Morning Star Pharmacy & Medical Supply 1; Decision And Order
| Published date | 19 August 2020 |
| Citation | 85 FR 51045 |
| Record Number | 2020-18083 |
| Section | Notices |
| Court | Drug Enforcement Administration,Justice Department |
Federal Register, Volume 85 Issue 161 (Wednesday, August 19, 2020)
[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Pages 51045-51065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18083]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17-20]
Morning Star Pharmacy & Medical Supply 1; Decision And Order
The Drug Enforcement Administration (hereinafter, DEA or
Government) served Morning Star Pharmacy & Medical Supply 1
(hereinafter, Respondent Pharmacy) with an Order to Show Cause
(hereinafter, OSC) seeking to revoke DEA Certificate of Registration
Number FM 3950070 (hereinafter, registration). Administrative Law Judge
Exhibit (hereinafter, ALJX) 1 (OSC). In response to the OSC, Respondent
Pharmacy submitted a timely request for a hearing before Administrative
Law Judge (hereinafter, ALJ) Charles Wm. Dorman. ALJX 2. The hearing
was held in Dallas, Texas from July 17-19, 2017.
On October 31, 2017, the ALJ issued a Recommended Rulings, Findings
of Fact, Conclusions of Law, and Decision (hereinafter, ``Recommended
Decision'' or ``RD''), which recommended that I revoke Respondent
Pharmacy's registration and that I deny any pending application for
renewal or modification of Respondent Pharmacy's registration.
Respondent Pharmacy filed Exceptions to the Recommended Decision, and
the record was forwarded to me for final agency action.
Having considered the record in its entirety, including Respondent
Pharmacy's Exceptions, I agree with the RD that the record established,
by substantial evidence, that Respondent Pharmacy's continued
registration is inconsistent with the public interest. I further agree
with the RD that Respondent Pharmacy failed to accept responsibility
for its failures to meet the responsibilities of a registrant and that
Respondent Pharmacy did not present adequate evidence of mitigation or
remedial measures. Accordingly, I conclude that the appropriate
sanctions are (1) for Respondent Pharmacy's DEA registration to be
revoked; and (2) for any pending application by Respondent Pharmacy to
modify or renew its registration be denied.
I. ALLEGATIONS
The Government alleged that Respondent Pharmacy has violated
various federal and state laws related to controlled substances.
1. Ijeoma Amadi (hereinafter, Ms. Amadi) employed her husband, Dr.
Emmanuel Amadi (hereinafter, Dr. Amadi), as a pharmacist at Respondent
Pharmacy, in violation of 21 CFR 1301.76(a). Having surrendered two DEA
registrations, Dr. Amadi is ineligible for employment in a capacity
where he has access to controlled substances absent a waiver from the
DEA. ALJX 1, at 2. Though Ms. Amadi wrote to the DEA in July 2015 to
ask for a waiver, her request was denied and, by continuing to employ
Dr. Amadi at Respondent Pharmacy, Respondent Pharmacy remains in
ongoing violation of 21 CFR 1301.76(a).
2. Ms. Amadi also employed Dr. Amadi as a pharmacist at a second
pharmacy she owned, Morning Star Pharmacy located in Cedar Hill, Texas
(hereinafter, Cedar Hill), in violation of 21 CFR 1301.76(a). Id. at 2.
3. Between August 2014 and May 2015, pharmacists at Respondent
Pharmacy and Cedar Hill filled over 200 controlled substance
prescriptions outside the usual course of professional practice, in
violation of 21 CFR Sec. 1306.06, and in contravention of their
``corresponding responsibility'' under 21 CFR 1306.04(a). Id. at 2.
4. Between August 2014 and June 2015, pharmacists at Respondent
Pharmacy and Cedar Hill, including Dr. Amadi, failed to comply with the
above federal laws and were also in violation of the following federal
and state laws relating to controlled substances, 21 U.S.C. 823(f)(4);
Tex. Health & Safety Code Sec. 481.074(a); Tex. Health & Safety Code
Sec. 481.128; and 22 Tex. Admin. Code Sec. 291.33(c)(2).
Additionally, Respondent Pharmacy engaged in conduct that demonstrates
negative experience in its dispensing with respect to controlled
substances. Id. at 3-4 (citing 21 U.S.C. 823(f)(2)). Specifically, the
OSC alleged that Respondent Pharmacy filled prescriptions that lacked
required information and/or that contained two or more of the following
red flags, without resolving those red flags: (1) Prescriptions for
highly abused controlled substances such as hydrocodone,\1\ alprazolam,
promethazine with codeine, and carisoprodol; (2) prescriptions written
to individuals who travelled long distances and/or unusual routes to
obtain their prescriptions and fill them at Respondent Pharmacy or
Cedar Hill; (3) prescriptions from individuals obtaining the same or
similar combinations of controlled substances from the same small
number of providers; (4) prescriptions for highly abused drug
cocktails, such as hydrocodone and alprazolam, hydrocodone and
promethazine with codeine, and hydrocodone and carisoprodol; and (5)
prescriptions for controlled substances which were purchased with cash.
Respondent Pharmacy also failed to document specific information as
legally required on either the hard-copies of the prescriptions or in
the pharmacy's electronic patient profiles. Id. at 3-7.
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\1\ All of the referenced prescriptions for hydrocodone are
actually for hydrocodone/APAP, which is hydrocodone plus
acetaminophen.
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5. Respondent Pharmacy failed to provide an initial inventory of
controlled substances, in violation of 21 U.S.C. 827(a)(1) and 21 CFR
1304.11(b). Id. at 7.
6. Respondent Pharmacy failed to document the date it received
approximately 80 different shipments of controlled substances on its
invoices, in violation of 21 U.S.C. 827(a)(3) and 21 CFR 1304.21(d).
Id. at 7.
[[Page 51046]]
7. Respondent Pharmacy, as a purchaser of controlled substances,
failed to document the date and number of items received on four DEA
222 Order Forms, in violation of 21 U.S.C. 828(a) and 21 CFR
1305.05(a).\2\ Id. at 7.
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\2\ As discussed, infra III.B.3.b, the federal regulation that
the Government cited in support of this allegation is unrelated to
the requirement to document the date and number of items received on
a DEA 222 Form.
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8. Respondent Pharmacy, as a purchaser of controlled substances,
authorized one or more individuals to issue orders for controlled
substances on its behalf without executing a power of attorney for each
such individual, in violation of 21 CFR 1305.05(a). Id. at 7.
II. Findings of Fact
A. DEA Registration
Respondent Pharmacy is registered with the DEA as a retail pharmacy
authorized to handle controlled substances in schedules II-V under DEA
Registration number FM3950070 at 2700 W. Pleasant Run Road, Suite W250,
Lancaster, Texas 75146.
Respondent Pharmacy is owned by a corporation called COIF-SOE,
Inc., which in turn is owned by Ms. Amadi.\3\ RD, at 13. COIF-SOE, Inc.
also owned Cedar Hill, which was previously registered with the DEA as
a retail pharmacy authorized to handle controlled substances in
schedules II-V under DEA Registration No. FM3343960. Id. at 14. The
Cedar Hill registration was surrendered on June 16, 2015. Id. In
December 2015, Ms. Amadi changed the point of contact with the DEA for
Respondent Pharmacy from herself to Dr. Amadi. GX 17, at 1.
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\3\ Although the parties stipulated that COIF-SOE, Inc. is owned
by Ms. Amadi and Stephen Amadi, the documentary evidence does not
indicate that Stephen Amadi is an owner. See RD, at 13-14; GX 19, at
14; GX 12, at 1 (waiver application to DEA in which Ms. Amadi refers
to Respondent Pharmacy as ``my pharmacy''). However, whether COIF-
SOE is owned solely by Ms. Amadi or jointly by Ms. Amadi and Stephen
Amadi is irrelevant to my ultimate finding in this matter.
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B. Government's Case
The Government presented its case through the testimony of four
witnesses. First, the Government presented the testimony of a Diversion
Investigator (hereinafter, Investigator One) who also testified as a
rebuttal witness. Hearing Transcript (hereinafter, Tr.) 27-214, 754-59.
Investigator One has served as a Diversion Investigator with the DEA
for 18 years. Id. at 28-29. Investigator One testified about the DEA
investigation of Respondent Pharmacy and Cedar Hill, the inspections of
Respondent Pharmacy and Cedar Hill on June 16, 2015, id. at 32, 57, and
the audit she conducted of two controlled substances at Respondent
Pharmacy, id. at 116-22. Investigator One also testified concerning Dr.
Amadi's surrender of the DEA registration for Cedar Hill, id. at 98-
104, 205-06, 759, and Dr. Amadi's surrender of a DEA registration for
Bestaid Pharmacy in 2011, a pharmacy that Dr. Amadi owned, id. at 90-
92, 194-95, 754-58.
I agree with the ALJ's finding that Investigator One's testimony
was credible. RD, at 7.
The Government next presented the testimony of its expert, Amy
Witte, Pharm.D. (hereinafter, Dr. Witte). Tr. 215-99, 330-454, 725-53.
After Respondent Pharmacy's counsel conducted voir dire examination of
Dr. Witte, he stated that he had no objection to Dr. Witte's
qualifications. Id. at 227. Dr. Witte was then accepted as an
``[e]xpert in the field of pharmacy in the state of Texas.'' Id.
Dr. Witte presented testimony concerning what a pharmacist
practicing in Texas is required to do before filling a prescription for
a controlled substance. Id. at 227-29. In addition, she testified about
those circumstances that may give rise to a red flag, which a
pharmacist would need to resolve before filling a prescription for a
controlled substance. E.g., id. at 229-34, 242, 250. She also provided
testimony based upon her review of Government Exhibits 2-10, which were
copies of prescriptions and prescription fill labels from Respondent
Pharmacy and Cedar Hill and the patient profiles Respondent Pharmacy
produced in response to a Government subpoena, and the ``updated''
patient profiles Respondent Pharmacy provided before the hearing. Dr.
Witte rendered her opinion as to whether filling various prescriptions
in those exhibits fell below the minimum standard of practice of
pharmacy in Texas and whether filling those prescriptions was within
the usual course of professional practice of pharmacists in Texas. See,
e.g., Tr. 256-57.
The ALJ found Dr. Witte's testimony to be credible, RD, at 8, and I
agree.
The Government's third witness was another Diversion Investigator
(hereinafter, Investigator Two), who participated in the inspection of
Respondent Pharmacy and delivering the OSC to Respondent Pharmacy. Tr.
457-88. Investigator Two testified that she has been a Diversion
Investigator with the DEA for 12 years. Id. at 458. She testified about
the process of a registrant voluntarily surrendering a DEA
registration. Id. at 459-60. She also provided testimony concerning Dr.
Amadi's surrender of the Bestaid Pharmacy registration in 2011 and the
Cedar Hill registration in 2015, having witnessed both surrenders. Id.
at 459-68, 470-73, 478-88.
I agree with the ALJ's finding that Investigator Two's testimony
was credible. RD, at 8.
The Government's final witness was Emmanuel Amadi, Pharm.D
(hereinafter, Dr. Amadi). Dr. Amadi was also called as a witness by
Respondent Pharmacy. An assessment of his credibility is contained
under the discussion of Respondent Pharmacy's case.
C. Respondent Pharmacy's Case
Respondent Pharmacy presented its case through the testimony of two
witnesses. The first witness Respondent Pharmacy called was Dr. Amadi.
Tr. 490-632. Dr. Amadi received his pharmacy degree from Temple
University, and he has been a pharmacist since 2008. Id. at 492. Dr.
Amadi presented testimony about his background, education, and
employment. Id. at 492-98, 512, 518. Dr. Amadi also testified
concerning: His employment duties at Respondent Pharmacy; his
interaction with the DEA concerning his surrender of two pharmacy
registrations, Bestaid and Cedar Hill; his production of Respondent
Pharmacy's records in response to a DEA subpoena; and his resolution of
red flags associated with prescriptions that Respondent Pharmacy
filled. Id. at 512-22, 531-37, 564-69, 571-601, 606-09, 620-21. The ALJ
found, however, and I agree, that there were ``numerous aspects of Dr.
Amadi's testimony that stretched the limits of belief.'' RD, at 9.
In his Recommended Decision, the ALJ detailed a number of
credibility issues in Dr. Amadi's testimony that included internal
inconsistencies, inconsistencies with documented evidence, and
conflicts with the credible testimony of other witness.\4\ Having
reviewed the record, including the hearing transcripts, I agree with
the ALJ that Dr. Amadi's testimony was riddled with inconsistencies and
merits only limited belief. I adopt the ALJ's findings regarding Dr.
Amadi's credibility and summarize them here. RD, at 9-13.
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\4\ The ALJ noted that he detailed only ``a few of the examples
that could be given'' of Dr. Amadi's ``shifting testimony and [ ]
inconsistencies.'' RD, at 13.
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First, Dr. Amadi testified that he did not talk to Ms. Amadi, the
owner of Respondent Pharmacy and Cedar Hill, before he surrendered the
registration
[[Page 51047]]
for Cedar Hill,\5\ and that he did not even have the authority to
interact with the DEA concerning Cedar Hill. Tr. 512, 517. His
testimony stands in stark contrast to that of Investigator One, who
testified that Dr. Amadi called Ms. Amadi, and put Investigator One on
the phone to speak with Ms. Amadi, who told Investigator One that Dr.
Amadi ``could take care of anything regarding the pharmacy.'' Id. at
103. Unlike Dr. Amadi, Investigator One had no problem recalling that
Dr. Amadi contacted Ms. Amadi, id. at 102-03, and Investigator One's
testimony was further corroborated by Investigator Two, id. at 467-68,
484-85.
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\5\ Later, Dr. Amadi modified his testimony indicating that he
did not recall talking to Ms. Amadi on the day he surrendered the
registration for Cedar Hill. Tr. 609.
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Dr. Amadi also testified that although he was the pharmacist-in-
charge of Respondent Pharmacy, his duties were limited to ``do[ing] all
the paperwork and direct[ing] the affairs of the pharmacy.'' Id. at
518. He also testified that he did not fill any prescriptions for
controlled substances at Respondent Pharmacy. Id. at 519. He explained
that he simply entered information about those prescriptions in
Respondent Pharmacy's computer system for the pharmacist who had the
authority to fill the prescriptions. Id. Yet, Dr. Amadi testified
rather extensively about how he did the clinical review of the
prescriptions to determine whether the prescriptions should be filled
and how he resolved the red flags of the prescriptions that were
presented to Respondent Pharmacy. Id. at 521-22, 564-621. The ALJ gave
no credence to this testimony, and I agree. First, Dr. Amadi's
description of what he did as the pharmacist-in-charge of Respondent
Pharmacy is inconsistent with the duties of a pharmacist-in-charge. In
essence, Dr. Amadi testified that he was the pharmacist-in-charge,
except he really was not a pharmacist. It is the pharmacist's
responsibility to perform the clinical review and to resolve red flags
before the pharmacist fills a prescription for a controlled substance.
Dr. Amadi's testimony is also undercut by the documentary evidence. The
operational standards issued by the Texas State Board of Pharmacy
require the ``dispensing pharmacist'' to put his or her initials on the
prescription fill sticker. See 22 Tex. Admin. Code Sec.
291.33(c)(7)(A)(iv) (2020) (emphasis added).\6\ Dr. Amadi's initials
appear on the fill sticker on almost every prescription contained in
Government Exhibits 2-9. His signature also appears as the
``pharmacist'' on numerous hard-copy prescriptions that contained a
signature block for the pharmacist. See GX 4, at 4, 8, 10, 16; GX 6, at
2, 7, 10, 12; GX 7, at 17, 20, 21; GX 8, at 5, 14, 16, 20.\7\ Clearly,
Dr. Amadi was filling prescriptions for controlled substances at
Respondent Pharmacy.
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\6\ Throughout this Decision, I have cited to the administrative
compilation for the state of Texas current as of June 1, 2020.
Although I have cited to a contemporary compilation, the portions of
the Texas Administrative Code that I cite in this Decision were in
effect when the prescriptions at issue in this matter were dispensed
in 2014 and 2015 and have remained unchanged. See Texas Secretary of
State, Historical Listing for the Texas Administrative Code, http://www.texreg.sos.state.tx.us (last visited June 1, 2020).
\7\ Significantly, these exhibits stand in stark contrast to the
exhibits offered by Respondent Pharmacy. While Respondent Pharmacy
presented prescriptions that contained a signature block for a
pharmacist to sign, not a single one of these prescriptions is
signed. Tr. 601; RX A, at 55, 58, 68, 80, 82, 93, 105; RX C, at 2,
3; RX E, at 8; RX H, at 12; RX I, at 4. In fact, GX 4, at 4 and RX
C, at 2, are the same document, except that Dr. Amadi's signature is
only on the Government's Exhibit.
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Dr. Amadi testified that he would call a prescriber's office when a
patient presented a prescription with a red flag to Respondent
Pharmacy, Tr. 567, but his testimony on these matters contained a
number of inconsistencies. For example, for one of the subject
patients, Dr. Amadi testified that there were no red flags on the
prescriptions, yet he also testified that he called the prescriber. Id.
at 564-67. This testimony is inconsistent. If there were no red flags,
there would have been no reason to call the prescribing doctor. Dr.
Amadi was also equivocal on how he handled prescriptions for drug
cocktails, such as hydrocodone and alprazolam. He testified that
Respondent Pharmacy knew that prescriptions for drug cocktails had a
``potential for abuse,'' and therefore, Respondent Pharmacy was
``sure'' to contact the doctor before filling such prescriptions. Id.
at 571. However, almost immediately after providing that testimony, Dr.
