Notice2024-20937
Awesome Care Pharmacy, Inc.; Decision and Order
Primary source
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Published
September 16, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 89 Issue 179 (Monday, September 16, 2024)</title>
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[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Notices]
[Pages 75573-75579]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20937]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-48]
Awesome Care Pharmacy, Inc.; Decision and Order
On June 1, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Awesome Care Pharmacy, Inc., (Respondent) of
Houston, Texas. OSC/ISO, at 1. The OSC/ISO informed Respondent of the
immediate suspension of its DEA Certificate of Registration Number
FA2332346 (registration), pursuant to 21 U.S.C. 824(d), alleging that
Respondent's continued registration constitutes ``an imminent danger to
the public health or safety.'' Id. at 1 (quoting 21 U.S.C. 824(d)).\1\
The OSC/ISO also proposed the revocation of Respondent's registration,
alleging that Respondent's continued registration is inconsistent with
the public interest. Id. (citing 21 U.S.C. 824(a)(4)).
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\1\ Respondent argues in its Exceptions to the Recommended
Decision (Exceptions) that the ISO ``led to the `wrongful takings'
of its DEA license'' because the hearing established that no
diversion occurred and there was ``no imminent harm, no harm, and no
damage, threat or harm to the `public interest.' '' Exceptions, at 1
(citing Tr. 8, 14, 52-53, 55, 69, 179-81, 192). However in this
case, the evidence showed that Respondent repeatedly dispensed
dangerous combinations of controlled substances that posed serious
risks to patients without first resolving blatant red flags of drug
abuse and diversion. Respondent's repeated dispensing of controlled
substances outside the usual course of the professional practice and
in violation of federal and state law established ``a substantial
likelihood of an immediate threat that death, serious bodily harm,
or abuse of a controlled substance . . . [would] occur in the
absence of the immediate suspension'' of Respondent's registration.
21 U.S.C. 824(d). Thus, the Agency finds that at the time the
Government issued the OSC/ISO, there was clear evidence of imminent
danger. Moreover, the immediate suspension aspect of the
Government's case was final as of the date the OSC/ISO was issued by
the Administrator, and is not the subject of these proceedings. 21
U.S.C. 824(d)(1) (``A[n immediate] suspension . . . shall continue
in effect until the conclusion of [administrative enforcement]
proceedings, including judicial review thereof, unless sooner
withdrawn by the Attorney General or dissolved by a court of
competent jurisdiction.''); 21 CFR 1301.36(h) (``Any suspension
shall continue in effect until the conclusion of all proceedings
upon the revocation or suspension, including any judicial review
thereof, unless sooner withdrawn by the Administrator or dissolved
by a court of competent jurisdiction.'').
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A hearing was held before DEA Administrative Law Judge Paul E.
Soeffing (the ALJ), who, on February 6, 2024, issued his Recommended
Rulings, Findings of Fact, Conclusions of Law, and Decision
(Recommended Decision or RD), which recommended revocation of
Respondent's registration. RD, at 59. Following the issuance of the RD,
Respondent filed exceptions.\2\ Having reviewed the entire record, the
Agency adopts and hereby incorporates by reference the entirety of the
ALJ's rulings, credibility findings,\3\ findings of fact, conclusions
of law, sanctions analysis, and recommended sanction as found in the RD
and summarizes and clarifies portions thereof herein.\4\
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\2\ The Agency has reviewed and considered the Respondent's
exceptions and addresses them herein, but ultimately agrees with the
ALJ's recommendation.
\3\ The Agency adopts the ALJ's summary of each witness'
testimony, as well as the ALJ's assessment of each witness'
credibility, except as clarified herein. See RD, at 4-53.
\4\ Respondent argues in its Exceptions that the ALJ was biased
towards the Government. Respondent's only record support for this
assertion is a citation to the transcript where the ALJ thanks the
Government for printing certain documents in large enough font for
him to read. Exceptions, at 3 (citing Tr. 46-47). Respondent cites
no authority suggesting that the ALJ's expression of appreciation
for a chosen font size reflects bias especially where, as here, the
ALJ thanked both parties at the end of the hearing for their zealous
advocacy. Tr. 522.
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I. Findings of Fact
Texas Standard of Care
Katherine Salinas testified as the Government's expert regarding
the standard of care for pharmacy practice in the State of Texas. RD,
at 6; Tr. 96-97. Ms. Salinas has been licensed as a pharmacist in Texas
for over thirty years and has dispensed medications in retail
pharmacies since 1992. RD, at 6; Tr. 89-91, 167. Ms. Salinas served as
a Compliance Officer with the Texas Board for approximately nine years,
where she inspected approximately 2,700 pharmacies, and she currently
works as the Medication Safety and Drug Diversion Supervisor for the
University of Texas Medical Branch. RD, at 6-7; Tr. 93-95.\5\
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\5\ For Ms. Salinas's full qualifications, see RD, at 6-7,
Government Exhibit (GX) 10.
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Dr. Okpala, Respondent's owner and Pharmacist-in-Charge (PIC),
testified on Respondent's behalf. Dr. Okpala testified that he has been
licensed as a pharmacist in Texas since 1993. RD, at 20; Tr. 373, 376-
77; RX 2, at 2.\6\ The Agency agrees with the ALJ that Dr. Okpala has a
significant personal interest in the outcome of these proceedings. RD,
at 24. Additionally, the Agency finds that Dr. Okpala's testimony at
times contradicted the language of Texas's regulations. Therefore, to
the extent that Dr. Okpala's testimony diverges from the Texas
regulations and the testimony of Ms. Salinas, the Agency will credit
Ms. Salinas's testimony.\7\
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\6\ The Agency incorporates herein the entire summary of Dr.
Okpala's testimony. RD, at 19-24.
\7\ The ALJ found Dr. Okpala's testimony to be ``generally
credible,'' while noting that Dr. Okpala failed to lay an adequate
foundation for his testimony that the patients in this case suffered
from chronic pain. RD, at 24. The ALJ determined that ``[t]o the
extent that [Dr. Okpala's] testimony differs from the testimony of
other testifying witnesses, I will consider his personal interest in
this case, and I will give his testimony the weight it deserves in
light of other evidence and testimony presenting during the
hearing.'' Id. The Agency agrees with the amount of weight that the
ALJ afforded Dr. Okpala's testimony, except as clarified herein.
