[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Pages 21008-21048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08018]
[[Page 21007]]
Vol. 86
Wednesday,
No. 75
April 21, 2021
Part III
Department of Justice
-----------------------------------------------------------------------
Drug Enforcement Administration
-----------------------------------------------------------------------
The Pharmacy Place Order; Notice
Federal Register / Vol. 86, No. 75 / Wednesday, April 21, 2021 /
Notices
[[Page 21008]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17-26]
The Pharmacy Place Order
On April 3, 2017, a former Assistant Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause (hereinafter, OSC) to The Pharmacy Place
(hereinafter, Respondent) of Plano, Texas. Administrative Law Judge
Exhibit 1 (OSC), at 1. The OSC proposed to revoke Respondent's DEA
Certificate of Registration No. FT4134805 and deny any pending
applications for a modified or new DEA registration pursuant to 21
U.S.C. 823(f) because Respondent's ``continued registration is
inconsistent with the public interest.'' Id.
In response to the OSC, Respondent timely requested a hearing
before an Administrative Law Judge. ALJ-5. The first two sessions of
the hearing in the matter were held in Dallas, Texas from September 12-
13, 2017. The Respondent's expert, however, failed to appear on either
of those days. To accommodate the Respondent, the hearing was
continued. On November 20, 2017, the hearing reconvened. The November
20, 2017 session of the hearing was conducted by video teleconference
from the DEA Hearing Facility in Arlington, Virginia, with the parties
and witnesses located at the DEA District Office in San Antonio, Texas.
On February 13, 2018, Administrative Law Judge Charles Wm. Dorman
(hereinafter, ALJ) issued the incorporated Recommended Rulings,
Findings of Fact, Conclusions of Law, and Decision (hereinafter,
Recommended Decision or RD). Respondent filed Exceptions to the
Recommended Decision on March 5, 2018, and, with the permission of the
ALJ, a Show to the Contrary on March 14, 2018 (hereinafter,
collectively Respondent's Exceptions or Exceptions). The Government
filed a Response to Respondent's Exceptions and Show to the Contrary on
March 28, 2018 (hereinafter, Govt Response). The record was then
forwarded to me for final agency action.
Suggestion of Mootness
On October 18, 2018, the Government filed a Notice of Suggestion of
Mootness (hereinafter, Suggestion of Mootness). The Government provided
evidence that Respondent had closed and that Respondent's owner had
transferred the inventory of controlled substances to a reverse
distributor. Suggestion of Mootness, at 2, Exs. 1-3.\A\ DEA regulations
promulgated pursuant to the authority delegated by the Controlled
Substances Act (CSA) provide that ``the registration of any person . .
. shall terminate, without any further action by the Administration, if
and when such person . . . discontinues business or professional
practice . . . .'' 21 CFR 1301.52. As Respondent discontinued business
and transferred its controlled substances, pursuant to the regulation,
its registration is terminated, and Respondent is no longer authorized
to dispense controlled substances under federal law. Id. The Government
argued that because Respondent no longer possesses a DEA registration,
the case is now moot. Suggestion of Mootness, at 3 (citing Louisiana
All Snax, Inc., 76 FR 20034 (2011); John G. Costino, D.O., 76 FR 4940
(2011)).
---------------------------------------------------------------------------
\A\ The Government also provided electronic correspondence
between a DEA attorney and Respondent's attorney informing
Respondent that DEA would treat the discontinuation of business as
``a surrender for cause and the registration history [would] be
documented as such.'' Suggestion of Mootness, Ex. 4 (citing 21 CFR
1301.76).
---------------------------------------------------------------------------
Since the Government filed its Suggestion of Mootness, however, the
Agency has published two decisions that are directly applicable to the
instant matter. The first, Jeffrey D. Olsen, M.D., in which my
predecessor ordered the revocation of an expired registration, stated
that ``mootness does not play the same role in administrative agency
adjudications as it plays in Article III court proceedings'' and ``
`[t]he agency, with like effect as in the case of other orders, and in
its sound discretion, may issue a declaratory order to terminate a
controversy or remove uncertainty.' '' 84 FR 68474, 68478 (2019)
(quoting Tennessee Gas Pipeline v. Federal Power Comm'n, 606 F.2d 1373,
1380 (D.C. Cir. 1979); 5 U.S.C. 554(e)); see also Climax Molybdenum Co.
v. Sec'y of Labor, Mine Safety and Health Admin., 703 F.2d 447, 451
(10th Cir. 1983) (``At the outset, we note that an administrative
agency is not bound by the constitutional requirement of a `case or
controversy' that limits the authority of [A]rticle III courts to rule
on moot issues.''). Olsen concluded, therefore, that the Agency was
free to, and would, adjudicate orders to show cause to finality in
matters with expired registrations. Id. at 68479.
The second, Steven M. Kotsonis, M.D., applied Olsen to matters
where a registration is terminated pursuant to 21 CFR 1301.52 for a
surrender for cause after an ALJ had issued a recommended decision and
transmitted the matter to the Administrator for final decision. 85 FR
85667, 85668 (2020). Kotsonis concluded that the termination of a DEA
registration under 21 CFR 1301.52 does not preclude DEA from issuing a
final decision on an order to show cause against that registration and
stated that the Agency would assess such matters on a case-by-case
basis to determine if a final adjudication is warranted or if the
matter should be dismissed. Id. at 85668-69.
In this matter, as in Kotsonis, Respondent's registration
terminated under 21 CFR 1301.52 after the ALJ had issued a recommended
decision on the order to show cause and had transmitted the record to
me for final decision. Accordingly, I am declining the Government's
Suggestion of Mootness as the matter is not mooted by the termination.
Instead, I have evaluated the particular circumstances of this matter
and determined that the matter should be adjudicated to finality. As my
predecessor identified in Olsen,
[f]inal adjudications are particularly helpful in supporting the
purposes of the CSA and my responsibilities to enforce the CSA
because nothing in the CSA prohibits an individual or an entity from
applying for a registration even when there is a history of being
denied a registration, or a history of having a registration
suspended or revoked. As such, having a final, official record of
allegations, evidence, and the Administrator's decisions regarding
those allegations and evidence, assists and supports future
interactions between the Agency and the registrant or applicant.
84 FR at 68479. Absent a final adjudication, there would be no final
record of the allegations and evidence from this matter.\B\
Adjudicating this matter to finality will create an official record the
Agency can use in any future interactions with Respondent's owners,
employees, or other persons who were associated with Respondent. As
additionally noted in Olsen, ``a final adjudication is a public record
of the Agency's expectations for current and prospective members of
that community,'' and adjudications inform stakeholders, such as
legislators and the public, about the Agency's work and allow them to
provide feedback to the Agency, thereby helping shape how the Agency
carries out its responsibilities under the CSA. Id. Adjudicating this
matter to finality will create a public record to educate current and
prospective registrants about the Agency's expectations regarding the
responsibilities of registrant pharmacies under the CSA and allow
stakeholders
[[Page 21009]]
to provide feedback regarding the Agency's enforcement priorities and
practices.
---------------------------------------------------------------------------
\B\ Contrast with Kotsonis in which the plea agreement and
judgment from the respondent's concurrent criminal case provided a
final record on which the Agency could rely in any future
interactions with the respondent. 85 FR at 85667.
---------------------------------------------------------------------------
Having determined that this matter should be adjudicated to
finality and considered the record in its entirety, including the
Respondent's Exceptions and the Govt Response, I have decided to adopt
the ALJ's recommended rulings, findings of fact, conclusions of law,
and proposed sanction from the Recommended Decision, with minor
modifications, where noted herein.\C\ A discussion of Respondent's
Exceptions follows.
---------------------------------------------------------------------------
\C\ I have made minor modifications to the Recommended Decision.
I have substituted initials or titles for the names of witnesses and
practitioners to protect their privacy, and I have made minor,
nonsubstantive grammatical changes. Where I have made substantive
changes to align the RD with my findings on Respondent's Exceptions
or otherwise added to or modified the ALJ's decision, I have placed
the edited text in brackets and included a specific description of
the modification in a footnote marked with an asterisk.
---------------------------------------------------------------------------
Respondent's Exceptions
Respondent filed 49 exceptions--19 exceptions to the RD's Findings
of Fact and 30 exceptions to the RD's Analysis and Conclusions of Law,
the final two of which were expounded upon in greater detail in
Respondent's Show to the Contrary.
Respondent's Exceptions to the Findings of Fact
I find that the majority of Respondent's exceptions to the Findings
of Fact do not actually dispute the RD's findings of fact but rather
provide explanations, arguments, or interpretations. Consequently, I
reject Respondent's Exceptions 1-2, 7, 9, 11-14, and 16-18. I also
reject Respondent's Exceptions 3, 6, 8, and 19. I have reviewed the
findings of fact to which Respondent objected in those exceptions and
have determined that the findings are supported by the administrative
record.
I am partially sustaining Respondent's Exceptions 10 and 15. In
Exception 10, Respondent objected to the ALJ's finding that ``Ms. Igwe
is familiar with the Texas regulation that requires a pharmacist to
document notes regarding the resolution of red flags.'' RD, at 29
(citing Tr. 585). Respondent stated in its exceptions that
Ms. Igwe is familiar with the Texas regulations that require a
pharmacist to document notes, but not every red flag, or its
resolution must be documented under Texas law. See 22 TAC Sec.
291.33(c)(2)(A)(ii) and (iv). (ii) requires documentation when a
clinically significant condition exists that is resolved by the
pharmacist, and (iv) requires documentation when the pharmacist has
a question about the drug regimen review per (A) of that
regulation.''
Respondent's Exceptions, at 4. While I find that Respondent's
explanation for Exception 10 provides an argument on what it believes
to be the correct interpretation of the Texas regulation rather than
disputing the factual finding, I am partially sustaining the exception
because I find that the RD's characterization of Ms. Igwe's testimony
was incomplete. When asked by the ALJ if she was familiar with ``a
Texas regulation that requires that if you check with a doctor about a
particular prescription, that you're supposed to document that,'' Ms.
Igwe answered ``Yes.'' Tr. 585. However, Ms. Igwe qualified her answer
stating ``[b]ut . . . it depends on what I check with the doctor about
. . . so it would depend--if I'm calling the doctor and saying anything
that isn't clinical in nature, I may not necessarily document it.'' Id.
The RD, therefore, correctly found that Ms. Igwe was familiar with the
regulation the ALJ was referencing in his question; however, I will add
the clarification to the finding that Ms. Igwe did not expressly
testify that the regulation requires a pharmacist to document notes
regarding the resolution of red flags.
Respondent's Exception 15 took exception to the RD's finding of
fact that
[t]he prescription that [L.R.] wrote for [M.W.] raises the following
red flags: No patient address; no provider DEA number; large
quantity of high-alert controlled substance; the prescription was
written on July 29, 2014, but not faxed to the Pharmacy until August
1, 2014 and not picked up until August 4, 2014; and an unusual path
and distance to obtain the prescription and get it filled.
RD, at 33-34 (citing Tr. 188-85). Respondent argues that ``[p]ursuant
to Dr. Witte, the prescription for hydrocodone that `[M.W.]' received
was a typical or therapeutic dosage.'' Respondent Exceptions, at 5
(citing Tr. 176, 283, 366, 679). I have reviewed Dr. Witte's testimony
regarding the red flags on the ``M.W.'' prescription and find that
while Dr. Witte did testify that the prescription was for a ``large
quantity,'' when asked if the quantity was a red flag, she stated that
``[i]t could be.'' Tr. 189 (emphasis added). I, therefore, will
partially sustain Respondent's Exception 15 as Dr. Witte did not
unequivocally testify that the quantity of the controlled substance in
the M.W. prescription was a red flag, only that such a quantity could
be a red flag on a prescription.
I have amended Findings of Fact 94 and 135 of the Recommended
Decision to reflect my determinations on Respondent's Exceptions to the
Recommended Decision's findings of fact.
Respondent's Exceptions to the ALJ's Analysis and Conclusions of Law
Respondent filed 30 exceptions to the Recommended Decision's
Analysis and Conclusions of Law and a Show to the Contrary that
provided further explanation and documentation for its final two
exceptions. I have reviewed the exceptions and find they can be grouped
into five general exceptions:
(1) Respondent objects to the Government's allegation that there
was no evidence of Respondent filling prescriptions prior to July 7,
2014; \D\
---------------------------------------------------------------------------
\D\ Exceptions, at 13, no. 38.
---------------------------------------------------------------------------
(2) Respondent objects to the ALJ's official notice of 22 Tex.
Admin. Code Sec. 291.33(c)(7)(A); \E\
---------------------------------------------------------------------------
\E\ Exceptions, at 17, nos. 48-49; Respondent's Show to the
Contrary.
---------------------------------------------------------------------------
(3) Respondent argues the Recommended Decision did not properly
weigh the five factors from 21 U.S.C. 823(f); \F\
---------------------------------------------------------------------------
\F\ Exceptions, at 10; nos. 31-32.
---------------------------------------------------------------------------
(4) Respondent objects to the ALJ's determination that it violated
various federal and state regulations when it dispensed controlled
substance prescriptions that raised red flags without properly
resolving the red flags and documenting the resolution; \G\ and
---------------------------------------------------------------------------
\G\ Exceptions, at 6-13, 16-17; nos. 20-30, 33-37, 39, 45-47.
---------------------------------------------------------------------------
(5) Respondent argues the recommended sanction is not supported by
the record.\H\
---------------------------------------------------------------------------
\H\ Exceptions, at 14-16, nos. 40-44.
---------------------------------------------------------------------------
1. Prescriptions Filled Prior to July 7, 2014
Respondent filed an exception against ``[t]he Government's
alleg[ation] that there was no evidence of prescriptions being filled
prior to July 7, 2014 due to the lack of earlier information in the
patient profiles.'' Exceptions, at 13 (citing Gov. Ex. 6). Respondent's
exception, however, does not object to any of the ALJ's findings or
conclusions from the Recommended Decision. As Respondent stated itself
in the exception, the ALJ ``found evidence of prior filled
prescriptions.'' Id. (citing RD, at 51 n.34 (``The Respondent did
produce evidence of dispensing prior to July 7, 2014 . . . Those
records, however, were not produced until long after the Pharmacy was
required to produce them.'')). See also RD, at 24 (citing Tr. 60, 76)
(``The dispensing records showed that the first dispensing took place
on July 7, 2014, but the PMP showed that the Pharmacy filled
prescriptions for hydrocodone between January and June 2014.'').
Pursuant to
[[Page 21010]]
21 CFR 1316.66, an exception must be to ``the recommended decision,
findings of fact and conclusions of law contained in the report'' from
the ALJ to the Administrator. Respondent's ``exception'' is, therefore,
invalid.
2. Official Notice of 22 Tex. Admin. Code Sec. 291.33(c)(7)(A)
In the RD, the ALJ took official notice of 22 Tex. Admin. Code
Sec. 291.33(c)(7)(A), which sets forth several requirements for labels
on prescription bottles. RD, at 59 n.41. Respondent objected to the
ALJ's notice of 22 Tex. Admin. Code Sec. 291.33(c)(7)(A), or in the
alternative, requested an opportunity to show to the contrary pursuant
to 21 CFR 1316.59(e). The ALJ issued an Order Granting Respondent
Request for Opportunity to Show to the Contrary on March 6, 2018. In
his Order, the ALJ cited two instances in the record where taking
notice of this regulation was helpful. First, the ALJ ``looked to the
regulation for additional support for Dr. Witte's testimony that the
dispensing pharmacist's initials must be associated with each
prescription and that [PIC] Igwe was the pharmacist who filled all the
prescriptions in the Administrative Record.'' See RD, at 39; Tr. 389-
90. Second, the ALJ stated that he relied on the regulation in
determining when a prescription was filled by Respondent, as the
regulation requires the label to include the date the drug was
dispensed.
I can find no reason why Respondent objected to the ALJ's official
notice of 22 Tex. Admin. Code Sec. 291.33(c)(7)(A) or why Respondent
filed the Show to the Contrary with documentation of labels from the
prescriptions at issue in this matter--all of which display the
initials of Respondent's Pharmacist in Charge Ijeoma Igwe (hereinafter,
PIC Igwe) and a date. Respondent asserts in the Show to the Contrary
that the labels demonstrate that Respondent fully complied with section
291.33(c)(7)(A), but there was never any allegation that Respondent did
not. In the RD, the ALJ assumed that Respondent had fully complied with
the regulation when labeling prescription bottles.
To the extent, if any, Respondent is objecting to the ALJ's
official notice of 22 Tex. Admin. Code Sec. 291.33(c)(7)(A),
Respondent's objection is denied as the RD properly characterized the
content of the regulation and Respondent acknowledges the regulation
applied to Respondent's pharmacy practice.
3. Weighing the Factors From 21 U.S.C. 823(f)
Respondent filed exceptions arguing that the ALJ did not properly
weigh all five factors from 21 U.S.C. 823(f). Specifically, Respondent
argues the ALJ did not properly consider that (1) ``there is no
evidence that the State licensing board has taken a disciplinary action
against [Respondent]'' or (2) Respondent's experience dispensing or
conducting research with respect to controlled substances. Exceptions,
at 10.
The DEA considers the five public interest factors from 21 U.S.C.
823(f) separately. Robert A. Leslie, M.D., 68 FR 15227, 15230 (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
37507, 37508 (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
10083, 10094-95 (2009) (basing sanction on all evidence on record).
Having reviewed the Recommended Decision, I find that the ALJ did
properly weigh the public interest factors. First, as stated above, the
ALJ was not required to enter findings on each of the factors or to
consider a factor in any given level of detail. Second, contrary to
Respondent's assertion, the ALJ did enter findings regarding the
recommendation of the State licensing board and concluded that Factor
One (21 U.S.C. 823(f)(1)) does not weigh for or against revocation in
this matter. The RD found that ``it is undisputed that the Respondent
holds a valid state pharmacy license in Texas'' and ``[t]he record
contains no evidence of a recommendation regarding the Respondent's
privilege to operate as a pharmacy by a relevant state licensing board
or professional disciplinary authority.'' RD, at 54. As accurately
stated in the RD, ``Agency precedent establishes that where the record
contains no evidence of a recommendation by a state licensing board,
that absence does not weigh for or against revocation.'' Id. (citing
Roni Dreszer, M.D., 76 FR 19434, 19444 (2011)). Accordingly, I agree
with the ALJ's findings and conclusions regarding Factor One.
Finally, I find that Respondent's assertion that the ALJ failed to
adequately consider evidence of Respondent's ``experience with her
other patients'' is without merit. Exceptions, at 10 (citing Jayam
Krishna-Iyer, 249 F. App'x 159 (11th Cir. 2007). Respondent argued that
Respondent ``dispensed over 900 hydrocodone/APAP prescriptions
prescribed from the 5 or 6 clinics under investigation, and only 75
prescriptions were submitted for adjudication for approximately 27
patients.'' Id. Under Factor 2, 21 U.S.C. 823(f)(2), the Agency must
consider a registrant's experience dispensing controlled substances. As
previously stated, however, 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; what matters is the
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D.,
74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has
recognized, findings under a single factor can support the revocation
of a registration. MacKay v. Drug Enf't Admin., 664 F.3d 808, 821 (10th
Cir. 2011).
In this matter, even presuming that the hundreds of other
prescriptions Respondent has referenced were legally dispensed, those
prescriptions do not render Respondent's unlawful dispensing of the
subject prescriptions any less unlawful or ``any less `acts which are
inconsistent with the public interest.' '' Jayam Krishna-Iyer, 74 FR at
462-463 (quoting 21 U.S.C. 823(f)). Moreover, the unlawful dispensings
were not an isolated incident--the Government has proven by substantial
evidence that Respondent dispensed 75 prescriptions that raised
multiple red flags to over two dozen patients in less than a year. RD,
at 88. The Agency has consistently taken the position that a
registrant's positive dispensing experience under Factor 2 can be
outweighed by acts held to be inconsistent with the public interest.
See, e.g., Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195,
77 FR 62316, 62340 (2012); Paul J. Cargine, Jr., 63 FR 51592, 51560
(1998) (``[E]ven though the patients at issue are only a
[[Page 21011]]
small portion of Respondent's patient population, his prescribing of
controlled substances to these individuals raises serious concerns
regarding [his] ability to responsibly handle controlled substances in
the future.''). I find that Respondent's repeated, serious violations
of federal and state laws related to controlled substances support the
ALJ's finding that the Government has made a prima facie case showing
that the Respondent's registration is inconsistent with the public
interest.
4. Unlawful Dispensing Allegations
Respondent has filed exceptions against the ALJ's determination
that Respondent dispensed 75 controlled substance prescriptions that
raised red flags without resolving those red flags and documenting the
resolution in contravention of Respondent's corresponding
responsibility under 21 CFR 1306.04; outside the usual course of
professional practice in violation of 21 CFR 1306.06; and in violation
of 22 Tex. Admin. Code Sec. 291.33(c)(2).\I\ Respondent has stated in
its Exceptions that, contrary to the ALJ's findings, the subject
prescriptions did not display the red flags of pattern prescribing,
distance, and cash payments, and, to the extent that there were red
flags on the subject prescriptions, Respondent cleared the red flags
before filling the prescriptions.
---------------------------------------------------------------------------
\I\ The Recommended Decision also found that Respondent violated
other state laws when dispensing the subject prescriptions, but
Respondent has not filed exceptions against those findings.
---------------------------------------------------------------------------
Red Flags on the Subject Prescriptions
Pattern Prescribing
As fully explained in the Recommended Decision, pattern prescribing
occurs when a provider or group of providers repeatedly prescribe
patients the same drug and the same quantity without any difference in
treatment. RD, at 25, 60-62 (citing Tr. 171, 228-29, 232-33, 244, 250,
264-65, 279, 289, 353, 745). The expert witnesses in this matter
testified that pattern prescribing raises a red flag because the lack
of individualized therapy can indicate the prescriber is not
prescribing the controlled substances for a legitimate medical purpose.
Tr. 171, 244, 745. See Jones Total Health Care Pharmacy, L.L.C., 81 FR
79188, 79195 (2016) (citing E. Main St. Pharmacy, 75 FR 66149, 66163
(2010)); 21 CFR 1306.04 (``A prescription for a controlled substance to
be effective must be issued for a legitimate medical purpose . . .'').
Unlike some red flags, such as distance and cash payments, pattern
prescribing can manifest over an extended period of time and may not be
immediately recognizable to a pharmacist. Tr. 210, 239-40, 333, 358-59.
Both experts agreed that a pharmacist can resolve a red flag of pattern
prescribing raised by a prescription by speaking with the prescriber
and receiving information that satisfies the pharmacist that a
prescription was issued for a legitimate medical purpose. Tr. 240, 332-
334, 660. The Government's expert, Dr. Witte, stated that if the
pharmacist is not satisfied by the prescriber's responses to their
questions, the pharmacist should refuse to fill the prescriptions. Tr.
171, 333-34.
In its Exceptions, Respondent objects to the ALJ's finding that
many of the subject prescriptions exhibited the red flag of pattern
prescribing and that Respondent filled the prescriptions without
resolving the red flag. Exceptions, at 10-12. Respondent claims that it
resolved the red flag of pattern prescribing in the subject
prescriptions by calling the prescriber whenever a patient presented a
controlled substance prescription for the first time. Id.
Respondent claims in the Exceptions that ``[e]ach new time a new
patients [sic] comes to [Respondent], or an existing patient received a
change in medication, the pharmacist places a call to the practitioner
to ensure the doctor/patient relationship, to verify the dosing and
prescriptions, and to inquire as to the condition or illness being
treated.'' Exceptions, at 11 (citing Tr. 477-78). Respondent's claim,
however, is unsupported by the record evidence and misrepresents PIC
Igwe's testimony. In the portion of PIC Igwe's testimony cited by
Respondent, PIC Igwe said ``if I have a patient who is a controlled
drug [sic] and they haven't been before, I would call the clinic and
make sure that the clinic did write the prescription, and the number
that I would use would not be--would be like a number in the--you know,
on my--it wouldn't be what's on the prescription, in case it was no--it
was forged, for example.'' Tr. 477-78. In other words, PIC Igwe
testified that she called the prescriber's office to ensure the
prescription was not forged, but she did not testify that she
``verif[ied] the dosing'' or ``inquire[d] as to the condition or
illness being treated'' as Respondent claims in its Exceptions.\J\
Checking that a prescription was, in fact, issued by a clinic would
show that the prescription is not an outright fraud, but it would not
ensure that the prescription was issued for a legitimate medical
purpose. 21 CFR 1306.04(a); Pharmacy Doctors Enterprises d/b/a/Zion
Clinic Pharmacy, 83 FR 10,876, 10,897 (2018), pet. for rev. denied, 789
F. App'x 724 (11th Cir. 2019).
---------------------------------------------------------------------------
\J\ Compare PIC Igwe's testimony at Tr. 477-78 with Respondent's
Exceptions at 11.
---------------------------------------------------------------------------
There is also no documentary evidence in the record that PIC Igwe
``verif[ied] the dosing,'' ``inquire[d] as to the condition or illness
being treated,'' or otherwise resolved the red flag of pattern
prescribing on the subject prescriptions as Dr. Witte testified was
required for a pharmacist following the accepted standard of practice
of pharmacy in Texas. See, e.g., Tr. 210-211. There are no notes in any
of Respondent's patient profiles documenting conversations with
prescribers. Tr. 210, 244; see GX 2. And while PIC Igwe testified that
she would sometimes mark a prescription with a ``V'' to indicate she
had verified a prescription, Tr. 477, 482, only one of the subject
prescriptions is marked with a ``V'' and that prescription was the
sixth time Respondent had filled that prescription for the patient, GX
2, at 44-46, 53-55. The credibility of Respondent's claim that PIC Igwe
always checked with the prescriber the first time she filled a
controlled substance prescription for a patient was also brought into
question by her testimony that she had never had a conversation with
Dr. C.V. regarding a patient and the only time she had spoken to him
was when Dr. C.V. called her to ask for the pharmacy's fax number. Tr.
561-62. Yet, Dr. C.V. prescribed 14 of the subject prescriptions for
hydrocodone, GX 2; and Respondent's dispensing logs show that
Respondent filled hundreds of additional hydrocodone prescriptions from
Dr. C.V., including 8 hydrocodone prescriptions in a single day.\K\ GX
6; RX G at 44-45; Tr. 424-25. Given the lack of documentary evidence
and the contrary testimony from PIC Igwe, I agree with the ALJ and find
that Respondent did not clear the red flags of pattern prescribing
before dispensing the subject prescriptions. Accordingly, I
[[Page 21012]]
reject Respondent's exceptions to the ALJ's findings on pattern
prescribing.\L\
---------------------------------------------------------------------------
\K\ The OSC did not allege that Respondent unlawfully dispensed
any prescriptions prior to August 2014. Accordingly, while
Respondent's dispensing history prior to August 2014 is relevant to
rebutting Respondent's claim that the subject prescriptions did not
display the red flag of pattern prescribing or that PIC Igwe had
resolved the red flags prior to dispensing the subject
prescriptions, any deficiencies in Respondent's prescription
dispensing practices outside of the subject prescriptions do not
weigh for or against Respondent retaining its registration.
\L\ Respondent also argues that the ALJ's finding that many of
the subject prescriptions presented the red flag of pattern
prescribing was inappropriate because the prescribers engaged in
``masking.'' Exceptions, at 12. Respondent's argument is contrary to
the expert testimony presented at the hearing. Both the Government's
expert, Dr. Witte, and Respondent's own expert, Mr. Litman,
testified that the subject prescriptions raised the red flag of
pattern prescribing. E.g., Tr. 745 (``Judge Dorman: `Do you consider
pattern prescribing to be a red flag?' [Mr. Litman]: `Yes.' Judge
Dorman: `Okay. Did you see anything in the documentation that you
were provided that would suggest pattern prescribing?' [Mr. Litman]:
`Yes.' '')
---------------------------------------------------------------------------
Distance
The ALJ found that the distances the patients travelled to obtain
the subject prescriptions were a red flag that Respondent failed to
clear before dispensing the prescriptions. RD at 63-65, 72-73, 76, and
79. Dr. Witte credibly testified that the distance or route a patient
travels to fill a prescription can be a red flag, Tr. 172-76; and
Agency decisions have long found that the distance a patient is willing
to travel to obtain a prescription is a factor a pharmacist must
consider pursuant to their corresponding responsibility; e.g., Morning
Star Pharmacy & Medical Supply 1, 85 FR 51045, 51052 (2020); Hills
Pharmacy, L.L.C., 81 FR 49,815, 49841 n. 45 (2016); East Main Street
Pharmacy, 75 FR 66149, 66165 (2010). Texas regulations also require
pharmacists to ``exercise sound professional judgment with respect to''
the legitimacy of a prescription, 22 Tex. Admin. Code Sec. 291.29(a),
and provide a non-exhaustive list of circumstances a pharmacist should
weigh when evaluating a prescription's legitimacy, including ``the
geographical distance between the practitioner and the patient or
between the pharmacy and the patient.'' 22 Tex. Admin. Code Sec.
291.29(c)(4).
Respondent filed exceptions against the ALJ's determination that
the distances traveled by the subject patients were a red flag.
Exceptions, at 16-17. Respondent argues that ``various pharmacists have
various thresholds for distances traveled,'' and that its expert, Mr.
Litman, testified that he would only be concerned about distance if a
patient were coming from out-of-state. Id.; Tr. 695-96, 730. Mr.
Litman, however, was not aware of DEA cases that deal with pharmacy
customers who had travelled long distances to obtain their
prescriptions and have them filled. Tr. 727. He was also not admitted
as an expert on Texas pharmacy practice or law (Mr. Litman was a
practicing pharmacist in Florida), Tr. 624, 655-56; and while Mr.
Litman stated that he had reviewed the Texas regulations for
pharmacists, Tr. 657, he seemed to be unaware of the Texas regulation
that requires pharmacists to consider the distance a customer traveled
to fill a prescription, see Tr. 727, 739. For these reasons, I agree
with, and will follow, the ALJ's decision to give no weight to Mr.
Litman's testimony that the distance the patients travelled to obtain
the subject prescriptions was not a red flag. See RD, at 65.
In contrast to Mr. Litman, the Government's expert, Dr. Witte,
testified that it would be outside the usual course of professional
practice in the state of Texas for a pharmacist to dispense a
prescription for a controlled substance without considering the
distance the patient traveled to obtain and fill the prescription. Tr.
171-76. The Government provided evidence that the roundtrip distance
between the subject patients' homes, providers, and Respondent ranged
between 55-121 miles through urban areas. Stipulations 9-45. Dr. Witte
testified that the distances traveled by the patients were a red flag,
noting concern about patients driving across the city of Dallas to
Respondent in Plano to fill the prescriptions because ``more than
likely, there are many pharmacies located between . . . where the
patient lives and where the clinic is.'' Tr. 174-75, 189-94, 281, 321.
I credit Dr. Witte's testimony that the distances traveled by
Respondent's patients to obtain the subject prescriptions were a red
flag and, accordingly, reject Respondent's exceptions.\M\
---------------------------------------------------------------------------
\M\ As the ALJ noted in the Recommended Decision, Dr. Witte was
accepted as an expert in the field of pharmacy in the state of
Texas, not geography. Tr. 169; RD, at 64. Thus, I do not credit her
testimony concerning distances and the availability of pharmacies as
that of an expert; I do, however, credit it as a reasonable
observation based upon common experience. As the ALJ found, common
experience suggests that one is more likely to pass a pharmacy in an
urban area than a rural one and that, in general, it is more time
consuming to travel a specific distance in an urban area than a
rural one. RD, at 64.
---------------------------------------------------------------------------
Cash Payments
The ALJ found that paying cash for a prescription can be a red flag
and determined that cash payments, combined with other red flags, can
be enough to find a pharmacist violated 21 CFR 1306.04. RD, at 66. This
determination is consistent with the testimony of both the Government
and Respondent's expert witnesses, see, e.g., Tr. 172-73; and with
other Agency decisions, which have found that paying cash for
controlled substances, rather than billing insurance, can be a red flag
that the patient is seeking the substances for illicit purposes; see,
e.g., Morning Star Pharmacy and Medical Supply 1, 85 FR 51045, 51052
(2020), Jones Total Health Care Pharmacy, L.L.C., and SND Health Care,
L.L.C., 81 FR 79,188, 79191 (2016); E. Main St. Pharmacy, 75 FR 66149,
66158 (2010).
Respondent concedes that cash payments can be a red flag.
Exceptions, at 13. Respondent, however, argues that the cash payments
made on the subject prescriptions were not red flags because ``many of
[Respondent's] patrons paid in cash'' and because many of the cash
payments for the subject prescriptions were ``just over'' $200, which
Respondent's expert, Mr. Litman, ``gave [as] a ceiling . . . for a
pretty reasonable average cash payment.'' Id. I am rejecting
Respondent's exception because it is inconsistent with the testimony of
Respondent's PIC and Mr. Litman and ignores the credible testimony of
Dr. Witte. RD, at 7.
Dr. Witte testified that cash payments for controlled substance
prescriptions, such as those for the subject prescriptions, are a red
flag. E.g., Tr. 172-73, 226, 313. The large majority of patients who
received the subject prescriptions paid Respondent $179.99 for 90
tablets of hydrocodone and $59.99 for 60 tablets of alprazolam. GX 2.
When a patient purchased prescriptions for both hydrocodone and
alprazolam at the same visit, the patient would pay $239.98. Id.
Respondent's expert, Mr. Litman, testified that he would be concerned
about cash payments in excess of $200. Tr. 692, 753. Mr. Litman
downplayed the significance of cash payments as a red flag because
``cash payments are more common these days.'' Tr. 753. PIC Igwe
testified, however, that the majority of Respondent's customers used
insurance to pay for their prescriptions, which brings into question
why all of the subject patients paid with cash. Tr. 496.
Accordingly, I reject Respondent's exceptions to the findings in
the Recommended Decision that the cash payments for the subject
prescriptions were a red flag.
ALJ's Determinations That Respondent Violated 21 CFR 1306.04 and
1306.06
In addition to arguing that the subject prescriptions did not raise
the red flags of distance, cash payments, and pattern prescribing and/
or those red flags were resolved before Respondent filled the
prescriptions, Respondent argues in its Exceptions that the Government
failed to establish that PIC Igwe had the requisite degree of scienter
to prove a violation of her corresponding responsibility under 21 CFR
1306.04(a). Exceptions, at 7-9, 12-13. Respondent
[[Page 21013]]
also argues that the Government has not met its burden under 21 CFR
1306.06 ``to prove the pharmacist repeatedly filled controlled
substance prescriptions that contained multiple red flags of diversion
and/or abuse without addressing or resolving those red flags, based on
a lack of documentation of the resolution, or a failure of the
corresponding responsibility.'' Id. at 6.