Amadi stated that a prescription for alprazolam along with a
prescription for a opioid was ``not necessarily'' a red flag and that
he did not consider it to be a red flag if a person were to fill one of
those two prescriptions on one day and return the following day to fill
the other prescription. Id. at 571-72. Again, this represents an
inconsistency in his testimony. Dr. Amadi also testified that if a
patient lived outside of the local geographic area, he would question
the prescription, id. at 591, but this testimony was contradicted by
the documentary evidence, which displayed no indication that Dr. Amadi
investigated prescriptions presented by such individuals, see id. at
588-89, 612, 617; GX 4, at 4. Finally, Dr. Amadi's testimony regarding
how he investigated and documented the resolution of red flags
presented further inconsistencies, including testimony regarding
calling prescribers that was both internally inconsistent and
conflicted with documentary evidence. See Tr. 573-81; RX A, at 27. See
also, Tr. 620-21; RX A, at 1.
Dr. Amadi also provided an explanation for the differences in the
content of the patient profiles contained in the Government's Exhibits
with the content of the patient profiles contained in Respondent
Pharmacy's Exhibits. Tr. 531-33, 537. He testified that, although the
profiles in Respondent Pharmacy's Exhibits were not printed until May
25, 2017, the information was in the Respondent Pharmacy's computer
system prior to 2017. Id. at 530-33. When Dr. Amadi was asked why those
patient profiles were not produced to the DEA in 2016, Dr. Amadi
responded: ``Because I didn't know how to add this remark at the
beginning--at that time. I had to call for system support to--for them
to show me how to get this included in the printout.'' Id. at 533. The
ALJ found that this explanation lacked credibility because Dr. Amadi
had been using this same software program since the Respondent Pharmacy
opened in 2013. Id. at 521. I agree with the ALJ that Dr. Amadi's
explanation lacks credibility both for the reason cited by the ALJ, and
because at the hearing, Dr. Amadi was evasive in his responses to
questions regarding the ``updated'' profiles. Id. at 531-34, 537-39.
Based on the ALJ's findings regarding Dr. Amadi's credibility and
my own assessment of the record, I give Dr. Amadi's testimony limited
credence, and where it conflicts with the testimony of other witnesses,
or with the documentary evidence of record, I credit that other
testimony and those documents over Dr. Amadi's testimony.
The Respondent Pharmacy's second witness was Kenneth Emelonye,
Pharm.D. (hereinafter, Dr. Emelonye). Following voir dire by counsel
for the Government, Dr. Emelonye was accepted as an expert witness,
without objection, ``in the area of pharmacy.'' Id. at 647. In general,
his testimony was consistent with the testimony of the Government's
expert witness, Dr. Witte.
The ALJ found Dr. Emelonye to be a credible witness, and I agree.
RD, at 13.
D. Dr. Amadi's Employment at Respondent Pharmacy
Respondent Pharmacy employed Dr. Amadi as a staff pharmacist and as
a pharmacist-in-charge. RD, at 14. Dr.
[[Page 51048]]
Amadi was unsure of his exact dates of employment, Tr. 517-18, but
information on file with the Texas State Board of Pharmacy showed that,
as of November 17, 2015, Dr. Amadi was a staff pharmacist at Respondent
Pharmacy, and he was the pharmacist-in-charge of Respondent Pharmacy,
as of November 7, 2016. GX 18, at 1, 3. Dr. Amadi was also the
pharmacist-in-charge at Cedar Hill, the second pharmacy owned by Ms.
Amadi, Respondent Pharmacy's owner, until he surrendered the Cedar Hill
DEA registration in June of 2015. GX 16, at 1.
Prior to working at Respondent Pharmacy and Cedar Hill, Dr. Amadi
was the owner of Bestaid Pharmacy, DEA registration number FB2238067.
Tr. 496. Dr. Amadi voluntarily surrendered the DEA registration for
Bestaid Pharmacy on October 5, 2011, by signing a form stating that the
surrender was ``in view of [his] alleged failure to comply with the
Federal requirements pertaining to controlled substances . . . .'' GX
11. Investigator Two, who witnessed the surrender, testified that Dr.
Amadi surrendered the Bestaid resignation at the end of a hearing
following an Order to Show Cause the DEA had issued to Bestaid, but
prior to the final decision. See GX 11; Tr. 460-64. Because Dr. Amadi
has surrendered the Bestaid registration for cause, he was ineligible
for employment in a capacity where he had access to controlled
substances absent a waiver by the DEA.\8\ \9\ 21 CFR 1301.76(a). Ms.
Amadi applied to the DEA for a waiver to employ Dr. Amadi as a
pharmacist at Respondent Pharmacy with access to controlled substances
by a letter dated June 25, 2015. GX 12. The DEA denied the waiver
request on August 8, 2016. GX 13, at 1-5; RD, at 14.
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\8\ During the hearing, Respondent Pharmacy seemed to argue that
the surrender of the Bestaid registration was not for cause. 21 CFR
1301.76(a) defines ``for cause'' to include ``a surrender in lieu
of, or as a consequence of, any federal . . . administrative . . .
action resulting from an investigation of the individual's handling
of controlled substances.'' Because Dr. Amadi's surrender of his
Bestaid registration occurred at the conclusion of a hearing in
which he was responding to an OSC as to why the Bestaid registration
should not be revoked, I find that the surrender of the Bestaid
registration was for cause. See JM Pharmacy Grp., Inc., d/b/a/
Farmacia Nueva & Best Pharma Corp., 80 FR 28,667, 28,669 (2015)
(``[P]ersons of ordinary intelligence cannot dispute that a
surrender which occurs in response to allegations of misconduct
raised by the Agency's Special Agents and Diversion Investigators is
`for cause,' . . . .'').
\9\ The Government also argued that Dr. Amadi is ineligible
based on his surrender of the DEA registration for Cedar Hill.
Respondent Pharmacy disputes both the Government's factual and legal
basis for this claim. I find it unnecessary to resolve this issue in
this case, however, because 21 CFR 1301.76(a) clearly is applicable
to Dr. Amadi's surrender of the Bestaid registration.
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The ALJ found that Dr. Amadi had access to controlled substances
while employed at Respondent Pharmacy in spite of his ineligibility.
RD, at 59-60. Respondent Pharmacy objected to this finding. Resp
Exceptions, at 13. Respondent Pharmacy argued that Dr. Amadi did not
have access to controlled substances while working at Respondent
Pharmacy--that Dr. Amadi testified that his job at Respondent Pharmacy
``was to assist with the intake of new customer [sic], enter the
prescriptions into their internal computer system, prep the
prescriptions to be filled, contact the doctors [sic] offices to
determine the validity of the prescriptions, do the clinical review,
check the Texas patient monitoring system, and other trivial
responsibilities.'' Id. Respondent Pharmacy stated the only person with
access to controlled substances at Respondent Pharmacy was pharmacist
Kweku Ohene. Id.
I reject this Exception and give no weight to Dr. Amadi's testimony
that he did not have access to controlled substances at the Respondent
Pharmacy, as it is controverted by the documentary evidence and the
credible testimony of DEA investigators. First, as I have already
found, the documentary evidence establishes that Dr. Amadi was filling
prescriptions for controlled substances at Respondent Pharmacy. Supra
II.C. Additionally, Dr. Amadi ordered and received controlled
substances on behalf of Respondent Pharmacy. Tr. 62, 70. He was
Respondent Pharmacy's sole employee with access to the DEA's Controlled
Substances Ordering System (``CSOS'') for electronic ordering of
Respondent Pharmacy's schedule II controlled substances, id.; GX 28,
and he used CSOS to record the date on which schedule II drugs were
received by Respondent Pharmacy, Tr. 70-71.\10\ Dr. Amadi also signed
invoices for controlled substances for Respondent Pharmacy. Id. at 140-
41; GX 23, at 7-12, 15-22, 25, 27, 34-38. Investigator One credibly
testified that the person who signs and dates an invoice has access to
controlled substances because to retrieve the invoice, the person must
open the box, allowing access to the controlled substances inside the
box. Tr. 140-41. Finally, Investigator One observed Dr. Amadi working
behind the counter at Respondent Pharmacy on several occasions,
including after Respondent Pharmacy's waiver to allow Dr. Amadi access
to controlled substances had been denied. Id. at 72-73, 97-98. Based on
the foregoing, I agree with the ALJ and find that Dr. Amadi had access
to controlled substances while employed at Respondent Pharmacy.
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\10\ Dr. Amadi lacked the necessary power of attorney to order
schedule II controlled substances for Respondent Pharmacy. The
Controlled Substance Act designates the DEA registrant--in this
case, Ms. Amadi--as the individual authorized to order controlled
substances on behalf of a pharmacy. Tr. 61; see 21 U.S.C. 822(b).
The CSA allows the pharmacy owner to delegate the authority to order
schedule II controlled substances to someone else via a power of
attorney, 21 CFR 1305.05, but Respondent Pharmacy did not have any
powers of attorney on file, Tr. 62.
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E. The Investigation and Inspection of Respondent Pharmacy and Cedar
Hill
DEA conducted simultaneous inspections of Respondent Pharmacy and
Cedar Hill on June 16, 2015. During the inspections, the DEA
investigators gathered and otherwise requested various types of records
from the pharmacies.
1. Respondent Pharmacy's Records
a. Initial Inventory
During the June 16 inspection, Inspector One requested the initial
inventory of Respondent Pharmacy's controlled substances from Dr.
Amadi. Tr. 59-60. Dr. Amadi claimed the initial inventory existed but
that he could not locate it. Id. Investigator One made a second request
for the initial inventory on June 23, 2015. Id. at 60. Dr. Amadi
responded to Investigator One's request by stating that he ``didn't
look for it,'' and Investigator One testified that she never did
receive an initial inventory for Respondent Pharmacy. Id. at 60-61.
Respondent Pharmacy filed an Exception to the ALJ's finding that
Respondent Pharmacy failed to provide an initial inventory to the DEA.
Resp Exceptions, at 22-23. Respondent Pharmacy claimed that it had
included the initial inventory as ``Exhibit U'' in its exhibits for the
hearing in this matter. Id. I reject Respondent Pharmacy's Exception.
Respondent Pharmacy's claim that an initial inventory was included in
the record as Respondent's Exhibit U is incorrect. There is no
Respondent's Exhibit U in the record, and Respondent Pharmacy did not
provide a citation to the transcript showing that ``Exhibit U'' was
introduced at the hearing. See 21 CFR 1316.66(a) (requiring a party's
exceptions to include a statement of supporting reasons with evidence
of record including specific citations of the pages of the transcript).
I have reviewed the transcripts of the hearing and find Respondent
Pharmacy did not introduce an ``Exhibit U'' or any other exhibit
[[Page 51049]]
which it purported to be an initial inventory. I have also reviewed all
of Respondent's Exhibits that were introduced at the hearing, and there
is no initial inventory in any of Respondent Pharmacy's introduced
exhibits. Accordingly, I find that Respondent Pharmacy did not produce
an initial inventory.
b. 222 Forms and Invoices for Controlled Substances
During the inspection, Investigator One collected copies of records
related to Respondent Pharmacy's purchases of controlled substances,
including DEA Form 222s (hereinafter, 222 Form) and invoices.
Pharmacies use 222 Forms to purchase schedule II controlled substances
and must document the date and number of items received on the form
when they receive the purchased items from the supplier. 21 CFR
1305.13(e). The Government has alleged that four 222 Forms from
Respondent Pharmacy were not in compliance with DEA requirements,
because they did not document the date on which the controlled
substance/s were receive and the quantity received. Respondent Pharmacy
ordered multiple controlled substances on each of the four subject 222
Forms. GX 22, at 1, 2, 4, 6. On three of the four forms, Respondent
Pharmacy recorded the date and quantity received for all but one of the
controlled substances on the form. Id. at 1, 4, 6. On the fourth of the
222 Forms, Respondent Pharmacy failed to record the date or quantity
received for three controlled substances. Id. at 2.
Although the four subject 222 Forms were missing receipt dates for
at least one of the controlled substances ordered on each of forms, GX
22, at 1, 2, 4, 6, there is no evidence that Respondent Pharmacy
received those controlled substances. Investigator One testified that
there was no evidence ``in front of [the ALJ] that the Pharmacy
actually received those controlled substances.'' Tr. 211. There is, in
fact, evidence that Respondent Pharmacy did not receive some of the
controlled substances. Invoices from Respondent Pharmacy's supplier
show that some of the controlled items were never shipped. The chart
below illustrates the four subject 222 Forms and shipping information
from their corresponding invoices when available:
----------------------------------------------------------------------------------------------------------------
Date/ packages
Exhibits received Shipped/not shipped Evidence of receipt
----------------------------------------------------------------------------------------------------------------
GX 22, at 1, 8..................... Blank................. Hydrocodone: No.
Unknown.
GX 22, at 4, 11.................... Blank................. Hydromorphone: No.
Unknown.
GX 22, at 6, 13.................... Blank................. Hydrocodone 10/ No.
325: Not Shipped.
GX 22, at 2, 9..................... Blank................. Hydrocodone 10/325 No.
(500): Not Shipped.
Hydrocodone 10/325
(1000): Not Shipped.
Hydrocodone 5/325:
Shipped.
----------------------------------------------------------------------------------------------------------------
The Government has also alleged that Respondent Pharmacy failed to
record the date it received shipments of controlled substances on 47
invoices, representing approximately 80 different shipments of
controlled substances, that the Government gathered from Respondent
Pharmacy. ALJX 1, at 7. DEA regulations require pharmacies to record
the date they receive orders of controlled substances. 21 CFR
1304.21(d), 1304.22(c).
Respondent Pharmacy conceded that ``several of the invoices
provided to the Government did not include dates'' but argued that all
of the subject invoices complied with DEA regulations. Resp Exceptions,
at 23. I have reviewed the invoices, and while I reject Respondent
Pharmacy's assertion that all of the invoices fully complied with DEA
regulations, I do find that 16 of the 47 subject invoices were mis-
categorized. The 16 mis-categorized invoices were for schedule II
controlled substances. GX 22, at 3; GX 23, at 16, 33, 41, 43, 45, 47-
49, 51-55, 57, 82. In contrast to schedules III-V, pharmacies must
record the date they receive schedule II substances on either the 222
Form or in CSOS, whichever was used to order the drugs--pharmacies are
not required to also record the date of receipt for schedule II
substances on the invoice.\11\ 21 CFR 1305.13(e), 1305.22(g). However,
I find that on the 31 invoices for schedule III-IV controlled
substances Respondent Pharmacy did not record the date it received the
controlled substances that were shipped by the supplier as required by
DEA regulations.
---------------------------------------------------------------------------
\11\ Two of the mis-categorized invoices also indicate that the
supplier did not ship any of the controlled substances listed on the
invoice to Respondent Pharmacy. GX 23, at 33 and 52. Respondent
Pharmacy could not record the date it received the controlled
substances because the controlled substances were never received.
---------------------------------------------------------------------------
2. DEA Inventory and Audit
Investigator One testified that during the inspection of Respondent
Pharmacy, another Diversion Investigator conducted an inventory of
Respondent Pharmacy's oxycodone 30mg and hydrocodone 10/325. Tr. 117-
19. Dr. Amadi signed the investigator's closing inventory, documenting
his agreement with the count. Id. at 119; GX 21, at 2. Following the
inspection, and after obtaining Respondent Pharmacy's records,
Inspector One conducted an audit of the two drugs the DEA had
inventoried, finding that Respondent Pharmacy had an overage of 16,731
tablets of hydrocodone 10/325 and a 200 tablet shortage of oxycodone
30mg.\12\ Tr. 116-22; GX 21, at 1. Investigator One testified that she
compared invoices she obtained from one of Respondent Pharmacy's
suppliers and found that Respondent Pharmacy was missing records for
purchases of controlled substances. Tr. 165-67. She believed that the
hydrocodone 10/325 overage she found in her audit could be attributed
to the missing purchase records. Id. In regard to the oxycodone 30mg
shortage, Investigator One testified that she had no evidence that
Respondent Pharmacy actually received the missing 200 tablets. Id. at
210.
---------------------------------------------------------------------------
\12\ An overage indicates that a pharmacy sold more drugs than
it had in inventory--an impossibility that is attributable to
recordkeeping or computation errors; a shortage indicates a pharmacy
could not account for all drugs that it had purchased. See Tr. 117,
121. Because Respondent Pharmacy did not provide an initial
inventory, Inspector One testified that she began her audit from the
time Respondent Pharmacy opened using the assumption that the
initial inventory count was zero. Id. at 121-22.
---------------------------------------------------------------------------
F. The Subject Prescriptions
During the inspections of Respondent Pharmacy and Cedar Hill, the
DEA Investigators also collected records for prescriptions, which the
Government alleged were filled despite containing ``one or more
unresolved red flags for diversion.'' Govt Posthearing, at 30. The
first set of prescriptions, Government Exhibits 2-9, were obtained
during the inspection of Respondent Pharmacy.
[[Page 51050]]
The second set, Government Exhibit 10, was obtained from Cedar Hill and
includes nearly 100 prescriptions all issued by a physician in Houston,
Texas, Dr. R.G.
On August 18, 2016, following the inspection, the DEA subpoenaed
Respondent Pharmacy for the patient profiles (or any other records that
Respondent Pharmacy maintained on the patients pursuant to state law)
for the 31 patients whose prescriptions were collected from Respondent
Pharmacy and included in Government Exhibits 2-9. GX 27; Tr. 74-79. The
DEA subpoena specifically requested ``a copy of the complete patient
profile record or any other patient record (paper or electronic) that
[the] pharmacy maintained [for the 31 subject patients], pursuant to
the requirements of Texas Administrative Code Title 22 Sec.