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Ms. Salinas testified that the standard of care in Texas is
informed by DEA regulations and Texas laws and regulations, including
Texas Administrative Code Sec. 291.29(b), which requires pharmacists
to ``make every reasonable effort to ensure that any prescription drug
order . . . has been issued for a legitimate medical purpose by a
practitioner in the course of medical practice.'' 22 Tex. Admin. Code
Sec. 291.29(b); RD, at 7-8; Tr. 98-100. Ms.
[[Page 75574]]
Salinas testified that this obligation is known as the pharmacist's
``corresponding responsibility,'' and it is the ``foundation . . . of
good pharmacy practice.'' RD, at 7; Tr. 98, 327.
Ms. Salinas testified that the Texas Administrative Code ``lists
out several patterns that the pharmacist needs to be aware of to assess
[a] prescription and determine if [it] was indeed issued for a
legitimate medical purpose.'' RD, at 7; Tr. 98. Consistent with Ms.
Salinas's testimony, Texas Administrative Code Sec. 291.29(f) states
that ``[a] pharmacist shall make every reasonable effort to prevent
inappropriate dispensing due to fraudulent, forged, invalid, or
medically inappropriate prescriptions in violation of a pharmacist's
corresponding responsibility,'' and provides a list of nineteen
``patterns (i.e., red flag factors) [that] are relevant to preventing
the non-therapeutic dispensing of controlled substances.'' 22 Tex.
Admin. Code Sec. 291.29(f). The statute further states that these red
flags ``shall be considered by evaluating the totality of the
circumstances rather than any single factor.'' Id. Ms. Salinas
testified that the statute's list of red flags is not exhaustive. RD,
at 8; Tr. 98, 104-06. A red flag is ``anything that should make the
pharmacist question [a] prescription and whether or not [it] is safe
and appropriate.'' Tr. 106. Ms. Salinas identified some examples of red
flags, including that multiple patients are receiving essentially the
same pattern of prescriptions from a small number of prescribers, or
that prescriptions are for commonly abused drugs, such as opioids,
benzodiazepines, and cough syrups. Tr. 105.
Ms. Salinas testified that a pharmacist should evaluate a
prescription for red flags by looking at all of the details on the face
of the prescription (e.g., name, address, date of birth, quantity of
drug prescribed), checking the Prescription Monitoring Program (PMP),
running a public search for the provider to see if there are any
disciplinary orders, talking to the patient, and calling the
prescribing doctor to discuss any potential red flags. RD, at 8; Tr.
106-08. If the pharmacist identifies any red flags that indicate that
the prescription might not be legitimate, then the pharmacist must
attempt to resolve those red flags by ``taking into account [the]
bigger picture,'' including conversations with the patient and
prescriber, relevant statutes and laws, discussions with colleagues,
and PMP data. RD, at 8, 10; Tr. 106-08, 209-10, 304-05, 307-08, 313,
317-18, 327. Ms. Salinas testified that if the pharmacist determines
that the red flag cannot be resolved, then the pharmacist should not
fill the prescription. RD, at 8; Tr. 107. If, on the other hand, the
pharmacist determines that the red flag can be resolved, Ms. Salinas
testified that the pharmacist must document the resolution of the red
flag, the rationale behind the decision to dispense the medication, and
the pharmacist's discussions with the prescriber. RD, at 8-10; Tr. 107-
12, 142, 327.
Consistent with Ms. Salinas's testimony, the Texas Administrative
Code states that ``[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 as
specified in subparagraph (C) of this paragraph.'' 22 Tex. Admin. Code
Sec. 291.33(c)(2)(A)(iv). Subparagraph C specifies that the following
information about the pharmacist's consultation with the prescriber
shall be documented ``on the prescription or in the pharmacy's data
processing system associated with the prescription'': ``(i) date the
prescriber was consulted; (ii) name of the person communicating the
prescriber's instructions; (iii) any applicable information pertaining
to the consultation; and (iv) initials or identification code of the
pharmacist performing the consultation clearly recorded for the purpose
of identifying the pharmacist who performed the consultation.'' Id. at
Sec. 291.33(c)(2)(C); RD, at 9; Tr. 112. Ms. Salinas testified that
the purpose of documentation is to show that the pharmacist saw the red
flags and resolved them. RD, at 9; Tr. 112.
Finally, the Texas Administrative Code requires pharmacists to
``exercise sound professional judgment with respect to the accuracy and
authenticity of any prescription drug order they dispense, which
requires ``verify[ing] the order with the practitioner prior to
dispensing'' ``[i]f the pharmacist questions the accuracy or
authenticity of a prescription drug order.'' 22 Tex. Admin. Code Sec.
291.34(b)(1)(A).
Respondent's Improper Dispensing
Ms. Salinas testified that she reviewed Respondent's PMP history,
dispensing history, and a subset of patient profiles, Tr. 115, and she
testified about the red flags that she observed with the prescriptions
for these patients, including drug cocktails, pattern prescribing,
prescriptions lacking diagnosis codes, patients receiving controlled
substances from multiple prescribers, and gaps in prescriptions
exceeding one month. RD, at 11-19.
Drug Cocktails
One of the potential red flags identified by the Texas
Administrative Code is when ``prescriptions by a prescriber . . . are
routinely for controlled substances commonly known to be abused drugs,
including opioids, benzodiazepines, muscle relaxants, . . . or any
combination of these drugs.'' 22 Tex. Admin. Code Sec. 291.29(f)(3).
Ms. Salinas testified that a combination of drugs is referred to as a
``drug cocktail.'' RD, at 11; Tr. 122, 328-29. For example, when
combined, hydrocodone (an opioid) and carisoprodol (a muscle
relaxant)--which are both highly abusable on their own--can create a
potentially dangerous drug cocktail that increases the risk of
respiratory depression, overdose, or death. RD, at 11; Tr. 118-22, 136,
143, 147, 153, 290, 328-29.\8\ Ms. Salinas testified that the risks to
patients from taking these drugs together continue for as long as they
are taking them, not just the first time they are prescribed. RD, at
11; Tr. 329. In this case, Ms. Salinas testified that A.T., T.B., K.B.,
and S.D. were all receiving a dangerous cocktail of hydrocodone and
carisoprodol. RD, at 11; Tr. 118-22, 136, 143, 147, 153, 328-29.
