apap, which was also issued by
Dr. Wyche.\33\ Id.
---------------------------------------------------------------------------
\33\ On November 5 and 10, 1999, Respondent
also dispensed a prescription and refill which Dr. Wyche wrote
for 180 ml. of acetaminophen with codeine elixir. GX 15-L, at
1.
---------------------------------------------------------------------------
Dr. Mulder testified that Respondent had not met its
corresponding responsibility in its dispensings to P.P. for
several reasons. In support of his conclusion, Dr. Mulder cited
"the numbers of prescriptions that were [being] dispensed
within each given month, the combination of two or more
narcotics at the same time, and [that] multiple physicians
[were] writing prescriptions for this patient.'' Tr. 523-24. Dr.
Mulder also observed that K.P. (GX 15-K) "had the same
address as'' P.P., and "there was a very significant amount
of narcotics going into this household every day.'' Id. at 524.
Dr. Mulder further explained that in his experience, it is
"highly unusual that you would have two family members with
medical problems that would require the same level of
prescribing within each individual month.'' Id.
Dr. Mulder also testified that he would have contacted law
enforcement officials regarding what "may be going on in
that particular household.'' Id. at 525. Finally, Dr. Mulder
testified that a pharmacist should not "fill what is
inappropriate from a dosage perspective,'' and that a pharmacist
should "notify the physicians that the patients are
receiving multiple prescriptions from multiple physicians for
the same thing.'' Id. at 524.
Mr. Street testified that P.P. was K.P.'s husband and that he
was another "chronic pain patient.'' May 24, 2005 Tr. at
95-96. Mr. Street further testified that P.P. mainly saw Dr.
Tochev, a primary care physician, and Dr. Tanner, who was also
in the same group. Id. at 96.
Mr. Street added that Dr. Tochev referred P.P. to a pain
management group, which started writing prescriptions for pain
meds for him. Id. Mr. Street then testified that "we
contacted pain management about that, and Dr. Tochev, and
neither one * * * [was] aware the other one was prescribing.
Well, after we contacted them, pain management cease to write [P
P.] any more pain meds.'' Id.
Concluding his testimony regarding P.P., Mr. Street stated
that "he had seen ER doctors a couple of times; he had seen
a dentist a couple of times.'' Id. Mr. Street then explained
that "if you knew the doctors in the area like I do, it
shouldn't present a problem.'' Id. Notably, Mr. Street offered
no testimony regarding the multiple
[[Page 375]]
prescriptions his pharmacy filled that were issued by Drs.
Wyche and Lynch. P.P. saw these doctors two years before he saw
Dr. Tochev, the physician who referred P.P. to the pain
management specialist.\34\ See GX 15-L, at 16-17. Moreover, of
the doctors who prescribed to P.P. during the period when Dr.
Tochev was also treating P.P., only Dr. Smyth's prescriptions
indicate a specialty of pain management, and the trace suggests
that P.P. saw Dr. Smyth on at least two occasions. Id. at 4.
---------------------------------------------------------------------------
\34\ Neither Dr. Wyche nor Dr. Lynch
presents him/ herself as a pain management specialist. See
GX15-L, at 16-17. Dr. Wyche's scripts indicate that he has a
"FAMILY PRACTICE,'' and Dr. Lynch's scripts contain no
indication of a specialty. Id.
---------------------------------------------------------------------------
On February 20, 2002, Dr. Smyth wrote P.P. a prescription for
30 hydrocodone/apap (5/500) with one refill. Id. at 8.
Respondent filled the initial prescription the same day and the
refill on March 19, 2002. Id. at 2. Moreover, the next day,
Respondent also filled a prescription issued by Dr. Haws for 24
hydrocodone/apap 7.5/500. Id. This was followed by a February
25, 2002 dispensing of 14 tablets of hydrocodone/apap 5/500
pursuant to a prescription of Dr. Pelletier, and the dispensing
of a March 5, 2002 prescription by Dr. Haws for another 40
tablets of hydrocodone/apap 7.5/500. Id.
Two days later on March 7, 2002, Respondent filled a
prescription for 60 tablets of hydrocodone/apap 7.5/500 which
P.P. obtained from Dr. Tochev; on March 25, Respondent refilled
the prescription. Id. at 2. Thereafter, on March 27, 2002, Dr.
Tochev issued another prescription for 60 hydrocodone/apap
7.5/500; Respondent filled the prescription the same day. Id.
Finally, on April 2, 2002, Respondent dispensed another
prescription for 62 hydrocodone/apap 7.5/500 which was issued by
Dr. Smyth, the pain management doctor who according to Mr.
Street, had stopped writing prescriptions after being informed
that Dr. Tochev was also writing prescriptions for the same
drug. Id.; May 24, 2005 Tr. 96. Furthermore, Government Exhibit
15-L also contains a copy of a prescription for methadone (a
schedule II drug, 21 CFR 1308.12(c)) which Dr. Smyth issued on
April 25, 2002; attached to the prescription is the sticker that
is created upon the dispensing of a drug which includes the Rx
number, name of the drug, the quantity and patient instructions,
and price. See GX 15-L, at 3-4. I thus find that on April 25,
2002, Respondent also dispensed 62 tablets of methadone to P.P.
In his testimony, Mr. Street did not specify the date that he
contacted the pain management doctor and Dr. Tochev regarding
the fact that both doctors were writing prescriptions for
narcotic pain medications. Perhaps at some point he did. The
fact remains, however, that Respondent filled multiple
prescriptions for hydrocodone that were being issued by multiple
doctors within the same time period. For example, Respondent
refilled a Dr. Smyth issued prescription on March 19,
notwithstanding that on March 7, it had filled Dr. Tochev's
prescription. On March 25, it refilled Dr. Tochev's prescription
even though it had refilled Dr. Smyth's prescriptions six days
earlier. Then, two days later, it filled another prescription by
Dr. Tochev; less than a week later, it filled another
prescription from Dr. Smyth. Finally, Respondent also filled
prescriptions issued by Dentist Haws during the same period it
was filling the prescriptions from Dr. Smith, Tochev, and two
other physicians (Goulding and Pelletier).\35\
---------------------------------------------------------------------------
\35\ Regarding P.P., Dr. Montgomery stated
that "[t]his patient has a tremendous pain syndrome due
to documented medical and trauma etiologies. It is my opinion
that this patient was appropriately treated and the large
numbers of pain medicines were reasonable care.'' RX 5, at 12.
Again, Dr. Montgomery's statement does not address whether it
was appropriate for Respondent to fill multiple prescriptions
from multiple doctors within the same time frame.
---------------------------------------------------------------------------
Patient S.P.
This trace shows numerous instances in which Respondent
filled prescriptions that were issued contemporaneously by
multiple providers for either the same or similar drugs. These
included narcotic pain medicines such as combination hydrocodone/apap,
codeine/apap, and propxyphene/apap, as well as benzodiazepines
such as clonazepam and temazepam. GX 15-M, at 1-2.
Dr. Ferrell noted that S.P. has seen multiple physicians
(fourteen by his count), and noted various instances in which
"two pain relievers of * * * essentially the same type
characteristics'' were prescribed by different doctors a day
apart. Tr. at 333 & 335. Dr. Ferrell specifically noted that
on February 8, 1999, Respondent filled a prescription for 40
tablets of acetaminophen with codeine 3 which was issued by Dr.
Varney; the next day, Respondent filled a prescription for 30
propoxyphene with acetaminophen which was issued by Dr.
Huddleston. Tr. 333. Similarly, on August 13, 1997, Respondent
filled a prescription for 30 acetaminophen with codeine 3 which
was issued by Dr. Sykes; the next day, Respondent filled a
prescription for 60 propoxyphene with acetaminophen which was
issued by Dr. Varney. Id. Dr. Mulder likewise noted that
Respondent had violated its corresponding responsibility based
on its having dispensed excessive quantities of pills, "two
or more narcotics at the same time, and [the] numbers of
physicians * * * for whom prescriptions were being filled.'' Id.
at 526.
The trace also shows that on January 14, 1999, Respondent
dispensed 25 tablets of acetaminophen with codeine 3 issued by
Dr. Huddleston; on January 19, it dispensed another 20 tablets
of the same drug issued by Dr. Varney. GX 15-M, at 2. On January
21, Respondent then dispensed 60 tablets of hydrocodone/apap
5/500 issued by Dr. Anderson, and on January 25, it dispensed
another 25 tablets of acetaminophen with codeine 3 issued by Dr.
Huddleston. Id. This was followed by a January 27 dispensing of
30 propoxyphene with acetaminophen, and a January 29 dispensing
of acetaminophen with codeine 3, both of which were authorized
by Dr. Varney. Id. The trace also shows that in April and May
1999, Respondent filled numerous prescriptions for narcotic pain
medicines that were issued by Drs. Varney, Huddleston, and
Hudson. Id.
Finally, the trace also shows numerous instances in which
Respondent dispensed temazepam prescriptions issued by Dr.
Varney and, sometimes within a day, dispensed clonazepam
prescriptions issued by Dr. Shah. See id. at 2. Both of these
drugs are benzodiazepines. As Dr. Mulder earlier testified,
taking multiple benzodiazepines has synergistic effects and
could be devastating to the patient. Tr. 515.
The ALJ found credible Mr. Street's testimony that S.P. had
knee surgeries, hip surgeries, rotator cuff surgeries, and a
partial amputation of her leg. ALJ at 49 (citing May 24, 2005
Tr. at 96). Mr. Street also testified that while it seemed like
she had seen 15 different doctors, five of the doctors practice
in the same orthopedic group and three of the doctors practice
in the mental health group. May 24, 2005 Tr. at 97. Mr. Street
also testified that Dr. Varney was "her primary care
physician'' and that he "likes to write two different pain
meds * * * one for severe pain and one for milder pain.'' Id.
Mr. Street also stated that Dr. Varney had referred S.P. to the
orthopedic group, which "was prescribing her some more pain
meds for acute pain,'' and he had "stayed in contact with''
the doctors who "thought it was okay.'' Id. at 98.
The Government did not rebut Mr. Street's testimony on these
points, and upon reviewing the prescriptions, it appears that
some of the doctors were in the same group. Mr. Street, however,
[[Page 376]]
offered no testimony regarding Respondent's numerous
dispensings of benzodiazepine prescriptions by Dr. Varney (S.P.'s
family practitioner), and Dr. Shaw. Moreover, while Dr.
Montgomery opined that S.P. was "a difficult patient who
received a lot of multiple narcotics and it was reasonable to
treat her in this fashion,'' RX 5, at 12, he offered no opinion
as to whether it was reasonable for her to receive multiple
benzodiazepines simultaneously.
Patient J.P.
This trace showed that Respondent dispensed multiple narcotic
pain medicines including Darvocet (propoxyophene/apap), Lortab (hydrocodone/
apap 5/500), Tylenol with codeine 4, and Stadol spray;
benzodiazepines including diazepam and temazepam; Pondimin (fenfluramine,
a schedule IV drug, 21 CFR 1308.14(d)); and phentermine, a
schedule IV stimulant (21 CFR 1308.14(e)). See GX 15-N. Most of
the drugs were prescribed by Dr. Varney, although the Lortab was
prescribed by Dr. Johnson, who issued fourteen prescriptions of
the drug to J.P. throughout 1999. See id. Moreover, the trace
shows that Dr. Varney would issue as many as four to five
prescriptions for different controlled substances at a time. See
id.
Dr. Ferrell testified that he did not "understand why a
doctor would prescribe two drugs like [Tylenol with Codeine and
propoxyphene/ apap] at the same time.'' Tr. 336. Dr. Ferrell
noted that Darvocet and Tylenol 3 provide "about the same
in relief of pain.'' Id. at 338. Dr. Ferrell also found
problematic the prescribing of Stadol at the same time that
Darvocet and Tylenol with codeine were being dispensed and noted
that this happened repeatedly. Id. at 337.
Dr. Mulder testified while "[t]he actual quantities of
pills looked at in an isolated manner were not * * * of that
much concern,'' J.P. "was prescribed seven different
addicting medications simultaneously.'' Id. at 527. Dr. Mulder
further explained that J.P. "had stimulants and
depressants, she had analgesics and anxiolytics and this is a
whole host of different sorts of addicting medications.'' Id.
