Notice2021-21429
Pharmacy 4 Less; Decision and Order
Primary source
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Published
October 1, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54550-54585]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21429]
[[Page 54549]]
Vol. 86
Friday,
No. 188
October 1, 2021
Part III
Department of Justice
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Drug Enforcement Administration
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Pharmacy 4 Less; Decision and Order; Notice
Federal Register / Vol. 86 , No. 188 / Friday, October 1, 2021 /
Notices
[[Page 54550]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 18-41]
Pharmacy 4 Less; Decision and Order
On July 5, 2018, a former Assistant Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause (hereinafter, OSC) to Pharmacy 4 Less,
(hereinafter, Respondent) of Altamonte Springs, Florida. Administrative
Law Judge Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at 1. The OSC
proposed to revoke its DEA Certificate of Registration (hereinafter,
COR) No. FP5459082, and deny any pending applications for renewal or
modification of such registration pursuant to 21 U.S.C. 823(f) and
824(a)(4) for the reason that 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 Ex. 2. The hearing in this
matter was held in Orlando, Florida, on November 5-7, 2018, and
continued in Arlington, Virginia, on February 25, 2019. On May 22,
2019, Administrative Law Judge Mark M. Dowd (hereinafter, the ALJ)
issued the Recommended Rulings, Findings of Fact, Conclusions of Law
and Decision (hereinafter, Recommended Decision or RD), and on June 11,
2019, the Government timely filed exceptions (hereinafter, Govt
Exceptions) to the Recommended Decision. On June 23, 2019, the
Respondent filed what it styled as a response to the Government's
Exceptions (hereinafter, Resp Exceptions).\*A\ According to the ALJ,
the Respondent Pharmacy did not request an extension of time to file
exceptions, nor did it request an extension of time to file a response
to the Government's Exceptions pursuant to 21 CFR 1316.66(c). See ALJ
Transmittal Letter dated June 25, 2019. Even though Respondent did none
of those things, I have decided to address the Exceptions filed by
Respondent as part of my review of the record.\*B\ Having reviewed the
entire record, I find the Respondent's Exceptions are without merit and
I adopt the ALJ's rulings, findings of fact, as modified, conclusions
of law and recommended sanction with minor modifications, where noted
herein.\*C\
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\*A\ Despite the title, Respondent's filing appears to assert
its own Exceptions to the RD rather than respond to the Government's
Exceptions.
\*B\ My decision to consider the Respondent's Exceptions is
based on the particular circumstances of this case, including but
not limited to, the withdrawal of Respondent's counsel after the
conclusion of the hearing.
\*C\ I have made minor modifications to the RD. I have
substituted initials or titles for the names of witnesses and
patients to protect their privacy, I have corrected an occasional
citation, and I have made minor, non-substantive, grammatical
changes. Where I have made substantive changes, omitted language for
brevity or relevance, or where I have added to or modified the ALJ's
opinion, I have noted the edits with an asterisk, and I have
included specific descriptions of the modifications in brackets
following the asterisk or in footnotes marked with an asterisk and a
letter.
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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.
FP5459082 issued to Pharmacy 4 Less. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby
deny the pending application for renewal or modification of this
registration by Pharmacy 4 Less in Florida. This Order is effective
November 1, 2021.
Anne Milgram,
Administrator.
The Government's Exceptions
The Government, though in agreement with much of the ALJ's opinion,
filed exceptions to the RD on June 11, 2019. The Government described
its primary concern as being delay caused by the ALJ's conditional
admission of documents and proffer testimony, and asked that I
``specify the manner in which the ALJ is to balance the risk of delay
with the risk of being reversed, and to, where appropriate, allow only
limited proffers.'' Govt Exceptions, at 3. The presiding ALJ has the
``duty to conduct a fair hearing, to take all necessary action to avoid
delay, and to maintain order'' and has the power to ``[r]eceive, rule
on, exclude, or limit evidence.'' 21 CFR 1316.52 and (f). In other
words, he possesses discretion to ``regulate the course of the
hearing.'' 5 U.S.C. 556(c)(5) (West 2021). As such, I decline to
broadly instruct ALJs in the manner requested by the Government.
Next, the Government alleged that the ALJ erroneously admitted
Respondent Exhibits 18-37, which consisted of due diligence files for
the patients at issue in this case which had been updated by Respondent
after the dates relevant to this case (and after a Government subpoena
for these same records). Govt Exceptions, at 3-6. The Government
conceded that the records could have been relevant to establish
remedial measures taken by Respondent Pharmacy, but argues that they
would have been relevant only if Respondent Pharmacy first accepted
responsibility for its actions. Id. The Government alleges that the
ALJ's admission of RX 18-37, even conditionally, was improper without
Respondent first establishing responsibility or proffering that
acceptance of responsibility was forthcoming. As I have already
discussed, I decline to instruct the ALJs on how to balance the risk of
delay against the need to receive evidence as it lies within their
discretion, because every case will be different. Here, the ALJ
ultimately found that the Respondent Pharmacy did not accept
responsibility for its actions, but it would have been difficult for
the ALJ to have reached that conclusion at the beginning of the
evidentiary hearing.
The remainder of the Government's exceptions are addressed in the
relevant sections of the RD as footnoted below.
The Respondent's Exceptions
On June 23, 2019, the Respondent filed its exceptions to the
Recommended Decision. Exceptions ``shall include a statement of
supporting reasons for such exceptions, together with evidence of
record (including specific and complete citations of the pages of the
transcript and exhibits) and citations of the authorities relied
upon.'' 21 CFR 1316.66. For the most part, the Respondent's Exceptions
not only fail to comply with this regulatory requirement, but also lack
evidentiary support in the Administrative Record. Some of Respondent's
Exceptions \*D\ repeat facts which were already raised at the hearing
in this matter and addressed by the ALJ in the adopted Recommended
Decision herein.
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\*D\ Respondent's Exceptions ] 1 asserting that starting doses
for opioid patients were not high and that the Pharmacy had detailed
medical records; ] 7 regarding the initial inventory; ] 8 asserting
the accuracy of the perpetual inventory; ] 12 claiming the opioid
naivety red flag was resolved by checking e-FORCSE. Respondent's
Exceptions, at 2-3.
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Most of Respondent's Exceptions introduce evidentiary facts that
Respondent Pharmacy appears to be offering to establish remedial
measures.\*E\ Many of these facts are not
[[Page 54551]]
supported by the record and were not under oath or subject to cross
examination when they were presented for the first time in Respondent's
Exceptions. Moreover, where a registrant has not accepted
responsibility it is not necessary to consider evidence of the
registrant's remedial measures. Jones Total Health Care Pharmacy,
L.L.C. & SND Health Care, L.L.C., 81 FR 79188, 79202-03 (2016).'' As
Respondent Pharmacy has failed to unequivocally accept responsibility
for its actions, the purported remedial measures offered by Respondent
in its Exceptions, even if they were part of the evidentiary record,
would have no impact on my decision in this case.
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\*E\ Respondent's Exceptions ] 4 asserting that the pharmacy can
now bill insurance companies and that 80% of the Schedule II
controlled substances prescriptions it fills are through insurance
now; ] 5 asserting the pharmacy now fills only 10% of the Schedule
II controlled substances prescriptions it was filling in 2015 and
2016, admitting they filled too many Schedule II prescriptions in
the past and claiming they are not ``extremely due diligent in
filling;'' ] 6 asserting that the pharmacy does not fill
prescriptions from a neighboring pain doctor who will not share
medical records; ] 7 asserting that Respondent Pharmacy passed every
Department of Health inspection from 2015 to 2019; ] 9 asserting
that Patient A.R. has been discharged; ] 11 asserting that Patient
A.V. was successfully taken off of opioids. Resp Exceptions, at 2-3.
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Similarly, the Respondent's Exceptions contained a number of
factual assertions regarding Owner Richard Sprys' purported work with
law enforcement bodies to report illegal pharmacy operations and
provide testimony, seemingly for the DEA in one instance, to hold those
pharmacies accountable. Id. at 3. None of these facts were given under
oath and none were subject to cross-examination; therefore, they are
simply not part of the evidentiary record. Even if Respondent's
assertions had been appropriately submitted through testimonial
evidence, they could only have been relevant in assessing whether
Respondent Pharmacy could be entrusted with a registration. Here, as
Respondent Pharmacy has failed to unequivocally accept responsibility
for its actions, such assertions would have had no impact on my
decision.
The remainder of the Respondent's Exceptions are addressed in their
relevant sections of the Recommended Decision as footnoted below.
The decision below is based on my consideration of the entire
administrative record, including all of the testimony, admitted
exhibits, and the oral and written arguments of both parties. I adopt
the ALJ's Recommended Decision with noted modifications.
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
The Assistant Administrator, Drug Enforcement Administration (DEA),
issued an Order to Show Cause,\1\ dated July 5, 2018, seeking to deny
the Respondent's Certificate of Registration, number FP5459082, on the
ground that the Respondent's registration would be inconsistent with
the public interest, pursuant to 21 U.S.C. 824(a)(4), and as defined in
21 U.S.C. 823(f). The Respondent requested a hearing on August 2,
2018,\2\ and prehearing proceedings were initiated.\3\ A hearing was
conducted in this matter on November 5-7, 2018, in Orlando, Florida,
and resumed on February 25, 2019, at the DEA Hearing Facility in
Arlington, Virginia.
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\1\ ALJ Ex. 1.
\2\ ALJ Ex. 2.
\3\ ALJ Ex. 3.
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The issue ultimately to be adjudicated by the Administrator,\*F\
with the assistance of this Recommended Decision, is whether the record
as a whole establishes by a preponderance of the evidence that the
Respondent's subject registration with the DEA should be revoked
pursuant to 21 U.S.C. 824(a)(4).
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\*F\ All references to ``Acting Administrator'' have been
changed to ``Administrator.''
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After carefully considering the testimony elicited at the hearing,
the admitted exhibits, the arguments of counsel, and the record as a
whole, I have set forth my recommended findings of fact and conclusions
of law below.
The Allegations
In the OSC, the Government contends that the DEA should revoke the
Respondent's DEA COR because it failed to comply with 21 U.S.C.
824(a)(4) and its registration is inconsistent with the public
interest, see 21 U.S.C. 823(f). Specifically, the Government alleges
the following:
1. The Respondent failed to ensure that it only filled
prescriptions issued for legitimate medical purposes and repeatedly
filled prescriptions in the face of obvious red flags of diversion, in
violation of both federal and state law (including 21 CFR 1306.06,
1306.04(a); Wheatland Pharmacy, 78 FR 69411, 69445 (2013); Fla. Admin.
Code r. 64B16-27.810, 64B16-27.831 \4\), specifically from at least
October 27, 2015 to at least June 19, 2017, to at least ten different
patients. ALJ Ex. 1 at ]] 2-4.
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\4\ It was noted that there was a scrivener's error by the
Government citing to r. 64B16-27.821. The Government later corrected
the cite to reflect the correct citation to r. 64B16-27.831.
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2. The Respondent routinely filled Schedule II controlled
substances without resolving the ``red flag'' of patients with ``very
high starting dosages,'' both with respect to the individual dose being
prescribed and with respect to the number of tablets being prescribed,
which is potentially fatal for a patient. ALJ Ex. 1 at ] 5.
3. The Respondent routinely filled controlled substance
prescriptions without resolving the ``red flag'' of immediate release
pain medication over long periods of time. A chronic pain patient
should be moved to a long acting medication. ALJ Ex. 1 at ] 6.
4. The Respondent routinely filled controlled substance
prescriptions without resolving the ``red flag'' of extremely high cash
prices. ALJ Ex. 1 at ] 7.
5. The Respondent routinely filled prescriptions without resolving
the ``red flag'' for patients who traveled long distances to visit the
Respondent's pharmacy. ALJ Ex. 1 at ] 8.
6. The Respondent would fill prescriptions without resolving the
``red flag'' for drug combinations that needed to be questioned, such
as the combination of buprenorphine and oxycodone. ALJ Ex. 1 at ] 9.
Treatment of Patients
Patient A.E.
From November 19, 2015, to at least June 1, 2017, the Respondent
filled at least 21 prescriptions for hydromorphone for A.E. outside the
usual course of professional practice, in violation of 21 CFR 1306.06,
and in violation of its corresponding responsibility under 21 CFR
1306.04(a). Specifically:
a. A.E.'s prescriptions were for 84 tablets of hydromorphone 8 mg,
which is a large amount of tablets at the highest dosage strength.
b. A.E. filled his prescriptions for short acting hydromorphone
since at least November 19, 2015, even though hydromorphone is not
prescribed for long-term use or chronic conditions.
c. A.E. paid cash for his prescriptions at inflated prices, paying
$500.00 for 84 tablets of hydromorphone 8 mg, approximately $5.95 per
pill, at a time when legitimate pharmacies were charging approximately
$1.50.
Patient A.R.
From March 17, 2016, to at least June 7, 2017, the Respondent
filled at least 17 prescriptions for oxycodone for A.R. outside the
usual course of professional practice, in violation of 21 CFR 1306.06,
and in violation of its corresponding responsibility under 21 CFR
1306.04(a). Specifically:
a. A.R. filled his prescriptions for immediate release oxycodone
since at least March 17, 2016, even though oxycodone is not prescribed
for long-term use or chronic conditions.
b. A.R. drove extremely long distances to fill oxycodone
prescriptions. A.R. drove approximately 37 miles southwest to visit the
prescribing doctor, an additional 17.9 miles further southwest
[[Page 54552]]
to the Respondent's pharmacy, an additional 45.4 miles to A.R.'s home,
for a total of 97.3 miles round-trip to fill the oxycodone
prescriptions.
Patient A.V.
From April 12, 2016, to at least April 10, 2017, the Respondent
filled at least 9 prescriptions for buprenorphine and at least 12
prescriptions for oxycodone for A.V. outside the usual course of
professional practice, in violation of 21 CFR 1306.06, and in violation
of its corresponding responsibility under 21 CFR 1306.04(a).
Specifically:
a. A.V.'s prescriptions were for 112 tablets of oxycodone 20 mg and
60 tablets buprenorphine 8 mg, which are large amounts of tablets at a
high dosage strength.
b. A.V. was filling prescriptions for opioid withdrawal at the same
time he was filling a prescription for an opioid.
c. A.V. filled his prescriptions for short acting oxycodone since
at least April 12, 2016, even though oxycodone was not prescribed for
long-term use or chronic conditions.
Patient B.F.
From October 27, 2015, to at least May 15, 2017, the Respondent
filled at least 17 prescriptions for hydromorphone and at least 5
prescriptions for oxycodone for B.F. outside the usual course of
professional practice, in violation of 21 CFR 1306.06, and in violation
of its corresponding responsibility under 21 CFR 1306.04(a).
Specifically:
a. B.F.'s prescriptions were for 84 tablets of hydromorphone 8 mg,
which is a large amount of tablets at the highest dosage strength.
b. B.F. filled his prescriptions for short acting hydromorphone
since at least October 27, 2015, even though hydromorphone is not
prescribed for long-term use or chronic conditions.
c. B.F. paid cash for his prescriptions at inflated prices, paying
$490.00 for 84 tablets of hydromorphone 8 mg, approximately $5.93 per
pill, at a time when legitimate pharmacies were charging approximately
$1.50.
Patient B.N.
From January 22, 2016, to at least June 2, 2017, the Respondent
filled at least 9 prescriptions for hydromorphone and at least 10
prescriptions for oxycodone for B.N. outside the usual course of
professional practice, in violation of 21 CFR 1306.06, and in violation
of its corresponding responsibility under 21 CFR 1306.04(a).
Specifically:
a. B.N.'s prescriptions were for 100 tablets of hydromorphone 8 mg,
which is a large amount of tablets at the highest dosage strength. In
September 2016, B.N. switched to 120 tablets of oxycodone 30 mg, which
is an even higher number of tablets at the highest dosage strength of
oxycodone.
b. B.N. filled his prescriptions for immediate release oxycodone
and hydromorphone since at least January 22, 2016, even though
oxycodone and hydromorphone are not prescribed for long-term use or
chronic conditions.
c. B.N. paid cash for his prescriptions at inflated prices, paying
up to $640.00 for 100 tablets of hydromorphone 8 mg, approximately
$6.40 per pill, at a time when legitimate pharmacies were charging
approximately $1.50. Similarly, B.N. paid prices up to $650.00 for 120
tablets of oxycodone 30 mg, approximately $5.51 per pill, at a time
when legitimate pharmacies were charging approximately $0.90 per
tablet.
Patient K.Y.D.\5\
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\5\ There are two patients with the same initials, K.D. In
pretrial filings, the Government and Respondent referred to these
patients as K.D.1 and K.D.2. However, the Government and Respondent
referred to different patients as K.D.1 and K.D.2 (i.e., the
Government's K.D.1 was Respondent's K.D.2). At the hearing, the
parties discussed this issue and decided to refer to these two
patients by the first two letters in their first name. All of the
Government's pre-trial filings referring to K.D.1 are now discussed
as K.Y.D. All of the Government's pre-trial findings referring to
K.D.2 are now discussed as K.E.D. The opposite is true for the
Respondent.
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From February 4, 2016, to at least June 12, 2017, the Respondent
filled at least 17 prescriptions for oxycodone and at least 17
prescriptions for morphine sulfate for K.Y.D. outside the usual course
of professional practice, in violation of 21 CFR 1306.06, and in
violation of its corresponding responsibility under 21 CFR 1306.04(a).
Specifically:
a. K.Y.D.'s prescriptions for hydromorphone were for 84 tablets of
oxycodone 30 mg, which is a large amount of tablets at the highest
dosage strength.
b. K.Y.D. paid cash for his prescriptions at inflated prices,
paying up to $290.00 for 84 tablets of oxycodone 30 mg, approximately
$3.45 per tablet, at a time when legitimate pharmacies were charging
approximately $0.90 per tablet.
Patient K.E.D.
From October 26, 2015, to at least June 7, 2017, the Respondent
filled at least 20 prescriptions for oxycodone for K.E.D. outside the
usual course of professional practice, in violation of 21 CFR 1306.06,
and in violation of its corresponding responsibility under 21 CFR
1306.04(a). Specifically:
a. K.E.D.'s prescriptions for oxycodone were for 112 tablets of
oxycodone 20 mg, which is a large amount of tablets at a high dosage
strength.
b. K.E.D. filled his prescriptions for immediate release oxycodone
since at least October 26, 2015, even though oxycodone is not
prescribed for long-term use or chronic conditions.
c. K.E.D. paid cash for his prescriptions at inflated prices,
paying up to $430.00 for 112 tablets of oxycodone, approximately $3.83
per tablet, at a time when legitimate pharmacies were charging
approximately $0.90 per tablet.
Patient R.R.
From October 28, 2015, to at least May 30, 2017, the Respondent
filled at least 21 prescriptions for oxycodone for R.R. outside the
usual course of professional practice, in violation of 21 CFR 1306.06,
and in violation of its corresponding responsibility under 21 CFR
1306.04(a). Specifically:
a. R.R.'s prescriptions for oxycodone were for 112 tablets of
oxycodone 15 mg, which is a large amount of tablets at a high dosage
strength.
b. R.R. filled his prescriptions for immediate release oxycodone
since at least October 28, 2015, even though oxycodone is not
prescribed for long-term use or chronic conditions.
Patient R.V.
From November 17, 2015, to at least June 19, 2017, the Respondent
filled at least 21 prescriptions for oxycodone for R.V. outside the
usual course of professional practice, in violation of 21 CFR 1306.06,
and in violation of its corresponding responsibility under 21 CFR
1306.04(a). Specifically:
a. R.V.'s prescriptions for oxycodone were for 112 to 120 tablets
of oxycodone 20 mg, which is a large amount of tablets at a high dosage
strength.
b. R.V. filled her prescriptions for immediate release oxycodone
since at least November 17, 2015, even though oxycodone is not
prescribed for long-term use or chronic conditions.
Patient V.W.