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\8\ DI Fernandez similarly testified that hydrocodone-
acetaminophen and carisoprodol are ``very popular in Houston and are
highly diverted,'' and they are considered ``a dangerous
combination.'' RD, at 34; Tr. 24-25.
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As for Respondent, Dr. Okpala testified that the combination of
hydrocodone-acetaminophen and carisoprodol did not present a red flag
because these medications are combined to produce a ``synergistic
effect'' that is more effective for treating chronic pain. RD, at 34-
35; Tr. 419-20, 457. However, Dr. Okpala did not produce adequate
evidence that these patients actually suffered from chronic pain or
that these drugs were prescribed together to produce a synergistic
effect. Nor did Dr. Okpala acknowledge that these drugs can be very
dangerous when combined. Thus, the ALJ found, and the Agency agrees,
that the frequent prescribing of the drug cocktail of hydrocodone and
carisoprodol was a red flag that Respondent should have identified,
resolved, and documented prior to dispensing. RD, at 36.
Pattern Prescribing
The Texas Administrative Code identifies several red flags that Ms.
Salinas referred to as ``pattern prescribing,'' including that: (1) the
pharmacy ``dispenses a reasonably discernible pattern of substantially
identical prescriptions for the same controlled substances, potentially
[[Page 75575]]
paired with other drugs, for numerous persons, indicating a lack of
individual drug therapy in prescriptions issued by the practitioner,''
22 Tex. Admin. Code Sec. 291.29(f)(1); (2) ``the pharmacy operates
with a reasonably discernible pattern of overall low prescription
dispensing volume, maintaining relatively consistent [one-to-one] ratio
of controlled substances to dangerous drugs and/or over-the-counter
products dispensed as prescriptions,'' id. at Sec. 291.29(f)(2); and/
or (3) ``prescriptions for controlled substances are commonly for the
highest strength of the drug and/or for large quantities (e.g., monthly
supply), indicating a lack of individual drug therapy in prescriptions
issued by the practitioner,'' id. at Sec. 291.29(f)(5). RD, at 11-12;
Tr. 129, 339.
In this case, Ms. Salinas testified that Respondent's dispensing to
A.T., T.B., K.B., and S.D. reflected a repeated pattern of large
quantities of carisoprodol and hydrocodone in the highest strength
available. RD, at 12, 37; Tr. 118-19, 132-33, 136, 143, 147, 339. The
highest strength of carisoprodol is 350 mg, and Respondent frequently
dispensed 60 to 80 tablets per month to patients. RD, at 12; Tr. 121.
The highest strength of hydrocodone-acetaminophen is 10/325 mg, and
Respondent frequently dispensed quantities exceeding 100 tablets per
month to patients, which Ms. Salinas testified is a red flag. RD, at
12, 37; Tr. 120-21, 143. Ms. Salinas testified that hydrocodone-
acetaminophen is highly addictive and is ``one of the pattern drugs
that [she sees] most often . . . with patterns of . . . abuse.'' RD, at
12-13; Tr. 120-21, 149. Ms. Salinas testified that hydrocodone is best
when limited to short-term use, so it is a red flag to see hydrocodone
prescribed month after month. RD, at 12-13, 37; Tr. 122, 143, 148-51,
339-40. Ms. Salinas testified that hydrocodone may be prescribed for
over three months to patients suffering from chronic pain,\9\ but the
pharmacist must still exercise the ``corresponding responsibility to
determine if that [is] appropriate.'' Tr. 150. Ms. Salinas also
testified that Respondent often dispensed hydrocodone and carisoprodol
along with non-controlled drugs, such as ibuprofen, naproxen, or
multivitamins, reflecting the one-to-one ratio identified in the Texas
Administrative Code. RD, at 11; Tr. 121-22, 129, 153.
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\9\ Ms. Salinas testified that chronic pain is pain that ``lasts
greater than three months.'' RD, at 14 n.51; Tr. 150.
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As for Respondent, Dr. Okpala testified that the repeated
prescriptions for maximum-strength controlled substances in large
quantities over multiple months did not present a red flag because
these patients all had chronic pain. RD, at 39; Tr. 406-08, 490, 497,
510. However, the ALJ found, and the Agency agrees, that Dr. Okpala did
not present sufficient evidence to establish that these patients had
chronic pain. RD, at 39. Dr. Okpala testified that he concluded that
they had chronic pain based on the frequency they saw their prescribing
doctors,\10\ the conversations and interactions he had with the
patients and prescribers, and the types of medications prescribed. RD,
at 39; Tr. 406-08, 490, 497, 510. Dr. Okpala testified that it was
``common sense'' for a pharmacist to conclude that a patient suffers
from chronic pain when the patient is receiving monthly prescriptions
for hydrocodone-acetaminophen. RD, at 39; Tr. 342, 497. He further
testified that knowing the cause of the patients' pain would not impact
his decision to dispense the prescriptions presented in this case. RD,
at 52; Tr. 501
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\10\ The ALJ found, and the Agency agrees, that Dr. Okpala's
testimony that he knew the patients had chronic pain based on the
frequency of their visits was concerning. RD, at 39. As the ALJ
noted, the fact ``[t]hat these patients frequently visited
prescribers and received repeated prescriptions for high quantities
and similar dosage units of controlled substances on a monthly basis
is the very red flag indicative of a lack of personalized care
identified by Ms. Salinas and the Texas Administrative Code.'' Id.
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However, Ms. Salinas testified that the nature of the drug
prescribed does not communicate a diagnosis to the pharmacist, and the
pharmacist should not assume why the drug was prescribed. RD, at 16;
Tr. 306, 329-30. Moreover, Ms. Salinas testified that there was no
documentation on the prescriptions suggesting that the repeated
hydrocodone prescriptions were for chronic pain. RD, at 15, 41-42; Tr.