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 her 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 28667,
28670-72 (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] controlled substances pursuant to prescriptions that
contained one or more unresolved red flags for diversion.'' Govt
Posthearing, at 29. See also OSC, at 5 (``Pharmacy Place's pharmacists
were willfully blind to or deliberately ignorant of the high
probability that the [subject prescriptions] lacked a legitimate
medical purpose. Pharmacy Place pharmacists were willfully blind to the
fact that large numbers of customers seeking controlled substance
prescriptions, often prescription cocktails, and residing long
distances from Pharmacy Place's location and/or their respective
physicians created a suspicious situation requiring increased
scrutiny.'').
As partially discussed above, I agree with the ALJ's findings that
the subject prescriptions presented multiple red flags including
pattern prescribing, distance, cash payments, drug cocktails, high
doses/quantities of high-alert controlled substances, 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.,
Morning Star Pharmacy and Medical Supply 1, 85 FR at 51061 (pattern
prescribing; distance; cash payments; drug cocktails; high doses/
quantities of high-alert controlled substances; different doctors
prescribing controlled substances to the same patient; prescriptions
lacking the patient's address or the prescriber's DEA number); Pharmacy
Doctors Enterprises d/b/a Zion Clinic Pharmacy, 83 FR at 10898 (long
distances; pattern prescribing; 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 59504,
59507, 59512-13 (2014) (unusually large quantity of a controlled
substance; pattern prescribing; irregular dosing instructions; drug
cocktails); Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195,
77 FR 62316, 62317-22 (2012) (long distances; pattern prescribing; cash
payments); East Main Street Pharmacy, 75 FR 66149, 66,163-65 (2010)
(long distances; pattern prescribing; drug cocktails; early fills/
refills; other pharmacies' refusals to fill the prescriptions). Dr.
Witte credibly testified that a Texas pharmacist acting in the usual
course of professional practice would have recognized these red flags
and that a Texas pharmacist acting in the usual course of professional
practice and fulfilling her corresponding responsibility will not fill
prescriptions for controlled substances without investigating,
documenting the investigation, and resolving any red flags. E.g., Tr.
171-82, 195, 210-211, 216-17, 227.
PIC Igwe also admitted during her testimony that she had actual
knowledge of some of the red flags on the prescriptions. See, e.g., Tr.
546-47. For example, PIC Igwe testified that she
[[Page 21014]]
was aware of, but unconcerned by, the distances the patients were
traveling and the large number of substantially identical prescriptions
for hydrocodone and alprazolam from the clinics that prescribed the
subject prescriptions because she assumed the clinics were pain
management clinics and based her dispensing decisions on that
assumption. Tr. 516, 537-38. In the State of Texas, pain management
clinics must be certified by the state, 22 Tex. Admin. Code Sec. Sec.
195.1-195.44; and the Texas regulations governing the professional
responsibilities of pharmacists state that a ``prescription drug order
may not be dispensed or delivered if issued by a practitioner
practicing at a pain management clinic'' that is not certified. 22 Tex.
Admin. Code Sec. 291.29(e) (2011).\N\ Yet, PIC Igwe testified that she
never checked if the clinics were certified as pain management clinics.
Tr. 537-38. Moreover, Dr. Witte testified that a Texas pharmacist
should still investigate and resolve the red flags on the subject
prescriptions even if they were from a specialty clinic, such as a pain
management clinic. Tr. 276-277; see also 22 Tex. Admin. Code Sec.
291.29(d) (2011) (``A pharmacist shall ensure that prescription drug
orders for the treatment of chronic pain have been issued in accordance
with the guidelines set forth by the Texas Medical Board in 22 Tex.
Admin. Code Sec. 170.3 (relating to Guidelines), prior to dispensing
or delivering such prescriptions.'').
---------------------------------------------------------------------------
\N\ 22 Tex. Admin Code Sec. 291.29 has subsequently been
amended since the time frame relevant to this matter. The citations
and quotations to the Texas Administrative Code in this decision
reflect the law as it was at the time the subject prescriptions were
dispensed.
---------------------------------------------------------------------------
I have considered and reject Respondent'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. Exceptions, at 7-9, 11-12. In its Exceptions,
Respondent claims that PIC Igwe testified that
when she initially gets a new customer's prescription, she calls the
clinic and practitioner to verify the patient is being seen by the
practitioner, the clinic is treating the patient, the condition that
is treated, and whether the medication prescribed for the patient is
appropriate. Upon the verification by the practitioner that the
patient is being treated for a condition with the prescribed drugs,
the pharmacist will discuss the prescription with the customer, as
appropriate. If a different pharmacy is shown on the PMP, the
pharmacist will occasionally call that pharmacy to discern that
pharmacist's comfort with the previous prescription.
Exceptions, at 7 (citing Tr. 477-80, 492). Respondent argues that
through this process it resolved any red flags on the subject
prescriptions. Id. at 9.
Once again, however, Respondent has partially misrepresented PIC
Igwe's testimony. PIC Igwe testified that for new patients presenting a
controlled substance prescription, she would always ``call the clinic
and make sure that the clinic did write the prescription.'' Tr. 477-
481. She did not testify that she asked about the condition being
treated or whether the medication prescribed for the patient is
appropriate. PIC Igwe did testify that she would check with the
prescriber if she had a concern about ``the dose, the interactions or
what not,'' but she did not testify that she did this for all patients
presenting controlled substance prescriptions for the first time. Tr.
481.
Additionally, as I discussed supra, there is no documentary
evidence in the administrative record that Respondent followed the
protocols she described in her testimony. The Government issued a
subpoena to Respondent requesting ``a copy of the complete patient
profile record or any other patient record (paper or electronic) that
your pharmacy maintained [for the subject patients], pursuant to the
requirements of the Texas Administrative Code Title 22 Sec.
291.33(c)(2)(A) & (C) Operational Standards'' and instructed Respondent
to include ``the entire patient record that your pharmacy maintained
for each individual, including, but not limited to, any and all
Pharmacist comments relevant to the individuals drug therapy, including
any information peculiar to the specific patient or drug as well as any
consultation with the prescribing practitioner . . . .'' GX 9 (Sept. 6,
2016 Subpoena) and 10 (June 14, 2017 Subpoena). There is no
documentation in any of the records Respondent provided in response to
the Government's subpoenas that Respondent ever contacted a
practitioner or other pharmacy regarding the subject patients the first
time they visited Respondent. GX 2. In fact, the only pharmacist notes
on any of the records was a ``V'' on one prescription, which PIC Igwe
testified meant she had verified the prescription, but the marked
prescription was not the first time Respondent had dispensed the same
controlled substances to the patient. Id.; GX 2, at 44-55.
Respondent claims that PIC Igwe made notes in the ``Demographics''
section of the patient profiles when she had discussions with a
prescriber regarding ``the dose, the interactions or what not.'' Tr.
481, 546; Exceptions, at 15. PIC Igwe, however, had no explanation for
why she did not produce this claimed documentation to the Government in
response to the subpoenas other than to say that it ``is not typically
printed in the patient profile sheet,'' and she had no explanation for
why she did not provide it as an exhibit or otherwise bring it to the
administrative hearing. Tr. 481-482, 546-47. PIC Igwe had a similar
response when asked why she filled controlled substance prescriptions
that lacked the prescriber's DEA number, a requirement for a valid
prescription. Tr. 391, 412; 21 CFR 1306.05(a); Tex. Health & Safety
Code Sec. 481.074(k). When a prescription lacks the prescriber's DEA
number, Dr. Witte testified that the pharmacist should contact the
prescriber and annotate the DEA number on the prescription itself or in
the patient profile. Tr. 391. PIC Igwe stated that she would have the
prescriber fax her a copy of his or her DEA license with the DEA
number, but she did not produce those faxes in response to the
Government subpoenas or bring them with her to the hearing. Tr. 535-36.
In light of the allegations against Respondent and the explicit
requests of the Government subpoenas, I find that it strains credulity
that Respondent's claimed documentation exists, but that Respondent did
not think it was necessary to provide it to the Government or at the
hearing. I, therefore, do not credit Respondent's claims that it
adequately investigated and resolved the red flags on the subject
prescriptions.
Further, this Agency has applied, and I apply here, the ``adverse
inference rule.'' E.g., Pharmacy Doctors Enterprises d/b/a/Zion Clinic
Pharmacy, 83 FR at 10899. As the D.C. Circuit explained, ``Simply
stated, 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 (D.C. Cir. 1972). The
Court reiterated this rule in Huthnance v. District of Columbia, 722
F.3d 371, 378 (D.C. Cir. 2013). According to this legal principle,
Respondent's decision not to provide records gives rise to an inference
that any such evidence is unfavorable to Respondent.
Based on Respondent's failure to adequately investigate and resolve
the many red flags on the subject prescriptions before filling them, I
find
[[Page 21015]]
that Respondent 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. Accordingly, I agree with the ALJ's finding
in the Recommended Decision that the Government has proven by
substantial evidence that Respondent filled prescriptions for
controlled substances that it knew were not prescribed for legitimate
medical purposes, or was willfully blind to such, in violation of its
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
acted outside the usual course of professional practice in violation of
21 CFR 1306.06.
ALJ's Determination That Respondent Violated 22 Tex. Amin. Code Sec.
291.33(c)(2)
Respondent filed additional exceptions to the ALJ's determination
that Respondent violated the Texas State Board of Pharmacy's
Operational Standards for Community Pharmacies, 22 Tex. Admin. Code
Sec. 291.33(c)(2). The Texas regulation requires that ``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: . . . reasonable dose and route of
administration; . . . duplication of therapy; . . . and, proper
utilization, including overutilization or underutilization.'' Id. at
Sec. 291.33(c)(2)(A)(i). If a pharmacist identifies one of the listed
``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
Sec. 291.33(c)(2)(A)(ii). The pharmacist must also document the
consultation with the prescriber including the date the pharmacist
consulted with the prescriber, the name of the person with whom the
pharmacist spoke, and any applicable information pertaining to the
consultation. Id. at Sec. 291.33(c)(2)(C).
The Government alleged, and the ALJ agreed, that Respondent
violated 22 Tex. Admin. Code Sec. 291.33(c)(2) by failing to contact
prescribers and document the conversations when presented with
prescriptions that raised red flags. OSC, at 2-5; e.g., RD, at 77-79,
82, 87. Respondent objects to the Government's and the ALJ's
interpretation of the regulation as requiring a pharmacist to consult
with prescribers and document the consultation for all red flags raised
by a prescription. Exceptions, at 9-10. Respondent argues that the
regulation only requires a pharmacist to document the resolution of ``a
clinically significant condition or drug regimen review related
question'' and that not all red flags, such as geographical distance,
are ``a clinically significant condition or drug regimen review
question'' that require documentation under the regulation. Id. (citing
22 Tex. Admin. Code Sec. 291.33(c)(2)(A)).
Neither the Government nor the Respondent elicited expert testimony
or provided other evidence of what conditions or situations qualify as
``clinically significant'' such that a Texas pharmacist is required by
the regulation to consult with the prescriber and document the
consultation. During the hearing, Dr. Witte was asked by the ALJ if she
was ``aware of whether or not Texas law requires the documentation of
red flags'' and she replied ``No. I don't believe so. . . . I'm not
aware if there's an actual law.'' \O\ Tr. 378. Because there is
insufficient evidence on the record through expert testimony or other
evidence of state law that the red flags raised by the subject
prescriptions are ``clinically significant'' and therefore required
documentation of their resolution under Texas regulation, I cannot
determine, based on the record before me, that Respondent violated 22
Tex. Admin. Code Sec. 291.33(c). Accordingly, I have edited the
Recommended Decision, which I am adopting, to remove the findings that
Respondent violated 22 Tex. Admin. Code Sec. 291.33(c).
---------------------------------------------------------------------------
\O\ Dr. Witte was later asked if she was familiar with the Texas
rule that ``mandates that, `Upon identifying any clinically
significant conditions, situation,' the pharmacist shall take
appropriate steps to avoid or resolve the problem, including
consultation with the prescribing practitioner . . .'' and also
mandates that ``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.''
Tr. 411-412. Dr. Witte responded that ``Yes'' the rule sounded
familiar. Id. Dr. Witte, however, did not provide any testimony
regarding which, if any, of the red flags raised by the subject
prescriptions were clinically significant conditions or situations
that required consultation and documentation under the rule.
---------------------------------------------------------------------------
However, my determination regarding 22 Tex. Admin. Code Sec.
291.33(c) has no effect on the ultimate outcome of this matter. The
substantial evidence on the record demonstrates that failing to resolve
and document the resolution of red flags falls below the minimum
standards of practice of pharmacy in the State of Texas and is,
therefore, a violation of 21 CFR 1306.06. See Tr. 178-82, 261-62.
5. Sanction
In the RD, the ALJ found that Respondent had taken ``no
responsibility for its egregious and repeated failure to fulfill its
corresponding responsibility to ensure the proper prescribing and
dispensing of controlled substances and other responsibilities of a
registration'' and ``presented no evidence of mitigation or
remediation'' RD, at 94. The ALJ, therefore, recommended that I revoke
Respondent's registration and deny any pending application for renewal
or modification. Id. Respondent filed exceptions to the ALJ's finding
that Respondent did not accept responsibility for its misconduct or
``show the requisite remorse for the wrongdoing alleged against
[Respondent].'' Exceptions, at 14.
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 18882,
18910 (2018) (citing Samuel S. Jackson, 72 FR 23848, 23853 (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 62339
(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 78745,
78749, 78754 (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).
I agree with the ALJ's finding that there is nothing in the
Administrative Record that suggests Respondent has accepted
responsibility for its actions. At the hearing, PIC Igwe was asked,
``Do you believe you failed to ensure that the prescriptions for
controlled substances which you dispensed were issued for a legitimate
medical purpose?'' and PIC
[[Page 21016]]
Igwe responded, ``I don't believe that I failed.'' Tr. 567. There is
also nothing in Respondent's Proposed Findings or Closing Brief
accepting responsibility for the controlled substances dispensed
outside the usual course of professional practice and in violation of
Respondent's corresponding responsibility. Respondent argues that PIC
Igwe took responsibility by admitting that she provided DEA
investigators with an incomplete inventory printout during the
Administrative Inspection. Exceptions, at 14. I acknowledge PIC Igwe's
admission to providing inaccurate documents; however, she did not
accept her responsibility as a registrant to have a ``readily
retrievable'' dispensing log that met the requirements of 21 CFR
1304.22(c)-repeatedly minimizing her conduct by blaming it on her
computer software and failing to correct her conduct by providing DEA
with an accurate and complete log within a reasonable time following
the inspection.\P\ See 21 CFR 1304.04(g) (requiring registrants to
maintain specified records such that the information is readily
retrievable); Edmund Chein, M.D., 72 FR 6580, 6593 (2007); Pharmacy
Doctors Enterprises d/b/a Zion Clinic Pharmacy, 83 FR at 10901, aff'd
Pharmacy Doctors Enterprises, Inc. v. Drug Enf't Admin., 789 F. App'x
724, 730 (2019) (finding that producing records as an exhibit for the
hearing did not comply with the ``readily retrievable'' requirement of
the regulation). Accordingly, I agree with the ALJ that Respondent has
not rebutted the Government's prima facie case and has not accepted
responsibility such that I can entrust it with a registration.
---------------------------------------------------------------------------
\P\ Although Respondent eventually produced Respondent Exhibit
C, which PIC Igwe testified was Respondent's complete dispensing log
for the controlled substance audited by DEA investigators, Tr. 467-
71, the document does not comply with the requirements of 21 CFR
1304.22(c), RD, at 85-86.
---------------------------------------------------------------------------
Respondent further argues that the ALJ should have weighed
sanctions other than revocation, such as temporary suspension.
Exceptions, at 15. While the Agency possesses the discretion to order a
sanction short of revocation, I conclude that exercising that
discretion here would ill-serve the public interest. Respondent has not
shown that it can be entrusted with the responsibility carried by its
registration--having failed to accept responsibility for its conduct, I
have no assurance that Respondent would not repeat the conduct if it
were to retain a registration. My predecessors have also revoked the
pharmacy registrations for conduct similar to Respondent's. See, e.g.,
Morning Star Pharmacy & Medical Supply 1, 85 FR 51045 (2020); Heavenly
Care Pharmacy, 85 FR 53402 (2020); Pharmacy Doctors Enterprises d/b/a/
Zion Clinic Pharmacy, 83 FR 10876 (2018).
Finally, Respondent has argued that revocation is inappropriate
because the ``DEA investigators did not make a finding of Imminent Harm
the day they presented the Administrative Inspection Warrant to
[Respondent] back in June of 2015.'' Exceptions, at 14. Respondent has
provided no citation for its argument, and I reject the claim as it
lacks any basis in Agency statute, regulation, or prior decisions.
For the reasons above, I reject Respondent's contention that the
ALJ's recommendation is overly broad and adopt the ALJ's recommended
sanction.
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
FT4134805 issued to The Pharmacy Place. 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 The Pharmacy Place to renew or modify
this registration. This order is effective May 21, 2021.
D. Christopher Evans,
Acting Administrator.
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
Charles Wm. Dorman
Administrative Law Judge
February 13, 2018
Appearances:
Frank W. Mann, Esq. for the Government
Lurese A. Terrell, Esq. for the Respondent
The Drug Enforcement Administration (``DEA'' or ``Government'')
served The Pharmacy Place (``Pharmacy'' or ``Respondent'') with an
Order to Show Cause (``OSC''), seeking to revoke DEA Certificate of
Registration (``COR''), Number FT4134805. Administrative Law Judge
Exhibit (``ALJ-'') 1. In response to the OSC, the Respondent timely
requested a hearing before an Administrative Law Judge. ALJ-2. The
first two sessions of the hearing in this matter were held in Dallas,
Texas, from September 12-13, 2017. The Respondent's expert, however,
failed to appear on either of those days. To accommodate the
Respondent, the hearing was continued. On November 20, 2017, the
hearing reconvened. The November 20, 2017 session of the hearing was
conducted by video teleconference from the DEA Hearing Facility in
Arlington, Virginia, with the parties and witnesses located at the DEA
District Office in San Antonio, Texas.
At the conclusion of the hearing on November 20, 2017, the Parties
were directed to submit their post-hearing briefs no later than January
10, 2018. Tr. 767. On January 8, 2018, however, the Government filed a
Consent Motion for Enlargement of Time to File Post-Hearing Briefs,
requesting a new filing date of January 24, 2018. ALJ-31. That motion
was granted. ALJ-32. Then on January 19, 2018, the Respondent filed a
similar motion, requesting an extension of time to file post-hearing
briefs until February 7, 2018. ALJ-33. That motion was also granted.
ALJ-34.
The issue before the Acting Administrator is whether a
preponderance of the evidence supports the revocation of the
Respondent's DEA Certificate of Registration (``DEA-COR''), No.
FT4134805, pursuant to 21 U.S.C. 824(a)(4) and 823(f), and the denial
of any pending applications for renewal or modification of such
registration, pursuant to 21 U.S.C. 823(f).
This Recommended Decision is based on my consideration of the
entire Administrative Record, including all of the testimony, admitted
exhibits, and the oral and written arguments of counsel.
Allegations
1. Between August 2014 and May 2015, the Pharmacy filled 75
controlled substance prescriptions outside the usual course of pharmacy
practice, in violation of 21 CFR 1306.06, and in contravention of the
Pharmacy's ``corresponding responsibility'' under 21 CFR 1306.04(a).
The Pharmacy did so by repeatedly filling controlled substance
prescriptions that contained red flags of diversion and/or abuse
without addressing or resolving those red flags. The Pharmacy's conduct
in doing so violated 21 U.S.C. 823(f)(4); Tex. Health & Safety Code
Sec. 481.070-.075; Tex. Health & Safety Code Sec. 481,128; and Tex.
Admin. Code Sec. 291.22(c)(2). Additionally, the Pharmacy engaged in
conduct that demonstrates negative experience in its dispensing of
controlled substances, in violation of 21 U.S.C. 823(f)(2). ALJ-1, at
2-3, para. 3, 6-8.
2. Between August 2014 and May 2015, the Pharmacy's pharmacists
filled numerous prescriptions for highly-abused controlled substances
that contained one or more of the following red flags, without
resolving those red
[[Page 21017]]
flags: (1) Prescriptions written to individuals traveling long and/or
unusual distances to obtain the prescriptions and/or to fill them at
the Pharmacy; (2) prescriptions from individuals obtaining the same or
similar combinations of controlled substances from the same small
number of providers; (3) prescriptions for highly-abused ``drug
cocktails'', such as hydrocodone and alprazolam; (4) prescriptions
containing inappropriate and/or unusual directions for use; and (5)
prescriptions for controlled substances which the customer purchased
with cash. The Pharmacy's practice of filling prescriptions for
controlled substances, despite unresolved red flags, included, but was
not limited to, the following instances:
a. On August 1, 2014, the Pharmacy filled a prescription for 120,
10 mg tablets of hydrocodone presented by an undercover agent. The
agent obtained the prescription from a practitioner in a clinic in
south Dallas, more than 30 miles from the Pharmacy, which is located
north of Dallas. There was no legitimate medical purpose for the
prescription and the agent's address on the prescription was
fictitious. The agent also sought to purchase the prescription with
cash. ALJ-1, at 3-4, para. 10(a).
b. From August 2014 to May 2015, the Pharmacy dispensed
prescription cocktails (hydrocodone and alprazolam) to 25 different
individuals, all of whom traveled unusual paths and distances to obtain
their prescriptions for these controlled substances and to have them
filled at the Pharmacy. Six individuals, J.W., H.J., M.H., A.S., K.S.,
and M.A., traveled more than 100 miles to obtain their prescriptions,
have them filled at the Pharmacy, and return home. Another 17
individuals, J.S., C.J., SW, J.W.2, S.H., R.E., R.N., R.H., B.B., S.N.,
I.B., M.W.2, Y.S., R.H.2, C.D., A.K., and S.B., traveled between 70-100
miles to obtain their prescriptions, have them filled at the Pharmacy,
and return home. Four individuals, R.N., E.H., B.B., and T.H., traveled
between 60-70 miles to obtain their prescriptions, have them filled at
the Pharmacy, and return home. All of these individuals sought to
purchase their prescriptions with cash. Additionally, the prescriptions
issued to M.W., J.S., J.W., C.J., S.N., J.W.2, S.H., H.J., E.H., A.S.,
R.E., K.S., S.B., R.H., T.W., I.B., M.W.2, Y.S., M.A., R.H.2, B.B.,
C.D., A.K., and R.N., were facially invalid and in violation of federal
and state law because they lacked the patient's address and the
practitioner's DEA number. ALJ-1, at 4, para. 10(b).
c. Many of the individuals mentioned in paragraph (b), above,
obtained the prescriptions from physicians who were engaged in
``pattern prescribing,'' i.e., prescribing the same controlled
substances in identical or substantially similar quantities. For
instance, between August 19, 2014 and October 2, 2014, C.J., SW, J.W.2,
S.H., and H.J. all received prescriptions for hydrocodone and
alprazolam from the same physician, I.I., and they traveled long and
unusual paths to obtain their prescriptions and have them filled at the
Pharmacy. Then between November 14, 2014, and May 1, 2015, the Pharmacy
filled 12 prescriptions for hydrocodone written by C.V. for patients
A.S., R.E., K.S., G.B., M.A., R.H.2, A.K., R.N., and M.H. All of these
patients traveled long and unusual paths to obtain their prescriptions
and have them filled. The Pharmacy also filled prescription cocktails
(hydrocodone and alprazolam), written by C.V. for patients M.A., R.H.2,
and A.K. on April 17, 21, and May 1, 2015, respectively. Additionally,
between January 13, 2015 and May 11, 2015, the Pharmacy dispensed
controlled substances pursuant to ``pattern-style'' prescriptions
issued by NE On 14 different occasions, the Pharmacy dispensed 90, 10
mg tablets of hydrocodone to 11 different customers. On 8 different
occasions, the Pharmacy filled identical prescription cocktails written
by NE consisting of 90, 10 mg tablets of hydrocodone and 60, 2 mg
tablets of alprazolam. Identical prescription cocktails were dispensed
to both I.B. and T.W. on April 10, 2015, and to B.B. and C.D. on April
23, 2015. ALJ-1, at 4, para. 10(c).
d. On April 17, 2015, the Pharmacy filled a prescription for
hydrocodone to G.B., who had traveled an unusual path and distance of
more than 75 miles to obtain her prescription and have it filled at the
Pharmacy, and then return home. ALJ-1, at 5, para. 10(d).
3. A DEA audit of the Pharmacy's 10 mg hydrocodone, covering the
period of September 25, 2013 through June 18, 2015, revealed a shortage
of 47,183 dosage units. Because the Controlled Substances Act requires
the maintenance of ``complete and accurate'' inventories, as well as a
``complete accurate record of each substance . . . received, sold,
delivered or otherwise disposed of,'' this shortage violated 21 U.S.C.
827(a). ALJ-1, at 5, para. 13.
Witnesses
I. The Government's Witnesses
The Government presented its case through the testimony of four
witnesses and a sworn declaration. The Government's first witness was
retired Diversion Investigator 1 (hereinafter, DI 1). Tr. 25-146. DI 1
served as a DI with the DEA for 14 years and was assigned to the
Dallas, Texas office since June 2008. Tr. 26, 78. As a DI, DI 1
conducted scheduled regulatory investigations, all of which required
that he conduct an audit of controlled substances. Tr. 78. DI 1
estimated that he had conducted about 70 audits in his career. Tr. 80.
DI 1 was part of a DEA team that conducted an Administrative
Inspection Warrant (``AIW'') of the Pharmacy on June 18, 2015. Tr. 26-
27, 60, 451. During that inspection, the DEA obtained documents from
the Pharmacy, including: Prescriptions; copies of order forms,
invoices, and packing forms concerning the Pharmacy's receipt of
controlled substances; and the Pharmacy's dispensing history of
hydrocodone. Tr. 35-36, 77-78.
While at the Pharmacy on June 18, 2015, DI 1 conducted a closing
inventory of the Pharmacy's hydrocodone, during which all of the
medication in the Pharmacy was examined. Tr. 47, 130, 132. That
inventory revealed that the Pharmacy was short more than 47,000 tablets
of hydrocodone. Tr. 87.
The primary purpose of DI 1's testimony was to lay the foundation
for the introduction of Government Exhibits 1-12. During his testimony,
all of those exhibits were admitted into evidence. Tr. 3-4. DI 1 also
testified that he asked the Pharmacy to provide the DEA with a
``complete history'' of its dispensing of hydrocodone, and that in
response to that request the Pharmacy provided the DEA with Government
Exhibit 6. Tr. 36-37.
DI 1's testimony was presented in a professional, candid and
straightforward manner. In addition, DI 1's testimony was sufficiently
objective, detailed, plausible, and internally consistent. Therefore, I
merit it as credible in this Recommended Decision.
The Government next presented the testimony of its expert, Dr. Amy
Witte, Pharm.D. (``Dr. Witte''). Tr. 150-345, 355-425, 763. Government
Exhibit 13 is a copy of Dr. Witte's curriculum vitae. Tr. 153-55. Dr.
Witte holds a Doctor of Pharmacy degree from the University of Texas at
Austin. Tr. 152. Dr. Witte has been a licensed pharmacist in Texas
since 2004. Tr. 152-53. Dr. Witte is currently employed with the
University of the Incarnate Word, Feik School of Pharmacy, Department
of Pharmacy Practice, in San Antonio, Texas, as a full professor, where
she has taught Federal and Texas pharmacy law. Tr. 150, 157-58. She is
currently the main professor in the endocrine module, with a
[[Page 21018]]
specialty in diabetes and thyroid disorders. Tr. 151, 163. She is also
currently employed as a clinical pharmacist with the Texas Veterans
Health Care System. Tr. 150, 156. Dr. Witte worked as a pharmacist for
Walgreens from 2004 until 2011. Tr. 157. Dr. Witte testified that she
was certified as an expert witness with the DEA in 2013. Tr. 156. After
Respondent's counsel conducted voir dire examination of Dr. Witte, Tr.
158-67, she objected to Dr. Witte being accepted as an expert because
Dr. Witte's qualifications were ``all academic.'' Tr. 167-69. The
Respondent's objection was overruled and Dr. Witte was then accepted as
an ``[e]xpert in the field of pharmacy in the state of Texas.'' Tr.
169.
Dr. Witte presented testimony concerning what a pharmacist is
required to do before filling a prescription for a controlled substance
in Texas. Tr. 169-71, 178-80, 192, 210. In addition, she testified
about circumstances that may give rise to a red flag, which a
pharmacist would need to resolve before filling a prescription for a
controlled substance. Tr. 171-74, 177-80, 189, 191-93, 244, 281, 321,
323. She also provided testimony based upon her review of Government
Exhibits 2, 3, and 12, and rendered her opinion as to whether filling
various prescriptions in those exhibits fell below the minimal standard
of the practice of pharmacy in Texas, whether filling those
prescriptions was within the usual course of the practice of pharmacy
in Texas, and whether the pharmacist who filled the prescriptions had
satisfied the corresponding responsibility to ensure that only
prescriptions issued for a legitimate medical purpose were filled. See,
e.g., Tr. 211, 217, 227-28, 236-37, 244-45.
Having closely listened to Dr. Witte's testimony, and having
closely reviewed the transcript of her testimony, I find that it was
sufficiently objective, detailed, plausible, and internally consistent
to be considered credible in this Recommended Decision.
The Government's third witness was DI 2. Tr. 426-440. She testified
that she has been a DI with the DEA since 2005. Tr. 426. To become a
DI, DI 2 received 12 weeks of training at the DEA Training Academy
concerning, ``diversion investigations, pharmacology of drugs,
regulatory audits, administrative inspection warrants, . . . and
criminal cases.'' Tr. 427. DI 2 is currently assigned to DEA's tactical
diversion squad in Dallas, Texas, where she primarily focuses on
criminal investigations. Tr. 427. Prior to becoming a DI, DI 2 was an
adjunct professor in NASA's aerospace education program at Oklahoma
State University. Tr. 427.
DI 2 provided testimony concerning her involvement of DEA's
investigation of the Pharmacy, indicating that the Pharmacy had come to
DEA's attention as part of a larger investigation into pill mills. Tr.
428. DI 2 was the case agent for the larger investigation. Tr. 428. DI
2 noted that the Pharmacy stood out to her because it was located quite
a distance from the offices of the pill mill doctors whose
prescriptions the Respondent was filling. Tr. 430. DI 2 participated in
the execution of the AIW. Tr. 430.
DI 2's testimony was presented in a professional, candid, and
straightforward manner. In addition, DI 2's testimony was sufficiently
objective, detailed, plausible, and internally consistent. Therefore, I
merit it as credible in this Recommended Decision.
Pursuant to an agreement with the Respondent, the Government did
not call Ms. Ijeoma Igwe, the Pharmacy's manager and pharmacist-in-
charge, as a witness so long as the Respondent called her to testify.
Thus, an assessment of her credibility is contained under the
discussion of the Respondent's witnesses.
The Government also presented the sworn declaration of UC 1. GE-11.
UC 1 presented to the Pharmacy as an undercover agent using the name
``M.W.'' Tr. 41; GE-10, at 3; GE-11, at 2. Prior to the hearing, the
Respondent filed an objection ``to the affidavit testimony of [UC 1]
because it deprives the Respondent of its cross examination of said
witness.'' ALJ-15, at 2. The Respondent's objection to the use of the
sworn declaration of UC 1 was overruled in a prehearing Order issued on
August 29, 2017. ALJ-18, at 1-2. When the Government introduced UC 1's
declaration at the hearing, the Respondent again objected, and again
that objection was overruled. Tr. 31-32. In admitting the declaration,
I noted that it was a hearsay document and Respondent's lack of
opportunity to cross examine UC 1 would be considered in determining
what weight to give to the Exhibit. Tr. 32; see 21 CFR 1316.58(b).
Having examined the sworn declaration of UC 1, I find that its contents
are consistent with other evidence of record. For example, UC 1's
description of the operation of the Redbird Medical Clinic is
consistent with the testimony of DI 2. Tr. 120, 428-31, 435-37. Also,
the declaration's statements that: UC 1 received a prescription from
Nurse L.R. at the Redbird Medical Clinic for 120 tablets of
hydrocodone; the prescription was faxed to the Pharmacy; he was waited
on by a female employee at the Pharmacy when he arrived; and he paid
$150 for the hydrocodone, are consistent with the content of Government
Exhibit 2, at 1, and the fact that the prescription was filled by Ms.
Igwe. Tr. 577-78. Finally, none of the evidence presented by the
Respondent contradicts the content of the sworn declaration of UC 1.
Accordingly, I fully credit the sworn declaration of UC 1.
II. The Respondent's Witnesses
The Respondent presented its case through the testimony of two
witnesses. The first witness the Respondent called was Ms. Ijeoma Igwe.
Tr. 442-607. Ms. Igwe obtained her pharmacy degree at the University of
Liverpool in England and she worked as a clinical pharmacist in
England. Tr. 445. Ms. Igwe immigrated to the United States in 2005. Tr.
445, 605-06. Ms. Igwe began her pharmacy career in the United States
serving an internship for 8 to 10 months with CVS Pharmacies in Texas.
Tr. 445, 606. Ms. Igwe then worked as a pharmacist for Target, filling
in where needed at different Target stores. Tr. 446. Ms. Igwe then
became interested in compounding pharmacy, which entails making custom
medications, and worked for a compounding pharmacy for three years
until April 2013. Tr. 447-48. Then in September 2013, Ms. Igwe opened
The Pharmacy Place. Tr. 448.
Ms. Igwe presented testimony about the character and operation of
the Pharmacy. Tr. 448-51. She also testified about being present at the
Pharmacy when the DEA executed the AIW on June 18, 2015, and her
interaction with the DEA investigators. Tr. 451-54, 456-58, 465-67. Ms.
Igwe described herself as being perplexed, surprised, and shocked
during the execution of the AIW, and that she did her best to assist
the investigators. Tr. 452. Ms. Igwe testified that after the DEA
investigators left the Pharmacy she discovered that she had not
provided them a complete record of her hydrocodone dispensing history,
attributing her error to a lack of familiarity with the software
program. Tr. 466-67. Working with her ``software people,'' Ms. Igwe was
able to print out another dispensing log, which she sent to her
attorney. Tr. 467-71, 548.