Continuing, Dr. Mulder added that "[a]t the very least, it
would have warranted a discussion with the physician [to] help
me understand what's going on here so I feel comfortable about
these ying-yang sorts of things I'm doing with this patient's
pharmacologic regime.'' Id.
Mr. Street testified that he "remember[ed] talking to
Dr. Varney'' about the five or six different controlled
substances he was prescribing. According to Mr. Street's
testimony, Varney was prescribing two drugs for pain pills. May
24, 2005 Tr. 98-99. The ALJ found credible Mr. Street's
testimony that J.P. weighed 350 to 400 pounds and that Dr.
Varney wrote her prescriptions for scheduled diet drugs to treat
obesity. ALJ at 50 (citing id.). Moreover, Varney also
"prescribed her something for sleep [and a] muscle relaxer.''
May 24, 2005 Tr. 99.
As for the Stadol, Mr. Street acknowledged that it was an
agonist- antagonist which might cause "withdrawal
problems.'' Id. Mr. Street testified, however, that the warning
in the Stadol insert applies only to a person who "is
severely dependent on narcotics.'' Id. at 100. Mr. Street
further testified that he talked with a physician, who he did
not identify, about the use of Stadol and was told its use would
not pose a problem unless the patient was "a street
addict.'' Id. Mr. Street also testified that he asked this
physician about whether it was appropriate to prescribe the drug
if a patient was "getting two or three pain pills a day.''
Id. According to Mr. Street, the physician told him that it
would not be a problem as long as the drug was used "on an
acute'' or an "as needed basis,'' and that he instructed
the patient not to take their "pain pill * * * in the same
time period.'' Id.
The ALJ found this testimony credible and the Government did
not rebut it. Mr. Street, however, offered no testimony as to
why Respondent also filled the prescriptions for Lortab that
were issued by Dr. Johnson during the same period it was also
filling the prescriptions issued by Dr. Varney for the three
opiates (Stadol, Darvocet and Tylenol 3).\36\
---------------------------------------------------------------------------
\36\ While Dr. Montgomery opined that
treating J.P. with narcotics was medically justified, his
affidavit does not address whether it was appropriate for
multiple physicians to be simultaneously prescribing opiates
to her. RX 5, at 12-13.
---------------------------------------------------------------------------
Patient A.S.
This trace showed that between April 25, 2001, and March 12,
2002, Respondent filled prescriptions which A.S. obtained for
various strengths of combination hydrocodone/apap products from
eight different practitioners. GX 15-Q. Dr. Ferrell specifically
noted that there were seventeen different prescriptions totaling
369 dosage units. Tr. 343- 44.
Dr. Mulder testified, however, that "the number of pills
were acceptable,'' and that "[t]he only disturbing thing
about this was the use of the number of different physicians for
filling these prescriptions.'' Id. at 531. Dr. Mulder further
testified that, under these circumstances, "[i]t would have
been appropriate for the pharmacist to have notified the
multiplicity of physicians that a number of different
prescriptions were being received for this narcotic so that they
could concentrate that in one place.'' Id. Dr. Mulder did not,
testify, however, that doing so was required for Mr. Street to
comply with his corresponding responsibility given the limited
number of pills being dispensed. See id.
Moreover, the ALJ found credible Mr. Street's testimony that
A.S. had to switch her primary care physician multiple times
because a physician closed her practice. ALJ 53. Furthermore,
several of the prescriptions were for small amounts and were
issued by her dentist and emergency room physicians. Id. Mr.
Street thus testified that this did not "throw up any red
flags.'' May 24, 2005 Tr. at 104; see also ALJ at 53. The
Government did not offer any evidence rebutting Mr. Streets'
testimony or demonstrate through other evidence that it was
implausible.
Patient R.S.
This trace showed that R.S. had received prescriptions from
nine different prescribers. See GX 15-R, at 1-4. According to
the trace, in 1999, Respondent filled thirty one prescriptions
for alprazolam, nineteen prescriptions for clonazepam, two
prescriptions for diazepam, and one prescription for lorazepam.
See id. at 1-3.
The alprazolam prescriptions were issued by Drs. Lynch,
Wiley, and Niner; the clonazepam prescriptions were written by
Dr. Wiley. See id. Most significantly, the trace showed that
both Drs. Lynch and Wiley were writing alprazolam prescriptions
during the same time period. More specifically, Dr. Lynch wrote
prescriptions for 100 alprazolam which Respondent filled on
January 5, February 11 and 24, March 11 and 15, April 15 and 26,
May 13, June 4 and 28, August 11, September 7 and 13, October 4,
November 24, and December 6, 1999. Id. Dr. Wiley wrote
prescriptions for 60 alprazolam which Respondent filled on
January 27, February 4 and 22, March 13 and 31, April 6 and 22,
May 10 and 29, June 15, July 5 and 22, August 9, and September
3, 1999. Id. Dr. Niner also wrote an alprazolam prescription on
September 25, 1999. Id. at 2.
Dr. Lynch was R.S.'s primary care physician. May 24, 2005 Tr.
105; see also id. at 8. Dr. Wiley was a psychiatrist. Id. at 26.
These physicians
[[Page 377]]
had offices in different cities and did not practice
together.
Respondent also filled numerous prescriptions for combination
hydrocodone/apap and oxycodone/apap drugs which were written by
Dentist Haws and Dr. Lynch; most of the prescriptions were
filled only days apart. Id. at 1-2. Specifically, on May 5,
1999, Respondent dispensed a prescription for 60 Lortab 10/500
issued by Dr. Lynch. Id. at 1. Moreover, pursuant to
prescriptions issued by Dr. Haws, on May 12 and 18, 1999,
Respondent dispensed two prescriptions for the schedule II drug
Endocet (oxycodone/apap 5/325), and on May 21 and June 8, 1999,
it dispensed two prescriptions for Percocet (also oxycodone/apap).
Id. at 2. Furthermore, on June 1, 1999, Respondent dispensed a
prescription issued by Dr. Lynch for 60 Lortab 10/500; on June
12, it refilled the prescription. Id.
During February through April 2002, there were again repeated
instances in which Respondent dispensed prescriptions for
combination hydrocodone/apap products which were issued by Drs.
Lynch and Haws only days apart. Id. at 4. More specifically,
Respondent dispensed prescriptions issued by Dr. Lynch for 60
hydrocodone/apap 10/650 on February 2, 14, and 26, March 7, 16,
21, and 29, and April 5, 9, and 22. Id. As for Dr. Haws'
prescriptions, Respondent dispensed 24 hydrocodone/apap
(typically 10/650) on February 21, March 13 and 14, and April 24
and 26, and prescriptions for 12 hydrocodone/apap on March 18
and April 8. Id.
Both Dr. Ferrell and Mulder found Respondent's dispensings of
both the benzodiazepine and narcotics to be in violation of
Respondent's corresponding responsibility. Tr. 347 & 532.
Dr. Ferrell testified that there "[s]hould have been some
coordination between the two prescribers.'' Id. at 347. Dr.
Mulder noted that the number of pills being dispensed
"exceeded safe, acceptable'' limits and that Respondent
should have notified the physicians "that multiple
prescriptions were being written.'' Id. at 532.
Mr. Street testified that R.S. had been wounded in a robbery
attempt and had "extreme chronic pain'' in his shoulder and
upper back. May 24, 2005 Tr. 104-05. Mr. Street further
testified he was seeing both a primary care doctor and was
"a mental health patient.'' Id. at 105. Continuing, Mr.
Street testified:
There was a question about similar drugs being prescribed
together. That was his mental health doctor that started that.
He was prescribing benzodiazepines; namely alprazolam for
anxiety and clonazepam for depression. So we called the doctor
and he told me the reason he was prescribing those. Now, later
on his primary care doctor, Dr. Lynch, started prescribing him
alprazolam exclusively for anxiety, but he continued to get the
clonazepam from his mental health doctor for the depression.
Id.
As for the multiple narcotic prescriptions, Mr. Street
testified that "Dr. Lynch was prescribing Lortab for his
chronic pain * * * due to the gunshot wound he had years ago.
And at the same time he started seeing Dr. Haws. And Dr. Haws *
* * more or less just pulled all of his teeth and made him a * *
* complete partial--complete full plate.'' Id. at 105-06.
Continuing, Mr. Street testified that "[w]e made contact
with both doctor and dentist to make them aware that both were
prescribing.'' Id. at 106. According to Mr. Street, Dr. Lynch
stated that she was prescribing for chronic pain and "realize[d]
the need for acute pain * * * when he sees Dr. Haws,'' and thus
Dr. Lynch approved the prescription as did Dr. Haws. Id. The ALJ
found Mr. Street's testimony credible.
There is evidence corroborating Mr. Street's testimony that
he called Dr. Lynch "regarding narcotic prescriptions.'' RX
5, at 14 (affidavit of Dr. Montgomery). In his testimony,
however, Mr. Street did not explain why for eight months, his
pharmacy repeatedly dispensed alprazolam prescriptions that were
being issued by both Drs. Lynch and Wiley, many of which were
filled only days apart. Relatedly, Dr. Montgomery's affidavit
does not address why it would be medically appropriate for two
physicians to be simultaneously prescribing alprazolam to a
patient.
Patient J.S.
Both Drs. Ferrell and Mulder identified Respondent's
simultaneous dispensings of pentazocine/naloxone and
acetaminophen with codeine 3 as problematic because pentazocine/naloxone
"is a narcotic antagonist,'' Tr. 351, and acetaminophen
with codeine 3 is a narcotic agonist. Id.; see also id. at 534;
GX 15-T. Mr. Street testified, however, that the antagonist part
of pentazocine/naloxone (naloxone) "is not active when you
take it by mouth or orally.'' May 24, 2005 Tr. 107. The ALJ
found this testimony to be credible and the Government offered
no evidence to rebut it.
Patient H.T.
This trace showed multiple instances in which Respondent
dispensed three different narcotic pain medications either on
the same day or within only a couple of days of dispensing the
other narcotic drugs. For example, on April 19, 1999, Respondent
dispensed 100 acetaminophen with codeine 3, 100 propoxyphene/apap,
and 100 hydrocodone/ apap 7.5/500. GX 15-U at 2. This pattern of
dispensing was repeated on May 10-12, July 2, August 10, October
6, October 28-29, and November 23. Id. at 1-2. Most of the
prescriptions were written by a single physician, Dr. Hartsell,
although a Dr. Sibley wrote several of the hydrocodone
prescriptions. Id. In addition, on January 20, 1999, Respondent
filled a prescription issued by Dr. Huddleston for 30
hydrocodone/apap 7.5/500; on January 23, it filled a
prescription issued by Dr. Hartsell for 100 hydrocodone/apap
5/500; and on January 27, it filled a prescription issued by Dr.
Sibley for 50 hydrocodone/ apap 7.5/500. Id. at 2.
Moreover, between April 10, 2001, and April 5, 2002,
Respondent dispensed 23 prescriptions for combination
hydrocodone/apap totaling 2,440 tablets. Id. at 4. The
prescriptions were issued by five different doctors including
Drs. Hartsell and Sibley. Id.
Dr. Ferrell testified that Respondent did not comply with its
corresponding responsibility because it should have closely
monitored the patient and communicated with the various
prescribers to make them aware of the multiple prescriptions and
the large number of dosage units being prescribed. Tr. 353-55.
Dr. Mulder testified that Respondent did not comply with its
corresponding responsibility because of the "[l]arge
numbers of pills being dispensed on a monthly basis of multiple
narcotics,'' and that "[i]n some cases, three different
narcotics [were] being dispensed within a couple of days of one
another and this was a repetitive pattern, month after month.''
Id. at 535-36. Dr. Mulder also noted that there were
"multiple physicians prescribing these medications.'' Id.
at 536. Dr. Mulder added that the pharmacy should have "notif[ied]
the physicians that multiple prescriptions were coming in from
this patient, not fill unsafe amounts of these medications,
[and] notify the patient that it's inappropriate to take [the]
medications together.'' Id.