150-51, 251-55. Finally, even assuming that Respondent did discuss the
diagnoses with the patients or prescribers, the lack of any
documentation of those conversations renders Respondent's dispensing
outside of the standard of care. RD, at 14, 38; Tr. 150-51; 22 Tex.
Admin. Code Sec. 291.33(c)(2)(A)(iv).
Thus, the ALJ found, and the Agency agrees, that repeated
prescriptions for high quantities and high strengths of commonly-abused
drugs, sometimes in combination with non-controlled substances in a
one-to-one ratio, was a red flag that Respondent should have
identified, resolved, and documented prior to dispensing. RD, at 39-40.
Prescriptions Lacking Specific Diagnoses
Another potential red flag identified by the Texas Administrative
Code is when prescriptions for controlled substances ``contain
nonspecific or no diagnoses, or lack the intended use of the drug.'' 22
Tex. Admin. Code Sec. 291.29(f)(4); RD, at 14; Tr. 128. Ms. Salinas
testified that the diagnosis code is especially important when
hydrocodone or carisoprodol is prescribed, because those medications
are a red flag. RD, at 14; Tr. 127. Ms. Salinas testified that in this
case, there was generally no documentation on the face of a
prescription related to a patient's diagnosis, so she could not
determine whether a patient was being prescribed hydrocodone for
chronic or acute pain, which may impact the length of time a patient is
prescribed hydrocodone. RD, at 15; Tr. 150-51. Ms. Salinas testified
that diagnoses of ``pain'' or ``chronic pain syndrome'' are not
specific enough under the Texas Administrative Code, and should trigger
a red flag analysis. RD, at 15; Tr. 331-32. Ms. Salinas testified that
she was unable to determine the purpose of the prescriptions or the
type of pain that the medications were intended to treat. RD, at 15-16;
Tr. 252-53, 329.
As for Respondent, Dr. Okpala presented conflicting testimony
regarding whether ``pain'' was a diagnosis, but ultimately testified
that pain may be used as a diagnosis. RD, at 42; Tr. 484-85. Dr. Okpala
also testified that neither DEA nor Texas regulations requires the
inclusion of diagnosis codes on the face of a prescription. RD, at 42;
Tr. 448, 507. Finally, Dr. Okpala testified that he knew that the
patients in this case had chronic pain, although the Agency found above
that this conclusion was not adequately supported.
The ALJ found, and the Agency agrees, that Ms. Salinas's testimony
was more credible on this issue because it was supported by the
relevant provisions of the Texas Administrative Code, which identify
nonspecific diagnosis codes as a relevant red flag factor. RD, at 42;
22 Tex. Admin. Code Sec. 291.29(f)(4). Thus, the ALJ found, and the
Agency agrees, that the lack of specific diagnoses to justify the
controlled substance prescriptions was a red flag that Respondent
should have identified, resolved, and documented prior to dispensing.
RD, at 42-43.
Gaps in Prescriptions
Ms. Salinas testified that another potential red flag is when gaps
between usually-consistent monthly
[[Page 75576]]
prescriptions exceed a month, because this indicates that the patient
is not taking the controlled substance as prescribed. RD, at 18, 48-49;
Tr. 140. Ms. Salinas testified that if a pharmacist observes a gap, the
pharmacist should have a discussion with the patient to ensure that the
patient is taking the medication correctly and document that
discussion. RD, at 18-19; Tr. 140, 142. The pharmacist should also
contact the prescribing physician to determine the purpose of the gap,
and document that conversation if the red flag is resolved. RD, at 19;
Tr. 341-42. The ALJ found, and the Agency agrees, that gaps between
prescriptions exceeding one month was a red flag that Respondent should
have identified, resolved, and documented prior to dispensing. RD, at
49-50.\11\
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\11\ Respondent, through counsel, argued in its closing argument
that the Government is improperly tasking Respondent with
communicating with prescribers during time periods where
prescriptions are not presented to the pharmacy. RD, at 49; Tr. 520.
Respondent argued that ``[t]he societal interest, including that of
pharmacies, is to minimize the use and abuse of opioids,'' and thus
Respondent should not be responsible for communicating with
physicians when a patient is not prescribed controlled substances
after previous, repeated monthly prescriptions. RD, at 49; Tr. 521.
The ALJ found, and the Agency agrees, that this argument
misconstrues Ms. Salinas's testimony. RD, at 49. According to Ms.
Salinas, lengthy gaps in habitual prescriptions provides evidence of
potential abuse and diversion. RD, at 49; Tr. 140. Ms. Salinas is
not testifying that Respondent must attempt to dispense more
medication to a patient when that patient is not issued the typical
monthly prescription. RD, at 49. Rather, Respondent must contact the
prescribing physician and document that communication when a patient
returns to the pharmacy to receive the previously regular medication
after a significant gap in treatment. Id.; Tr. 140-42, 154, 341-42.
Aside from the argument presented in its closing statement, the
Respondent presented no evidence to rebut Ms. Salinas's expert
testimony that gaps between prescriptions presented a red flag that
required documented resolution prior to dispensing. RD, at 49.
Therefore, the Agency agrees with the ALJ and credits Ms. Salinas's
unrebutted expert testimony about this red flag. Id. at 49-50.
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Respondent's Dispensing to A.T., T.B., K.B., and S.D.
Ms. Salinas testified in more detail about the prescriptions that
she reviewed for A.T., T.B., K.B., and S.D. Ms. Salinas testified that
she identified the following red flags with the prescriptions that
Respondent dispensed to A.T.: (1) A.T. was receiving pattern
prescriptions for a dangerous cocktail of hydrocodone and carisoprodol,
RD, at 12; Tr. 118-19, 120-21; (2) A.T. was receiving the same
controlled substances from at least six prescribers,\12\ RD, at 17; Tr.