Ms. Igwe testified concerning her standard procedures she used when
filling prescriptions. Tr. 477-81. Those procedures included calling a
prescriber to verify a prescription for a new patient, checking the
prescription monitoring program (``PMP''), as well as checking the
dosing and normal things a pharmacist looks for. Tr. 477-84, 503, 517,
586, 590, 607. She also testified
[[Page 21019]]
that she would sometimes put a ``V'' on prescriptions to indicate that
she had verified them. Tr. 482, 557. She also testified that she would
make notes in the ``Demographics'' section of the patient profile to
resolve a red flag if she had a discussion with a prescriber about a
``clinical'' matter. Tr. 481, 585.
Ms. Igwe testified that the Pharmacy receives prescriptions from
other providers similar to the prescriptions at issue in this case. Tr.
518-22. She noted that there was an orthopedist downstairs from the
Pharmacy and he prescribes hydrocodone which she fills, and that there
is one customer who gets 150 tablets a month and another who gets 180
tablets a month. Tr. 476-77, 518, 522. She further testified that
because she gets other similar prescriptions she believed the
prescriptions at issue in this case were in line with what other
patients were receiving from other clinics. Tr. 522.
Ms. Igwe also testified that she was not concerned about the
distance a customer traveled if they lived in the Dallas-Fort Worth
metroplex. Tr. 493-94. Later she testified that distance would be a
concern if she did not know the source of the prescription. Tr. 578.
She also testified that she did not know where Everman, Texas, was
located, yet she filled multiple prescriptions for patient A.S., who
lived in Everman. Tr. 579; GE-2, at 22-33. Ms. Igwe also testified that
she would not fill a prescription if the address on the prescription
did not match the address on the customer's driver's license. Tr. 539.
While Ms. Igwe seemed confident while she testified, and her
testimony appeared sincere and candid, there are several issues with
her testimony that detract from its overall believability. First, she
testified that she would call the prescriber the first time a patient
presented with a prescription for a controlled substance and that she
would sometimes mark the prescription with a ``V'' to indicate that she
had verified the prescription. Tr. 477, 482, 557. The documentary
evidence, however, does not support that testimony. For example, there
are 68 prescriptions contained in Government Exhibit 2, but only one is
marked with a ``V.'' \1\ GE-2, at 49. Furthermore, the alprazolam
prescription marked with a ``V'' for patient K.S. is dated February 26,
2015. Id. K.S., however, had filled prescriptions for both alprazolam,
as well as hydrocodone, at the Pharmacy six times before Ms. Igwe
marked the February 26, 2015 prescription with a ``V.'' GE-2, at 44-46,
53-55. In addition, Government Exhibit 6 establishes that Dr. C.V.
wrote many prescriptions for hydrocodone, but in spite of all those
prescriptions, Ms. Igwe never had a conversation with Dr. C.V. about a
patient. Tr. 561. In fact, the only time Ms. Igwe talked with Dr. C.V.
was when he called her about a non-patient matter. Tr. 561.
---------------------------------------------------------------------------
\1\ None of the prescriptions submitted by the Respondent in
Respondent Exhibit H are marked with a ``V.''
---------------------------------------------------------------------------
Second, Ms. Igwe testified that she did not find the prescriptions
at issue in this case to be out of line with other prescriptions she
filled. Tr. 522. She also testified that she filled prescriptions for
an orthopedist, who performed surgery downstairs from the Pharmacy, and
that the orthopedist prescribed hydrocodone. Tr. 476, 518. She further
testified that she had one customer who took 150 hydrocodone tablets a
month and another who took 180. Tr. 518, 522. While the documentary
evidence does not necessarily contradict that testimony, the
documentary evidence clearly does not support Ms. Igwe's testimony. For
example, Government Exhibit 6 details 929 prescriptions that the
Pharmacy filled for hydrocodone. All but 25 of those prescriptions were
written by the same small group of prescribers, whose prescriptions are
identified on the patient profiles contained in Government Exhibit 2.
Further examination of Government Exhibit 6 fails to reveal any patient
with a prescription for 150 or 180 tablets of hydrocodone. In addition,
there is only one prescription written by a prescriber, Dr. V.K., with
the same address as the Pharmacy; she wrote a prescription for 30
tablets of hydrocodone. GE-6, at 13.
Third, Ms. Igwe's explanation about why she was not concerned about
the delay between the hydrocodone that was prescribed for pain and the
date the patient picked it up with respect to Government Exhibit 2, at
1, makes little sense. She explained that a patient with chronic pain
might possibly have pain medicine they had received before to tide them
over until they could pick up a new prescription. Tr. 564-65. She also
testified that she always checked the PMP before filling prescriptions.
Tr. 479. The prescription on page 1 of Government Exhibit 2 was for an
undercover agent using a fake name. Had Ms. Igwe checked the PMP for
that patient, she would not have found any prior prescriptions,
eliminating the possibility that the patient had leftover medication to
tide him over. Clearly, as Government counsel suggested, Ms. Igwe was
simply speculating about reasons for the delay. Tr. 545, 565; see also
ALJ-35, at 24.
When initially explaining the ``Rx Date'' on the entries in
Government Exhibit 6, Ms. Igwe testified that all of the hydrocodone
prescriptions identified in Government Exhibit 6 were electronic
prescriptions and the ``Rx Date'' was the date the prescriptions were
received. Tr. 533, 560, 562. She backtracked from that position when
confronted by the fact that the prescription at Government Exhibit 2,
at 1, was a handwritten prescription and it was also recorded on page 8
of Government Exhibit 6. Tr. 562, 580. Other handwritten prescriptions
contained in Government Exhibit 2 are also recorded in Government
Exhibit 6. Compare GE-2, at 16 with GE-6, at 28; compare GE-2, at 28
with GE-6, at 65. At the hearing, my impression was that Ms. Igwe was
downplaying the significance of the ``Rx Date,'' because to do so
decreased the likelihood that she would have observed one prescription
after another for hydrocodone coming into the Pharmacy, written by the
same doctors and for the same strengths and normally for the same
quantity.
Finally, Ms. Igwe testified that when she received faxed
prescriptions from medical clinics, the clinics also faxed additional
information such as the patient's address and identification on
separate pages. Tr. 488-89, 539-40. Ms. Igwe also testified that when
she would resolve red flags concerning clinical matters about a
prescription she would make notes in the demographics section of the
patient profile. Tr. 481, 546. She further explained that these notes
did not print out when she printed the patient profile. Tr. 482. When
asked why she did not bring copies of the materials the medical clinics
had faxed to her, or copies of her notes that showed she had resolved
red flags, Ms. Igwe testified that she did not think she needed to or
that she did not think it was necessary. Tr. 547. This explanation
makes no sense in light of the allegations against her and it is not
credible. Ms. Igwe's credibility on this issue is further undermined by
the fact that this type of information was sought by the investigators
during the execution of the AIW and by the September 6, 2016 subpoena.
Tr. 78, 356-57; GE-9.
In light of the aspects of Ms. Igwe's testimony outlined above, and
those are but a few of the examples that could be given, I find that
her testimony merits only limited belief. Thus, where Ms. Igwe's
testimony conflicts with the testimony of other witnesses, or with the
documentary evidence of record, I credit that other testimony and those
documents over Ms. Igwe's testimony.
[[Page 21020]]
The Respondent's second witness was Mr. Robert Litman. Tr. 623-762.
His curriculum vitae is contained in Respondent's Exhibit B. Tr. 632.
Mr. Litman testified concerning his background education and work
history. Tr. 624-631, 652-655. Mr. Litman earned his pharmacy degree
from the University of Florida in 1981 and he has worked as a
pharmacist since then. Tr. 624. Mr. Litman has managed about a dozen
small pharmacies over the past 36 years. Tr. 624. He is currently the
Director of Consultant and Management Services with Ultimed Health
Advisors, dealing with, among other things, the ``management of retail
pharmacy operations.'' Tr. 622; RE-B, at 1. Mr. Litman is also a
Clinical Assistant Professor of Pharmacy Practice in geriatric medicine
at Nova Southeastern University, Ohio State University, and Palm Beach
Atlantic University. Tr. 641, 644; RE-B, at 2. Mr. Litman has
previously testified as an expert witness, but only in Florida. Tr.
623, 638-39. Mr. Litman currently works a couple of days per month as a
retail pharmacist. Tr. 650, 652. Following voir dire by Government
counsel, Mr. Litman was accepted as an expert witness, without
objection, in the area of ``retail pharmacy practices.'' Tr. 656.
Mr. Litman presented his testimony in a direct, straightforward,
and candid manner. Mr. Litman had a professional demeanor while he
testified. During voir dire of Mr. Litman, the Government noted that
Mr. Litman's expert testimony was evaluated by another Administrative
Law Judge (``ALJ'') in an earlier case before the DEA. Tr. 650-52; see
Howard N. Robinson, M.D., 79 FR 19356 (2014). While the ALJ in that
case found some portions of a report that Mr. Litman prepared to be
``peculiar,'' the ALJ credited his testimony, describing it as
``sufficiently detailed, authoritative and candid.'' Tr. 652; Robinson,
M.D., 79 FR at 19364-65. While I too find portions of Mr. Litman's
testimony to be a bit peculiar or inconsistent, in general I find that
he presented testimony that was ``sufficiently detailed, authoritative,
and candid'' to be generally credited in this decision.
Some portions of Mr. Litman's testimony that were peculiar or
inconsistent concerned the following areas: Distance that customers
traveled; a lack of concern for pattern prescribing; drug cocktails;
and a delay between the date a prescription was written to treat pain
and the date the customer picked up the prescription. Mr. Litman was
not particularly concerned about the distance a customer traveled to
fill a prescription. Tr. 726-30. While he did testify that as a
pharmacist working in Miami, he would find it a little leery if a
customer traveled from South Carolina to fill a prescription, he also
testified that there was no problem if the customers were from in-
state. Tr. 730. Mr. Litman's approach seemingly ignores the fact that
portions of South Carolina are closer to Miami than is, ``in-state'',
Pensacola, Florida. Further, and of greater significance, Mr. Litman
was not familiar with DEA case law concerning pharmacy customers
driving long distances, or of the Texas requirement for pharmacists to
consider distance. Tr. 727. Thus, without an understanding of the law,
it is understandable why Mr. Litman has little concern for the distance
a customer travels to obtain a prescription and have it filled.
Mr. Litman also testified that he would not be concerned about
pattern prescribing when filling 23 successive prescriptions for
hydrocodone from the same provider. Tr. 747-49. Nevertheless, Mr.
Litman testified that he would call the prescriber every time he was
presented with a new prescription for hydrocodone. Tr. 747, 749. Mr.
Litman also testified that he would not be concerned about pattern
prescribing if he had spoken with the doctor and was comfortable that
there was a legitimate doctor-patient relationship. Tr. 748.
Mr. Litman's testimony concerning drug cocktails was difficult to
follow. Mr. Litman first acknowledged that a customer presenting
prescriptions for hydrocodone and alprazolam would be presenting
prescriptions for a drug cocktail. Tr. 740. Mr. Litman further
testified that he would only be concerned about filling such
prescriptions if the customer was diverting or abusing the controlled
substances. Tr. 741. Mr. Litman, however, could not explain how a
pharmacist would know if the customer was diverting or abusing the
controlled substances. Tr. 741. He later explained that the combination
of these two drugs could be a drug cocktail depending on the reason the
patient received the prescription. Tr. 741-42. Mr. Litman's explanation
ignores the fact that the only way the pharmacist could make an
informed decision as to whether the prescriptions had been issued for a
legitimate medical purpose would be to call the prescriber. Coming full
circle, Mr. Litman then testified that when confronted with
prescriptions for hydrocodone and alprazolam he would call the
prescriber to ``make sure that [the prescriber] wrote those
prescriptions, that they were valid prescriptions for a patient, and
there was a doctor-patient relationship.'' Tr. 743.
Mr. Litman was also asked whether he would have any concern where a
patient delayed picking up a prescription written for pain, and he said
it would not concern him at all. Tr. 749-50. When asked why he would
have no concern, not surprisingly he gave the same speculative answer
given by Ms. Igwe--he would assume the patient had some medication left
over from a prior prescription or the patient had obtained medication
samples directly from the prescriber. Tr. 750-52. The answer is not
surprising because Mr. Litman was able to read Ms. Igwe's testimony
before he testified. Tr. 683. Although this delay would be of no
concern to Mr. Litman, he did testify that he would call the doctor to
``let him know that the patient hadn't filled [the prescription] for a
week, and [ask] if there was an issue.'' Tr. 751. Mr. Litman's
explanation suggests that he would be concerned about a delay in
picking up a prescription for pain medication, even though he would not
acknowledge it.
These four examples of areas in which Mr. Litman's testimony was
peculiar or inconsistent are not all-inclusive. Thus, while I find Mr.
Litman's testimony to be generally worthy of belief, where it conflicts
with Dr. Witte's testimony, or laws, regulations, or DEA precedent, I
give greater weight to her testimony and to legal authority.
The Facts
I. Stipulations of Fact
The parties agree to 45 stipulations (``Stip.''), which are
accepted as facts in these proceedings:
1. Respondent Pharmacy Place is registered with DEA as a retail
pharmacy authorized to handle controlled substances in Schedules II-V
under DEA COR number FT4134805 at 4031 W. Plano Parkway, Suite 211,
Plano, Texas 75093. DEA COR FT4134805 expires on November 30, 2019.
2. The pharmacy is owned by HOIC Enterprises, LLC, a Texas limited
liability company, and does business as The Pharmacy Place. It is
operated and managed by Harrison and Ijeoma Igwe.
3. According to the Texas Office of the Comptroller, Harrison Igwe
and Ijeoma Igwe are listed as managers of HOIC Enterprises LLC.
4. According to the Texas Board of Pharmacy, The Pharmacy Place is
a licensed community pharmacy in the State of Texas, license no. 28650.
5. According to the Texas Board of Pharmacy, Ijeoma Igwe is a
licensed pharmacist (License No. 44785) in the
[[Page 21021]]
State of Texas and is the Pharmacist-in-Charge (``PIC'') of The
Pharmacy Place.
6. Norco is a brand name of a combination medication containing the
Schedule II generic drug hydrocodone.
7. Xanax is the brand name of the Schedule IV generic drug
alprazolam.
8. Promethazine with codeine is a Schedule V controlled substance.
9. Government Exhibit (``GE'') 3, pp. 1-5, is a Mapquest printout
showing the path and distance from M.A.'s residence (as listed in
Respondent's Patient Profile) to (1) Dr. C.V. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) M.A.'s
residence. (107 miles total).
10. Government Exhibit (``GE'') 3, pp. 6-10, is a Mapquest printout
showing the path and distance from B.B.'s residence (as listed in
Respondent's Patient Profile) to (1) Dr. NE on 201 Billings Street in
Arlington, Texas (as listed in Respondent's Patient Profile) to (2)
Respondent's address to (3) B.B.'s residence. (80 miles total).
11. Government Exhibit (``GE'') 3, pp. 11-15, is a Mapquest
printout showing the path and distance from B.B.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. NE on 2617 Bolton Boone
Drive in DeSoto, Texas (as listed in Respondent's Patient Profile) to
(2) Respondent's address to (3) B.B.'s residence. (66 miles total).
12. Government Exhibit (``GE'') 3, pp. 16-19, is a Mapquest
printout showing the path and distance from G.B.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) G.B.'s
residence. (55 miles total).
13. Government Exhibit (``GE'') 3, pp. 20-24, is a Mapquest
printout showing the path and distance from I.B.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. NE (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) I.B.'s
residence. (79 miles total).
14. Government Exhibit (``GE'') 3, pp. 25-29, is a Mapquest
printout showing the path and distance from S.B.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. NE (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) S.B.'s
residence. (79 miles total).
15. Government Exhibit (``GE'') 3, pp. 30-34, is a Mapquest
printout showing the path and distance from C.D.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. NE (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) C.D.'s
residence. (81 miles total).
16. Government Exhibit (``GE'') 3, pp. 35-39, is a Mapquest
printout showing the path and distance from R.E.'s residence (as listed
in Respondent's Patient Profile) to (1) C.Z., S.G., and/or L.R. (as
listed in Respondent's Patient Profile) to (2) Respondent's address to
(3) R.E.'s residence. (86 miles total).
17. Government Exhibit (``GE'') 3, pp. 40-44, is a Mapquest
printout showing the path and distance from R.E.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) R.E.'s
residence. (94 miles total).
18. Government Exhibit (``GE'') 3, pp. 45-48, is a Mapquest
printout showing the path and distance from E.H's residence (as listed
in Respondent's Patient Profile) to (1) I.I. and/or Dr. A.Q. (as listed
in Respondent's Patient Profile) to (2) Respondent's address to (3)
E.H's residence. (68 miles total).
19. Government Exhibit (``GE'') 3, pp. 49-53, is a Mapquest
printout showing the path and distance from M.H.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. NE (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) M.H.'s
residence. (116 miles total).
20. Government Exhibit (``GE'') 3, pp. 54-58, is a Mapquest
printout showing the path and distance from M.H.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) M.H.'s
residence. (121 miles total).
21. Government Exhibit (``GE'') 3, pp. 59-63, is a Mapquest
printout showing the path and distance from R.H.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. A.Q. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) R.H.'s
residence. (79 miles total).
22. Government Exhibit (``GE'') 3, pp. 64-68, is a Mapquest
printout showing the path and distance from R.H.'s residence (as listed
in Respondent's Patient Profile) to (1) J.W. (as listed in Respondent's
Patient Profile) to (2) Respondent's address to (3) R.H.'s residence.
(76 miles total).
23. Government Exhibit (``GE'') 3, pp. 69-73, is a Mapquest
printout showing the path and distance from R.H.2's residence (as
listed in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3)
R.H.2's residence. (92 miles total).
24. Government Exhibit (``GE'') 3, pp. 74-78, is a Mapquest
printout showing the path and distance from S.H.'s residence (as listed
in Respondent's Patient Profile) to (1) I.I. (as listed in Respondent's
Patient Profile) to (2) Respondent's address to (3) S.H.'s residence.
(76 miles total).
25. Government Exhibit (``GE'') 3, pp. 79-83, is a Mapquest
printout showing the path and distance from C.J.'s residence (as listed
in Respondent's Patient Profile) to (1) I.I. (as listed in Respondent's
Patient Profile) to (2) Respondent's address to (3) C.J.'s residence.
(81 miles total).
26. Government Exhibit (``GE'') 3, pp. 84-88, is a Mapquest
printout showing the path and distance from H.J.'s residence (as listed
in Respondent's Patient Profile) to (1) I.I. (as listed in Respondent's
Patient Profile) to (2) Respondent's address to (3) H.J.'s residence.
(105 miles total).
27. Government Exhibit (``GE'') 3, pp. 89-93, is a Mapquest
printout showing the path and distance from A.K.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) A.K.'s
residence. (81 miles total).
28. Government Exhibit (``GE'') 3, pp. 94-98, is a Mapquest
printout showing the path and distance from R.N.'s residence (as listed
in Respondent's Patient Profile) to (1) the Billings Street address in
Arlington, Texas, where C.Z., S.G., Dr. NE and/or L.R. are listed as
practicing according to Respondent's Patient Profile) to (2)
Respondent's address to (3) R.N.'s residence. (95 miles total).
29. Government Exhibit (``GE'') 3, pp. 99-103, is a Mapquest
printout showing the path and distance from R.N.'s residence (as listed
in Respondent's Patient Profile) to (1) the Bolton Boone Drive address
in DeSoto, Texas, where Dr. NE is listed as practicing according to
Respondent's Patient Profile) to (2) Respondent's address to (3) R.N.'s
residence. (78 miles total).
30. Government Exhibit (``GE'') 3, pp. 104-108, is a Mapquest
printout showing the path and distance from R.N.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) R.N.'s
residence. (64 miles total).
31. Government Exhibit (``GE'') 3, pp.109-112, is a Mapquest
printout showing the path and distance from S.N.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. NE (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) S.N.'s
residence. (81 miles total).
32. Government Exhibit (``GE'') 3, pp.113-117, is a Mapquest
printout showing the path and distance from A.S.'s residence (as listed
in Respondent's Patient Profile) to (1) C.Z., Dr. NE, L.R., and/or S.G.
(as listed in
[[Page 21022]]
Respondent's Patient Profile) to (2) Respondent's address to (3) A.S's
residence. (104 miles total).
33. Government Exhibit (``GE'') 3, pp.118-122, is a Mapquest
printout showing the path and distance from A.S.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) A.S.'s
residence. (111 miles total).
34. Government Exhibit (``GE'') 3, pp.123-127, is a Mapquest
printout showing the path and distance from J.S.'s residence (as listed
in Respondent's Patient Profile) to (1) L.R. (as listed in Respondent's
Patient Profile) to (2) Respondent's address to (3) J.S.'s residence.
(80 miles total).
35. Government Exhibit (``GE'') 3, pp.128-133, is a Mapquest
printout showing the path and distance from K.S.'s residence (as listed
in Respondent's Patient Profile) to (1) C.Z., Dr. NE, S.G., and/or L.R.
(as listed in Respondent's Patient Profile) to (2) Respondent's address
to (3) K.S.'s residence. (101 miles total).
36. Government Exhibit (``GE'') 3, pp.134-139, is a Mapquest
printout showing the path and distance from K.S.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) K.S.'s
residence. (109 miles total).
37. Government Exhibit (``GE'') 3, pp.140-144, is a Mapquest
printout showing the path and distance from Y.S.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. NE on Billings Street in
Arlington, Texas, (as listed in Respondent's Patient Profile) to (2)
Respondent's address to (3) Y.S.'s residence. (97 miles total).
38. Government Exhibit (``GE'') 3, pp.145-150, is a Mapquest
printout showing the path and distance from Y.S.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. NE on Bolton Boone Drive in
DeSoto, Texas (as listed in Respondent's Patient Profile) to (2)
Respondent's address to (3) Y.S.'s residence. (79 miles total).
39. Government Exhibit (``GE'') 3, pp.151-156, is a Mapquest
printout showing the path and distance from J.W.'s residence (as listed
in Respondent's Patient Profile) to (1) S.G. (as listed in Respondent's
Patient Profile) to (2) Respondent's address to (3) J.W.'s residence.
(108 miles total).
40. Government Exhibit (``GE'') 3, pp.157-161, is a Mapquest
printout showing the path and distance from J.W.2's residence (as
listed in Respondent's Patient Profile) to (1) I.I. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3)
J.W.2's residence. (98 miles total).
41. Government Exhibit (``GE'') 3, pp.162-166, is a Mapquest
printout showing the path and distance from M.W.2's residence (as
listed in Respondent's Patient Profile) to (1) L.R. (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3)
M.W.2's residence. (97 miles total).
42. Government Exhibit (``GE'') 3, pp.167-171, is a Mapquest
printout showing the path and distance from M.W.2's residence (as
listed in Respondent's Patient Profile) to (1) Dr. NE (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3)
M.W.2's residence. (79 miles total).
43. Government Exhibit (``GE'') 3, pp.172-176, is a Mapquest
printout showing the path and distance from SW's residence (as listed
in Respondent's Patient Profile) to (1) I.I. (as listed in Respondent's
Patient Profile) to (2) Respondent's address to (3) SW2's residence.
(99 miles total).
44. Government Exhibit (``GE'') 3, pp.177-181, is a Mapquest
printout showing the path and distance from T.W.'s residence (as listed
in Respondent's Patient Profile) to (1) Dr. NE (as listed in
Respondent's Patient Profile) to (2) Respondent's address to (3) T.W.'s
residence. (66 miles total).
45. Government Exhibit (``GE'') 12, pp.1-5, is a Mapquest printout
showing the path and distance from 5944 Callaston Lane, Ft. Worth,
Texas to (1) Redbird Medical Clinic (3107 Camp Wisdom Road, Dallas,
Texas) to (2) Respondent's location to (3) 5944 Callaston Lane, Ft.
Worth, Texas.
II. Findings of Fact
The factual findings below are based on a preponderance of the
evidence, including the detailed, credible, and competent testimony of
the aforementioned witnesses, the exhibits entered into evidence, and
the record before me.
The Pharmacy
1. Ms. Ijeoma Igwe (``Ms. Igwe'') graduated from pharmacy school at
the University of Liverpool in England in 1989. Tr. 445, 605-06. After
graduating, she worked as a clinical pharmacist in England until she
relocated to the United States in 2005. Id. at 445.
2. Ms. Igwe began practicing pharmacy in Texas in 2006 by working
as a pharmacy intern with CVS for 8-10 months. Id. at 445-46, 606. She
then worked as a full-time floater pharmacist at various Target stores.
Id. at 446-47. She eventually left Target and worked for a
rehabilitation hospital for three months. Id. at 447. She then worked
as a pharmacist at Albertson's. Id. at 447.
3. Ms. Igwe is a licensed Texas pharmacist. Id. at 516.
4. While working at Albertson's, Ms. Igwe developed an interest in
compounding pharmacy. Tr. 447. She then worked at a compounding
pharmacy for approximately three years until April 2013. Id. at 447.
5. Ms. Igwe opened the Pharmacy in September 2013. Id. at 448.
6. The Pharmacy is owned by HOIC Enterprises, LLC, and Ms. Igwe is
the pharmacist-in-charge of the Pharmacy. Id. at 35.
7. The Pharmacy is a small pharmacy. Id. at 433, 449. When the DEA
inspected the Pharmacy, the Pharmacy was filling approximately 60-100
prescriptions a day. Id. at 474, 696-97.
8. Ms. Igwe is the only pharmacist who works at the Pharmacy. Id.
at 449, 481-82, 577.
9. Because Ms. Igwe is the only pharmacist at the Pharmacy, she
filled all the prescriptions in Government Exhibit 2. Id. at 577-78.
10. Most of the Pharmacy's prescriptions are electronically
received through ``e-script.'' Id. at 487-88. Some prescriptions are
sent by fax. Id. at 488.
11. The Pharmacy began seeing prescriptions from Redbird Medical
Clinic, and other clinics under investigation, around January or
February 2014. Id. at 475.
The Inspection
12. The Pharmacy came to DEA's attention during a larger
investigation of ``pill mill'' clinics in the Dallas area in 2013. Id.
at 428. The DEA went to the Pharmacy because it had been identified as
a pharmacy that was filling prescriptions issued by ``pill mill''
clinics. Id. at 63-64, 430.
13. The DEA suspected that some prescriptions the Pharmacy filled
were not issued for legitimate medical purposes because they were
issued from a ``pill mill'' clinic. Id. at 120. The suspected ``pill
mill'' clinic had a security guard in the parking lot who ushered
people into the clinic. Id. at 120.
14. At least two doctors and four nurse practitioners involved in
the DEA's investigation of Dallas-area pill mills were indicted. Id. at
437-38. One of the doctors pled guilty and was sentenced. Id. at 437.
Additionally, two pharmacists were indicted, pled guilty, and
sentenced. Id. at 438.
15. On June 18, 2015, Diversion Investigators, DI 1and DI 2 were
part of the DEA investigative team that executed an Administrative
Inspection
[[Page 21023]]
Warrant (``AIW'' or ``Inspection'') at the Pharmacy. Id. at 27, 60,
431, 451.
16. During the inspection, Ms. Igwe was the only employee working
at the Pharmacy. Id. at 141-42.
17. During the inspection, DEA investigators discussed their
concerns about the Pharmacy with Ms. Igwe. Id. at 431-32.
18. During the inspection, DEA asked Ms. Igwe for any documentation
she had to show that the Pharmacy had verified the prescriptions it had
filled. Id. at 78, 431-32.
19. DEA investigators also requested that the Pharmacy turn over
all of the notes it had concerning the resolution of red flags. Id. at
356-57, 431-32; GE-9.
20. Ms. Igwe told investigators that she did not verify the
legitimacy of every prescription the Pharmacy filled. Tr. 432.
21. During the inspection, DI 1 and DI 2 asked Ms. Igwe if she
believed the prescriptions were genuine, and Ms. Igwe stated that she
believed they were. Id. at 457.
22. The Pharmacy was asked to provide DEA with a complete history
of its dispensing of hydrocodone \2\ from the date the Pharmacy opened
to the date of the inspection, June 18, 2015. Id. at 36, 431-32.
---------------------------------------------------------------------------
\2\ All of the hydrocodone dispensed by the Pharmacy in this
case was hydrocodone/APAP 10/325 mg. This Recommended Decision will
simply refer to it as ``hydrocodone.'' ``APAP'' is the abbreviation
for acetaminophen. Tr. 398.
---------------------------------------------------------------------------
23. During the inspection, when DEA investigators asked Ms. Igwe
for documentation concerning the Pharmacy, Ms. Igwe pointed to where
the documentation was located. Id. at 66, 431-32. At the time of the
inspection, the Pharmacy was in disarray. Id. at 66. Investigators also
seized invoices, 222 Forms, hard-copy prescriptions, and the Pharmacy's
dispensing history for hydrocodone. Id. at 35-36, 77-78, 434, 456.
24. Government Exhibit 6 is the hydrocodone dispensing log Ms. Igwe
printed from the Pharmacy's computer and provided to DI 2 and DI 1 when
they executed the AIW at the Pharmacy. Id. at 37, 67, 135, 456, 553.
25. The date range printed at the top of Government Exhibit 6 runs
from October 23, 2013, to June 18, 2015. Id. at 553.
26. Ms. Igwe later realized that the dispensing log she gave to the
investigators was incomplete. Id. at 466. She had never printed an
inventory report before. Id. at 466.
27. Sometime after the inspection, Ms. Igwe contacted the
manufacturer of the software the Pharmacy used, and the manufacturer
showed her how to run the complete hydrocodone dispensing report. Id.
at 467. She then gave this report, contained in Respondent Exhibit C,
to an attorney to forward to the DEA. Id. at 468-69, 470-71, 549.
28. There are no dates or date range on any of the documents in
Respondent Exhibit C. Id. at 551.
29. Pages 5-133 of Government Exhibit 2 contain prescriptions
obtained from the Pharmacy during the administrative inspection on June
18, 2015, and patient profiles the Pharmacy provided to the DEA in
response to an administrative subpoena. Id. at 44-45; GE-2.
30. The Pharmacy's computer system automatically assigns a date,
time, and prescription number to the prescription when it is received.
Tr. 533-34, 562, 580.
31. Government Exhibit 8 contains invoices showing the quantity of
hydrocodone shipped to the Pharmacy. Id. at 49-50. The invoices in
Government Exhibit 8 are some of the invoice documents DI 1 reviewed in
conducting an audit of the Pharmacy's hydrocodone during the
inspection. Id. at 52-54. DI 1 conducted the inspection at DI 2's
direction. Id. at 64-65.
32. During the inspection, Ms. Igwe informed DEA investigators that
they had all the documentation they had requested. Id. at 77.
33. During the inspection, Ms. Igwe was ``pretty upset'' and ``a
little freaked out.'' Id. at 95, 97, 452.
34. During the inspection, Ms. Igwe had no response when asked if
she found it suspicious that customers were traveling from a clinic 30
miles away to get their prescriptions filled at the Pharmacy. Id. at
76-77, 101-02.
35. During the inspection, Ms. Igwe told DEA investigators that she
had spoken to one of the prescribers, Dr. C.V., on one occasion. Id. at
106.
36. After the administrative inspection, DI 1 conducted an audit of
the Pharmacy's inventory of hydrocodone 10/325 mg. Id. at 45-46.
37. In conducting the audit, the Pharmacy's initial inventory
showed zero hydrocodone. Id. at 46-47. DI 1 reviewed the Pharmacy's
receiving documents for controlled substances and he took a closing
inventory for hydrocodone on June 18, 2015. Id. at 47. The audit
revealed that the Pharmacy was short 47,183 tablets of hydrocodone 10/
325 mg. Id. at 56-58; GE-7.
38. DI 1 looked at all medications in the Pharmacy when he
conducted the closing inventory of hydrocodone on June 18, 2015. Tr.
130, 132.
39. During the inspection, Ms. Igwe signed the closing inventory.
Id. at 141.
40. In all of the audits that DI 1 has conducted in his career, he
has never identified a shortage as large as the shortage he identified
at the Pharmacy. Id. at 90. Even a shortage of 2500 tablets of
hydrocodone is a substantial shortage. Id. at 88-89.
41. The Texas Prescription Monitoring Program (``PMP'') did not
match up with the Pharmacy's dispensing records. Id. at 60. The
dispensing records showed that the first dispensing took place on July
7, 2014, but the PMP showed that the Pharmacy filled prescriptions for
hydrocodone between January and June 2014. Id. at 60. Those
prescriptions are not contained in the Pharmacy's dispensing record for
hydrocodone. Id.; GE-6. The shortage that DI 1 found when auditing the
Pharmacy's hydrocodone would be reduced if the information contained in
the PMP concerning the prescriptions the Pharmacy filled prior to July
7, 2014, were considered. Tr. 76.
42. The PMP is not a Pharmacy record. Id. at 123-24.
43. The DEA did not receive any explanation from the Pharmacy
concerning why its distribution report, Government Exhibit 6, did not
report a distribution of hydrocodone until July 7, 2014. Id. at 138.
44. DI 1 was never informed that the Pharmacy had additional
information to provide him concerning the audit he conducted. Id. at
85.
Controlled Substances
45. Hydrocodone has been a schedule II controlled substance since
October 6, 2014. Id. at 132-33.
46. The highest strength of hydrocodone is 10/325 mg. Id. at 176.
47. A prescription for 90 tablets of hydrocodone would be a large
quantity of tablets. Id. at 366-67, 394.
48. Hydrocodone is usually prescribed to be taken once every 4 to 6
hours, as needed for moderate to severe pain, not to exceed 6 tablets
in 24 hours. Id. at 176, 283, 366, 680. Normally a patient would have
another medication for moderate to severe pain. Id. at 176-77, 681.
49. The highest strength for alprazolam is 2 mg. Id. at 177, 723.
50. A prescription for 60 tablets of alprazolam would be a large
quantity of tablets. Id. at 394-95.
51. Prescriptions for the highest strength of a controlled
substance raise a concern that the patient could exceed the maximum
daily dose. Id. at 230.
52. The maximum dose of acetaminophen is 4 grams per day. Id. at
531, 680. A pharmacist's concern with the dose of hydrocodone would lie
with the acetaminophen component of
[[Page 21024]]
the drug. Id. at 531, 662. Ten tablets of hydrocodone contain 3.25
grams, which is below the maximum per day. Id. at 531, 680. According
to the standard instruction of one tablet every four to six hours, a
patient would take no more than six tablets of hydrocodone per day,
which would be less than the maximum daily dose of acetaminophen. Id.
at 531, 680.
53. Alprazolam, hydrocodone, and promethazine with codeine are
high-alert drugs. Id. at 269.