291.33(c)(2)(A) & (C) Operational Standards.'' GX 27, at 1. The
subpoena further clarified that the response should include any and all
``[p]harmacist comments relevant to the individuals [sic] drug therapy,
including any other information peculiar to the specific patient or
drug as well as any consultation with the prescribing practitioner . .
. .'' Id. Respondent Pharmacy responded to that subpoena through its
counsel in October 2017, nearly a month after a response was due, with
records containing all of the requested profiles. See id. at 6-52. A
review of the patient profiles Respondent Pharmacy provided reveals
that none of the profiles contain any pharmacist remarks regarding
consultations with prescribing practitioners. See id. Respondent
Pharmacy provided no other records in response to the August 18
subpoena.
On June 27, 2017, less than three weeks before the hearing on the
OSC, Respondent Pharmacy filed a complete set of ``Amended Exhibits.''
ALJX 21. These exhibits included patient profiles (hereinafter,
Respondent's profiles) that contained additional information that was
not in the profiles provided to the DEA in October 2016. The
Respondent's profiles contain the patient's address, phone number, date
of birth, allergies, and a remarks section with comments. See RX A-J.
None of the comments in the remarks section of the Respondent's
profiles contain a date indicating when the comment was added to the
profile, and there are no other dates on the Respondent's profiles that
provide documentary support that the additional information in the
profiles was in the records at the time of the Government subpoena. See
id.
The ALJ wrote in the RD that, although he would discuss the
Respondent's profiles when considering the Government's allegations
against Respondent Pharmacy, he would give no weight to any of the
information contained therein that was not contained in the patient
profiles Respondent Pharmacy provided in response to the DEA subpoena
in October 2016. RD, at 52. The ALJ decided not to give any weight to
the information in Respondent's profiles, because (1) per the subpoena,
Respondent Pharmacy was required to provide the information to the DEA
by September 7, 2016; (2) Respondent Pharmacy did not produce the
information until shortly before the hearing; (3) all of Respondent's
profiles have a date range that runs until at least May 2017, more than
eight months after Respondent Pharmacy was supposed to have produced
the documents ordered by the DEA subpoena; (4) the ALJ did not find Dr.
Amadi's testimony credible that he did not know how to print off the
remarks section of the patient profiles in October 2016; and (5) the
comments in the remarks section of the Respondent's profiles do not
contain any dates that establish that the remarks were entered into the
profile contemporaneously with Respondent Pharmacy filling the
prescriptions involved with this matter. RD, at 52-53.
Respondent Pharmacy has objected to the ALJ's decision to give no
weight to Respondent's profiles. Resp Exceptions, at 14. Respondent
Pharmacy acknowledges that Respondent's profiles contain information
that was not provided to the DEA in October 2016, but it argues that
the DEA subpoena did not specify the exact information it was seeking
in its request. Id. Respondent Pharmacy further explained that when
printing the profiles for the DEA in October 2016, Dr. Amadi ``did not
check the box to include the patient remarks to be outputted,'' and
after receiving the Government's Prehearing Statement, Dr. Amadi
``contacted tech support to help him print out the client profiles with
the remarks section included.'' Id. at 14-15.
Having considered Respondent Pharmacy's arguments, I agree with the
ALJ that Respondent's profiles deserve no weight. Contrary to
Respondent Pharmacy's assertions, the DEA subpoena clearly specified
the exact information it was requesting from Respondent Pharmacy--all
of which was information Respondent Pharmacy was legally required to
maintain pursuant to the Texas Operational Standards for Community
Pharmacies--and further highlighted that the subpoena was requesting
all documentation of the pharmacists' consultations with prescribing
physicians. GX 27, at 1; see 22 Tex. Admin. Code Sec. 291.33(c)(2).
This information was clearly missing from the patient profiles
Respondent Pharmacy provided in response to the subpoena. See GX 27, at
13-40, 49-52. If Respondent Pharmacy needed to contact tech support to
learn how to print the requested information, the time to do that was
when responding to the subpoena, not three weeks before the hearing. I
further agree with the ALJ that Dr. Amadi's testimony regarding the
patient profiles is not credible. RD, at 52-53. Dr. Amadi testified
that the pharmacist's remarks from Respondent's profiles were
contemporaneous documentation, but none of the remarks contain dates or
other evidence that establish the remarks were entered into the
profiles contemporaneously with the time Respondent Pharmacy filled the
prescriptions, a requirement under Texas law. 22 Tex. Admin. Code Sec.
291.33(c)(2)(i). See, e.g., RX A; RX B, at 7; RX C, at 1; RX E, at 7;
RX H, at 4. Finally, as I will explain in detail below, even had
Respondent's profiles been credible, the remarks on the profiles were
insufficient to meet the minimum requirements set forth by Texas law.
1. Texas Pharmacists' Standard of Practice
Dr. Witte, the Government's expert witness, and Dr. Emelonye, the
Respondent Pharmacy's expert witness, testified about a Texas
pharmacy's/pharmacist's standard of practice and how pharmacists apply
federal and state law when presented with a prescription for a
controlled substance. Dr. Witte's testimony was largely uncontroverted
or supported by Dr. Emelonye's testimony. As will be discussed infra,
Dr. Emelonye's testimony did have minor disagreements with Dr. Witte's
testimony in regard to whether particular circumstances presented a red
flag on a controlled substance prescription.
When presented with a prescription, a Texas pharmacist must first
look over the prescription to ensure it meets all of the requirements
of Texas and federal law. Tr. 228. The pharmacist must check the
prescription has the patient's name, address, date of birth, the
physician's signature and DEA number; the drug name and strength; the
quantity; and instructions for use. Id. at 228, 242, 647; Tex. Health &
Safety Code Ann. Sec. 481.074(k)(3), (7) (West 2019) (mandating that a
``prescription for a controlled substance'' must show ``the name,
address, and date of birth or age of the patient'' as well as the
``Federal
[[Page 51051]]
Drug Enforcement Administration number'' of the practitioner issuing
the prescription). If a prescription is missing the patient's address
and date of birth, the pharmacist should contact the prescriber for the
missing information. Tr. 424-26. Alternatively, if the prescription was
missing only the address, the pharmacist could check the name and the
patient's date of birth against a valid government identification to
obtain the patient's address.\13\ Id. at 424-27, 650. Once the
pharmacist verifies the patient's information, the pharmacist should
fill in the required information on the prescription and only then
dispense the controlled substance. Id. at 335, 424-27.
---------------------------------------------------------------------------
\13\ Dr. Witte testified that a pharmacist should always call
the prescriber if the prescription is missing the address and date
of birth because many people share the same name. Tr. 425.
---------------------------------------------------------------------------
The pharmacist must also review the prescription for red flags--any
issue that calls into question a prescription's legitimacy. Id. at 228.
If the prescription has a red flag, the pharmacist must investigate and
resolve the red flag before dispensing the prescription. The
investigation would include steps such as interviewing the patient,
speaking with the prescriber, and reviewing the Texas Prescription
Monitoring Program. Id. at 228-29, 233-34, 675. The pharmacist should
refuse to fill a prescription if he or she is unable to resolve a red
flag on the prescription. Id. at 233-34. Filling a prescription without
resolving a red flag would fall outside the minimal standard of
practice of pharmacy in the state of Texas. Id. at 235.
These standards of practice are broadly codified in Texas law,
which provides that ``[a] pharmacist may not: (1) Dispense . . . a
controlled substance . . . except under a valid prescription and in the
course of professional practice.'' Tex. Health & Safety Code Ann. Sec.
481.074(a). Texas law further provides that ``[a] pharmacist may not:
(2) Dispense a controlled substance if the pharmacist knows or should
have known that the prescription was issued without a valid patient-
practitioner relationship.'' Id. It is also unlawful in Texas for any
``registrant or dispenser'' to deliver a controlled substance in
violation of section 481.074 of the Texas Health and Safety Code. Id.
at Sec. 481.128. A Texas pharmacist is expected to ``exercise sound
professional judgment with respect to'' determining if a prescription
was issued for a legitimate medical purpose by a practitioner in the
course of medical practice. 22 Tex. Admin. Code Sec. 291.29(a), (b)
(2020).
In addition to the Texas statutes, the Texas Board of Pharmacy has
issued rules for the operational standards that Texas pharmacists are
expected to follow when filling a new or refill prescription. Those
operational standards dictate that:
[f]or the purpose of promoting therapeutic appropriateness, a
pharmacist shall, prior to or at the time of dispensing a
prescription drug order, review a patient's medication record. Such
review shall at a minimum identify clinically significant: . . .
(III) reasonable dose and route of administration; (IV) drug-drug
interactions; . . . [and] (X) proper utilization, including
overutilization and underutilization.
22 Tex. Admin. Code Sec. 291.33(c)(2)(A)(i).
The operational standards also mandate that ``[u]pon identifying
any clinically significant conditions, [or] situations . . . the
pharmacist shall take appropriate steps to avoid or resolve the problem
including consultation with the prescribing practitioner.'' Id. at
291.33(c)(2)(A)(ii). Furthermore, ``[p]rior to dispensing, any
questions regarding a prescription drug order must be resolved with the
prescriber and written documentation of these discussions made and
maintained.'' Id. at Sec. 291.33(c)(2)(A)(iv).
If the pharmacist fills the prescription, the pharmacist is obliged
to document the results of his investigation in the electronic patient
notes or on the prescription and the documentation should always be
contemporaneous. Tr. 234; see 22 Tex. Admin, Code Sec. 291.33(c)(2)(C)
(requiring pharmacists to document discussions with the prescriber
concerning red flags either ``on the prescription or in the pharmacy's
data processing system''). While Texas law does not dictate the amount
of detail and specificity a pharmacist's note must include to
adequately resolve a red flag, Tr. 738, Texas operational standards
state the documentation, at a minimum, must include ``(i) date the
prescriber was consulted; (ii) name of the person communicating the
prescriber's instructions; (iii) any applicable information pertaining
to the consultation; and (iv) initials . . . of the pharmacist . . .
clearly recorded for the purpose of identifying the pharmacist who
performed the consultation,'' 22 Tex. Admin. Code Sec.
291.33(c)(2)(C). These notes are used upon a patient's return to the
pharmacy to demonstrate to the pharmacist or to the next pharmacist
that the red flags have been investigated and resolved. Tr. 723, 738,
743.
Drs. Witte and Emelonye testified regarding some of the red flags
that a Texas pharmacist is expected to recognize and resolve before
filling a prescription for a controlled substance. The Texas State
Board of Pharmacy also has non-exhaustive, codified lists of
circumstances and red flags that a pharmacist must weigh when
evaluating a prescription's legitimacy. 22 Tex. Admin. Code Sec.
291.29(c), (f). Dr. Witte explained that there is no exhaustive list of
every red flag of diversion and no specific number of red flags trigger
a pharmacist's obligation to refuse to fill a prescriptions. Rather,
pharmacists are expected to exercise judgment in detecting and
responding to red flags. Tr. 234, 288. Dr. Witte's testimony on this
matter is supported by Texas regulations, which require pharmacists to
use their professional judgment to determine if a prescription was
issued for a legitimate medical purpose. See 22 Tex. Admin. Code Sec.
291.29(a), (b).
Dr. Witte first explained the concept of high-alert drugs. High-
alert drugs are referred to as such because they are highly abused
controlled substances. Tr. 229-30. Hydrocodone, oxycodone, alprazolam,
and promethazine with codeine are high-alert drugs. Id. at 229. A
prescription consisting of some combination of high alert drugs is
referred to as a ``drug cocktail'' and is a red flag. Id. at 229-32,
352-53; see 22 Tex. Admin. Code Sec. 291.29(f)(3). A drug cocktail
will generally include a narcotic, such as hydrocodone or oxycodone,
along with alprazolam, carisoprodol, or promethazine with codeine. Tr.
229-31, 251, 282, 352.
Travelling a long distance or an unusual route from the patient's
home to see a particular physician and then to fill the prescription is
also a red flag. Id. at 231-32, 400; 22 Tex. Admin. Code Sec.
291.29(c)(4) (reasons to suspect a prescription is not legitimate
include ``the geographical distance between the practitioner and the
patient or between the pharmacy and the patient''). Dr. Witte testified
that the distance a patient travels to obtain and fill a prescription
can, by itself, be sufficient reason for a pharmacist to decline to
fill a prescription, while Dr. Emelonye minimized the significance of
distance, testifying that distance alone would not be sufficient to
raise his concern. Tr. 671-74. Dr. Emelonye agreed with Dr. Witte,
however, that a pharmacist should investigate why an out-of-town
patient was at a pharmacy to fill a prescription for a controlled
substance. Id. at 400, 671-72, 718-19. To the extent Dr. Witte and Dr.
Emelonye's testimony on this matter differ, I credit Dr. Witte's
testimony as it is consistent with 22
[[Page 51052]]
Tex. Admin. Code Sec. 291.29(c)(4), which states that distance is a
red flag.\14\
---------------------------------------------------------------------------
\14\ The experts' disagreement on this matter was also
inconsequential to this matter, as I found that all of the subject
prescriptions had multiple red flags. Infra II.F.2.
---------------------------------------------------------------------------
Paying cash for a prescription can be a red flag. Tr. 232, 387; 22
Tex. Admin. Code Sec. 291.29(f)(12). A cash payment for a
prescription, in isolation, may be not a great concern to a pharmacist
as some patients do not have insurance. Tr. 659. When a cash payment,
however, is coupled with other issues, then the cash payment is a
concern. Id.
Prescriptions from individuals obtaining the same or similar
combinations of controlled substances from the same prescriber is a red
flag commonly referred to as ``pattern prescribing.'' Id. at 228-29,
232-33, 353. Pattern prescribing can take several forms including when
prescriptions by a prescriber are routinely for controlled substances
commonly known to be abused drugs, 22 Tex. Admin. Code Sec.
291.29(f)(3); prescribers that commonly write prescriptions for the
highest strength and/or for large quantities of controlled substances,
id. at (f)(5); and prescriptions from a prescriber that display a
reasonably discernable pattern of substantially identical prescriptions
for controlled substances for numerous persons, indicating a lack of
individual drug therapy, id. at (f)(1). Unlike some red flags, such as
drug cocktails and cash payments, pattern prescribing can manifest over
an extended period of time and may not be immediately recognizable to a
pharmacist. See Tr. 439, 449.
Other relevant red flags identified by Drs. Witte and Emelonye and/
or codified in the Texas Administrative Code include, doctor shopping,
when a patient receives prescriptions for controlled substances from
different doctors, Tr. 678, 728; 22 Tex. Admin Code Sec. 291.29(c)(7);
pharmacy shopping, when a patient is using multiple pharmacies to fill
prescriptions for controlled substances, 22 Tex. Admin. Code Sec.
291.29(c)(7); Tr. 656; inappropriate dosing instructions, Tr. 664; and
prescriptions for multiple drugs in the same class, such as multiple
narcotics, id. at 234, 440-42.
2. Alleged Red Flags on the Subject Prescriptions
The Government has alleged that the subject prescriptions from
Respondent Pharmacy and Cedar Hill all presented two or more red flags
and that Respondent Pharmacy and Cedar Hill filled the prescriptions
without resolving the red flags. The Government alleged that by filling
prescriptions with these red flags without properly investigating,
documenting, and resolving the red flags, Respondent Pharmacy and Cedar
Hill fell below the minimum standards of the practice of pharmacy in
Texas and were outside the usual course of professional practice of a
pharmacy in Texas.
a. Prescriptions Issued by Dr. T.T.
From August 2014 to March 2015, Respondent Pharmacy filled
prescriptions issued by Dr. T.T. GX 4; GX 5, at 13-15; GX 6, at 1-15;
GX 7, at 16-29; GX 8, at 11-22. The Government alleged that the Dr.
T.T. prescriptions had red flags including cash payments, distance,
drug cocktails, and inappropriate dosing; and that, taken together, the
Dr. T.T. prescriptions evince the red flag of pattern prescribing. ALJX
1, at 4-6. The Government further alleged that Respondent Pharmacy
filled the prescriptions with red flags from Dr. T.T. without
investigation, documentation, or resolution of the alleged red flags.
Id.
To support these allegations, the Government submitted
prescriptions written by Dr. T.T. and Respondent Pharmacy's patient
profiles for five patients: H.P., V.S., R.J., M.H., and K.L. GX 4; GX
5, at 13-15; GX 6, at 1-15; GX 7, at 16-29; GX 8, at 11-22. Dr. Witte
testified that the prescriptions showed red flags. First, Dr. T.T.
prescribed all five patients red flag drug cocktails of high-alert
controlled substances. See GX 4; GX 5, at 13-15; GX 6, at 1-15; GX 7,
at 16-29; GX 8, at 11-22. As part of the drug cocktails, all five
patients were prescribed large quantities of hydrocodone, another red
flag. GX 4; GX 5, at 13-15; GX 6, at 1-15; GX 7, at 16-29; GX 8, at 11-
22; see Tr. 419-20. All of the prescriptions were also paid for in
cash. See GX 4; GX 5, at 13-15; GX 6, at 1-15; GX 7, at 16-29; GX 8, at
11-22.
Dr. Witte also testified that the prescriptions from Dr. T.T.
displayed pattern prescribing. Tr. 265, 353. Dr. Witte observed that
Dr. T.T. repeatedly prescribed cocktails containing combinations of
hydrocodone, alprazolam, and promethazine with codeine, and all of Dr.
T.T.'s prescriptions for hydrocodone had been for 120 tablets. Id. at
419-20. Dr. Witte also highlighted that Dr. T.T. prescribed
promethazine with codeine for a cough over several months. Id. at 340-
41. In her expert opinion, Dr. Witte would not expect a patient to need
a cough syrup month after month. Id. Dr. Witte also testified that the
Dr. T.T. prescriptions for promethazine with codeine were written for a
suboptimal dose,\15\ another red flag. See id. at 233, 392-95; see also
id. at 664-65 (Dr. Emelonye testifying that the dose was suboptimal and
that he would call the prescriber if presented with a promethazine with
codeine prescription with those dosing instructions.). Dr. Witte also
pointed out that many of Dr. T.T.'s prescriptions included the same
diagnosis, providing further evidence of an illegitimate pattern. Id.
at 264-65, 279.