From November 30, 2015, to at least May 31, 2017, the Respondent
filled at least 20 prescriptions for oxycodone for V.W. outside the
usual course of professional practice, in violation of 21 CFR 1306.06,
and in violation of its corresponding responsibility under 21 CFR
1306.04(a). Specifically:
a. V.W.'s prescriptions for oxycodone were for 84 to 112 tablets of
oxycodone 15 mg, which is a large amount of tablets at a high dosage
strength.
[[Page 54553]]
b. V.W. filled his prescriptions for immediate release oxycodone
since at least November 30, 2015, even though oxycodone is not
prescribed for long-term use or chronic conditions.
c. V.W. paid cash for his prescriptions at inflated prices, paying
up to $400.00 for 112 tablets of oxycodone, approximately $3.57 per
tablet, at a time when legitimate pharmacies were charging
approximately $0.90 per tablet.
Recordkeeping Violations
1. The Respondent did not have an initial inventory, when requested
by DEA during an on-site inspection of June 6, 2017, in violation of 21
CFR 1304.11(b).
2. The Respondent's biennial inventory failed to indicate whether
it was taken at the opening or closing of business as required by 21
CFR 1304.11(a).
3. The Respondent's pharmacist on duty, Amy Mincy, stated that the
biennial inventory was performed over several days, in violation of 21
CFR 1304.11(a).
4. The Respondent's pharmacist on duty during the June 6, 2017 on-
site inspection admitted to using the pharmacy owner's, Mr. Richard
Sprys, CSOS credentials to order controlled substances in violation of
21 CFR 1311.30(a) & (c).
5. The Respondent's receiving records showed that the Respondent
failed to create an electronically linked record of a quantity and date
received for its controlled substances in violation of 21 CFR
1305.22(g). The Respondent also possessed 89 invoices without the date
of receipt recorded in violation of 21 CFR 1304.22(c).
The Hearing
Preliminary Matters
At the outset of the hearing, the Government confirmed that it was
not going forward with pursuing any independent violation against the
Respondent for a delay by the Respondent in complying with the July
2018 administrative subpoena. Tr. 14-15.\6\ This Tribunal also noticed
the Government that if it intended to assert a new allegation or expand
the charges, it must inform this Tribunal at the time the new matter is
broached at the hearing. Id. at 15-16. This would also give the
Respondent the opportunity to either litigate the issue by consent or
to object to the new allegation. Id. at 15-16. No supplemental
allegations were broached by the Government.
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\6\ Tr.--Refers to the hearing transcript. The number(s)
immediately following refer to the transcript page numbers.
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The Respondent noted that they would be withdrawing their motion to
suppress evidence, a motion that this tribunal had only preliminarily
ruled upon. Id. at 17; ALJ Ex. 35. This Tribunal noted that the
preliminary evidentiary rulings were for guidance and that the parties
would still need to make their objections at the time of the hearing to
preserve those objections. Tr. 17. The Respondent further requested
that this Tribunal take official notice of 21 CFR 1304.21(a) and 21
U.S.C. 827(a)(3), to which this Tribunal acceded. Id. at 17-18. Next,
the Respondent made preliminary objections as to authentication,
failure to meet the business records exception, and improper burden
shifting as to Government's Proposed Exhibits 9, 11, and 13. Id. at 18-
19. This Tribunal carried those objections over to the hearing. Id. at
19. Then, the Respondent clarified that Government's Proposed Exhibit
25 had been ruled inadmissible and excluded.\7\ Id. at 20. The
Respondent then discussed a number of other matters related to proposed
exhibits, which will be later discussed. Id. at 20-22. Finally, the
Respondent objected to Government's Proposed Exhibit 26, which
objection was also carried to the hearing. Id. at 23.
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\7\ GX 25 consisted of over 1000 pages of an Excel spreadsheet
involving records of patients additional to the ten patients who are
the subject of the allegations. GX 25 was ruled inadmissible as
generally irrelevant. The Government was permitted to reconstitute
the exhibit reflecting only the ten subject patients. The
Government's substitute exhibit was introduced as GX 35.
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Government's Opening Statement
In the Government's Opening Statement, it previewed that the DEA
conducted an audit of Pharmacy 4 Less on June 6, 2017. Id. at 25. The
Government intended to explain the on-site audit through the testimony
of DI1, including the findings from the audit, and explain the record
keeping and regulatory violations that were discovered. Id. at 25. The
Government also intended to offer the testimony of Dr. Hamilton
regarding his review of the prescriptions and due diligence files that
Pharmacy 4 Less maintained and how the Respondent filled prescriptions
for controlled substances without resolving red flags. Id. at 25.
Finally, the Government argued that the Respondent had not accepted
responsibility for any of the alleged violations. Id. at 25-26.
Respondent's Opening Statement
In the Respondent's Opening Statement, it described Pharmacy 4 Less
as a small, independent pharmacy. Id. at 27. Pharmacy 4 Less has two
pharmacists and a low volume of patients. Id. at 27. The Respondent
contrasted it from Publix, the pharmacy where Dr. Hamilton is employed.
Id. at 27-28. The Respondent stated that Pharmacy 4 Less cannot
purchase in volume like other retail pharmacies, and cannot sell at the
same prices as other larger pharmacies. Id. at 28.
The Respondent described Mr. Richard Sprys, the owner and operator
of Pharmacy 4 Less. Id. at 28. The Respondent detailed Mr. Sprys'
community involvement in his capacity as a pharmacist, and how he has
previously testified as a witness in several cases for the Government
in whistleblower cases against pharmacies. Id. at 28. The Respondent
further asserted that Mr. Sprys has always attempted to cooperate with
the Government, including the process involving the July 9, 2018
administrative subpoena. Id. at 28-29. The Respondent also described
Ms. Amy Mincy, another pharmacist that works at Pharmacy 4 Less,
including her extensive background and experience as a pharmacist. Id.
at 30.
The Respondent described the June 6, 2017 on-site inspection of
Pharmacy 4 Less. Id. at 29. The Respondent asserted that the DEA
diversion investigators related to Ms. Mincy, the pharmacist on-site at
the time of the inspection, that the inspection would only last ten to
fifteen minutes when the inspection actually lasted over six hours. Id.
at 29.
The Respondent asserted that the Government's portrayal that the
Respondent has not accepted responsibility is misplaced. Id. at 30. The
Respondent stated that they submitted a corrective action plan (which
the DEA rejected), they have modified their behavior, they have reduced
the number of patients they see and fill prescriptions for, and they
have implemented a number of other remedial changes. Id. at 30.
The Respondent further described the treatment of patients when
they visit Pharmacy 4 Less. Id. at 30-32. The Respondent asserted that
each patient receives specialized attention by the pharmacists because
of Pharmacy 4 Less's small size. Id. at 31. The Respondent also stated
that not only does Pharmacy 4 Less contact patients' doctors to resolve
red flags, but Pharmacy 4 Less goes beyond that of other pharmacies
because they will request and keep medical records of their patients to
assist in the resolution of red flags. Id. at 31-32.
Finally, the Respondent stressed that while Pharmacy 4 Less may not
be
[[Page 54554]]
perfect, they keep their practice above-average. Id. at 32. The
Respondent maintains that before and after the DEA on-site inspection,
Pharmacy 4 Less has a clean record with the Florida Department of
Health for their on-site inspections. Id. at 32.
Government's Case in Chief
The Government presented its case in chief through the testimony of
two witnesses. First, the Government presented the testimony of a
Diversion Investigator (hereinafter DI1). Secondly, the Government
presented the testimony of its expert, Dr. Thomas D. Hamilton.
Diversion Investigator DI1
DI1 has been a Diversion Investigator for approximately seven
years. Id. at 33. He is currently assigned to the Orlando District
Office, in Orlando, Florida. Id. at 33. DI1 described his training and
experience at the DEA Academy and in the field at the Baltimore and
Orlando offices, including experience in at least 50-70 pharmacy
investigations. Id. at 34-35.
DI1 first met with the staff at Pharmacy 4 Less on June 6, 2017.
Id. at 37. He explained that Diversion Investigators \8\ were doing
regulatory inspections and Pharmacy 4 Less was randomly picked for a
regulatory inspection. Id. at 37. When they arrived, the DIs showed
their credentials and presented Ms. Amy Mincy, a pharmacist at Pharmacy
4 Less, with a DEA Form 82 Notice of Inspection.\9\ Id. at 37-38; GX
30.\10\ The form was signed by Ms. Mincy and the DIs began their on-
site inspection. Tr. 38-39.
---------------------------------------------------------------------------
\8\ DI1 was accompanied by Group Supervisor DI2 during the on-
site inspection. Tr. 41.
\9\ A Notice of Inspection is a DEA Form evidencing a voluntary
consent to search.
\10\ GX--Government's Exhibit.
---------------------------------------------------------------------------
The DIs began by asking questions about Pharmacy 4 Less's customer
base and prescriptions, and looked at the prescriptions records, log
books, and other required records. Id. at 39. When DI1 asked Ms. Mincy
about inventories, she could not locate the initial inventory; so Mr.
Richard Sprys, the owner of Pharmacy 4 Less, was contacted via
speakerphone by Ms. Mincy to determine where the initial inventory
could be located. Id. at 39-40.\11\ DI1 asked Mr. Sprys over the phone
if Pharmacy 4 Less had an initial inventory, and Mr. Sprys replied that
it did not. Id. at 40.
---------------------------------------------------------------------------
\11\ Richard Sprys was not present at Pharmacy 4 Less during the
on-site inspection on June 6, 2017. Tr. 40.
---------------------------------------------------------------------------
DI1 next inquired as to whether Pharmacy 4 Less had performed a
biennial inventory. Id. at 40-41. Ms. Mincy provided DI1 with a
document purported to be a biennial inventory. Id. at 41. DI1 concluded
that the document did not comply with DEA regulations as the purported
biennial inventory did not include a statement that it had been
completed either at the opening or closing of business.\12\ Id. at 41-
42. Further, DI1 claimed that Ms. Mincy had indicated that she had
completed it over several days. Id. at 41. DI1 indicated that biennial
inventories need to be completed either at the opening or closing of
business and it needs to be notated on the biennial inventory. Id. at
41-42. DI1 claimed that during this exchange, Ms. Mincy said, ``what
was [I] supposed to do, shut down the pharmacy? '' Id. at 42. As part
of his later audit of the pharmacy's inventories, DI1 did not use the
biennial inventory because he could not verify its accuracy due to the
issues he had discovered during his review. Id. at 56, 61, 66, 154-56.
---------------------------------------------------------------------------
\12\ See 21 CFR 1304.11(a).
---------------------------------------------------------------------------
DI1 then inquired of Ms. Mincy as to recordkeeping and CSOS
records.\13\ Id. at 42. DI1 asked Ms. Mincy how Pharmacy 4 Less
documents and records their ordering of controlled substances and
validation of a prescription's legitimacy. Id. at 43.\14\ When DI1
asked Ms. Mincy to produce the CSOS records (including records of
receipt for Schedule 2s), he observed that Ms. Mincy proceeded to a
laptop in the pharmacy to log into the CSOS system. Id. at 45. DI1
asked Ms. Mincy if she had her own CSOS credentials (which DI1 asserted
is required for anyone accessing the CSOS system and cannot be shared
with anyone else). Id. at 46. In response, Ms. Mincy stated she did not
have her own credentials and did not have a power of attorney for
anyone else's credentials. Id. at 46. Ms. Mincy stated to DI1 that she
was using Mr. Richard Sprys credentials to log onto CSOS. Id. at 46.
---------------------------------------------------------------------------
\13\ CSOS--Controlled Substance Ordering System.
\14\ DI1 asserted during his testimony that when a pharmacy
orders and receives controlled substances on-site, they are required
to notate that they received them with the date and the initials of
the person that received them. Tr. 44.
---------------------------------------------------------------------------
DI1 later contacted Mr. Chris Jewell, one of the personnel in
charge of the CSOS system at DEA Headquarters, to determine which
personnel at Pharmacy 4 Less had access to the CSOS system. Id. at 47-
48. Mr. Jewell ran a report and the report stated that Ms. Mincy
received her own CSOS credentials in July 2018. Id. at 48-49; GX
29.\15\
---------------------------------------------------------------------------
\15\ The Respondent objected to admission of GX 29 on the basis
of lack of authentication and not meeting the exception of a
business record. Tr. 49. DI1 made it clear that he did not
personally produce this record, but requested it from Mr. Jewell.
Id. at 49-50. This Tribunal noticed that it appears to be a
government record and did not appear to have any indication of
inaccuracy or unreliability. Id. at 50. The Respondent argued that
portions of the document appeared to have inaccuracies as related to
Mr. Sprys, but agreed that if the Government was only offering the
document as related to Ms. Mincy, it would not object if the rest of
the document was blackened out to only show Ms. Mincy's records. Id.
at 50-52. The Government agreed that it was only offering the
document for Ms. Mincy's records on the top line and would not
object to blackening out Mr. Spry's records. Id. at 51-52. This
Tribunal admitted GX 29 on that basis as altered and is only
considering GX 29 for the top line as related to Ms. Mincy's
records. Id. at 51-52.
---------------------------------------------------------------------------
DI1 described the audit \16\ of Pharmacy 4 Less's records and
inventories.\17\ Tr. 53-85, 919-26; GX 4, 31, 32.\18\ DI1 conducted an
audit of Pharmacy 4 Less's records and inventories at a starting date
of January 1, 2017. Tr. 55-56. DI1 selected this date because Pharmacy
4 Less maintained handwritten Schedule 2 controlled substance logs,
there was no initial inventory, and the investigating DIs were unsure
of how accurate the biennial inventory was. Id. at 56, 61. For example,
DI1 had used the pharmacy's handwritten perpetual inventory forms for
Methadone 10 mg tablets and Oxycodone 30 mg tablets during the audit,
which had been provided to DI1 by Ms. Mincy during the on-site
inspection on June 6, 2017. Id. at 56-60; GX 31, 32.\19\
---------------------------------------------------------------------------
\16\ The audit occurred both at the pharmacy and later during a
review of Pharmacy 4 Less's records. Tr. 100.
\17\ DI1 was later asked about his receipt and possession of
records obtained from the pharmacy during the June 6, 2017 on-site
inspection. Tr. 949-54; Proposed RX 10 (not offered into evidence)
(The Government also had a standing objection to this line of
questioning as outside the scope of redirect examination. Tr. 951.).
Proposed RX 10 was a DEA-12, a receipt of items taken by the DIs
after their inspection. Tr. 951. The DEA-12 forms indicated that the
DEA had taken possession of six California folders containing C-2
prescriptions, and 13 manila folders containing C-2 invoices. Tr.
951-53.
\18\ The Government initially offered GX 4 during the first
portion of the hearing in Orlando, Florida. Tr. 67. The Respondent
conducted voir dire and objected that it was unreliable. Tr. 68-81.
This Tribunal initially admitted the exhibit. Tr. 81-85. However,
this Tribunal reconsidered its ruling and found that GX 4 in its
then present condition would not be helpful to the factfinder. Tr.
146. This Tribunal then afforded the Government the opportunity to
resubmit GX 4 at a later time. Tr. 146-48. During the portion of the
hearing in Arlington, Virginia, the Government reintroduced a
corrected version of GX 4. Tr. 925. The Respondent did not object
and the corrected version of GX 4 was admitted. Tr. 925-26.
\19\ For a full discussion of how DI1 conducted his audit, see
Tr. 61-67.
---------------------------------------------------------------------------
DI1 explained that under DEA regulations, records need to be
readily retrievable and maintained at the pharmacy. Tr. 86. It does not
satisfy the regulations that records may later be retrieved. Id. at 86.
He discovered that
[[Page 54555]]
Pharmacy 4 Less did not have readily retrievable records available
during the June 6, 2017 on-site inspection. Id. at 87.\20\
---------------------------------------------------------------------------
\20\ DI1 explained that ``readily retrievable'' means that when
DIs go into a pharmacy to perform an audit or to review a record,
the pharmacy should be able to provide those records within a
reasonable time. Tr. 87.
---------------------------------------------------------------------------
Following the June 6, 2017 on-site inspection, DIs \21\ returned to
Pharmacy 4 Less again on June 21, 2017. Id. at 88. Ms. Mincy was again
at the pharmacy, and Mr. Richard Sprys joined them later that day. Id.
at 88. DI1 stated that he discussed his findings from the initial on-
site inspection and audit (including the invoices and prescriptions)
with Mr. Sprys and Ms. Mincy during this second visit. Id. at 88.
During the discussion, DI1 asked Mr. Sprys and Ms. Mincy how they
determined whether prescriptions were for a legitimate medical purpose,
based on a review of the records the DIs had retrieved during the first
on-site inspection. Id. at 89-90. The pharmacists (both Mr. Sprys and
Ms. Mincy) responded that they checked E-FORCSE, the Florida
prescription monitoring program website, and that they would verify
prescriptions by contacting the doctor's office and/or requesting
patient medical files. Id. at 90-91. When asked how this information is
documented, one of the pharmacists (DI1 could not remember if it was
Mr. Sprys or Ms. Mincy) provided a red folder that they maintained. Id.
at 91-92. The red folder contained screenshots from the computer
system, Rx30.\22\ Tr. 92. The red folder contained information related
to multiple patients. Tr. 93, 119-31; GX 5, 7, 13, 17, 21, 23. DI1 did
not find any ``due diligence files'' for Patients A.V., B.F., K.Y.D.,
or R.R. in the files provided to him by Pharmacy 4 Less. Tr. 131-36.
---------------------------------------------------------------------------
\21\ DI1 noted that on this second visit, he was present, along
with DI Debbie George, Group Supervisor Linda Stocum, and Division
Program Manager of the State of Florida, Susan Langston. Tr. 88.
\22\ Rx30 is a computer software that Pharmacy 4 Less used to
maintain their inventory, the dispensing of controlled substances,
and as DI1 testified, patient profile screens where the pharmacist
can input notes about the patient, including information about the
patient, treatment, injuries, and other diagnosis notes. Tr. 92-93.
The Respondent identified this as the patient record maintenance
form (PRM). Id. at 93.
---------------------------------------------------------------------------
The following day on June 22, 2017, an administrative subpoena was
served on Pharmacy 4 Less, requesting hard copy prescriptions for all
Schedules 2-5 controlled substance prescriptions from October 2015
through June 22, 2017, all controlled substance prescription data from
Rx30, and all due diligence patient files. Tr. 93-94; GX 2. Pharmacy 4
Less complied by delivering a gray tote container that contained
``California'' folders filled with Schedule 2 hard copy prescriptions,
a thumb drive containing all Rx30 data, and the red folder seen during
the June 21 on-site inspection. Id. at 96. The Schedules 3-5
prescriptions were delivered to the DIs by Pharmacy 4 Less at an
unidentified later date. Id. at 97. The red folder contained
screenshots from the Rx30 program. Id. at 96. The red folder also
contained the pharmacists' notes on patients, referred to as ``due
diligence files.'' Id. at 96-97. The ``California'' folders were
organized by prescription number, which DI1 sorted through to locate
prescriptions for the 10 charged patients at issue in this case. Tr.
97-111; GX 6, 8, 10, 12, 14, 16, 18, 20, 22, 24.\23\ DI1 also discussed
the Rx30 data retrieved from the thumb drive related to the 10 charged
patients. Tr. 111-16; GX 35, 36.\24\
---------------------------------------------------------------------------
\23\ These exhibits were admitted with the qualification that
these exhibits only contained the Schedule 2 hard copy prescriptions
for each of the 10 charged patients, not all of the prescriptions.
Tr. 102-11. [The Government noted, that ``some of the prescriptions
here are not Schedule 2s, but [the Government did] not litigat[e]
those prescriptions,'' and they are therefore not relevant to the
Government's prima facie case. Tr. 103.]
\24\ GX 35 is a narrowed version of Government's Proposed
Exhibit 25, which was previously ruled inadmissible during
prehearing proceedings. GX 35 only included information related to
the 10 charged patients. Tr. 116-18. See ALJ Ex. 32.
---------------------------------------------------------------------------
Diversion Investigators (the DIs were not identified by DI1)
returned to Pharmacy 4 Less during approximately February 2018. Tr.