54. Any combination of alprazolam, hydrocodone, promethazine with
codeine, and carisoprodol constitutes a drug cocktail of high-alert
drugs. Id. at 178, 270-71, 710, 740.
55. When taken together, alprazolam and hydrocodone can produce a
euphoric and addictive effect very similar to that of a heroin high.
Id. at 178, 269, 711.
56. Alprazolam and hydrocodone are among the top 10 most frequently
prescribed controlled substances in the United States. Id. at 271, 273,
668.
Red Flags
57. The term ``red flag'' is not contained in any DEA regulation.
Id. at 256, 657.
58. Pharmacists use the term ``red flag'' to denote a potential
issue with a prescription. Id. at 170-71, 569, 657. The minimum
standard of the practice of pharmacy in Texas requires a pharmacist to
look for red flags. Id. at 171.
59. A red flag can be indicative of drug abuse or diversion. Id. at
172, 741.
60. Ms. Igwe did not learn the term ``red flag'' during her
pharmacist training in England, but she now understands what it means.
Id. at 521.
61. Pattern prescribing is a red flag because it indicates no
individualization of therapy. Id. at 171, 244, 745. An example of
pattern prescribing would be multiple prescriptions from the same
prescriber or medical group for the same medications, in the same
quantities, dosages, and strengths, written for different patients. Id.
at 171.
62. When a medical provider only prescribes the maximum strength of
a controlled substance, the prescriptions suggest that the provider is
engaged in pattern prescribing. Id. at 231-32.
63. The distance a person travels, or the route a person travels,
to fill a prescription can be a red flag because it is likely there are
multiple pharmacies along the same route. Id. at 172, 174-75.
64. When a patient travels all over a metropolitan area to get to a
doctor and then to a pharmacy to fill a prescription, that behavior
raises a red flag because there would be multiple pharmacies along the
way where the patient could fill the prescription.\3\ Id. at 281, 321,
323.
---------------------------------------------------------------------------
\3\ In this case, the term ``round-trip distance'' refers to the
distance from a patient's residence to the prescriber, continuing to
the Pharmacy, and then returning home. Tr. 176.
---------------------------------------------------------------------------
65. Paying cash for a prescription can be a red flag. Id. at 172,
692.
66. Most patients have some sort of third-party payer, such as
health insurance, to pay for their prescriptions. Id. at 358.
67. Hydrocodone and alprazolam are normally covered by insurance.
Id. at 399.
68. The lack of a patient's address and/or the prescriber's DEA
registration number on a prescription is a red flag. Id. at 179, 391,
412, 693-94.
69. Prescriptions for high-alert drugs such as alprazolam,
hydrocodone, and promethazine with codeine, have the potential for
abuse and diversion, and thus can be a red flag. Id. at 172-74, 720.
70. A drug cocktail is a red flag. Id. at 178.
71. Dosing instructions for hydrocodone that require the patient to
take one tablet twice a day for moderate to severe pain would be a red
flag, because it is less than the normal dosage for hydrocodone. Id. at
177.
72. Many of the prescriptions for hydrocodone contained in
Government Exhibit 2 had dosing instructions to take one tablet every
four to six hours, which is the normal dosing for hydrocodone, and not
a red flag. Id. at 343-44
73. Dosing instructions for alprazolam that require the patient to
take one tablet twice a day for anxiety raises a red flag because
alprazolam is typically dosed more frequently than twice per day when
it is prescribed for anxiety. Id. at 177.
74. Alprazolam can be prescribed to treat pain. Id. at 665-66.
75. A delay between the date that a prescription is written for
moderate to severe pain and the date the prescription is filled can be
a red flag. Id. at 396-97.
Standards of Pharmacy Practice
76. When a customer presents a prescription to a pharmacy, the
pharmacist should examine the prescription, looking at the date of the
prescription, the patient's name and address, the medication and its
strength and quantity, as well as its directions for use, and the
signature of the provider. Id. at 169-70.
77. If the prescription does not contain the patient's address or
the prescriber's DEA number, the prescription is invalid and the
pharmacist should not fill the prescription. Tr. 179, 391, 412; see
also 21 CFR 1306.05(a); Tex. Health & Safety Code Sec. 481.074(k).
When the prescription lacks a patient address, the pharmacist could
resolve that red flag by speaking with the patient, checking the
patient's driver's license, or checking the patient's profile, and then
documenting the action the pharmacist took to resolve the red flag. Tr.
179-80. When the prescription lacks the prescriber's DEA number, the
pharmacist should contact the prescriber and annotate the DEA number on
the prescription itself and in the patient profile. Id. at 391.
78. Information contained on a cover sheet of a faxed prescription
could resolve a red flag, but that information still must be
documented. Id. at 302-03. That information must be documented so that
when the customer returns with an identical prescription there would be
no need to call the provider. Id. at 319-20. The Respondent has
produced no cover sheets. Id. at 547.
79. When a pharmacist is presented with a prescription that
contains one or more red flags, the pharmacist should call the
prescriber to try to resolve the red flag or flags and then document
the information that resolves the red flag on the prescription itself
or in the patient's profile. Id. at 178-79.
80. A reasonably prudent pharmacist would investigate prescriptions
after seeing several prescriptions written by the same doctor or
medical practice for the same drugs and the same quantity, and with the
same dosing instructions. Id. at 210.
81. The first time a patient presents prescriptions for hydrocodone
and alprazolam to a pharmacy, the pharmacist might fill the
prescriptions. Id. at 239-40. But when the patient keeps returning with
the same prescriptions, the pharmacist should contact the provider. Id.
at 239-40.
82. When presented with the first prescription of the day for
hydrocodone and alprazolam, a pharmacist might not think much about
filling the prescription, but after seeing a handful of prescriptions
written for the same drug, the same dose, the same strength, and by the
same providers, the pharmacist should identify and resolve those red
flags. Id. at 333.
83. Evidence of pattern prescribing raises the concern of diversion
and/or the abuse of high-alert drugs. Id. at 257.
84. After seeing a handful of prescriptions for the same controlled
substances with the same strengths and instructions for use, the
prescriptions become suspicious. Id. at 358-59.
[[Page 21025]]
85. A pharmacist concerned about pattern prescribing should call
the prescriber to ask about the medical purpose and dosing, and then
document the discussion the pharmacist had with the prescriber. Id. at
261.
86. A pharmacist cannot resolve problems concerning the medication,
directions for use, or medical purpose by talking to the patient. Id.
at 179.
87. The patient profile should contain the correct address for the
prescriber. Id. at 361-62.
88. A prudent pharmacist would question the distance a patient
traveled if a patient lives in Fort Worth but sees a doctor in Dallas.
Id. at 192.
89. A pharmacist could resolve a red flag concerning the distance a
patient traveled by talking with the patient and documenting the
conversation. Id. at 402-05.
90. The failure to document the resolution of a red flag is below
the minimum standard of the practice of pharmacy in Texas. Id. at 180.
91. A pharmacist can use the PMP to determine whether a patient is
filling prescriptions at another pharmacy. Id. at 398. Most pharmacies
have access to the PMP. Id. at 398.
92. The PMP shows the names of the doctors and pharmacies a patient
has been using. Id. at 479-82.
93. Information regarding a patient is only in the PMP if a
pharmacy inputs the information into the system. Id. at 484.
The Pharmacy's Practices
94. Ms. Igwe is familiar with a Texas regulation that [she
testified requires a pharmacist to document conversations with
practitioners regarding clinical matters about a particular
prescription.] \*A\ Id. at 585.
---------------------------------------------------------------------------
\*A\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------
95. There are no pharmacist notes in the record that resolve the
red flags in Government Exhibit 2. Id. at 566-67.
96. Sometimes Ms. Igwe would write a ``V'' indicating ``verified''
on the hard-copy prescription, but she did not do this for every
prescription. Id. at 482, 557.
97. Ms. Igwe testified that when she verified a prescription, she
would make a note on the ``demographics'' page of the patient's profile
that the provider confirmed the prescription. Tr. 481, 585. This
information does not print out along with the patient profile. Id. at
482.
98. When a customer came to the Pharmacy for the first time to fill
a prescription for a controlled substance, she would call the
prescriber's office to confirm that the doctor wrote the prescription
and that the patient was actually seen at the clinic. Id. at 477-78,
503, 517, 586, 590, 607.
99. Ms. Igwe has never verified whether Redbird, AC Medical, or
Arlington Oaks was registered with the State of Texas as a pain
management clinic. Id. at 537-38.
100. There were no notes in the Pharmacy's records concerning
specialty clinics or other pharmacies refusing to fill prescriptions
filled by the Pharmacy. Id. at 360-61.
101. If the doctor confirmed that he or she wrote the prescription,
Ms. Igwe would look up the patient in the PMP to make sure the patient
was not doctor or pharmacy shopping. Id. at 478, 484, 573.
102. Ms. Igwe does not consider it doctor shopping if a patient
obtains prescriptions from multiple providers in the same practice. Id.
at 556. She only considers it doctor shopping if the patient obtains
prescriptions from ``totally different'' clinics with which she was
unfamiliar. Id. at 556.
103. Ms. Igwe testified that before filling a prescription for a
controlled substance, she would search the patient's name in the PMP,
verify the dosage was correct, and check for any potential drug
interactions. Id. at 478, 554.
104. Ms. Igwe testified that if she received multiple prescriptions
from the same provider, she would not check with the provider for
subsequent prescriptions because she did not ``see the point of doing
it'' again when she already contacted the provider about the first
prescription the patient presented to the Pharmacy. Id. at 478-79, 517.
She would only contact the provider again if the prescription changed.
Id. at 482.
105. Ms. Igwe testified that she checked the PMP each time a
customer came back to the Pharmacy to make sure that customer had not
been obtaining controlled substances from other doctors. Id. at 479,
504, 517.
106. Ms. Igwe testified that the first page of a faxed prescription
would be a cover sheet with the patient's identification (typically a
driver's license) and home address. Id. at 489.
107. Ms. Igwe testified that when a patient picked up a controlled
substance at the Pharmacy, she would ask the patient for his or her
driver's license and check it against the copy of the driver's license
faxed by the provider. Id. at 490. She would then scan the patient's
identification card into the Pharmacy's computer database. Id. at 490.
108. Ms. Igwe testified that if the identification card presented
by the patient at the Pharmacy did not match the information faxed with
the prescription, then she would not fill the prescription. Id. at 491,
539.
109. There were no notes in the Pharmacy's records concerning the
distances customers traveled to get their prescriptions filled at the
Pharmacy. Id. at 360-61.
110. The Pharmacy's records do not make a distinction between cash
payments and insurance payments. Id. at 522. Ms. Igwe testified that
approximately half of the prescriptions the Pharmacy fills are paid for
using insurance. Id. at 496-97, 522. The remaining prescriptions are
paid for in cash. Id. at 497.
111. The ``co-pay'' information on the Pharmacy's fill stickers
indicates the amount the customer paid for the prescription. Id. at
499-500. On Government Exhibit 6, the information under ``billed'' is
the amount the Pharmacy billed to the customer or insurance. Id. at
498. On Government Exhibit 6, ``margin'' represents the Pharmacy's
profit on a particular sale. Id.
112. On the Pharmacy's fill stickers, the number underneath the
patient's name is the prescription, or ``Rx'', number, which is
assigned when the prescription is entered into the pharmacy's computer
system. Id. at 184-85, 583; GE-2, at 1. The Rx numbers are assigned
sequentially; the higher the number the more recent the prescription
was filled. Id. at 185-86. For example, the Rx number ending in 6330
would have been filled prior to Rx number 6331. Id. at 185-86.
113. The fill sticker also shows the date the prescription was
filled, but not the date it was written. Id. at 186. The date the
prescription was written is recorded on the prescription itself. Id.
114. On the fill stickers, the abbreviation ``Cpy'' stands for
copay. Id. at 499.
115. Ms. Igwe spoke to Dr. C.V. on only one occasion. Id. at 500,
561, 587. Dr. C.V. called the Pharmacy to ask for the Pharmacy's fax
number to send a statement that he was leaving Redbird Clinic. Id. at
500, 561. During that phone call, Ms. Igwe did not talk to Dr. C.V.
about any prescriptions. Id. at 561-62.
116. Ms. Igwe would sometimes ask her customers if the medications
they were prescribed were still working for them. Id. at 527.
117. Ms. Igwe did not always fill a bottle with medication on the
same day that she printed its label. Id. at 560, 575.
[[Page 21026]]
The Prescribers \4\
---------------------------------------------------------------------------
\4\ The medical professionals mentioned in Findings of Fact 118-
121, and 155, when referred to as a group, will be referred to as
``the Prescribers'' in this Recommended Decision. This group is
comprised of C.V., L.R., I.I., L.O., A.Q., J.W., S.G., C.Z., and NE
---------------------------------------------------------------------------
118. The prescription pad for Redbird Medical clinic (``Redbird'')
contains the names of the following medical providers: C.V., M.D.;
L.R., ACNS-BC; I.I., DNP-FNP; L.O., FNP-C; and J.W., ANP-BC, with an
address on West Camp Wisdom Road in Dallas, Texas. Id. at 207-08; GE-2,
at 12, 67. Although a prescriber identified as Dr. A.Q. was not listed
on the prescription pad for Redbird, he had the same address on West
Camp Wisdom Road. GE-2, at 70.
119. On October 2, 2014, the prescription pad for AC Medical clinic
(``AC Medical'') contained the names of the following medical
providers: C.V., M.D.; I.I., DNP-FMP; L.R., ACNS-BC; S.G., FNP; and
C.Z., PA, with an address on Billing Street in Arlington, Texas. GE-2,
at 16.
120. On January 13, 2015, the prescription pad for AC Medical
contained the names of the following medical providers: C.V., M.D.; NE,
M.D.; L.R., ACNS-BC; S.G., FNP; and C.Z., PA, with an address on East
Arkansas Lane in Arlington, Texas. Tr. 207; GE-2, at 132.
121. The prescription pad for Arlington Oaks medical clinic
(``Arlington Oaks'') contains the names of the following medical
providers: C.V., M.D.; S.G., FNP; L.R., ACNS-BC; and C.Z., PA, with an
address on Billing Street in Arlington, Texas. Tr. 206; GE-2, at 5.
The M.W. Prescription
122. DI 1 identified Government Exhibit 11 as the declaration of UC
1, an agent of the Texas Department of Public Safety. Tr. 30. In the
declaration, UC 1 describes an undercover operation in which he
obtained a prescription from the Redbird Clinic and filled the
prescription at the Pharmacy. Id. at 30.
123. DI 1 knew UC 1 from his work on the investigation of the
Pharmacy, but he did not know that UC 1 was going undercover. Id. at
68-69, 140. DI 1 reviewed UC 1's declaration and discussed it with him.
Id. at 31-32.
124. During the undercover operation, UC 1 used the name M.W., and
he used a driver's license with that name. Tr. 41; GE-10, at 3. The
driver's license had a fictitious Fort Worth address. Tr. 189, 541; GE-
11, at 2. The Pharmacy maintained a copy of the prescription it filled
for M.W. and a copy of M.W.'s patient profile. Tr. 41; GE-10, at 4-
5.\5\
---------------------------------------------------------------------------
\5\ Government Exhibit 2, page 1, is another copy of the
prescription issued to ``M.W.'' Tr. 40. Government Exhibit 2, page
2, is a photo of the prescription bottle of hydrocodone filled by
the Pharmacy for ``M.W.'' Tr. 43.
---------------------------------------------------------------------------
125. At 6:55 a.m. on July 29, 2014, undercover agent UC 1 was in a
car in the Redbird parking lot. GE-11, at 2. There were about 15 other
occupied vehicles in the parking lot at that time. Id. An individual
came out of the clinic and asked the drivers to inform him how many
people were in each vehicle, and the drivers indicated between two and
five persons were in each car. Id. The individual then began directing
traffic and controlling the flow of traffic into the clinic. Id.
126. When UC 1 entered the Redbird clinic he was searched by an
armed security guard and was seated in the order that he had entered
the clinic. GE-11, at 2. When called to the receptionist's counter, UC
1 paid a fee of $170.00, and filled out a questionnaire, using the
``M.W.'' alias. Id. He provided the fictitious address of 5944
Callaston Lane, Fort Worth, Texas.\6\ Id. UC 1 indicated that he was
experiencing back pain due to sleeping on an old mattress. GE-11, at 3.
---------------------------------------------------------------------------
\6\ I find that the fact that M.W. used a fictitious address to
be irrelevant. See Tr. 191; infra note 40.
---------------------------------------------------------------------------
127. At 10:40 a.m. UC 1 met with L.R., ACNS-BC, who checked his
heart, looked at his back, and an old scar on his knee. GE-11, at 3.
L.R. then issued ``M.W.'' three prescriptions, to include 120 tablets
of hydrocodone 10 mg. Id. Redbird informed ``M.W.'' that the
prescription would be sent to the Pharmacy and UC 1 confirmed that the
Pharmacy received it on August 1, 2014. Id.; Tr. 190.
128. The M.W. prescription was written on July 29, 2014, and
received by the Pharmacy on August 1, 2014. Tr. 543, 562-63; GE-2, at
1; GE-11, at 3; RE-G, at 8.
129. The M.W. prescription was written to treat pain. Tr. 543; GE-
2, at 1.
130. The M.W. prescription was faxed by Redbird to the Pharmacy.
Tr. 192, 430, 571-72, 592; GE-2, at 1; GE-11, at 3; RE-G, at 8.
131. A copy of the prescription that undercover agent UC 1 received
from Redbird, under the name of ``M.W.,'' as well as the Pharmacy's
fill sticker for that prescription, are both contained on page 1 of
Government Exhibit 2. Tr. 183-84.
132. On August 4, UC 1 presented to the Pharmacy as ``M.W.,'' and
purchased the prescriptions, paying $150.00 for the hydrocodone. Tr.
576, 591; GE-2, at 1; GE-11, at 3.
133. The fact that the M.W. prescription was written on July 29,
2014, and not picked up until August 4, 2014, did not cause Ms. Igwe
any concern. Tr. 577.
134. Ms. Igwe did not look up the address on M.W.'s driver's
license to verify whether it was a real or fictitious address. Tr. 541;
GE-11, at 3.
135. The prescription that L.R. wrote for M.W. raises the following
red flags: No patient address; no provider DEA number; [ ] \*B\ the
prescription was written on July 29, 2014, but not faxed to the
Pharmacy until August 1, 2014, and not picked up until August 4, 2014;
and an unusual path and distance to obtain the prescription and get it
filled.\7\ Tr. 188-94.
---------------------------------------------------------------------------
\*B\ Text adjusted in response to Respondent's Exceptions.
\7\ Dr. Witte testified that the delay in picking up this
prescription raises the question of whether the patient actually
needed the prescription for pain and whether the prescription was
written for a legitimate medical purpose. Tr. 193. That concern is
exacerbated by the fact that the patient waited an additional three
days to pick up the prescription after Redbird faxed it to the
Pharmacy. Tr. 193; GE-2, at 1; GE-11, at 3. [Dr. Witte also
testified that M.W. received a ``large quantity'' of a high-alert
drug, which could be a red flag. Tr. 189.]*
---------------------------------------------------------------------------
136. There are no notes on the M.W. prescription or in the
Pharmacy's patient profile for M.W. indicating that any of the red
flags were resolved prior to filling the prescription. Tr. 194-95; GE-
2, at 1; GE-10, at 4-5.
137. Based on the information provided to the Pharmacy, M.W., more
likely than not, would have passed many pharmacies as he traveled the
99 miles from his purported residence in Fort Worth, to Redbird south
of Dallas, to the Pharmacy, north of Dallas, and then return to his
purported Fort Worth home. Tr. 193-94, 364-65; GE-12.
138. Ms. Igwe had no concern about the distance between M.W.'s
fictitious address in Fort Worth and the Pharmacy in Plano. Tr. 542-43.
139. There is transmission data printed along the top of the page
that contains the M.W. prescription and fill sticker indicating that
the page was ``4 of 4'' of the pages Redbird faxed to the Pharmacy. GE-
2, at 1. Dr. Witte was not provided pages one through three to review,
nor are those pages contained in the Administrative Record. Tr. 255;
GE-2, at 1.
The Other Prescriptions
140. Government Exhibit 2 contains 77 prescriptions for 27 of the
Pharmacy's customers. Tr. 254; GE-2. Government Exhibit 2 also contains
patient profiles for 26 of the Pharmacy's customers. GE-2. Several of
the patient profiles contained in Government Exhibit 2 reveal
prescriptions the Pharmacy filled for hydrocodone and
[[Page 21027]]
alprazolam prior to August 2014, for which the actual prescriptions are
not contained in the Administrative Record. Id. at 32-33, 42-43, 54-55,
82.
141. On several occasions, prescription cocktails of hydrocodone
and alprazolam, contained in Government Exhibit 2, were written or
filled on different days. Tr. 311; GE-2, at 28-30, 34-36, 50-52, 94-96,
109-11, 117-19.
142. The patient profile for A.S. raises a red flag of pattern
prescribing: The same controlled substances; the same strength and
dosages (90 hydrocodone 10/325 mg, 60 alprazolam 2 mg); the same small
group of providers; and cash payments. Tr. 241, 408-09; GE-2, at 22-33.
Between February 24, 2014 and March 30, 2015, A.S. filled six
prescriptions for hydrocodone and six prescriptions for alprazolam at
the Pharmacy. GE-2, at 31-33. On February 24, 2014, the Pharmacy filled
prescriptions of 120, 10 mg tablets of hydrocodone and 60 tablets of
alprazolam for A.S., written by S.G., a family nurse practitioner at AC
Medical and Arlington Oaks. Id. at 32-33; see also id. at 5, 16
(displaying S.G.'s name on prescription pads of those two practices).
On May 1, 2014, the Pharmacy filled prescriptions of 90, 10 mg tablets
of hydrocodone and 60 tablets of alprazolam for A.S., written by S.G.
Id. at 32. The round-trip distance \8\ for A.S. to obtain her
prescriptions and have them filled at the Pharmacy was 104 miles. Stip.
32.
---------------------------------------------------------------------------
\8\ The ``round-trip distance'' is the distance, as measured by
MapQuest, from the patient's address as recorded in the Pharmacy's
records, to the prescriber's office, as reflected in the patient's
profile maintained by the Pharmacy, then to the Pharmacy, and
returning to the patient's home. See, e.g., GE-3, at 1-5. There is
no evidence that any patient traveled this round-trip distance, as a
continuous or single trip, upon leaving the patient's home.
Nevertheless, the three addresses used to calculate the distances
are taken from the Pharmacy's records.
---------------------------------------------------------------------------
143. The patient profile for R.E. raises a red flag of pattern
prescribing: The same controlled substances; the same strength and
dosages (90 hydrocodone 10/325 mg, 60 alprazolam 2 mg); the same small
group of providers; and cash payments. Tr. 237-39; GE-2, at 34-43.
Between April 3, 2014 and March 23, 2015, R.E. filled five
prescriptions for hydrocodone and five prescriptions for alprazolam at
the Pharmacy. GE-2, at 42-43. On April 3, 2014, the Pharmacy filled
prescriptions of 90, 10 mg tablets of hydrocodone and 60 tablets of
alprazolam for R.E., written by S.G. Id. at 43. On May 30, 2014, the
Pharmacy filled prescriptions of 90, 10 mg tablets of hydrocodone and
60 tablets of alprazolam for R.E., written by C.Z., a physician's
assistant at AC Medical and Arlington Oaks. Id. at 42-43; see also Id.
at 5, 16 (displaying C.Z.'s name on prescription pads of those two
practices). The round-trip distance for R.E. to obtain his
prescriptions and have them filled at the Pharmacy was 86 miles. GE-3,
at 35-40.
144. On March 18, 2014, the Pharmacy filled prescriptions of 120,
10 mg tablets of hydrocodone and 60 tablets of alprazolam for K.S.,
written by L.R., a nurse practitioner at Redbird, AC Medical, and
Arlington Oaks. GE-2, at 55; see also id. at 5, 12, 16 (displaying
L.R.'s name on prescription pads of those three practices). On April
15, 2014, the Pharmacy filled prescriptions of 90, 10 mg tablets of
hydrocodone and 60 tablets of Alprazolam for K.S., written by S.G. Id.
at 55. On May 27, 2014, the Pharmacy filled prescriptions of 90, 10 mg
tablets of hydrocodone and 60 tablets of alprazolam for K.S., written
by S.G. Id. at 54-55. Then on June 26, 2014, the Pharmacy filled
prescriptions of 120, 10 mg tablets of hydrocodone and 60 tablets of
alprazolam for K.S., written by S.G. Id. at 54. The round-trip distance
for K.S. to obtain her prescriptions and have them filled at the
Pharmacy was 101 miles. Stip. 35
145. On June 19, 2014, the Pharmacy filled prescriptions of 120, 10
mg tablets of hydrocodone and 60 tablets of alprazolam for M.W.2,
written by L.R. Id. at 82. The round-trip distance for M.W.2 to obtain
her prescriptions and have them filled at the Pharmacy was 97 miles.
Stip. 41.
146. The patient profile for R.N. raises a red flag of pattern
prescribing: The same controlled substances; the same strength and
dosages (90 hydrocodone 10/325 mg, 60 alprazolam 2 mg); the same small
group of providers; and cash payments. Tr. 239-41; GE-2, at 117-29.
Between November 17, 2014 and May 11, 2015, R.N. filled five
prescriptions for hydrocodone and five prescriptions for alprazolam at
the Pharmacy. GE-2, at 128-29.
147. On August 6, 2014, L.R. wrote prescriptions for 120 tablets of
hydrocodone and 60 tablets of alprazolam for patient J.S. GE-2, at 3-4.
The prescriptions were filled the same day at the Pharmacy where the
customer paid $59.99 for the alprazolam and $150.00 for the
hydrocodone. Id. at 3. To obtain the prescription and have it filled,
J.S. would have traveled 80 miles. Stip. 34.
148. On August 8, 2014, S.G. wrote prescriptions for a drug
cocktail of 90 hydrocodone and 60 alprazolam for patient J.W. Tr. 197-
98, 399; GE-2, at 5. The prescriptions were filled at the Pharmacy on
August 11, 2014, where the customer paid $59.99 for the alprazolam and
$125.00 for the hydrocodone. GE-2, at 5. To obtain the prescription and
have it filled, J.W. would have traveled 108 miles. Stip. 39.
149. On August 29, 2014, S.G. wrote prescriptions for 120
hydrocodone and 60 alprazolam for patient J.W. GE-2, at 6. The
prescriptions were filled at the Pharmacy on September 12, 2014, where
the customer paid $59.99 for the alprazolam and $160.00 for the
hydrocodone. Id. To obtain the prescription and have it filled, J.W.
would have traveled 108 miles. Stip. 39. The patient picked up the
prescription at the Pharmacy 14 days after the prescription was
written. GE-2, at 6. Neither the prescriptions for J.W. nor his patient
profile, maintained by the Pharmacy, contain any notes resolving the
red flags presented by these prescriptions. Tr. 208-10.
150. The January 16, 2015 prescription for R.H. for alprazolam
raises a red flag. Tr. 242. The prescription indicates that the
alprazolam was to be taken once every eight hours, but the prescription
label has instructions indicating that it was to be taken one tablet
twice per day.\9\ Tr. 242, 753-54; GE-2, at 66.
---------------------------------------------------------------------------
\9\ Litman testified that a pharmacist should document in the
pharmacy's computer system if he or she was dispensing a medication
with dosing instructions different than prescribed. Tr. 753-54.
There is no such documentation in this Administrative Record.
---------------------------------------------------------------------------
151. The January 16, 2015 prescription for R.H. for hydrocodone
raises several red flags. Tr. 242. The prescription indicates that the
hydrocodone was to be taken once every 8 to 12 hours for moderate to
severe pain. Id. at 396; GE-2, at 64-65. If the patient had moderate to
severe pain, the patient would be taking the medication once every four
to six hours. Tr. 396, 681, 686. In addition, while the prescription
was written for moderate to severe pain on January 16, 2015, the
prescription was not filled until January 20, 2015. Tr. 396; GE-2, at
64-65. Filling a prescription for moderate to severe pain four days
after it was written raises a red flag. Tr. 193, 396-97. Further, R.H.
paid cash for his hydrocodone and alprazolam prescriptions, paying a
total of $212.98 on January 20, 2015. GE-2, at 65-66. Finally, to
obtain his prescriptions and have them filled, R.H. would have traveled
more than 75 miles. Stips. 21, 22.
152. The April 6, 2015 prescription for R.H. for hydrocodone
indicates that it was to be taken 1 to 2 tablets every 8 to 12 hours
for moderate to severe pain. Tr. 241; GE-2 at 68. These dosing
[[Page 21028]]
instructions are a red flag because for moderate to severe pain the
patient should be taking the medication more frequently. Tr. 241, 395-
96; GE-2, at 64-65, 68-69.
153. R.H. was receiving two different controlled substances from
two different doctors, hydrocodone from Dr. A.Q. and promethazine with
codeine from Nurse J.W. Tr. 242-43, 341; GE-2, at 70. Dr. A.Q. and
Nurse J.W. had different addresses. Tr. 243, 362-64; GE-2, at 70. A
pharmacist would want to determine why a patient was obtaining
controlled substances from two different doctors from different
locations. Tr. 243, 362-64.
154. There are no pharmacist's notes or remarks written on R.H's
prescriptions or in his patient profile that resolves the red flags
raised by his controlled substance prescriptions. Tr. 243.
155. Government Exhibit 6 contains the Pharmacy's hydrocodone
dispensing history between July 7, 2014 and May 21, 2015. Tr. 37, 138,
168; GE-6, at 1, 85. Government Exhibit 6 documents 927 prescriptions
that the Pharmacy filled for hydrocodone. GE-6. All but 25 of those
prescriptions were written by the same small group of prescribers, who
wrote the prescriptions identified on the patient profiles contained in
Government Exhibit 2: Dr. C.V., Dr. NE, ANP J.W., Dr. A.Q., PA C.Z., NP
L.O., DNP I.I., NP S.G., and ACNS L.R.\10\ The Pharmacy filled 104
prescriptions for hydrocodone before it filled the hydrocodone
prescription for J.S. on August 6, 2014. GE-2, at 3; GE-6, at 1-10.
---------------------------------------------------------------------------
\10\ See GE-6, at 13, 17, 41, 43, 47, 53, 56, 58, 64, 65, and 85
for prescriptions written by eight other prescribers.
---------------------------------------------------------------------------
156. Between October 10-23, 2014, the Pharmacy received 26
consecutive prescriptions for 90 tablets of hydrocodone written by Dr.
C.V. GE-6, at 29-31. Between November 7-12, 2014, the Pharmacy filled
17 consecutive prescriptions for 90 tablets of hydrocodone written by
Dr. C.V. GE-6, at 33-35.
157. Between November 12-20, 2014, the Pharmacy received 20
consecutive prescriptions for hydrocodone written by Dr. C.V., all but
one of which were for 90 tablets. GE-6, at 35-37.
158. The Pharmacy received 9 prescriptions for 90 tablets of
hydrocodone 10/325 mg on December 31, 2014. Tr. 424-25, 560; RE-G, at
44-45; GE-6, at 44-45. Eight of the nine prescriptions were written by
Dr. C.V. Tr. 424-25; RE-G, at 44-45; GE-6, at 44-45. Receiving these
nine prescriptions on the same date did not cause Ms. Igwe any concern.
Tr. 561.
159. Between April 9 and May 8, 2015, the Pharmacy received 105
consecutive prescriptions for hydrocodone written by either Dr. C.V. or
Dr. NE, all but six of which were for 90 tablets. GE-6, at 69-79.
Finally, between May 18-21, 2015, the Pharmacy filled 23 consecutive
prescriptions for hydrocodone 10/325 mg written by Dr. NE, all but one
of which were for 90 tablets. Tr. 594-95; GE-6, at 83-85.
160. The prescriptions identified in Findings of Fact 155-159 are
examples of pattern prescribing. Tr. 171, 231, 388.
161. All the prescriptions in Government Exhibit 6 were filled by
Ms. Igwe. Tr. 390; see also 22 Tex. Admin. Code Sec.
291.33(c)(7)(A)(iv) (requiring the dispensing pharmacist to write his
or her initials on the prescription label).
162. Prescriptions Written by Nurse Practitioner I.I.:
----------------------------------------------------------------------------------------------------------------
Controlled Round-trip
Patient Date prescription substance(s); distance Cost Record citations
written; filled quantity (miles)
----------------------------------------------------------------------------------------------------------------
J.W.2.................. 8/18/14; 8/20/14. Hydrocodone 98 $150.00; $59.99.. Tr. 234; GE-2, at
(120); 12; Stip. 40.
Alprazolam (60).
C.J.................... 8/18/14; 8/19/14. Hydrocodone (90); 81 $125.00; $59.99.. Tr. 233; GE-2, at
Alprazolam (60). 8; Stip. 25.
S.W.................... 8/19/14; 8/19/14. Hydrocodone 99 $150.00; $59.99.. Tr. 234; GE-2, at
(120); 10; Stip. 43.
Alprazolam (60).
S.H.................... 9/4/14; 9/4/14... Hydrocodone (90); 76 $120.00; $59.99.. Tr. 234-35; GE-2,
Alprazolam (60). at 14; Stip. 24.
H.J.................... 10/2/14; 10/2/14. Hydrocodone 105 $160.00; $59.99.. Tr. 235; GE-2, at
(120); 16; Stip. 26.
Alprazolam (60).
----------------------------------------------------------------------------------------------------------------
[[Page 21029]]
163. These prescriptions written by Nurse Practitioner I.I. are
indicative of pattern prescribing: Same controlled substances; same
quantity; same dosages; same prescriber; same drug cocktails. Tr. 236.
This pattern indicates a lack of individualization of therapy. Id. at
209. In addition, these patients took unusual paths and distances to
obtain and fill their prescriptions. Id. at 236. The similarities would
make a pharmacist wonder why multiple patients from this medical
provider were being prescribed the same quantity of hydrocodone, and in
the same strength and dosing. Id. at 258.
164. The unusual path and distance that I.I.'s patients traveled to
obtain their prescriptions and get them filled is a red flag. Id. at
236.
165. The fill stickers for all of I.I.'s patients indicate that
they paid $120 to $160 for their prescriptions for hydrocodone, which
is much higher than the usual cost of hydrocodone. Id. at 222-23. The
cash price for 90 tablets of hydrocodone is about $70, and the cash
price for 60 tablets of alprazolam is about $35. Id. at 223.