---------------------------------------------------------------------------
\15\ Both Dr. Witte and Dr. Emelonye testified that the standard
dosing instruction for promethazine with codeine cough syrup is one
to two teaspoons every four to six hours. Tr. 261, 392, 663. The
prescriptions the Government presented from Dr. T.T. were for one
teaspoon every twelve hours. Dr. Emelonye testified that, although a
prescriber may have a legitimate medical reason to prescribe a
suboptimal dose, he would always call the prescriber in such
circumstances. Id. at 665-68.
---------------------------------------------------------------------------
Finally, Dr. Witte testified that all of the patients travelled
unusual distances or routes to Dr. T.T. to obtain their prescriptions
and/or to Respondent Pharmacy to fill their prescriptions. Id. at 263,
271-72, 280-81, 298-99, 342. The Government presented evidence of the
routes and distances the patients travelled: H.P. travelled
approximately 123 miles, V.S. travelled approximately 106 miles; R.J.
travelled approximately 59 miles; and M.H. and K.L. each travelled
approximately 65 miles. See GX 25. Dr. Witte opined that in an urban
setting such as the Dallas/Ft. Worth Metroplex, where all of the
patients lived, she would consider all of the distances and/or routes
the patients travelled to raise red flags.\16\ See Tr. 263, 271-72,
280-81, 298-99, 342-43.
---------------------------------------------------------------------------
\16\ The ALJ made the following finding in the Recommended
Decision, which I adopt: ``Dr. Witte was accepted as an expert in
the field of pharmacy in the state of Texas, not geography. Tr. 227.
Thus, I do not credit her testimony concerning distances, routes,
and general availability of pharmacies as that of an expert. I do
credit it, however, as a reasonable observation based upon common
experience. Certainly one is more likely to pass by a location to
fill prescriptions in an urban area than a rural one. Common
experience also suggests that, in general, it is more time consuming
to travel even a short distance in an urban area than in a rural
one.'' RD, at 57, n.27.
---------------------------------------------------------------------------
The ALJ concurred with Dr. Witte's testimony and found that
Respondent Pharmacy filled prescriptions from Dr. T.T. that displayed
red flags of drug cocktails, high dosages of high-alert drugs,
inappropriate dosing, pattern prescribing, unusual routes and/or
distances, and cash payments. RD, at 29-32. I agree.
Respondent Pharmacy objected to the ALJ's findings that the
prescriptions from Dr. T.T. presented the red flags of pattern
prescribing, unusual or long distances, and cash payments. Resp
Exceptions, at 17-22. In its Exceptions,
[[Page 51053]]
Respondent Pharmacy stated that it ``did not intentionally or
unintentionally identify or detect pattern prescribing when filling any
of its prescriptions from Dr. T.T.'' Id. at 18. Respondent Pharmacy
argued that ``filling a small number of prescriptions from Dr. T.T.
does not equate to [sic] red flag indicating pattern prescribing,''
because ``pattern prescribing occurs when a physician prescribes the
same drug and dosage to every patient the physician sees,'' and the
prescriptions filled by Respondent Pharmacy were for varying drugs such
as hydrocodone, alprazolam, and promethazine with codeine. Id. at 17-
18.
Respondent Pharmacy correctly argues that varying substances and
doses could weigh against a finding of pattern prescribing, but I
credit Dr. Witte's expert testimony that the Dr. T.T. prescriptions did
display pattern prescribing. As Dr. Witte testified, Respondent
Pharmacy's experience filling prescriptions from Dr. T.T., in which he
routinely prescribed an identical, large amount of hydrocodone and
suboptimal dosing of promethazine with codeine, was sufficient for
Respondent Pharmacy to have recognized Dr. T.T.'s pattern prescribing.
I, therefore, reject Respondent Pharmacy's Exception to the ALJ's
finding that the Dr. T.T. prescriptions displayed pattern prescribing.
Respondent Pharmacy also argued that the distances the Dr. T.T.
patients travelled was not a red flag. Resp Exceptions, at 18.
Respondent Pharmacy argued that its patients travel from all over the
Dallas/Forth Worth Metroplex, an area Respondent Pharmacy states covers
9,286 square miles, to visit their doctors and run errands. Id. at 19.
I reject this Exception.
The Government submitted evidence of the long distances that Dr.
T.T.'s patients travelled with routes that had them pass from one side
of Dallas to the other (some also passed through Ft. Worth and
Arlington, Texas). See GX 25. In its Exceptions, Respondent Pharmacy
specifically highlighted patient H.P.--arguing that the 123-mile trip
she took from her home west of Ft. Worth to Dr. T.T.'s office in North
Dallas to Respondent Pharmacy in South Dallas was not unusual. Resp
Exceptions, at 19-20. Respondent Pharmacy's argument strains credulity.
Clearly, a 123-mile trip is a long distance to travel to obtain a
prescription and fill it in an urban setting.\17\ Although there could
have been a valid reason for the distances and routes the Dr. T.T.
patients travelled, the minimum standards of practice in Texas obligate
a pharmacist to at least raise this concern with the provider to
determine the prescription's legitimacy, and then document the
explanation. 22 Tex. Admin. Code Sec. 291.33(c)(2); see id. at Sec.
291.29 (c)(4) (requiring a pharmacist to consider geographic distance
between the practitioner and the patient or between the pharmacy and
the patient when evaluating a prescription's legitimacy).
---------------------------------------------------------------------------
\17\ In light traffic, it would take 2 hours and 16 minutes to
complete this round trip. GX 25, at 1; see E. Main St. Pharmacy, 75
FR 66149, 66164 (2010) (finding that driving two or more hours to
fill a prescription would be a red flag to any pharmacist).
---------------------------------------------------------------------------
Respondent Pharmacy finally argued that the cash payments for the
Dr. T.T. prescriptions did not present a red flag because ``in the
absence of other signs of diversion, prices in the range of $25 to $220
may be insufficient to prove that a pharmacist violated his or her
corresponding responsibility.'' Resp Exceptions, at 21-22 (citing Hills
Pharmacy, L.L.C., 81 FR 49,816, 49,839 n.39 (2016)). The Dr. T.T.
prescriptions, however, presented multiple other red flags of diversion
in addition to cash payments. The Texas Administrative Code also states
that cash payments are a red flag without reference to price. 22 Tex.
Admin. Code Sec. 291.29(f)(12). Accordingly, I reject Respondent
Pharmacy's Exception.
After finding the Dr. T.T. prescriptions displayed red flags, the
ALJ found that Respondent Pharmacy had no documentation on the hard-
copies of the prescriptions or the patient profiles that the red flags
were investigated or resolved and that any documentation that was in
Respondent's profiles was inadequate. RD, at 66, 68, 71-73, 78. For the
reasons that follow, I agree with the ALJ's finding.
Respondent Pharmacy argued that it had resolved any red flags that
existed on the Dr. T.T. prescriptions before filling the prescriptions.
Resp Exceptions, at 15. Dr. Amadi testified regarding the protocol
pharmacists at Respondent Pharmacy followed when presented with a
prescription for a controlled substance. Tr. 565-66. He stated that a
pharmacist at Respondent Pharmacy would look for previous records that
the patient had received the prescription before, and if the patient
had, he would look at the prescriber, the dosing, and the duration; if
the pharmacist still had questions, he would then check the
prescription monitoring program; and, if there was reason to, the
pharmacist would call the prescriber. Id. There is no evidence,
however, that Respondent Pharmacy followed this protocol for the Dr.
T.T. prescriptions. None of the hard-copy prescriptions or the patient
profiles have documentation of any investigation pharmacists at
Respondent Pharmacy allegedly conducted on the Dr. T.T. prescriptions.
See GX 4; GX 5, at 13-15; GX 6, at 1-15; GX 7, at 16-29; GX 8, at 11-
22. Respondent's profiles, the patient profiles Respondent Pharmacy
furnished three weeks before the hearing, have pharmacists' remarks for
some of the Dr. T.T. prescriptions, but none of them meet the minimal
requirements of 22 Tex. Admin. Code 231.33(c)(2)(C). See RX C, at 1; RX
D, at 13; RX H, at 10. Dr. Witte also credibly testified that the
pharmacist remarks from Respondent's profiles were insufficient to
satisfactorily resolve the red flags on the prescriptions. Tr. 346-47.
Furthermore, as discussed supra at II.F, I give Respondent's profiles
no weight.
In summary, I find that the Dr. T.T. prescriptions displayed red
flags including pattern prescribing, distance, cash payments, drug
cocktails, and high dosages of high-alert controlled substances and
that the pharmacists at Respondent Pharmacy knew or should have known
the prescriptions raised red flags. I further find that, even if the
red flags were resolvable, there was no credible evidence that
Respondent Pharmacy addressed or resolved them before filling the
prescriptions. I do not place any weight on Dr. Amadi's testimony that
Respondent Pharmacy resolved the red flags, because Respondent Pharmacy
did not maintain contemporaneous documentary evidence in accordance
with Texas standards of practice to support the claim that it resolved
the red flags before filling the prescriptions, and because Dr. Amadi's
testimony was not credible. See supra II.C.
b. Prescriptions From AC Medical Clinic
The Government alleged that Respondent Pharmacy filled
prescriptions written by prescribers at AC Medical Clinic in Arlington,
Texas that raised red flags without proper investigation, resolution,
and documentation of the red flags. ALJX 1, at 4-6. The Government
further alleged that filling the prescriptions without resolving and
documenting the red flags fell below the minimum standard of practice
for a Texas pharmacy/pharmacist and was outside the usual course of
professional practice for a pharmacy/pharmacist in Texas. Id.
To support these allegations, the Government presented into
evidence
[[Page 51054]]
dozens of prescriptions written by prescribers at AC Medical and filled
at Respondent Pharmacy between August 16, 2014 and May 8, 2015
(hereinafter, the AC Medical prescriptions). GX 2, 5-9. The Government
also introduced Respondent Pharmacy's electronic patient profiles for
the patients who received the AC Medical prescriptions. Id. Finally,
the Government presented testimony from Dr. Witte that all of the AC
Medical prescriptions presented red flags, that there was no evidence
that Respondent Pharmacy resolved the red flags prior to filling the
prescriptions, and that filling the prescriptions fell below the
minimum standard of practice and was outside the usual course of
professional practice of pharmacy in Texas. See, e.g., Tr. 270-73, 278,
293-94, 332-35.
The AC Medical staffers who prescribed the AC Medical prescriptions
were Dr. N.E; Dr. C.V.; L.R., ACNS-BC; S.G., FNP; and C.Z., PA. Id.
Almost all of the paper AC Medical prescriptions were written on
prescription pads from AC Medical making it easy to identify that the
prescription came from a prescriber at the clinic.\18\ Many of the AC
Medical prescriptions prescribed by Dr. C.V. were electronic
prescriptions, which all listed an address different from the address
listed on the paper AC Medical prescriptions, but Dr. C.V.'s electronic
prescriptions still clearly identified that they came from AC Medical.
See, e.g., GX 2, at 13, 24, 34.
---------------------------------------------------------------------------
\18\ For unexplained reasons, Dr. C.V. wrote three of the
subject prescriptions and Dr. NE wrote one of the subject
prescriptions from a prescription pad individual to that doctor. See
GX 2, at 3, 19, 33; GX 8, at 5.
---------------------------------------------------------------------------
i. December 12 and 13, 2014 AC Medical Prescriptions
On December 12, 2014, Respondent Pharmacy dispensed identical
prescriptions of alprazolam to patients M.B. and L.B. at approximately
the same time.\19\ GX 8, at 3, 7. L.B. and M.B. reside at the same
address. Id. The next day, Respondent Pharmacy filled identical
prescriptions for hydrocodone for M.B. and L.B. Id. at 1, 9. These
prescriptions were also filled one right after the other according to
the prescription numbers. Id. All of the prescriptions were prescribed
by Dr. NE Id. M.B. and L.B. paid for the alprazolam and hydrocodone
prescriptions with cash. Id. at 1-9.
---------------------------------------------------------------------------
\19\ On December 12, 2014, M.B. and L.B filled five
prescriptions at Respondent Pharmacy. The prescription numbers for
those five prescriptions are in sequential order from 37218 through
37222. GX 8, at 3, 7.
---------------------------------------------------------------------------
As already discussed, hydrocodone and alprazolam are a drug
cocktail, which constitutes a red flag. Supra II.F.1. Paying cash for
controlled substances is also a red flag. Id. Additionally, Dr. Witte
testified that when two patients living at the same address obtain
prescriptions from the same provider for the same highly abused drug
cocktail, in this case hydrocodone and alprazolam, it is a red flag
indicating diversion. Tr. 293; see also 22 Tex. Admin. Code Sec.
291.29(f)(11) (It is a red flag when ``multiple persons with the same
address present substantially similar controlled substance
prescriptions from the same practitioner.'').
Despite the red flags on the prescriptions, there was no
documentation on M.B.'s and L.B.'s prescriptions or patient profiles
that Respondent Pharmacy had resolved the red flags of pattern
prescribing, drug cocktails, or cash payments. GX 8, at 1, 3, 6, 7. The
Respondent's profiles did contain remarks on both M.B. and L.B.'s
profiles, RX A, at 62, 66, but as discussed supra at II.F, I give the
Respondent's profiles no weight. I also credit Dr. Witte's testimony
that neither remark adequately resolved the red flags, see Tr. 734-35,
and agree with the ALJ's finding that neither remark had the minimum
information a pharmacist must document regarding a resolved red flag
under the Texas Operational Standards,\20\ RD, at 63-64; 22 Tex. Admin.
Code Sec. 291.33(c)(2). Respondent Pharmacy claimed the remarks in the
Respondent's profiles met the Texas Operational Standards. Resp
Exceptions, at 15. The remarks on the December 12, 2014 AC Medical
prescriptions, however, did not meet the standards as they were missing
the date of the consultation, the name of the person communicating the
prescriber's instructions, and the initials of the pharmacist
performing the consultation--all required information under the Texas
Operational Standards when documenting the resolution of a red flag.
See 22 Tex. Admin. Code Sec. 291.33(c)(2)(C).
---------------------------------------------------------------------------
\20\ The remark on L.B.'s Respondent profile reads, ``md. oked
rx.'' RX A, at 66. The remark on M.B's Respondent profile reads,
``rx info, did not have a diagnosis code. md confirmed pt has lower
back pain.'' Id. at 62.
---------------------------------------------------------------------------
ii. January 14 and 15, 2015 AC Medical Prescriptions
On January 14 and 15, 2015, Respondent Pharmacy dispensed
prescriptions for alprazolam and hydrocodone to patients L.H., R.C.,
and K.W. (male). GX 7, at 1, 5, 9. Respondent Pharmacy filled
prescriptions for alprazolam for L.H. and R.C. on January 14. Id. at 1,
5. On January 15, Respondent Pharmacy filled an alprazolam prescription
for K.W. (male) and hydrocodone prescriptions for all three patients.
Id. at 1, 5, 9. All of the alprazolam prescriptions were identical and
prescribed by Dr. NE Id. All of the hydrocodone prescriptions were
identical and prescribed by Dr. C.V. Id. The three patients paid cash
for the prescriptions. GX 7, 1-15.
The ALJ found, and I concur, that the prescriptions displayed red
flags of drug cocktails, cash payments, and pattern prescribing. RD, at
33. I further find that K.W. (male)'s alprazolam prescription is
invalid because it does not list the patient's address. GX 7, at 15;
Tr. 423-24, 647-49. Dr. Witte testified that to resolve a missing
address on a prescription, a pharmacist should confirm the address and
fill it in on the prescription itself. Tr. 335. The line on K.W.
(male)'s prescription for the patient address remains blank. GX 7, at
15.
I further find, as the ALJ did, that nothing in the record
demonstrates that Respondent Pharmacy resolved the red flags on the
prescriptions. See RD, at 69-71. Respondent Pharmacy argued it had
resolved the red flags on patient R.C.'s prescription because Dr. Amadi
testified that he had identified the hydrocodone and alprazolam
combination as a red flag and had contacted the prescribing doctor's
office to ensure the validity of the prescription. Resp Exceptions, at
15 (citing Tr. 572). I do not credit Dr. Amadi's testimony. There is no
documentation on any of the three patients' prescriptions or patient
profiles that any of the red flags on the prescriptions had been
resolved. See GX 7. The Respondent's profiles do contain remarks for
these patients, but even assuming I were to give those profiles any
weight, the remarks do not comply with the operational rules for Texas
pharmacists and are inadequate to address the red flags.\21\ See 22
Tex. Admin. Code Sec. 291.33(c)(2)(C).
---------------------------------------------------------------------------
\21\ The remark on K.W. (male)'s Respondent profile does not
refer to any controlled substances, only two antidepressants. Tr.
729-30. The remark on R.C.'s profile states that a doctor was
consulted and approved the combination of hydrocodone, alprazolam,
and methocarbomal, but the comment does not specify which of the
three doctors listed on the profile was consulted, identify the date
of the consultation, or explain why the patient was receiving
prescriptions from controlled substances from multiple doctors and
paying in cash. RX A, at 21. The remark on L.H.'s Respondent profile
states that the doctor said the patient had an accident and approved
the medication. The remark, however, does not identify which of the
two doctors on the profile the pharmacist spoke with, does not
address why the patient was receiving controlled substances from two
doctors, is undated, and according to Dr. Witte, did not resolve the
red flags. RX A, at 43, Tr. 732.