136. During this visit, DI1 acquired copies of invoices for controlled
substances. Tr. 136. DI1 noted that a few of these invoices violated
DEA regulations by failing to provide a date of receipt.\25 *G\ Tr.
136-39.
---------------------------------------------------------------------------
\25\ The Respondent conducted voir dire of DI1 on this point and
argued that 21 CFR 1305 only applies to Schedule 2 controlled
substances. Tr. 140-45. For further analysis, see infra section
``Date of Receipt on Invoices.''
\*G\ DI clarified his testimony to say that ``only a few of them
actually contained the . . . date of receipt;'' specifically, there
were only ``four that contain[ed] the actual date of receipt,'' and
``eighty-five'' were not properly dated. Tr. 137-38.
---------------------------------------------------------------------------
Another administrative subpoena was served on Pharmacy 4 Less on
July 9, 2018. Tr. 95; GX 3.
DI1 was recalled during the second portion of the hearing at the
DEA Hearing Facility in Arlington, Virginia. DI1 credibly explained the
purpose of the corrected GX 4, and how he arrived at his results during
his audit of the pharmacy's records and inventories. Tr. 919-26. DI1
also testified to GX 38--Redacted (Initial Response from Florida E-
FORCSE reflecting only the 10 charged patients) and GX 40 (A
declaration by DI3 as to an administrative subpoena sent to the Florida
E-FORCSE for user history), which was introduced at the second portion
of the hearing. Tr. 929-36.\26\ DI3 was asked by DI1 to send an
administrative subpoena to the Florida E-FORCSE program to request a
user history report. Id. at 929-30. Based on a follow-up request by
DI1, the Florida E-FORCSE personnel reviewed their system to see when
Mr. Sprys and Ms. Mincy had accessed the Florida PDMP to look up
patients. Tr. 931-32; GX 40, Att. C.
---------------------------------------------------------------------------
\26\ GX 38--Redacted was admitted and substituted in place of
the original GX 38. Tr. 934. GX 40, p. 1, Att. A, and Att. C. were
also admitted into evidence. Tr. 935-36.
---------------------------------------------------------------------------
DI1 also offered three arrest records for Patient K.Y.D. Tr. 937;
GX 41-43. The arrest records were produced from ``<a href="http://arrest.org">arrest.org</a>,'' a
public website where members of the public can retrieve arrest
information about individuals, which DI1 occasionally uses in the
course of his employment. Id. at 938-39. DI1 indicated that this
website is a tool that pharmacists or doctors can utilize to look up
patients to see if they have ever been arrested for controlled
substance violations. Id. at 940. According to the records, Patient
K.Y.D. had previously been arrested on December 31, 2015, for
possession of oxycodone with an intent to sell. Id. at 940; GX 43.
Patient K.Y.D. had also previously been arrested on May 2, 2016, for
operating with a suspended license, possession of Schedule 2 controlled
substances, and possession of a Schedule 4 controlled substance. Tr.
941; GX 41. Finally, Patient K.Y.D. had also previously been arrested
on February 25, 2017, for possession of a Schedule 2 controlled
substance and resisting an officer without violence. Tr. 941-42; GX
42.\27\
---------------------------------------------------------------------------
\27\ The Respondent objected and argued that the arrest records
were unreliable and irrelevant to this matter. This Tribunal found
that these records were available to the public, and not being
offered for the truth of the matter of the arrests, but as a
resource that an individual such as a doctor or pharmacist would be
confronted with if they accessed this website. They were admitted
over objection. Tr. 942-43. Reviewing such arrest websites is not
required by the relevant standard of care, nor is it something that
Dr. Hamilton or the other pharmacists did at Publix Pharmacies. Tr.
1022-23.
---------------------------------------------------------------------------
Dr. Thomas Hamilton, Pharm. D.
Dr. Hamilton received his Doctor of Pharmacy degree at Nova
Southeastern University in Fort Lauderdale. Tr. 167. He has worked as a
pharmacist for 18 years. Id. at 169; GX 27. After being licensed in
1999, he worked for a short time at a small pharmacy before beginning
full-time at Publix pharmacy as a pharmacist. Tr. 172. He served in
[[Page 54556]]
various capacities at Publix, including Pharmacist, Assistant Manager
of the Pharmacy, and Pharmacy Manager. GX 27. He also served as a
``fixer,'' or a temporary Pharmacy Manager, who would ``clean up''
pharmacies. Tr. 169. Dr. Hamilton later transitioned to a Pharmacy
Supervisor, in which he oversaw up to 40-45 \*H\ pharmacies, in hiring,
firing and daily operations. Tr. 170. Additionally, Dr. Hamilton
evaluated stand-alone, independent pharmacies for purchase by Publix
Supermarkets. Id. at 170. This evaluation included review of the drug
invoices, the filled prescriptions, and the nature of the pharmacy's
overall business. Id. at 170-71. In order to spend more time with his
young family, Dr. Hamilton decreased his responsibilities with the
company, gave up his supervisory role, and now serves as a Pharmacy
Manager of a single pharmacy with Publix. Id. at 286-87.
---------------------------------------------------------------------------
\*H\ Amended pursuant to Tr. 170.
---------------------------------------------------------------------------
In connection with the investigation into Pharmacy 4 Less, Dr.
Hamilton reviewed the materials sent to him by the Government, which
included prescriptions (front and back), related patient medical notes,
and patient addresses. Id. at 177, 380-81. Additionally, Dr. Hamilton
reviewed prescription pricing via GoodRx. Id. at 177-78. Dr. Hamilton
noticed ``red flags'' in connection with the reviewed prescriptions.
Id. at 178. ``Red flags'' are concerns resulting from the review of the
prescription. Id. at 178-79. These concerns can be resolved through
some investigation by the pharmacist, such as speaking with the
patient, reviewing the medical history, or checking with the
prescriber. Id. at 179. Dr. Hamilton noted that the resolution of the
``red flag'' had to be documented in the file as part of the Florida
Standard of Care,\*I\ noting, ``[i]f it's not documented, there's no
evidence that . . . it was resolved *[or a phone call was made, or an
answer was given].'' Id. at 179-81, 306, 318, 337, 1006-11, 1016.\28\
---------------------------------------------------------------------------
\*I\ Throughout the case, the Government's expert and all
parties appear to have used the phrases ``standard of care'' and
``corresponding responsibility'' and ``standard of pharmacy
practice'' interchangeably. The testimony regarding the requirement
to resolve red flags is clearly related to Respondent Pharmacy's
corresponding responsibility under 21 CFR 1306.04. The
interchangeable use of this terminology does not impact my ultimate
finding that Respondent Pharmacy failed to resolve red flags in
contravention of Respondent's corresponding responsibility under 21
CFR 1306.04 and outside the usual course of professional practice in
violation of 21 CFR 1306.06. For consistency purposes, I will use
the language regarding standard of care to encompass the standard of
pharmacy practice and corresponding responsibility herein.
\28\ *[Omitted for clarity. The ALJ found that the Government
did not allege a separate violation regarding the documentation of
the resolution of red flags, but instead chose to consider such lack
of documentation as an inference supporting a finding that the red
flag was not resolved. In this case, I find that the Government's
expert credibly testified that documenting the resolution of red
flags was required by the standard of professional practice in
Florida. Furthermore, the issue of whether documentation was
required by the standard of practice in Florida was thoroughly
addressed by both parties at the hearing. See id. 179-81, 434-38,
1007-08. I find that it is unimportant to find an independent
violation related to the lack of documentation, because such lack of
documentation already supports the overall finding that Respondent
filled these alleged prescriptions in violation of its corresponding
responsibility and outside the usual course of professional practice
in Florida.]
---------------------------------------------------------------------------
Dr. Hamilton indicated the source of pharmacy standards in Florida
included ``Florida Regulation 64B,'' \29\ and guidance from the
National Board of Pharmacy Association. Id. at 180, 351-58. Dr.
Hamilton noted these standards are enforced by the Board of Pharmacy in
Florida. Id. at 180.
---------------------------------------------------------------------------
\29\ See West's Florida Administrative Code, Title 64.
Department of Health, Subtitle 64b16, Chapter 64B16-27--Pharmacy
Practice.
---------------------------------------------------------------------------
Dr. Hamilton explained that if the prescription involved a
controlled substance, that in itself was a red flag. Id. at 182. The
strength of medication and the duration of the medication therapy was a
concern, which needed to be addressed. Id. The pricing structure of the
controlled substance represented a concern, as well as the distance of
travel. Id. at 182, 360-61.
Dr. Hamilton noted ``red flags'' in a prescription to Patient A.E.,
for 84 tablets of 8 mg. of hydromorphone. Id. at 183-84; GX. 6, pp. 1-
2, GX. 5; RX 18, pp. 1-2, RX 19.\30\ Dr. Hamilton noted that 8 mg was
the highest dosage made of hydromorphone, a Schedule 2 controlled
substance. Tr. 184. Further, the number of dosage units prescribed, 84,
was also concerning. Id. at 184. Dr. Hamilton noted that, based on the
records, the first ``red flag'' involving a dangerously high dosage
level, had not been resolved. Id. at 186. Dr. Hamilton noted the
absence of any information relating to the patient's prescribing
history suggesting the patient was acclimated to this significant
dosage, and not ``opiate na[iuml]ve'' to this dosage. Id. at 188-90,
316-17. Dr. Hamilton indicated the Florida standard of care required
the starting date of the prescribed medication to be disclosed on the
face of the prescription or in a note readily available to the
pharmacist. Id. at 186-87, 350-51, 392-94. Dr. Hamilton acknowledged
that a pharmacist had access to the Florida PDMP, or ``E-FORCSE''
database, which contained prescribing history. Id. at 348-49.
---------------------------------------------------------------------------
\30\ Dr. Hamilton compared GX 5 with RX 18.
---------------------------------------------------------------------------
Dr. Hamilton noted that an identical prescription for hydromorphone
was issued to A.E. for two more consecutive months. Tr. 191-92; GX 6,
pp. 3-6. Dr. Hamilton noted the Florida standard of care regarding
``individualization'' required that the pharmacist consider whether an
extended high dosage of controlled medication should be continued or
should be reduced. Tr. 192-93. Dr. Hamilton expected to see a reduction
in dosage over time, or an explanation by the pharmacist for continuing
to dispense the same high dosage. Id. at 1013-14. Dr. Hamilton noted
there was no evidence that any reevaluation of the patient's continued
need for this strong medication had been made. Id. at 193. The fact
that the patient was on immediate release tablets further heightened
the ``red flag.'' GX 28, p. 6. Dr. Hamilton explained that immediate
release tablets typically addressed acute versus chronic or long-term
conditions, as suggested here by ongoing prescriptions for
hydromorphone. Tr. 193-94, 1013-14. This ``red flag'' was not resolved
on the face of the prescription, or in the medical notes. Tr. 194; GX
5, GX 6, pp. 5-6. Dr. Hamilton was also concerned by the cash purchase
of the prescription and the ``extremely high prices'' paid, of $5.95
per pill. Tr. 194, 199; GX, 28, p. 6.
Dr. Hamilton explained that medications are typically priced at the
``average wholesale price'' plus 20%. Tr. 195. Dr. Hamilton explained
that the appropriate price \*J\ of 8 mg. of hydromorphone was $1.50 per
tablet. He cautioned that this was an approximation by reviewing
pharmacy prices in his area, both of big chain pharmacies as well as
independents. Id. at 195, 326, 330-31. Dr. Hamilton opined that prices
per pill from wholesalers would be fairly consistent across the state.
Id. at 195, 1011-13. However, he noted that, at the retail level, the
purchase of just a few pills could result in an extremely high price
per pill versus the purchase of a large number of pills. Tr. 198.
---------------------------------------------------------------------------
\*J\ Dr. Hamilton referred to it as ``the market retail price.''
Tr. 195.
---------------------------------------------------------------------------
On rebuttal, Dr. Hamilton compared versions of the same medical
records as to A.E. See GX 5 and RX 18, 19. After pointing out
differences in the two versions, and granting the reliability of the
Respondent's versions, Dr. Hamilton opined that considering the GX 18,
19 version, his previous opinions as to A.E.'s dispensing remained the
same. Tr. 957-65. As related to the differences
[[Page 54557]]
between the Government and Respondent versions of the same records, Dr.
Hamilton conceded that the Respondent versions could be updated
versions of the Government versions. Id. at 1019-20. Dr. Hamilton
observed that updating medical records was required by the standard of
care. Id. at 1020.
Turning to patient A.R., Dr. Hamilton noted a prescription for 112
tablets of 15 mg of oxycodone represented several ``red flags'', citing
significant dosage, high quantity, frequency of prescribed usage (4
times daily), and high price.\31\ Id. at 204-05, 329; GX 8, pp. 1-2; RX
20. Dr. Hamilton was unable to find that these ``red flags'' were
resolved on the face of the prescription or on the ``information
sheet'' within the patient record. Tr. 205-06; GX 7. Dr. Hamilton
explained that, although the patient's ``information sheet'' contained
information relating to diagnoses and medical conditions, it did not
include information justifying the long-term use of the subject
oxycodone prescription. Tr. 206, 329-30; GX 28, pp. 12-14. As relates
to price per pill, Dr. Hamilton estimated the retail price to be
approximately 90 cents. Tr. 330-31. The next prescription for A.R. also
involved 15 mg of oxycodone, but for 140 tablets at a directed
frequency of 5 times per day at a price of $350. Tr. 207-08; GX 8, pp.
3-4. Dr. Hamilton noted the distance between A.R.'s residence and the
prescribing doctor's office and Pharmacy 4 Less. Tr. 208. Dr. Hamilton
estimated A.R. lived approximately 40 miles from the prescribing
doctor, and another 13 miles further to the subject pharmacy. Id. at
209. Dr. Hamilton indicated this distance represented a ``red flag,''
which went unresolved within the subject records. Tr. 209-10, 332-37;
GX 7, GX 8, p. 3.
---------------------------------------------------------------------------
\31\ Patient A.R. paid $280 for 112 pills of oxycodone in
connection with this prescription, or $2.50 per pill. *[Later,
Patient A.R. paid between $340 and $350 for 140 pills of oxycodone,
or approximately $2.43-$2.50 per pill. GX 8, at 3-6, 33-34.]
---------------------------------------------------------------------------
The next two prescriptions for A.R., which Dr. Hamilton indicated
disclosed the same ``red flags'' were identical prescriptions for 15 mg
of oxycodone, for 140 tablets, but at a price of $340. Tr. 212-14; GX
8, pp. 5-6, 33-34. *[Omitted based on further review of the record].
Dr. Hamilton opined the subject oxycodone prescriptions for A.R.
remained unresolved within the records reviewed, and were thus below
the standard of care in Florida. Tr. 215-16; GX 7.
On rebuttal, Dr. Hamilton compared versions of the same medical
records as to A.R. See GX 7 and RX 20, 21. After pointing out
differences in the two versions, and granting the reliability of the
Respondent's versions, Dr. Hamilton opined that considering the GX 20
and 21 version, his previous opinions as to A.R.'s dispensing remained
the same. Tr. 965-69.
As to Patient B.F., Dr. Hamilton reviewed a series of prescriptions
for hydromorphone 8 mg, 84 count, 3 times daily. Tr. 216-22; GX 12, pp.
13-14, 17-18, 21-22, 25-26; RX 24. The ``red flags'' revealed included
the controlled substance itself, the dosage at the highest available,
the high quantity (84 tablets), the immediate release, the ongoing
length of time it is being prescribed, and the high price ($490).\32\
Tr. 216-22.
---------------------------------------------------------------------------
\32\ Eighty-four tablets at $490 equals $5.83 per tablet. *[The
ALJ then found that Dr. Hamilton estimated the expected retail price
to be $0.90 per pill citing to Tr. 218-22 and GX 28, p. 11, but the
record does not support this finding. Dr. Hamilton originally
testified that hydromorphone had an estimated retail price of $0.90,
Tr. 218; however, after he refreshed his recollection with his
expert report he stated, ``I might have misspoke at $0.90. It's a
little bit more expensive for [D]ilaudid, or [h]ydromorphone . . .
.'' Tr. 222. Dr. Hamilton's export report stated that the estimated
retail price of hydromorphone was approximately $1.50 per pill. GX
28, at 11. Dr. Hamilton also testified elsewhere in the record that
the market retail price for hydromorphone was $1.50 per pill. See
e.g. Tr. 195-97. Moreover, albeit in a different context, Dr.
Hamilton testified that to the extent numbers appearing in his
expert report differed from numbers to which he was testifying based
on his recollection, the numbers in the expert report would be
``[m]ore accurate.'' Tr. 209. Based on the entirety of the record, I
find that Dr. Hamilton estimated the expected retail price of
hydromorphone to be $1.50 per pill.]
---------------------------------------------------------------------------
On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored
versions of medical records as to B.F., RX 24, 25. Dr. Hamilton noted
references to a discharge date of May 15, 2017, a reference to liver
cancer, stage 3, and the last fill of the subject prescription on May
15, 2017. Tr. 976-77. Even granting the reliability of the records, Dr.
Hamilton stuck with his original opinions as to B.F.'s dispensing. Id.
at 975-80.
As to Patient B.N., Dr. Hamilton identified ``red flags'' related
to a series of prescriptions for hydromorphone. Id. at 223. The first
was of 8 mg, 90 count, priced at $580. Tr. 222-23; GX 14, pp. 1-2; GX
13; RX 26. Dr. Hamilton reiterated the hydromorphone itself represented
an unresolved ``red flag,'' as well as the dosage, quantity and cost.
Tr. 223, 226. The second and third prescriptions for hydromorphone,
again with the same unresolved a ``red flags,'' involved 8 mg, 100
count, priced at $640. Tr. 224-28; GX 14, pp. 3-6; GX 13. The fourth
hydrocodone prescription, again with the same unresolved ``red flags,''
involved 8 mg, 100 count, priced at $600. Tr. 229-30; GX 14, pp. 15-16.
This prescription prompted an additional ``red flag'' as it represented
ongoing prescribing of hydromorphone without demonstrated
justification. Tr. 230. Dr. Hamilton reviewed a prescription for
oxycodone, 30 mg (the highest dosage available), 120 count, priced at
$600. Id. at 231-32. Dr. Hamilton opined the medication itself
represented a ``red flag,'' as well as the dosage, the quantity and the
cost. Id.; GX 14, pp. 19-20, GX 13. Additionally, transitioning from
hydromorphone to oxycodone required an explanation, which was not
contained within the records reviewed by Dr. Hamilton. Tr. 232. A
second prescription for oxycodone for B.N., for 30 mg, quantity 40, had
the same unresolved ``red flags.'' Tr. 233; GX 14, pp. 21-22. As this
represented the second consecutive prescription for oxycodone, an
additional ``red flag'' was raised regarding the ongoing unjustified
prescribing. Tr. 233-34. The next two oxycodone prescription for B.N.
involving the same unresolved ``red flags,'' involved 30 mg, 120 count,
priced at $600.\*K\ Tr. 234-36; GX 13; GX 14, pp. 23-24, 37-38.
---------------------------------------------------------------------------
\*K\ Dr. Hamilton also testified that additional prescriptions
falling between the November 11, 2016, and June 2, 2017,
prescriptions had the same unresolved ``red flags.'' Tr. 236.
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[[Page 54558]]
On rebuttal, Dr. Hamilton compared versions of the same medical
records as to B.N., GX 13 and RX 26, 27. After pointing out differences
in the two versions, and granting the reliability of the Respondent's
versions, Dr. Hamilton opined that considering the RX 26 and 27
version, his previous opinions as to B.N.'s dispensing remained the
same. Tr. 980-85.
As to patient K.Y.D., Dr. Hamilton identified a series of oxycodone
prescriptions with unresolved ``red flags.'' Tr. 237; GX16, pp. 1-2, 5-
6, 9-10, 63-64; RX 30, 31, pp. 2-4. The first three involved a dosage
of 30 mg, quantity 84, price $290. Tr. 237-39 *[For these
prescriptions, Dr. Hamilton testified that the red flags included the
highest strength dosage, high quantity, frequency of prescribed usage
(3 times daily), and high price.] By the third prescription, it also
triggered an additional ``red flag'' involving the ongoing unjustified
prescribing of oxycodone. Tr. 239. The fourth example for the identical
prescription triggered the same unresolved ``red flags.'' \*L\ Id. at
240.