118-19, 136-38; (3) A.T. was also receiving non-controlled substances,
such as ibuprofen and biofreeze, which implicates the one-to-one
controlled to non-controlled substances pattern identified in the Texas
Administrative Code, RD, at 17; Tr. 132, 137-38; (4) A.T. repeatedly
received a high quantity of carisoprodol along with a high quantity of
hydrocodone, which is a strong opioid that is best when limited to
short-term use, RD, at 12; Tr. 119, 122-23; (5) many of A.T.'s
prescriptions lacked a diagnosis code or any language indicating the
purpose of the prescription, and others contained a non-specific
diagnosis code of ``chronic pain syndrome,'' RD, at 15; Tr. 136-37,
331-32; GX 2, at 10-11, 84; and (6) there was a gap in A.T.'s
prescriptions of over a month that indicated that she was not taking
the medications as prescribed, RD, at 18-19; Tr. 139-41. Ms. Salinas
testified that there was no documentation indicating that Respondent
identified or resolved any of these red flags, and that Respondent
therefore failed to exercise its corresponding responsibility and abide
by the standard of care in its dispensing to A.T. RD, at 9; Tr.
139.\13\
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\12\ The Texas Administrative Code identifies patients
``obtaining similar drugs from multiple practitioners'' as a
potential red flag factor, and Ms. Salinas testified that this is a
common red flag that must be identified, resolved, and documented
prior to dispensing. 22 Tex. Admin. Code Sec. 291.29(f)(10); RD, at
16; Tr. 123-34; 340. The ALJ found that the Government had not
proven that multiple prescribers was a red flag in this case because
Dr. Okpala testified that several of the prescribers worked together
in a group practice, that he visited the group practice frequently
to ensure that the patients were being treated appropriately, and
that he maintained professional relationships with all of the
prescribers. RD, at 23, 43-47; Tr. 386-89, 391, 394, 398-99, 406,
467, 490, 502. However, Dr. Okpala's testimony on this issue is more
relevant to whether the red flag of multiple prescribers can be
resolved in this case, not whether multiple prescribers is a red
flag that warrants follow up. Dr. Okpala's testimony actually
supports the conclusion that multiple prescribers was a red flag. He
testified that he visited the group practice on at least twenty
occasions to ``make sure [the prescribers] [did] what [they were]
supposed to do for patients,'' RD, at 23, 44; Tr. 387-89, 391, 394,
which suggests that he felt the need to surveil the clinic, and he
even testified that the doctors told him, ``okay, if you're doubting
me, stay there and watch.'' Tr. 393. Thus, the Agency credits Ms.
Salinas's credible expert testimony, as supported by Texas law, that
multiple prescribers was a red flag that should have been
identified, resolved, and documented. Dr. Okpala did not document
any of his discussions with the prescribers or any other steps that
he took to resolve this red flag, which is required by Texas law and
the standard of care. 22 Tex. Admin. Code Sec. 291.33(c)(2)(A)(iv);
RD, at 8-10; Tr. 107-12, 142, 327. Even without this finding, the
combination of other red flags is ``so suspicious as to support a
finding that the pharmacists who filled them violated their
corresponding responsibility due to actual knowledge of, or willful
blindness to, the prescriptions' illegitimacy.'' Lewisville Medical
Pharmacy, 87 FR at 59,459 (citing The Pharmacy Place, 86 FR 21,008,
21,013 (collecting Agency decisions)).
\13\ For more details about the prescriptions that Respondent
filled for A.T. without identifying and resolving these red flags,
see RD, at 30-50; GX 2-3.
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Ms. Salinas testified that she identified the following red flags
with the prescriptions that Respondent dispensed to T.B.: (1) T.B. was
receiving pattern prescriptions for a dangerous cocktail of hydrocodone
and carisoprodol, RD, at 11, Tr. 132-22; GX 5; (2) T.B. was also
receiving non-controlled substances, such as ibuprofen and lisinopril,
which implicates the one-to-one controlled to non-controlled substances
pattern identified in the Texas Administrative Code, RD, at 12-13; Tr.
129-30, 131-32; GX 5; (3) T.B. was receiving these medications from
multiple prescribers, RD, at 13, 17; Tr. 130-33; (4) T.B. repeatedly
received a high quantity of carisoprodol along with a high quantity of
hydrocodone (always over 100 tablets), which is a strong opioid that is
best when limited to short-term use, RD, at 12-13; Tr. 122-23, 129-33;
and (5) none of T.B.'s prescriptions for a fifteen-month period
contained diagnosis codes. RD, at 15; Tr. 125-126, 333-34. Ms. Salinas
testified that there was no documentation indicating that Respondent
identified or resolved any of these red flags, and that Respondent
therefore failed to exercise its corresponding responsibility and abide
by the standard of care in its dispensing to A.T. RD, at 9; Tr. 134-
35.\14\
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\14\ For more details about the prescriptions that Respondent
filled for T.B. without identifying and resolving these red flags,
see RD, at 30-50; GX 4-5.
---------------------------------------------------------------------------
Ms. Salinas testified that she identified the following red flags
with the prescriptions that Respondent dispensed to K.B.: (1) K.B. was
receiving pattern prescriptions for a dangerous cocktail of hydrocodone
and carisoprodol in the same quantity each month, RD, at 11, 13; Tr.
143; GX 7; (2) K.B. was also receiving non-controlled substances, such
as ibuprofen and biofreeze, which implicates the one-to-one controlled
to non-controlled substances pattern identified in the Texas
Administrative Code, RD, at 17; Tr. 129-32, 144-45; GX 6, at 1-2; (3)
K.B. was receiving these medications from multiple prescribers, RD, at
17; Tr. 143-45; GX 6 at 1-2; (4) K.B. repeatedly received a high
quantity of hydrocodone (over 100 tablets), which is a strong opioid
that is best when limited to short-term use, RD, at 13; Tr. 122-23,
143; and (5) the vast majority of K.B.'s prescriptions lacked a
diagnosis code. RD, at 15; Tr. 143-44; GX 6, at 24-25. Ms. Salinas
testified that there was no documentation indicating that Respondent
identified or resolved any of these red flags, and that Respondent
[[Page 75577]]
therefore failed to exercise its corresponding responsibility and abide
by the standard of care in its dispensing to K.B. RD, at 9; Tr. 146,
155; GX 6, 7.\15\
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\15\ For more details about the prescriptions that Respondent
filled for K.B. without identifying and resolving these red flags,
see RD, at 30-50; GX 6-7.
---------------------------------------------------------------------------
Ms. Salinas testified that she identified the following red flags
with the prescriptions that Respondent dispensed to S.D: (1) S.D was
receiving pattern prescriptions for a dangerous cocktail of hydrocodone
and carisoprodol in the same quantity each month, RD, at 11, 13; Tr.