---------------------------------------------------------------------------
[[Page 51055]]
iii. March 2-6, 2015 AC Medical Prescriptions
On March 2, 2015, Respondent Pharmacy dispensed alprazolam to
patients V.B., F.S., and K.M.\22\ GX 5, at 1, 4, 10. The following day,
March 3, 2015, Respondent Pharmacy filled hydrocodone prescriptions for
the same three patients.\23\ Id. On March 4, 2015, Respondent Pharmacy
filled alprazolam prescriptions for patients A.W. and C.M. GX 2, at 37;
GX 9, at 12. The next day, March 5, 2015, Respondent Pharmacy filled
hydrocodone prescriptions for A.W. and C.M. and alprazolam and
hydrocodone prescriptions for patients J.W. and D.T. GX 2, at 38; GX 9,
at 1, 5, 12. On March 6, 2015, Respondent Pharmacy filled another
prescription for hydrocodone for D.T. GX 9, at 1. The prescriptions
were all written by prescribers at AC Medical. The patients paid for
the prescriptions with cash. GX 2, at 37-38; GX 5, at 1-12; GX 9.
---------------------------------------------------------------------------
\22\ The three patients filled a total of 9 prescriptions at
Respondent Pharmacy on March 2, 2015. All 9 prescriptions fell
between prescription fill numbers 39126 and 39138. GX 5, at 2, 5,
12. When asked for her assessment of the prescriptions, Dr. Witte
testified ``you wonder, did all the patients happen to be in the
pharmacy at the same time, dropping of the same prescriptions from
the same practice, or were they delivered by one person.'' Tr. 270.
\23\ The prescription fill numbers for the three prescriptions
were 192, 193, and 195. Tr. 176.
---------------------------------------------------------------------------
The instructions on the alprazolam prescriptions stated the
alprazolam was to be taken twice a day. GX 2, at 37-38; GX 5, at 1-12;
GX 9. Three times a day, however, is the standard dose for alprazolam.
Tr. 389-91, 661-62. The prescriptions for hydrocodone were all for 90
tablets and contained dosing instructions of 1 tablet to be taken 3
times a day as needed.\24\ GX 2, at 38; GX 5, at 3, 6, 11; GX 9, at 3,
4, 10, 14. All of the hydrocodone prescriptions were written by Dr.
C.V., a different doctor than the practitioners who wrote the
prescriptions for alprazolam. GX 2, at 38; GX 5, at 3, 6, 11; GX 9, at
3, 4, 10, 14; Tr. 277-78.
---------------------------------------------------------------------------
\24\ Dr. Witte testified that hydrocodone is typically dosed one
tablet every four to six hours. Tr. 252-53.
---------------------------------------------------------------------------
Based on the documentary evidence and the testimony of Dr. Witte
and Dr. Emelonye,\25\ the ALJ found dispensing alprazolam and
hydrocodone one day apart or the same day to the same patients, under
these circumstances, raises the following red flags: Pattern
prescribing, different prescribers of controlled substances; drug
cocktails; and cash payments. RD, at 30, 34-35. I concur with the ALJ's
findings. The expert testimony of Dr. Witte established that the same
patient filling separate prescriptions for alprazolam and hydrocodone
is a drug cocktail whether filled on the same day or on consecutive
days. Tr. 344, 725. The pharmacist who filled the prescriptions one day
apart for V.B., F.S., K.M, and C.M. should have known the patients were
receiving a drug cocktail by looking at the patients' profiles. Tr.
432-34. The identical, suboptimal dosing instructions for patients
filling prescriptions for controlled substances from the same medical
clinic at the same time also evidences pattern prescribing as does that
fact that all of the patients received the same hydrocodone
prescription from Dr. C.V. Tr. 270, 278; see 22 Tex Admin Code Sec.
291.29(f).
---------------------------------------------------------------------------
\25\ Dr. Emelonye testified that he would ``ask questions to
find out what was going on'' if a patient presented prescriptions
for two different controlled substances written by two different
doctors a day apart. Tr. 678.
---------------------------------------------------------------------------
Respondent Pharmacy claimed the prescriptions did not display red
flags of pattern prescribing and cash payments. Resp Exceptions, at 17-
18, 21-22. Respondent Pharmacy did not provide any reasoning or
argument why the prescriptions do not display pattern prescribing, see
id. at 17-18; while the Government presented credible expert testimony
that a Texas pharmacist would have recognized the pattern prescribing
on the subject prescriptions. Tr. 270, 278. For the cash payments,
Respondent Pharmacy argued that ``in the absence of other signs of
diversion, prices in the range of $25 to $220 may be insufficient to
prove that a pharmacist violated his or her corresponding
responsibility.'' Id. at 21-22 (citing Hills Pharmacy, L.L.C., 81 FR
49,816, 49,839 n.39 (2016)). The subject prescriptions, however,
presented multiple other red flags of diversion in addition to cash
payments. The Texas Administrative Code also states that cash payments
are a red flag without reference to price. See 22 Tex. Admin. Code
Sec. 291.29(f)(12). Accordingly, I reject the Respondent Pharmacy's
Exceptions to the ALJ's findings that the prescriptions presented the
red flags of pattern prescribing and cash payments.
Despite the numerous red flags on the prescriptions, there is no
documentation on either the hard-copy prescriptions or in Respondent
Pharmacy's electronic patient profiles that the red flags were
resolved. See GX 2, at 36-38; GX 5, 9. Additionally, and significantly,
there are no notes explaining why patient D.T. obtained 180 tablets of
hydrocodone in two prescriptions on consecutive days. The Respondent's
profiles, to which I do not give weight, all have a remark for these
patients, RX A, at 47, 50, 74; RX D, at 10, but the remarks fail to
address all of the red flags raised by the suspect prescriptions and
fail to meet the requirements set forth by the Texas Operational
Standards. 22 Tex. Admin. Code Sec. 291.33(c)(2)(C). Dr. Witte also
testified that all of the Respondent's profiles fell below the minimum
acceptable standard of practice for a pharmacy in Texas and
specifically testified that the remarks for patients K.M. and C.M.
failed to adequately resolve the prescriptions' red flags. Tr. 733,
746.
As with all of the subject prescriptions that had remarks in the
Respondent's profiles, Respondent Pharmacy filed an Exception to the
ALJ's finding that the remarks did not meet the Texas Operational
Standards. Resp Exceptions, at 15. The remarks on the March 2-6, 2015
AC Medical prescriptions, however, did not meet the standards, as they
were all missing the date of the consultation, the name of the person
communicating the prescriber's instructions, and the initials of the
pharmacist performing the consultation--all required information under
the Texas Operational Standards when documenting the resolution of a
red flag. 22 Tex. Admin. Code Sec. 291.33(c)(2)(C).
In its Exceptions, Respondent Pharmacy also specifically argued
that Dr. Amadi resolved the red flags on the prescriptions filled on
March 4 and 5, 2015, for a patient A.W. before filling them. Resp
Exceptions, at 15. Dr. Amadi testified during the hearing that he
recognized that A.W.'s prescriptions for alprazolam and hydrocodone
filled on consecutive days was a red flag drug cocktail and that he
resolved the red flag by contacting the prescribing doctor's office to
ensure the validity of the prescription. Tr. 563-65. Having considered
Respondent Pharmacy's argument, I find there is substantial evidence to
support the Government's allegation that Respondent Pharmacy filled
prescriptions for patient A.W. without resolving the red flags on the
prescriptions. Despite Dr. Amadi's claim that he resolved the red flags
on the prescriptions, there is no documentation of his investigation on
either the prescriptions or A.W.'s patient profile. See GX 2, at 36-38.
The Respondent's profiles do have a remark for patient A.W., but it
does not resolve the red flags on the prescriptions. RX A, at 1.\26\
[[Page 51056]]
I, therefore, do not place any weight on Dr. Amadi's testimony that he
resolved the red flag on A.W's prescription because Respondent Pharmacy
produced no contemporaneous documentary evidence to support its claim
that Dr. Amadi resolved the red flags before filling the prescriptions
and because Dr. Amadi's testimony was not credible.
---------------------------------------------------------------------------
\26\ The remark states ``Dr. consulted and she confirmed that pt
needs the meds for his conditions.'' This remark does not identify
which of the two doctors listed on the profile the pharmacist spoke
with, does not address why the patient was receiving controlled
substances from two doctors, does not address why the patient was
paying with cash, and is undated. Further, Dr. Witte provided
credible expert testimony that the remark was inadequate to resolve
the red flags on the prescriptions. Tr. 726-28.
---------------------------------------------------------------------------
iv. Other AC Medical Prescriptions
The Government presented patient profiles and prescriptions
demonstrating that Respondent Pharmacy filled prescriptions from AC
Medical for patients receiving both hydrocodone and alprazolam to seven
additional patients. GX 2, at 1-14, 17-27, 31-35, 39-42. As already
discussed, a combination of hydrocodone and alprazolam is a drug
cocktail and a red flag. The prescriptions were also all paid for with
cash--another red flag. Id. There is no documentation on the hard-copy
prescriptions or the patient profiles that Respondent Pharmacy resolved
the red flags before dispensing the prescriptions. Id. The Respondent's
profiles did contain pharmacist's remarks for most of these patients,
but none of the remarks contained the minimum information required by
the Texas Operational Standards. RX A, at 27, 34, 38, 53, 67; see Tex.
Admin. Code Sec. 291.33(c)(2)(C). Dr. Witte also testified that none
of the remarks adequately resolved the red flags on the prescriptions.
Tr. 346-47, 726-737, 746. I therefore find that Respondent Pharmacy
filled prescriptions from AC Medical that had red flags of drug
cocktails and cash payments without resolving the red flags or
documenting the resolution of the red flags.
In summary, I find the AC Medical prescriptions displayed red flags
including pattern prescribing, cash payments, patients receiving
controlled substance prescriptions from different doctors, and drug
cocktails and that the pharmacists at Respondent Pharmacy knew or
should have known the prescriptions raised red flags. Notably, all of
the patients who filled the subject prescriptions from AC Medical at
Respondent Pharmacy received the drug cocktail of alprazolam and
hydrocodone. I also find that one of the AC Medical prescriptions
Respondent Pharmacy filled was facially invalid because it did not list
the patient's address.\27\ I further find that, even if the red flags
on the prescriptions were resolvable, there was no credible evidence
that Respondent Pharmacy addressed or resolved them before filling the
prescriptions. I do not place any weight on Dr. Amadi's testimony that
Respondent Pharmacy resolved the red flags because Respondent Pharmacy
did not maintain contemporaneous documentary evidence in accordance
with Texas standards of practice to support the claim that it resolved
the red flags before filling the prescriptions and because Dr. Amadi's
testimony was not credible. See supra II.C.
---------------------------------------------------------------------------
\27\ A review of the subject prescriptions from AC Medical in
the Government's exhibits shows that many of the other prescriptions
were missing addresses and/or the prescriber's DEA number, but the
Government only charged one prescription from AC Medical as facially
invalid. See ALJX 1, at 4-6. I am, therefore, only including a
finding on the single prescription.
---------------------------------------------------------------------------
c. Prescriptions From KSW Medical Clinic
In March 2015, two of the prescribers from the AC Medical Clinic,
Dr. NE and S.G., FNP, began writing prescriptions from a different
clinic, KSW Medical Clinic in Desoto, Texas. The Government alleges
that Respondent Pharmacy continued to fill prescriptions from these
providers after they moved from AC Medical to KSW Medical without
investigation, resolution, or documentation of red flags on the
prescriptions in violation of the standard of practice for a Texas
pharmacy/pharmacist and outside the usual course of professional
practice for a Texas pharmacy/pharmacist. ALX 1, at 4-6. To support
these allegations, the Government introduced prescriptions written by
prescribers at KSW Medical Clinic and filled by Respondent Pharmacy
between March 31, 2015 and May 8, 2015. GX 2, at 15-16, 29-30; GX 3.
All of the KSW prescriptions were written on prescription pads from the
KSW Medical Clinic making it easy to identify that the prescription
came from a prescriber at the clinic. Id.
i. May 8, 2015 KSW Medical Prescriptions
On May 8, 2015, Respondent Pharmacy filled nine controlled
substance prescriptions from KSW Medical for patients D.B., K.W., O.F.,
M.J., and C.F. GX 3. Dr. Witte testified that the prescriptions
presented red flags that Respondent Pharmacy failed to resolve and that
filling the prescriptions fell below the minimum standard of practice
and was outside the usual course of professional practice of pharmacy
in Texas. Tr. 250-57.
The ALJ found that the prescriptions for patients D.B., K.W., O.F.,
and M.J. raised the following red flags: Pattern prescribing,
specifically, the prescriptions had the same directions for use, the
prescriptions were issued by the same medical practice (KSW Medical),
and the prescriptions were all presented to Respondent Pharmacy at
approximately the same time; \28\ drug cocktails (hydrocodone and
alprazolam); and cash payments. RD, at 28. The ALJ also found that the
alprazolam prescriptions for all four patients were facially invalid.
Id. To be facially valid, a prescription must contain the patient's
address and the provider's DEA number. Tr. 242, 335, 423-25, 647-49;
Tex. Health & Safety Code Sec. 481.074(k)(3), (7). The alprazolam
prescriptions for K.W., O.F., and M.J. did not contain an address or
the provider's DEA number, Tr. 242, 245-48; GX 3, at 6, 10, 14, and the
alprazolam prescription for D.B. was missing the patient's address, Tr.
370; GX 3, at 2. On May 8, 2015, Respondent Pharmacy also filled a
prescription for hydrocodone for patient C.F. GX 3, at 20. The ALJ
found this prescription raised the red flags of pattern prescribing,
specifically the prescription was the same quantity and dosing as the
other hydrocodone prescriptions from KSW Medical that were brought to
Respondent Pharmacy that day; a prescription for a high-alert
controlled substance; and cash payment. RD, at 28. Having reviewed the
record, I concur with the ALJ's findings.
---------------------------------------------------------------------------
\28\ Dr. Witte testified that the fill stickers for the
prescriptions indicate the patients either came into the pharmacy at
the same time or that one person was dropping of the prescriptions
for all of the patients. Tr. 250-51.
---------------------------------------------------------------------------
Respondent Pharmacy filed an Exception to the ALJ's finding that
the May 8, 2015 KSW Medical prescriptions displayed the red flags of
pattern prescribing. Resp Exceptions, at 17-18. I reject Respondent
Pharmacy's Exception and find that a reasonable pharmacist practicing
within the standard of practice for a Texas pharmacist would have
recognized the pattern prescribing displayed by the prescriptions. Dr.
Witte credibly testified that a pharmacist working a typical 8 to 10
hour shift would be unlikely to encounter nine prescriptions on the
same day in close proximity to one another for the same controlled
substances, with similar dosing and instructions, all from the same
medical practice. Tr. 251. While the pattern might not have been
apparent when the first or second prescription was presented, Dr. Amadi
should have realized by the time he received the third or fourth
prescription that drug cocktails repeatedly coming from KSW Medical for
hydrocodone and
[[Page 51057]]
alprazolam on the same date raised the concern of illegitimacy and
diversion.
Respondent Pharmacy also argued that the prescriptions displayed
the red flag of cash payments for the same reasons it objected to this
finding for the Dr. T.T. and AC Medical prescriptions. Resp Exceptions,
at 21-22. As with those prescriptions and for the same reasons, I
reject Respondent Pharmacy's argument.
During the hearing Dr. Amadi agreed that the May 8, 2015
prescriptions from KSW Medical contained some red flags \29\ but argued
that he had investigated and resolved the red flags before the
prescriptions were dispensed by calling the prescribers and checking
the patients' identifications for the missing addresses. Tr. 584-85.
The ALJ did not credit Dr. Amadi's testimony and found that (1)
Respondent Pharmacy had not resolved the red flags before filling the
prescriptions because there was no documentation on the prescriptions
or the patient profiles that it had done so, RD, at 26; (2) the
documentation in the Respondent's profiles did not adequately resolve
the red flags on the prescriptions or meet the minimum standards for
documenting the resolution of red flags, id. at 83-86; and (3)
Respondent Pharmacy had not added the missing addresses as required to
resolve the problems with the invalid prescriptions, id. at 28.
Respondent Pharmacy disagreed with these findings. Resp Exception, at
15-17. I agree with the ALJ.
---------------------------------------------------------------------------
\29\ Dr. Amaldi testified that the combination of ``the Xanax
and the alprazolam'' in the prescriptions was cause for concern and
would need to be addressed. Tr. 585. As alprazolam is the generic
name for Xanax, I presume Dr. Almadi misspoke and intended to say it
was the combination of the hydrocodone and the alprazolam that was
the cause for concern. Dr. Amaldi also stated that a missing address
is a red flag. Id.
---------------------------------------------------------------------------
A pharmacist practicing in Texas must record notes on the hard-copy
of the prescription or in the pharmacy's electronic patient profiles
explaining whether a red flag was resolved and how it was resolved. 22
Tex. Admin. Code Sec. 291.33(c)(2)(C). None of the hard-copies of the
prescriptions or the patient profiles contained any notes resolving the
red flags of drug cocktails, cash payments, or pattern prescribing. GX
3; RD, at 26. The hard-copy of the prescriptions for D.B., K.W., O.F.,
and M.J. also do not contain any notes or comments indicating how the
pharmacist resolved the issue of the missing address before dispensing
the high-alert controlled substance. GX 3; RD, at 26.
The Respondent's profiles for the patients contain remarks, but the
remarks lack the information required by the Texas Operational
Standards for resolving red flags. RX A, at 86, 88, 106, 112; 22 Tex.