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\*L\ Dr. Hamilton also testified that additional prescriptions
issued between March 31, 2016, and June 12, 2017, had the same
unresolved ``red flags.'' Tr. 241.
---------------------------------------------------------------------------
On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored
versions of medical records as to K.Y.D., RX 30, 31. Dr. Hamilton noted
references to a discharge date of June 12, 2017. Tr. 990-91. Even
granting the reliability of the records, Dr. Hamilton stuck with his
original opinions as to K.Y.D.'s dispensing. Tr. 990-94.
As to Patient K.E.D., Dr. Hamilton determined there were unresolved
``red flags'' involved in a series of oxycodone prescriptions. The
first was for 20.5 mg, quantity 112, for $430. Tr. 241-45; GX 17, GX
18, pp. 1-2, 3-4, 5-6, 41-42; RX 28, RX 29, p. 2. For the first, the
dosage of 20.5 mg represents a dosage outside common dosage units, and
would have been a compounded dosage, a ``red flag'' in itself. Tr. 242.
*[Additionally, Dr. Hamilton noted that the quantity, and price were
unresolved red flags for this prescription. Id.] The second and third
oxycodone prescription noted were for 20 mg, 112 quantity, priced at
$430. Tr. 244-45. Again, the medication itself represented a ``red
flag,'' as well as the dosage, quantity and price. Tr. 245. The fourth
oxycodone prescription was identical to the second and third, except
that the price was $400. Tr. 245-46. *[In addition to the ``red flags''
identified with the prior two prescriptions,] the fourth prescription
triggered the ``red flag'' of an extended prescription without apparent
justification.\*M\ Id. at 246.
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\*M\ Dr. Hamilton testified collectively regarding the remaining
prescriptions in GX 18 issued between December 21, 2015, and June 7,
2017, and opined that there were similar red flags for all of those
prescriptions and that none of those red flags were resolved. Tr.
246.
---------------------------------------------------------------------------
On rebuttal, Dr. Hamilton compared versions of the same medical
records as to K.E.D. See GX 17; RX 28, 29. After pointing out
differences in the two versions, and granting the reliability of the
Respondent's versions, Dr. Hamilton opined that considering the RX 28
and 29 version, his previous opinions as to K.E.D.'s dispensing
remained the same. Tr. 986-90.
As to Patient R.R., Dr. Hamilton identified a series of oxycodone
prescriptions, each which involved unresolved ``red flags.'' Tr. 247-
50; GX 20, pp. 1-6, 41-42; RX 32, p. 1; RX 33, p. 5. The first
prescription was of 18 mg, 112 quantity, priced at $250. Tr. 247. The
first ``red flag'' is that the dosage has been compounded, without
explanation. Id. The high quantity is a ``red flag,'' as well as the
high price paid. Id. The second and third prescriptions involved 15 mg,
quantity of 112, priced at $270. Tr. 248. The fourth prescription is
identical to the second and third, except for the price was $260. Tr.
249-50. The third and fourth prescriptions *[had the same unresolved
red flags as the earlier prescriptions, and] additionally triggered a
``red flag'' as extended prescriptions without apparent
justification.\*N\ Id.
---------------------------------------------------------------------------
\*N\ Dr. Hamilton testified collectively regarding the remaining
prescriptions in GX 20 issued between December 21, 2015, and May 30,
2017, and opined that there were similar red flags for all of those
prescriptions and that none of those red flags were resolved. Tr.
250.
---------------------------------------------------------------------------
On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored
versions of medical records as to R.R. See RX 32, 33. Dr. Hamilton
noted references to a discharge date of May 2, 2017, yet another
prescription fill on May 30, 2017. Tr. 994-95. Even granting the
reliability of the records, Dr. Hamilton stuck with his original
opinions as to R.R.'s dispensing. Id. at 994-97.
As to Patient R.V., Dr. Hamilton identified a series of oxycodone
prescriptions, each which involved unresolved ``red flags.'' Tr. 251-
56; GX 21; GX 22, pp. 27-28, 31-32, 34-35, 78-79; RX 34, p. 1; RX 35.
The first prescription was for 20 mg, 112 quantity, priced at $340. Tr.
251; GX 28. The first ``red flag'' was the high dosage. Tr. 251. The
next ``red flag'' was the quantity. Id. And the third was the high
price paid. Id. *[Dr. Hamilton testified that there was no evidence on
either the face of the prescription or in the patient record for R.V.
that these ``red flags'' were resolved. Id. at 251-52.] The second
prescription was identical to the first *[and had the same unresolved
``red flags.'']. Id. at 253. The third was identical to the first two,
except that it was priced at $310. Id. The third prescription *[had the
same unresolved red flags as the earlier prescriptions, and] had the
additional ``red flag'' as an extended prescription without apparent
justification. Id. The fourth prescription for oxycodone was of 20 mg,
quantity 120, priced at $340 *[and had the same unresolved red flags as
the third].\*O\ Id. at 254-55.
---------------------------------------------------------------------------
\*O\ Dr. Hamilton testified collectively regarding the remaining
prescriptions in GX 22 issued between January 11, 2016, and June 19,
2017, and opined that there were similar red flags for all of those
prescriptions and that none of those red flags were resolved. Tr.
255.
---------------------------------------------------------------------------
On rebuttal, Dr. Hamilton compared versions of the same medical
records as to R.V. See GX 21 and RX 34, 35. After pointing out
differences in the two versions, and granting the reliability of the
Respondent's versions, Dr. Hamilton opined that considering the RX 34
and 35 version, his previous opinions as to R.V.'s dispensing remained
the same. Tr. 997-1001.
As to Patient V.W., Dr. Hamilton identified a series of oxycodone
prescriptions, each which involved unresolved ``red flags.'' Tr. 256-
60; GX 23, GX 24, pp. 1-2, 3-4, 5-6, 41-42; RX 36. The first
prescription was for 15 mg, quantity of 84, priced at $300. Tr. 256.
The first ``red flag'' was the relatively high dosage. Tr. 256. The
next ``red flag'' was the quantity. Id. And the third was the high
price paid. Id. The second prescription involved 15 mg, quantity 112,
priced at $400. Tr. 257. The third prescription was identical to the
second, but was priced at $350. Tr. 258. The third prescription had
*[the same unresolved ``red flags'' as prior prescriptions based on the
dose and quantity] and additional [unresolved] ``red flags'' *[because
the prescription was written for four times a day and filled for only
three times a day and] as an extended prescription without apparent
justification. Id. The fourth prescription was identical to the third,
except priced at $285. Id. at 259. *[The fourth prescription shared the
``red flags'' arising based on the dose, quantity, price, and ``length
of time for immediate-release medication.'' \*P\ Id. at 259-60.
---------------------------------------------------------------------------
\*P\ Dr. Hamilton testified collectively regarding the remaining
prescriptions in GX 24 issued between January 25, 2016, and May 21,
2017, and opined that each had the same red flags as the fourth
prescription discussed herein and that none of those red flags were
resolved. Tr. 260.
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[[Page 54559]]
On rebuttal, Dr. Hamilton compared versions of the same medical
records as to V.W. See GX 23 and RX 36, 37. After pointing out
differences in the two versions, and granting the reliability of the
Respondent's versions, Dr. Hamilton opined that considering the RX 36
and 37 version, his previous opinions as to R.V.'s dispensing remained
the same. Tr. 1001-04.
As to Patient A.V., Dr. Hamilton discovered a series of controlled
substance prescriptions that were filled by Pharmacy 4 Less despite
unresolved ``red flags.'' Tr. 261-67; GX 10, pp. 1-2, 3-4, 5-6, 9-10,
15-16, 37-38, 41-42, 43-44, 45-46, 47-48, 59-60; RX 22. The first such
prescription involved 29 tablets of 8 mg of buprenorphine. Tr. 261-62.
The second prescription, filled 9 days after the buprenorphine was
filled, involved 112 tablets of oxycodone, 20 mg each, priced at $290.
Tr. 262. The oxycodone prescription itself presented ``red flags,''
which needed to be resolved, as discussed earlier, including the drug
itself, the large quantity, the relatively high dosage, and the price.
Id. Additionally, Dr. Hamilton observed the 20 mg oxycodone was being
prescribed in conjunction with the buprenorphine. Id. at 263.
Buprenorphine is used to wean someone off of an opiate, such as
oxycodone. Id. The prescribing of buprenorphine along with an opioid
prescription creates a ``red flag,'' which needs to be resolved. Id. at
262-63. The acceptable protocol would be to introduce the buprenorphine
as the dosage of oxycodone is reduced, until the oxycodone is
completely replaced by the buprenorphine. Id. at 262-65. Here, the
buprenorphine is introduced, yet nine days later the 20 mg of oxycodone
was filled, which is inconsistent with the typical detoxification
protocol, and can present some contraindication issues. Id. at 266-67.
Additionally, detoxification would require physician monitoring. Id. at
265. Dr. Hamilton noted there was no indication in the reviewed records
\*Q\ *[that the ``red flag'' was resolved]. Id. at 265-66. Another 8 mg
buprenorphine prescription of 60 tablets was filled almost two months
after the first buprenorphine prescription. Id. at 267-68. On the same
day, a second identical prescription for 20 mg of oxycodone was filled,
triggering the same set of ``red flags'' as previously described *[and,
according to Dr. Hamilton, there was no documentation that those ``red
flags'' were resolved]. Id. at 268-69. This second prescription for
oxycodone,\*R\ *[according to Dr. Hamilton, raised the same unresolved
``red flags'' as the first one, and an additional unresolved ``red
flag'' because the medication dosage and frequency remained unchanged
and ``[y]ou would see a de-escalation of medication with a patient
going through detox.'' Id. at 268-69. The next month saw a repeat of an
8 mg buprenorphine prescription *[for 60 tablets], along with a 20 mg
prescription for oxycodone, thus repeating the same unresolved ``red
flags.'' Id. at 271-72. Less than one month later, dual prescriptions
for 8 mg of buprenorphine and 20 mg of oxycodone were filled, repeating
the same unresolved ``red flags'' as described earlier. Id. at 271-73.
Additionally, as to the oxycodone, the repeated prescribing created the
unresolved ``red flag'' related to *[the length of time] without a
reduction in dosage. Id. at 273-74. Dr. Hamilton addressed another set
of dual prescriptions for 8 mg of buprenorphine and 20 mg of oxycodone,
thus repeating the same unresolved ``red flags'' discussed earlier.\*S\
Id. at 274-77.
---------------------------------------------------------------------------
\*Q\ The ALJ found that ``Dr. Hamilton noted that there was no
indication in the reviewed records that the physician was monitoring
any attempted detoxification.'' I have omitted the finding because I
do not see support for it in the record and find it to be
irrelevant. The record is clear that Dr. Hamilton did not see any
documentation of resolution of the ``red flag,'' which is ultimately
the fact at issue in this case.
\*R\ The ALJ found that the second prescription ``highlighted
the `red flag' relating to the absence of any evaluation as to the
reduction in the dosage or frequency of the oxycodone.'' I have
revised this finding to quote Dr. Hamilton.
\*S\ Dr. Hamilton testified collectively regarding the remaining
prescriptions for buprenorphine and oxycodone in GX 10 issued
between August 2, 2016, and February 13, 2017, and opined that each
oxycodone prescription had the same red flags as the other oxycodone
prescriptions discussed herein and that there was no documentation
that these red flags were resolved. Tr. 276.
---------------------------------------------------------------------------
On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored
versions of medical records as to A.V. See RX 22, 23. Dr. Hamilton
noted references to a consultation with Dr. Seaford, to ``tapering''
and to ``detox.'' Tr. 970-72. Even granting the reliability of the
records, Dr. Hamilton stuck with his original opinions as to A.V.'s
dispensing. Id. at 970-75.
Again on rebuttal, Dr. Hamilton confirmed that nothing in the
testimony of Mr. Parrado or Ms. Mincy has caused Dr. Hamilton to change
his previously offered opinions in this case. Id. at 1004-05. Dr.
Hamilton did agree with Mr. Parrado's observation that it was proper to
fill a pain prescription up to a month after the patient was released
from the hospital. Id. at 1017. Dr. Hamilton further commended the
Respondent's practices of maintaining medical records within their
pharmacy files. Id. at 1015-16.
Respondent's Case in Chief
The Respondent presented its case through the testimony of two
witnesses. First, the Respondent presented the testimony of Ms. Amy
Mincy (Ms. Mincy). Second, the Respondent presented the testimony of
its expert, Robert M. Parrado (Mr. Parrado).
Ms. Amy Mincy, R.Ph.\33\
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\33\ Ms. Mincy testified the entire day of November 7, 2018. She
was recalled to the stand during the second portion of the hearing
at the DEA Hearing Facility in Arlington, Virginia on February 25,
2019, for the remainder of her testimony.
---------------------------------------------------------------------------
Ms. Mincy testified to the following. Several of Ms. Mincy's claims
were contested by the government and will be discussed later. As
background, Ms. Mincy graduated from Mercer University in Atlanta,
Georgia, and has been a pharmacist since 1983. Tr. 569. She is licensed
in the State of Florida and has inactive licenses in Tennessee and
Virginia. Id. She has worked for a number of pharmacies for varying
lengths of time, including independent pharmacies, as a relief
pharmacist, and as a pharmacy consultant, over the course of her
career. Id. at 569-76, 579-83; RX 1.\34\ She has also previously been
disciplined by the Florida Board of Pharmacy for filling a prescription
for her mother, was placed on probation, and successfully completed the
terms of her probation in 1998. Id. at 579-82. She began working as a
pharmacist at Pharmacy 4 Less in January 2016. Id. at 576-77. She is
one of two pharmacists that works at Pharmacy 4 Less, along with Mr.
Sprys. Id. at 577. She works at Pharmacy 4 Less four days per week,
Monday through Thursday, with Mr. Sprys working on Friday. Id. at 822.
---------------------------------------------------------------------------
\34\ Ms. Mincy's CV was admitted over objection with the
corrections noted through Ms. Mincy's testimony. Tr. 584.
---------------------------------------------------------------------------
Ms. Mincy was working as the pharmacist on duty at Pharmacy 4 Less
on June 6, 2017, when the DEA conducted its on-site inspection at the
pharmacy. Id. at 584. She testified that DI1 and another Diversion
Investigator (hereinafter DI2) arrived at the pharmacy sometime between
10:00 a.m.-12:00 p.m. that day. Id. at 585. She did not know the DEA
was planning to conduct the on-site inspection that day. Id. at 585-86.
She was told that the inspection would take between 20-30 minutes or up
to an hour. Id. at 586.\35\ She related that Mr. Sprys' son, William
Sprys, was also in the pharmacy. Id. at
[[Page 54560]]
587. William Sprys acts as the administrator for the pharmacy, but is
not a registered pharmacist, so he primarily handles clerical
administrative duties. Id. at 587-88.
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\35\ When asked, Ms. Mincy said that it was primarily DI1 that
spoke to her and asked her questions during the inspection. Tr. 586.
She stated that DI2 was primarily observing. Tr. 587.
---------------------------------------------------------------------------
During the inspection, Ms. Mincy was handed a DEA Form 82, Notice
of Inspection. Tr. 589; GX 30. She was uneasy about consenting to an
inspection because she only works as an independent contractor at
Pharmacy 4 Less, not as a regular employee. Tr. 590-91. She asked to
contact Mr. Richard Sprys to ask about the form and whether she should
consent and sign the form. Id. at 591-92. She had William Sprys contact
Mr. Richard Sprys on the telephone because Richard was out of the
country at the time of the inspection. Id. at 592. The DIs were also
present during the telephone call. Id. She spoke to Mr. Richard Sprys
on speakerphone about the DEA inspection and the DIs request to inspect
the pharmacy. Id. Mr. Sprys then gave permission and directed Ms. Mincy
to sign the form. Id. at 592-93. Ms. Mincy then signed the Form 82. Tr.
594.
After signing the form, Ms. Mincy was taken into a separate room in
the pharmacy. Id. at 596. DI1 asked to see the pharmacy's perpetual
inventory. Id. at 598. DI1 proceeded to count pills of controlled
substances contained in the pharmacy. Id. DI1 asked for the perpetual
inventory pages for January 1, 2017, through June 6, 2017. Tr. 604-05.
The perpetual inventory was handwritten and was designed to keep track
of the pharmacy's prescription inventory. Tr. 630-31; RX 31
(Methadone), 32 (Oxycodone).
He then requested the pharmacy's biennial inventory. Tr. 605-06,
773-74; GX 37; RX 38.\36\ The pharmacy keeps its inventories in a
binder that is located inside the locked medication room. Tr. 607. The
Respondent's version of the biennial inventory indicated that it was
completed on April 26, 2017, at 8:00 a.m. by Ms. Mincy and Mr. Sprys.
Id. at 617-18, 767-73; RX. 38, pp. 1, 2, 3, 8-16. The inventory was
completed by entering the drug room, verifying the number of pills,
scanning the prescription bottles, and verifying their entry into the
pharmacy's computer system. Tr. 626-27. Ms. Mincy testified she
completed the biennial inventory in about three hours. Id. at 628. Ms.
Mincy indicated her understanding that the biennial inventory must be
completed either in the morning before the start of business or at the
end of the day at the close of business, and that it was completed
before the opening of business. Id. at 620-21, 817-19. The biennial
inventory was kept inside a binder with the C-2 perpetual inventory.
Id. at 622. The biennial inventory was later sent by the pharmacy to
DI1 after he left it at the pharmacy following the inspection. Id. at
638-42; 782-88. She indicated she was not aware that a biennial
inventory containing Schedule 2 prescriptions needed to be separate
from an inventory containing Schedules 3 through 5 prescriptions. Id.
at 818. To complete the biennial inventory, she would open the narcotic
cabinet and would hand-count the Schedule 2 pills inside. Id. at 820-
21.
---------------------------------------------------------------------------
\36\ Each version was admitted following the Government's voir
dire and request to admit GX 37 if this Tribunal were to admit RX
38. The Government agreed to redact the pricing information
contained at the Respondent's request. Tr. 775-82. However, the
Government later requested to withdraw the original GX 37 and offer
an alternative version of GX 37, with only pages 1-7 considered for
record. Tr. 912-17.
---------------------------------------------------------------------------
For the inventories in the pharmacy, Ms. Mincy would keep a
perpetual inventory of the prescriptions that had been filled. Id. at
628-34; GX 31, 32. The perpetual inventories were usually filled out by
Ms. Mincy, but were sometimes updated by Mr. Sprys. Tr. 628-29. Every
time a prescription was filled, it would be noted by either Mr. Sprys
or Ms. Mincy so that they could keep up with their inventory that was
on hand. Id. at 631. These were provided by Ms. Mincy to DI1 when he
asked to see the pharmacy's inventory to determine if it was correct.
Id. at 634-35. Ms. Mincy explained from the perpetual inventories how
it can be determined how many pills were currently in the inventory.
Id. at 635.
DI1 also asked to see the pharmacy's computer software, including
print-outs and reports. Id. at 609-11. DI1 then requested to inspect
the pharmacy's CSOS system. Id. at 612-13. CSOS is the pharmacy's
electronic controlled substance ordering system. Id. at 611, 865-66.
The pharmacy uses the CSOS system sourced through AmerisourceBergen.
Id. at 612. Ms. Mincy showed DI1 the steps to order, but could not
order because she did not have CSOS credentials at the time of the
inspection. Id. at 613, 839-40, 867. Each authorized user receives an
individual code that must be kept confidential to that user. Id. at
613. When showing the program to DI1, Ms. Mincy stated she did not put
in any credentials because she did not have any at the time. Id. at
615, 867-68. DI1 then accused her of ordering with Mr. Richard Spry's
credentials, which she promptly denied. Id. at 615. DI1 then proceeded
to take all the original copies of the pharmacy's Schedule 2
prescriptions and some of the Schedules 3-5 prescriptions from January
1, 2017, to June 6, 2017. Id. at 615-17, 891-93, 894-96; RX 59, 60.\37\
Ms. Mincy could not explain how there were differences between the
original copy of RX 59 she had maintained at the pharmacy and the
version that the Government had introduced into evidence, as the
version the Government had seized on June 6, 2017. Tr. 901-903; compare
GX 26, pg. 50 with RX 59.