147; GX 9; (2) S.D. was also receiving non-controlled substances, such
as gabapentin and naproxen, which implicates the one-to-one controlled
to non-controlled substances pattern identified in the Texas
Administrative Code, RD, at 13; Tr. 153; (3) S.D. was receiving these
medications from multiple prescribers, RD, at 17; Tr. 132, 147, 151-52;
GX 8 at 1-2; (4) S.D. repeatedly received a high quantity of
hydrocodone, which is a strong opioid that is best limited to short-
term use, RD, at 13; Tr. 122-23, 147; (5) none of S.D.'s prescriptions
contain diagnosis codes, RD, at 15; Tr. 151; GX 8, at 9-10; and (6)
there were gaps in S.D's prescriptions that indicated that S.D. was not
taking the medications as prescribed. RD, at 19; Tr. 154. Ms. Salinas
testified that there was no documentation indicating that Respondent
identified or resolved any of these red flags, and that Respondent
therefore failed to exercise its corresponding responsibility and abide
by the standard of care in its dispensing to S.D. RD, at 9; Tr. 153-54;
GX 8, 9.\16\
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\16\ For more details about the prescriptions that Respondent
filled for S.D. without identifying and resolving these red flags,
see RD, at 30-50; GX 8-9.
---------------------------------------------------------------------------
As for Respondent, Dr. Okpala testified that he did not observe any
red flags with any of the prescriptions in this case, so there was
``[n]othing to resolve'' and nothing to document. Tr. 402. Respondent's
counsel asked Dr. Okpala what he did if he encountered
``[prescriptions] that looked like red flags,'' and Dr. Okpala
testified that he would follow up, call physicians, and speak to
patients. RD, at 21; Tr. 402, 467, 479-80. Dr. Okpala testified that he
``did that on all these prescriptions.'' Tr. 467. When Government
counsel asked Dr. Okpala why there were no notes on the prescriptions
or in the patient file, Dr. Okpala replied, ``I mean, I know the
patients; I know the doctors. I did my job professionally as a
pharmacist, and I used my professional judgment, and that's what I
did.'' Tr. 480.
Dr. Okpala's testimony that the prescriptions in this case did not
present any red flags is simply not credible. The patterns presented by
these prescriptions are specifically identified in the Texas
Administrative Code as potential red flag factors, and Ms. Salinas
offered credible expert testimony with respect to each red flag. Dr.
Okpala testified that he took steps to verify the legitimacy of these
prescriptions, despite his belief that there were no red flags.
However, even assuming arguendo that Dr. Okpala did take these steps
for the relevant prescriptions, he did not document his actions as
required by the Texas standard of care. Moreover, it is unclear what
Dr. Okpala would have discussed with the patients and physicians if he
did not believe that any red flags existed. RD, at 51. Therefore, the
Agency does not credit Dr. Okpala's testimony that these prescriptions
did not present red flags, or that Dr. Okpala satisfied his obligation
to ensure that there were no red flags. RD, at 51.
Thus, the ALJ found, and the Agency agrees, that the standard of
care in Texas requires that any red flags present for a prescription
must be resolved before dispensing and that the resolution must be
documented. RD, at 27-53. The ALJ also found, and the Agency agrees,
that Respondent failed to do this, rendering Respondent's dispensing to
A.T., T.B., K.B., and S.D. outside the usual course of professional
practice and in violation of the Texas standard of care. Id. The Agency
further finds that Respondent failed to exercise sound professional
judgment in filling the prescriptions in this case. RD, at 9; Tr. 328.
II. Discussion
A. The Five Public Interest Factors
Under the CSA, ``[a] registration . . . to . . . dispense a
controlled substance . . . may be suspended or revoked by the Attorney
General upon a finding that the registrant . . . has committed such
acts as would render [its] registration under section 823 of this title
inconsistent with the public interest as determined under such
section.'' 21 U.S.C. 824(a). In making the public interest
determination, the CSA requires consideration of the following factors:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
The Agency considers these public interest factors in the
disjunctive. Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Each
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin.,
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37,507,
37,508 (1993).
The Government has the burden of proof in this proceeding. 21 CFR
1301.44. While the Agency has considered all of the public interest
factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of
its prima facie case for revocation of Respondent's registration is
confined to Factors B and D. RD, at 27-33; see also id. at 27 n.78
(finding that Factors A, C, and E do not weigh for or against
revocation \17\).
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\17\ Regarding Respondent's argument that the lack of
disciplinary action against Respondent or Dr. Okpala was not given
appropriate weight in the public interest analysis (Exceptions, at
2-3), this point was addressed by the ALJ in considering Public
Interest Factors A, C, and E and the Agency agrees with the ALJ's
analysis.
---------------------------------------------------------------------------
Having reviewed the record and the RD, the Agency agrees with the
ALJ, adopts the ALJ's analysis, and finds that the Government's
evidence satisfies its prima facie burden of showing that Respondent's
continued registration would be ``inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4); RD, at 27-54.
B. Factors B and D
Evidence is considered under Public Interest Factors B and D when
it reflects compliance (or non-compliance) with laws related to
controlled substances and experience dispensing controlled substances.
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D.,
87 FR 21,156, 21,162 (2022). In the current matter, the Government has
alleged that Respondent violated numerous federal and state laws
regulating controlled substances. OSC/ISO, at 2-9. Specifically,
federal law requires that ``[a] prescription for a controlled substance
may only be filled by a pharmacist, acting in the usual course of his
professional practice,'' and that ``[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.'' 21 CFR 1306.04(a), 1306.06; see also 21 U.S.C.
829. Federal law also
[[Page 75578]]
emphasizes that although ``[t]he responsibility for the proper
prescribing and dispensing of controlled substances is upon the
prescribing practitioner . . . a corresponding responsibility rests
with the pharmacist who fills the prescription.'' 21 CFR 1306.04(a).