Admin. Code Sec. 291.29(c)(2)(C). Every comment falls short of all
four requirements outlined in the Texas regulation. Additionally, the
patients' profiles show that all of the patients were receiving
multiple drugs, both controlled and non-controlled substances, but the
pharmacist's comments never say which drug the comment was addressing.
Therefore, even if I were to give weight to the Respondent's profiles,
and for the reasons I discussed supra I do not, the remarks fail to
meet the standard of practice for a Texas pharmacy.
ii. Other KSW Medical Prescriptions With Red Flags
The Government presented prescriptions demonstrating that
Respondent Pharmacy filled prescriptions from KSW Medical for patients
receiving both hydrocodone and alprazolam on two other occasions. GX 2,
at 15-16; GX 3, at 18-19. As already discussed, a combination of
hydrocodone and alprazolam is a drug cocktail and a red flag. The
prescriptions were also all paid for with cash, another red flag. GX 2,
at 15-16; GX 3, at 18-19. There is no documentation on the hard-copy
prescriptions or the patient profiles that Respondent Pharmacy resolved
the red flags before dispensing the prescriptions. GX 2, at 9, 15-16;
GX 3, at 17-19. I therefore find that Respondent Pharmacy filled
prescriptions from KSW Medical that had red flags of drug cocktails and
cash payments without resolving the red flags or documenting the
resolution of the red flags.
In summary, I find the KSW Medical prescriptions displayed red
flags including pattern prescribing, cash payments, and drug cocktails
and that the pharmacists at Respondent Pharmacy knew or should have
known the prescriptions raised red flags. I also find that four of the
KSW Medical prescriptions Respondent Pharmacy filled were facially
invalid because they did not list the patient's address or the
prescriber's DEA registration number. I further find that, even if the
red flags on the prescriptions were resolvable, there was no credible
evidence that Respondent Pharmacy addressed or resolved them before
filling the prescriptions. I do not place any weight on Dr. Amadi's
testimony that Respondent Pharmacy resolved the red flags, because
Respondent Pharmacy did not maintain contemporaneous documentary
evidence in accordance with Texas standards of practice to support the
claim that it resolved the red flags before filling the prescriptions
and because Dr. Amadi's testimony was not credible. See supra II.C.
d. The Cedar Hill Prescriptions
The Government next alleged that between October 2014 and June
2015, Cedar Hill dispensed nearly 100 prescriptions that displayed red
flags that were unresolvable.\30\ The Cedar Hill prescriptions were all
prescribed by the same doctor, Dr. R.G., in Houston for 21 patients who
lived in the Dallas area. See GX 10. The Cedar Hill prescriptions
contained 47 prescriptions for oxycodone, 49 for hydrocodone, and 26
for hydrocodone-oxycodone cocktails. Id. According to the fill
stickers, the prescriptions were filled by pharmacist Kweku Ohene. Tr.
81; see GX 10. In addition to working at Cedar Hill, Mr. Ohene was also
the pharmacist-in-charge of Respondent Pharmacy. GX 16, at 1.
---------------------------------------------------------------------------
\30\ Respondent Pharmacy objected to the introduction of the
Cedar Hill prescriptions on the basis of relevancy. I address
Respondent Pharmacy's argument infra at III.B.2.
---------------------------------------------------------------------------
Dr. Witte testified that the Cedar Hill prescriptions contained
several red flags. First, hydrocodone and oxycodone are both high-alert
controlled substances. Prescribed together, they constitute a red flag
drug cocktail. Supra II.F.1. Dr. Witte testified that a prescription
for multiple drugs in the same class, such as oxycodone and
hydrocodone, which both treat pain, raises the concern of overdose. Tr.
440-41. She noted that two narcotics could be prescribed together under
some circumstances; for example, prescribing one narcotic for break-
through pain and the other for chronic pain, but that the directions on
Cedar Hill prescriptions were not written that way. Id. at 289.
Second, Dr. Witte testified that the distance travelled to obtain
the prescriptions in Houston and fill them at Cedar Hill is a red flag.
Tr. 288. All of the patients lived in the Dallas area, meaning they
travelled more than 400 miles round trip to obtain prescriptions for
highly-abused controlled substances. Id. at 287. The diagnoses provided
on the Cedar Hill prescriptions further call the distance travelled
into question. Dr. Witte observed that many diagnoses on these
prescriptions were chronic back pain, lumbar disc pain, or spinal
stenosis, and the prescriptions stated, ``Pain functional limitation.''
Id. at 290; GX 10, at 35, 50, 68, 81, 99, 191, 157, 163, 167. Dr. Witte
credibly testified
[[Page 51058]]
that she would not expect a patient suffering from mobility-impairing
back pain to be capable of sitting in a car for the multi-hour trip
between Dallas and Houston. Tr. 290.
Dr. Witte additionally testified that the prescriptions presented
the red flag of pattern prescribing. All of the prescriptions were
written by the same physician, Dr. R.G., and all were for hydrocodone,
oxycodone, or a combination of the two. Tr. 287-89; see GX 10. Most of
the prescriptions were also paid for in cash, another red flag. Tr.
287-88; GX 10, at 1-35, 38-41, 54-110, 131-192.\31\ Only 19 of the
prescriptions were billed to insurance. GX 10, at 36-37, 42-53, 111-30.
---------------------------------------------------------------------------
\31\ Respondent Pharmacy charged $480 for 120 tablets of
oxycodone 500 30mg and $100 for 60 tablets of hydrocodone 10/325 mg
meaning most patients who obtained hydrocodone-oxycodone cocktails
from Dr. R.G. paid $580 for high-alert controlled substances that
are typically covered by insurance. See, e.g., GX 10, at 2, 4, 6, 8,
10, 12, 14, 16, 18, 20, 22, 24.
---------------------------------------------------------------------------
Dr. Witte opined that the combination of red flags on the Cedar
Hill prescriptions--the extraordinary distances traveled by the
patients to obtain their prescriptions, the pattern prescribing, the
cash payments--were so egregious that they were unresolvable. Tr. 288-
89. She explained that when a prescription has unresolvable red flags,
there is ``nothing that could be done that would convince you as a
pharmacist to fill these prescriptions.'' Id. at 436. Dr. Witte
testified that with the Cedar Hill prescriptions, a pharmacist could
perhaps have resolved the red flags on the first prescription he saw
based on an explanation from the prescriber, but that after a few
prescriptions, the pattern was apparent and the pharmacist should have
refused to fill the prescriptions regardless of any explanation from
the prescriber. Id. at 436-40. The ALJ concurred with Dr. Witte and
found that the Cedar Hill prescriptions raised red flags and that the
red flags were unresolvable. RD, at 87-89.
Respondent Pharmacy argued that the cash payments for the Cedar
Hill prescriptions did not present a red flag. Resp Exceptions, at 21-
22. Respondent Pharmacy argued that ``in the absence of other signs of
diversion, prices in the range of $25 to $220 may be insufficient to
prove that a pharmacist violated his or her corresponding
responsibility.'' Id. (citing Hills Pharmacy, L.L.C., 81 FR 49,816,
49,839 n.39 (2016). The Cedar Hill prescriptions, however, presented
multiple other red flags of diversion in addition to cash payments. The
Texas Administrative Code also states that cash payments are a red flag
without reference to price. See 22 Tex. Admin. Code Sec.
291.29(f)(12). Accordingly, I reject Respondent Pharmacy's Exception.
Based on the evidence on the record, I find that the Cedar Hill
prescriptions raised red flags and that the pharmacists at Cedar Hill
knew or should have known that the prescriptions raised the red flags.
I further find that the pharmacists at Cedar Hill filled the
prescriptions without resolving the red flags, as the red flags were
unresolvable.\32\
---------------------------------------------------------------------------
\32\ The Cedar Hill prescriptions do not contain any notes or
comments documenting the resolution of the red flags on the hard
copies of the prescriptions, see GX 10; but the Government did not
obtain the electronic patient profiles for the Cedar Hill
prescriptions, which could have contained the documentation. I find,
however, that it is irrelevant whether the Cedar Hill pharmacists
investigated the red flags on the Cedar Hill prescriptions as Dr.
Witte credibly testified that they were unresolvable. Further,
Respondent Pharmacy did not argue in its Posthearing Brief or in the
Exceptions that it filed to the Recommended Decision that Cedar Hill
pharmacists had investigated or resolved the red flags on the Cedar
Hill prescriptions.
---------------------------------------------------------------------------
III. Discussion
The Government alleged that Respondent Pharmacy's registration
should be revoked because Respondent Pharmacy committed acts that would
render its registration inconsistent with the public interest as
provided in 21 U.S.C. 823(f). The gravamen of the Government's
allegations and evidence in this case focuses on whether Respondent
Pharmacy violated federal and state laws relating to controlled
substances when it filled prescriptions, employed Dr. Amadi in a
position with access to controlled substances, and failed to properly
maintain certain records.
Section 304(a) of the Controlled Substances Act (hereinafter, CSA)
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 [its] registration under section 823 of this title
inconsistent with the public interest as determined under such
section.'' 21 U.S.C. 824(a). In the case of a practitioner, which
includes a pharmacy, the CSA requires the Agency consider the following
factors in determining whether Respondent Pharmacy's registration would
be inconsistent with the public interest:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(3) The [registrant'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.
21 U.S.C. 823(f).
The DEA considers these public interest factors in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Each factor is
weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d
165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of
factors, may be decisive. David H. Gillis, M.D., 58 FR 37,507, 37,508
(1993). Thus, there is no need to enter findings on each of the
factors. Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005).
Furthermore, there is no requirement to consider a factor in any given
level of detail. Trawick v. Drug Enf't Admin., 861 F.2d 72, 76-77 (4th
Cir. 1988). The balancing of the public interest factors ``is not a
contest in which score is kept; the Agency is not required to
mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest . . . .'' Jayam
Krishna-Iyer, M.D., 74 FR 459, 462 (2009). When deciding whether
registration is in the public interest, the DEA must consider the
totality of the circumstances. See generally Joseph Gaudio, M.D., 74 FR
10,083, 10,094-95 (2009) (basing sanction on all evidence on record).
The Government has the burden of proving that the requirements for
revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21
CFR 1301.44(e). When the Government has met its prima facie case, the
burden then shifts to the Respondent to show that revoking registration
would not be appropriate, given the totality of the facts and
circumstances on the record. Med. Shoppe-Jonesborough, 73 FR 364, 387
(2008).
While I have considered all of the public interest factors, the
Government's case invoking the public interest factors of 21 U.S.C.
823(f) seeks the revocation of Respondent Pharmacy's registration based
primarily on conduct most aptly considered under Public Interest
Factors Two and Four. I find that the Government's evidence with
respect to Factors Two and Four satisfies its prima facie burden of
showing that Respondent Pharmacy's continued registration would be
``inconsistent with the public interest.'' 21 U.S.C. 823(f). I further
find that Respondent Pharmacy
[[Page 51059]]
failed to provide sufficient evidence to rebut the Government's prima
facie case. Specifically, I find that the record contains substantial
evidence that pharmacists at Respondent Pharmacy and Cedar Hill
violated their corresponding responsibility when they dispensed over
two hundred prescriptions. I also find there is substantial evidence on
the record that Respondent Pharmacy employed Dr. Amadi in a capacity
where he had access to controlled substances, a position for which he
was ineligible under federal law, and violated multiple federal and
state recordkeeping requirements.
A. Factors One and Three
Respondent Pharmacy filed exceptions to the findings in the
Recommended Decision that Factors One and Three do not weigh for or
against revocation of Respondent Pharmacy's registration. Respondent
Pharmacy argues that Factors One and Three should weigh in favor of
Respondent Pharmacy retaining its registration, because Respondent
Pharmacy holds a valid state license to operate as a pharmacy and none
of its employees have a conviction record related to controlled
substances. Resp Exceptions, at 7-8.
It is undisputed that Respondent Pharmacy holds a valid state
pharmacy license in Texas. However, possession of a state license does
not entitle a holder of that license to a DEA registration. Mark De La
Lama, P.A., 76 FR 20,011, 20,018 (2011). It is well established that a
``state license is a necessary, but not a sufficient condition for
registration.'' Robert A. Leslie, M.D., 68 FR at 15,230. The ultimate
responsibility to determine whether a DEA registration is consistent
with the public interest resides exclusively with the DEA, not to
entities within state government. Edmund Chein, M.D., 72 FR 6580, 6590
(2007), aff'd Chein v. Drug Enf't Admin., 533 F.3d 828 (DC Cir. 2008).
In determining the public interest under Factor One, the
``recommendation of the appropriate State licensing board or
professional disciplinary authority . . . shall be considered.'' 21
U.S.C. 823(f)(1). ``Two forms of recommendations appear in Agency
decisions: (1) A recommendation to DEA directly from a state licensing
board or professional disciplinary authority (hereinafter, appropriate
state entity), which explicitly addresses the granting or retention of
a DEA COR; and (2) the appropriate state entity's action regarding the
licensure under its jurisdiction on the same matter that is the basis
for the DEA OSC.'' John O. Dimowo, 85 FR 15,800, 15,809 (2020); see,
also, Vincent J. Scolaro, D.O., 67 FR 42,060, 42,065 (2002) (``While
the State Board did not affirmatively state that the Respondent could
apply for a DEA registration, [the ALJ] found that the State Board by
implication acquiesced to the Respondent's application because the
State Board has given state authority to the Respondent to prescribe
controlled substances.'').
The record in this case contains no evidence of a recommendation
regarding Respondent Pharmacy's privilege to operate as a pharmacy by
the relevant state licensing board or professional disciplinary
authority or any action by the state licensing board that demonstrates
that it has considered the same facts in relation to Respondent
Pharmacy's continued licensure. Prior Agency decisions have found that
where the record contains no evidence of a recommendation by a state
licensing board, that absence does not weigh for or against revocation.
See, e.g., Ajay S. Ahuja, M.D., 84 FR 5479, 5490 (2019) (finding that
``where the record contains no evidence of a recommendation by a state
licensing board that absence does not weigh for or against
revocation.''); Holiday CVS LLC dba CVS Pharmacy Nos 219 and 5195, 77
FR 62,316, 62,340 (2012); Roni Dreszer, M.D., 76 FR 19,434, 19,444
(2011). Accordingly, I agree with the ALJ's finding that Factor One
does not weigh for or against revocation in this matter.
As to Factor Three, there is no evidence that Respondent Pharmacy's
owner or any of its employees have been convicted of an offense under
either federal or state law ``relating to the manufacture,
distribution, or dispensing of controlled substances.'' 21 U.S.C.
823(f)(3). However, there are a number of reasons why even a person who
has engaged in criminal misconduct may never have been convicted of an
offense or even prosecuted for one. Dewey C. MacKay, M.D., 75 FR
49,956, 49,973 (2010), pet. for rev. denied, MacKay v. Drug Enf't
Admin., 664 F.3d 808, 822 (10th Cir. 2011). Therefore, the DEA has held
that ``the absence of such a conviction is of considerably less
consequence in the public interest inquiry'' and is not dispositive.
Id. Accordingly, I agree with the ALJ and find that Factor Three weighs
neither for nor against revocation in this case.
B. Factors Two and Four
As already discussed, pursuant to section 304 of the CSA, in
conjunction with section 303 of the CSA, I am to consider evidence of
Respondent Pharmacy's compliance (or non-compliance) with laws related
to controlled substances and experience dispensing controlled
substances in determining whether Respondent Pharmacy's continued
registration is ``consistent with the public interest.'' 21 U.S.C.
824(a)(4). ``[A] registrant's `ignorance of the law is no excuse' for
actions that are inconsistent with responsibilities attendant upon a
registration.'' Daniel A. Glick, D.D.S., 80 FR 74,800, 74,809 (2015)
(quoting Sigrid Sanchez, M.D., 78 FR 39,331, 39,336 (2013)). Instead,
``[a]ll registrants are charged with knowledge of the CSA, its
implementing regulations, as well as applicable state laws and rules.''
Id. at 74,809 (internal citations omitted). Further, the Agency has
consistently concluded that a pharmacy's registration is subject to
revocation due to the unlawful activity of the pharmacy's owners,
majority shareholders, officers, managing pharmacist, or other key
employee. EZRX, LLC, 69 FR 63,178, 63,181 (2004); Plaza Pharmacy, 53 FR
36,910, 36,911 (1988).
In this matter, the Government alleged and presented evidence that
pharmacists at Respondent Pharmacy and Cedar Hill filled over 200
prescriptions ``in contravention of their `corresponding
responsibility' under 21 CFR 1306.04(a)'' and ``outside the usual
course of pharmacy practice in violation of 21 CFR 1306.06.'' ALJX 1,
at 2. The Government further alleged that in the course of filling the
prescriptions, Respondent Pharmacy violated Texas Health and Safety
Code Sec. Sec. 481.074(a), (k) and 481.128 and Title 22 of the Texas
Administrative Code Sec. 291.33(c)(2). Id. at 3-4. The Government also
alleged and presented evidence that Respondent Pharmacy violated 21 CFR
1301.76(a) by employing Dr. Amadi in a position where he had access to
controlled substances. Id. at 2. Finally, the Government alleged that
Respondent Pharmacy committed several recordkeeping violations:
Respondent Pharmacy failed to maintain an initial inventory as required
by 21 U.S.C. 827(a)(1) and 21 CFR 1304.11; Respondent Pharmacy failed
to notate whether individual controlled substances that it ordered were
actually received, and if so, on what date they were received on DEA-
222 forms, as required by 21 U.S.C. 828(a) and 21 CFR 1305.05, and on
its invoices, as required by 21 U.S.C. 827(a)(3) and 21 CFR 1304.21(d);
Respondent Pharmacy authorized Dr. Amadi to issue orders for controlled
substances on Respondent Pharmacy's behalf without executing a
[[Page 51060]]
power of attorney, as required by 21 CFR 1305.05(a); and an audit of
Respondent Pharmacy's oxycodone and hydrocodone revealed a shortage of
oxycodone and an overage of hydrocodone.\33\ Id. at 7. These
allegations and the evidence of record are addressed below.