---------------------------------------------------------------------------
\37\ Testimony related to RX 59 and 60 were objected to by the
Government for lack of notice and being beyond the scope of cross-
examination that was conducted on November 7, 2018. This Tribunal
permitted the Respondent to make a record of the testimony for the
Administrator's consideration, but sustained the Government's
objection as to being beyond the scope of cross examination. Tr.
885-91, 893, 896-900.
---------------------------------------------------------------------------
Ms. Mincy would use the Florida E-FORCSE system as part of her
resolution of red flags. Tr. 642-43. It is used to assist medical
personnel in keeping track of medications individuals are taking. Id.
at 642, 870-71. It contains a log of a patient's controlled substances
that are disbursed from a prescription written by a doctor and filled
by a pharmacist. Id. Pharmacies upload prescriptions daily into the E-
FORCSE system. Id. at 643. E-FORCSE contains prescriptions for
Schedules 2-4 controlled substances. Id. Ms. Mincy would use it daily
and prior to every fill of a new prescription for clients. Id. at 643.
E-FORCSE allows a pharmacist to immediately access a patient's name,
date of birth, address, and the aforementioned prescriptions. Id. at
645. It also allows a pharmacist to see which pharmacies a patient goes
to, or if the patient is doctor shopping or trying to fill
prescriptions early. Tr. 645.
At the pharmacy each morning, either Mr. Sprys or Ms. Mincy would
log on to the E-FORCSE system and it would be left open on the computer
to be accessed. Id. at 871. Ms. Mincy understood that when E-FORCSE
started, it was permissible to use another person's login since the
pharmacy manager or pharmacist would log in first thing in the morning
and it could be used throughout the day under that person's login
information. Id. at 903-908.\38\ The login systems for CSOS and E-
FORCSE are two separate systems. Id. at 872. CSOS is regulated directly
by the DEA and individual authorization and access has to be
[[Page 54561]]
granted by the DEA. Id. at 872. Ms. Mincy had a key and certificate
specific to her that had to be used to access the CSOS system. Id. at
872. On the other hand, E-FORCSE could be properly accessed by either
Mr. Sprys or Ms. Mincy and could be left open on the computer for
either person to access. Id. at 872.
---------------------------------------------------------------------------
\38\ Ms. Mincy explained that this is why sometimes another
person's E-FORCSE number would appear on the search records when she
had actually done the search. Tr. 908-09. There was further
testimony about the pharmacy's use of E-FORCSE and Ms. Mincy's
understanding of its use, along with discussion about proposed RX
57. Tr. 903-09. However, proposed RX 57 was later withdrawn by the
Respondent and GX 38 (redacted) was used instead after its
introduction during DI1's rebuttal testimony. Tr. 927-34; 1024-25.
---------------------------------------------------------------------------
Ms. Mincy would turn away patients if she found discrepancies on
the E-FORCSE, and did so, up to 10 to 12 times per month. Id. at 646.
She would turn them away if she suspected their ID was not legitimate,
if they were also filling their prescriptions somewhere else, if it
appeared they were doctor shopping, or if there were signs of diversion
or abuse. Id. at 647. She would also call the patient's doctor and
discuss the patient's medical needs and the prescriptions that had been
provided to her. Id. at 648. She would send patients away if there were
discrepancies between the identification provided and the information
provided on the prescription. Id. at 648. She would also look to see if
any of the patients had overdosed, which would help her determine
whether to fill a prescription. Id. at 841. She would also investigate
whether there was any indication that any of the patients were selling
their prescribed medications. Id. at 841-45.\39\ She would then place a
sticker on the prescription to signify that she had resolved any
potential red flags for the prescription. Id. at 648-49, 827-28.
---------------------------------------------------------------------------
\39\ The Government confronted Ms. Mincy with arrest records of
Patient K.Y.D. during its cross-examination. She was surprised to
hear that he had been arrested on December 31, 2015, for possession
of oxycodone with intent to sell, and later arrested on February 25,
2017, for possession of a Schedule 2 controlled substance. She said
he had later been discharged as a patient and that he was unruly.
Tr. 845-84; GX 41-43.
---------------------------------------------------------------------------
Ms. Mincy was familiar with each of the 10 charged patients in this
matter. Id. at 649. She has filled prescriptions for controlled
substances for each of the 10 subject patients. Id. at 830. She would
try to resolve red flags for each of the 10 subject patients by using
the previously discussed methods, including determining whether any of
them were opiate na[iuml]ve.\*T\ Id. at 813-14. One way she would do so
was by accessing E-FORCSE. Id. at 814, 831.\40\ Her E-FORCSE number is
*[redacted]. Id. at 831. She conceded there was no documentary evidence
that indicated that any of the subject ten patients started at lower
doses of opioids, including oxycodone and hydromorphone, and worked
their way up because they become opioid tolerant. Id. at 815-16. She
had medical release forms for Patient K.Y.D., but not for the other 9
charged patients. Id. at 828-29. Ms. Mincy confirmed she had previously
reviewed E-FORCSE in relation to the 10 charged patients. Id. at 875-
79. Ms. Mincy indicated that while the policy at the pharmacy was
presently (at the time of the hearing) to run each controlled substance
patient through E-FORCSE, it had previously been only to run each
Schedule 2 prescription. Id. at 880-81.
---------------------------------------------------------------------------
\*T\ Ms. Mincy, responded ``No'' to the question ``Did you ever
fill any prescription the first time for a patient where it was
contra-indicated for the amount because a patient might have been
opiate na[iuml]ve?'' Tr. 649-50.
\40\ When asked, Ms. Mincy stated that she had not printed out
any documents from E-FORCSE that would show she had looked at the 10
charged patients. Tr. 814-15.
---------------------------------------------------------------------------
The pharmacy used the Rx30 computer software to fill prescriptions.
Id. at 650. This was an internal system the pharmacy used to collect
information, such as patient's names, addresses, phone numbers,
allergies, and diagnostic codes. Id. at 650-51, 687-90; see, e.g., GX
5; RX 18, p. 1; RX 19. It is also used to input information related to
the patient's doctor, prescriptions, directions for the prescriptions,
and number of days for the supply. Tr. 652. Each prescription was
entered into the program one at a time, even if the doctor had put
multiple substances on a single prescription form. Id. at 652-53. The
Rx30 program would flash red with an alert if there was a contra-
indication that something in the prescription did not match with the
information on file to let Ms. Mincy know that some follow up was
necessary. Id. at 652-54.
The pharmacy maintained patient record maintenance files through
their internal system. Id. at 687-90, 706-09, 713-16, 722-31, 733-67;
RX 18-37. These records were also used to maintain due diligence on the
pharmacy's patients and resolve red flags as they arose. Id. at 707-08,
840-41.
Ms. Mincy had been present at Pharmacy 4 Less during inspections by
the Florida Department of Health, including on February 28, 2017. Id.
at 657-58. Ms. Mincy assisted the DOH inspector throughout the state
inspections. Id. at 659-60. There were no deficiencies found during the
February 28, 2017 inspection. Id. at 662; RX 15. She was also present
during an inspection of the pharmacy on September 5, 2017. Tr. 669,
674. This inspection was done by the Board of Pharmacy. Id. at 667,
671-72. Ms. Mincy was given an inspection report at the end of that
inspection, although the inspection report appeared to be incomplete.
Tr. 675-81; RX 14.
At the end of the DEA inspection, DI1 took ten ``California
folder'' files of Schedule 2 prescriptions dated between January 1,
2017, through June 6, 2017. Tr. 799-801. A ``California file'' consists
of bundles of prescriptions that the pharmacy keeps for its records.
Id. at 801. DI1 later requested twenty-four additional ``California
files'' from Mr. Sprys. Id. at 801-02. The pharmacy kept a receipt that
documented originals of the Schedule 2 prescriptions in the pharmacy.
Tr. 802-03; RX 12.
Ms. Mincy was present during the inventory taken by DI1 on June 6,
2017. Tr. 835. She signed a DEA closing inventory sheet, confirming
that the drug counts were correct. Tr. 835-37; GX 39.\41\
---------------------------------------------------------------------------
\41\ While she could not recall signing the inventory sheet, she
stated that it was her signature on the document. Tr. 837.
---------------------------------------------------------------------------
Mr. Robert M. Parrado, BPharm., R.Ph.
Robert Parrado graduated from the University of Florida in 1970
with a B.S. in Pharmacy. Tr. 401. Mr. Parrado has been licensed in
Florida as a Pharmacist since 1971. Id.; RX 5, at 1. He was formerly
licensed as a Consulting Pharmacist by the State of Florida up until
1989, which involved work with institutional facilities. Tr. 401; RX5,
at 1. Mr. Parrado has received several awards over the years: The R.Q.
Richards Award from the Florida Pharmacy Association for pharmaceutical
public relations, and the Generation Rx Award in the field of
prescription drug abuse and drug diversion from Cardinal Health. Tr.
402. He is presently President and CEO of Parrado Pharmacy Consultants,
Inc., which involves pharmacy consulting with pharmacies, pharmacists,
and with government agencies. Id. at 402-03; RX 5. Mr. Parrado
previously worked for CVS Pharmacy from 2000 to 2009 as a Pharmacist.
Tr. 403. For nine months in 2007, Mr. Parrado was a Regional
Acquisition Specialist, involved in acquiring independent pharmacies by
CVS. Id. Prior to working for CVS, Mr. Parrado worked for approximately
three years for Eckerd Drugs and Albertson's. Id. at 404. Previously,
Mr. Parrado worked for St. Joseph's Hospital as an Inpatient Staff
Pharmacist, during which time he consulted with physicians on a daily
basis. Id. Prior to St. Joseph's, Mr. Parrado was the Director of
Pharmacy at Centro Hispano Hospital in Tampa. Id. at 404-05. Prior to
that, for a few months, Mr. Parrado worked as a Pharmacist at SupeRx
Drugs. Id. at 405.
From 2001 to 2004, Mr. Parrado was a member of the Florida Board of
[[Page 54562]]
Pharmacy. Id. at 406. From 2003 to 2009, he was on the Board's
Accreditation Council on Pharmacy Education. Id. As such, Mr. Parrado
was involved in the accreditation of Florida schools of pharmacy. Id.
While on the Board, Mr. Parrado was on the Rules Committee. Id. at 407.
He also served on the Legislative Affairs Committee, which wrote
proposed legislation for presentation to the Florida Department of
Health, and for consideration by the Florida legislature. Id. During
2004, Mr. Parrado was Chairman of the Florida Board of Pharmacy. Id. at
408. Since 2001, Mr. Parrado has been a perpetual member of the
National Association of Boards of Pharmacy. Id. Mr. Parrado was a
member of the National ``Rules Committee,'' which developed ``model
rules'' for consideration by individual states. Id. at 408-09. For 18
months, ending in 2001, Mr. Parrado was President-elect of the Florida
Pharmacy Association. Id. at 409. Later, Mr. Parrado served as Speaker
of the House of Delegates for the Association. Id. at 410. Since 2014,
Mr. Parrado has been guest lecturer on pharmacy law at the University
of South Florida College of Pharmacy. Id. As part of a recurring
continuing education course, Mr. Parrado taught ``Resolving Red Flags,
Allowing Patients to Legally Obtain Their Lawful Medical
Prescriptions.'' Id. at 411. He has taught this course at universities,
to county and state pharmacy associations, and other professional
organizations. Id. at 411-12. He has presented to various professional
organizations a course on ``Identifying Drug Diversion.'' Id. at 412.
Mr. Parrado has testified as an expert witness previously, including an
estimated eight or nine times as an expert called by DEA. Id. at 414-
16.
Mr. Parrado had last prescribed a controlled substance
approximately three or four years prior to the instant hearing when
working as a substitute pharmacist at Genoa Healthcare. Id. at 418.
Regarding his most recent dispensing of opioids on a regular basis, Mr.
Parrado estimated it to be 2011. Id. at 419. Mr. Parrado was certified
as a pharmacy expert. Id. at 431.
As relates to opioid na[iuml]ve patients, Mr. Parrado described
various scenarios in which a patient, even one who has been dispensed
opioids in the past but who has been deprived of opioids for a month or
two, can become dangerously opioid na[iuml]ve. Id. at 433. To ensure a
patient prescribed opioids is not opioid na[iuml]ve, Mr. Parrado
described several tools available to the pharmacist. Id. at 433-34. The
pharmacist should ask a number of questions to alleviate concerns. Id.
at 434. He can also reference the E-FORCSE database. Id.
Mr. Parrado was critical of the limited records Dr. Hamilton
reviewed to form his opinion in this case. Id. at 434. Mr. Parrado
suggested he would have asked the DEA to share more documentation with
him than was shared with Dr. Hamilton. Id. at 443.
As related to resolving red flags, Mr. Parrado opined that in
addition to consulting the E-FORCSE database, a pharmacist may obtain
medical records directly from the physician, or access the ``patient
record maintenance'' from the Rx30 computer program. Id. at 435-36. As
to Dr. Hamilton's opinion that the resolution of ``red flags'' had to
be documented under Florida law, either on the prescription or
somewhere else readily available to the pharmacist, Mr. Parrado
disagreed, claiming there was no such requirement under Florida law.
Id. at 434, 438. Mr. Parrado conceded documenting the resolution of
``red flags'' may represent the ``best practice.'' \*U\ Id. at 434. As
to the subject documentation, Mr. Parrado observed that most
pharmacists do ``document somewhat.'' Id. at 435. Most document on the
back of the prescription. Id. However, if that wasn't possible, Mr.
Parrado opined that it was acceptable to ``document'' in a card file
system, or in the ``note'' field on your computer system. Id. Mr.
Parrado also noted he created a computer program, called ``Red Flag
Resolver,'' which would preserve such documentation on the computer
server. Id. Mr. Parrado suggested diagnostic codes could be used on the
prescription to demonstrate the medication was justified on the basis
of the medical condition. Id.
---------------------------------------------------------------------------
\*U\ Mr. Parrado testified that there is ``no regulation that
says you have to document . . . It may be a best practice to do
that. But it [does not] say you have to.'' Tr. 434. When asked by
the ALJ whether ``documenting the resolution of this red flag issue
might be the best practice,'' Mr. Parrado testified ``It might be,
[it is] a good, I do it.'' Id. at 436. Later, Mr. Parrado testified
that, ``[y]ou have to resolve the flag . . . . Does it say anywhere
that you have to document it? No. Should you? Of course. How are you
going to remember; how is your partner coming going to know, because
there [are] many pharmacists coming in and out of the pharmacy.''
Id. at 438.
---------------------------------------------------------------------------
Mr. Parrado explained that to resolve any red flag regarding
``immediate release'' medication, the physician can be consulted. Id.
at 447-48. Mr. Parrado noted that ``immediate release'' medications are
cheaper than the extended release versions, and that the insurance
company may not pay for extended release. Id. at 448.
Mr. Parrado also disagreed with Dr. Hamilton's estimated price for
each pill of oxycodone at .90 cents. Id. at 449. Mr. Parrado suggested
the price of Schedule 2 controlled substances are often inflated to
accommodate the added expenses inherent in dispensing them, such as
additionally scrutiny, legwork, record-keeping, and inventories. Id.
Mr. Parrado conceded that pharmacy pricing was very competitive. Id. at
449-50. Mr. Parrado explained that insurance issues can explain why a
pharmacy may only accept cash payments \*V\ *[omitted]. Id. at 450-51.
Mr. Parrado explained that ``cash'' in the pharmacy business may
include by credit card or even by check. Id. at 460.
---------------------------------------------------------------------------
\*V\ The ALJ further found that the insurance issues can explain
why a customer would pay cash. That portion of the finding is
neither relevant to the alleged conduct nor did I find support for
it in the record. Tr. 450-51.
---------------------------------------------------------------------------
The only explanations Mr. Parrado could give for a pharmacy
charging different prices for the same medication was a potential
higher cost from a different wholesaler, the use of discount coupons,
or indigent pricing programs. Id. at 451-52.
Regarding inordinate travel to fill a prescription, Mr. Parrado
agreed it was a red flag, which needed to be resolved. Id. at 453.
*[But Mr. Parrado did not go on to opine as to whether or not the red
flag was resolved with regard to the patient file for A.R. at issue in
this case. Id.] As to the 8.5 mg prescription for hydromorphone, Mr.
Parrado did not recognize it as requiring any investigation.\*W\ Id. at
454. Prescriptions for compounded medications are a normal part of
pharmacy work. Id. at 453-54; GX 12, p. 17-18.
---------------------------------------------------------------------------
\*W\ Mr. Parrado did not testify in the positive or the negative
regarding the need for an investigation, and he was never asked
whether an 8.5 mg prescription for hydromorphone raised a red flag
that needed to be resolved. Tr. 454.
---------------------------------------------------------------------------
As to Patient B.F., who was apparently suffering from stage 3
hepatic cancer, Mr. Parrado opined that absent an inconsistent physical
presentation by the patient at the pharmacy, the diagnosis itself
resolved any ``red flag'' created by the large amount of opioids
prescribed. Id. at 455-56.
Mr. Parrado disagreed with Dr. Hamilton's concept of the ``minimum
standard of care,'' which Dr. Hamilton attributed to both the Florida
Administrative Code, specifically ``Florida Regulation 64B,'' \42\ and
guidelines from the National Board of Pharmacy Association. Id. at 180,
351-58. Mr. Parrado understood the ``minimum standard of care'' as a
violation of a law or rule of the Pharmacy Act, or of the Florida
[[Page 54563]]
Administrative Code. Id. at 456. Mr. Parrado did not recognize any
violation of the Florida minimum standard of care by Pharmacy 4 Less in
the documents he reviewed and interviewing the two pharmacists
involved. Id. at 456-58. Mr. Parrado reviewed favorable Florida
Department of Health Inspection Reports dated February 28, 2017,
September 5, 2017. Id. at 475-80, 546; RX 14, 15, 16, 17. One of the
documents Mr. Parrado reviewed at Pharmacy 4 Less was their biennial
inventory completed April 26, 2017. Tr. 489.
---------------------------------------------------------------------------
\42\ See West's Florida Administrative Code, Title 64.
Department of Health, Subtitle 64b16, Chapter 64B16-27--Pharmacy
Practice.
---------------------------------------------------------------------------
Mr. Parrado disagreed with Dr. Hamilton's opinion that 84 or 112
opioid tablets, *[for 30 mg of oxycodone,] represented ``red flags,''
which needed to be resolved. Id. at 461-63. He did not consider these
to be inordinate amounts. Id. at 463.
Mr. Parrado agreed that the simultaneous prescribing of oxycodone
and buprenorphine to Patient A.V. represented a ``red flag'' which
needed to be resolved. Id. at 463. Mr. Parrado was able to resolve it
by reviewing the PRM records. Id. at 464. It revealed the pharmacy had
contacted the physician, who advised he was attempting to wean the
patient off of the oxycodone. Id. at 463-65.
In reviewing the PRM for each of the ten subject patients, Mr.
Parrado found evidence that Pharmacy 4 Less contacted or attempted to
contact the physician in each of ten cases to resolve red flags, and
that each ''red flag'' described by Dr. Hamilton was properly resolved.
Id. at 490-92.
Mr. Parrado found none of the dosage units inordinately high, not
even the 8 mg of hydromorphone. Id. at 491. He actually deemed 15 to 20
mg of oxycodone a ``very low dose,'' in contrast to Dr. Hamilton's
assertion that those doses were relatively high. Id. at 510. As to the
high prices charged, Mr. Parrado disagreed that the subject prices were
suspiciously high. Id. at 492-93, 534. Mr. Parrado explained that
following the crackdown on ``pill mills'' in Florida, opioids became
more difficult for patients to obtain. Id. at 457, 539. They may have
to travel to multiple pharmacies to even find the medication, so they
would be willing to pay higher prices for them. Id. at 457, 539.