Mr. Street testified that H.T. "had a host of medical
conditions'' including "severe chronic lung problems,'' as
well as "severe chronic pain in the knees, and lower
back.'' May 24, 2005 Tr. 108. Mr. Street further testified that
H.T. was seeing both Dr. Hartsell, who was her primary care
physician, and Dr. Sibley, who was her internal medicine doctor,
[[Page 378]]
and that Dr. May "practice[d] in the same group'' as Dr.
Sibley. Id.
Mr. Street added that Dr. Hartsell's prescribing of
propoxyphene and Tylenol 3 and Dr. Sibley's simultaneous
prescribing of Lortab "thr[ew] up a red flag.'' Id. at 109.
Mr. Street then testified to having called both doctors who
"confirmed they were both treating her.'' Id. Mr. Street
added that both doctors "were aware they were both giving
her meds[,] one for milder pain, one was for more severe pain.''
Id. Mr. Street further testified that H.T. also had to see some
specialists who wrote her prescriptions for acute pain. Id.
Finally, Mr. Street testified that he documented his contacts
with Drs. Sibley and Hartsell in the computer and that both had
"okayed'' the prescribings. Id. The ALJ found Mr. Street's
testimony credible and the Government produced no evidence to
rebut it.
Patient W.T.
This trace shows that Respondent dispensed prescriptions for
W.T. that were written by fifteen different physicians for such
drugs as alprazolam, Endocet 325 (a combination of oxycodone and
acetaminophen), generic oxycodone with acetaminophen (5/500),
various strengths of hydrocodone/apap, and propoxyphene-hcl 65
mg. See GX 15-V, at 1-3. The trace also shows that Respondent
repeatedly dispensed prescriptions for both propoxyphene and
oxycodone throughout the same time period, and that in some
instances, did so on the same day. See id. at 1. Regarding these
prescriptions, Dr. Ferrell testified that "it's unusual to
see a patient who's taking Oxycodone and also taking
Propoxyphene.'' Tr. 356- 57.
Most significantly, the trace shows that Respondent dispensed
two separate prescriptions on a single day, each being for 300
tablets of schedule II drugs containing oxycodone which were
issued under the name of Dr. Donovan. See GX 15-V, at 1. More
specifically, on July 31, 1997, Respondent dispensed to W.T. 300
tablets of oxycodone/apap 5/500 pursuant to prescription number
2003283, and 300 tablets of Endocet 325 pursuant to prescription
number 2003284. See id. at 1 & 21. Regarding one of these
dispensings, Dr. Ferrell testified that 300 tablets of oxycodone/apap
"is an unusual quantity'' and "would be more than a
month's supply.'' Tr. 357. On this day, however, Respondent
dispensed to W.T a total of 600 tablets of drugs containing
oxycodone.\37\ While Dr. Donovan had previously prescribed both
Endocet and generic oxycodone/apap to W.T., the prescriptions
had never exceeded 100 tablets and he had never prescribed both
drugs at the same time.
---------------------------------------------------------------------------
\37\ According to Dr. Montgomery's review of
W.T.'s medical records, a progress note prepared on the same
day stated that "she has become dependent upon Xanax and
Darvocet.'' RX 5, at 17. Dr. Montgomery did not specify the
name of the doctor who prepared this note. However, at the
beginning of this paragraph, Dr. Montgomery noted that "[f]urther
records indicate that this patient was followed by HG
Barbarito, MD, at the medical group in Johnson City,'' and Mr.
Street testified that Drs. Donovan and Barbarito were in the
same group. May 24, 2005 Tr. 110. Notably, the affidavit does
not address whether it was appropriate for Respondent to
dispense this quantity of drugs (600 dosage units) or to
dispense prescriptions for these drugs that were being issued
in the same timeframe by multiple prescribers.
---------------------------------------------------------------------------
Moreover, on August 14, only fourteen days after dispensing
600 tablets of oxycodone, Respondent dispensed another 40
tablets of Endocet 325, and six days later, on August 20, it
dispensed another 100 tablets of oxycodone/apap 5/500. See GX
15-V, at 21-22. Finally, the trace also shows that Respondent
dispensed to W.T. several prescriptions for Endocet 325 that
were written by Dr. Haynes during the same period in which it
was filling Dr. Donovan's prescriptions for the same drug. See
id. at 1. Drs. Donovan and Haynes did not practice in the same
group. See id. at 22.
Dr. Mulder concluded that Respondent violated its
corresponding responsibility because of the "very large
quantities of pills being dispensed on a monthly basis.'' Tr.
537. He also noted that there were "multiple analgesic
agents,'' and that there were "multiple numbers of
physician[s] on a monthly basis.'' Id.
Regarding W.T., Mr. Street testified that she had
"started off seeing a Dr. Donovan and a Dr. Barbarito, who
was in the same group,'' and then "had to switch to a Dr.
Steffner.'' May 24, 2005 Tr. 110. Mr. Street further testified
that W.T. had seen "numerous specialists because of
surger[ies] she's had'' on various body parts including her
hand, shoulder, and gall bladder. Id. Mr. Street added that
W.T.'s "primary care doctor was the one that was
prescribing the bulk of her pain meds,'' and that she also had
"chronic abdominal pain.'' Id. Mr. Street testified that
W.T.'s primary care physician had "prescribed her a
stronger pain med for severe pain, and a weaker pain med for
less severe or milder pain.'' Id.
Notably, at no time in his testimony did Mr. Street state
that either he or any other of Respondent's pharmacists had
contacted any of the doctors who prescribed to W.T. to verify
the legitimacy of the prescriptions. Mr. Street likewise offered
no testimony regarding his pharmacy's dispensing of 600 dosage
units of schedule II drugs containing oxycodone on a single day.
Nor did he testify as to why Respondent filled prescriptions for
drugs containing oxycodone that were issued by Drs. Donovan and
Haynes, who did not practice together, within the same
timeframe.
Patient B.W.
Respondent dispensed numerous prescriptions issued by Dr.
Blackmon for Lortab 7.5/500 and Valium (diazepam) between May
1996 and March 1997, when Dr. Blackmon's prescriptions ended. GX
15-X at 1-3. Also, between February 16 and November 11, 1999,
Respondent filled each month prescriptions issued by Dr. Egidio
for several controlled substances including Oxycontin 20 mg.,
Lortab 7.5/500, and alprazolam 0.5 mg. Id. at 2. All but the
first two Oxycontin prescriptions were for 60 tablets; most of
the Lortab prescriptions were for 90 tablets. Id. The trace
further showed that between April 19, 2001, and April 9, 2002,
Respondent dispensed thirteen prescriptions issued by Dr. Egidio
for Oxycontin 40 mg. Id. at 3. The first five of the
prescriptions were for 60 tablets; the remaining eight
prescriptions were for 90 tablets. Id.
Dr. Ferrell noted that Dr. Blackmon had prescribed 1,621
dosage units of hydrocodone and 1,300 dosage units of diazepam
and that both quantities were "high.'' Tr. 361. He also
noted that several of Dr. Egidio's prescriptions for Oxycontin
gave "PRN'' as the direction for taking the drug, id; this
term means to take as needed. Id. Oxycontin is, however,
typically taken on a scheduled basis. Id. While Dr. Ferrell
concluded that Respondent violated its corresponding
responsibility in dispensing the prescriptions issued by Dr.
Blackmon, he concluded that Respondent's dispensings of Dr.
Egidio's prescriptions were not improper even though they
contained the erroneous directions for taking the Oxycontin. Id.
at 362.
Relatedly, Dr. Mulder concluded that Respondent had not met
its corresponding responsibility because "the number of
pills being dispensed within a given month * * * exceeded safe
limits.'' Id. at 540. Dr. Mulder further testified that the
pharmacist should have told the patient that "he cannot
fill those'' prescriptions and notified the doctor. Id.
Mr. Street testified that B.W. had degenerative disk disease
and chronic pain in the lower back. May 24, 2005 Tr. 111-12. Mr.
Street testified that Dr. Blackmon's prescribing of hydrocodone
[[Page 379]]
and diazepam was standard treatment. Id. at 112. He further
testified that Dr. Blackmon had been called and "verified
what he was treating [B.W.] for when we called him.'' Id. Mr.
Street was thus "certain that her meds were for a
legitimate medical purpose.'' Id. Finally, Mr. Street testified
that "we called Dr. Egidio * * * when [B.W.] started seeing
him, and confirmed the diagnosis and treatment[,] so all her
meds were given for a legitimate medical purpose.'' Id. The ALJ
found Mr. Street's testimony credible and the Government offered
no evidence to rebut it.
Patient J.Y.
Most of the prescriptions listed on this trace were written
by Drs. Blackmon and Haws. See GX-15Y. Between August 16, 1996
and March 3, 1997, Dr. Blackmon issued and Respondent dispensed
eleven prescriptions for combination hydrocodone/apap drugs and
five for diazepam. Id. at 2.
Moreover, between April 7 and December 1, 1997, Dr. Haws
issued, and Respondent dispensed, seventeen prescriptions for
various strengths of hydrocodone/apap products and one
prescription for Percodan, a schedule II drug which contains
oxycodone and aspirin. See id. at 2; see also 21
CFR 1308.12(b)(1). There is then a gap in the trace until
March 30, 1999, when Respondent recommenced dispensing
prescriptions issued by Dr. Haws for combination hydrocodone/apap.
GX15-Y, at 2. Between March 30 and November 22, 1999, Respondent
dispensed a total of 20 such prescriptions. Id. Moreover,
between June 29, 2001, and February 18, 2002, Respondent
dispensed another five prescriptions issued by Dr. Haws to J.Y.
for combination hydrocodone/apap drugs. Id. at 1.
Regarding Dr. Haws' prescriptions, Dr. Ferrell testified that
"[y]ou've got to wonder what point in time was he actually
having dental problems,'' and that "[i]n that long of a
treatment, I would have had to have some kind of documentation
on what's wrong with the patient.'' Tr. 363. Dr. Ferrell further
testified that Respondent "should have verified that [the]
patient had a legitimate need for a controlled substance for
that long a period of time.'' Id. at 364.
While Dr. Mulder found that the prescriptions issued by Dr.
Blackmon "could have been dispensed for legitimate
purposes,'' he further explained that "in [his] experience,
to have prolonged dental pain that requires narcotics over that
length or period of time is somewhat problematic.'' Id. at 541.
Dr. Mulder added that "this is unusual for dentists to be
prescribing [analgesic medications] for an ongoing period of
time,'' and that "[f]or dentists to prescribe, it's usually
short-term, episodic, due to acute pain * * * or for operative
issues and not for long-term chronic pain problems.'' Id. at
542. Dr. Mulder further testified that it "would be quite
unusual'' for a dentist to be "qualified to treat chronic
pain,'' id. at 543, and that the dentist should have been called
and asked what type of treatment the patient was undergoing. Id.
at 542.
On re-direct examination, Dr. Mulder testified that "[t]here's
obviously a finite limit to how many teeth you can pull out.''
Tr. 563- 64. Dr. Mulder then testified, however, that "the
repetitive prescription, month after month after month, it just
seemed * * * with that particular file, I--it probably--I
couldn't state that it violated standards. It just seemed a
little unusual to have that many sequential prescriptions from a
dentist for the same patient.'' Id. at 564.
Mr. Street testified that J.Y. "was another typical Dr.
Haws patient'' who had "low income, no insurance,'' and
needed much work. May 24, 2005 Tr. 112. Mr. Street further
testified that "we stayed in contact with * * * Dr. Haws''
office * * * frequently to confirm that they were still getting
treatment * * * on a regular basis[,]'' and asked "[i]s
this patient still getting work done?'' Id. Mr. Street then
testified that "they would confirm that, and that would be
documented in the computer.'' Id. at 112-13. Here, again, the
ALJ found this testimony credible, see ALJ at 62, and the
Government offered no evidence to rebut it.\38\
---------------------------------------------------------------------------
\38\ While Dr. Montgomery could not review
J.Y.'s medical record because they were "not available,''
he then stated that "Dr. Haws is a dentist and I probably
can surmise the patient was having significant dental problems
given the number of prescriptions that are recorded.'' RX 5,
at 18. Dr. Montgomery's statement is nothing more than
speculation.