---------------------------------------------------------------------------
\33\ As will be discussed, infra, the regulations the Government
cited in the OSC for the alleged recordkeeping violations do not
always align with the stated allegations.
---------------------------------------------------------------------------
1. Unlawful Employment
The Government alleged that Respondent Pharmacy employed Dr. Amadi
as a pharmacist in violation of 21 CFR 1301.76(a). ALJX 1, at 2.
Section 1301.76(a) provides, in part, that a ``registrant shall not
employ, as an agent or employee who has access to controlled
substances, any person who has . . . surrendered a DEA registration for
cause.'' \34\ The Agency has explained that the purpose of this
regulation is to prevent a DEA registrant from hiring an individual who
would probably be denied a DEA registration due to his or her past
experience with controlled substances. Registration of Manufacturers,
Distributers, and Dispensers of Controlled Substances, 56 FR 36,727
(August 1, 1991). ``To hire such a person, the registrant must obtain a
waiver under circumstances which clearly show that the registrant has
been fully informed about the proposed employee's past experience with
controlled substances and that the registrant intends to take adequate
measures to ensure that no increased risk of diversion is occasioned by
the proposed employment.'' Id. The employment prohibition in Sec.
1301.76(a) applies both to an individual who that surrendered his or
her own registration as a practitioner and to an individual who
surrendered a registration on behalf of a pharmacy owned or principally
operated by the individual. See id.
---------------------------------------------------------------------------
\34\ The regulation further defines ``for cause'' to include
``surrender in lieu of, or as a consequence of, any federal . . .
administrative . . . action resulting from an investigation of the
individual's handling of controlled substances.'' 21 CFR 1301.76(a).
---------------------------------------------------------------------------
The ALJ recommended that I sustain the Government's allegation that
Respondent Pharmacy violated Sec. 1301.76(a) by employing Dr. Amadi as
a pharmacist because Dr. Amadi had previously surrendered for cause the
DEA registration of a pharmacy that he owned, Bestaid Pharmacy. RD, at
60. Respondent Pharmacy argued the ALJ's recommendation was incorrect
because the Government did ``not meet its burden that Dr. Amadi
controlled or had access to controlled substances during his
employment'' at Respondent Pharmacy. Resp Exceptions, at 13. I agree
with the ALJ.
Respondent Pharmacy employed Dr. Amadi as a staff pharmacist and
pharmacist-in-charge. Supra II.D. Prior to his employment at Respondent
Pharmacy, Dr. Amadi had surrendered the DEA registration for Bestaid
Pharmacy for cause. Id. He was therefore ineligible for employment in a
position with access to controlled substances pursuant to Sec. 1301.76
absent a waiver from the DEA. As I already found, there is substantial
evidence in the record that Dr. Amadi had access to controlled
substances at Respondent Pharmacy--he was listed with the state as the
pharmacist-in-charge, his initials appear on the prescription fill
stickers for controlled substances throughout the Government's
Exhibits, his signature appears on some of the filled prescriptions for
controlled substances, and he ordered Respondent Pharmacy's controlled
substances. Id. Accordingly, I find that Respondent Pharmacy violated
21 CFR 1301.76(a) by employing Dr. Amadi in a capacity where he had
access to controlled substances absent a waiver from DEA.
2. Unlawful Dispensing Allegations
According to the CSA's implementing regulations, a lawful
controlled substance order or prescription is one that is ``issued for
a legitimate medical purpose by an individual practitioner acting in
the usual course of his professional practice.'' 21 CFR 1306.04(a).
While the ``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. The regulations establish the parameters of the
pharmacy's corresponding responsibility.
An order purporting to be a prescription issued not in the usual
course of professional treatment . . . is not a prescription within
the meaning and intent of . . . 21 U.S.C. 829 . . . and the person
knowingly filling such a purported prescription, as well as the
person issuing it, shall be subject to the penalties provided for
violations of the provisions of law relating to controlled
substances.
Id. ``The language in 21 CFR 1306.04 and caselaw could not be more
explicit. A pharmacist has his own responsibility to ensure that
controlled substances are not dispensed for non-medical reasons.''
Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730
(1990) (citing United States v. Hayes, 595 F.2d 258 (5th Cir. 1979),
cert. denied, 444 U.S. 866 (1979); United States v. Henry, 727 F.2d
1373 (5th Cir. 1984) (reversed on other grounds)). As the Supreme Court
explained in the context of the CSA's requirement that schedule II
controlled substances may be dispensed only by written prescription,
``the prescription requirement . . . ensures patients use controlled
substances under the supervision of a doctor so as to prevent addiction
and recreational abuse . . . [and] also bars doctors from peddling to
patients who crave the drugs for those prohibited uses.'' Gonzales v.
Oregon, 546 U.S. 243, 274 (2006).
To prove a pharmacist violated his corresponding responsibility,
the Government must show that the pharmacist acted with the requisite
degree of scienter. See 21 CFR 1306.04(a) (``[T]he person knowingly
filling [a prescription issued not in the usual course of professional
treatment] . . . shall be subject to the penalties provided for
violations of the provisions of law relating to controlled
substances.'') (emphasis added). DEA has also consistently interpreted
the corresponding responsibility regulation such 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); see, also JM Pharmacy
Group, Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR
28,667, 28,670-72 (2015) (applying the standard of willful blindness in
assessing whether a pharmacist acted with the requisite scienter).
Pursuant to their corresponding responsibility, pharmacists must
exercise ``common sense and professional judgment'' when filling a
prescription issued by a physician. Bertolino, 55 FR at 4730. When a
pharmacist's suspicions are aroused by a red flag, the pharmacist must
question the prescription and, if unable to resolve the red flag,
refuse to fill the prescription. Id.; Medicine Shoppe-Jonesborough, 300
F. App'x 409, 412 (6th Cir. 2008) (``When pharmacists' suspicions are
aroused as reasonable professionals, they must at least verify the
prescription's propriety, and if not satisfied by the answer they must
refuse to dispense.'').
In this matter, the Government did not allege that Respondent
dispensed the subject prescriptions having actual knowledge that the
prescriptions lacked a legitimate medical purpose. Instead, the
Government alleged that Respondent violated the corresponding
responsibility regulation as evidenced by it ``repeatedly
distribut[ing]
[[Page 51061]]
controlled substances pursuant to prescriptions that contained one or
more unresolved red flags for diversion.'' Govt Posthearing, at 30.
As I already found, the subject prescriptions from Respondent
Pharmacy and Cedar Hill presented multiple red flags including pattern
prescribing, distance, cash payments, drug cocktails, high doses/
quantities of high-alert controlled substances, different doctors
prescribing controlled substances to the same patient, patients with
the same last name and address presenting the same prescription within
a short period of time, therapeutic duplication (two drugs in the same
class prescribed together), and prescriptions lacking the patient's
address or the prescriber's DEA number. Agency decisions have
consistently found that prescriptions with the same red flags at issue
here were so suspicious as to support a finding that the pharmacists
who filled them violated the Agency's corresponding responsibility rule
due to actual knowledge of, or willful blindness to, the prescriptions'
illegitimacy. 21 CFR 1306.04(a); see, e.g., Pharmacy Doctors
Enterprises d/b/a Zion Clinic Pharmacy, 83 FR 10,876, 10,898, pet. for
rev. denied, 789 F. App'x 724 (11th Cir. 2019) (long distances; pattern
prescribing; customers with the same street address presenting the same
prescriptions on the same day; drug cocktails; cash payments; early
refills); Hills Pharmacy, 81 FR 49,816, 49,836-39 (2016) (multiple
customers filling prescriptions written by the same prescriber for the
same drugs in the same quantities; customers with the same last name
and street address presenting similar prescriptions on the same day;
long distances; drug cocktails); The Medicine Shoppe, 79 FR 59,504,
59,507, 59,512-13 (2014) (unusually large quantity of a controlled
substance; pattern prescribing; irregular dosing instructions; drug
cocktails); Holiday CVS, 77 FR 62,316, 62,317-22 (2012) (long
distances; multiple customers filling prescriptions written by the same
prescriber for the same drugs in the same quantities; customers with
the same last name and street address presenting virtually the same
prescriptions within a short time span; payment by cash); East Main
Street Pharmacy, 75 FR 66,149, 66,163-65 (2010) (long distances; lack
of individualized therapy or dosing; drug cocktails; early fills/
refills; other pharmacies' refusals to fill the prescriptions). Texas
state law also leaves no question that Respondent Pharmacy and Cedar
Hill knew, or should have known, that the prescriptions presented red
flags as all of the red flags are explicitly identified in state law as
circumstances a Texas pharmacist must identify before filling a
prescription.\35\ Dr. Witte credibly testified that a Texas pharmacist
acting in the usual course of professional practice should have
recognized these red flags and that a Texas pharmacist acting in the
usual course of professional practice will not fill prescriptions for
controlled substances without investigating, documenting the
investigation, and resolving any red flags. Supra II.F.1. Dr. Amadi
also admitted during his testimony that he had actual knowledge of some
of the red flags on the prescriptions. For example, Dr. Amadi testified
that he knew that a drug cocktail of hydrocodone and alprazolam has the
potential for abuse and claimed that he often called doctors when
patients presented with prescriptions for drug cocktails, demonstrating
his awareness that drug cocktails are a red flag that require
resolution, yet he repeatedly filled prescriptions for drug cocktails
without adequate investigation and resolution of the red flag. Tr. 571-
72, 575. From the fact that there is no evidence that Respondent
Pharmacy or Cedar Hill adequately investigated and resolved the
multiple, egregious red flags on the subject prescriptions before
filling them, I find that Respondent Pharmacy and Cedar Hill either
knew the prescriptions were issued without a legitimate medical purpose
or dispensed the prescriptions knowing there was a high probability
that the prescriptions were issued without a legitimate medical
purpose.
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\35\ 22 Tex. Admin. Code Sec. 291.29(c) (distance, doctor
shopping), (f) (pattern prescribing, drug cocktails, high doses/
quantities or high-alert controlled substances, multiple persons
with the same address present substantially similar controlled
substance prescriptions from the same practitioner, cash payments);
id. at Sec. 291.33 (c)(2)(A) (therapeutic duplication); Tex. Health
& Safety Code Sec. 481.074(k)(3), (7) (prescription for controlled
substance must contain patient address and prescriber DEA number).
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Accordingly, I agree with the ALJ's finding in the RD that the
Government has proven by substantial evidence that Respondent Pharmacy
and Cedar Hill filled prescriptions for controlled substances that the
pharmacists knew were not prescribed for legitimate medical purposes,
or were willfully blind to such, in violation of their corresponding
responsibility under 21 CFR 1306.04(a). I also agree with the ALJ's
finding that by filling the subject prescriptions without resolving the
red flags and documenting the resolution, Respondent Pharmacy violated
Tex. Health & Safety Code Sec. Sec. 481.074(a) and 481.128 and 22 Tex.
Admin. Code Sec. 291.33(c) and acted outside the usual course of
professional practice in violation of 21 CFR 1306.06.\36\
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\36\ As discussed supra, Tex. Health & Safety Code Sec.
481.074(a) provides in relevant part that ``[a] pharmacist may not:
(1) Dispense or deliver a controlled substance . . . except under a
valid prescription and in the course of professional practice; (2)
dispense a controlled substance if the pharmacist knows or should
have known that the prescription was issued without a valid patient-
practitioner relationship; (3) fill a prescription that is not
filled or issued as prescribed by [the Texas Controlled Substances
Act].'' Section 481.128 states in relevant part ``[a] registrant or
dispenser commits an offense if the registrant or dispenser
knowingly: (1) Distributes, delivers, administers, or dispenses a
controlled substance in violation of [Sec. 481.074].'' 22 Tex.
Admin. Code Sec. 291.33(c)(2) provides in relevant part that
(A)(i) . . . [a] pharmacist shall, prior to or at the time of
dispensing a prescription drug order, review the patient's
medication record. Such review shall at a minimum identify
clinically significant . . . (III) reasonable dose and route of
administration; . . . (V) duplication of therapy; (IV) drug-drug
interactions; . . . (X) proper utilization, including
overutilization or underutilization. . . . (ii) Upon identifying any
clinically significant situations conditions, situations, or items
listed in clause (i) of this subparagraph, the pharmacist shall take
appropriate steps to avoid or resolve the problem including
consultation with the prescribing practitioner . . . . (iv) Prior to
dispensing, any questions regarding a prescription drug order must
be resolved with the prescriber and written documentation of these
discussions made and maintained. . . . (C) . . . [A]nd [such
documentation] shall include the following information: (i) Date the
prescriber was consulted; (ii) name of the person communicating the
prescriber's instructions; (iii) any applicable information
pertaining to the consultation; and (iv) initials or identification
code of the pharmacist performing the consultation clearly recorded
for the purpose of identifying the pharmacist who performed the
consultation.
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I considered and reject Respondent Pharmacy's claim that it
investigated and resolved the red flags on the subject prescriptions
before they were filled and therefore complied with its corresponding
responsibility. Resp Exceptions, at 10, 15; Resp Posthearing, at 5, 8-
10, 12-13. In its Exceptions, Respondent Pharmacy summarized Dr.
Amadi's testimony regarding Respondent Pharmacy's protocol for filling
controlled substance prescriptions, which he stated included ``looking
to see if a prior record exist [sic] for the customer, had the filled
the same prescription before [sic], which doctor prescribed the
prescription, the dosage amount, duration, check the Texas prescription
monitoring program, and call the doctor.'' Resp Exceptions, at 17
(citing Tr. 566). I reject Respondent Pharmacy's Exception for the
following reasons. First, as I already discussed, I do not credit Dr.
Amadi's testimony regarding his investigation and resolution of red
flags on Respondent Pharmacy's prescriptions. His testimony
[[Page 51062]]
was riddled with inconsistencies, and the ALJ observed, and I agree,
that ``I am left with the sense that Dr. Amadi was making up testimony
to fit the questions that were posed to him.'' RD, at 12-13. Second,
Respondent Pharmacy did not present contemporaneous documentation of
its resolution of the red flags--documentation that is required in the
state of Texas. None of the prescriptions or patient profiles from
Respondent Pharmacy contain pharmacist remarks regarding the red flags
on the prescriptions, and the remarks in the Respondent's profiles
(which I give no weight for reasons already discussed) are undated,
fail to address all of the red flags on the prescriptions, and
universally lack information required by Texas law. Finally, the red
flags on the Cedar Hill prescriptions were unresolvable. Dr. Witte
credibly testified that the red flags on the Cedar Hill prescriptions
were so egregious that no explanation from the prescriber could have
justified filling the prescriptions. Tr. 288-89, 436; see United States
v. Hayes, 595 F.2d at 260 (``Verification by the issuing practitioner
on request of the pharmacist is evidence that the pharmacist lacks
knowledge that the prescription was issued outside the scope of
professional practice. But it is not an insurance policy against a fact
finder's concluding that the pharmacist had the requisite knowledge
despite a purported but false verification. . . . What is required by
[a pharmacist] is the responsibility not to fill an order that purports
to be a prescription but is not a prescription within the meaning of
the statute because he knows that the issuing practitioner issued it
outside the scope of medical practice.'').
I also considered Respondent Pharmacy's objection to the
introduction of the Cedar Hill prescriptions on the bases of relevancy
both during the hearing and in the Exceptions it filed to the
Recommended Decision. Tr. 81-82; Resp Exceptions, at 22. Respondent
Pharmacy argued that the propriety of filling the Cedar Hill
prescriptions is a moot point as Cedar Hill ceased operating as a
pharmacy and surrendered its DEA registration before the OSC issued and
any violations of controlled substance laws by Cedar Hill are not
relevant to Respondent Pharmacy.
The DEA treats two separately organized business entities as one
integrated enterprise based on overlap of ownership, management, and
operations of the two entities. Jones Total Health Care Pharmacy, 81 FR
at 79,222 (citing MB Wholesale, Inc., 72 FR 71,956, 71,958 (2007)).
``[W]here misconduct has previously been proved with respect to the
owners, officers, or key employees of a pharmacy, the Agency can deny
an application or revoke a registration of a second or subsequent
pharmacy where the Government shows that such individuals have
influence over the management or control of the second pharmacy.''
Superior Pharmacy I and Superior Pharmacy II, 81 FR 31,310, 31,341,
n.71 (2016). Further, the Agency may revoke a registration, even if
there is no misconduct that can be attributed to the registration, if
the Agency finds that the registrant committed egregious misconduct
under a second registration. Roberto Zayas, M.D., 82 FR 21,410, 21,430
(2017) (revoking physician's DEA registration in Florida due to conduct
attributed to a Texas registration which had expired).
In this case, the evidence established that Respondent Pharmacy and
Cedar Hill, though nominally two separate entities, were commonly
owned, managed, and operated. COIF-SOE and Ms. Amadi own both
pharmacies, supra II.A., and Ms. Amadi and Stephen Amadi are listed
with the Texas State Board of Pharmacy as the only officers of the two
pharmacies, GX 16, at 2; GX 18, at 2. In terms of management and
operations, the pharmacies shared the same key employees. The
pharmacist that filled the subject Cedar Hill prescriptions, Mr. Ohene,
was the pharmacist-in-charge at Respondent Pharmacy at the time he
filled the Cedar Hill prescriptions, and Mr. Ohene was still employed
as a pharmacist at Respondent Pharmacy as of the hearing for this
matter. GX 16, at 1; GX 18, at 3; GX 10 (prescriptions with Mr. Ohene's
signature and fill stickers with his initials); Resp Posthearing, at 4
(claiming Mr. Ohene was the only person with access to controlled
substances at Respondent Pharmacy). Dr. Amadi was the pharmacist-in-
charge at Cedar Hill when the subject Cedar Hill prescriptions were
filled and was the pharmacist-in-charge at Respondent Pharmacy at the
time of the hearing. GX 16, at 1; GX 18, at 2. Additionally, when Cedar
Hill surrendered its registration in June 2015, all of its controlled
substances were transferred to Respondent Pharmacy further
demonstrating the commonality between the ownership and operation of
the two pharmacies.