166. There are no notes on I.I.'s prescriptions or the patient
profiles documenting the Pharmacy's resolution of any red flag or
consultation with I.I. regarding the red flags. Id. at 236; GE-2, at 4,
7, 9, 11, 13, 15, 17, 21, 31-33, 42-43, 53-55, 59, 63, 70, 74, 78, 82,
85, 92-93, 97, 102, 104-05, 107-08, 112, 116, 128-29, 133.
167. Prescriptions Written by Dr. C.V.:
----------------------------------------------------------------------------------------------------------------
Controlled Round-trip
Patient Date prescription substance(s); distance Cost Record citations
written; filled quantity (miles)
----------------------------------------------------------------------------------------------------------------
R.E.................... 11/14/14; 11/14/ Hydrocodone (90) 94 $180............. Tr. 218, 226, 238-
14. \11\. 39; GE-2, at 35-
36; Stip. 17.
R.N.................... 11/15/2014; 11/17/ Hydrocodone (90) 64 $180............. Tr. 221, 226; GE-
2014. \12\. 2, at 117-118;
Stip. 30.
R.N.................... Filled: 12/19/14. Hydrocodone (90) 64 Unknown.......... Tr. 222; GE-2, at
\13\. 129; Stip. 30.
A.S.................... Filled: 12/22/14. Hydrocodone (90) 111 Unknown.......... Tr. 217-18, 226,
\14\. 241; GE-2, at
32; Stip. 33.
M.H.................... 1/13/15; 1/13/15. Hydrocodone (90) 121 $179.99.......... Tr. 222, 226; GE-
\15\. 2, at 130-31;
Stip. 20.
K.S.................... 1/27/15; 1/27/15. Hydrocodone (90) 109 $179.99; $59.99.. Tr. 204, 219,
\16\. 226; GE-2, at 44-
46; Stip. 36.
K.S.................... 2/26/15; 2/26/15. Hydrocodone (90) 109 $179.99.......... Tr. 205, 219,
\17\. 226; GE-2, at 47-
48; Stip. 36.
R.E.................... 3/23/15; 3/23/15. Hydrocodone (90) 94 $179.99; $59.99.. Tr. 218, 226; GE-
\18\. 2, at 39-42;
Stip. 17.
K.S.................... 3/26/15; 3/26/15. Hydrocodone (90) 109 $179.99.......... GE-2, at 50-52;
\19\. Stip. 36.
A.S.................... 3/28/15; 3/30/15. Hydrocodone (90) 111 $179.99.......... Tr. 217, 226; GE-
\20\. 2, at 28-30;
Stip. 33.
G.B.................... 4/16/15; 4/17/15. Hydrocodone (90). 55 $179.99.......... Tr. 219-20, 226;
GE-2, at 83-84;
Stip. 12.
M.A.................... 4/17/15; 4/17/15. Hydrocodone (90) 107 $179.99.......... Tr. 205-06, 220,
\21\. 226; GE-2, at 94-
95; Stip. 9.
R.H.2.................. 4/20/15; 4/21/15. Hydrocodone (90) 92 $179.99 $59.99... Tr. 220, 226; GE-
\22\. 2, at 98-100;
Stip. 23.
A.K.................... 5/1/15; 5/1/15... Hydrocodone (90) 81 $179.99 $59.99... Tr. 221, 226; GE-
\23\. 2, at 113-115;
Stip. 27.
----------------------------------------------------------------------------------------------------------------
[[Page 21030]]
168. The prescription that Dr. C.V. wrote for G.B. on April 16,
2015, contained unusual dosing instructions for hydrocodone, of one
tablet three times per day. Tr. 383; GE-2, at 83. Faced with these
dosing instructions, the pharmacist should have called the prescriber
to confirm the dosing instructions before filling the prescription. Tr.
383.
---------------------------------------------------------------------------
\11\ The day before Dr. C.V. wrote R.E. a prescription for
hydrocodone, S.G. FNP, of the same medical practice as Dr. C.V.,
wrote R.E. a prescription for 60 tablets of alprazolam 2 mg. The
Pharmacy filled this prescription the same day it was written,
November 13, 2014. GE-2, at 34-36. Although Dr. C.V. and FNP S.G.
were with the same medical practice, the patient profile shows Dr.
C.V. being located at 916 Wynnewood Shopping Center, Dallas, Texas,
and FNP S.G. being located at 201 Billings Street, Arlington, Texas.
GE-2, at 42.
\12\ The day before Dr. C.V. wrote R.N. a prescription for
hydrocodone, L.R., ACNS-BC, of the same medical practice as Dr.
C.V., wrote R.N. a prescription for 60 tablets of alprazolam 2 mg.
GE-2, at 119. The Pharmacy filled both prescriptions the same day,
November 17, 2014. GE-2, at 117-19. Although Dr. C.V. and ACNS L.R.
were with the same medical practice, the patient profile shows Dr.
C.V. being located at 916 Wynnewood Shopping Center, Dallas, Texas,
and ACNS L.R. being located at 202 Billings Street, Arlington,
Texas. GE-2, at 119, 129.
\13\ The same day the Pharmacy filled the prescription for
hydrocodone, written by Dr. C.V. for R.N., it also filled a
prescription for 60 tablets of alprazolam 2 mg, written by L.R.,
ACNS-BC, for R.N. GE-2, at 129. Although Dr. C.V. and ACNS L.R. were
with the same medical practice, the patient profile shows Dr. C.V.
being located at 916 Wynnewood Shopping Center, Dallas, Texas, and
ACNS L.R. being located at 202 Billings Street, Arlington, Texas.
GE-2, at 119, 129.
\14\ The same day the Pharmacy filled the prescription for
hydrocodone, written by Dr. C.V., for A.S., it also filled a
prescription for 60 tablets of alprazolam 2 mg, written by L.R.,
ACNS-BC, for A.S. GE-2, at 32. Although Dr. C.V. and ACNS L.R. were
with the same medical practice, the patient profile shows Dr. C.V.
being located at 916 Wynnewood Shopping Center, Dallas, Texas, and
ACNS L.R. being located at 202 Billings Street, Arlington, Texas.
GE-2, at 30, 32.
\15\ On the same day that Dr. C.V. wrote M.H. a prescription for
hydrocodone, Dr. NE, of the same medical practice as Dr. C.V., wrote
M.H. a prescription for 60 tablets of alprazolam 2 mg. Both
prescriptions were filled by the Pharmacy on the same day, January
13, 2015. GE-2, at 130-32. Although Dr. C.V. and Dr. NE were with
the same medical practice, the patient profile shows Dr. C.V. being
located at 916 Wynnewood Shopping Center, Dallas, Texas, and Dr. NE
being located at 201 Billings Street, Arlington, Texas. GE-2, at
132-33. Further, the address for Dr. NE in the patient profile is
different from her address listed on the prescription, 2596 East
Arkansas Lane, Arlington, Texas. Id.
\16\ On the same day that Dr. C.V. wrote K.S. a prescription for
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V.,
wrote K.S. a prescription for 60 tablets of alprazolam 2 mg. Cf. GE-
2, at 46. Both prescriptions were filled by the Pharmacy on the same
day, January 27, 2015. GE-2, at 44-46. The Pharmacy fill sticker for
the alprazolam prescription inaccurately lists Dr. C.V. as the
prescriber. Compare GE-2, at 46 with known signatures of C.Z. at GE-
2, at 30, 52, 122-23. Although Dr. C.V. and C.Z. were with the same
medical practice, the patient profile shows Dr. C.V. being located
at 916 Wynnewood Shopping Center, Dallas, Texas, and C.Z. being
located at 201 Billings Street, Arlington, Texas. GE-2, at 53.
Further, the address for C.Z. in the patient profile is different
from his address listed on the prescription for alprazolam, 2596
East Arkansas Lane, Arlington, Texas. Compare GE-2, at 46 with GE-2,
at 53.
\17\ On the same day that Dr. C.V. wrote K.S. a prescription for
hydrocodone, Dr. NE, of the same medical practice as Dr. C.V., wrote
K.S. a prescription for 60 alprazolam 2 mg. GE-2, at 49. Both
prescriptions were filled by the Pharmacy on the same day, February
26, 2015. GE-2, at 47-49. Although Dr. C.V. and Dr. NE were with the
same medical practice, the patient profile shows Dr. C.V. being
located at 916 Wynnewood Shopping Center, Dallas, and Dr. NE being
located at 201 Billings Street, Arlington, Texas. GE-2, at 49, 53.
Further, the address for Dr. NE in the patient profile is different
from her address listed on the prescription, 2596 East Arkansas
Lane, Arlington, Texas. Id.
\18\ Two days before Dr. C.V. wrote R.E. a prescription for
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V.,
wrote R.E. a prescription for 60 tablets of alprazolam 2 mg. GE-2,
at 41. Both prescriptions were filled by the Pharmacy on the same
day, March 23, 2015. GE-2, at 39-41. The Pharmacy fill sticker for
the prescription for alprazolam inaccurately lists Dr. C.V. as the
prescriber. Compare GE-2, at 41 with known signatures of C.Z. at GE-
2, at 30, 52, 122-23. Although Dr. C.V. and C.Z. were with the same
medical practice, the patient profile shows Dr. C.V. being located
at 916 Wynnewood Shopping Center, Dallas, Texas, and C.Z. being
located at 201 Billings Street, Arlington, Texas. GE-2, at 42.
Further, the address for C.Z. in the patient profile is different
from his address listed on the prescription for alprazolam, 2596
East Arkansas Lane, Arlington, Texas. Compare GE-2, at 41 with GE-2,
at 42.
\19\ The day before Dr. C.V. wrote K.S. a prescription for
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V.,
wrote K.S. a prescription for 60 tablets of alprazolam 2 mg. GE-2,
at 52. Both prescriptions were filled by the Pharmacy the next day,
March 26, 2015. GE-2, at 50-52. Although Dr. C.V. and PA C.Z. were
with the same medical practice, the patient profile shows Dr. C.V.
being located at 916 Wynnewood Shopping Center, Dallas, and PA C.Z.
being located at 201 Billings Street, Arlington, Texas. GE-2, at 49,
53. Further, the address for PA C.Z. in the patient profile is
different from his address listed on the prescription, 2596 East
Arkansas Lane, Arlington, Texas. Id.
\20\ The day after Dr. C.V. wrote A.S. a prescription for
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V.,
wrote A.S. a prescription for 60 tablets of alprazolam 2 mg. GE-2,
at 30. Both prescriptions were filled by the Pharmacy the next day,
March 30, 2015. GE-2, at 28-30. Although Dr. C.V. and PA C.Z. were
with the same medical practice, the patient profile shows Dr. C.V.
being located at 916 Wynnewood Shopping Center, Dallas, Texas, and
PA C.Z. being located at 201 Billings Street, Arlington, Texas. GE-
2, at 30-31. Further, the address for Dr. C.V. in the patient
profile is different from his address listed on the prescription,
8222 Douglas Avenue, Dallas, Texas, and the address for PA C.Z. in
the patient profile is different from his address listed on the
prescription, 2596 East Arkansas Lane, Arlington, Texas. GE-2, at
28, 30-31.
\21\ The day before Dr. C.V. wrote M.A. a prescription for
hydrocodone, L.R., ACNS-BC, of the same medical practice as Dr.
C.V., wrote M.A. a prescription for 60 tablets of alprazolam 2 mg.
GE-2, at 96. Both prescriptions were filled by the Pharmacy the next
day, April 17, 2015. GE-2, at 94-96. Although Dr. C.V. and ACNS L.R.
were with the same medical practice, Dr. C.V.'s prescription lists
an address of 201 Billing Street, Arlington, Texas, and the
prescription that L.R. wrote shows her address as being, 2596 East
Arkansas Lane, Arlington, Texas. GE-2, at 94, 96. In addition, while
the prescription for alprazolam clearly bears the signature of ACNS
L.R., the fill sticker indicates that Dr. C.V. wrote the
prescription. GE-2, at 96.
---------------------------------------------------------------------------
169. The prescriptions written by Dr. C.V. are indicative of
pattern prescribing: Same controlled substances; same quantity; same
dosages; same prescriber; same drug cocktails. Id. at 215. This pattern
indicates a lack of individualization of therapy. Id. at 209. In
addition, these patients took unusual paths and distances to obtain and
fill their prescriptions. Id. at 226-27. The similarities would make a
pharmacist wonder why multiple patients from this doctor/medical
practice were being prescribed the same quantity of hydrocodone, and in
the same strength and dosing. Id. at 258.
---------------------------------------------------------------------------
\22\ Three days before Dr. C.V. wrote R.H.2 a prescription for
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V.,
wrote R.H.2 a prescription for 60 tablets of alprazolam 2 mg. GE-2,
at 100. Both prescriptions were filled by the Pharmacy on April 21,
2015. GE-2, at 98-100. The Pharmacy fill sticker for the
prescription for alprazolam inaccurately lists Dr. C.V. as the
prescriber. Compare GE-2, at 100 with known signatures of C.Z. at
GE-2, at 30, 52, 122-23. Although Dr. C.V. and C.Z. were with the
same medical practice, the patient profile shows Dr. C.V. being
located at 916 Wynnewood Shopping Center, Dallas, Texas, yet the
prescription for hydrocodone lists his address as 201 Billings
Street, Arlington, Texas. GE-2, at 101. The prescription pad that
C.Z. used to write the prescription for alprazolam lists his address
as 2596 East Arkansas Lane, Arlington, Texas. GE-2, at 100.
\23\ On the same day that Dr. C.V. wrote A.K. a prescription for
hydrocodone, C.Z. wrote A.K. a prescription for 60 tablets of
alprazolam 2 mg. GE-2, at 115. Both prescriptions were filled by the
Pharmacy on the same day, May 1, 2015. GE-2, at 113-15. The Pharmacy
fill sticker for the prescription for alprazolam inaccurately lists
Dr. C.V. as the prescriber. Compare GE-2, at 115 with known
signatures of C.Z. at GE-2, at 30, 52, 122-23. Although Dr. C.V. and
C.Z. were with the same medical practice, the patient profile shows
Dr. C.V. being located at 916 Wynnewood Shopping Center, Dallas,
Texas, yet the prescription for hydrocodone lists his address as 201
Billings Street, Arlington, Texas. GE-2, at 113. The prescription
pad that C.Z. used to write the prescription for alprazolam lists
his address as 2596 East Arkansas Lane, Arlington, Texas. GE-2, at
115.
---------------------------------------------------------------------------
170. The unusual path and distance that Dr. C.V.'s patients
traveled to obtain their prescriptions and get them filled is a red
flag. Id. at 236.
171. The fill stickers for all of these patients indicate that they
paid $179.99 for their prescriptions for hydrocodone, which is much
higher than the usual cost of 90 tablets of hydrocodone. Id. at 222-23.
The cash price for 90 tablets of hydrocodone is about $70, and the cash
price for 60 tablets of alprazolam is about $35. Id. at 223.
172. There are no notes on Dr. C.V.'s prescriptions or the patient
profiles documenting that the Pharmacy resolved any red flag or
consulted with Dr. C.V., or other prescribers. Tr. 227,
[[Page 21031]]
404-05; GE-2, at 4, 7, 9, 11, 13, 15, 17, 21, 31-33, 42-43, 53-55, 59,
63, 70, 74, 78, 82, 85, 92-93, 97, 102, 104-05, 107-08, 112, 116, 128-
29, 133.
173. Prescriptions written by Dr. NE:
----------------------------------------------------------------------------------------------------------------
Controlled Round-trip
Patient Date prescription substance(s); distance Cost Record citations
written; filled quantity (miles)
----------------------------------------------------------------------------------------------------------------
A.S.................... 1/24/15;......... Hydrocodone (90) 104 $179.99.......... Tr. 200-01; GE-2,
1/26/15.......... \24\. at 22-23; Stip.
32.
R.N.................... 2/2/2015; 2/3/ Hydrocodone (90) 95 $179.99.......... Tr. 239-41; GE-2,
2015. \25\. at 120-21; Stip.
28.
R.E.................... 2/2/2015; 2/2/ Hydrocodone (90) 86 $179.99.......... GE-2, at 38, 42;
2015. \26\. GE-3, at 35-40.
A.S.................... 2/27/2015; 2/27/ Hydrocodone 104 $179.99.......... GE-2, at 26-27,
2015. (90)\27\. 31; Stip. 32.
B.B.................... 3/20/2015; 3/20/ Hydrocodone (90); 80 $179.99; $59.99.. Tr. 214; GE-2, at
2015. Alprazolam (60). 102-04; Stip.
10.
S.B.................... 3/26/2015; 3/27/ Hydrocodone (90); 79 $179.99; $59.99.. Tr. 212; GE-2, at
2015. Alprazolam (60). 56-58; Stip. 14.
S.N.................... 4/2/2015; 4/2/ Hydrocodone (90); 81 $179.99; $59.99.. Tr. 214, 214-15;
2015. Alprazolam (60). GE-2, at 60-62;
Stip. 31.
T.W.................... 4/10/2015; 4/10/ Hydrocodone (90); 66 $179.99; $59.99.. Tr. 212-13, 215;
2015. Alprazolam (60). GE-2, at 71-73;
Stip. 44.
I.B.................... 4/10/2015; 4/10/ Hydrocodone (90) 79 $179.99; $59.99.. Tr. 213, 215; GE-
2015. \28\. 2, at 75-77;
Stip. 13.
M.W.2.................. 4/13/2015; 4/13/ Hydrocodone (90) 79 $179.99; $59.99.. Tr. 214, 215; GE-
2015. \29\. 2, at 79-81;
Stip. 42.
Y.S.................... 4/17/2015; 4/17/ Hydrocodone (90); 78 $179.99; $59.99.. Tr. 214-15; GE-2,
2015. Alprazolam (60). at 86-88; Stip.
38.
B.B.................... 4/22/2015; 4/23/ Hydrocodone (90); 66 $179.99; $59.99.. GE-2, at 105-107;
2015. Alprazolam (60). Stip. 11.
C.D.................... 4/23/2015; 4/23/ Hydrocodone (90) 81 $179.99; $59.99.. Tr. 214-15; GE-2,
2015. \30\. at 109-111;
Stip. 15.
R.N.................... 5/11/2015; 5/11/ Hydrocodone (90); 78 $179.99; $59.99.. Tr. 214-15; GE-2,
2015. Alprazolam (60). at 125-27; Stip.
29.
Y.S.................... 5/18/2015; 5/18/ Hydrocodone (90) 78 $179.99; $59.99.. GE-2, at 89-91.
2015. \31\.
----------------------------------------------------------------------------------------------------------------
174. The prescriptions written by Dr. NE are indicative of pattern
prescribing: same controlled substances; same quantity; same dosages;
same prescriber; same drug cocktails. Tr. 215. This pattern indicates a
lack of individualization of therapy. Id. at 209. In addition, these
patients took unusual paths and distances to obtain and fill their
prescriptions. Id. at 215-16.
---------------------------------------------------------------------------
\24\ The day before Dr. NE wrote A.S. a prescription for
hydrocodone, L.R., ACNS-BC, also with the AC Medical practice, wrote
A.S. a prescription for 60 tablets of alprazolam 2 mg. GE-2, at 24.
Both prescriptions were filled by the Pharmacy on January 26, 2015.
GE-2, at 22-24. The fill sticker, however, erroneously lists Dr. NE
as the prescriber. The prescription pad for AC Medical shows an
address on East Arkansas Lane, but Dr. NE's electronic prescription
for A.C. shows an address of 201 Billings Street, and the patient
profile for A.S. shows L.R's address as 202 Billing Street. Id. at
22, 31.
\25\ On the same day that Dr. NE wrote R.N. a prescription for
hydrocodone, C.Z., PA, of the same medical practice as Dr. NE, wrote
R.N. a prescription for 60 tablets of alprazolam 2 mg. GE-2, at 122-
23. Both prescriptions were filled by the Pharmacy on the following
day, February 3, 2015. Id. at 120-23.
\26\ The Administrative Record contains the Pharmacy's fill
sticker for this prescription, but not the actual prescription. GE-
2, at 38, 42. On the same day that the Pharmacy filled this
prescription it also filled a prescription for 60, 2 mg tablets of
alprazolam, which was written by L.R., ACNS-BC, on the same day. GE-
2, at 37. Dr. NE's address is listed on R.E.'s patient profile as
being at Billings Street in Arlington, Texas, while the office
address on the prescription pad that L.R. used to write the
prescription for alprazolam is East Arkansas Lane, Arlington, Texas.
Id. at 37, 42.
\27\ The day before Dr. NE wrote A.S. a prescription for
hydrocodone, C.Z., PA, also with the AC Medical practice, wrote A.S.
a prescription for 60, 2 mg tablets of alprazolam. GE-2, at 25. The
Pharmacy also filled that prescription for alprazolam the day before
it filled the prescription that Dr. NE wrote for hydrocodone. Id. at
25. The prescription pad for AC Medical shows an address on East
Arkansas Lane for both Dr. NE, and C.Z., but Dr. NE's electronic
prescription for A.C. shows an address of 201 Billings Street,
Arlington, Texas. Id. at 22-26.
\28\ On the same day that Dr. NE wrote I.B. a prescription for
hydrocodone, S.G., FNP, of the same medical practice as Dr. NE,
wrote I.B. a prescription for 60 tablets of alprazolam 2 mg. GE-2,
at 77. Both prescriptions were filled by the Pharmacy on the same
day, April 10, 2015. Id. at 75-77. The fill sticker for the
alprazolam, however, erroneously lists Dr. NE as the prescriber. Id.
at 77.
\29\ On the same day that Dr. NE wrote M.W.2 a prescription for
hydrocodone, S.G., FNP, of the same medical practice as Dr. NE,
wrote M.W.2 a prescription for 60 tablets of alprazolam 2 mg. GE-2,
at 81. Both prescriptions were filled by the Pharmacy on the same
day, April 13, 2015. Id. at 79-81. The fill sticker for the
alprazolam, however, erroneously lists Dr. NE as the prescriber. Id.
at 81.
\30\ The day before Dr. NE wrote C.D. a prescription for
hydrocodone, S.G., FNP, of the same medical practice as Dr. NE,
wrote C.D. a prescription for 60 tablets of alprazolam 2 mg. GE-2,
at 111. Both prescriptions were filled by the Pharmacy on April 23,
2015. Id. at 109-11. The fill sticker for the alprazolam, however,
erroneously lists Dr. NE as the prescriber. Id. at 111.
\31\ On the same day that Dr. NE wrote Y.S. a prescription for
hydrocodone, S.G., FNP, of the same medical practice as Dr. NE,
wrote Y.S. a prescription for 60 tablets of alprazolam 2 mg. GE-2,
at 91. Both prescriptions were filled by the Pharmacy on the same
day, May 18, 2015. Id. at 89-91. The fill sticker for the
alprazolam, however, erroneously lists Dr. NE as the prescriber. Id.
at 91.
---------------------------------------------------------------------------
175. The unusual paths and distances that Dr. NE's patients
traveled to obtain their prescriptions and get them filled is a red
flag. Id.
176. The fill stickers for all of Dr. NE's patients indicate that
they paid $179.99 for their prescriptions for hydrocodone, which is
much higher than the usual cost of 90 tablets of hydrocodone. Id. at
222-23. The average cash price at other pharmacies for 90 tablets of
hydrocodone is about $70, and the cash price for 60 tablets of
alprazolam is about $35. Id. at 223.
177. There are no notes on the hard-copies of Dr. NE's
prescriptions or the patient profiles documenting that the Pharmacy
resolved any of the red flags, or consulted with Dr. NE or any other
prescriber regarding the red flags. Id. at 216-17; GE-2, at 4, 7, 9,
11, 13, 15, 17, 21, 31-33, 42-43, 53-55, 59, 63, 70, 74, 78, 82, 85,
92-93, 97, 102, 104-05, 107-08, 112, 116, 128-29, 133.
Additional facts required to resolve the issues in this case are
included in the Analysis section of this Recommended Decision.
[[Page 21032]]
Analysis
To revoke a respondent's registration, the Government must prove,
by a preponderance of the evidence, that the regulatory requirements
for revocation are satisfied. Steadman v. SEC, 450 U.S. 91, 100-02
(1981); 21 CFR 1301.44(e). Under 21 U.S.C. 824(a)(4), the DEA may
revoke a registrant's COR if the registrant acted in a way that renders
continued registration ``inconsistent with the public interest.'' The
DEA considers the following five factors to determine whether continued
registration is in 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.\32\
---------------------------------------------------------------------------
\32\ The Government has not made any Factor Five allegations
against the Respondent. ALJ-35, at 27.
21 U.S.C. 823(f).
These public interest factors are considered separately. See Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a
case-by-case basis. Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005).
Any one factor, or combination of factors, may be decisive. David H.
Gillis, M.D., 58 FR 37507, 37508 (1993). Thus, there is no need to
enter findings on each of the factors. Hoxie v. DEA, 419 F.3d 477, 482
(6th Cir. 2005). Further, there is no requirement to consider a factor
in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76-77 (4th
Cir. 1988). When deciding whether registration is in the public
interest, the totality of the circumstances must be considered. See
generally Joseph Gaudio, M.D., 74 FR 10083, 10094-95 (2009).
The Government bears the initial burden of proof, and must justify
revocation by a preponderance of the evidence. Steadman, 450 U.S. at
100-03. If the Government makes a prima facie case for revocation, the
burden of proof shifts to the registrant to show that revocation would
be inappropriate. Med. Shoppe--Jonesborough, 73 FR 364, 387 (2008). A
registrant may prevail by successfully attacking the veracity of the
Government's allegations or evidence. Alternatively, a registrant may
rebut the Government's prima facie case for revocation by accepting
responsibility for wrongful behavior and by taking remedial measures to
``prevent the re-occurrence of similar acts.'' Jeri Hassman, M.D., 75
FR 8194, 8236 (2010) (citations omitted). In addition, when assessing
the appropriateness and extent of sanctioning, the DEA considers the
egregiousness of the offenses and the DEA's interest in specific and
general deterrence. David A. Ruben, M.D., 78 FR 38363, 38385 (2013).
Here, the Government's allegations focus on the manner in which the
Pharmacy, through its agents, dispensed controlled substances. In
addition, the Government has alleged recordkeeping violations.
I. The Government's Position
The Government submitted its Proposed Findings of Fact, Conclusions
of Law, and Argument (``Government's Brief'') on February 7, 2018.\33\
In its brief, the Government addressed: Numerous instances of the
Pharmacy dispensing controlled substances in violation of its
corresponding responsibility to ensure that the prescribing and
dispensing of controlled substances was done only for legitimate
medical purposes. ALJ-35, at 9-21. The Government also addressed the
Pharmacy's recordkeeping violations, and as a result of those
recordkeeping violations, the Pharmacy's inability to account for over
47,000 tablets of hydrocodone. ALJ-35, at 21.
---------------------------------------------------------------------------
\33\ The Government's Brief has been marked as ALJ-35.
---------------------------------------------------------------------------
With respect to the Pharmacy dispensing in violation of its
corresponding responsibility, the Government pointed out the testimony
of its expert witness, Dr. Witte. ALJ-35, at 6-21. Dr. Witte's
testimony touched upon virtually each prescription contained in
Government Exhibit 2. ALJ-35, at 9-21. The Government noted that Dr.
Witte identified numerous red flags concerning the prescriptions the
Pharmacy filled, to include: Pattern prescribing; long and unusual
distances traveled to obtain and fill prescriptions; delay in filling
prescriptions; cash payments for prescriptions; prescriptions for high-
alert drugs, such as hydrocodone, alprazolam, and promethazine with
codeine; prescriptions for high dosage strengths of the controlled
substance; prescription cocktails, such as hydrocodone and alprazolam
prescribed together; and prescriptions containing atypical directions
for use. ALJ-35, at 7-9. In addition, Dr. Witte testified that to
resolve a red flag, a pharmacist in Texas should call the prescriber
and then document the prescriber's explanation either on the
prescription itself, or in the patient's profile maintained by the
pharmacy. ALJ-35, at 8. Failing to document the resolution of a red
flag falls below the minimum standards of the practice of pharmacy in
Texas. Id.
With respect to recordkeeping violations, the Government's Brief
detailed that during execution of the Administrative Inspection Warrant
in June 2015, the Pharmacy was asked for its inventories and its
dispensing history for hydrocodone. ALJ-35, at 21. The dispensing
records provided by the Pharmacy did not account for any dispensing
prior to July 7, 2014, while other non-Pharmacy records showed
dispensing prior to that date, and the Pharmacy had opened in September
2013. ALJ-35, at 21-22. As a result of the documentation provided by
the Pharmacy, the Pharmacy could not account for over 47,000 tablets of
hydrocodone. Id
Based upon the allegation contained in the OSC, and the evidence
produced by the Government, the Government argues that Factors 2 and 4
of the five factors listed in 21 U.S.C. 823(f), are the relevant
factors to consider in this case, specifically the registrant's
experience in dispensing controlled substances and its compliance with
applicable state, federal, or local laws relating to controlled
substances. ALJ-35, at 27.
The Government argues that the Pharmacy violated 21 CFR 1306.04(a)
and 1306.06 when it failed to meet its corresponding responsibility by
filling prescriptions outside the usual course of professional
practice. ALJ-35, at 27-34. Specifically, the Government alleges that
the Pharmacy ``repeatedly distributed controlled substances pursuant to
prescriptions that contained one or more unresolved red flags for
diversion.'' Id. at 29. The Government notes that all of the
prescriptions in Government Exhibit 2 gave rise to one or more of the
above mentioned red flags. Id. Significantly, the Government notes
there is no evidence that the Pharmacy documented the resolution of any
of the red flags concerning the prescriptions presented in this case.
Id. at 30. The Government also notes that the Respondent was served
with a subpoena that specifically requested any and all documentation
concerning the resolution of red flags, yet no such documentation has
been produced. Id.
The Government noted that the Pharmacy also had recordkeeping
shortcomings, and an audit revealed a substantial shortage of
hydrocodone. Id. at 34-36. While recognizing that the Respondent
produced records, Respondent Exhibit C, claiming they
[[Page 21033]]
represent all of the Respondent's dispensing of hydrocodone, the
Government further argues that there is ``no record of any dispensing
prior to July 7, 2014.'' \34\ ALJ-35, at 34. Citing Alexander Drug Co.,
66 FR 18299, 18303 (2001), the Government noted that recordkeeping
violations alone can serve as a sufficient bases to revoke a
registration. Id. at 35. In addition, the Government cites to Paul H.
Volkman, 73 FR 30630, 30644 (2008), for the proposition that failing to
maintain dispensing logs with respect to an extraordinary quantity of
controlled substances provides sufficient reason by itself to revoke a
registration as being inconsistent with the public interest. Id. at 35.
---------------------------------------------------------------------------
\34\ This argument is an overstatement. The Respondent did
produce evidence of dispensing prior to July 7, 2014, though it
takes some digging to find it. The lowest RX number for a
prescription for hydrocodone dispensed by the Pharmacy on July 7,
2014, is 105254. GE-6, at 1. The Respondent demonstrated that it
dispensed more than 300 prescriptions for hydrocodone with
prescription numbers lower than 10525. See RE-C, at 31-42. Based on
the RX numbers of those prescriptions, and the manner in which those
numbers are assigned to prescriptions, those 300 prescriptions were
filled prior to July 7, 2014. Those records, however, were not
produced until long after the Pharmacy was required to produce them.
---------------------------------------------------------------------------
In conclusion, the Government argued that the Pharmacy's COR should
be revoked because a preponderance of the evidence establishes that
allowing the Pharmacy to keep its registration would be contrary to the
public interest. Id. at 39. In support of this argument, the Government
noted that the Pharmacy had not accepted any responsibility for its
actions and it had not indicated what actions it would take to ensure
future compliance with laws and regulations governing the handling of
controlled substances. Id.
II. The Respondent's Position
The Respondent submitted its Proposed Findings of Fact and
Conclusions of Law (``Respondent's Proposed Findings'') on February 7,
2018.\35\ The Respondent also submitted the Respondent's Closing Brief
(``Respondent's Brief'') on February 7, 2018.\36\ I have read and
considered both documents in preparing this Recommended Decision.
---------------------------------------------------------------------------
\35\ The Respondent's Proposed Findings has been marked as ALJ-
36.
\36\ The Respondent's Brief has been marked as ALJ-37.
---------------------------------------------------------------------------
In the Respondent's Proposed Findings, the Respondent highlighted
the policies and procedures the Pharmacy has in place to confirm the
legitimacy of new prescriptions for controlled substances. ALJ-36, at
4-7. Some of those policies and procedures include: verifying a
prescriber's authorization to prescribe; checking the PMP for doctor
shopping; entering prescription and patient information into the
Pharmacy's computer system; contacting the prescriber's office when new
patients present to the Pharmacy to ensure there is a doctor-patient
relationship; questioning the patient about the need for the
medication; and marking prescriptions with a ``V'' once the
prescription has been verified.\37\ Id. at 5-7. The Respondent also
highlights testimony suggesting that it saw nothing unusual with the
prescriptions contained in Government Exhibit 2. Id. at 8. For example,
the Respondent notes that: It considered the prescriptions to be
therapeutic and commonly prescribed; other physicians prescribe in
similar patterns; the Prescribers only wrote 10% of the prescriptions
the Pharmacy filled; the patients were not filling their prescriptions
early or doctor shopping; and the patients did not show up in groups.
Id. at 8.
---------------------------------------------------------------------------
\37\ There is only one prescription in Government Exhibit 2 that
is marked with a ``V''. See GE-2, at 49.
---------------------------------------------------------------------------
Based upon the Respondent's proposed findings of fact,\38\ the
Respondent also offers several conclusions of law. Significantly, the
Respondent concludes that the Government failed to meet its burden of
proof to show that the Pharmacy had filled prescriptions for controlled
substances that contained red flags without resolving those red flags.
Id. at 15. The Respondent also concludes that the Pharmacy was never
asked to provide the DEA with evidence of its documentation.\39\ Id. at
15-16. Citing Superior Pharmacy I & Superior Pharmacy II, 81 FR 31310,
31335 (2016), the Respondent also concludes that the Government
presented no proof of willful indifference, and that ``a reasonable
suspicion is not enough to establish that a pharmacist acted with the
requisite scienter.'' Id. at 15. Further, citing JM Pharmacy Group,
Inc., d/b/a Farmacia Nueva and Best Pharma Corp., 80 FR 28667, 28667
n.2 (2015), the Respondent concludes that there is no evidence of
willful blindness. Id. at 16.
---------------------------------------------------------------------------
\38\ Some of the Respondent's Proposed Findings of Fact
(``PFF'') are not supported by the Administrative Record.