---------------------------------------------------------------------------
Respondent's Other Evidence
As previously stated, Respondent elicited extensive testimony
on a variety of factual issues from Mr. Richards, a private
investigator it hired following the initiation of this
proceeding. Beyond the testimony that has been discussed above,
Mr. Richards also testified about interviews he conducted with
some of the physicians, some employees of both the physicians
and Mr. Street, and some of the patients whose prescriptions
were discussed above.
All of this testimony was, of course, hearsay, and while
hearsay is admissible in these proceedings, it must still be
"reliable, probative, and substantial.'' 5 U.S.C. 556(d).
As for the reliability of this evidence, when asked by the ALJ
whether he found the people he interviewed to be credible, Mr.
Richards attempted to bolster their credibility by asserting
that "they didn't have a dog in the fight,'' \39\ but then
added "whether they were 100% credible, who the heck
knows.'' May 24, 2005 Tr. 72. Moreover, it is undisputed that
these statements were gathered during the course of, and for the
very purpose of being used in, this litigation. The statements
which Mr. Richards testified to were generally not sworn and
were made by their various declarants long after the underlying
events. Furthermore, the record does not reflect what
preliminary discussions occurred between Mr. Richards and the
declarants and the extent to which the declarants needed to have
their memories refreshed or may have been prompted by suggestive
interviewing techniques. Finally, the statements were generally
vague as to dates of the underlying events and lack probative
force.
---------------------------------------------------------------------------
\39\ The evidence suggests, however, that
Drs. Blackmon, Egidio, and Slonaker had previously been
investigated by various law enforcement and licensing
authorities including DEA. Tr. 60; May 24, 2005 Tr. 56-58.
Furthermore, those patients who were having their illegitimate
prescriptions filled by Respondent clearly had "a dog in
the fight.''
---------------------------------------------------------------------------
With regard to the prescribers that he interviewed, Mr.
Richards testified that Dr. Blackmon stated that Mr. Street
"called many times checking on patients and prescriptions
that he wrote.'' Id. at 19. Dr. Blackmon's statement does not
discuss any specific conversations or prescriptions and thus,
even if I held that it was reliable, lacks probative value. To
similar effect is Mr. Richard's testimony regarding the
statements of Dr. Lynch and Dr. Slonaker. Id. at 21-22; id. at
24.
Mr. Richards also testified that Dr. Hartsell stated to him
that:
[m]y file on Ms. [H.T.] reflects that Jeff or someone in his
pharmacy called and verified one of her Lorazepam prescriptions.
Her file shows that on July 19, 2001, * * * the Medicine Shoppe
called and said that she was trying to have an Ativan
prescription filled a little early. I had cut her dosage down on
Ativan, but since she was out of the drug she must have been
doubling up.
Id. at 20-21. The prescription trace for H.T. indicates,
however, that the actual prescription was telephoned in to
Respondent. See GX 15-U, at 15. Thus, Dr. Hartsell's statement
does not accurately reflect the circumstances surrounding the
filling of the prescriptions. And given all of the prescriptions
that Dr. Hartsell wrote for
[[Page 380]]
H.T., that he frequently wrote prescriptions for as many as
three different opiates at a time,\40\ and that Mr. Street
testified that both Drs. Hartsell and Sibley were aware that
each was prescribing opiates to H.T. at the same time and that
each doctor "okayed it,'' May 24, 2005 Tr. 109, it is
perplexing that Dr. Hartsell did not relate that H.T.'s file
contained a note that he had received a phone call from Mr.
Street or his employees regarding the prescriptions being issued
by Dr. Sibley and thus corroborating Mr. Street's testimony.\41\
---------------------------------------------------------------------------
\40\ The drugs were hydrocodone/apap, apap/codeine
4, and propoxyphene/apap. See GX 15U at 1-2.
\41\ Mr. Richards also testified that Dr.
Egidio had stated that Mr. Street had called him regarding
four specific patients, R.S., B.R., D.C., and B.W. Id. at 19.
With respect to three of the patients (D.C., B.R. and R.S.),
the Government's experts did not find Mr. Street's dispensing
to be improper. Finally, because I conclude that the
Government did not prove that Respondent's dispensings to B.W.
were unlawful, I need not decide whether Mr. Richard's
testimony should be given any weight.
Mr. Richard's testimony regarding the interviews he conducted
with the employees of various doctors was also typically lacking
in probative force. For example, Mr. Richards testified that an
employee of a clinic "said that she talks frequently to
people in Jeff's pharmacy.'' May 24, 2005 Tr. at 22. Likewise,
Mr. Richards also testified that an employee of a neurology
group had told him that she had worked for the group "for
three years, and during that period Jeff has called my office
questioning prescriptions written by physicians in our group.''
Id. at 23.\42\ Again, neither this testimony--nor the other
hearsay statements of various doctors' employees--addresses any
of the specific prescriptions at issue in this proceeding.
---------------------------------------------------------------------------
\42\ Mr. Richards further testified that
during his interview of Ms. Timbs, "she was shown a copy
of a prescription'' that was written by one of the physicians
who practiced with her employer, Doctor's Care. May 24, 2005
Tr. 22. Mr. Richards went on to testify that "Mr. Street
felt the prescription was suspicious and called Doctors
Care,'' which told him that the physician had not prescribed
Xanax, but only Triamcinolone Cream. Id. Notably, Mr. Richards
did not testify that Ms. Timbs told him that she recalled Mr.
Street's phone call or the circumstances surrounding the
prescription. See id.
---------------------------------------------------------------------------
Mr. Richards also testified as to interviews he conducted of
several employees of Mr. Street. According to Mr. Richards,
these employees generally stated that they had seen Mr. Street
call physicians to verify prescriptions. However, none of these
statements relate to any specific patient or prescription. See
id. at 25-26; 27- 30. Mr. Richards further testified that these
employees had told him Mr. Street "called doctors anytime
he had a prescription that he was not certain about, and that he
documented it in his computer.'' \43\ Id. at 28.
---------------------------------------------------------------------------
\43\ Given this, it is perplexing that Mr.
Street did not produce any printouts from his computer to
support his claims of having called the physicians who issued
the many suspicious prescriptions which he filled, and that he
testified that he did not even know if he could print this
information. See May 24, 2005 Tr. 154.
---------------------------------------------------------------------------
According to Mr. Richards, a pharmacy technician who worked
for Mr. Street "was aware of several instances where Mr.
Street reported customers to the police for forged
prescriptions.'' Id. at 30. Mr. Richards subsequently testified
that he had talked with a retired detective regarding various
police reports involving Respondent. According to Mr. Richards,
Mr. Street reported incidents of suspected prescription fraud to
the police on January 16 and September 13, 2001, and February 11
and April 5, 2002. Id. at 71-72. The actual incident reports
were not, however, introduced into evidence and Mr. Richards
testified only to the date, time and drug involved and not the
underlying circumstances of each incident. See id.
Mr. Richards also testified that he had interviewed many of
the patients whose prescriptions were discussed above. While the
patients typically related to Mr. Richards that Mr. Street had
never refilled their medications early and had counseled them
regarding the addictive nature of their drugs, only two of the
patients related that Mr. Street had called a particular
physician. See May 24, 2005 Tr. at 45-46 (statement of W.L. that
Mr. Street had called Dr. Blackmon many times); id. at 50 (B.W.'s
statement that she was aware that Mr. Street called Dr. Egidio
but not specifying the date). Because Mr. Street specifically
testified that he called Dr. Blackmon regarding W.L.'s
prescriptions, id. at 90-91, and Dr. Egidio regarding B.W.'s
prescriptions, id. at 112, and the ALJ credited Mr. Street's
testimony in each instance, it is unnecessary to decide whether
to give either of these statements any weight.
Discussion
Section 304(a) of the Controlled Substance Act provides that
"[a] registration * * * to * * * dispense a controlled
substance * * * may be suspended or revoked by the Attorney
General upon a finding that the registrant * * * has committed
such acts as would render his registration under section
823 of this title inconsistent with the public interest as
determined under such section.'' 21
U.S.C. 824(a). In determining the public interest, the Act
directs that the Attorney General consider the following
factors:
(1) The recommendation of the appropriate State licensing
board or professional disciplinary authority.
(2) The applicant's experience in dispensing * * *
controlled substances.
(3) The applicant's conviction record under Federal or
State laws relating to the manufacture, distribution, or
dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local
laws relating to controlled substances.
(5) Such other conduct which may threaten the public health
and safety.
Id. section
823(f).
"[T]hese factors are * * * considered in the
disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230
(2003). I "may rely on any one or a combination of factors,
and may give each factor the weight [I] deem[] appropriate in
determining whether a registration should be revoked.'' Id.
Moreover, case law establishes that I am "not required to
make findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d
477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165,
173-74 (D.C. Cir. 2005). Finally, where the Government has made
out its prima facie case, the burden shifts to the Respondent to
show why its continued registration would be consistent with the
public interest. See, e.g., Theodore Neujahr, 65 FR 5680, 5682
(2000); Service Pharmacy, Inc., 61 FR 10791, 10795 (1996).
In this case, having considered all of the factors, I
conclude that the Government's evidence with respect to factors
two and four establishes a prima facie case that Respondent's
continued registration is "inconsistent with the public
interest,'' 21 U.S.C. 823(f), and that Respondent failed to
refute this showing. Accordingly, Respondent's registration will
be revoked and its pending application for renewal of its
registration will be denied.
Factor Two--Respondent's Experience in Dispensing
Controlled Substances
Under DEA's regulation, a prescription for a controlled
substance is unlawful unless it has been "issued for a
legitimate medical purpose by an individual practitioner acting
in the usual course of his professional practice.'' 21 CFR
1306.04(a). The regulation further provides that while "[t]he
responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, * *
* a corresponding responsibility rests with the pharmacist who
fills the prescription.'' Id. (emphasis added). Continuing, the
[[Page 381]]
regulation states that "the person knowingly filling
such a purported prescription, as well as the person issuing it,
[is] subject to the penalties provided for violations of the
provisions of law relating to controlled substances.'' Id.
DEA has consistently interpreted this provision as
prohibiting a pharmacist from filling a prescription for a
controlled substance when he either "knows or has reason to
know that the prescription was not written for a legitimate
medical purpose.'' Medic-Aid Pharmacy, 55 FR 30043, 30044
(1990); see also Frank's Corner Pharmacy, 60 FR 17574, 17576
(1995); Ralph J. Bertolino, 55 FR 4729, 4730 (1990); United
States v. Seelig, 622 F.2d 207, 213 (6th Cir. 1980). This Agency
has further held that "[w]hen prescriptions are clearly not
issued for legitimate medical purposes, a pharmacist may not
intentionally close his eyes and thereby avoid [actual]
knowledge of the real purpose of the prescription.'' Bertolino,
55 FR at 4730 (citations omitted).\44\
---------------------------------------------------------------------------
\44\ As the Supreme Court recently
explained, "the prescription requirement * * * ensures
patients use controlled substances under the supervision of a
doctor so as to prevent addiction and recreational abuse. As a
corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses.'' Gonzales v.
Oregon, 546 U.S. 243, 274 (2006) (citing United States v.
Moore, 423 U.S. 122, 135 (1975)).
---------------------------------------------------------------------------
Accordingly, when a customer presents a suspicious
prescription, at a minimum, a pharmacist has a duty to verify
the prescription with the prescriber. Moreover, even if a
prescriber tells a pharmacist that a prescription has been
issued for a legitimate medical purpose, a pharmacist cannot
ignore evidence which provides reason to believe that the
prescription has not been issued for a legitimate medical
purpose or that the prescriber is acting outside of the usual
course of his or her professional practice.
The ALJ found that Respondent's dispensed "over 124
controlled substance prescriptions'' which were written by Dr.
