[Federal Register Volume 73, Number 1 (Wednesday, January 2, 2008)]
[Notices]
[Pages 364-388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25342]
[[Page 363]]
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Part V
Department of Justice
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Drug Enforcement Administration
Medicine Shoppe--Jonesborough; Revocation of Registration; Notice
Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 /
Notices
[[Page 364]]
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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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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.
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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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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