DEA has consistently interpreted this provision as prohibiting a
pharmacist from filling a prescription for a controlled substance when
he either ``knows or has reason to know that the prescription was not
written for a legitimate medical purpose.'' Medicine Shoppe-
Jonesborough, 73 FR 364, 381 (2008) (citing Medic-Aid Pharmacy, 55 FR
30,043, 30,044 (1990)). DEA has further held that ``[w]hen
prescriptions are clearly not issued for legitimate medical purposes, a
pharmacist may not intentionally close his eyes and thereby avoid
[actual] knowledge of the real purpose of the prescription.'' Ralph J.
Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730 (1990).
As for state law, Texas Administrative Code Sec. 291.29(b)
requires pharmacists to ``make every reasonable effort to ensure that
any prescription drug order . . . has been issued for a legitimate
medical purpose by a practitioner in the course of medical practice.''
22 Tex. Admin. Code Sec. 291.29(b). The statute further requires
pharmacists to ``make every reasonable effort to prevent inappropriate
dispensing due to fraudulent, forged, invalid, or medically
inappropriate prescriptions in violation of a pharmacist's
corresponding responsibility,'' by considering a list of nineteen
``patterns (i.e., red flag factors) [that] are relevant to preventing
the non-therapeutic dispensing of controlled substances.'' Id. Sec.
291.29(f). These red flag factors ``shall be considered by evaluating
the totality of the circumstances rather than any single factor.'' Id.
In addition, Texas law requires pharmacists to ``exercise sound
professional judgment with respect to the accuracy and authenticity of
any prescription drug order they dispense,'' which requires
``verify[ing] the order with the practitioner prior to dispensing''
``[i]f the pharmacist questions the accuracy or authenticity of a
prescription drug order.'' Id. 291.34(b)(1)(A). Finally, Texas law
requires that ``[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. Sec. 291.33(c)(2)(A)(iv).
In the current matter, the Agency agrees with the ALJ's analysis
that Respondent's dispensing fell below the Texas standard of care, and
thus was outside the usual course of professional practice, because, as
detailed above, Respondent dispensed numerous controlled substance
prescriptions to four patients without properly addressing and
resolving clear red flags of abuse and diversion including dangerous
drug cocktails, pattern prescriptions for high doses and quantities of
commonly abused controlled substances, and patients receiving
controlled substances from multiple prescribers. See RD, at 27-53.
As Respondent's conduct displays clear violations of the federal
and state regulations described above, the Agency agrees with the ALJ
and hereby finds that Respondent repeatedly violated federal and state
law relating to controlled substances. RD, at 27-53. Accordingly, the
Agency finds that Factors B and D weigh in favor of revocation of
Respondent's registration and thus finds Respondent's continued
registration to be inconsistent with the public interest in balancing
the factors of 21 U.S.C. 823(g)(1). Id.
Respondent's Exceptions
Respondent argues in its Exceptions that the determination of
whether a red flag exists is subjective and it is made by the
pharmacist based on the totality of circumstances at the time of
dispensing. Exceptions, at 3, 8-11. Respondent argues that the ALJ
erred by giving more weight to Ms. Salinas's testimony about the
existence of red flags than to Dr. Okpala's, because ``an expert
witness's testimony cannot replace the subjective thoughts of a
pharmacist when they are filling a prescription.'' Id. Respondent
further argues that the duty to resolve and document the resolution of
a red flag only arises if the pharmacist subjectively determines that a
red flag exists. Id.
The Agency has repeatedly rejected these arguments. In a recent
case in Texas, the respondent's owner and PIC testified, like Dr.
Okpala, that red flags explicitly listed in Texas law were not actually
red flags, and that there is no duty to document if the pharmacist does
not identify any red flags. Lewisville Medical Pharmacy, 87 FR 59,456,
59,459 (2022). The Agency found that this testimony was ``evidence that
Respondent was willfully blind to red flags on the prescriptions it
filled,'' and that it ``evidences, at best, a deep and endemic
understanding of Texas and federal law.'' Id. at 59,459-60. Here, the
Agency likewise finds that Dr. Okpala's testimony reflects a troubling
indifference towards Texas law and supports a finding that he was
willfully blind to the numerous red flags presented by the
prescriptions in this case.
Respondent also argues in its Exceptions that Dr. Okpala knew that
the prescriptions were issued for a legitimate medical purpose because
he had spoken to the doctors and he knew that they had valid doctor-
patient relationships with the patients at issue. Exceptions, at 7-10.
This argument again reflects a deep misunderstanding of a pharmacist's
professional obligations under federal and Texas law. A pharmacist must
always exercise his corresponding responsibility to identify, resolve,
and document red flags, even where the prescriptions are ultimately
determined to be legitimate, and even where there ultimately is a valid
doctor-patient relationship. Respondent undeniably failed to fulfill
this obligation. Respondent's Exception also implies that every
prescription that is issued in a valid doctor-patient relationship is
legitimate, but Respondent offers no support for this assertion. And
regardless of whether Respondent believed that the prescribers in this
case had valid doctor-patient relationships with their patients, the
evidence overwhelmingly suggests that the prescriptions that they
issued were not legitimate. Prior Agency decisions have consistently
found that prescriptions with a similar list of red flags were ``so
suspicious as to support a finding that the pharmacists who filled them
violated their corresponding responsibility due to actual knowledge of,
or willful blindness to, the prescriptions' illegitimacy,'' \18\ and
Ms. Salinas credibly testified that there were numerous red flags that
created doubt as to whether the prescriptions in this case were
legitimate. RD, at 9; Tr. 336. Ms. Salinas's testimony that the
prescriptions raised numerous suspicions--such as repeated pattern
prescriptions for high-dose opioids and dangerous combinations of
controlled substances--stands in stark contrast to Dr. Okpala's
testimony that it was ``common sense'' to assume that hydrocodone was
permissibly being prescribed for chronic pain. RD, at 39; Tr. 342, 497.
This testimony reflects a troubling indifference towards the dangers
posed by repeated prescriptions for a Schedule II controlled substance,
and it further reinforces that Dr. Okpala does not understand his
corresponding responsibility.
---------------------------------------------------------------------------
\18\ Lewisville Medical Pharmacy, 87 FR at 59,459 (citing The
Pharmacy Place, 86 FR 21,008, 21,013 (collecting Agency decisions)).