Watts, a veterinarian, and which were presented by Dr. Watts'
brother even though they were written in the names of fictitious
patients. ALJ at 17. The drugs were then diverted to Dr. Watts,
who personally abused the drugs. During the period in which
Respondent filled these prescriptions, Dr. Watts did not hold a
DEA registration or a state license as he had allowed both to
expire. See United Prescription Services, Inc., 72 FR 50397,
50407(2007) ("A controlled-substance prescription issued by
a physician who lacks the license necessary to practice medicine
within a State is * * * unlawful under the CSA.''); United
States v. Moore, 423 U.S. 122, 140-41 (1975) ("In the case
of a physician, [the CSA] contemplates that he is authorized by
the State to practice medicine and to dispense drugs in
connections with his professional practice.'').\45\
---------------------------------------------------------------------------
\45\ A pharmacy has a duty to periodically
check to see that a practitioner retains the authority to
practice medicine and dispense a controlled substance. As the
ALJ recognized, failure to do so could threaten public health
and safety because there is usually a good reason for why a
practitioner has lost his or her state license and DEA
registration. In light of the other evidence regarding
Respondent's filling of Dr. Watts' prescriptions, I need not
decide whether it also violated this duty.
---------------------------------------------------------------------------
Moreover, the prescriptions were being presented "almost
every day [or] every other day,'' Tr. 62, and were for drugs
which contain hydrocodone. As Respondent's own witness
testified, "all of the prescriptions that Dr. Watts wrote
that [Mr. Street] filled for any kind of pain drugs contained
acetaminophen,'' a drug which "is toxic to certain
animals.'' May 24, 2005 Tr. 16.
While the ALJ did not consider this evidence in her analysis
of whether Respondent dispensed controlled substances in
violation of the prescription requirement,\46\ she nonetheless
noted that "the pattern of Dr. Watts' brother bringing
these prescriptions to the Respondent for filling, and the fact
that the prescriptions were written in other people's names,
should have caused Mr. Street to investigate the prescriptions
prior to dispensing the medications.'' ALJ at 76. The ALJ also
noted that "[s]uch conduct by the Respondent's main
pharmacist could threaten the public health and safety, for such
conduct [by Dr. Watts] easily could have indicated diversion of
controlled substances. Yet Mr. Street filled these prescriptions
without further investigation.'' Id. at 76-77.
---------------------------------------------------------------------------
\46\ The ALJ considered the evidence
regarding Respondent's filling of Dr. Watts' prescriptions
only under factor five. ALJ at 76. This evidence is, however,
also highly relevant in the consideration of Respondent's
experience in dispensing controlled substances.
---------------------------------------------------------------------------
I agree. There was ample evidence available to Mr. Street
(and Respondent) to question the legitimacy of the prescriptions
even if Mr. Street was unaware that Dr. Watts no longer held a
DEA registration and a state license. Beyond the testimony that
veterinarians usually purchase the controlled substances they
dispense directly from wholesale distributors and dispense the
drugs directly to an animal's owner, the repeated appearance of
Dr. Watts' brother at Respondent to present prescriptions which
were issued in other persons' names and pick up the drugs was
highly suspicious and should have prompted Mr. Street to
question the legitimacy of the prescriptions. Finally, Dr. Watts
was writing prescriptions that according to Mr. Richards, were
for pain drugs which "contained acetaminophen'' and
"acetaminophen is toxic to certain animals.'' This should
have alerted Mr. Street to the fact that Dr. Watts'
prescriptions were not being issued for a "legitimate
medical purpose'' and that Watts was not acting in the
"usual course of his professional practice.'' 21 CFR
1306.04(a). I thus conclude that Mr. Street (and his pharmacy)
had reason to know that these prescriptions were unlawful under
federal law and that he repeatedly violated his corresponding
responsibility when he filled them.\47\
---------------------------------------------------------------------------
\47\ The Show Cause Order also alleged that
Dr. Blackmon "issued numerous controlled substance
prescriptions for no legitimate medical reason'' and that
Respondent filled large numbers of these prescriptions. Show
Cause Order at 1-2. While the Government appears to rely on
the fact that some of Blackmon's patients traveled great
distances to have their prescriptions filled at Respondent,
some other area pharmacies continued to fill Blackmon's
prescription.
The record does not establish, however, how
many of Dr. Blackmon's patients were traveling great distances
to fill their prescriptions at Respondent. Moreover, with
respect to J.Y., one of Blackmon's patients whose
prescriptions were entered into evidence, the Government's own
experts testified that Respondent's dispensings were not
improper. I thus conclude that the appropriate resolution of
whether Respondent was unlawfully dispensing prescriptions
should focus on the evidence of its actual dispensings as
indicated in the traces and not on the Government's
generalized assertions.
---------------------------------------------------------------------------
The Prescription Traces
As explained above, the Government also introduced into
evidence twenty-five prescription traces which it contends show
that Mr. Street and Respondent repeatedly dispensed controlled
substances in violation of federal law. While noting that the
traces and the Government's expert testimony suggest that the
Government had "met its burden of proof,'' the ALJ then
concluded that "Respondent presented evidence that
demonstrated that Dr. Mulder and Dr. Ferrell did not have the
complete picture of the Respondent's dispensing practices from
the selected prescription traces.'' ALJ at 75. In support of her
conclusion, the ALJ specifically noted "Mr. Street's
credible testimony concerning his personal knowledge of his
customers, the actions he took to coordinate his dispensings
with the patients' health care providers,'' and the testimony of
Mr. Richards. Id. The ALJ thus rejected the entirety of the
Government's prescription trace evidence.
[[Page 382]]
While I agree that the Government failed to prove that
Respondent unlawfully dispensed control substances to a number
of the patients, in other instances the ALJ ignored relevant
evidence. More specifically, with respect to multiple patients,
the ALJ ignored clear evidence of doctor shopping for which Mr.
Street had no explanation. She also ignored several instances in
which Mr. Street's testimony failed to address the Government
experts' testimony, as well as instances in which his testimony
was inconsistent with other evidence.
As found above, either one or both of the Government's
experts concluded that Respondent did not violate its
corresponding responsibility in the dispensings it made to the
following patients: M.B. (GX 15-A); D.C. 2 (GX 15-C), D.E. &
J.E. (GX 15-E), B.R. (GX 15- O); W.B. (GX 15-P), R.S. (GX 15-S),
and W.T. (GX 15-W). Based on my findings with respect to J.S. (GX
15-T), I also conclude that the Government did not prove by a
preponderance of the evidence that Respondent unlawfully
dispensed controlled substances to him.
With respect to patient A.S., to whom Respondent dispensed a
total of 369 dosage units of combination hydrocodone/apap drugs
over a ten- and-a-half month period pursuant to prescriptions
issued by eight different prescribers, Dr. Mulder testified only
that "[i]t would have been appropriate for [Respondent] to
have notified'' the various physicians that it was receiving a
number of different prescriptions "for this narcotic so
that they could concentrate that in one place.'' Tr. 531. Dr.
Mulder did not testify that Respondent's failure to notify the
physicians was a breach of its corresponding responsibility.
Moreover, the ALJ credited Mr. Street's testimony that A.S. had
to switch her primary care physicians because they closed their
practices and had also gone to the emergency room. The
Government did not rebut this testimony. I therefore conclude
that Respondent's dispensings to A.S. did not violate federal
law.
With respect to patient B.W., Drs. Ferrell and Mulder
respectively concluded that Dr. Blackmon's hydrocodone/apap
(7.5/500) prescriptions were high and "exceeded safe
limits.'' Tr. 540. These dispensings averaged, however, only 170
tablets per month and less than six tablets per day and were
thus substantially under the four gram level at which
acetaminophen causes toxicity. Finally, the ALJ found credible
Mr. Street's testimony that he had verified the prescriptions
with Dr. Blackmon and the Government offered no evidence to
rebut his contention. I therefore conclude that Respondent's
dispensings to B.W. did not violate federal law.
Next, both patients D.C. (GX 15-B) and J.Y. (GX 15-Y)
received large numbers of prescriptions from Dr. Haws, a
dentist. As found above, on re-direct examination regarding J.Y.,
Dr. Mulder testified that "[t]here's obviously a finite
limit to how many teeth you can pull out.'' Tr. 563-64.
Continuing, Dr. Mulder testified that "the repetitive
prescription, month after month after month, it just seemed * *
* with that particular file, I--it probably--I couldn't state
that it violated standards. It just seemed a little unusual to
have that many sequential prescriptions from a dentist for the
same patient.'' Id. at 564.
Based on Dr. Mulder's testimony, I conclude that the
Government has not proved that Respondent violated federal law
in its dispensings to J.Y. Furthermore, because Respondent's
dispensings to D.C., fit the same pattern, I also conclude that
the Government has not proved that Respondent violated federal
law in its dispensings to D.C.
The evidence pertaining to the remaining patients does,
however, establish that Respondent repeatedly dispensed
controlled substances in violation of federal law. In
particular, the record shows that Respondent repeatedly filled
prescriptions presented by persons who were clearly engaged in
doctor shopping. Moreover, the evidence shows that Respondent
also filled prescriptions which could have been toxic if taken
in the prescribed amounts or were for drugs which were
contraindicated for the patient.
It is true that in some instances, Mr. Street testified that
he had contacted a patient's prescribers and that they were
"okay'' with the fact that the other doctor was also
prescribing. While the ALJ credited this dubious testimony, I
need not reject her credibility findings in toto to conclude
that the Government proved its case with respect to the
remaining patients because there were numerous dispensings for
which Mr. Street offered no explanation at all. Indeed, there is
even evidence that Respondent filled prescriptions which Mr.
Street himself acknowledged were outside of the course of the
practitioner's professional practice and did so after Mr. Street
claimed to have notified the prescriber that the prescriptions
for that drug were unlawful.
For example, Respondent repeatedly dispensed to Patient E.C.
alprazolam prescriptions issued by Dr. Hussain and diazepam
prescriptions issued by Dr. Slonaker. GX 15-D. In several
instances, the prescriptions were dispensed only days apart and
the Government's experts testified that these drugs "have a
synergistic effect'' when taken together, Tr. 297, and that
taking these drugs in combination could have devastating
effects. Id. 515. Moreover, Respondent also dispensed to E.C.
three prescriptions for hydrocodone/apap that were issued by Dr.
Hussain (who wrote two of the Rxs) and Dr. Wiles within a
four-day period; the first two of these prescriptions were
filled on consecutive days.
Mr. Street testified only as to why Respondent had also
filled the prescriptions which Dr. Slonaker simultaneously
issued for two combination hydrocodone/apap drugs. He offered no
testimony to explain why Respondent dispensed the hydrocodone
prescriptions issued by Drs. Hussain and Wiles and the
benzodiazepine prescriptions issued by Drs. Hussain and Slonaker.
I thus conclude that Respondent repeatedly violated federal law
in dispensing these prescriptions to E.C.
With respect to patient S.F., the Government's evidence
showed that Respondent simultaneously dispensed extraordinary
quantities of Lorcet, a combination hydrocodone/apap 10/650
drug, and Dilaudid, a schedule II controlled substance, based on
prescriptions which were written by Dr. Blackmon. More
specifically, Dr. Ferrell testified that S.F. was receiving
approximately 17 tablets a day of Lorcet and 12 tablets a day of
Dilaudid. Tr. 306. Dr. Ferrell further noted that S.F. was
"physically dependent'' on the drugs. Id. at 308. Moreover,
Respondent was dispensing Lorcet in amounts which, as Dr. Mulder
testified, clearly exceeded "acceptable limits'' and
"would be potentially toxic.'' \48\ Id. at 511. The trace
also showed that Respondent dispensed a prescription for
Buprenex, a drug which can cause acute withdrawal symptoms in
patients taking Dilaudid and other opiates. Tr. 307.
---------------------------------------------------------------------------
\48\ Although Dr. Mulder testified that the
dosages of hydrocodone/apap products was twice the acceptable
limits, when Respondent was dispensing an average of 17
tablets a day, the amount was nearly three times the
acceptable limit.
While there was testimony that patients can
develop a tolerance to opiates, see RX 5, at 5, Respondent
offered no evidence as to why it would be appropriate to
continue to prescribe combination hydrocodone drugs at this
level when other stronger opiates, which do not contain
acetaminophen, are available. In any event, I do not rely
solely on the quantity of the hydrocodone/apap prescriptions,
but rather on all the evidence related to S.F. in concluding
that Respondent should not have filled the prescriptions.