Mr. Parrado did not address the ``red flag'' described by Dr.
Hamilton for the ongoing opioid prescriptions without considering a
reduction in dosage, ``individualization.'' \*X\ Id. at 492.
---------------------------------------------------------------------------
\*X\ Though Mr. Parrado did not specifically address this red
flag, he did testify generally that assuming there were red flags
with every one of the patients, those red flags ``seemed to be''
resolved in every case and that he ``saw documentation where they
had written down the resolutions.'' Tr. 492.
---------------------------------------------------------------------------
On cross-examination, Mr. Parrado was confronted with Florida
Administrative Code Section 64(B)16-27.800, requiring pharmacies to
maintain patient records. Id. at 495-96. It specifically requires the
pharmacy to ``provide for the immediate retrieval of information
necessary for the dispensing pharmacist to identify previously
dispensed drugs at the time a new or refill prescription is presented
for dispensing,'' *[and requires that a ``reasonable effort is made to
obtain, record and maintain . . . pharmacist comments relevant to the
individual's drug therapy, including any other information peculiar to
the specific patient or drug.'' Tr. 496.]
Mr. Parrado indicated the ``red flag'' identified by Dr. Hamilton
regarding whether patients could be opioid na[iuml]ve had been resolved
by the subject pharmacists. Id. at 497. Mr. Parrado learned this by
interviewing the pharmacists, and being satisfied with the steps they
*[told Mr. Parrado that they generally] took, including checking with
the PDMP. Id. at 496-99.
Mr. Parrado did not observe the ten patients increasing their
dosage above the norm. Id. at 511. Most appeared to remain at
``maintenance levels.'' Id. at 511-12.
As to Patient R.V., who, according to the pharmacy notes, was
suffering from a neoplasm, Mr. Parrado was not ``concerned'' by a
medical record from the pain doctor, which described her condition as
cervicalgia resulting from a ``fender bender.'' Id. at 516-22, 549; RX
34, p. 1, RX 35, p. 2.
As to Patient B.F., who Mr. Parrado testified was suffering from
liver cancer, however, Mr. Parrado was unable to identify the cancer
diagnosis by virtue of the diagnostic codes contained in the records.
Id. at 514. However, he recalled seeing the cancer diagnosis in a
medical note. Id. at 513-16.
Regarding RX 22, pp. 2-3; GX 10, Mr. Parrado discovered the
pharmacists resolved the red flag by speaking with the subject
pharmacists, who advised they confirmed they contacted the physician,
who advised he was weaning the patient off of oxycodone with
buprenorphine. Tr. 522-25. However, in GX 10, it appears the
buprenorphine was prescribed for sciatica pain. Id. at 524-25. Mr.
Parrado dismissed the medical codes as likely erroneous, choosing to
rely on the conversation between the pharmacist and the physician. Id.
at 525-26. As to the nearly one year period of *[unchanged strength]
oxycodone prescriptions from April 12, 2016 to April 10, 2017, in
conjunction with the buprenorphine intervention, Mr. Parrado recognized
it to be a red flag, which would require the pharmacist to investigate
by contacting the physician, pursuant to Fla. Admin. Code Sec. 16-
27.810. Tr. 526-27. *[Mr. Parrado did not testify specifically as to
whether or not this ``red flag'' was in fact resolved with a call to
the physician. Tr. 527.]
As to Patient R.R., who apparently suffered a ``broken back'' and
fractured tibia from a car accident, Mr. Parrado was not concerned that
the patient was discharged from the hospital on May 2, 2017, yet the
final prescription was issued on May 30, 2017. Id. at 527-28, 551; RX
32, pp. 1-2. Mr. Parrado did not consider a prescription issued a month
after discharge unusual, and assumed the patient had not yet found
another doctor. Tr. 528. Mr. Parrado was not concerned by the medical
report denying any surgical history for R.R., as it was not
contradictory of the above pharmacy notes, explaining a broken tibia
does not necessarily require surgery. Tr. 529.
As to Patient A.E., although Mr. Parrado reviewed the relevant
medical records, which contained some obvious contradictions, including
the patient claiming a pain level of 10 of 10, yet the physical
examination by the physician showed no physical restrictions. Id. at
532. Mr. Parrado did not appear to have evaluated the substance of the
medical records, but only the fact that the pharmacist had obtained the
records and verified the patient was being treated for pain.\*Y\ Tr.
529-32; RX 18, RX 19, pp. 2, 3.
---------------------------------------------------------------------------
\*Y\ Mr. Parrado testified, that he was not considering the
medical records with specificity for their content, but ``was
looking to see that they had gotten something from the doctor to
help them resolve [red flags]. . . . [he] considered the fact that
they had [the medical record], and that the doctor was treating pain
and that they had gotten that.'' Tr. 532.
---------------------------------------------------------------------------
As to Patient K.E.D., who was reportedly suffering from ``chronic
pain'' as the result of a ``severe auto accident,'' yet the medical
records deny past hospitalization, Mr. Parrado focused on the key
findings of ``chronic pain'' and ``auto accident'' and not on
contradictions in the medical records. Tr. 532-33, 552; RX 28, 29, p.
3.
As to Patient A.R., who apparently drove 45.4 miles *[one way] to
see his physician and to obtain his medications at Pharmacy 4 Less, Mr.
Parrado did not find that distance unusual, citing the difficulty in
locating pharmacies which carried opioids. Tr. 539. Mr. Parrado
conceded he has testified in other cases that driving 40 miles was a
red flag. Id. at 541-42. Mr. Parrado distinguished his prior testimony
as the distance was also part of a suspicious pattern. Id. at 542.
[[Page 54564]]
Mr. Parrado conceded that dual prescriptions for hydromorphone and
methadone represented a red flag, but one which could be resolved by
contacting the physician. Id. at 542-43. As to Patient B.F., Mr.
Parrado did not consider multiple different opioid prescriptions
concerning, explaining that physicians often try different medications
to find an effective treatment. Id. at 543-44; RX 24, pp. 2-3. Further,
Mr. Parrado did not view the simultaneous prescription of methadone and
hydromorphone concerning, as methadone could be used as an extended
release reliever, while the hydromorphone was an immediate release. Id.
at 544. Mr. Parrado conceded he had testified previously that that
combination was a red flag, but a resolvable red flag. Id.
As to Patient A.V., the prescription bore a code for sciatica. Id.
at 545. Mr. Parrado \*Z\ *[testified that the diagnostic code for
sciatica was inherently reliable because it was handwritten as opposed
to created by a computer.] Id. at 545-46, 551; GX 10, p. 15.
---------------------------------------------------------------------------
\*Z\ The ALJ found that Mr. Parrado was not concerned by the
sciatica code, as errors happen. I understand, and have edited this
finding accordingly, Mr. Parrado's testimony to be that here the
sciatica code was inherently reliable because it was handwritten
rather than generated by a computer error, which he previously
testified occurs frequently. Tr. 545.
---------------------------------------------------------------------------
Mr. Parrado testified that ``due diligence files'' in a pharmacy
would include all information used by the pharmacists to resolve red
flags. Tr. 546.
Mr. Parrado's Sur-Rebuttal Testimony
During the second part of the hearing, the Respondent recalled Mr.
Parrado to give sur-rebuttal testimony to the Government's rebuttal
case. The Government objected to the testimony by Mr. Parrado and
argued that sur-rebuttal testimony was not permitted by the rules. Id.
at 1027. This Tribunal sustained the government's objection, but
permitted the Respondent to continue questioning Mr. Parrado to make
his record for the Administrator's consideration should the
Administrator find this Tribunal's evidentiary ruling in error. Id. at
1028-29.
This Tribunal instructed the parties to brief the issue as to the
propriety of sur-rebuttal testimony. In their Posthearing Brief, the
Government concedes that there is no express prohibition of sur-
rebuttal testimony, however, the regulations provide that unduly
repetitious testimony will not be admitted. Govt Posthearing Brief at
46-47; 21 CFR 1316.59(a). The Government argues that the Respondent did
not identify what was being proffered and the additional testimony
``was doing nothing more than seeking to bolster [the Respondent's]
case.'' Govt Posthearing Brief at 46.
Upon a review of the Government's brief and the transcript of the
proceedings, I find that sustaining the Government's objection to sur-
rebuttal testimony was ill-advised. Although there is no relevant
regulation or rule authorizing sur-rebuttal, neither is there a
regulation or rule authorizing rebuttal testimony.\43\ However, the
Attorney General's Manual on the APA finds in Presentation of Evidence,
Section 7 (c) that ``[e]very party shall have the right to present his
case or defense by oral or documentary evidence, to submit rebuttal
evidence, and to conduct such cross-examination as may be required for
a full and true disclosure of the facts.'' Accordingly, this Tribunal
recommends that the Administrator find the subject ruling in error and
fully consider Mr. Parrado's sur-rebuttal testimony as direct evidence,
to the extent it does not exceed the scope of rebuttal evidence.\44\
---------------------------------------------------------------------------
\43\ The Agency has permitted and considered surrebuttal
evidence in the past. Flavio D. Gentile, M.D.; 55 FR 3113 (1990).
\44\ Sur-rebuttal evidence is permitted to confront the opposing
party's rebuttal evidence.
---------------------------------------------------------------------------
On sur-rebuttal, in explaining the differences between the
Government's and the Respondent's versions of the medical record
exhibits, Mr. Parrado affirmed the propriety of updating pharmacy
records as relevant information is learned. Id. at 1029-30. Mr. Parrado
further affirmed the propriety of including Schedules 3-5 prescriptions
within the pharmacy records to reflect the totality of the dispensing,
and not just the Schedule 2 prescriptions.\*AA\ Id. at 1033-34.
---------------------------------------------------------------------------
\*AA\ Mr. Parrado testified that when considering the ``total
profile'' of all prescriptions for these patients, ``the patients
were getting all their medications there . . . . [that is] what you
want. . . . You [do not] want him just buying controls from you
because now you [do not] know what else is going on with that
patient. . . . It essentially resolved that red flag'' meaning the
person is not ``just trying to obtain narcotics from [the
pharmacy].'' Tr. 1033-34.
---------------------------------------------------------------------------
Mr. Parrado further opined that many of the medical conditions and
diagnoses noted in Pharmacy 4 Less files, ``chronic pain, cancer,
neoplasms, broken backs'' are conditions which cannot be treated by
surgery, but rather by opioid therapy. Id. at 1029-31. The dosage and
frequency of such opioid therapy is designed to permit the patient to
operate at a normal level. Id. at 1032. As to Dr. Hamilton's
expectation of the tapering down of opioid doses, Mr. Parrado noted
tapering in chronic pain patients was often difficult and ineffective.
Id. at 1036. Finally, Mr. Parrado offered that the Respondent issued a
below average number of oxycodone tablets as compared to other Florida
pharmacies during the relevant period. Id. at 1037-40. Mr. Parrado
conceded there were no pharmacy records explaining that the long
distances traveled by customers of the Respondent was due to pharmacies
going out of business. Id. at 1041. Nor did Mr. Parrado observe records
in this case suggesting patients could not afford extended release
medications. Id. at 1041.
The Facts
Stipulations of Fact
The Government and the Respondent, through counsel, have agreed to
thirteen stipulations, which I recommend be accepted as fact in these
proceedings:
1. Pharmacy 4 Less, LLC, is registered with the DEA to handle
controlled substances under Schedules II to V under DEA COR No.
FP5459082. Its registered address is: 805 Douglas Avenue, Suite 159,
Altamonte Springs, Florida 32714.
2. Pharmacy 4 Less's COR was issued on February 2, 2018.
3. Richard Sprys, R.Ph., C.Ph., is the owner and manager of
Pharmacy 4 Less.
4. Amy Mincy, R.Ph., is a pharmacist at Pharmacy 4 Less.
5. On June 6, 2017, DEA conducted an audit of Pharmacy 4 Less.
6. Proposed Government's Exhibit 2 is a true and correct copy of
the June 22, 2017 Administrative Subpoena served upon Pharmacy 4 Less.
7. Pharmacy 4 Less completed its compliance with the administrative
subpoena on July 11, 2017.
8. DEA served Pharmacy 4 Less with an Order to Show Cause on July
5, 2018.
9. Pharmacy 4 Less submitted a Corrective Action Plan to John J.
Martin, Assistant Administrator for the Diversion Control Division of
DEA, on July 31, 2018.
10. Pharmacy 4 Less submitted a Request for Hearing to the Office
of the Administrative Law Judges at DEA Headquarters on August 1, 2018.
11. On August 8, 2018, Mr. Martin denied Respondent's request to
discontinue or defer administrative proceedings.
12. Ms. Amy Mincy signed the DEA Form 82, Notice of Inspection of
Controlled Premises on behalf of Pharmacy 4 Less during the June 6,
2017 on-site inspection. Tr. 38.
13. RX 19, 21, 23, 25, 27, 29, 31, 33, 35, 37 were supplied to the
DEA in response to the July 9, 2018 administrative subpoena. Tr. 812-
13.
[[Page 54565]]
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.
1. The Respondent currently holds active COR FP5459082. ALJ Ex. 1.
2. DI1 conducted an on-site inspection of Pharmacy 4 Less on June
6, 2017. Tr. 37.
3. Pharmacy 4 Less was randomly picked for regulatory inspection by
the DEA. Tr. 37.
4. Ms. Amy Mincy signed the Notice of Inspection presented to her
by DI1. Tr. 38-39; GX 30.
5. Ms. Mincy could not locate an initial inventory, and Mr. Richard
Sprys confirmed via speakerphone with DI1 that Pharmacy 4 Less did not
have an initial inventory. Tr. 39-40.
6. Ms. Mincy provided DI1 with a purported biennial inventory, but,
*[according to DI1,] it did not indicate whether it had been completed
either at the opening or closing of business. Tr. 41-42; GX 37.
7. When asked about the pharmacy's CSOS system, Ms. Mincy
demonstrated to DI1 how the pharmacy ordered controlled substances on
the system. Tr. 43-45.
8. DI1 contacted Mr. Chris Jewell, one of the personnel in charge
of the CSOS system at DEA Headquarters. Mr. Jewell ran a report which
stated that Ms. Mincy received her own CSOS credentials in July 2018.
Tr. 47-49; GX 29.
9. DI1 conducted an audit of Pharmacy 4 Less's records and
inventories. Tr. 53-93, 919-26; GX 4, 31, 32. DI1 selected a starting
date of January 1, 2017, due to discrepancies in the biennial
inventory, the lack of an initial inventory, and Pharmacy 4 Less
maintained handwritten Schedule 2 controlled substance logs. Tr. 56,
61.
10. DI1 and other personnel returned to Pharmacy 4 Less on June 21,
2017. Both Ms. Mincy and Mr. Sprys were present. Tr. 88-89.
11. DI1 asked Ms. Mincy and Mr. Sprys how they determined whether
prescriptions were for a legitimate medical purpose. Both pharmacists
responded they would check E-FORCSE and that they would verify
prescriptions by contacting the patients' doctors. The DIs were
provided with a red folder that contained screenshots from the
pharmacy's computer system, Rx30. Tr. 89-92. The red folder contained
screenshots from the Rx30 program. Id. at 96. The red folder also
contained the pharmacists' notes on patients, referred to as ``due
diligence files.'' Id. at 97.
12. On June 22, 2017, an administrative subpoena was issued to
Pharmacy 4 Less, requesting hard copy prescriptions for all Schedules
2-5 controlled substance prescriptions from October 2015 through June
22, 2017, all controlled substance prescription data from Rx30, and all
due diligence patient files. Id. at 93-94; GX 2. Pharmacy 4 Less
complied by delivering a gray tote container that contained
``California'' folders filled with Schedule 2 hard copy prescriptions,
a thumb drive containing all Rx30 data, and the red folder seen during
the June 21 on-site inspection. Id. at 96. The Schedules 3-5
prescriptions were delivered to the DIs by Pharmacy 4 Less at an
unidentified later date. Id. at 97.
Treatment of Patient A.E.
13. Pharmacy 4 Less dispensed hydromorphone 8 mg to Patient A.E. on
21 occasions between November 19, 2015, and June 1, 2017. GX 6.
14. On November 19, 2015, Pharmacy 4 Less dispensed Patient A.E. 84
tablets of hydromorphone 8 mg without determining whether Patient A.E.
was opioid na[iuml]ve. Tr. 183-86; GX 28, p. 6; GX 37, p. 11.
15. Between November 19, 2015, and June 1, 2017, Pharmacy 4 Less,
on 21 separate occasions, dispensed hydromorphone 8 mg tablets to
Patient A.E. at a price of approximately $5.95 per tablet, even though
other retail pharmacies were selling hydromorphone 8 mg at
approximately $1.50 per tablet. Tr. 195-99; 200-03; GX 28, pp. 6-7.
16. Between December 17, 2015, and June 1, 2017, Pharmacy 4 Less,
on 20 separate occasions, dispensed hydromorphone to Patient A.E.
without determining why hydromorphone was being prescribed on a long-
term basis without the presence of a long-acting pain medication. Tr.
192-95; 200-03; GX 28, p. 6.
Treatment of Patient A.R.
17. Pharmacy 4 Less dispensed oxycodone 15 mg to Patient A.R. on 17
occasions between March 17, 2016, and June 7, 2017; GX 8.
18. On March 17, 2016, Pharmacy 4 Less dispensed Patient A.R. 112
tablets of oxycodone 15 mg without determining whether Patient A.R. was
opioid na[iuml]ve. Tr. 205-07; GX 28, p. 12.
19. Between March 17, 2016, and June 7, 2017, Pharmacy 4 Less, on
17 separate occasions, dispensed oxycodone 15 mg tablets to Patient
A.R. at a price of approximately $2.23 to $2.50 per tablet, even though
other retail pharmacies were selling oxycodone 15 mg at approximately
$0.90 per tablet at the time. Tr. 205-07, 212-14; GX 28, pp. 12-13.
20. Between May 11, 2016, and June 7, 2017, Pharmacy 4 Less, on 15
separate occasions, dispensed oxycodone 15 mg to Patient A.R. without
determining why oxycodone was being prescribed on a long-term basis
without the presence of a long-acting pain medication. Tr. 212-14, GX
28 p. 12.
21. Between March 17, 2016, and June 7, 2017, Pharmacy 4 Less, on
17 separate occasions, dispensed oxycodone 15 mg tablets to Patient
A.R., even though Pharmacy 4 Less's records do not show that Pharmacy 4
Less ever addressed why Patient A.R. traveled southwest approximately
37 miles from his house in Daytona Beach, Florida to his doctor's
office in Sanford, Florida; traveled approximately 15 miles further
southwest to buy his controlled substances from Pharmacy 4 Less, and
then returned approximately 45 miles northeast to his home in Daytona
Beach, Florida. Tr. 207-14, 334-35, GX 28, p. 13.
Treatment of Patient A.V.
22. Pharmacy 4 Less dispensed buprenorphine and/or oxycodone to
Patient A.V. on 14 occasions between April 12, 2016, and April 10,
2017. GX 10.
23. On March 17, 2016, Pharmacy 4 Less dispensed Patient A.V. 112
tablets of oxycodone 20 mg without determining whether Patient A.V. was
opioid na[iuml]ve. Tr. at 262, 267-68; GX 28, p. 8.
24. Between April 12, 2016, and February 13, 2017, on 8 separate
occasions, Pharmacy 4 Less filled prescriptions for Patient A.V. for
112 tablets of oxycodone 20 mg, an opioid, within nine days of filling
a prescription for 29-60 tablets of buprenorphine 8 mg, a controlled
substance used to treat opioid addiction. Seven of the eight fills took
place on the same day. Tr. at 261-76; GX 28, p. 8.
25. Between April 21, 2016, and April 10, 2017, Pharmacy 4 Less, on
12 separate occasions, dispensed oxycodone 20 mg tablets to Patient
A.V. at a price of approximately $2.59 per tablet, even though other
retail pharmacies were selling oxycodone 20 mg at approximately $1.25
per tablet at the time. Tr. at 262-76; GX 28, pp. 8-9.