Representative examples follow. In PFF 7 the Respondent states that
the Pharmacy was under visual surveillance by DEA. ALJ-36, at 3. At
best the Administrative Record would support a finding that DI 1
thinks that the ``tactical diversion squad was going out there and
watching it.'' Tr. 93. This ``fact,'' whether accurate or not, is
not relevant to the issues in this case. In PFF 38 the Respondent
cites Government Exhibit 6 for its position that not more than 10%
of the prescriptions issued each day were issued by one of the
medical clinics under investigation. ALJ-36, at 7. Government
Exhibit 7, however, only concerns hydrocodone. The Administrative
Record makes abundantly clear that the ``Prescribers wrote far more
prescriptions than just hydrocodone.'' PFF 32 has little resemblance
to the actual testimony cited in support of the PFF. ALJ-36, at 6.
In PFF 44 the Respondent states that distance and route traveled by
the patients who obtained prescriptions from one of the Prescribers
``was often based on convenience to work, or proximity to the clinic
rather than convenience to home.'' ALJ-36, at 8. There is no
evidence to support this assertion. Rather, the citation to the
record provided by the Respondent of Tr. 494-95, provides more
reasonable support for the conclusion that Ms. Igwe did not find it
uncommon for patients to be coming from different locations around
the Dallas-Fort Worth area, and because it was not uncommon she did
not question it. Further, the investigation of the Pharmacy began
because the ``Pharmacy Place was so far from these clinics.'' Tr.
430. The Respondent also states that Mr. Litman testified that the
only way to determine a physician was prescribing non-controlled
substances to mask the illegitimate prescribing of controlled
substances was to find another red flag in the prescription. See PFF
77, ALJ-36, at 13. That, however, is not Mr. Litman's testimony. He
begins his answer by saying, ``the only thing to do is call the
physician . . . .'' Tr. 683.
\39\ This conclusion seemingly ignores Government Exhibit 9. See
also Tr. 357.
---------------------------------------------------------------------------
In the Respondent's Brief, the Respondent minimally summarizes some
of the testimony.\40\ The Respondent then sets out the standards that
must be met to prove that a Pharmacy violated its corresponding
responsibility, once again relying on Superior Pharmacy I & Superior
Pharmacy II, 81 FR at 31335 and JM Pharmacy, 80 FR at 28667 n.2. In
conclusion, the Respondent argues:
---------------------------------------------------------------------------
\40\ On at least two instances, the Respondent significantly
mischaracterizes the testimony. The Respondent states that the ``DEA
undercover agent did not divert the drugs . . . . nor was the
Pharmacy Place related to any diversion activity by the Agent.''
ALJ-37, at 3. This statement reflects a total misunderstanding of
diversion by the Respondent. Diversion occurs whenever anyone
received a controlled substance they should not have received. Then
the Respondent states that Dr. Witte testified ``she would probably
not check the distance travelled by the customer.'' ALJ-37, at 5.
Actually when the transcript is examined, what Dr. Witte said was
that she would ``probably not'' check to see if an address was
legitimate. Tr. 191. This issue is also not relevant to the issues
in this case. What is relevant is the fact that the Pharmacy's own
records indicate the patient in question traveled from Fort Worth to
a clinic south of Dallas, then to the Pharmacy north of Dallas, and
then back to Fort Worth in order to obtain a prescription and have
it filled, yet the Pharmacy asked no questions about that distance
the patient traveled or the unusual route the patient would have
taken.
Taking the admitted evidence and testimony as a whole, there is
no evidence the pharmacist isn't completely committed to her duties
as a pharmacist. She verifies early and checks the PMP every
prescription. There was no evidence of diversion based on the
surveillance by the DEA, and the 47000 doses of hydrocodone is
probably wrong pursuant to the testimony of the man who wrote the
report. Further, there is no evidence of willful blindness or
willful indifference by the pharmacist. The
[[Page 21034]]
pharmacy is a neighborhood pharmacy that compounds medication and
caters to children . . . . The Pharmacy Place is minority owned and
operated by the owner. It compounds medications. Based on the
pharmacist (sic) testimony in the trial, pharmacists' (sic) differ
in approach and protocol based on experience, knowledge and
background. The continued operation of the pharmacy is consistent
---------------------------------------------------------------------------
with the public interest.
ALJ-37, at 7.
Factor One & Three: The Recommendation of the Appropriate State
Licensing Board or Professional Disciplinary Authority, and Conviction
Record Under Federal or State Laws Relating to the Manufacture,
Distribution, or Dispensing of Controlled Substances
In this case, it is undisputed that the Respondent holds a valid
state pharmacy license in Texas. The record contains no evidence of a
recommendation regarding the Respondent's privilege to operate as a
pharmacy by a relevant state licensing board or professional
disciplinary authority. 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 20011, 20018 (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 15,227, 15,230 (2003).
The ultimate responsibility to determine whether a DEA registration is
consistent with the public interest has been delegated exclusively to
the DEA, not to entities within state government. Edmund Chein, M.D.,
72 FR 6580, 6590 (2007), aff'd Chein v. DEA, 533 F.3d 828 (D.C. Cir.
2008).
Agency precedent establishes 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 Roni Dreszer, M.D., 76 FR
19434, 19444 (2011) (``The fact that the record contains no evidence of
a recommendation by a state licensing board does not weigh for or
against a determination as to whether continuation of the Respondent's
DEA certification is consistent with the public interest.'')
Accordingly, Factor One does not weigh for or against revocation in
this matter.
As to Factor Three, there is no evidence that Respondent, or any of
its agents, have been convicted of an offense under either federal or
Texas 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 49956, 49973 (2010),
pet. for rev. denied, MacKay v. DEA, 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, Factor Three weighs
neither for nor against revocation in this case.
Factors Two and Four: The Respondent's Experience in Dispensing
Controlled Substances and Compliance With Applicable State, Federal, or
Local Laws Relating to Controlled Substances
Factors Two and Four are often analyzed together. See, e.g., Fred
Samimi, M.D., 79 FR 18698, 18709 (2014); John V. Scalera, M.D., 78 FR
12092, 12098 (2013). Under Factor Two, the DEA analyzes a registrant's
``experience in dispensing . . . controlled substances.'' 21 U.S.C.
823(f)(2). Factor Two analysis focuses on a registrant's acts that are
inconsistent with the public interest, rather than on a registrant's
neutral or positive acts and experience. Randall L. Wolff, M.D., 77 FR
5106, 5121 n.25 (2012) (explaining that ``every registrant can
undoubtedly point to an extensive body of legitimate [dispensing] over
the course of [the registrant's] professional career'') (quoting Jayam
Krishna-Iyer, M.D., 74 FR 459, 463 (2009)). Similarly, under Factor
Four, the DEA analyzes an applicant's compliance with federal and state
laws concerning controlled substances. 21 U.S.C. 823(f)(4). Factor Four
analysis also focuses on violations of state and federal regulations.
Volkman v. DEA, 567 F.3d 215, 223-24 (6th Cir. 2009) (citing Gonzales
v. Oregon, 546 U.S. 243, 272, 274 (2006)); see Joseph Gaudio, M.D., 74
FR 10083, 10090-91 (2009).
[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 her 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 28667,
28670-72 (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
[[Page 21035]]
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] controlled substances pursuant to prescriptions that
contained one or more unresolved red flags for diversion.'' Govt
Posthearing, at 29. See also OSC, at 5 (``Pharmacy Place's pharmacists
were willfully blind to or deliberately ignorant of the high
probability that the [subject prescriptions] lacked a legitimate
medical purpose. Pharmacy Place pharmacists were willfully blind to the
fact that large numbers of customers seeking controlled substance
prescriptions, often prescription cocktails, and residing long
distances from Pharmacy Place's location and/or their respective
physicians created a suspicious situation requiring increased
scrutiny.'').] \*C\
---------------------------------------------------------------------------
\*C\ I am omitting some language from the RD and adding the
above to clarify the analysis of a pharmacist's corresponding
responsibility under 21 CFR 1306.04(a).
---------------------------------------------------------------------------
Because the Pharmacy is located in Texas, it is important to review
the requirements of Texas law as it relates to pharmacists. To begin,
Texas law 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 Sec.
481.074(a)(1). 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. at Sec. 481.074(a)(2). 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. Additionally, the Texas
Health and Safety Code mandates 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 Drug Enforcement Administration
number'' of the practitioner issuing the prescription. Id. at Sec.
481.074(k)(3), (7).
In addition to Texas statutes, the Texas State 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 the patient's medication record.
Such review shall at a minimum identify clinically significant: . .
. (III) reasonable dose and route of administration; (IV) reasonable
directions for use; (V) duplication of therapy; (VI) drug-drug
interactions; . . . [and] (X) proper utilization, including
overutilization or underutilization.
See 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
Sec. 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). [ ]\*D\ Texas
operational standards require at a minimum that such documentation be
on the prescription or in the pharmacy's data processing system
associated with the prescription . . . and shall include . . . (1)
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 for
the purpose of identifying the pharmacist who performed the
consultation.
---------------------------------------------------------------------------
\*D\ Text adjusted in response to Respondent's Exceptions.
Id. at Sec. 291.33(c)(2)(C). [ ]\*E\
---------------------------------------------------------------------------
\*E\ Text removed in response to Respondent's Exceptions.
---------------------------------------------------------------------------
The Texas State Board of Pharmacy has also issued rules concerning
the labels that a pharmacist puts on the bottles of controlled
substances being dispensed by a pharmacy. Those standards require that
[a]t the time of delivery of the drug, the dispensing container
shall bear a label in plain language and printed in an easily
readable font size, unless otherwise specified, with at least the
following information: (i) name, address and phone number of the
pharmacy; (ii) unique identification number of the prescription that
is printed in an easily readable font size comparable to but no
smaller than ten-point Times Roman; (iii) date the prescription is
dispensed; (iv) initials or an identification code of the dispensing
pharmacist; (v) name of the prescribing practitioner; . . .
Id. at Sec. 291.33(c)(7)(A). While this particular section of the
operational standards was not cited in the OSC, it is relevant in this
case because the Pharmacy should have been following these requirements
when filling prescriptions.\41\
---------------------------------------------------------------------------
\41\ [The ALJ used this footnote to take official notice under
the Administrative Procedure Act of 22 Tex. Admin. Code Sec.
291.33(c)(7)(A). In the section on Respondent's Exceptions, supra, I
addressed Respondent's response and found that the ALJ properly
applied the regulation.]*
---------------------------------------------------------------------------
Finally, ``[t]he corresponding responsibility to ensure the
dispensing of valid prescriptions extends to the pharmacy itself.''
Holiday CVS, 77 FR at 62341 (citing Med. Shoppe--Jonesborough, 73 FR at
384; United Prescription Servs., Inc., 72 FR 50397, 50407-08 (2007);
EZRX, L.L.C., 69 FR 63178, 63181 (2004); Role of Authorized Agents in
Communicating Controlled Substance Prescriptions to Pharmacies, 75 FR
61613, 61617 (2010); Issuance of Multiple Prescriptions for Schedule II
Controlled Substances, 72 FR 64921, 64924 (2007) (other citations
omitted)). The DEA has consistently held that the registration of a
pharmacy may be revoked as the result of the unlawful activity of the
pharmacy's owners, majority shareholders, officers, managing
pharmacist, or other key employee. EZRX, L.L.C., 69 FR at 63,181; Plaza
Pharmacy, 53 FR 36,910, 36,911 (1988). Similarly, ``[k]nowledge
obtained by the pharmacists and other employees acting within the scope
of their employment may be imputed to the pharmacy itself.'' Holiday
CVS, 77 FR at 62341.
In support of its allegations that the Pharmacy violated its
corresponding responsibility, the Government convincingly argues that
the Pharmacy filled prescriptions to customers without documenting the
resolution of numerous red flags. Regarding the documentation of red
flags in Texas, [Dr. Witte credibly testified that it would be below
the minimum standards of practice and outside the usual course of
professional practice for a Texas pharmacist to fail to document the
resolution of red flags on a prescription before dispensing it. Tr.
178-82, 209-211 244-47]; \*F\ see also The Medicine Shoppe, 79 FR
59,504, 59,509 n.14, 59,516 (2014) (concluding a Texas pharmacy
violated its corresponding
[[Page 21036]]
duty by failing to document the resolution of red flags on hard-copy
prescriptions and that the record as a whole lacked evidence that red
flags were resolved).
---------------------------------------------------------------------------
\*F\ Text adjusted to add reference and citation to Dr. Witte's
testimony.
---------------------------------------------------------------------------
Pattern Prescribing
[Both expert witnesses in this matter testified that pattern
prescribing is a red flag that can be indicative of drug abuse or
diversion. FF 58-59, 61; Tr. 171-72.] \*G\ `` `Pattern prescribing'
occurs when a physician prescribes the same drug and the same dosage to
every patient the physician sees.'' The Medicine Shoppe, 79 FR 59504,
59512 (2014); see also Jones Total Health Care Pharmacy, L.L.C., & SND
Health Care, L.L.C., 81 FR 79188, 79215 (2016) (noting expert's
definition of pattern prescribing as `` `patients going to the same
doctor for the same ailments, receiving the same prescriptions in the
same quantity without any difference in the treatment.' ''). Pattern
prescribing raises a red flag because a ``prescription should be
tailored to each patient's individual needs based on their chronic
conditions.'' The Medicine Shoppe, 79 FR at 59,512; see also United
States v. Hammond, 781 F.2d 1536, 1538 (11th Cir. 1986) (accepting
expert testimony that ``the lack of individualized dosing'' is
indicative of diversion). When a doctor prescribes the same controlled
substances to different patients with similar doses for everybody, it
suggests the doctor is simply churning out controlled substance
prescriptions indiscriminately rather than conducting legitimate
medical treatment. [See FF 61;] \*H\ Jones Total Health Care Pharmacy,
L.L.C., & SND Health Care, L.L.C., 81 FR at 79195; 21 CFR 1306.04(a)
(requiring controlled substances to be prescribed only for ``legitimate
medical purpose[s]''). Ultimately, the concern with pattern prescribing
is that it indicates a lack of individualization of therapy. [FF 61.]
\*I\
---------------------------------------------------------------------------
\*G\ Text and citations added for clarity.
\*H\ Citation added.
\*I\ Citation replaced and text removed for brevity.
---------------------------------------------------------------------------
Agency [cases involving similar factual scenarios and credible
expert testimony] \*J\ demonstrate that pattern prescribing manifests
itself in one of two forms. One form of pattern prescribing occurs
where one physician or clinic prescribes the same controlled substances
to different patients over an extended time period. See Holiday CVS,
L.L.C., 77 FR 62316, 62323 (2012) (determining that a doctor was
clearly ``engaged in pattern prescribing'' where the doctor repeatedly
prescribed ``oxycodone and alprazolam based on nearly uniform
diagnoses'' over the course of six months). Another form of pattern
prescribing occurs where one doctor or clinic writes the same
prescription to different patients on the same day. See Superior
Pharmacy I & Superior Pharmacy II, 81 FR 31310, 31322 (2016)
(describing instance where various doctors of same clinic wrote 16
prescriptions for oxycodone 30 mg on the same date to different
patients). The Respondent's expert witness, Mr. Litman, however, was
only concerned about the second category of pattern prescribing--seeing
the same prescription 20 times in one day. Tr. 659-60.
---------------------------------------------------------------------------
\*J\ Text adjusted for clarity.
---------------------------------------------------------------------------
Some red flags, such as prescription cocktails, suboptimal dosing,
and cash payment, should capture a pharmacist's attention early on, if
not immediately. In contrast, with respect to the first variety of
pattern prescribing--and to a lesser extent the second variety--the
problem manifests itself over an extended period of time and is not
immediately recognizable. FF 67, 92. Quite literally, pattern
prescribing occurs when a single provider's or group of providers'
prescriptions all share common characteristics and over time create a
pattern of the same substances, doses, and strengths. Tr. 228-29, 232-
33, 250, 264-65, 279, 289, 353.
In East Main Street Pharmacy, the respondent repeatedly dispensed
similar prescription cocktails to different patients that were written
by the same provider. 75 FR at 66163. The Deputy Administrator's
decision in East Main Street Pharmacy observed that the prescriptions
for hydrocodone and alprazolam were always prescribed at the maximum
strength, and that the cocktails always contained some combination of
the same substances. Id. Examples can be found in this case with the
prescriptions issued to J.W., H.J., M.H., A.S., K.S., and M.A., where
each patient received prescriptions for 90 to 120 tablets of 10 mg
hydrocodone and 60 tablets of 2 mg alprazolam. Tr. 208-09. Dr. Witte
noted that these prescriptions constituted a drug cocktail, and were
indicative of pattern prescribing, with the ``same medications, the
same directions, [and] the same quantity for different patients.'' Id.
at 209. Dr. Witte further testified that upon receipt of such
prescriptions ``a reasonably prudent pharmacist'' should investigate
the red flag presented by the prescriptions. Id. at 210. [She further
testified that a pharmacist acting in the usual course of professional
practice and following the minimum standard of practice in Texas would
not fill the prescriptions without resolving the red flag and
documenting the resolution. Tr. 210-211.] \*K\ There is no
documentation in the Administrative Record, however, showing that the
Pharmacy resolved any of the red flags. Id. at 210. Additional examples
of unresolved pattern prescribing can also be seen in the prescriptions
issued by I.I., C.V., and NE See FF 163, 169, 174.
---------------------------------------------------------------------------
\*K\ Text added for clarity.
---------------------------------------------------------------------------
Repeat prescriptions for the same handful of drug cocktails issued
by the same providers for different patients should ``create[ ] an
obvious and compelling level of suspicion that the prescriptions lacked
a legitimate medical purpose.'' Jones Total Health Care Pharmacy,
L.L.C., 81 FR at 79199. Such is the case with the prescriptions filled
by the Pharmacy. FF 162-177. Based upon her review of Government
Exhibit 2, Dr. Witte credibly testified that while the prescriptions
presented numerous red flags, the issue of pattern prescribing stood
out and was suspicious. Tr. 171, 244, 296, 335, 358-59.
Varying the substances and doses, however, would weigh against a
finding of pattern prescribing. In Hills Pharmacy, for example, the
Administrator rejected the Government's claim of pattern prescribing
because the dosages ranged from 140 to 240 tablets. 81 FR at 49841
n.46. Additionally, out of a set of 20 prescriptions provided by the
Government, there were 3 different controlled substances prescribed in
various strengths. Id.
In this case, Dr. Witte identified pattern prescribing as a
recurring issue with the prescriptions she reviewed that had been
filled by the Pharmacy [and testified that a pharmacist dispensing
prescriptions within the minimum standard of practice in Texas would
have recognized the pattern prescribing in the subject prescriptions as
a red flag].\*L\ Tr. 171, 244, 296, 335, 358-59; FF 61-62. Her
testimony and analysis concerning those prescriptions is consistent
with the DEA cases discussed above. FF 61-62. Furthermore, when
examining the prescriptions filled by the Pharmacy beginning in August
2014 and running through May 2015, the pattern prescribing becomes more
and more apparent with each prescription filled. Because Ms. Igwe
filled all of these prescriptions, the pattern should have become
obvious to her. Tr. 578.
---------------------------------------------------------------------------
\*L\ Text adjusted for clarity.
---------------------------------------------------------------------------
Distance
The distance a patient is willing to travel to obtain a
prescription and fill it is one factor a pharmacist must consider when
discharging his or her
[[Page 21037]]
corresponding responsibility. [Tr. 172;] \*M\ see also Hills Pharmacy,
L.L.C., 81 FR at 49841 n.45; Samuel Mintlow, M.D., 80 FR 3630, 3650
(2015) (applying the distance factor to a physician case and reasoning
that a doctor should be suspicious when a patient travels a long
distance and ``bypass[es] numerous other potential treating
physicians''). This is not a new consideration. Medical and pharmacy
experts have testified in DEA cases for at least the past eight years
that traveling long distances to obtain or fill controlled substance
prescriptions is a red flag indicative of diversion and abuse.\42\
Although there is no ``categorical rule'' dictating the precise number
of miles that raise a red flag, a pharmacist must nevertheless take the
distance traveled into account when deciding whether to dispense
controlled substances. Hills Pharmacy, 81 FR at 49841 n.45. [ ] \*N\
---------------------------------------------------------------------------
\*M\ Citation added.
\42\ Marcia L. Sills, M.D., 82 FR 36423, 36434 (2017); Jones
Total Health Care Pharmacy, L.L.C., 81 FR 79188, 79188 (2016); Edge
Pharmacy, 81 FR 72092, 72103 (2016); Hills Pharmacy, L.L.C., 81 FR
49816, 49820, 49822 (2016); Superior Pharmacy I & Superior Pharmacy
II, 81 FR 31310, 31323 (2016); Grider Drug #1 & Grider Drug #2, 77
FR 44070, 44083 (2012), Holiday CVS, L.L.C., 77 FR 62316, 62319
(2012); Jacobo Dreszer, M.D., 76 FR 19836, 19393 (2011); E. Main St.
Pharmacy, 75 FR 66149, 66150 (2010); George C. Aycock, M.D., 71 FR
17529, 17539 (2009).
\*N\ Text removed for brevity.
---------------------------------------------------------------------------
Additionally, Texas regulations include the distance a patient
traveled as one factor pharmacists should be aware of before dispensing
a controlled substance. The Texas State Board of Pharmacy, echoing the
federal standard, requires pharmacists to ``exercise sound professional
judgment with respect to'' the legitimacy of a prescription. 22 Tex.
Admin. Code Sec. 291.29(a); see also 21 CFR 1306.04(a), 1306.06. The
Board then goes on to provide a non-exhaustive list of circumstances a
pharmacist should weigh when evaluating a prescription's legitimacy,
including ``the geographical distance between the practitioner and the
patient or between the pharmacy and the patient.'' 22 Tex. Admin. Code
Sec. 291.29(c)(4).
As Dr. Witte noted, seeing a doctor in south Dallas and filling a
prescription in Plano (north of Dallas) when the patient lives in Fort
Worth raises a concern Tr. 189-93, 281, 321. While testifying, Dr.
Witte asked an appropriate rhetorical question, ``Why did these
patients feel the need to drive clear across Dallas, all the way up to
Plano, north of the city, to fill these prescriptions?'' Id. at 281.
Nothing in the Administrative Record provides an answer to that
question. Dr. Witte further opined that, ``more than likely, there are
many pharmacies located between . . . where the patient lives and where
the clinic is.'' \43\ Id. at 263; see also id. at 323. Certainly there
could have been valid reasons for the distances and routes traveled,
but the minimum standards 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. [FF 63-64, 79, 90].\*O\
This was not done here. FF 79, 88, 90; GE-2; RE-E. Dr. Witte's
testimony is consistent with DEA precedent and Texas law. Further,
while Ms. Igwe did not seem to have the slightest concern about the
distance her customers were traveling to obtain their prescriptions and
get them filled, she also apparently had not the slightest curiosity as
to why this small group of prescribers had referred so many patients to
her relatively small and out of the way Pharmacy. While nothing in the
Administrative Record directly answers that question, that facts alone
should have raised a question about the legitimacy of the
prescriptions.
---------------------------------------------------------------------------
\43\ Dr. Witte was accepted as an expert in the field of
pharmacy in the state of Texas, not geography. Tr. 169. 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 a rural one.
\*O\ Text removed and citation corrected.
---------------------------------------------------------------------------
The Respondent's expert witness, Mr. Litman, however, minimized the
significance of distance, noting that we live ``in a very mobile
society now, and people are on the go all the time.'' Tr. 730. Mr.
Litman added that on some days he commutes 80 miles. Id. As a
pharmacist, who at times works in a retail pharmacy in Miami, Florida,
Mr. Litman would be concerned with a patient traveling from South
Carolina to fill a prescription. Id. at 695. Mr. Litman, however, was
not aware of DEA cases that deal with pharmacy customers who had driven
long distances to obtain their prescriptions and have them filled. Id.
at 727. And as previously noted, the DEA has considered distance to be
a red flag of diversion for at least the past 8 years. See supra note
42 and accompanying text. Further, Mr. Litman was apparently unaware of
the Texas requirement to at least consider the distance a customer has
traveled to fill a prescription. Tr. 739; see 22 Tex. Admin. Code Sec.
291.29(c)(4). [His testimony concerning distance contradicts cases
based on credible expert testimony that distance is a red flag under
the usual course of professional practice of pharmacy. Morning Star
Pharmacy and Medical Supply 1, 85 FR at 51052; Hills Pharmacy, L.L.C.,
81 FR at 49841 n.45 (2016); Jones Total Health Care Pharmacy, L.L.C. &
SND Healthcare, L.L.C., 81 FR at 79194-95; 21 CFR 1306.04(a) (creating
the pharmacist's corresponding responsibility). It also contradicts Dr.
Witte's credible testimony that the distances the patients traveled to
fill the subject prescriptions were red flags that a pharmacist
following the minimum standards of practice in Texas should have
investigated, resolved, and documented before filling the
prescriptions. E.g., Tr. 401-404.] \*P\ Accordingly, I give no weight
to Mr. Litman's testimony that distance is not a red flag. Tr. 726-27.
---------------------------------------------------------------------------
\*P\ Text adjusted for clarity and additional citations.
---------------------------------------------------------------------------
Cash Payments
Dr. Witte testified that paying cash for prescriptions was a red
flag. See, e.g., Tr. 172-73, 229-30, 263. She also testified that the
average cash price for 90 tablets of hydrocodone was about $70.00 and
the average price for 60 tablets of alprazolam was about $35.00 Id. at
223, 229. Here, the Pharmacy's customers were routinely paying $179.99
and $59.99, respectively. FF 167, 173. When a customer purchased
prescriptions for both hydrocodone and alprazolam at the same visit to
the Pharmacy, the customer would pay $239.98. Id. Even Mr. Litman
expressed concern for cash payments in excess of $200.00. Tr. 692, 753.
Mr. Litman also downplayed the significance of cash payments because
many individuals do not have medical insurance and ``cash payments are
much more common these days.'' Id. Ms. Igwe testified, however, that a
majority of customers used insurance to pay for their prescriptions.
Id. at 496. If that is the case, it is more concerning that all of the
customers from Government Exhibit 2 paid cash when filling
prescriptions for hydrocodone and/or alprazolam. FF 111, 165, 171, 176.
Paying cash for controlled substances, rather than billing
insurance, is a red flag that the patient is seeking the substances for
illicit purposes. ``` [A]ny reasonable pharmacist knows that a patient
that (sic) wants to pay cash for a large quantity of controlled
substances is immediately suspect.' '' Jones Total Health Care
Pharmacy, 81 FR at 79194 (quoting E. Main St. Pharmacy, 75 FR at
66158). Paying for a prescription in cash is ``the preferred payment
method for
[[Page 21038]]
illegitimate prescriptions,'' because it is not traceable. Masters
Pharmaceutical, Inc. v. DEA, 861 F.3d 206, 220 (DC Cir. 2017). Like all
red flags, paying in cash for controlled substances, or cash
equivalent, such as credit card or check, is viewed in combination with
other evidence of diversion. See Edge Pharmacy, L.L.C., 81 FR 72092,
72103, 72111-12 (2016) (concluding substantial distances, large
quantities of highly-abused controlled substances, and cash payments
indicated the prescriptions lacked a legitimate medical purpose).
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. Hills Pharmacy, L.L.C., 81 FR at
49839 n.39. DEA cases relying on expert testimony instruct, however,
that not all red flags ``have the same hue.'' Superior Pharmacy I &
Superior Pharmacy II, 81 FR at 31335 n.54. ``[W]here there are multiple
red flags, none of which alone would establish the requisite scienter,
the combination of red flags may well create a subjective belief that
there is a high probability that a prescription lacks a legitimate
medical purpose.'' Id. Thus, as in this case, cash payments, combined
with other red flags, can be enough to find a pharmacist violated 21
CFR 1306.04(a). Edge Pharmacy, L.L.C., 81 FR at 72111-12; Superior
Pharmacy I & Superior Pharmacy II, 81 FR at 31335 n.54.
The Allegations
The Prescriptions
1. Initially, the Government alleged that between August 2014 and
May 2015 the Pharmacy filled 75 controlled substance prescriptions
outside the usual course of pharmacy practice, in violation of 21 CFR
1306.06, and in contravention of the Pharmacy's ``corresponding
responsibility'' under 21 CFR 1306.04(a). ALJ-1, at 2, para. 3. The
Pharmacy did so by repeatedly filling controlled substance
prescriptions that contained red flags of diversion and/or abuse
without addressing or resolving those red flags. The Pharmacy's conduct
in doing so violated 21 U.S.C. 823(f)(4); Tex. Health & Safety Code
Sec. 481.070-.075; Tex. Health & Safety Code Sec. 481.128; 22 Tex.
Admin. Code Sec. 291.22(c)(2); and 22 Tex. Admin. Code Sec. 291.33.
Additionally, the Pharmacy engaged in conduct that demonstrated
negative experience in its dispensing of controlled substances, in
violation of 21 U.S.C. 823(f)(2). ALJ-1, at 2-3, para. 3, 6-8.
The regulation concerning the usual course of pharmacy practice
provides that, ``[a] prescription for a controlled substance may only
be filled by a pharmacist, acting in the usual course of his
professional practice . . . .'' 21 CFR 1306.06. The DEA has also
promulgated regulations concerning a pharmacist's corresponding
responsibility. That regulation provides:
A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice. The responsibility for the proper prescribing and
dispensing of controlled substances is upon the prescribing
practitioner, but a corresponding responsibility rests with the
pharmacist who fills the prescription. An order purporting to be a
prescription issued not in the usual course of professional
treatment . . . is not a prescription within the meaning of section
309 of the [Controlled Substances] Act (21 U.S.C. 829) and the
person knowingly filling such 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.
21 CFR 1306.04(a). Texas regulations require 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.'' 22 Tex.
Admin. Code Sec. 291.33(c)(2)(A)(ii). That resolution must be
documented [on the prescription itself or ``in the pharmacy's data
processing system associated with the prescription.'' Id. at Sec. Sec.
291.33(c)(2)(A)(iv) and 291.33(c)(2)(C). The minimum documentation
requirements include] \*Q\ recording the date the pharmacist discussed
the matter with the prescriber, recording the name of the person with
whom the pharmacist discussed the matter, and any applicable
information pertaining to the discussion. Id. [ ] \*R\
---------------------------------------------------------------------------
\*Q\ Text adjusted in response to Respondent's Exceptions.
\*R\ Text removed in response to Respondent's Exceptions.
---------------------------------------------------------------------------
The Government's first allegation asserts that the Pharmacy
violated its corresponding responsibility in filling the prescriptions
contained in Government Exhibit 2, which were all filled between August
2014 and May 2015. ALJ-1, at 2, para. 3. The testimony of Dr. Witte,
supported by DEA cases, makes clear that pattern prescribing cannot be
established by only a few prescriptions. Tr. 332-33. At first blush,
the allegation seems inconsistent with DEA precedent and Dr. Witte's
testimony that pattern prescribing cannot be established by only a few
prescriptions.\44\ The Pharmacy, however, did not start filling
prescriptions for the ``Prescribers'' in August 2014.
---------------------------------------------------------------------------
\44\ The inconsistency results because the number of
prescriptions issued by each individual prescriber in Government
Exhibit 2 might be insufficient by itself to establish a pattern
that the Pharmacy should have been reasonably expected to notice.
Looking solely at the hard-copy prescriptions in Government Exhibit
2, and not the patient profiles, reveals the following breakdown of
the number of prescriptions issued by each practitioner. Nurse J.W.
issued 1 prescription. GE-2, at 67. Dr. A.Q. issued 5 prescriptions.
Id. at 18, 20, 64, 66, 68. Nurse L.R. issued 7 prescriptions. Id. at
1, 3, 24, 37, 96, 119. Nurse Practitioner I.I. issued 10
prescriptions. Id. at 8, 10, 12, 14, 16. Nurse S.G. issued 10
prescriptions. Id. at 5, 6, 34, 77, 81, 91, 111, 124. C.Z., PA,
issued 8 prescriptions. Id. at 25, 30, 41, 46, 52, 100, 115, 122.
Dr. C.V. issued 12 prescriptions. Id. at 28, 35, 39, 44, 47, 50, 83,
94, 98, 113, 117, 130. Dr. NE issued 23 prescriptions. Id. at 22,
26, 49, 56, 58, 60, 62, 71, 73, 75, 79, 86, 88, 89, 102, 104, 105,
107, 109, 120, 125, 127, 132. When written over the course of 10
months, from August 2014 to May 2015, the volume of prescriptions
issued by each practitioner might not be suspicious. Thus, in
determining whether the Pharmacy filled pattern-style prescriptions,
consideration is also given to additional documentary evidence in
the Administrative Record beyond the 10 month period in the
allegation. For example, consideration has been given to Government
Exhibit 6 and Respondent Exhibit C. Consideration is also given to
the fact that all the prescribers were associated with the same
medical clinics.
---------------------------------------------------------------------------
The Pharmacy started receiving prescriptions from Redbird in
January or February 2014. FF 11; Tr. 475. In fact, prior to filling the
cocktail prescriptions for J.S. on August 6, 2014, the Pharmacy had
filled at least 104 prescriptions for hydrocodone written by the same
small group of prescribers.\45\ FF 155. In addition, the Pharmacy had
filled at least 11 prescriptions written by this small group of
prescribers for cocktails of hydrocodone and alprazolam prior to August
2014, for patients who had to travel a significant distance to fill
those prescriptions. FF 140, 142-45. In each case the prescriptions
raised numerous red flags: The patient was receiving a large quantity
of controlled substances; the controlled substances constituted a drug
cocktail; the prescription was written by one of a small number of
prescribers of hydrocodone and alprazolam whose prescriptions the
Pharmacy filled for those controlled
[[Page 21039]]
substances; the prescriber was located a significant distance from the
Pharmacy; and the round-trip distance for the patient to obtain the
prescription and have it filled at the Pharmacy was also significant.
Id.\*S\
---------------------------------------------------------------------------
\45\ Actually, if Respondent's Exhibit C is taken into
consideration, the Pharmacy filled far more than 104 prescriptions
for hydrocodone written by the same small group of Prescribers prior
to filling the hydrocodone prescription for J.S. in August 2014. The
104 figure only takes into account those prescriptions documented by
Government Exhibit 6. A review of Respondent's Exhibit C, which the
Pharmacy claims to be its complete dispensing history of hydrocodone
from the date the Pharmacy opened until the date of the DEA
inspection, Tr. 470-71, reveals that the overwhelming majority of
prescriptions the Pharmacy filled for hydrocodone were written by
one of the Prescribers identified in Findings of Fact 118-121, 155.