---------------------------------------------------------------------------
Mr. Street testified that he contacted Dr. Blackmon
frequently because S.F. "was always wanting his medications
[[Page 383]]
early,'' and was presenting prescriptions "too close
to'' the other prescriptions "he brought in.'' May 24, 2005
Tr. 85. He also asserted that Dr. Blackmon was "monitoring
him closely,'' and that Blackmon told him that S.F. needed large
amounts of narcotics to "function.'' Id. Mr. Street offered
no evidence to refute the testimony of Dr. Mulder--who is a pain
management specialist--that the level of drugs being prescribed
by Blackmon was potentially toxic. Consistent with the testimony
of Dr. Mulder that a pharmacist has an obligation "not to
dispense medication knowingly harmful to the patient,'' I
conclude that contacting Dr. Blackmon was not enough and that
Mr. Street had an affirmative obligation to refuse to dispense
these drugs to S.F.
The quantities of drugs which Dr. Blackmon was prescribing
were extraordinary, greatly exceeded acceptable levels of
acetaminophen, and were potentially toxic. Moreover, that S.F.
was "always wanting his medications early'' and presenting
prescriptions "too close to'' other prescriptions he had
brought in were telltale signs that he was either a drug abuser
or selling the drugs to others.
Dr. Blackmon's issuance of the Buprenex prescription provided
a further reason why Mr. Street should have questioned the
legitimacy of the prescriptions and stopped filling them. Mr.
Street justified dispensing this drug on the ground that "[t]he
only precaution regarding Buprenex and hydrocodone is that the
combination may increase drowsiness,'' May 24, 2005 Tr. at 87
(emphasis added). Mr. Street's testimony is false. As found
above, under the caption "Use in Narcotic-Dependent
Patients,'' the package insert clearly states that: "[b]ecause
of the narcotic antagonist activity of Buprenex, use in the
physically dependent individual may result in withdrawal
effects.'' Given the prescriptions Dr. Blackmon was writing and
S.F.'s conduct which indicated--as Dr. Ferrell observed--that he
was physically dependent, I conclude that Mr. Street had reason
to know that Dr. Blackmon was not writing prescriptions for
legitimate medical purposes. Respondent therefore violated
federal law by filling these prescriptions.\49\
---------------------------------------------------------------------------
\49\ Under the CSA, it does not matter
whether S.F. was physically dependent on the drugs or was
selling them on the street.
---------------------------------------------------------------------------
Patient B.J. obtained controlled-substance prescriptions
(which Respondent filled) from twenty-one different prescribers
for five different benzodiazepines, three different schedule III
narcotics (hydrocodone/apap, propoxyphene/apap, and Fiorinal
with codeine), Endocet, a schedule II drug, and Stadol. GX 15-G.
More specifically, the evidence showed that Respondent
repeatedly dispensed multiple prescriptions issued by Dr.
Greenwood for alprazolam and Dr. Varney for lorazepam for a
period of six months. The trace also showed that in multiple
instances, Respondent dispensed schedule III narcotics such as
Fiorinal with codeine and propoxyphene which were issued by
different doctors within the same timeframe. Id.
Mr. Street testified that he called both Dr. Varney and Dr.
Greenwood's practice group and that "[t]hey were both aware
they were both prescribing at the same time.'' May 24, 2005 Tr.
89. Mr. Street did not, however, testify as to why, between
March and October 1999, his pharmacy repeatedly filled
prescriptions for propoxyphene/apap, which were written by Dr.
Gastineau, and Fiorinal (butalbital) with codeine, which were
written by Dr. Varney. Here again, the evidence establishes that
Mr. Street and Respondent failed to comply with their
corresponding responsibility under federal law.
The evidence regarding W.L. showed that Dr. Blackmon
prescribed, and Respondent dispensed, 239 controlled substance
prescriptions in a fourteen-month period. In 1996, Respondent
made 163 dispensings (totaling 5,380 dosage units) of Buprenex,
thirty-one dispensings of hydrocodone/apap (totaling 2550 dosage
units), and twenty-two dispensings of diazepam (totaling 1530
dosage units). Furthermore, the Buprenex package insert warns
that "[p]articular care should be taken when Buprenex is
used in combination with central nervous system depressant
drugs,'' that "[p]atients receiving Buprenex in the
presence of other narcotic analgesics [and] benzodiazepines * *
* may exhibit increased CNS depression,'' and that "[w]hen
such combined therapy is contemplated, it is particularly
important that the dose of one or both agents be reduced.''
(emphasis added).
Blackmon did not, however, reduce the dosing of the Buprenex,
the hydrocodone, or the diazepam. Rather, he prescribed to W.L.
increasingly large amounts of the three drugs and Respondent
filled these prescriptions.
The ALJ credited Mr. Street's testimony that "the only
thing the package insert says about combining the two drugs of
respiratory problems when Diazepam is given with Buprenex'' and
that the physician should "proceed with caution if you're
going to administer the two drugs.'' ALJ at 43. Mr. Street's
testimony did not accurately reflect the entire scope of the
Buprenex warnings,\50\ which clearly showed that Blackmon's
prescriptions were improper.
---------------------------------------------------------------------------
\50\ I therefore also reject the ALJ's
credibility finding.
---------------------------------------------------------------------------
As the testimony established, a pharmacist is responsible for
knowing how a drug will interact with other drugs his patient is
taking. Tr. 280-81; see also Tennessee Bd. of Pharmacy R. 1140-
3.01(3)(a). I thus adopt Dr. Mulder's conclusion that the
prescriptions should not have been filled. Tr. 516. I further
conclude that Mr. Street and Respondent failed to comply with
their corresponding responsibility under federal law in the
dispensings to W.L.
The evidence regarding Angela L. showed that she had received
numerous prescriptions from a dentist, Michael Haws. While most
of the prescriptions were for combination hydrocodone/apap
drugs, on September 11, 1997, Respondent also dispensed a
prescription (which was also issued by Haws) for Tussionex
Pennkinetic Suspension, a combination of hydrocodone and
chlorpheniramine. Respondent also dispensed two refills of the
Tussionex to Angela L.
As found above, Respondent had previously made three
dispensings of large quantities of Tussionex (which again was
prescribed by Dr. Haws) to Rex L., who was Angela's spouse.
Regarding Respondent's dispensings of Tussionex to Rex L., Dr.
Ferrell testified that it is "unusual to see a dentist
write for cough syrup.'' Tr. 325. Responding to this testimony,
Mr. Street explained that "this was filled by a relief
pharmacist,'' and that when he "came back to work'' and
caught it, he then "alerted Dr. Haws to the fact that * * *
it's not within your usual course of practice to prescribe
Tussionex.'' May 24, 2005 Tr. at 93. Mr. Street then testified
that "he [Haws] ceased doing that[,]'' and "I've never
seen him do it again.'' Id.
While Mr. Street's testimony did not specify which of the
dispensings to Rex L. had prompted him to contact Dr. Haws, the
evidence clearly shows that Respondent dispensed Tussionex to
Angela L. pursuant to prescriptions issued by Dr. Haws on three
occasions after the dispensings it made to her husband. Based on
Mr. Street's testimony that prescribing Tussionex was outside of
the course of Dr. Haws's professional practice, I also conclude
that the Tussionex prescriptions which Haws wrote, and
Respondent filled for Angela L., were also outside of the
[[Page 384]]
course of his professional practice. Mr. Street offered no
explanation as to why his pharmacy filled these prescriptions. I
thus conclude that Mr. Street and Respondent violated federal
law in dispensing them.\51\
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\51\ I also reject the ALJ's finding that
Mr. Street credibly testified that following his phone call to
Dr. Haws, Respondent did not receive any more Tussionex
prescriptions that were issued by Dr. Haws.
---------------------------------------------------------------------------
Relatedly, the Tussionex prescriptions issued to Rex L. were
for very large quantities. As the evidence showed, on August 1,
1997, Respondent dispensed to Rex L. 720 ml. of this drug; three
days later, it dispensed to him another 360 ml. Moreover, on
August 29, 1997, Respondent dispensed to Rex L. another 720 ml.
of the drug. Dr. Ferrell testified that "the usual dosage''
of this drug "is 5 milliliters every 12 hours,''
(approximately 300 ml. for a thirty day period) and that he
could not "think of any reason why a prescription for'' 720
ml. would be necessary. Tr. 324-25.
Dr. Mulder also noted the evidence that Rex L. was engaged in
doctor shopping. As found above, between November 10, 1997 and
January 9, 1998, Respondent filled numerous prescriptions for
opiates which included Lorcet, Lortab, Tussionex, MS Contin, and
Dilaudid. The prescriptions were written by three different
doctors (Drs. Haws, Caudill, and Egidio), and most of them were
dispensed only days apart.
While the ALJ found credible Mr. Street's testimony that a
relief pharmacist filled the Tussionex prescription that was
issued by Dr. Haws, ALJ at 46, the evidence shows that
Respondent made a total of three dispensings of this drug
pursuant to prescriptions by Dr. Haws. Moreover, even if a
relief pharmacist made all three dispensings, Respondent is
still properly charged with violating its corresponding
responsibility. Moreover, Mr. Street did not testify as to why
his pharmacy filled the prescriptions that Rex L. presented for
opiates from Drs. Haws, Caudill, and Egidio. I thus conclude
that Mr. Street and Respondent violated their corresponding
responsibility in making these dispensings.
The evidence showed that K.P. (GX 15-K) received
prescriptions from more than two dozen prescribers which were
dispensed by Respondent. Most of the prescriptions were for
combination hydrocodone/apap drugs, although she also obtained
prescriptions for several other controlled substances. Between
April 20, 2001, and April 19, 2002, Respondent dispensed to K.P.
58 prescriptions for a total of 2,355 dosage units of
combination hydrocodone/apap drugs. Both Drs. Ferrrell and
Mulder concluded that K.P. was a doctor shopper.\52\
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\52\ This Agency is well familiar with
"doctor shopping.'' Expert testimony is not essential to
prove that a person engaged in it. Rather, "doctor
shopping'' can be proved based solely on documentary evidence.
---------------------------------------------------------------------------
The ALJ credited Mr. Street's testimony that K.P. had seen
five different primary care physicians either because the
physicians closed their practices or the State's Tenncare
program had moved her to a different physician. The ALJ also
credited Mr. Street's testimony that K.P. had seen neurosurgeons
who referred her to a pain management specialist (Dr. Smyth),
who also proceeded to prescribe narcotics for her, and that both
were "aware that they were prescribing them at the same
time.'' \53\ ALJ at 47 (citing May 24, 2005 Tr. 94). Finally,
the ALJ credited Mr. Street's testimony that K.P. had seen seven
emergency room doctors because of complications she had from
major surgeries.
---------------------------------------------------------------------------
\53\ The implication of Mr. Street's
testimony was that the doctors agreed that K.P. could receive
narcotics from multiple physicians in different practices.
K.P.'s pain management specialist was also Dr. Smyth, the same
doctor who Mr. Street, in testifying about P.P. (K.P.'s
husband), claimed had stopped writing prescriptions for
narcotics upon being notified by Mr. Street that he was also
receiving "pain meds'' from his primary care physician.
May 24, 2005 Tr. at 96.
---------------------------------------------------------------------------
Notably, two of the physicians K.P. obtained prescriptions
from were orthopedic surgeons (Drs. Beaver and J. Williams) and
Mr. Street offered no testimony that he had contacted them to
verify their prescriptions and make them aware that K.P. was
also obtaining prescriptions from Dr. Wiles (the neurosurgeon).
Nor did he testify that he contacted Dr. Wiles to inform him
that K.P. was obtaining prescriptions from Drs. Beaver and
Williams. Accordingly, I conclude that Mr. Street and Respondent
violated their corresponding responsibility under federal law in
dispensing to K.P.
Patient P.P. (GX 15-L), who was K.P.'s husband, obtained
prescriptions from eleven prescribers which were dispensed by
Respondent. The evidence showed that during the same period in
which it was dispensing hydrocodone/apap prescriptions written
by Dr. Lynch, it was also dispensing prescriptions for
hydrocodone/apap, propoxyphene/ apap, and codeine/apap which
were written by Dr. Wyche. The trace also showed that between
June 2001 and April 2002, Respondent dispensed to P.P.
prescriptions for hydrocodone/apap which she obtained from seven
different doctors.