26. Between July 5, 2016, and April 10, 2017, Pharmacy 4 Less, on
10 separate occasions, dispensed oxycodone to Patient A.V. without
determining why oxycodone was being
[[Page 54566]]
prescribed on a long-term basis without the presence of a long-acting
pain medication. Tr. at 268-76; GX 28, p. 8.
Treatment of Patient B.F.
27. Pharmacy 4 Less dispensed hydromorphone to Patient B.F. on 17
occasions between October 27, 2015, and May 15, 2017. GX 12.
28. On October 27, 2015, Pharmacy 4 Less dispensed Patient B.F. 64
tablets of hydromorphone 8 mg without determining whether Patient B.F.
was opioid na[iuml]ve. Tr. at 217-18; GX 28, p. 10; GX 38, p. 5.
29. Between November 24, 2015, and May 15, 2017, Pharmacy 4 Less,
on 16 separate occasions, dispensed hydromorphone 8 mg tablets to
Patient B.F. at a price of approximately $5.70 to $5.83 per tablet,
even though other retail pharmacies were selling hydromorphone 8 mg at
approximately $1.50 per tablet at the time. Tr. at 218-22; GX 28, p.
11.
30. Between December 30, 2015, and May 15, 2017, Pharmacy 4 Less,
on 15 separate occasions, dispensed hydromorphone to Patient B.F.
without determining why hydromorphone was being prescribed on a long-
term basis without the presence of a long-acting pain medication. Tr.
219-22; GX 28, p. 10.
Treatment of Patient B.N.
31. Pharmacy 4 Less dispensed either hydromorphone or oxycodone to
Patient B.N. on 19 occasions between January 22, 2016, and June 2,
2017. GX 14.
32. On January 22, 2016, Pharmacy 4 Less dispensed to Patient B.N.
90 tablets of hydromorphone 8 mg without determining whether Patient
B.F. was opioid na[iuml]ve. Tr. 222-27; GX 28, p. 14.
33. Between January 22, 2016, and August 15, 2016, Pharmacy 4 Less,
on nine separate occasions, dispensed hydromorphone 8 mg tablets to
Patient B.N. at a price of approximately $5.95 to $6.45 per tablet,
even though other retail pharmacies were selling hydromorphone 8 mg at
approximately $1.50 per tablet at the time. Tr. 222-35; GX 28, p. 15.
34. Between September 9, 2016, and June 2, 2017, Pharmacy 4 Less,
on ten separate occasions, dispensed oxycodone 30 mg tablets to Patient
B.N. at a price of approximately $5.00 per tablet, even though other
retail pharmacies were selling oxycodone 30 mg tablets at approximately
$0.90 per tablet at the time; Tr. 232-35; GX 28, p. 15.
35. Between March 15, 2016, and June 2, 2017, Pharmacy 4 Less, on
17 separate occasions, dispensed hydromorphone and oxycodone to Patient
B.N. without determining why hydromorphone and oxycodone were being
prescribed on a long-term basis without the presence of a long-acting
pain medication. Tr. 222-35; GX 28, pp. 14-15.
Treatment of Patient K.E.D.
36. Pharmacy 4 Less dispensed oxycodone to Patient K.E.D. on 21
occasions between October 26, 2015, and June 7, 2017. GX 18.
37. On October 26, 2015, Pharmacy 4 Less dispensed to Patient
K.E.D. 112 tablets of oxycodone 20.5 mg without determining whether
Patient K.E.D. was opioid na[iuml]ve. Tr. 241-44; GX 28, p. 16; GX 38,
p. 7.
38. Between October 26, 2015, and June 7, 2017, Pharmacy 4 Less, on
21 separate occasions, dispensed oxycodone 20 mg tablets to Patient
K.E.D. at a price of approximately $3.57 to $3.84 per tablet, even
though other retail pharmacies were selling oxycodone 20 mg at
approximately $0.90 per tablet at the time. Tr. 241-47; GX 28, p. 17.
39. Between December 21, 2015, and June 7, 2017, Pharmacy 4 Less,
on 19 separate occasions, dispensed oxycodone to Patient K.E.D. without
determining why oxycodone was being prescribed on a long-term basis
without the presence of a long-acting pain medication. Tr. 244-47; GX
28, pp. 16-17.
Treatment of Patient K.Y.D.
40. Pharmacy 4 Less dispensed oxycodone to Patient K.Y.D. on 17
occasions between February 4, 2016, and June 12, 2017. GX 16.
41. On February 4, 2016, Pharmacy 4 Less dispensed to Patient
K.Y.D. 84 tablets of oxycodone 30 mg without determining whether
Patient K.Y.D. was opioid na[iuml]ve. Tr. 237-38; GX 28, p. 20.
42. Between February 4, 2016, and June 12, 2017, Pharmacy 4 Less,
on 17 separate occasions, dispensed oxycodone 30 mg tablets to Patient
K.Y.D. at a price of approximately $3.45 per tablet, even though other
retail pharmacies were selling oxycodone 30 mg at approximately $0.90
per tablet at the time. Tr. 237-41; GX 28, pp. 20-21.
43. Between March 31, 2016, and June 12, 2017, Pharmacy 4 Less, on
15 separate occasions, dispensed oxycodone to Patient K.Y.D. without
determining why oxycodone was being prescribed on a long-term basis
without the presence of a long-acting pain medication. Tr. 237-41; GX,
p. 20.
Treatment of Patient R.R.
44. Pharmacy 4 Less dispensed oxycodone to Patient R.R. on 21
occasions between October 28, 2015, and May 30, 2017. GX 20.
45. On October 28, 2015, Pharmacy 4 Less dispensed to Patient R.R.
112 tablets of oxycodone 18 mg without determining whether Patient R.R.
was opioid na[iuml]ve. Tr. 247-50; GX 28, p. 18; GX 38, p. 8.
46. Between November 23, 2015, and May 30, 2017, Pharmacy 4 Less,
on 20 separate occasions, dispensed oxycodone 15 mg tablets \*BB\ to
Patient R.R. at a price of approximately $2.28 to $2.41 per tablet,
even though other retail pharmacies were selling oxycodone 15 mg at
approximately $0.90 per tablet at the time. Tr. 247-50; GX 28, p. 19.
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\*BB\ Additionally, on October 28, 2015, Pharmacy 4 Less,
dispensed oxycodone 18 mg tablets to Patient R.R. at a price of
approximately $2.23.
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47. Between December 21, 2015, and May 30, 2017, Pharmacy 4 Less,
on 19 separate occasions, dispensed oxycodone to Patient R.R. without
determining why oxycodone was being prescribed on a long-term basis
without the presence of a long-acting pain medication. Tr. 248-50; GX
28, pp. 18-19.
Treatment of Patient R.V.
48. Pharmacy 4 Less dispensed oxycodone to Patient R.V. on 22
occasions between November 17, 2015, and June 19, 2017. GX 22.
49. On November 17, 2015, Pharmacy 4 Less dispensed to Patient R.V.
112 tablets of oxycodone 20 mg without determining whether Patient R.V.
was opioid na[iuml]ve. Tr. 251-53; GX 28, p. 22; GX 38, p. 7.
50. Between November 17, 2015, and June 19, 2017, Pharmacy 4 Less,
on 21 separate occasions,\45\ dispensed oxycodone 20 mg tablets \*CC\
to Patient R.V. at a price of approximately $2.23 to $3.04 per tablet,
even though other retail pharmacies were selling oxycodone 20 mg at
approximately $0.90 per tablet at the time. Tr. 251-55; GX 28, pp. 22-
23.
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\45\ The Government is not alleging that the price charged on
March 27, 2017 was unreasonable.
\*CC\ Except for on April 22, 2017, when Oxycodone 15 mg was
dispensed at a price of $2.23 per tablet. GX 22, p. 71.
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51. Between January 11, 2016, and June 19, 2017, Pharmacy 4 Less,
on 20 separate occasions, dispensed oxycodone to Patient R.V. without
determining why oxycodone was being prescribed on a long-term basis
without the presence of a long-acting pain medication. Tr. 252-55; GX
28, p. 22.
Treatment of Patient V.W.
52. Pharmacy 4 Less dispensed oxycodone to Patient V.W. on 21
occasions between November 30, 2015, and May 31, 2017. GX 24.
[[Page 54567]]
53. On November 30, 2015, Pharmacy 4 Less dispensed to Patient V.W.
84 tablets of oxycodone 15 mg without determining whether Patient V.W.
was opioid na[iuml]ve. Tr. 256-57; GX 28, p. 24; GX 38, p. 9.
54. Between November 30, 2015, and May 31, 2017, Pharmacy 4 Less,
on 21 separate occasions, dispensed oxycodone 15 mg tablets to Patient
V.W. at a price of approximately $2.54 to $3.57 per tablet, even though
other retail pharmacies were selling oxycodone 15 mg at approximately
$0.90 per tablet at the time. Tr. 256-60; GX 28, pp. 24-25.
55. Between January 25, 2016, and May 31, 2017, Pharmacy 4 Less, on
19 separate occasions, dispensed oxycodone to Patient V.W. without
determining why oxycodone was being prescribed on a long-term basis
without the presence of a long-acting pain medication. Tr. 258-60; GX
28, pp. 24.
Recordkeeping
56. Pharmacy 4 Less did not have an initial inventory readily
available during DI1's on-site inspection. Tr. 39-40.
57. [According to DI1, the copy of Pharmacy 4 Less's biennial
inventory that he viewed in-person during the inspection on June 6,
2017, did not notate whether the inventory was completed at the opening
or closing of business. Tr. 41-42.] \*DD\
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\*DD\ Finding of fact modified for clarity.
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58. Pharmacy 4 Less's biennial inventory (apparently revised
sometime after June 6, 2017) did not indicate whether it was conducted
at the ``close'' or ``opening of business,'' instead listing the time
that it was completed. Compare GX 37, p. 2 with RX 38, p. 1.
*[Specifically, the content appeared on a blank document that Ms. Mincy
described as a cover page with handwriting stating ``Biennial
Inventory; Completed April 26, 2017; 8AM'' and with signatures by both
pharmacists. Id. The cover page was included in a fax to DI1 from
Respondent pharmacy on June 7, 2017.] \*EE\
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\*EE\ There is insufficient information in the record for me to
conclusively determine whether or not the cover page was attached to
the biennial inventory at the time of DEA's inspection. On the one
hand, I fully credit DI1's testimony that the biennial inventory did
not notate whether the inventory was ``completed at either the
opening or closing of business.'' Tr. 41-42. However, I cannot tell
whether DI was testifying that the specific words ``opening or
closing of business'' did not appear on the biennial inventory
(which I agree is true) or if he was testifying that the cover page
at GX 37, p. 2 was not included on the biennial inventory that DI1
was handed on the date of the inspection. If DI1's testimony meant
the latter, it was unclear, and unfortunately, the biennial
inventory was not seized during the inspection. Instead, the
biennial inventory was faxed to DI1 the following day and the cover
page was included. Notably, Mr. Sprys was out of the country at the
time of the inspection and subsequent fax. As Mr. Spry's signature
appears on the biennial inventory cover page that was faxed, it does
not seem implausible to conclude that the cover page existed prior
to Mr. Sprys leaving the country and prior to the inspection.
Therefore, I cannot find substantial evidence to support the
Government's allegation that the biennial inventory lacked the
notation regarding whether it was conducted at the opening or
closing of business.
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59. Pharmacy 4 Less's records were inaccurate, and included
shortages and overages. GX 4. Specifically, the shortages and overages
are as follows
a. Oxycodone 15 mg: Shortage of 73 tablets
b. Oxycodone 20 mg: Shortage of 212 tablets
c. Oxycodone 30 mg: Shortage of 731 tablets
d. Hydromorphone 8 mg: Shortage of 149 tablets
e. Methadone 10 mg: Overage of 1,488 tablets
f. Suboxone 8 mg/2 mg: Overage of 224 tablets
g. Carisoprodol 350 mg: Shortage of 526 tablets
60. Pharmacy 4 Less's [invoices] \*FF\ did not include the date the
order was received for 84 invoices. Tr. 137-38; GX 26.
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\*FF\ Modified because he ALJ referred to these documents as
``222 Forms,'' but I find that they are more accurately described as
``invoices.''
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Analysis
Credibility Analysis of Fact Witnesses
Ability To Recall Events
DI1
Generally speaking, individuals experiencing an event out of the
ordinary, such as an on-site inspection as occurred here, are likely to
have a better memory of those events than the Government Diversion
Investigator, who performs similar inspections on any number of
clinics. It seems to me, all other factors being equal, it would be
easier for a DI to forget or confuse events than the person inspected.
However, in this matter, DI1 presented an overall clear description of
events surrounding the June 6, 2017, and June 21, 2017 on-site
inspections of Pharmacy 4 Less.
DI1 occasionally had difficulty recalling the specific individual
who responded to his questions. See, e.g., Tr. 90-91. This cuts
slightly against his reliability. However, he was generally able to
recall the key events as to what had occurred during the on-site
inspections and the substance of the relevant conversations. His
testimony is also generally corroborated by the documentary evidence.
Further, DI1 demonstrated a basic understanding of the relevant DEA
regulations as provided in the Code of Federal Regulations in order to
properly perform his duties.\46\ He had some difficulty citing specific
relevant provisions of the CFR when asked, which is quite
understandable. However, part of DI1's testimony involved an issue
contested by the Respondent regarding the necessity of the date of
receipt on invoices maintained by the pharmacy, which this Tribunal
finds necessary to separately analyze and discuss.\47\ Tr. 136-39.
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\46\ While this Tribunal heard testimony from DI1 about the
regulations, it does not rely on DI1's understanding of the
regulations in this Recommended Decision.
\47\ See infra at section ``Date of Receipt on Invoices.''
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Based on a complete review of DI1's presentation of testimony,
ability to recall events, and comparison with the other evidence, I
find his testimony to be credible and should be afforded considerable
weight.
Ms. Amy Mincy
Ms. Amy Mincy's credibility presents more of a challenge for this
Tribunal to address. During the first portion of the hearing in
Orlando, Florida, Ms. Mincy appeared on the stand for the entire
duration of the third day of testimony. At the beginning of her
testimony, Respondent's counsel attempted to cover Ms. Mincy's
professional background and C.V. Ms. Mincy struggled greatly
remembering details about pharmacies where she had previously worked,
and other details about her own professional background. While the
transcript does not fully capture Ms. Mincy's difficulties in
discussing her background, there are indications within the transcript
that demonstrate these issues.\48\
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\48\ ``MR. INDEST: And since she's having a little bit of
difficulty remembering some of these, I'd like the clerk to give her
the hearing book and let her, if she needs to refer to the CV.
THE WITNESS: I'm good.
MR. INDEST: No, let's have it in front of you so we've got the
dates right and everything, okay?'' Tr. 571.
``Q Okay, but where did you work next after that? Where did you
work next? If you're having trouble remembering, if you need to
refresh your recollection, please look at the CV because you're
taking a long, long pause before you answer my questions. This might
help speed things up.'' Tr. 572-73.
``Q Okay, and did you work as a pharmacy consultant after that?
A For some places, yes.
Q According to your CV, Ms. Mincy, listen, these are simple
straightforward questions, and if you can't remember the answers.''
Tr. 573.
``MR. INDEST: Your Honor, I'd like the record to reflect I'm
asking the questions and she's taking a long, long pause.'' Tr. 574.
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[[Page 54568]]
Following the testimony of Ms. Mincy's background, Respondent's
counsel moved on to the facts of this matter. Throughout her testimony,
Ms. Mincy appeared to encounter great difficulty in remembering details
of the June 6, 2017 on-site inspection. While Ms. Mincy appeared to
remember some details, her presentation and delivery of those details
appeared sometimes confused and disoriented. Throughout the direct
examination, I noticed that Respondent's counsel had trouble eliciting
answers from Ms. Mincy about the June 6, 2017 on-site inspection.\49\
Further, Respondent's counsel made a number of statements on the record
that demonstrated his difficulty in eliciting testimony from Ms. Mincy,
leading to a number of objections by Government counsel for leading the
witness.\50\ While understandable that a lay witness may have some
difficulties due to being nervous or anxious about her time on the
witness stand, Ms. Mincy's inability to answer questions posed by her
own attorney suggest issues with Ms. Mincy's ability to reliably recall
events one would expect to be otherwise fairly memorable. Her
presentation in Orlando clearly diminishes her reliability as a
witness, especially as relates to her Orlando testimony.
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\49\ ``ADMIN. LAW JUDGE DOWD: And I know you're having some
difficulty with Ms. Mincy, but try not to lead, Mr. Indest.'' Tr.
588.
\50\ ``MR. MANN: She needs to answer his questions and not
listen to him repeat the answers to her.
MR. INDEST: Your Honor, she's having a very difficult time
answering these questions.
ADMIN. LAW JUDGE DOWD: It is what it is. But I'm going to
sustain the objection as to leading.
MR. INDEST: And, Your Honor, with that understanding, a witness
that is hard to answer the questions should be given some, the
counsel should be given some leeway to at least get the basic
information.
ADMIN. LAW JUDGE DOWD: I think I've given you leeway, Mr.
Indest.
MR. INDEST: Okay, thank you.
ADMIN. LAW JUDGE DOWD: We have to have the testimony come from
the witness.
MR. INDEST: Okay, we'll try.'' Tr. 595-96.
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During the second portion of the hearing in Arlington, Virginia,
Ms. Mincy appeared to be more relaxed on the stand, which appeared to
increase her ability to recall and to reliably convey her perception of
the relevant events.
Overall, I find that the reliability of her testimony was
significantly diminished by her inability to recall details about both
her own personal history and those surrounding the events of the on-
site inspections at Pharmacy 4 Less.\51\
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\51\ In its Posthearing Brief, the Government argues that Ms.
Mincy's false testimony should not be credited. Govt Posthearing
Brief at 33-36. The Government argues that she ``lied'' about
checking E-FORCSE every time before she filled a prescription. I
will not go to the extreme the Government suggests, especially in
light of Ms. Mincy's demonstrated memory deficits. *[However, I do
find that when comparing the testimony to GX 38, Ms. Mincy
overstated her use of E-FORCSE and that her credibility on the
subject is diminished. Remainder of footnote omitted for brevity.]
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The parties only presented one fact witness each as to the events
surrounding the on-site inspections at Pharmacy 4 Less. It will
therefore be necessary for me to compare and weigh the testimony of DI1
and Ms. Mincy regarding the factual circumstances surrounding the on-
site inspections of Pharmacy 4 Less and the subsequent
investigation.\52\ Physical evidence is more corroborative of DI1's
testimony than that of Ms. Mincy's. When their testimony is in
conflict, I find that it is proper to give greater weight to the
testimony of DI1 over that of Ms. Mincy.
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\52\ As to the lack of corroboration of portions of Ms. Mincy's
testimony, the owner of Pharmacy 4 Less and the only other
pharmacist at the pharmacy, Mr. Richard Sprys, had the ability to
corroborate crucial details about the pharmacy Ms. Mincy's testimony
about the pharmacy's operations, details regarding the June 6, 2017
phone call, and the June 21, 2017 on-site inspection. However,
neither the Government nor the Respondent decided to call Mr. Sprys
as a witness during the hearing. This Tribunal will not question
either parties' trial strategy or determination of which witnesses
to call, and notes that neither party has suggested any inference
should be drawn regarding the failure to present evidence through
Mr. Sprys. As such, we are without the benefit of Mr. Sprys
testimony and are left only with the testimony evidence of DI1 and
Ms. Mincy.
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Motivation to Color Testimony
DI1, as a public servant, typically has no personal stake in the
outcome of the instant inspection or in the revocation of the
Respondent's Registration. The instant investigation was initiated at
random. I noted no animus on his part as to the Respondent, its owner,
or employees. Although he may be viewed as being part of the
prosecution team, I saw no indication from his testimony that any
partiality interfered with his reliable testimony.
On the other hand, Ms. Mincy appeared to be very defensive of
Pharmacy 4 Less and the pharmacy's practices. As one of the two
pharmacists on staff at the pharmacy, the investigation directly
implicates her practices and her employment at the pharmacy. I suspect
that she would be more likely to color her testimony than would DI1.