---------------------------------------------------------------------------
Finally, Respondent argues in its Exceptions that the Government
failed to prove that the prescriptions were
[[Page 75579]]
invalid, that they were issued for non-therapeutic purposes, or that
Respondent dispensed them inaccurately. Exceptions, at 2, 7-8. Again,
Respondent's Exception misconstrues the applicable legal standard. The
Government need not demonstrate that a prescription was invalid, non-
therapeutic, or illegitimate in order to prove that a pharmacist
violated his corresponding responsibility. The Government need only
prove that the pharmacist failed to identify, resolve, and document red
flags presented by a prescription, which, here, Respondent repeatedly
failed to do.
III. Sanction
Where, as here, the Government has established sufficient grounds
to revoke Respondent's registration, the burden shifts to the
registrant to show why it can be entrusted with the responsibility
carried by a registration. Garret Howard Smith, M.D., 83 FR 18,882,
18,910 (2018). When a registrant has committed acts inconsistent with
the public interest, it must both accept responsibility and demonstrate
that it has undertaken corrective measures. Holiday CVS, L.L.C., dba
CVS Pharmacy Nos 219 and 5195, 77 FR 62,316, 62,339 (2012) (internal
quotations omitted). Trust is necessarily a fact-dependent
determination based on individual circumstances; therefore, the Agency
looks at factors such as the acceptance of responsibility, the
credibility of that acceptance as it relates to the probability of
repeat violations or behavior, the nature of the misconduct that forms
the basis for sanction, and the Agency's interest in deterring similar
acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR 33,738, 33,746
(2021).
Here, and as noted by the ALJ, Respondent's PIC explicitly denied
any responsibility for repeatedly filling prescriptions in violation of
state and federal law. RD, at 55. Dr. Okpala repeatedly testified that
he did not observe any red flags with any of the prescriptions in this
case and that he strictly follows the relevant law and regulations. RD,
at 55; Tr. 402, 414-15, 452, 460, 467, 474-75, 503. As such, the ALJ
concluded, and the Agency agrees, that Respondent has not demonstrated
unequivocal acceptance of responsibility for its actions. RD, at 56-57
(citing Jones Total Health Care Pharmacy, L.L.C. & SND Health Care,
L.L.C., 81 FR 79,188, 79,201-202 (2016)).\19\
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\19\ When a registrant fails to make the threshold showing of
acceptance of responsibility, the Agency need not address the
registrant's remedial measures. Ajay S. Ahuja, M.D., 84 FR 5,479,
5,498 n.33 (2019) (citing Jones Total Health Care Pharmacy, 81 FR at
79,202-303); Daniel A. Glick, D.D.S., 80 FR 74,800, 74,801, 74,810
(2015). Even so, in the current matter, Respondent did not identify
any relevant remedial measures.
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In addition to acceptance of responsibility, the Agency considers
both specific and general deterrence when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR 74,800, 74,810 (2015). In this
case, the Agency agrees with the ALJ that the interests of specific
deterrence motivate in favor of revocation given that Respondent's PIC
filled many of the prescriptions at issue, yet failed to acknowledge
that any red flags existed or required resolution. RD, at 58-59. As the
ALJ noted, Respondent continues to reject the notion that pharmacists
have a duty to identify and resolve red flags prior to dispensing,
which indicates that Respondent has not been rehabilitated. Id. at 55-
56. Respondent argues in its Post-Hearing Brief (PHB) that ``there is
no cause of action in Texas for `red flags' or failing to meet
`corresponding duty,' '' despite having been confronted in this
proceeding with numerous federal and state laws that explicitly
articulate this obligation. Id. (citing Respondent's PHB, at 5).
Portions of Dr. Okpala's testimony indicate that Dr. Okpala is more
focused on avoiding further government scrutiny than complying with
federal and state law. RD, at 56. Dr. Okpala testified that he has
never had a problem in his thirty years of practicing pharmacy, but
that he will maintain better documentation in the future because
``having this court order [ ] told [him] that.'' RD, at 56; Tr. 402-03,
468. Further, Dr. Okpala's failure to acknowledge the dangers of
concurrent prescriptions for opioids and benzodiazepines is troubling
and indicates that Respondent cannot be trusted to safely dispense
controlled substances. The Agency also agrees with the ALJ that the
interests of general deterrence support revocation, as a lack of
sanction in the current matter would send a message to the registrant
community that the failure to properly address and document resolution
of red flags can be excused. Id. at 59.
Moreover, the Agency agrees with the ALJ that Respondent's actions
were egregious. Id. at 57-58. As the ALJ noted, Respondent dispensed
dangerous combinations of controlled substances to four patients over a
two-year period without resolving multiple red flags indicative of
abuse and diversion. Id. at 57-58. Ms. Salinas testified that the
nature of the controlled substances issued by the Respondent ``put
people in danger.'' \20\ Id. at 58; Tr. 288. In sum, Respondent has not
offered any credible evidence on the record that rebuts the
Government's case for revocation of its registration and Respondent has
not demonstrated that it can be entrusted with the responsibility of
registration. RD, at 58-59. Accordingly, the Agency will order that
Respondent's registration be revoked.
---------------------------------------------------------------------------
\20\ Respondent noted in its Exceptions that none of the
medications it dispensed caused adverse reactions, which Respondent
argues supports a conclusion that ``Respondent did not fill any
`unlawful' prescription [sic].'' Exceptions, at 7. However, it is
not necessary for the Agency to find patient harm to revoke a
registration. Melanie Baker, N.P., 86 FR 23,998, 24,009 (2021);
Larry C. Daniels, M.D., 86 FR 61,630, 61,660-61 (2021); Jeanne E.
Germeil, M.D., 85 FR 73,786, 73,799 n.32 (2020). Moreover, Ms.
Salinas testified that a pharmacist's corresponding responsibility
to address red flags remains in place even if a patient does not
physically suffer any adverse effects from a medication or drug
cocktail. RD, at 9; Tr. 329.
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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 No.
FA2332346 issued to Awesome Care Pharmacy. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Awesome Care Pharmacy, to renew
or modify this registration, as well as any other pending application
of Awesome Care Pharmacy, for additional registration in Texas. This
Order is effective October 16, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 10, 2024, by Administrator Anne Milgram. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-20937 Filed 9-13-24; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on September 16, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.