In his testimony, Dr. Mulder concluded that Respondent had
failed to comply with its corresponding responsibility because
of the number of prescriptions that were being dispensed each
month, the dispensing of multiple narcotics at the same time,
and that multiple physicians were prescribing to P.P. Dr.
Ferrell also noted the prescribing by multiple physicians.
Finally, Dr. Mulder noted that K.P. and P.P. lived at the same
address and that it is "highly unusual'' for two family
members to have "medical problems that * * * required the
same level of prescribing within each * * * month.'' Tr. 524.
Mr. Street testified that P.P. was mainly seen by Drs. Tochev
and Tanner, who were his primary care physicians, and that Dr.
Tochev referred P.P. to a pain management group, which started
prescribing pain medications for him. Mr. Street further
testified that "we contacted'' the pain management group
and Dr. Tochev, and that "neither one * * * were [sic]
aware [that] the other one was prescribing.'' May 24, 2005 Tr.
at 96. Mr. Street added that "after we contacted them, pain
management cease[d] to write any more pain meds'' for P.P. Id.
As for the other evidence of doctor shopping, Mr. Street
explained that P.P. had seen dentists and emergency room doctors
a couple of times and that "if you knew the doctors in the
area like I do, it shouldn't present a problem.'' Id. Mr. Street
did not testify that his pharmacy called any of these other
prescribers and the fair inference to be drawn from this
testimony is that Mr. Street did not call either the dentists or
the emergency rooms before filling the prescriptions.\54\
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\54\ In rejecting the Government's evidence,
the ALJ also relied on Mr. Street's "knowledge of [his
customer's] medical history and treatments.'' ALJ at 74. While
acknowledging that "Mr. Street reviewed medical records
in preparation for this hearing,'' the ALJ credited his
testimony because it "demonstrated a more generic
knowledge of each patient's situation, [and] not a prompted,
detailed knowledge that would come from reviewing and
attempting to memorize patients' medical conditions.'' ALJ at
74 n.12. The ALJ thus concluded that Mr. Street's testimony
was "a credible rendition'' of what he knew about his
customers "at the time he dispensed the controlled
substances.'' Id.
Even assuming that Mr. Street would recall
the medical conditions of these twenty-five patients out of
the 17,000 patients he testified Respondent had, and crediting
Mr. Street's testimony, see May 24, 2005 Tr. 95, a
pharmacist's knowledge of a customer's medical conditions does
not excuse him from his duty to verify the legitimacy of
prescriptions when there is reason to suspect that the
customer is engaged in doctor shopping. Nor does it excuse a
pharmacist from his responsibility not to dispense drugs that
are either being prescribed in quantities which would be toxic
to the patient if taken as directed, or contraindicated
because of other drugs a patient is taking or the patient's
medical conditions.
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[[Page 385]]
Mr. Street offered no testimony as to why his pharmacy filled
(sometimes only days apart) the multiple narcotic prescriptions
that were issued by Drs. Lynch and Wyche during October and
November 1999. Moreover, his testimony that he contacted P.P.'s
pain management doctor (Dr. Smyth) to inform him that Dr. Tochev
was still prescribing and that Dr. Smyth stopped writing is not
consistent with the evidence. While Mr. Street did not specify
the date that he contacted Dr. Smyth, the evidence shows that
his pharmacy filled multiple prescriptions for hydrocodone/apap
drugs that were issued by both Drs. Smyth and Tochev between
February and April 2002. Indeed, the evidence shows that Dr.
Smyth issued, and Respondent filled, a prescription for
hydrocodone/ apap nearly six weeks after P.P. presented the
first prescription he obtained from Dr. Smyth, and only a week
after it had filled two additional prescriptions for the same
drug that were issued by Dr. Tochev. Moreover, three weeks
later, Respondent filled a prescription for methadone which was
also issued by Dr. Smyth.
In short, the evidence does not support Mr. Street's
testimony. Moreover, his statement to the effect that his
dispensings of prescriptions issued by dentists and emergency
room physicians should not present a problem if you know the
doctors "like I do,'' is a non- explanation. Even if a
pharmacist knows the practice specialty of a prescriber, he must
still verify the legitimacy of a prescription when a person is
repeatedly presenting prescriptions for the same drug from other
prescribers and doing so at frequent intervals. Consistent with
the testimony of Drs. Ferrell and Mulder, I thus conclude that
Mr. Street and Respondent violated their corresponding
responsibility under federal law in dispensing to P.P.
S.P. (GX 15-M) was another patient who presented
prescriptions from numerous providers. While most of the
testimony focused on narcotic prescriptions, the evidence also
showed that in numerous instances, Respondent dispensed to S.P.
temazepam prescriptions issued by Dr. Varney and clonazepam
prescriptions issued by Dr. Shah. In some instances, the
dispensings occurred only a day (or a couple of days) apart.
Both of these drugs are benzodiazepines, and as Dr. Mulder
testified, taking multiple benzodiazepines has a synergistic
effect and can be devastating to the patient.
Mr. Street offered no testimony regarding Respondent's
dispensings of these drugs. I therefore conclude that Mr. Street
did not contact either prescriber to verify the legitimacy of
the prescriptions and to inform them that S.P. was presenting
prescriptions from the other physician for another
benzodiazepine. Accordingly, I also conclude that Mr. Street and
Respondent did not comply with their corresponding
responsibility under federal law in dispensing these
prescriptions to S.P.
The evidence regarding patient J.P. (GX 15-N) showed that
Respondent was dispensing to her multiple opiates (Stadol,
Darvocet (propoxyphene/apap) and Tylenol 3 (codeine/apap)), as
well as benzodiazepines and schedule IV drugs such as
fenfluramine and phentermine based on prescriptions issued by
Dr. Varney. Moreover, for nearly a year, Respondent repeatedly
dispensed to J.P. hydrocodone/apap (for a total of 14 Rxs) that
were issued by Dr. Johnson at the same time that it was
dispensing the prescriptions issued by Dr. Varney.
Dr. Mulder noted that J.P. was receiving "seven
different addicting medications simultaneously,'' which included
"stimulants and depressants,'' and "analgesics and
anxiolytics.'' Tr. 527. Dr. Ferrell also noted that Darvocet and
Tylenol 3 provide "about the same'' level of pain relief
and did not understand why a physician would simultaneously
prescribe them. Id. at 336-38.
While Mr. Street testified that he called Dr. Varney
regarding his prescribing to J.P. and that there were legitimate
medical purposes for this regime, May 24, 2005 Tr. 99, Mr.
Street offered no evidence that refuted Dr. Ferrell's testimony
on the simultaneous prescribing of Darvocet and Tylenol 3.
Moreover, Mr. Street offered no testimony as to why Respondent
repeatedly dispensed the Darvocet and Tylenol 3 prescriptions
issued by Dr. Varney during the same period in which it also
dispensed the fourteen Lortab prescriptions that were issued by
Dr. Johnson.
I therefore conclude that Mr. Street and Respondent did not
verify the legitimacy of the Lortab prescriptions with Dr.
Johnson and inform him that J.P. was receiving multiple opiates.
I further conclude that Mr. Street and Respondent violated
federal law in dispensing the Lortab prescriptions to J.P. when
it was also dispensing the Darvocet and Tylenol 3 prescriptions
issued by Dr. Varney.
The evidence regarding R.S. (GX 15-R) showed that during
1999, Respondent dispensed to him 30 prescriptions for
alprazolam, 19 prescriptions for clonazepam, two prescriptions
for diazepam, and one prescription for lorazepam. Most
significantly, for approximately eight months, Respondent
dispensed prescriptions for 100 tablets of alprazolam which were
written by Dr. Lynch (R.S.'s primary care physician), while it
was also dispensing prescriptions for 60 tablets of alprazolam
which were written by Dr. Wiley (R.S.'s psychiatrist). Dr. Wiley
also prescribed clonazepam, another benzodiazepine, throughout
1999. Both Drs. Ferrell and Mulder found that Respondent's
dispensing of the drugs was a violation of its corresponding
responsibility.
Mr. Street's justification for the dispensings was that Dr.
Wiley had started prescribing the benzodiazepines, "namely
alprazolam for anxiety and clonazepam for depression,'' and that
"we called the doctor and he told me the reason he was
prescribing those.'' May 24, 2005 Tr. at 105. Mr. Street then
explained that "later on [R.S.'s] primary care doctor, Dr.
Lynch, started prescribing him alprazolam exclusively for
anxiety, but he continued to get the clonazepam from his mental
health doctor for the depression.'' Id.
Mr. Street's testimony suggests that after Dr. Lynch began
prescribing alprazolam, R.S. received only clonazepam from Dr.
Wiley. But as explained above, for approximately eight months,
Respondent repeatedly dispensed alprazolam to R.S. pursuant to
prescriptions written by both doctors and many of the
dispensings occurred only days apart. Mr. Street offered no
explanation for why his pharmacy did so. I thus conclude that
Mr. Street and Respondent violated federal law in dispensing the
alprazolam prescriptions to R.S.
The evidence shows that Respondent dispensed prescriptions
for W.T. (GX 15-V) that were written by fourteen different
prescribers for such drugs as alprazolam, Endocet 325, generic
oxycodone with acetaminophen, various strengths of hydrocodone/apap,
and propoxyphene-hcl. Most significantly, on a single day,
Respondent dispensed to W.T. two separate 300-count
prescriptions purportedly written by Dr. Donovan for schedule II
drugs containing oxycodone and acetaminophen, Endocet 325 and
generic oxycodone/apap 5/500. This, as Dr. Ferrell explained,
was "an unusual quantity.'' Tr. 357. Indeed, while Dr.
Donovan had previously prescribed these drugs to W.T., the
prescriptions had never exceeded 100 tablets and he had never
prescribed both drugs at the same time.
[[Page 386]]
Moreover, during the same period, Respondent was also
simultaneously dispensing propoxyphene prescriptions written by
Dr. Donovan. Finally, Respondent also dispensed three
prescriptions for Endocet 325 written by Dr. Haynes during the
same period in which it was dispensing Dr. Donovan's
prescriptions for drugs containing oxycodone. Dr. Haynes and
Donovan did not practice together.
While Mr. Street testified as to the various doctors that W.T.
had seen and her medical conditions, at no time did he state
that either he or his employees had contacted any of W.T's
doctors to verify the legitimacy of the prescriptions. See May
25, 2005 Tr. at 110. Mr. Street likewise offered no testimony as
to why Respondent dispensed 600 dosage units of oxycodone on a
single day or as to why Respondent filled prescriptions for
oxycodone that W.T. had presented from Drs. Donovan and Haynes
in the same time frame. I thus conclude that Mr. Street and
Respondent failed to comply with their corresponding
responsibility under federal law when they dispensed to W.T. 600
units of oxycodone on a single day and the oxycodone
prescriptions that were written by Drs. Haynes and Donovan
during the same period.\55\
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\55\ In light of the abundant evidence of
Respondent's unlawful dispensings, it is unnecessary to make
any legal conclusions regarding Respondent's dispensing to
Patient H.T, (GX 15-U), who received numerous prescriptions
for three different narcotic pain medicines from two
prescribers. The ALJ credited Mr. Street's testimony that he
had contacted each prescriber, that each was aware that the
other was prescribing as well, and that they both
"okayed'' H.T.'s receipt of the prescriptions.
Putting aside that Dr. Hartsell's statement
to Mr. Richards made no mention of Mr. Street ever having
called him to discuss the fact that H.T. was also presenting
prescriptions for hydrocodone/apap from another physician, May
24, 2005 Tr. at 20-21, the notion that a competent physician
would willingly continue to prescribe highly abused drugs
knowing that her patient was also receiving similar drugs from
another prescriber stretches the limits of plausibility. While
the Government's experts testified that the prescribing of
controlled substances should be coordinated between a
patient's physicians so that only one physician is
prescribing, neither definitively stated that it is a
violation of standards of medical practice for two physicians
to be doing so. See, e.g., Tr. 570.