\*S\ The OSC did not allege that Respondent unlawfully dispensed
any prescriptions prior to August 2014. Accordingly, while
Respondent's dispensing history prior to August 2014 is relevant to
establishing patterns in the subject prescriptions, any deficiencies
in Respondent's prescription dispensing practices outside of the
subject prescriptions do not weigh for or against Respondent
retaining its registration.
---------------------------------------------------------------------------
Here, Government Exhibit 2 documents that the Pharmacy filled more
than 75 controlled substance prescriptions between August 2014 and May
2015 for 27 different customers. FF 140. Those prescriptions contain
many of the same red flags as are contained in the prescriptions the
Pharmacy filled prior to August 2014 that were written by the same
small group of Prescribers.\46\ Furthermore, there is no credible
evidence that the Pharmacy ever took any steps to resolve any of these
red flags, either before or after August 2014. Tr. 216-17, 227, 236.
---------------------------------------------------------------------------
\46\ Government Exhibit 6 is the Pharmacy's dispensing log for
hydrocodone. FF 24. The stated date range on Government Exhibit 6 is
October 23, 2013 to June 18, 2015. FF 25. The earliest date recorded
on Government Exhibit 6, however, is July 7, 2014. GE-6, at 1. The
actual hard-copy prescriptions for most of the prescriptions
recorded on the dispensing log are not contained in the
Administrative Record. Nevertheless, the dispensing log identifies
the prescriber, the prescriber's address, the patient, the patient's
address, the quantity of hydrocodone tablets dispensed, and amount
the customer paid for the prescription. Thus, Government Exhibit 6
documents that most of the prescriptions would have contained the
following red flags: Pattern prescribing; a highly abused controlled
substance; unusual routes of travel and/or long distances to obtain
the prescriptions and have them filled at the Pharmacy; and cash
payments.
---------------------------------------------------------------------------
Accordingly, the allegations contained in paragraphs [3, 6, and 8]
\*T\ of the OSC asserting that between August 2014 and May 2015 the
Pharmacy filled 75 controlled substance prescriptions outside the usual
course of pharmacy practice, in violation of 21 CFR 1306.06, and in
contravention of the Pharmacy's ``corresponding responsibility'' under
21 CFR 1306.04(a), as well as 21 U.S.C.Sec. 823(f)(2) and (4); Tex.
Health & Safety Code Sec. 481.070-.075; Tex. Health & Safety Code
Sec. 481.128; 22 Tex. Admin. Code Sec. 291.22(c)(2) [ ],\*U\ are
sustained, and weigh in favor of revoking the Pharmacy's DEA
registration.
---------------------------------------------------------------------------
\*T\ Text adjusted in response to Respondent's Exceptions.
\*U\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------
2. The Government next alleged four situations in which the
Pharmacy filled prescriptions that contained one or more red flags that
the Pharmacy did not resolve prior to filling the prescriptions. The
Government listed the following as examples of red flags the Pharmacy
did not resolve: (a) Prescriptions for highly-abused controlled
substances such as hydrocodone, alprazolam, and promethazine with
codeine; (b) prescriptions written to individuals traveling long and/or
unusual distances to obtain their prescriptions and/or fill their
prescriptions at the Pharmacy; (c) prescriptions for individuals
obtaining the same or similar combinations of controlled substances
from the same small number of providers; (d) prescriptions for highly-
abused drug cocktails, such as hydrocodone and alprazolam; (e)
prescriptions containing inappropriate and/or unusual directions for
use; and (f) prescriptions for controlled substances purchased with
cash. ALJ-1, at 3-5, paras. 10, 10(a)-(d).
Ms. Igwe testified that she did not see any red flags in the
prescriptions introduced by the Government because they came from
clinics with which she was familiar.\47\ Tr. 512-13. Also, the types of
controlled substances in these prescriptions were consistent with the
clinics' specialty, chronic pain management. Id. at 512. Additionally,
some of the controlled substances were prescribed with appropriate non-
controlled substances. Id. at 514, 663-65. For example, some of the
prescriptions, such as the M.W. prescription, contained Mobic, an anti-
inflammatory that can reduce the need for an opioid. Id. at 513, 663-
64; GE-2, at 1. Some prescriptions, as in the case of M.W.
prescription, also contained Robaxin, which is a muscle relaxant. Tr.
513, 664-65; GE-2, at 1. Mobic and Robaxin are relevant treatment
options involving non-scheduled drugs for a patient suffering from
chronic pain. Tr. 513, 663-65. Ms. Igwe found it common that different
doctors practicing in the same specialty prescribed the same or similar
types of controlled substances. Id. at 519; see also id. at 658.
---------------------------------------------------------------------------
\47\ A former Administrator overruled a similar argument in the
past. See Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55
FR 4729, 4729-4730 (1990) (deciding that the ``sheer quantity and
frequency of [Preludin] prescriptions'' should have tipped off the
pharmacy that the prescriptions lacked a legitimate medical purpose
even though the pharmacy argued that the prescriptions were ``not
surprising'' given the provider's medical specialty).
---------------------------------------------------------------------------
Ms. Igwe also testified that customers would come into the Pharmacy
wearing braces or other ``mobilization'' (sic) devices, consistent with
the patient needing a controlled substance to treat pain. Id. at 516.
Sometimes a customer would say something that indicated to Ms. Igwe the
customer needed the medications to treat pain. Id. at 516.
In addition, Ms. Igwe was not concerned with patients coming from
Fort Worth. FF 138. Ms. Igwe testified that it was not unusual to see
patients with a Fort Worth address.\48\ Id. at 494. The Pharmacy had
patients from towns surrounding the Plano area, such as Lavon,
Princeton, Farmersville, Gladewater, DeSoto, and Lancaster. Id. at 494,
584. The Pharmacy had patients who came from throughout the Dallas-Fort
Worth metroplex. Id. at 495, 584.
---------------------------------------------------------------------------
\48\ In fact, there are numerous Fort Worth addresses for the
Pharmacy's customers listed in Government Exhibit 6. Most of those
customers, however, also received their prescriptions for
hydrocodone from the same small group of Prescribers.
---------------------------------------------------------------------------
Although Ms. Igwe testified that she was not concerned about red
flags, in part, because she was familiar with the clinics the customers
were coming from, Ms. Igwe also testified that she never checked to see
if the Prescribers' clinics were registered with the State of Texas as
pain management clinics. FF 99. Thus, her belief that she was receiving
prescriptions from pain management specialists was, at best,
uninformed. While it is true that many of the prescriptions in
Government Exhibit 6 also included non-controlled substances that could
also be used to treat pain symptoms, it is possible that the
Prescribers were simply ``masking'' the fact that they were issuing
prescriptions for illegitimate reasons. Even the Respondent's own
expert, Mr. Litman, concluded that he thought the Prescribers were
engaged in masking. Tr. 713. Mr. Litman further testified that the only
way to sniff out masking, or at least to ``reduce the suspicions,'' is
to ``call the physician.'' Id. at 687, 727. The Administrative Record
contains no evidence documenting such calls being made to the
Prescribers.
With respect to distance, Ms. Igwe, as well as Mr. Litman,
apparently had no concerns about the distances the Pharmacy's customers
were driving to obtain their prescriptions and have them filled at the
Pharmacy. Id. at 492-95, 542-43, 695-96, 727. Contributing to Ms.
Igwe's lack of concern about distance was the fact that she believed
the customers were coming from pain management clinics. Id. at 512-13.
Further, both Ms. Igwe and Mr. Litman seemed oblivious to the Texas
requirement that a pharmacist should consider ``the geographical
distance between the practitioner and the patient or between the
pharmacy and the patient'' when evaluating a
[[Page 21040]]
prescription's legitimacy. 22 Tex. Admin. Code Sec. 291.29(c)(4).
Finally, there is no documentation in the Administrative Record of
the Pharmacy ever: Resolving any red flags; consulting with providers
about red flags; checking the Texas PMP; or having discussions with
customers to resolve missing addresses on prescriptions. Tr. 216-17,
227, 236. In fact, although Ms. Igwe testified that she had such
documentation, she did not believe she needed to present it.\49\ Id. at
547. This belief is unreasonable given the allegations contained in the
OSC and because Ms. Igwe was asked to produce any notes she had
concerning the resolution of red flags during the AIW. FF 18-19.
---------------------------------------------------------------------------
\49\ In this regard the Respondent is like the student who
neglected to turn in his homework. They both get no credit.
---------------------------------------------------------------------------
A. The M.W. Prescription
The Government alleged that on August 1, 2014, the Pharmacy filled
a prescription for 120, 10 mg tablets of hydrocodone presented by an
undercover agent without resolving the red flags presented by the
prescription. The agent obtained the prescription from a practitioner
in a clinic in south Dallas, more than 30 miles from the Pharmacy,
which is located north of Dallas. There was no legitimate medical
purpose for the prescription and the agent used a fictitious address.
The agent also sought to purchase the prescription with cash. ALJ-1, at
3-4, paras. 10, 10(a).
The basic facts that support this allegation are contained in the
sworn declaration of the undercover investigator, UC 1. GE-11. During
his undercover investigation, UC 1 used the name M.W. FF 124. On July
29, 2014, M.W. went to the Redbird Medical Clinic, where Nurse
Practitioner L.R. conducted a cursory examination. FF 126-27. L.R. then
issued M.W. a prescription for 120, 10 mg tablets of hydrocodone, as
well as prescriptions for Robaxin (methocarbamol) and Mobic
(meloxicam). FF 127; GE-2, at 1; GE-10, at 5. Instead of simply giving
M.W. his prescription so that he could have it filled at the pharmacy
of his choice, Redbird informed M.W. that they were sending his
prescription to the Pharmacy. FF 127. The Pharmacy, however, did not
receive the prescription until August 1, 2014. FF 129. In spite of the
fact that the prescription was written for pain, M.W. did not pick up
his prescriptions until August 4, 2014. FF 132. Based on the addresses
contained in the Pharmacy's records, M.W. would have needed to travel
almost 100 miles to obtain his prescriptions from Redbird, have them
filled at the Pharmacy, and return to his recorded, though fictitious,
address. GE-12. M.W. paid the Pharmacy $206.00 for his three
prescriptions, to include $150.00 for the hydrocodone. GE-2, at 1; GE-
11, at 3.
In the three weeks before the Pharmacy filled M.W.'s prescription
for hydrocodone on August 1, 2014,\50\ the Pharmacy had already filled
83 prescriptions for hydrocodone, and L.R. had written 27 of those
prescriptions. GE-6, at 1-8. In addition, every one of those
prescriptions had been written by one of the Prescribers. Id., see also
FF 118-21.
---------------------------------------------------------------------------
\50\ The allegation alleges that this prescription was filled on
August 1, 2014, which corresponds to the date on the fill sticker.
See GE-2, at 1. Ms. Igwe acknowledged that the date on the fill
sticker is not necessarily the date the customer picked up his or
her prescription. FF 117. Ms. Igwe also testified that she had no
reason to dispute that M.W. prescription was picked up on August 4,
2014. Tr. 576.
---------------------------------------------------------------------------
The prescription that L.R. wrote for M.W. raises the following red
flags: No patient address; no provider DEA number; [ ] \*V\ the
prescription was written on July 29, 2014, but not faxed to the
Pharmacy until August 1, 2014, and not picked up until August 4, 2014;
\51\ and an unusual path and distance to obtain the prescription and
get it filled. FF 47, 63, 69, 75, 135. In addition, M.W. paid over $200
cash to pick up his three prescriptions.\52\ FF 65; GE-2, at 1; GE-11,
at 3.
---------------------------------------------------------------------------
\*V\ Text adjusted in response to Respondent's Exceptions.
\51\ While Ms. Igwe was not concerned about the delay between
the date M.W.'s prescription was written for pain and when it was
picked up six days later, her reasoning was based on pure
speculation that M.W. could have had other medication left over. Tr.
564-65. Had Ms. Igwe checked the PMP she would have learned that not
to be the case. Further, Dr. Witte credibly testified that such a
delay would call into question whether the patient needed pain
medication and whether the prescription was for a legitimate medical
purpose. Id. 192-93, 397.
\52\ Even the Respondent's expert expressed some concern for
cash payments in excess of $200. Tr. 692, 753.
---------------------------------------------------------------------------
There are no notations on the M.W. prescription or on M.W.'s
patient profile, maintained by the Pharmacy, to suggest that any of the
above noted red flags were resolved either before or after Ms. Igwe
filled the prescription for hydrocodone. Tr. 194-95; GE-2, at 1; GE-10,
at 4-5. Accordingly, the M.W. prescription for hydrocodone was not
dispensed in the usual course of pharmacy practice. Tr. 195. In
addition, the pharmacist who filled these prescriptions did not follow
the minimum standard of the practice of pharmacy in the State of Texas,
and did not satisfy the pharmacist's corresponding responsibility to
ensure that prescriptions are issued for legitimate medical purposes.
Id.
The allegation concerning the M.W. prescription is also included in
the allegation contained in paragraphs 3-7 of the OSC that between
August 2014 and May 2015 the Pharmacy filled 75 controlled substance
prescriptions outside the usual course of pharmacy practice and in
contravention of the Pharmacy's corresponding responsibility to ensure
that prescriptions are dispensed for legitimate medical purposes. ALJ-
1, at 2-3, paras. 3-7. The Government has not advanced any theory as to
why this same allegation should be considered twice. See ALJ-35.
Therefore, the allegations contained in paragraphs 10 and 10(a) of the
OSC, that the Pharmacy filled the M.W. prescription for 120, 10 mg
tablets of hydrocodone on August 1, 2014, without resolving red flags
presented by the prescription, are sustained, and weighs in favor of
revoking the Respondent's DEA registration. The substance of these
allegations, however, will only be considered once.
B. Prescription Cocktails, Distance, Cash Payments, and Facially
Invalid Prescriptions
(i.) Next, the Government alleged that from August 2014 to May
2015, the Pharmacy dispensed prescription cocktails (hydrocodone and
alprazolam) to 25 different individuals, all of whom traveled unusual
paths and distances to obtain their prescriptions for these controlled
substances and to have them filled at the Pharmacy. ALJ-1, at 3-4,
paras. 10, 10(b).
Government Exhibit 2 reveals that between August 8, 2014, and May
18, 2015, the Pharmacy filled prescriptions for hydrocodone and
alprazolam on the same day for 25 different customers. GE-2, at 3-81,
86-132. Of the 27 customers identified in Government Exhibit 2, only
patients M.W. and G.B. did not have prescriptions for both hydrocodone
and alprazolam filled by the Pharmacy on the same day. See id. at 1,
and 83-84.
(ii.) The Government also alleged that six individuals, J.W., H.J.,
M.H., A.S., K.S., and M.A., traveled more than 100 miles to obtain
their prescriptions, have them filled at the Pharmacy, and return home.
ALJ-1, at 3-4, para. 10, 10(b).
Based upon round-trip distance calculations, each of these Pharmacy
customers, J.W., H.J., M.H., A.S., K.S., and M.A., traveled more than
100 miles to obtain their prescriptions and have them filled at the
Pharmacy. FF 162, 167, 173. Of these six customers, K.S.
[[Page 21041]]
had the shortest round trip of 101 miles, which would have taken 1 hour
and 51 minutes to travel during light traffic. GE-3, at 128. Customer
M.H. had the longest round-trip distance of 121 miles, which would have
taken 2 hours and 19 minutes to travel with heavy traffic. GE-3, at 54.
(iii.) The Government next alleged that 17 individuals, J.S., C.J.,
SW, J.W.2, S.H., R.E., R.N., R.H., B.B., S.N., I.B., M.W.2, Y.S.,
R.H.2, C.D., A.K., and S.B., traveled between 70-100 miles to obtain
their prescriptions, have them filled at the Pharmacy, and return home.
ALJ-1, at 3-4, para. 10, 10(b).
Based upon round-trip distance calculations, each of these Pharmacy
customers, J.S., C.J., SW, J.W.2, S.H., R.E., R.N., R.H., B.B., S.N.,
I.B., M.W.2, Y.S., R.H.2, C.D., A.K., and S.B., traveled between 70 to
100 miles to obtain their prescriptions and have them filled at the
Pharmacy. FF 47, 151, 162, 167, 173. Of these 17 customers, K.S. had
the shortest round trip of 76.6 miles, which would have taken 1 hour
and 27 minutes to travel during light traffic. GE-3, at 74. Customer SW
had the longest round-trip distance of 99.7 miles, which would have
taken 1 hour and 54 minutes to travel in moderate traffic. GE-3, at
167.
(iv.) The Government alleged that four individuals, R.N., E.H.,
B.B., and T.H.,\53\ traveled between 60-70 miles to obtain their
prescriptions, have them filled at the Pharmacy, and return home. ALJ-
1, at 3-4, para 10, 10(b).
---------------------------------------------------------------------------
\53\ The OSC alleged that ``T.H.'' had a round-trip distance of
between 60-70 miles. ALJ-1, at 4, para. 10(b). There is no patient
T.H. in Government Exhibit 2. There is, however, a patient T.W.
addressed in Government Exhibit 2. GE-2, at 71-74. The round-trip
distance for T.W. was 66.9 miles. GE-3, at 177.
---------------------------------------------------------------------------
Based upon round-trip distance calculations for Pharmacy customers
R.N., E.H., B.B., and T.W., they each traveled between 60 to 70 miles
to obtain their prescriptions and have them filled at the Pharmacy. FF
167, 173; GE-2, at 71-73; GE-3, at 45-48, 177-181. Of these four
customers, R.N. had the shortest round trip of 64.8 miles, which would
have taken 1 hour and 33 minutes to travel during heavy traffic. GE-3,
at 104. Customer E.H. had the longest round-trip distance of 68.1
miles, which would have taken 1 hour and 22 minutes to travel in
moderate traffic. GE-3, at 45.
(v.) Next, the Government alleged that all of the above customers
sought to purchase their prescriptions with cash. ALJ-1, at 3-4, para.
10, 10(b).
Each of the Pharmacy's fill stickers shows a dollar amount preceded
by the abbreviation ``Cpy''. See, e.g., GE-2, at 1. That dollar amount
is the amount the customer paid the Pharmacy for the prescription. FF
111. Thus, each prescription in Government Exhibit 2 was purchased with
cash. In addition, when prescriptions of hydrocodone and alprazolam
were purchased on the same day, as they frequently were, a customer
would normally pay $179.99 for the hydrocodone and $59.99 for the
alprazolam, for a total of $239.98 for the two prescriptions. FF 167,
173, 176; see, e.g., GE-2, at 80-81.
(vi.) The Government also alleged that the prescriptions issued to
M.W., J.S., J.W., C.J., S.N., J.W.2, S.H., H.J., E.H., A.S., R.E.,
K.S., S.B., R.H., T.W., I.B., M.W.2, Y.S., M.A., R.H.2, B.B., C.D.,
A.K., and R.N., were facially invalid and in violation of federal and
state law because they lacked the patient's address and the
practitioner's DEA number. ALJ-1, at 3-4, para. 10, 10(b).
Federal regulations require that, among other information, a
prescription must contain the patient's address and the registration
number of the prescriber. FF 68, 77; 21 CFR 1306.05(a). Texas law also
requires that prescriptions contain the patient's address and the
prescriber's DEA number. FF 68, 77; Tex. Health & Safety Code Sec.
481.074(k). The prescriptions issued to M.W., J.S., J.W., C.J., S.N.,
J.W.2, S.H., H.J., E.H., A.S., R.E., K.S., S.B., R.H., T.W., I.B.,
M.W.2, Y.S., M.A., R.H.2, B.B., C.D., A.K., and R.N., did not contain
the patient's address. GE-2, at 1, 3, 5, 6, 8, 12, 14, 16, 20, 24, 25,
30, 34, 37, 41, 46, 49, 52, 58, 62, 66, 67, 73, 77, 81, 88, 91, 96,
100, 104, 107, 111, 115, 119, 122, 124, 127. In addition, all of these
prescriptions, except those issued to S.N. and S.B., and one of the
prescriptions issued to B.B., did not contain the prescriber's DEA
registration number. See GE-2, at 58, 62, 104. Therefore, all of these
prescriptions were facially invalid under federal and Texas law.
It is also noted that Nurse Practitioner S.G. wrote cocktail
prescriptions of hydrocodone and alprazolam for J.W. on August 29,
2014. Id. at 6. The prescription for alprazolam indicated that J.W. was
to take one tablet twice a day. Id. Alprazolam, however, is normally
taken more frequently than twice a day. Tr. 177. In addition, J.W.
waited 14 days before filling these prescriptions. GE-2, at 6. Such a
delay raises a question of whether the prescription is legitimate. Tr.
193. In addition to these two red flags, the two prescriptions combined
constituted a drug cocktail. FF 54. The prescription was also written
by one of the Prescribers, calling into question pattern prescribing,
and J.W. paid $219.99 for the two prescriptions. GE-2, at 6. The
Administrative Record does not document that Ms. Igwe resolved any of
these issues before filling these two prescriptions for J.W. on
September 12, 2014. FF 177.
The allegations addressed in subparagraphs (i.)-(vi.), discussed
above, concern: Dispensing drug cocktails; the long and unusual routes
that the Pharmacy customers traveled to obtain their prescriptions and
have them filled; paying cash for prescriptions; and prescriptions that
were facially invalid. Each of these concerns is a red flag. FF 63, 65,
68, 69, 70, 77; Tr. 391-92. When a prescription presents a red flag, a
Texas pharmacist must resolve that red flag [and document the
resolution] \*W\ prior to filling the prescription. FF 77, 79. [ ] \*X\
Neither the hard-copy prescriptions nor the patient profiles maintained
by the Pharmacy contain any documentation showing that the Pharmacy
resolved the above-noted red flags. GE-2; see also Tr. 216-17, 227,
236. Accordingly, the prescriptions addressed in subparagraph (i.)-
(vi.) above were not dispensed in the usual course of the professional
practice of pharmacy in the State of Texas. Id. at 217, 227, 236.
Furthermore, the pharmacist who filled these prescriptions did not
follow the minimum standard of the practice of pharmacy in the State of
Texas, and did not satisfy the pharmacist's corresponding
responsibility to ensure that prescriptions are issued for legitimate
medical purposes. Tr. 217, 227-28, 236-37; see 21 CFR 1306.04(a).
---------------------------------------------------------------------------
\*W\ Text adjusted in response to Respondent's Exceptions.
\*X\ Text removed in response to Respondent's Exceptions.
---------------------------------------------------------------------------
The allegations contained in paragraphs 10 and 10(b) of the OSC are
also included in the allegation that between August 2014 and May 2015
the Pharmacy filled 75 controlled substance prescriptions outside the
usual course of pharmacy practice and in contravention of the
pharmacist's corresponding responsibility to ensure that prescriptions
are dispensed for legitimate medical purposes. ALJ-1, at 2-3, paras. 3-
7. The Government has not advanced any theory as to why this same
allegation should be considered twice. See ALJ-35. Therefore, the
allegations contained in paragraphs 10 and 10(b) of the OSC, that the
Pharmacy filled numerous prescriptions without resolving red flags
concerning drug cocktails, distance traveled, cash payments, and
facially invalid prescriptions, are sustained, and weigh in favor of
revoking the Respondent's
[[Page 21042]]
registration. The substance of these allegations, however, will only be
considered once.
C. Pattern Prescribing
The Government next alleged that many of the individuals mentioned
in paragraph B, above, obtained their prescriptions from physicians who
were engaged in pattern prescribing. ALJ-1, at 3-4, paras. 10, 10(c).
(i.) The Government alleged that between August 19, 2014 \54\ and
October 2, 2014, patients C.J., SW, J.W.2, S.H., and H.J. all received
prescriptions for hydrocodone and alprazolam from Nurse Practitioner
I.I., and they traveled long and unusual paths to obtain their
prescriptions and have them filled at the Pharmacy. ALJ-1, at 3-4,
paras. 10, 10(c).
---------------------------------------------------------------------------
\54\ The first two prescriptions written by Nurse Practitioner
I.I. were written on August 18, 2014, rather than August 19. GE-2,
at 8, 12.
---------------------------------------------------------------------------
In the month and a half between August 19, 2014, and October 2,
2014, the Pharmacy filled five identical cocktail prescriptions for
customers, C.J., SW, J.W.2, S.H., and H.J. FF 162. The Pharmacy
provided each of these customers with 90, 10 mg tablets of hydrocodone,
and 60, 2 mg tablets of alprazolam based upon prescriptions they had
received from I.I. FF 162. Of the 5 customers, S.H. traveled the
shortest round-trip distance of 76 miles, taking 1 hour and 27 minutes
in light traffic. GE-3, at 74. H.J. had the longest round trip of 105
miles, taking 1 hour and 56 minutes in light traffic. GE-3, at 84.
Further, by the time the Pharmacy filled the first of I.I.'s
prescriptions for hydrocodone for 1 of these 5 customers, the Pharmacy
had already filled 149 prescriptions for hydrocodone since July 7,
2014, and I.I. had written 43 of those prescriptions. GE-6, at 1-14. In
addition, every one of those prescriptions had been written by one of
the Prescribers. Id.; see also FF 118-21. Thus, by the time Ms. Igwe
filled the prescription for hydrocodone for C.J. on August 19, 2014, a
prescription written by I.I., Ms. Igwe would have had ample time to
have identified the pattern of I.I.'s prescribing, and that of I.I.'s
fellow Prescribers. FF 80-82, 84. Pattern prescribing is a red flag. FF
61. When presented with evidence of pattern prescribing, a Texas
pharmacist should contact the prescriber, ask about the prescription's
medical purpose, and then document that discussion. FF 80, 85 [ ].\*Y\
While Ms. Igwe testified that she had discussions with providers
whenever a new patient presented a prescription, those discussions are
not documented as required by [the minimum standards of professional
practice in Texas].\*Z\
---------------------------------------------------------------------------
\*Y\ Text removed in response to Respondent's Exceptions.
\*Z\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------
In addition, prescribing hydrocodone and alprazolam together
constitutes a cocktail of high-alert drugs. FF 55. When taken together,
these two controlled substances can create a euphoric and addictive
effect similar to a heroin high. FF 55. A drug cocktail is a red flag.
FF 70. Here, on August 19, 2014, the Pharmacy was filling drug cocktail
prescriptions written by I.I., but as noted earlier in this Recommended
Decision, the Pharmacy had already been filling drug cocktails of
hydrocodone and alprazolam, written by the same small group of
Prescribers to which I.I. belonged. See FF 130, 140, 142-45, 155.
This allegation is also included in the allegation that between
August 2014 and May 2015, the Pharmacy filled prescription cocktails of
hydrocodone and alprazolam to 25 different individuals. ALJ-1, at 4,
para. 10(b). The Government has not advanced any theory as to why this
same allegation should be considered twice. See ALJ-35. Thus, while
this allegation is sustained, and weighs in favor of revoking the
Respondent's registration, its substance will only be considered once.
(ii.) The Government alleged that between November 14, 2014, and
May 1, 2015, the Pharmacy filled 12 prescriptions for hydrocodone
written by Dr. C.V. for patients A.S., R.E., K.S., G.B., R.H.2, A.K.,
R.N., and M.H.\55\ All of these patients traveled long and unusual
paths to obtain their prescriptions and have them filled. ALJ-1, at 3-
4, paras. 10, 10(c).
---------------------------------------------------------------------------
\55\ Actually, the Pharmacy filled 13 prescriptions for these 8
customers, plus a prescription for an additional customer, M.A., all
of which were written by Dr. C.V. FF 167.
---------------------------------------------------------------------------
The Pharmacy filled prescriptions for customers A.S., R.E., K.S.,
G.B., R.H.2, A.K., R.N., and M.H., all written by Dr. C.V. for 90, 10
mg tablets of hydrocodone. FF 167. Significantly, at the same time the
Pharmacy filled these prescriptions, it also filled a prescription for
60, 2 mg tablets of alprazolam for each of these customers, written by
one of the Prescribers other than Dr. C.V. FF 167. Of these 8
customers, G.B. traveled the shortest round-trip distance of 55.8
miles, taking 1 hour and 31 minutes in heavy traffic. GE-3, at 16. A.S.
had the longest round trip of 111 miles, taking 2 hours in light
traffic. GE-3, at 118.
Further, by the time the Pharmacy filled the first of Dr. C.V.'s
prescriptions for hydrocodone for 1 of these 8 customers on November
14, 2014, the Pharmacy had already filled 379 prescriptions for
hydrocodone since July 7, 2014, and Dr. C.V. had written 60 of those
prescriptions. GE-6, at 1-14. Of the prescriptions Dr. C.V. wrote, the
Pharmacy received 28 consecutive prescriptions from Dr. C.V. for
hydrocodone between October 9 and October 23, 2014, and it had received
19 in the week before it received the prescription for patient R.E. on
November 14, 2014. GE-6, at 29-31, 33-35. In addition, all but 11 of
the 379 prescriptions had been written by one of the Prescribers. GE-6,
at 1-35; see also FF 118-21. Thus, by the time Ms. Igwe filled the
prescription for hydrocodone for R.E. on November 14, 2014, a
prescription written by Dr. C.V., Ms. Igwe would have had ample time to
identify the pattern of Dr. C.V.'s prescribing, and that of his fellow
Prescribers. FF 80-82, 84. Pattern prescribing is a red flag. FF 61.
When presented with evidence of pattern prescribing, a Texas pharmacist
should contact the prescriber, ask about the prescription's medical
purpose, and then document that discussion. FF 80, 85. While Ms. Igwe
testified that she had discussions with providers whenever a new
patient presented a prescription, those discussions are not documented
as required by [the minimum standards of practice in Texas].\*AA\
---------------------------------------------------------------------------
\*AA\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------
With the exception of G.B.'s hydrocodone prescription,\56\ filled
by the Pharmacy on April 17, 2015, this allegation is included in the
allegation that between August 2014 and May 2015 the Pharmacy filled
prescription cocktails of hydrocodone and alprazolam to 25 different
individuals who had to travel long and/or unusual routes to obtain and
fill their prescriptions. ALJ-1, at 4, para. 10(b). It is also included
in the allegation that the Pharmacy filled 75 controlled substance
prescriptions outside the usual course of pharmacy practice, in
violation of 21 CFR 1306.06, and in contravention of the Pharmacy's
``corresponding responsibility'' under 21 CFR 1306.04(a). ALJ-1, at 2,
para. 3. The Government has not advanced any theory as to why this same
allegation should be considered three times. See ALJ-35. Thus, while
this allegation is sustained, and weighs in favor of
[[Page 21043]]
revoking the Respondent's registration, its substance will only be
considered once. The portion of this allegation that alleges that the
Pharmacy filled a hydrocodone prescription for G.B., written by Dr.
C.V., is included in the allegation that the Pharmacy filled 75
controlled substance prescriptions outside the usual course of pharmacy
practice, in violation of 21 CFR 1306.06, and in contravention of the
Pharmacy's ``corresponding responsibility'' under 21 CFR 1306.04(a).
ALJ-1, at 2, para. 3. The Government has not advanced any theory as to
why this same allegation should be considered twice. See ALJ-35. Thus,
while the allegation concerning the hydrocodone prescription for G.B.
is sustained, and weighs in favor of revoking the Respondent's
registration, its substance will only be considered once.
---------------------------------------------------------------------------
\56\ G.B. is not mentioned in paragraph 10(b) of the OSC. ALJ-1,
at 4.
---------------------------------------------------------------------------
(iii.) Next, the Government alleged that the Pharmacy also filled
prescription cocktails (hydrocodone and alprazolam), written by Dr.
C.V., for patients M.A., R.H.2, and A.K. on April 17, 2015, and May 1,
2015, respectively. ALJ-1, at 3-4, paras. 10, 10(c).
As noted above, Dr. C.V. wrote prescriptions for 90, 10 mg tablets
of hydrocodone for M.A., R.H.2, and A.K. FF 167. The Pharmacy also
filled prescriptions of 60, 2 mg tablets of alprazolam for these three
customers. See supra notes 21-23. Dr. C.V., however, did not write
prescriptions for alprazolam for those three customers. While the
Pharmacy's fill stickers for the alprazolam that those three customers
received indicates that Dr. C.V. was the prescribing doctor, the
prescriptions themselves clearly show that Dr. C.V. did not write those
prescriptions. FF 167; see supra notes 21-23; GE-2, at 96, 100, 115.
Nurse Practitioner L.R. wrote the prescription for alprazolam for M.A.
GE-2, at 96. Physician's Assistant C.Z. wrote the prescriptions for
alprazolam for R.H.2 and A.K.\57\
---------------------------------------------------------------------------
\57\ Compare known C.Z. signatures at GE-2, at 52, 122-23, with
signatures on the R.H.2 and A.K. prescriptions at GE-2, at 100, 115.
---------------------------------------------------------------------------
The significance of the alprazolam prescriptions, however, does not
depend on the prescriber. Rather, the significance is that the Pharmacy
filled the alprazolam prescriptions for M.A., R.H.2, and A.K., as well
as for all the other customers who received prescriptions for
hydrocodone from Dr. C.V., at the same time that it also filled
hydrocodone prescriptions for them. In addition, the Pharmacy filled
all of these prescriptions even though the customers presented
prescriptions for hydrocodone written by Dr. C.V. at the same time that
they presented prescriptions for alprazolam written by another one of
the other Prescribers. FF 167.
This allegation is included in the allegation that between August
2014 and May 2015, the Pharmacy filled prescription cocktails of
hydrocodone and alprazolam to 25 different individuals. ALJ-1, at 4,
para. 10(b). The Government has not advanced any theory as to why this
same allegation should be considered twice. See ALJ-35. Thus, to the
extent that this allegation asserts that the Pharmacy filled
prescription cocktails for these three identified patients, though the
hydrocodone was written by Dr. C.V. and the alprazolam was written by
another Prescriber, it is sustained, and weighs in favor of revoking
the Respondent's registration. The allegation's substance, however,
will only be considered once.
(iv.) The Government alleged that between January 13, 2015, and May
11, 2015, the Pharmacy dispensed controlled substances pursuant to
``pattern-style'' prescriptions issued by Dr. NE On 14 different
occasions, the Pharmacy dispensed 90, 10 mg tablets of hydrocodone to
11 different customers. ALJ-1, at 3-4, para 10, 10(c).
