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\
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\26\ Some of the refills may have dispensed
in the first week of January of the next year.
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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 sa