Due to the commonality of ownership, management, and key employees
between Respondent Pharmacy and Cedar Hill, any misconduct related to
controlled substances at Cedar Hill is relevant to the determination of
whether Respondent Pharmacy can be entrusted with registration. It is
therefore appropriate that I consider whether the pharmacists at Cedar
Hill satisfied their corresponding responsibility when filling the
Cedar Hill prescriptions. However, even if I were to exclude the Cedar
Hill prescriptions from consideration in this matter, it would in no
way affect my decision in this case.
3. Recordkeeping Allegations
In addition to its mandate that controlled substances be dispensed
properly, the CSA also recognizes that controlled substances are
fungible and that a truly closed system requires that certain records
and inventories be kept by all registrants who either generate or take
custody of controlled substances in any phase of the distribution chain
until they reach the ultimate user. Satinder Dang, M.D., 76 FR 51,424,
51,429 (2011) (``Recordkeeping is one of the central features of the
CSA's closed system of distribution.'') (internal citations omitted);
Paul H. Volkman, 73 FR 30,630, 30,644 (2008), pet. for rev. denied 567
F.3d 215, 224 (6th Cir. 2009) (``Recordkeeping is one of the CSA's
central features; a registrant's accurate and diligent adherence to
this obligation is absolutely essential to protect against the
diversion of controlled substances.''). The OSC alleged that Respondent
Pharmacy violated multiple federal laws related to the maintenance of
records.
a. Initial Inventory
The Government alleged Respondent Pharmacy violated 21 U.S.C.
827(a)(1) and 21 CFR 1304.11(b) by failing to provide an initial
inventory of its controlled substances. ALJX 1, at 7. 21 U.S.C.
827(a)(1) requires all registrants to conduct an initial inventory of
all controlled substances on hand on the first day it engages in the
manufacture, distribution, or dispensing of controlled substances. See
also 21 CFR 1304.11(b) (``Every person required to keep records shall
take an inventory of all stocks of controlled substances on hand on the
date he/she first engages in the . . . distribution of controlled
substances.''). Further, the inventory ``must be kept by the registrant
and be available, for at least 2 years from the date of such inventory
. . . for inspection and copying by authorized employees of the
Administration.'' 21 CFR 1304.04(a).\37\ Investigator One credibly
testified that Respondent Pharmacy failed to provide
[[Page 51063]]
an initial inventory to the Government despite repeated requests from
Investigator One both during and following the inspection of Respondent
Pharmacy. Supra II.E.1.a. I also already found that Respondent Pharmacy
did not produce an initial inventory during the hearing on this matter
to counter the Government's allegation.\38\ Id. I find, therefore, that
there is substantial record evidence that Respondent Pharmacy failed to
maintain an initial inventory and, therefore, violated 21 U.S.C.
827(a)(1) and 21 CFR 1304.11(b).
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\37\ The Government did not allege that Respondent Pharmacy
violated 21 CFR 1304.04 as part of its recordkeeping allegations and
therefore I am making no findings related to this section, but am
instead including this reference in order to support my findings
related to the alleged violation of 21 CFR 1304.11.
\38\ As discussed supra, Respondent Pharmacy claimed it had
produced an initial inventory as Respondent's Exhibit U, but there
was no Respondent's Exhibit U in the record and none of Respondent
Pharmacy's other exhibits contained an initial inventory. This
Agency has applied, and I apply here, the ``adverse inference
rule.'' As the D.C. Circuit explained, ``the rule provides that when
a party has relevant evidence within his control which he fails to
produce, that failure gives rise to an inference that the evidence
is unfavorable to him.'' Int'l Union, United Auto., Aerospace &
Agric. Implement Workers of Am. (UAW) v. Nat'l Labor Relations Bd.,
459 F.2d 1329, 1336 (DC Cir. 1972). The Court reiterated this rule
in Huthnance v. District of Columbia, 722 F.3d 371, 378 (DC Cir.
2013). According to this legal principle, Respondent Pharmacy's
decision not to provide evidence within its control gives rise to an
inference that any such evidence is unfavorable to Respondent
Pharmacy.
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b. 222 Order Forms
Next, the Government alleges that Respondent Pharmacy, as a
purchaser of controlled substances, failed to document the date and
number of items received on four 222 Forms, in violation of 21 U.S.C.
828(a) and 21 CFR 1305.05(a).\39\ To support this allegation, the
Government presented four 222 Forms on which Respondent Pharmacy failed
to record the date received or the quantity of items received for at
least one of the controlled substances ordered on each of the subject
222 Forms. Supra II.E.1.b.
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\39\ Although cited by the Government in the OSC, 21 CFR
1305.05(a) has nothing to do with a registrant's obligation to
document the date and number of controlled substances received on
the purchaser's copy of the 222 Form. Neither the Government nor
Respondent Pharmacy addressed this allegation in their posthearing
briefs.
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Under the CSA, purchases of schedule II controlled substances must
be made using an Agency order form. 21 U.S.C. 828(a). DEA regulations
require those order forms, known as 222 Forms, to be signed and dated
by an authorized person. 21 CFR 1305.12(d). The regulations further
provide that a purchaser of controlled substances must indicate on the
222 Form itself the date on which each substance was received and the
quantity received. 21 CFR 1305.13(e). The purchaser, however, is under
no regulatory obligation to document its failure to receive a
controlled substance on a 222 Form if the controlled substance does not
arrive from the seller. Hills Pharmacy, L.L.C., 81 FR at 49,843 (``DEA
regulations do not require a purchaser to notate on the order form that
no portion of a particular item was received and a date.''). 21 CFR
1305.13(e) only requires recording the date and quantity of controlled
substance actually received. There is no requirement to indicate the
date of non-receipt.
Here, there is no evidence that Respondent Pharmacy ever received
the controlled substances for which the date and quantity received were
missing from the four 222 Forms presented by the Government. Supra
II.E.1.b. The mere existence of an improperly completed 222 Form is
insufficient to show that a registrant actually received the controlled
substances listed on the form. Superior Pharmacy, 81 FR at 31,338.
Thus, I find the Government has failed to prove this allegation.
c. Invoices
The Government also alleged that Respondent Pharmacy violated 21
U.S.C. 827(a)(3) and 21 CFR 1304.21(d), when it failed to document the
date it received shipments of controlled substances on the shipment
invoices. ALJX 1, at 7. 21 U.S.C. 827(a)(3) requires registrants that
dispense controlled substances, such as pharmacies, to maintain, on a
current basis, an accurate record of each controlled substance it
receives. DEA regulations implementing this requirement state that
pharmacies must maintain a record of each order of controlled
substances that includes the date of receipt, the quantity acquired,
and the name, address, and registration number of the person from whom
the substances were acquired. 21 CFR 1304.22(a)(2)(iv) and (c). DEA
regulations further state that when recording the dates of receipt, the
date on which the controlled substances are actually received will be
used as the date of receipt. Id. at Sec. 1304.21(d). I already found
that Respondent Pharmacy did not record the date it received controlled
substances on 31 invoices for schedule III-V controlled substances.
Respondent Pharmacy thus failed to comply with its obligation to
maintain an accurate record of each controlled substance it received.
d. Audit Discrepancies
The Agency has also considered a pharmacy registrant's inability to
account for controlled substances under Factor Four. Ideal Pharmacy
Care, Inc., 76 FR 51,415, 51,416 (2011). Under the CSA, every
registrant ``distributing, or dispensing a controlled substance or
substances shall maintain, on a current basis, a complete and accurate
record of each such substance . . . received, sold, delivered, or
otherwise disposed of by [it].'' 21 U.S.C. 827(a)(3). In evaluating
shortages under Factor Four, the Agency has held that, ``[w]hether the
shortages are attributable to outright diversion by either pharmacy or
store employees, theft, or the failure to maintain accurate records,
does not matter.'' Ideal Pharmacy Care, 76 FR at 51,416. As the Agency
has explained, the ``inability to account for [a] significant number of
dosage units creates a grave risk of diversion.'' Fred Samimi, 79 FR
18,698, 18,712 (2014). The Agency has also made it clear that it is not
only concerned with shortages, but that overages are equally indicative
that a pharmacy registrant has ``failed to maintain complete and
accurate records as required by the CSA.'' Superior Pharmacy, 81 FR at
31,341; see also Hills Pharmacy, 81 FR at 49,843-45 (considering
allegations of overages and shortages).
Investigator One's audit of Respondent Pharmacy revealed an overage
of 16,731 doses of hydrocodone 10/325 mg and a shortage of 200 doses of
oxycodone 30 mg. GX 21, at 1. There is no evidence, however, that
Respondent Pharmacy actually received the 200 tablets of oxycodone that
were missing. Tr. 210. I find, therefore, that there is substantial
evidence to support the allegation that Respondent Pharmacy failed to
keep a current and accurate record of hydrocodone 10/325mg but that the
Government did not prove by a preponderance of the evidence that
Respondent Pharmacy failed to keep a current and accurate record of
oxycodone 30mg.
e. Authority To Order Controlled Substances
Lastly, the Government alleged that Respondent Pharmacy, as a
purchaser of controlled substances, authorized one or more individuals
to issue orders for controlled substances on Respondent Pharmacy's
behalf without executing a power of attorney for such individuals, in
violation of 21 CFR 1305.05(a). ALJX 1, at 7. Section 1305.05(a)
provides that a registrant may authorize an individual to order
``[s]chedule I and II controlled substances on the registrant's behalf
by executing a power of attorney for each such individual.'' 21 CFR
1305.05(a).
I found, supra, that Dr. Amadi ordered schedule II controlled
substances for Respondent Pharmacy. He was Respondent Pharmacy's sole
employee with access to CSOS, through which Respondent Pharmacy placed
electronic orders for schedule II controlled substances, and his
signature
[[Page 51064]]
appears on 222 Order forms from Respondent Pharmacy. Compare GX 22, at
1, 2, 4, 8, 9, 12, with GX 23, at 7, 36; Tr. 70-71. In order for Dr.
Amadi to lawfully order controlled substances, Ms. Amadi would have
needed to grant power of attorney to Dr. Amadi. \40\ Respondent
Pharmacy did not have any powers of attorney on file. Tr. 62; Resp
Posthearing, at 10 (admitting Ms. Amadi never executed a power of
attorney to Dr. Amadi). Without the requisite power of attorney
allowing Dr. Amadi to order controlled substances, his doing so
violated 21 CFR 1305.05(a).
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\40\ 21 CFR 1305.05(d) states that the power of attorney must be
executed by the person who signed the most recent application for
DEA registration or reregistration. Ms. Amadi signed the application
for Respondent Pharmacy's DEA registration. GX 17, at 1.
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Accordingly, I find that there is substantial evidence to support
the Government's allegation that Respondent Pharmacy violated 21 CFR
1305.05(a).
C. Summary of the Public Interest Factors
As found above, Respondent Pharmacy and Cedar Hill filled
controlled substance prescriptions for dozens of patients in violation
of their corresponding responsibility and Texas law. Respondent
Pharmacy also violated numerous federal and state record keeping
requirements related to controlled substances and knowingly violated
DEA regulations by employing Dr. Amadi in a position where he had
access to controlled substances after Respondent Pharmacy's waiver was
denied. Thus, I conclude that Respondent Pharmacy has engaged in
misconduct which supports the revocation of its registration. I
therefore hold that the Government has established a prima facie case
that Respondent Pharmacy's continued registration ``would be
inconsistent with the public interest.'' 21 U.S.C. 823(f).
IV. Sanction
Where, as here, the Government has met its prima facie burden of
showing that the respondent's continued registration is inconsistent
with the public interest due to its violations pertaining to controlled
substance dispensing and recordkeeping, the burden shifts to the
respondent to show why it can be entrusted with the responsibility
carried by its registration. Garret Howard Smith, M.D., 83 FR 18,882,
18,910 (2018) (citing Samuel S. Jackson, 72 FR 23,848, 23,853 (2007)).
DEA cases have repeatedly found that when a registrant has committed
acts inconsistent with the public interest, ``the Respondent is
required not only to accept responsibility for [the established]
misconduct, but also to demonstrate what corrective measures [have
been] undertaken to prevent the reoccurrence of similar acts.'' Holiday
CVS, 77 FR at 62,339 (internal quotations omitted). See, also, Hoxie v.
Drug Enf't Admin., 419 F.3d 477, 483 (6th Cir. 2005); Ronald Lynch,
M.D., 75 FR 78,745, 78,749, 78,754 (2010) (holding that respondent's
attempts to minimize misconduct undermined acceptance of
responsibility); Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008)
(noting that the respondent did not acknowledge recordkeeping problems,
let alone more serious violations of federal law, and concluding that
revocation was warranted).
The issue of trust is necessarily a fact-dependent determination
based on the circumstances presented by the individual respondent;
therefore, the Agency looks at factors, such as the acceptance of
responsibility and the credibility of that acceptance as it relates to
the probability of repeat violations. Jeffrey Stein, M.D., 84 FR
46,968, 46,972 (2019). A registrant's candor during the investigation
and hearing is an important factor in determining acceptance of
responsibility and the appropriate sanction, Garret Howard Smith, M.D.,
83 FR at 18,910 (collecting cases); as is whether the registrant's
acceptance of responsibility is unequivocal, Lon F. Alexander, M.D., 82
FR 49,704, 49,728 (2017) (collecting cases). In determining whether and
to what extent a sanction is appropriate, consideration must be given
to both the egregiousness of the offense established by the
Government's evidence and the Agency's interest in both specific and
general deterrence. Wesley Pope, 82 FR 14,944, 14,985 (2017) (citing
Joseph Gaudio, 74 FR 10,083, 10,095 (2009)); David A. Ruben, M.D., 78
FR 38,363, 38,364 (2013). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 (2d
Cir. 2005) (upholding SEC's express adoption of ``deterrence, both
specific and general as a component in analyzing the remedial efficacy
of sanctions.'').
Regarding all of these matters, I agree with the analyses and
conclusions contained in the Recommended Decision. RD, at 101-04. I
agree with the ALJ that there is nothing in the record that suggests
Respondent Pharmacy has accepted responsibility for its actions. Dr.
Amadi took no responsibility for his actions or the actions of
Respondent Pharmacy's other pharmacists during his testimony, and
Respondent Pharmacy's owner, Ms. Amadi, did not appear at the hearing.
A review of Respondent Pharmacy's Posthearing Brief and its Exceptions
to the Recommended Decision also give no hint of acceptance of
responsibility. Further, even if Respondent Pharmacy had unequivocally
accepted responsibility for all its unlawfulness such that I would
reach the matter of remedial measures, Respondent Pharmacy has not
presented any remedial measures for me to consider.
The ALJ found that the record supports the imposition of a
sanction. RD, at 105. I agree that is the appropriate result on the
record in this case.
The egregiousness of Respondent Pharmacy's conduct and the
interests of specific and general deterrence support a sanction of
revocation. Respondent Pharmacy and Cedar Hill filled approximately 200
prescriptions that contained red flags of diversion and abuse
sufficiently flagrant that they provide substantial evidence that the
pharmacists knowingly filled prescriptions that lacked a legitimate
medical purpose. The red flags surrounding the Cedar Hill prescriptions
were so egregious the ALJ found that they support a conclusion that
Cedar Hill was involved in the diversion of controlled substances. RD,
at 103. Respondent Pharmacy also knowingly employed Dr. Amadi in a
position where he had access to controlled substances, even after
Respondent Pharmacy's request for a waiver was denied. As the ALJ found
``[s]uch a knowing violation totally undercuts any suggestion that the
[Respondent] Pharmacy can be entrusted with the responsibilities
inherent to a DEA certificate of registration.'' RD, at 103.
``Past performance is the best predictor of future performance,''
ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995),
and there is nothing in the record that lends support to the
proposition that Respondent Pharmacy's future behavior will deviate in
any positive respect from its past behavior. Due to the fact that
Respondent Pharmacy has accepted no responsibility nor offered any
remedial measures, it has given me no reassurances that I can entrust
it with a controlled substances registration and no evidence that it
will not repeat its egregious behavior.
Regarding general deterrence, the Agency bears the responsibility
to deter similar misconduct on the part of others for the protection of
the public at large. David A. Ruben, 78 FR at 38,385. Based on the
number and egregiousness of the established violations in this case, a
[[Page 51065]]
sanction less than revocation would send a message to the regulated
community that compliance with the law is not a condition precedent to
maintaining registration.
A balancing of the statutory public interest factors, coupled with
consideration of Respondent Pharmacy's failure to accept
responsibility, the absence of any evidence of remedial measures to
guard against recurrence, and the Agency's interest in deterrence,
supports the conclusion that Respondent Pharmacy should not continue to
be entrusted with a registration. Accordingly, I shall order the
sanctions the Government requested, as contained in the Order below.
V. ORDER
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration
FM3950070 issued to Morning Star Pharmacy & Medical Supply 1. Further,
pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C.
823(f), I hereby deny any pending application of Morning Star Pharmacy
& Medical Supply 1 to renew or modify this registration. This order is
effective September 18, 2020.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-18083 Filed 8-18-20; 8:45 am]
BILLING CODE 4410-09-P