The Pharmacy filled 15 prescriptions for 11 customers, A.S., R.N.,
R.E., B.B., S.B., S.N., T.W., I.B., M.W.2, Y.S., and C.D., between
January 24, 2015 and May 18, 2015. FF 173; GE-2, at 22-23, 89-90. These
prescriptions were written by Dr. NE for 90, 10 mg tablets of
hydrocodone. FF 173. Significantly, at the same time the Pharmacy
filled these prescriptions, it also filled a prescription for 60, 2 mg
tablets of alprazolam for each of these customers, written by either
Dr. NE or one of the other Prescribers. FF 173. Of the 11 customers,
T.W. traveled the shortest round-trip distance of 66.9 miles, taking 1
hour and 23 minutes in moderate traffic. GE-3, at 177. A.S. had the
longest round trip of 104 miles, taking 1 hour and 54 minutes in light
traffic. GE-3, at 113. Every prescription was purchased with cash. FF
173. The price for hydrocodone and alprazolam together totaled $239.98.
Id.
Further, by the time the Pharmacy filled the first of Dr. NE's
prescriptions for hydrocodone for 1 of these 11 customers, which was
A.S. on January 26, 2015, GE-6, at 52, the Pharmacy had already filled
563 prescriptions for hydrocodone since July 7, 2014, and Dr. NE had
written 60 of those prescriptions. GE-6, at 1-52. Of the prescriptions
Dr. NE wrote, the Pharmacy received seven consecutive prescriptions
from Dr. NE for hydrocodone on November 5, 2014, four consecutive
prescriptions from Dr. NE for hydrocodone on November 23, 2014, and six
consecutive prescriptions from Dr. NE for hydrocodone on December 30,
2014. GE-6, at 32-33, 37, 44. In addition, all but 18 of the 563
prescriptions had been written by one of the Prescribers. GE-6, at 1-
52; see also FF 118-21. Thus, by the time Ms. Igwe filled the
prescription for hydrocodone for A.S. on January 26, 2015, a
prescription written by Dr. NE, Ms. Igwe would have had ample time to
identify the pattern of Dr. NE's prescribing, and that of her fellow
Prescribers. FF 80-82, 84. Pattern prescribing is a red flag. FF 61.
When presented with evidence of pattern prescribing, a Texas pharmacist
should contact the prescriber, ask about the prescription's medical
purpose, and then document that discussion. FF 80, 85. While Ms. Igwe
testified that she had discussions with providers whenever a new
patient presented a prescription, those discussions are not documented
as required by [the minimum standards of practice in Texas.] \*BB\
---------------------------------------------------------------------------
\*BB\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------
This allegation is included in the allegation that between August
2014 and May 2015 the Pharmacy filled prescription cocktails of
hydrocodone and alprazolam to 25 different individuals. ALJ-1, at 4,
para. 10(b). The Government has not advanced any theory as to why this
same allegation should be considered twice. See ALJ-35. Thus, while
this allegation is sustained, and weighs in favor of revoking the
Respondent's registration, its substance will only be considered once.
(v.) The Government next alleged that on 8 different occasions, the
Pharmacy filled identical prescription cocktails written by Dr. NE
consisting of 90, 10 mg tablets of hydrocodone and 60, 2 mg tablets of
alprazolam. Identical prescription cocktails were dispensed to both
I.B. and T.W. on April 10, 2015, and to B.B. and C.D. on April 23,
2015. ALJ-1, at 3-4, para. 10, 10(c).
The Pharmacy filled drug cocktail prescriptions of 90, 10 mg
tablets of hydrocodone and 60, 2 mg tablets of alprazolam written by
Dr. NE seven different times. FF 173. These prescriptions were filled
for customers B.B., S.B., S.N., T.W., Y.S., R.N., and again for B.B. FF
173; GE-2, at 56-58, 60-62, 71-73, 86-88, 102-04, 105-07, 125-27. While
the Pharmacy also filled identical cocktail prescriptions for I.B. and
T.W. on April 10, 2015, and again for B.B. and C.D. on April 23, 2015,
Dr.
[[Page 21044]]
NE did not write all of the prescriptions for alprazolam. Nurse
Practitioner S.G. wrote the prescriptions for alprazolam for I.B. and
C.D. GE-2, at 77, 111. The Pharmacy fill labels for those prescriptions
improperly indicate, however, that those prescriptions were written by
Dr. NE Id.
As noted earlier, the significance of the Pharmacy filling
prescriptions for alprazolam, however, does not depend on the
prescriber. Rather, the significance is that the Pharmacy filled a
prescription cocktail of alprazolam and hydrocodone for I.B., T.W.,
B.B., and C.D., as well as for all the other customers above who
received prescriptions for hydrocodone from Dr. NE In addition, the
Pharmacy filled all of these prescriptions even though the customers
presented prescriptions for hydrocodone written by Dr. NE, while the
prescriptions for alprazolam were written by a different one of the
Prescribers. Further, as noted above, all of these prescriptions
exhibited the red flags of pattern prescribing, the customers all
traveled long or unusual routes to obtain their prescriptions and have
them filled, and all of the prescriptions were purchased with cash.
This allegation is included in the allegation that between August
2014 and May 2015, the Pharmacy filled prescription cocktails of
hydrocodone and alprazolam to 25 different individuals. ALJ-1, at 4,
para. 10(b). The Government has not advanced any theory as to why this
same allegation should be considered twice. See ALJ-35. Thus, to the
extent that Dr. NE only wrote seven prescription cocktails of
hydrocodone and alprazolam, and wrote only one such cocktail
prescription on April 10, 2015, and one on April 23, 2015, this
allegation is sustained, and weighs in favor of revoking the
Respondent's registration. The substance of the allegation, however,
will only be considered once.
Therefore, the allegations contained in paragraphs 10 and 10(c) of
the OSC, that the Pharmacy filled numerous prescriptions without
resolving red flags concerning drug cocktails, distance traveled, cash
payments, and facially invalid prescriptions, are sustained, and weigh
in favor of revoking the Respondent's registration. With one exception,
these sustained allegations are all included in the allegations
contained in paragraphs 10 and 10(b) of the OSC, and with that one
exception will not be considered as separate allegations in determining
whether the Respondent's registration should be revoked. The portion of
this allegation that alleged, in paragraph 10(c) of the OSC, that the
Pharmacy filled a prescription for G.B. for hydrocodone, written by Dr.
C.V., is sustained, but it is included in the allegation that the
Pharmacy filled 75 controlled substance prescriptions outside the usual
course of pharmacy practice, in violation of 21 CFR 1306.06, and in
contravention of the Pharmacy's ``corresponding responsibility'' under
21 CFR 1306.04(a), ALJ-1, at 2, para. 3, and it will not be considered
twice.
(vi.) The Government's next allegation is that on April 17, 2015,
the Pharmacy filled a hydrocodone prescription for G.B., who had
traveled an unusual path and distance of more than 75 miles to obtain
her prescription and have it filled at the Pharmacy, and then return
home. ALJ-1, at 5, para. 10, 10(d).
Government Exhibit 2 documents that the Pharmacy filled a
prescription for G.B. for 90, 10 mg tablets of hydrocodone on April 17,
2015. GE-2, at 84. The prescription was written by Dr. C.V. one day
earlier. GE-2, at 83. This allegation is included in the allegation
that the Pharmacy filled 75 controlled substance prescriptions outside
the usual course of pharmacy practice, in violation of 21 CFR 1306.06,
and in contravention of the Pharmacy's ``corresponding responsibility''
under 21 CFR 1306.04(a). ALJ-1, at 2, para. 3. It is also included in
the allegation that between November 14, 2014 and May 1, 2015, the
Pharmacy filled 12 \58\ prescriptions for hydrocodone written by Dr.
C.V. ALJ-1, at 4, para. 10(c). Again, the Government has not advanced
any theory as to why this same allegation should be considered three
times. See ALJ-35. Thus, while the allegation contained in paragraph
10(d) of the OSC is sustained, and weighs in favor of revoking the
Respondent's registration, the allegation's substance will only be
considered once.
---------------------------------------------------------------------------
\58\ See supra notes 45 and 56.
---------------------------------------------------------------------------
Recordkeeping Violation
Finally, the Government alleged that a DEA audit of the Pharmacy's
10 mg hydrocodone, covering the period of September 25, 2013, through
June 18, 2015, revealed a shortage of 47,183 dosage units. Because the
Controlled Substances Act requires the maintenance of ``complete and
accurate'' inventories, as well as a ``complete accurate record of each
substance . . . received, sold, delivered or otherwise disposed of,''
this shortage violated 21 U.S.C. 827(a). ALJ-1, at 5, para. 13.
As noted above, the CSA mandates that ``[e]very registrant . . .
shall maintain, on a current basis, a complete and accurate record of
each [ ] substance manufactured, received, sold, delivered, or
otherwise disposed of . . . .'' 21 U.S.C. 827(a)(3). On June 18, 2015,
DEA investigators conducted an inspection of the Pharmacy, and asked
Ms. Igwe to produce a copy of the Pharmacy's dispensing history of
hydrocodone. FF 15, 23. In response, Ms. Igwe gave the inspectors a
report of the Pharmacy's hydrocodone dispensing history, contained in
Government Exhibit 6, with a date range of October 23, 2013 to June 18,
2015. FF 24-25. Following the inspection, and using the report provided
by Ms. Igwe, DI 1 conducted an audit of the Pharmacy's hydrocodone. FF
36; Tr. 47-48. DI 1's audit revealed that the Pharmacy was short 47,183
tablets of hydrocodone. FF 37.
Government Exhibit 6 clearly does not report all of the hydrocodone
that the Pharmacy dispensed. FF 41. After the inspection, Ms. Igwe
discovered that she had not provided the DEA inspectors with a complete
listing of the hydrocodone the Pharmacy had dispensed. FF 26-27. At the
hearing, the Respondent produced Respondent's Exhibit C for the first
time, which Ms. Igwe claimed is the complete dispensing report. FF 27,
43-44. Although Ms. Igwe testified that she had provided Respondent's
Exhibit C to an attorney so that he might provide it to the DEA, there
is no evidence the DEA ever received it. FF 27, 43-44. At the hearing,
both Ms. Igwe and Mr. Litman testified that if Respondent's Exhibit C
was considered during the audits of the Pharmacy's hydrocodone, there
would have been no shortage. Tr. 472-73, 730. Ms. Igwe, however, did
not know if her own audit showed an overage. Id. at 605.
The Administrative Record reveals several deficiencies concerning
the Respondent's records. First, the Respondent's hydrocodone
dispensing log was not ``readily retrievable'' as is required under 21
U.S.C. 827. Second, the ``complete'' dispensing log which Ms. Igwe
allegedly gave to DEA sometime after the inspection does not comply
with DEA regulations. Lastly, even a manual count of the Respondent's
``complete'' dispensing log reveals a substantial overage.
Although the Pharmacy takes the position that it produced
``complete and accurate'' records after the inspection, these records
were not ``readily retrievable'' as is required by the CSA and DEA
regulations. [The regulatory definition of ``readily retrievable''
calls for locating the records ``in a reasonable time.'' 21 CFR
1300.01(b). In Edmund Chein, M.D., the Agency stated ``what
[[Page 21045]]
constitutes `a reasonable time' necessarily depends on the
circumstances'' but that ``under normal circumstances if a practice is
open for business, it should be capable of producing a complete set of
records within several hours of the request.'' 72 FR 6580, 6593 (2007),
pet. for rev. denied, Chein v. Drug Enforcement Admin., 533 F.3d 828,
832 n.6 (D.C. Cir 2008), cert. denied, 555 U.S. 1139 (2009). During the
hearing, Ms. Igwe was unable to specify the date on which she gave the
``complete'' dispensing log to her then-attorney to forward to DEA, but
it is safe to say it was at least several days after the inspection.
See Tr. 466-69. Moreover, there is nothing in the record establishing
that DEA ever received the log until it was exchanged in the course of
these proceedings.\59\ Tr. 549-50. For these reasons, the Respondent
violated its duty to maintain records that were ``readily
retrievable.'' 21 U.S.C. 827(b); 21 CFR 1304.04(a), 1304.04(h)(1), (3);
see Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy, 83 FR at
10901, aff'd Pharmacy Doctors Enterprises, Inc. v. Drug Enf't Admin.,
789 F. App'x 724, 730 (2019) (finding that producing records as an
exhibit for the hearing did not comply with the ``readily retrievable''
requirement of the regulation).] \*CC\
---------------------------------------------------------------------------
\59\ See supra note 50.
\*CC\ Text adjusted for clarity.
---------------------------------------------------------------------------
Additionally, not only were the Pharmacy's dispensing records
produced significantly late, but they also failed to include required
information. This was the situation in Chein, where the registrant's
dispensing records, produced after a delay of several hours, lacked
information required by DEA regulations. 72 FR at 6593. The same has
occurred here to the extent that Respondent Exhibit C, the Pharmacy's
``complete'' hydrocodone dispensing report, is missing the patient's
addresses and the dispensing pharmacist's initials, in violation of 21
CFR 1304.22(c). Significantly, the dispensing log Ms. Igwe gave to
investigators at the time of the inspection does contain this required
information. 21 CFR 1304.22(c); GE-6; RE-G. It is also noteworthy that
the ``complete'' dispensing log's format is strikingly different than
the original dispensing log printed during the inspection. Compare RE-C
with GE-6 and RE-G. Additionally, the lack of any date or date range on
the ``complete'' dispensing log makes it difficult, if not impossible,
to ascertain whether the document is ``complete and accurate.'' 21
U.S.C. 827(a)(3); RE-C; Tr. 551.
Further, a manual count of the quantities listed in the
``complete'' dispensing log revealed an overage, itself a violation of
the CSA and DEA regulations, albeit different than that alleged in the
OSC. Respondent Exhibit C is broken into four sections separated by
green pages. RE-C, at 1, 2, 3-30, 31-43; Tr. 470-71, 603; FF 27-28. The
third section represents the same information in Government Exhibit 6
that Ms. Igwe gave to investigators during the inspection and that DI 1
used to conduct an audit. RE-C, at 3-30; GE-6, at 1-85; Tr. 47-48. The
first, second, and fourth sections contain additional dispensing
information not contained in the report that DI 1 used to conduct his
audit. RE-C, at 1-2, 31-43. The information in the third column from
the left is the quantity of hydrocodone dispensed. Id. A manual count
of the quantity dispensed in the first, second, and fourth sections of
Respondent Exhibit C revealed a total of 48,288 dosage units of
hydrocodone. Id. The Government alleged that the Respondent's
hydrocodone shortage was 47,183. ALJ-1, at 5, para. 13.
Applying the 48,288 units counted in Respondent Exhibit C to DI 1's
audit computation produces an overage of 1,105 units. GE-7, at 1. The
computation report shows that DI 1 reached the 47,183 figure by
subtracting ``distributions in period'' (90,209) and ``closing
inventory'' (3,908) from ``purchases in period'' (141,300). GE-7, at 1.
The difference between the shortage calculated by DI 1 (47,183) and the
total derived from a count of Respondent Exhibit C (48,288) is
+1,105.\60\ If DI 1 had the information in Respondent Exhibit C when he
conducted the audit, he would have found an overage of hydrocodone
instead of a shortage. Cf. Tr. 76. An overage of a thousand tablets of
hydrocodone, however, is still sufficient circumstantial evidence that
the Pharmacy failed to maintain complete and accurate records. See
Superior Pharmacy I & Superior Pharmacy II, 81 FR at 31,337 (finding
recordkeeping violation where audit revealed overage of about 4,000
dosage units).
---------------------------------------------------------------------------
\60\ This overage amount would be different, or reduced
entirely, if the on-hand quantity was closer to 1,200 tablets as Ms.
Igwe claimed at one point in the hearing. Tr. 602-03. At first, Ms.
Igwe was unable to recall the quantity on the shelf: ``I don't
remember what it [was] without looking.'' Tr. 602. When I asked if
the on-hand quantity was 1,200, as stated in her Prehearing
Statement, she agreed that was the correct figure. Tr. 602. She also
stated early in her testimony that Respondent Exhibit C showed that
her inventory was accurate in that all the hydrocodone she purchased
and dispensed was accounted for. Tr. 472. When pressed further
regarding the accuracy of her hydrocodone records, her testimony
waivered. Tr. 605. I asked if there was an overage and she stated,
``I can't really say yes or no to that . . . .'' Tr. 605. Overall,
this part of Ms. Igwe's testimony created the impression that she
was unsure about the on-hand quantity of hydrocodone on the day of
the inspection and whether her inventory was in fact completely
accurate. Further, Mr. Litman testified that there was no way of
knowing whether the information contained in Respondent's Exhibit C
was created prior to the DEA audit. Tr. 723-25. For that reason, I
give more weight to the on-hand quantity counted on the day of the
inspection contained in Government Exhibit 7--3,908 tablets of
hydrocodone on-hand--than I do to Ms. Igwe's testimony that the
Pharmacy had 1,200 hydrocodone pills on the shelves. GE-7, at 1.
---------------------------------------------------------------------------
Accordingly, the Government's allegation contained in paragraph 13
of the OSC that the Pharmacy failed to maintain ``complete and
accurate'' records in violation of 21 U.S.C. 827(a)(3) is sustained,
and weighs in favor of revoking the Pharmacy's registration.
Discussion and Conclusions of Law
I have sustained, with minor variations, [the overwhelming
majority]\*DD\ of the Government's allegations contained in the OSC.
Specifically, I find that between August 2014 and May 2015, the
Pharmacy filled 75 controlled substance prescriptions outside the usual
course of pharmacy practice, in violation of 21 CFR 1306.06, and in
contravention of the Pharmacy's ``corresponding responsibility'' under
21 CFR 1306.04(a). The Pharmacy did so by repeatedly filling controlled
substance prescriptions that contained red flags of diversion and/or
abuse without addressing or resolving those red flags. The Pharmacy's
conduct in doing so violated 21 U.S.C. 823(f)(4); Tex. Health & Safety
Code Sec. 481.070-.075; and Tex. Health & Safety Code Sec. 481.128; [
] \*EE\. These allegations are contained in paragraphs [3 and 6] \*FF\
of the OSC. ALJ-1, at 2-3.\*GG\
---------------------------------------------------------------------------
\*DD\ Text adjusted in response to Respondent's Exceptions.
\*EE\ Text removed in response to Respondent's Exceptions.
\*FF\ Text removed in response to Respondent's Exceptions.
\*GG\ For the reasons given, supra, in the section on
Respondent's Exceptions, the Government's allegation from paragraph
7 of the OSC that Respondent violation 22 Tex. Admin. Code Sec.
291.33(c)(2) is not sustained.
---------------------------------------------------------------------------
I also find that all of the specific allegations contained in
paragraphs 10 and 10(a)-(d) of the OSC are included in the general
allegation that the Pharmacy violated 21 CFR 1306.04(a) and 21 CFR
1306.06 when it filled 75 prescriptions between August 2014 and May
2015. ALJ-1, at 2, para. 3. Thus, while the allegations contained in
paragraphs 10 and 10(a)-(d) of the OSC are sustained, the substance of
those allegations will not be considered more than once in assessing
whether the
[[Page 21046]]
Government has presented a prima facie case for revocation of the
Pharmacy's COR. Stated differently, the prescriptions discussed in
paragraphs 10 and 10(a)-(d) are subsumed within the allegation in
paragraph 3.
Lastly, I have sustained the allegation contained in paragraph 13
of the OSC, alleging that the Pharmacy violated 21 U.S.C. 827(a) by
failing to maintain accurate records. The records in question in this
case were the Pharmacy's receipt and dispensing records for
hydrocodone. An audit of the records the Pharmacy produced in response
to a DEA inspection warrant revealed that the Pharmacy could not
account for a significant portion of the hydrocodone it had received
when called upon to do so.
The preponderance of evidence clearly establishes that the Pharmacy
violated its corresponding responsibility by dispensing controlled
substances outside the normal course of professional practice.
Beginning in August 2014 and continuing into May 2015, the Pharmacy
repeatedly filled 75 prescriptions from the Prescribers, who over and
over again prescribed the same medications and usually in the same
dosages, strengths, and quantities. Frequently, too, the patients would
present with prescriptions for drug cocktails, where the hydrocodone
prescription was written by one of the Prescribers and the alprazolam
was written by a different Prescriber. This is a well-known behavior of
those seeking to hide the true reason they are obtaining drug
cocktails. Most of the prescriptions were issued in a manner that
should have given rise to concerns of the therapeutic value of the
prescription. [The minimum standard of the practice of pharmacy in
Texas requires pharmacists to have consultations with prescribers when
there are concerns about the medical legitimacy of a prescription and
then to document that consultation. FF 90.] \*HH\ In this case there
are no records that document any such consultations. FF 177.
---------------------------------------------------------------------------
\*HH\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------
The Government's expert testified that an overriding concern she
had concerning the prescriptions at issue in this case was that of
pattern prescribing and the lack of individualization of treatment. Tr.
171, 244, 260, 296, 317, 333, 335, 358-59; FF 61-62. Unquestionably, it
is easier to identify patterns in retrospect. In addition, DEA has
stated that ``two prescriptions do not establish pattern prescribing.''
Superior Pharmacy, 81 FR at 31325 n.27. But this is not a case of only
two similar prescriptions. This is a case of the Prescribers writing
essentially the same prescriptions to various patients who had their
prescriptions filled by the same pharmacist, Ms. Igwe, over an extended
period of time. In fact, apparently out of the blue, the Pharmacy, a
small pharmacy north of Dallas, started receiving prescriptions written
by the Prescribers at the Redbird clinic in January or February of
2014. FF 11. The Redbird clinic was located 31 miles from the Pharmacy.
GE-12, at 3. In addition, many of the prescriptions were sent directly
to the Pharmacy by the Prescribers, rather than giving the patient the
option of going to a pharmacy possibly more convenient for the patient.
FF 10, 127.
The Respondent has attempted to make much out of the fact that
Government Exhibit 2 contains prescriptions of less than 30 patients,
while the Prescribers wrote ``over a thousand scripts.'' Tr. 368; see
also Tr. 289. While true that less than 30 patients is a small
percentage of the prescriptions written by the Prescribers, I concur
with Dr. Witte's assessment that ``if [she] reviewed a thousand
[prescriptions], more than likely there would be more than 26 that had
some of the same similarities'' based on the patterns she observed. Tr.
370-71. Indeed, a review of Government Exhibit 6 reveals many of the
same similarities. That exhibit shows that of the 927 prescriptions for
hydrocodone the Pharmacy filled between July 7, 2014 and May 21, 2015,
all but 25 were written by one of the Prescribers. Respondent Exhibit C
reveals even more prescriptions for hydrocodone written by one of the
Prescribers. See supra note 46. In fact, at one point Ms. Igwe filled
28 consecutive prescriptions for hydrocodone written by Dr. C.V. and at
another time she filled 23 consecutive prescriptions for hydrocodone
written by Dr. NE GE-6, at 29-31, 83-85. In the face of such repetitive
prescriptions, Ms. Igwe simply assumed ``that that's what the doctor
preferred . . . .'' Tr. 595. While she did testify that she would call
the prescriber the first time a patient presented with a prescription
for a controlled substance ``if [she] was concerned,'' she provided no
documentation of those calls. Tr. 546-47, 595; FF 177. With close to
the thousand prescriptions, documented in Government Exhibit 6, written
by the Prescribers, beginning in January or February 2014, and
extending until May 2015, Ms. Igwe should have easily recognized
pattern prescribing.\*II\ Her failure to do so, her unwillingness to
acknowledge the pattern, [demonstrates willful blindness to the high
probability] \*JJ\ that many of the prescriptions she filled lacked a
legitimate medical purpose.
---------------------------------------------------------------------------
\*II\ The Government's allegations of unlawful dispensing were
limited to the prescriptions listed in the OSC that Respondent
dispensed between August 2014 and May 2015. Evidence of additional
prescriptions Respondent dispensed is relevant in this matter only
to the extent that it supports findings of violations in the subject
prescriptions or rebuts Respondent's Exceptions. I have not
considered the evidence of additional prescriptions from the
Prescribers as evidence of further violations for consideration
under Factors 2 and 4.
\*JJ\ Text adjusted clarity.
---------------------------------------------------------------------------
Dr. Witte also addressed the red flag of cash payments with respect
to many of the prescriptions involved in this case. See, e.g., Tr. 172,
223, 238. Here, the Administrative Record supports a finding that most
of the prescriptions involved a large quantity of controlled substances
of both hydrocodone and alprazolam. FF 47, 50. A reasonable pharmacist
should know paying cash for a large quantity of controlled substances
raises a red flag, see Jones Total Health Care Pharmacy, 81 FR at
79194; however, there is no evidence that the Pharmacy's customers were
paying exorbitant prices for their prescriptions. Nevertheless, paying
for a prescription in cash is ``the preferred payment method for
illegitimate prescriptions,'' because it is not traceable. Masters
Pharm., 861 F.3d at 220. DEA has noted, however, that absent 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. Hills Pharmacy, 81 FR at 49839 n.39.
Here, numerous patients paid $239.98 upon picking up prescriptions
for both alprazolam and hydrocodone at the same time. Tr. 498; FF 167,
173. While these fees were not exorbitant, the Pharmacy made between
$154.00 and $161.00 profit when a customer paid $179.99 for an order of
hydrocodone. Tr. 498; GE-6, at 45, 54. Furthermore, most insurance
plans cover hydrocodone. FF 39. Such a heavy profit margin per sale
could certainly be an incentive to turn a blind eye to illegitimate
prescriptions, particularly when they were so numerous. Nevertheless,
were cash payments the only red flag involved in the prescriptions in
this case, I would not sustain a violation of the Pharmacy's duty to
resolve that red flag. As noted, however, cash purchases were not the
only red flags that Ms. Igwe should have readily identified.
Dr. Witte also testified that the distance and route that several
[[Page 21047]]
customers took to obtain and then fill their prescriptions created a
red flag. FF 62, 63. Additionally, even Texas regulations include the
distance a patient traveled as one factor pharmacists should be aware
of before dispensing a controlled substance. 22 Tex. Admin. Code Sec.
291.29(c)(4). The distances that most of the Pharmacy customers
traveled are detailed in Government Exhibit 3, and range from 64 miles
to 121 miles. GE-3, at 54, 104. More telling than the miles, however,
are the routes these customers would have traveled.\61\ While Ms. Igwe
might not have known the actual routes a customer took to arrive at the
Pharmacy, from having been in the Dallas/Fort Worth area since at least
2006, Tr. 445-46, she should have had an appreciation for the distances
and traffic involved. Even a short distance, such as 30-40 miles, may
be a concern where the route involves ``a lot of stop lights'' and
traffic, making a relatively short distance appear suspicious given the
added inconvenience. Hills Pharmacy, 81 FR at 49826. Given the facts in
this case, particularly the paths the customers would have taken in a
metropolitan environment, at a minimum, Ms. Igwe should have made
inquiry of the six customers whose round trip distances exceeded 100
miles, J.W., H.J., M.H., A.S., K.S., and M.A. Ms. Igwe's failure to do
so, and her failure during these proceedings to acknowledge that she
should have, demonstrates willful blindness to the [high probability]
\*KK\ that many of the prescriptions she filled lacked a legitimate
medical purpose.
---------------------------------------------------------------------------
\61\ While Respondent's counsel argued at the hearing that the
customers might not live where the addresses on the fill stickers
say they do, those are the addresses the Pharmacy was on notice of
concerning where those customers lived. Tr. 377-79.
\*KK\ Text adjusted for clarity.
---------------------------------------------------------------------------
With respect to the Pharmacy's recordkeeping violations, the
Government has established by a preponderance of the evidence that the
Pharmacy failed to produce a complete dispensing log for the
hydrocodone it dispensed between the date the Pharmacy opened and June
18, 2015. FF 22, 24-28, 44. As a result of this poor recordkeeping,
when the DEA conducted an audit of the Pharmacy's hydrocodone, the
Pharmacy had a shortage of over 47,000 tablets of hydrocodone. FF 37.
Although the Respondent eventually produced Respondent Exhibit C, which
Ms. Igwe testified was the Pharmacy's complete dispensing log, Tr. 467-
71, it does not comply with DEA's requirements for a dispensing log. 21
CFR 1304.22(c); Chein, 72 FR at 6593. Further, even using the data
contained in Respondent Exhibit C, the Pharmacy's inventory of
hydrocodone does not balance out. The Pharmacy's recordkeeping
shortcomings reinforce the DEA's position that strict adherence to
inventory requirements is crucial so that DEA can ``closely monitor the
flow of controlled substances'' and effectively combat diversion.
United States v. Blanton, 730 F.2d 1425, 1428 (11th Cir. 1984).
Prima Facie Showing and Balancing
Factors Two and Four strongly weigh in favor of revoking the
Pharmacy's COR. Considering the public interest factors in their
totality, I find that the Government has made a prima facie case
showing that the Pharmacy's registration is inconsistent with the
public interest.
After the Government presents a prima facie case for revocation,
the Respondent has the burden of production to present ``sufficient
mitigating evidence'' to show why it can be entrusted with a DEA
registration. See Medicine Shoppe--Jonesborough, 73 FR 364, 387 (2008)
(quoting Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)). To
rebut the Government's prima facie case, the Respondent must both
accept responsibility for its actions and demonstrate that it will not
engage in future misconduct. Patrick W. Stodola, M.D., 74 FR 20,727,
20,734-35 (2009).
The Respondent may accept responsibility by providing evidence of
its remorse, its efforts at rehabilitation, and its recognition of the
severity of its misconduct. See Robert A. Leslie, M.D., 68 FR 15227,
15228 (2003). To accept responsibility, a respondent must show ``true
remorse'' for wrongful conduct. Michael S. Moore, M.D., 76 FR 45867,
45877 (2011). An expression of remorse includes acknowledgment of
wrongdoing. Wesley G. Harline, M.D., 65 FR 5665, 5671 (2000). A
respondent must express remorse for all acts of documented misconduct,
Jeffrey Patrick Gunderson, M.D., 61 FR 26208, 26211 (1996), and may be
required to acknowledge the scope of its misconduct. Arvinder Singh,
M.D., 81 FR 8247, 8250-51 (2016). Acceptance of responsibility and
remedial measures are assessed in the context of the ``egregiousness of
the violations and the [DEA's] interest in deterring similar misconduct
by [the] Respondent in the future as well as on the part of others.''
David A. Ruben, M.D., 78 FR 38,363, 38,364 (2013) (citation omitted).
There is nothing in the Administrative Record that suggests the
Pharmacy has accepted responsibility for its actions. During her
testimony, Ms. Igwe took no responsibility. Tr. 567. Further, a review
of the Respondent's Proposed Findings and the Respondent's Brief gives
no hint of acceptance of responsibility. See ALJ-36-37.
Because I have determined that the Government has met its prima
facie burden, and that the Pharmacy has not accepted responsibility, I
must next determine whether it is consistent with the public interest
for the Pharmacy to maintain its DEA registration. When considering
whether a registrant's continued registration is consistent with the
public interest, the ALJ must consider both the egregiousness of the
registrant's violations and the DEA's interest in deterring future
misconduct by both the registrant as well as other registrants. Ruben,
78 FR at 38364; see also Richard J. Settles, D.O., 81 FR 64940, 64,945
n.17 (2016) (``In short, this 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; what matters is the seriousness of the registrant's
misconduct.'' (quoting Jayam Krishna-Iyer, M.D., 74 FR 459, 462
(2009))).
Here, I find that both aspects of the misconduct proven in the
Administrative Record are egregious and support the revocation of the
Pharmacy's registration. First, time and again, Ms. Igwe filled
prescriptions that ought not have been filled without the resolution of
red flags. Significantly, this case started with the DEA investigating
a pill mill. Tr. 31. Over a period of eight to nine months, Ms. Igwe
filled prescriptions for a small group of medical practitioners, who
wrote essentially identical prescriptions, including drug cocktail
prescriptions involving hydrocodone and alprazolam, in such a manner
that a preponderance of evidence establishes that those practitioners
were engaged in pattern prescribing. Such lack of individualized dosing
of these two highly-abused controlled substances [should have indicated
to a pharmacist following the minimum standards of practice in Texas
that there was a high probability that the medical practitioners were
operating a controlled substance pill mill. Tr. 258-261;] \*LL\ Jones
Total Healthcare Pharmacy, 81 FR at 79195. This evidence of pattern
prescribing by the Prescribers circumstantially establishes
[[Page 21048]]
that the Pharmacy knew, or should have known, that many of the
Prescribers' prescriptions lacked a legitimate medical purpose. In
addition to the pattern prescribing, the prescriptions raised other
numerous red flags, to include: distance and route traveled; drug
cocktails; multiple prescribers for controlled substances; suboptimal
dosing; filling prescriptions on consecutive days to avoid filling drug
cocktails on the same day; as well as some concern about cash payments.
---------------------------------------------------------------------------
\*LL\ Text adjusted to add references and citations to Dr.
Witte's testimony.
---------------------------------------------------------------------------
Second, I find that the Pharmacy did not take its recordkeeping
responsibilities seriously. The Pharmacy's failure to produce a
complete dispensing record clearly prevented the DEA from being able to
``closely monitor the flow of controlled substances'' flowing in and
out of the Pharmacy and to effectively combat diversion. See United
States v. Blanton, 730 F.2d at 1428. In response, the Pharmacy
subsequently produced a document that did not meet the requirements of
a dispensing log, and asserted that all was well. Such a feeble
response exacerbates the Pharmacy's recordkeeping failure.
I further find that the DEA's interest in deterring future
misconduct by the Pharmacy, as well as by other pharmacies, supports
revocation of the Pharmacy's registration.
Recommendation
In this case, the Government has established a prima facie case for
revocation of the Pharmacy's Certificate of Registration. It did so by
proving by a preponderance of the evidence that the Pharmacy:
Repeatedly violated its corresponding responsibility [and acted outside
the usual course of professional practice between August 2014 and May
2015 by filling 75 prescriptions that contained red flags of diversion
and/or abuse, without addressing or resolving those red flags; and by
failing to properly produce and maintain records of the controlled
substances for which the Pharmacy was accountable.] \*MM\
---------------------------------------------------------------------------
\*MM\ Text adjusted for clarity.
---------------------------------------------------------------------------
The evidence is clear in this case that the Pharmacy has taken no
responsibility for its egregious and repeated failure to fulfill its
corresponding responsibility to ensure the proper prescribing and
dispensing of controlled substances, and other responsibilities of a
registrant. In addition, the Pharmacy presented no evidence of
mitigation or remediation.
Therefore, based upon my review of the entire Administrative
Record, I recommend that the Certificate of Registration of The
Pharmacy Place, Certificate of Registration Number FT4134805, be
revoked. I further recommend that any pending application for renewal
or modification of the Certificate of Registration of The Pharmacy
Place be denied.
Dated: February 13, 2018.
Charles Wm. Dorman,
U.S. Administrative Law Judge
[FR Doc. 2021-08018 Filed 4-20-21; 8:45 am]
BILLING CODE 4410-09-P