---------------------------------------------------------------------------
Accordingly, having reviewed all of the evidence, I conclude
that in numerous instances, Respondent violated federal law in
dispensing controlled substances. In so holding, I acknowledge
that pharmacists do not practice medicine. But requiring a
pharmacist to identify doctor shopping does not require him to
practice medicine.
In his affidavit, Dr. Montgomery opined that the prescribing
physician "is the primary responsible party for drug
selection and quantity based upon the physician's assessment of
the patient.'' RX 5, at 6. While acknowledging--in his
words--that "[t]here are a few occasions when it would
appear that [Respondent] fell short of what I would consider
optimal pharmacy recognition of a potential drug abuser
profile,'' Dr. Montgomery then asserted that "the
physicians who prescribed the patients controlled substances
were more responsible for any abuse than the pharmacy filling
said prescriptions.'' Id.
Respondent's attempt to deflect responsibility for its
unlawful dispensings is unavailing. Under the Tennessee Board of
Pharmacy's Standards of Practice, a pharmacist is required to
review "a patient's record prior to dispensing each * * *
prescription order.'' GX 21, at 2 (Rule 1140-3.01(3)(a)). As
part of this review, the pharmacist is further required to
evaluate the prescription for, inter alia, "over-
utilization,'' "therapeutic duplication,'' "drug-drug
interactions,'' "incorrect drug dosage or duration of drug
treatment,'' and "clinical abuse/misuse.'' Id. Holding Mr.
Street and his pharmacy accountable for dispensing prescriptions
when there was reason to believe those prescriptions were not
issued for legitimate medical purposes (because those
prescriptions were contraindicated to other drugs a patient was
taking or the drugs were being prescribed in amounts that would
be potentially toxic if taken as directed) thus does no more
than require him to comply with the duties imposed on him as a
pharmacist under the State of Tennessee's regulations.
Contrary to Dr. Montgomery's opinion, this case is not simply
about a few dispensings which "fell short of * * * optimal
pharmacy recognition of a potential drug abuser.'' RX 5, at 6.
Rather, it is about the numerous instances in which Respondent
and Mr. Street unlawfully dispensed a controlled substance under
federal law by ignoring evidence which provided reason to
believe that the prescription was illegitimate. Bertolino, 55 FR
at 4730 (citations omitted). Accordingly, Mr. Street and
Respondent are responsible for the numerous unlawful dispensings
found above including those which were made to Dr. Watts.
Furthermore, many of the dispensings cannot be attributed to
mere oversight, but rather, are flagrant violations of federal
law because they involved repeated dispensings to persons who
were clearly engaged in doctor shopping and went on for months
on end. Moreover, the quantities and combinations of drugs
dispensed (including the interactions which would occur if the
drugs were actually taken) also support the conclusion that the
violations were flagrant. Accordingly, notwithstanding the
evidence that Respondent had 17,000 patients, May 24, 2005 Tr.
95, I conclude that Respondent's experience in dispensing
controlled substances warrants a finding that its continued
registration is inconsistent with the public interest.\56\ This
finding provides reason alone to revoke Respondent's
registration.
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\56\ The fundamental question under the CSA
is whether Respondent "has committed acts as would render
[its] registration inconsistent with the public interest.'' 21
U.S.C. Sec. 824(a)(4). No amount of legitimate dispensings
can render Respondent's flagrant violations "consistent
with the public interest.''
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Factor Four--Respondent's Compliance With Applicable Laws
As found above, Respondent repeatedly violated DEA
regulations and federal law in its dispensings of controlled
substances. That analysis is incorporated herein and will not be
repeated.
Respondent also failed to comply with federal law and DEA
regulations by failing to maintain "a complete and accurate
record of each [controlled] substance [it] received, sold,
delivered, or otherwise disposed of.'' 21
U.S.C. 827(a); see also 21
CFR 1304.21(a). While the ALJ credited Mr. Street's
testimony regarding the 1998 computer "crash,'' the fact
remains that significant discrepancies were found during each of
the three audits that were subsequently conducted. Moreover,
while Mr. Street challenged the accuracy of each of these audits
and presented his own figures, even his audits found that his
pharmacy had substantial shortages in multiple drugs.
For example, according to Mr. Street's December 1999 audit,
his pharmacy was short 800 tablets of generic hydrocodone/apap
5/500, 589 tablets of generic hydrocodone/apap 7.5/500, 380
tablets of Lortab 7.5/ 500, 485 tablets of acetaminophen with
codeine 300/60, 704 tablets of diazepam 10mg., 200 tablets of
Dilaudid (hydromorphone) 4 mg., and 193 tablets of generic
hydromorphone 4 mg. There were also numerous overages. These
discrepancies are especially noteworthy as the audit period used
Respondent's January 11, 1999 inventory as the beginning date
and covered only an eleventh-month period.
As for Mr. Street's assertion that the DEA audit was in error
because Respondent's diazepam dispensings were recorded on
multiple drug usage
[[Page 387]]
reports, under federal law it is Respondent's responsibility
to maintain accurate dispensing records. Respondent's failure to
do so further supports the conclusion that its recordkeeping is
not in compliance with federal law.
Mr. Street's April 2001 audit found shortages of 657 tablets
of generic hydrocodone/apap 10/500, 656 tablets of generic
hydrocodone/ apap 7.5/500, 171 tablets of generic hydrocodone/apap
5/500, and 196 tablets of Lortab 10. Respondent was also short
312 tablets of diazepam 5 mg. and 554 tablets of diazepam 10
mg., 166 tablets of acetaminophen with codeine 4, and 152
tablets of methadone 40 mg.
Finally, while the April 2002 audit involved only twelve
drugs and covered a period of a little more than a year, once
again even Mr. Street's figures showed substantial
discrepancies. More specifically, Respondent was short 498
tablets of diazepam 10 mg., 754 tablets of generic hydrocodone/apap
(7.5/500), and 910 tablets of generic hydrocodone/apap (10/500).
While the ALJ reasoned that these discrepancies "only
represented 2% of the Respondent's business,'' ALJ at 70, they
are nonetheless substantial and occurred at each of the three
audits. Moreover, having conducted his own audit following the
April 2001 DEA visit, Mr. Street was clearly aware that
Respondent had serious recordkeeping problems. Yet substantial
discrepancies were still found during the subsequent audit even
though only twelve drugs were audited. Moreover, at the hearing,
Mr. Street offered no evidence to show that he and Respondent
had taken corrective action to prevent similar discrepancies
from occurring in the future.\57\ I therefore also find that
Respondent's failure to maintain complete and accurate records
of its handling of controlled substances supports an adverse
finding under this factor. This factor thus further supports the
conclusion that Respondent's registration is "inconsistent
with the public interest.'' 21 U.S.C. 823(f).\58\
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\57\ I place no weight on the statements of
Mr. Pierce and Mr. Street that there was no deliberate
diversion of drugs. As found above, Mr. Pierce's affidavit
frequently did not even address the shortages that Mr.
Street's audits found. Moreover, Mr. Street did not testify
that he had investigated any of his employees to determine
whether they may have been diverting. Instead, he attributed
the discrepancies to human error. As for Mr. Street's
assertion that "if we could have audited both name brand
and generic'' versions of a drug, "they might have
balanced out there,'' May 24, 2005 Tr. 144, Mr. Street was not
prevented from doing exactly that in his own audits. Mr.
Street's testimony that the discrepancies are the result of
human error is as much speculation as his assertion that there
was no deliberate diversion. In fact, no one knows.
\58\ I acknowledge that the state board has
not taken any action against Mr. Street or Respondent and that
neither Mr. Street nor his pharmacy has been convicted of a
crime. My findings regarding Respondent's dispensing and
recordkeeping violations, however, greatly outweigh these
factors.
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Sanction
As found above, Respondent's numerous violations pertaining
to its dispensing practices and its failure to maintain complete
and accurate records establish a prima facie case that its
continued registration is "inconsistent with the public
interest'' and that its registration should therefore be
revoked. Id. Where the Government has made out its prima facie
case, the burden shifts to the Respondent to show why its
continued registration would nonetheless be consistent with the
public interest. See, e.g., Theodore Neujahr, 65 FR 5680, 5682
(2000); Service Pharmacy, Inc., 61 FR10791, 10795 (1996).
In discussing the appropriate sanction, the ALJ relied
largely on her conclusion that the Government had failed to
prove that Respondent had improperly dispensed controlled
substances. While the ALJ noted Mr. Street's "bothersome''
conduct in filling the prescriptions which Dr. Watts (the
veterinarian) wrote for his personal use, she further reasoned
that this conduct had occurred in 1996-97, and that "the
lack of any more recent evidence of similar carelessness,'' does
not now support revoking Respondent's registration. ALJ at 78.
Respondent's dispensing violations were not, however, limited
to what the ALJ found. Rather, the violations include numerous
instances in which it flagrantly violated federal law and
regulations by: (1) Dispensing controlled substances to persons
clearly engaged in doctor shopping, (2) dispensing controlled
substances which were contraindicated to other controlled
substances it was also dispensing to the same patient, (3)
dispensing controlled substances that were outside of the scope
of the prescriber's professional practice, and (4) dispensing
various controlled substances in quantities that clearly were
excessive and would, with respect to some of the drugs, be toxic
if they were taken as prescribed. Moreover, the record contains
evidence--specifically, the unlawful dispensings Respondent made
to K.P. and P.P.--which occurred shortly before this proceeding
was commenced.
In Respondent's favor, there is some evidence that Mr. Street
reported four forged prescriptions to the police.\59\ Respondent
did not, however, submit the actual reports that were filed and
the circumstances surrounding these incidents were not
established. Moreover, I conclude that the harm to public health
and safety caused by Respondent's unlawful dispensings was far
greater than the benefits that may have resulted from his
reporting of the fraudulent prescriptions.
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\59\ The ALJ also reasoned that "Mr.
Street's assistance to the DEA during its audit and his
provision to the DEA of all the information and documentation
it requested'' was "a factor to be weighed.'' ALJ at 70.
Mr. Street had, however, been served with a warrant prior to
each audit. See GXs 4, 6, 9, and 12. Mr. Street's assistance
during the audits is thus entitled to only slight weight.
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Most significantly, under Agency precedent, where the
Government has proved that a registrant has committed acts
inconsistent with the public interest, a registrant must
"'present[] sufficient mitigating evidence to assure the
Administrator that [it] can be entrusted with the responsibility
carried by such a registration.''' Samuel S. Jackson, 72 FR
23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932
(1988)). Moreover, because "past performance is the best
predictor of future performance,'' ALRA Labs., Inc., v. DEA, 54
F.3d 450, 452 (7th Cir. 1995), this Agency has repeatedly held
that where a registrant has committed acts inconsistent with the
public interest, the registrant must accept responsibility for
its actions and demonstrate that it will not engage in future
misconduct. See Jackson, 72 FR at 23853; John H. Kennedy, 71 FR
35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887
(1995). See also Hoxie v. DEA, 419 F.3d at 483 ("admitting
fault'' is "properly consider[ed]'' by DEA to be an
"important factor[]'' in the public interest
determination). Here, Respondent has not even acknowledged that
it has serious recordkeeping problems, let alone that it
committed numerous violations of federal law in dispensing
controlled substances. Relatedly, Respondent has presented no
evidence that it has reformed its shoddy recordkeeping practices
and its abysmal dispensing practices.\60\ Accordingly, it has
not rebutted the Government's prima facie showing that its
continued registration "is inconsistent with the public
interest.'' 21
U.S.C. 823(f). I therefore conclude that revocation of its
registration is essential to protect the public interest.
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\60\ As Respondent's own expert
acknowledged, its recognition of drug abusers "fell short
of * * * optimal.'' RX 5-6. Yet Respondent does not even admit
that it has a problem.
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[[Page 388]]
Order
Pursuant to the authority vested in me by 21
U.S.C. 823(f) & 824(a),
as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA
Certificate of Registration, BM3913781, issued to the Medicine
Shoppe-- Jonesborough, be, and it hereby is, revoked. I further
order that any pending application of Respondent for renewal or
modification of its registration be, and it hereby is, denied.
This order is effective February 1, 2008.
Dated: December 13, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-25342 Filed 12-31-07; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).