Ms. Mincy made statements during her testimony that make her
motivation to color her testimony more likely. When confronted about
the testimony of DI1, recalling statements made by Ms. Mincy during the
June 6, 2017 on-site inspection, Ms. Mincy seemed to personalize the
conflict. Ms. Mincy claimed that DI1 would have been ``lying,'' or that
``he was confused.'' Tr. 823-25. Ms. Mincy said that DI1 ``was like a
kid in a candy store.'' Id. at 824-25. She said that ``the longer he
was there and the more he got access to, the wilder and crazier he
got.'' Id. at 825. Ms. Mincy described her interactions with DI1 as
``tormenting'' and ``almost, like, harassment'' of the Respondent. Id.
at 825-26. While Ms. Mincy may have been testifying as to how she felt
during the surprise on-site inspection with DI1, this colorful
language, along with her description and characterization of the
inspection, makes her testimony suspect as a possible attempt to
improperly discredit DI1's testimony and his characterization of the
on-site inspection.\53\ In combination with the previous discussion of
Ms. Mincy's ability to recall events, I find that Ms. Mincy has more
motivation to color her testimony than DI1.
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\53\ In its Posthearing Brief, the Government asserts that Ms.
Mincy's testimony should be discredited when it is contradicted by
DI1. Govt Posthearing Brief at 37. While I cannot reach the
Government's assertion that Ms. Mincy is ``lying,'' I have already
found that greater weight will be given to DI1's testimony whenever
there is conflict between DI1 and Ms. Mincy's testimony.
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Credibility Analysis of Expert Witnesses and Opinions
The relevant standard of care may be established by an expert
witness through his experience in the field, and through his reliance
upon and application of state and federal professional standards.
*[Omitted for brevity.]
Dr. Thomas Hamilton, Pharm.D.
Dr. Hamilton testified as the Government's expert witness in this
matter. Dr. Hamilton was offered and was qualified as an expert in the
practice of pharmacy in Florida. Tr. 174. Dr. Hamilton has worked as a
pharmacist for 18 years. Id. at 167-69. His experience includes time at
a small pharmacy before moving to work full-time as a pharmacist for
Publix, where he has served in a variety of roles, including as a
Pharmacist, the Assistant Manager of the Pharmacy, and as the Pharmacy
Supervisor. He has served as a ``fixer'' or temporary Pharmacy Manager
in order to ``clean up'' pharmacies. Id. at 169. In his role as
Pharmacy Supervisor, he was in charge of overseeing up to 60
pharmacies, and his duties included the hiring and firing of employees,
and overseeing daily operations. Id. at 170. Additionally, Dr. Hamilton
evaluated stand-alone, independent pharmacies for purchase
[[Page 54569]]
by Publix. This evaluation included review of the drug invoices, filled
prescriptions and the nature of each pharmacy's overall business. Id.
at 170-71. In order to spend more time with his young family, Dr.
Hamilton decreased his responsibilities with the company, gave up his
supervisory role, and now serves as a Pharmacy Manager of a single
pharmacy. Id. at 286-87.
During the hearing in this matter, Dr. Hamilton reviewed a number
of materials provided to him by the DEA, including prescriptions (front
and back), related patient medical notes, and patient addresses. Id. at
177, 380-81. Additionally, Dr. Hamilton reviewed prescription pricing
via GoodRX. Id. at 177-78. Dr. Hamilton also prepared an expert report
in this matter based on the information and materials provided to him.
GX 28.
In general, Dr. Hamilton provided detailed assessments of each of
the 10 charged patients in this matter. He detailed his review of the
prescriptions provided for each of the 10 charged patients and any
``red flags'' that he noticed through his review. His explanation that
``red flags'' can be resolved through a review of the prescription and
some investigation, including speaking with the patient, reviewing
medical history, or speaking with the prescriber, were all consistent
with his ultimate opinions in this matter. His opinions in this matter
were bolstered by his knowledge and experience in this field, as well
as his knowledge of ``Florida regulation 64B'' and guidance provided by
the National Board of Pharmacy Association, which provide the source of
pharmacy standards of care in Florida. Id. at 180, 351-58.
On cross-examination, Dr. Hamilton's credibility was bolstered by
his willingness to provide straightforward answers that were consistent
with those opinions he had provided on direct examination. Dr. Hamilton
conceded that he only reviewed the documents provided to him by the
Government, but he was present throughout the hearing and was present
to observe the testimony from the Respondent's witnesses. He indicated,
when recalled during the Government's rebuttal case, that even after
hearing the testimony and opinions from the Respondent's witnesses, his
opinions in this matter had not changed. Tr. 1005. Further, Dr.
Hamilton demonstrated objectivity. While Dr. Hamilton had differing
opinions from Mr. Parrado in a variety of subjects, he was willing to
concede areas in which he agreed with Mr. Parrado and did not appear to
form opinions solely to favor the Government.
Overall, I find Dr. Hamilton's testimony and opinions in this
matter to be credible and reliable.
Mr. Robert Parrado, BPharm., R.Ph.
Mr. Parrado testified as the Respondent's expert witness in this
matter. Mr. Parrado was offered and qualified as a pharmacy expert. Id.
at 431. Mr. Parrado has an extensive history in the pharmacy field. He
appears to be approaching legend status in the field in Florida. He has
been a licensed pharmacist in Florida since 1971. He was formerly
licensed as a Consulting Pharmacist by the State of Florida until 1989.
He has received numerous awards during his career. He is currently
President and CEO of Parrado Pharmacy Consultants, Inc., which involves
consulting with pharmacies, pharmacists, and with government agencies.
Id. at 399-402; RX 5. He has previously worked at several pharmacies.
From 2001 to 2004, Mr. Parrado was a member of the Florida Board of
Pharmacy. From 2003 to 2009, he was on the Board's Accreditation
Council in Pharmacy Education. While on the Board, Mr. Parrado also
served on the Rules Committee and the Legislative Affairs Committee.
During 2004, Mr. Parrado was Chairman of the Florida Board of Pharmacy.
Since 2001, Mr. Parrado has been a perpetual member of the National
Association of Boards of Pharmacy. Mr. Parrado was a member of the
National ``Rules Committee'' which developed ``model rules'' for
consideration by individual states. Id. at 409. For 18 months, ending
in 2001, Mr. Parrado was President-elect of the Florida Pharmacy
Association. Later, Mr. Parrado served as Speaker of the House of
Delegates for the Association.
Since 2014, Mr. Parrado has been guest lecturer on pharmacy law at
the University of Florida College of Pharmacy. Id. at 410. As part of a
recurring continuing education course, Mr. Parrado taught ``Resolving
Red Flags, Allowing Patients to Legally Obtain Their Lawful Medical
Prescriptions.'' Id. at 411. He has also presented to various
professional organizations a course on ``Identifying Drug Diversion.''
Id. at 412. Mr. Parrado has testified as an expert witness previously,
including an estimated eight or nine times as an expert called by DEA
in these administrative proceedings. Id. at 414-16.
It is undisputed that Mr. Parrado has an extensive and impressive
background in the pharmacy field. In particular, Mr. Parrado has a vast
amount of experience in the practice of pharmacy within the state of
Florida. His experience as a member of the Board of Pharmacy, including
as a member of the Rules and Legislative Affairs Committees and as the
Chairman of the Board, are highly instructive as to the Florida
standard of care and those regulations governing Florida pharmacists.
Mr. Parrado even noted that he was a co-author of Rule 64B16-27.831,
which is the Florida state requirement that pharmacists question
prescriptions that may not be valid and only fill the prescriptions if
the pharmacist is able to validate the prescription. Id. at 420.
As it has been noted, Mr. Parrado has previously testified in
similar DEA administrative proceedings. In Superior Pharmacy I and II,
the Agency found that the ALJ in that matter properly qualified Mr.
Parrado as an expert witness in that proceeding given his extensive
experience in the pharmacy field. See Superior Pharmacy I and II, 81 FR
31,309, 31,322 n.16 (2016). Mr. Parrado was also previously certified
as an expert in community pharmacy practice. Hills Pharmacy, LLC, 81 FR
49,815, 49,820 (2016). The Agency also gave credit to Mr. Parrado's
expertise in Edge Pharmacy, 81 FR 72,092 (2016). As such, I further
find that Mr. Parrado's background and expertise is more than
sufficient to lend weight towards his testimony in this matter.
In this matter, Mr. Parrado provided generally reliable statements
as to his review of the materials and his ultimate opinions. He
testified that he had reviewed not only the Respondent's exhibits, but
also was provided and reviewed the DEA's exhibits. Tr. 432. Mr. Parrado
suggested that if he were in Dr. Hamilton's position, he would have
asked the Government to provide more documentation.\54\ As to ultimate
opinions, while Dr. Hamilton generally provided specific answers to the
questions posed by the parties, Mr.
[[Page 54570]]
Parrado would occasionally provide more summary or conclusory opinions
to the questions posed to him. For example, Mr. Parrado gave the
blanket conclusory opinion that based on the discussions between Mr.
Parrado and Mr. Sprys and Ms. Mincy, of which there was no record or
report, Mr. Parrado opined that in every instance of a red flag, they
properly resolved the red flag prior to dispensing the subject
controlled substance.
---------------------------------------------------------------------------
\54\ There was a question as to what requirement, if any, an
expert witness has in requesting additional documents. Mr. Parrado
indicated that it was his experience from Superior Pharmacy I and II
that he should request more documents. Respondent's counsel argued
that Superior Pharmacy I and II holds that if information to resolve
red flags is not documented in materials provided to the expert, the
additional documentation should be requested and provided to the
expert if it exists. Tr. 444-45. The Government's objection to the
question was sustained and the parties were invited to brief this
issue in their Posthearing Brief. The Government argues in its
Posthearing Brief that Superior Pharmacy I and II do not stand for
the argument that the Respondent asserted. Govt Posthearing Brief at
42-43. Upon a review of Superior Pharmacy I and II, this Tribunal
agrees with that assessment. It was not established that Superior
Pharmacy I and II have created such an obligation on the part of an
expert witness to request additional documentation.
---------------------------------------------------------------------------
There were also a number of disagreements between Dr. Hamilton and
Mr. Parrado in a number of areas, which will be discussed infra.
However, Mr. Parrado's testimony was diminished by his failure to
include important details as to the bases of his opinions in this
matter. First, Mr. Parrado failed to disclose that he interviewed Mr.
Sprys and Ms. Mincy in forming his opinions in this matter. Tr. 497-
500, 504-06. As bases for his opinions and having testified as an
expert in a number of these proceedings, Ms. Parrado should be well
aware of his obligations and the necessity to disclose the bases of his
opinions, particularly if interviewing witnesses in this matter formed
the bases of his opinions. My Order for Prehearing Statements
specifically requires witnesses who rely on hearsay statements to
identify those individuals in the prehearing statement. ALJ Ex. 3. Mr.
Parrado's opinions were further diminished by the fact that Mr. Sprys
did not testify, so he could not be subject to cross-examination on
this issue. Therefore, Mr. Parrado's subject opinions are based on
hearsay statements that were not subject to cross-examination. The
Government was given an opportunity to cross examine Ms. Mincy.
Additionally, Mr. Parrado testified that Ms. Mincy and Mr. Sprys
confirmed to him that checking the E-FORCSE database was instrumental
in their resolving certain red flags. As GX 38 reveals, Mr. Sprys and
Ms. Mincy's access of the E-FORCSE was not as diligent as claimed. See
infra section ``Opioid Tolerance High Starting Dosages.'' This suggests
that Mr. Parrado's opinions in this regard are diminished by less than
reliable claims made to him by Mr. Sprys and Ms. Mincy. Additionally,
as there was little or no documentary support for Mr. Sprys and Ms.
Mincy's claims to Mr. Parrado that they appropriately resolved each of
the subject red flags, one would have to credit them with extraordinary
memory, based on specific events over a few year period which the
record does not establish.
Secondly, when cross-examined about his conclusions regarding the
distance traveled by Patient A.R., Mr. Parrado was asked why he did not
provide certain details about his opinions in his expert report. Tr.
540-41. When asked why he didn't put anything in his report about the
pharmacist's relationship with Patient A.R., he stated ``I didn't see
cause for that. My eloquence is not that great.'' These statements
further diminish Mr. Parrado's bases for his opinions in this matter.
Further, there was an inconsistency in Mr. Parrado's evaluation. In
defending the Respondent's resolution of red flags, Mr. Parrado often
relied on the PRM records maintained in the pharmacy file to justify
the resolution. However, in instances where the PRM did not establish
justification of the red flag, Mr. Parrado dismissed this fact and
credited the Respondent's resolution by virtue of the mere effort of
contacting the physician. This is contrary to the pharmacist's
corresponding responsibility. The pharmacist must resolve red flags. An
unsuccessful attempt to resolve red flags is insufficient.
However, overall, I do not find that Mr. Parrado was disingenuous
or lacking candor in his testimony, even when he occasionally failed to
answer questions in a direct manner or to provide notice of all facts
and materials upon which he relied in making his opinions. I do find
his testimony to be generally credible and reliable, to the extent the
information upon which he relied was accurate.
As to both experts in this matter, I consider their opinions and
the merits of each when weighing the factors and the law. Here, the
experts had differing strengths. Mr. Parrado has a tremendous amount of
experience in Florida Pharmacy law and practice, while Dr. Hamilton
seems to have the edge regarding existing pharmacy practice and market
forces. However, as with any battle of experts, it is the expert's
justification, or explanation for his opinion, which is key. As
developed in detail infra, generally Dr. Hamilton's justifications and
explanations for his opinions appeared more consistent with existing
market forces, the relevant law, and Agency precedent than those of Mr.
Parrado.
*[Omitted for clarity.]
Conflicting Findings of Dr. Hamilton and Mr. Parrado
Florida Minimum Standard of Care
Dr. Hamilton provided testimony that he understood the Florida
minimum standard of care to be guided by the Florida Administrative
Code, specifically ``Regulation 64B'' and guidelines provided by the
National Board of Pharmacy Association. Tr. 180-81. Specifically, Dr.
Hamilton noted that the Florida standard of care included
responsibilities not specifically included within the relevant Florida
regulations. Id. at 1007-08. On the other hand, Mr. Parrado testified
that he understood the minimum standard of care to be set strictly and
exclusively by the [Florida] Pharmacy Act or the Florida Administrative
Code. Id. at 456. Further, the experience that Mr. Parrado has in the
creation and implementation of these standards give his testimony
significant weight in determining the import and scope of Florida
law.\*GG\
---------------------------------------------------------------------------
\*GG\ Sentence was relocated for clarity.
---------------------------------------------------------------------------
A careful review of Florida law and regulations guiding the
practice of pharmacy within the State of Florida shows that the
practice is generally guided by Chapter 465 of the Florida Pharmacy
Act,\55\ and Florida Administrative Code rule 64B16, which governs
pharmacy practice. Based strictly on this review, Mr. Parrado's
testimony as to the law and regulations governing the practice of
pharmacy in Florida appears to be correct. While Dr. Hamilton may also
be correct about the guidelines set by the National Board of Pharmacy
Association that have guided the State of Florida in its implementation
of laws and regulations setting the minimum standard of care, it cannot
be ascertained from the literal text of relevant Florida regulations
where the Association's guidelines have been given any legal force
beyond those provided for in the statutes and regulations cited to by
Mr. Parrado. *[However, I likewise find no support for the proposition
that Florida law encompasses the entirety of the standard of care in
the State of Florida. Here, Mr. Parrado testified that Florida
pharmacists are required to take thirty hours of continuing education
every two years, and that ``two of those hours have to be on the . . .
opioid abuse and resolving red flags.'' Tr. 413. In this case, I find
that Florida state law can be reasonably interpreted to support both
Dr. Hamilton's and Mr. Parrado's testimony.]
---------------------------------------------------------------------------
\55\ Fla. Stat. Sec. 465.001 et seq.
---------------------------------------------------------------------------
Mr. Parrado's testimony would generally be credited as to the
governing laws and regulations within the Florida Pharmacy Act and the
Florida Administrative Code. *[And Dr. Hamilton's testimony would
generally be credited as to the usual course of existing pharmacy
practice.] However, individual scrutiny will be given to the sections
of the Florida Administrative
[[Page 54571]]
Code under which the Government has raised allegations against the
Respondent for failing to meet the minimum standard of care.
Requirement To Document Resolution of Red Flags
Dr. Hamilton provided testimony that resolution of each ``red
flag'' had to be documented somewhere in a patient's file to
demonstrate that the ``red flag'' had been resolved. He noted that this
would be required under the Florida standard of care and that ``[i]f
[it is] not documented, there's no evidence that . . . it was
resolved.'' Id. at 179-81. Dr. Hamilton conceded that although this
requirement was not specifically written in the relevant Florida
regulations, it was without question required in the context of the
Florida regulations as part of the Florida standard of care. Id. at
1007-08.
Despite its obvious logic, Mr. Parrado disagreed with Dr.
Hamilton's assertion that such documentation is required in Florida.
Mr. Parrado conceded that documenting the resolution of ``red flags''
may represent ``best practice,'' including that he would also do it as
a pharmacist, but that it is not required under Florida law or the
standard of care. He provided that most pharmacists complete at least
some kind of documentation to indicate resolution of ``red flags.'' He
also stated that he had created a computer program called ``Red Flag
Resolver'' to assist pharmacists in documenting the resolution of red
flags in their own practice.
*[Omitted. Here both experts agree that documentation of red flag
resolution is not explicitly required by Florida law. However, the
regulations generally support the testimony of Dr. Hamilton regarding
the importance of documentation in the usual course of professional
practice in Florida. See also Suntree Pharmacy and Suntree Medical
Equipment, L.L.C., 85 FR 73,753, 73,772.\*HH 56\]
---------------------------------------------------------------------------
\*HH\ In Suntree, the Respondent implied that the Government's
expert's ``inability to draw a solid conclusion as to where the
requirement to document the resolution of red flags is written
somehow demonstrated that there is no such requirement in the
standard of practice.'' Id. The Acting Administrator rejected that
reasoning and found ``that Florida state law can be reasonably
interpreted to support [the Government expert's] testimony, but that
her testimony [was] independently credible that documentation of the
resolution of red flags is a requirement of the practice of pharmacy
in the State of Florida.'' Id. I find the same. Here, Dr. Hamilton
clearly testified that the resolution of the ``red flag'' had to be
documented in the file as part of the Florida Standard of Care,
noting, ``[i]f it's not documented, there's no evidence that . . .
it was resolved, or a phone call was made, or an answer was given.''
Id. at 179-80; see also id. at 306, 318, 337, 1006-11, 1016.
\56\ *[Omitted text where original footnote was included.]
---------------------------------------------------------------------------
Therefore, under Florida regulations and findings of the Agency on
this issue, I credit Dr. Hamilton's testimony that pharmacists are
required under the Florida standard of care to document the resolution
of ``red flags.''
Pricing of Prescriptions \*II\
---------------------------------------------------------------------------
\*II\ I have made modifications as indicated throughout this
section to more directly address the issue in this case--that the
patients identified in the OSC were paying cash, and excessively
high prices at that, for controlled substances which created a red
flag.
---------------------------------------------------------------------------
Dr. Hamilton expressed concerns that *[the patients' willingness to
pay cash for these] \*JJ\ highly priced prescriptions was a ``red
flag'' that should be addressed. Dr. Hamilton indicated that it does
not make sense that a patient would continue to go to a pharmacy that
is charging high prices when there are pharmacies that sell the same
medications for much less. Tr. 194. For example, high prices were a red
flag for Patient A.E. (paying up to $500 a month) because A.E. was
paying up to $5.95 per pill *[in cash when he could have gotten the
controlled substances elsewhere for 1.50 per pill]. Tr. 199; GX 28, pp.
6-7. He opined that patients do not want to pay more than they have to,
and if the same prescription was offered at a lower price at a
different pharmacy, the patient would have gone to that other pharmacy.
Tr. 199. Dr. Hamilton also noted he has observed different pricing
schemes for the same prescriptions for the same person, *[paying cash]
for which he could not provide a rational explanation. Id. at 203-04.
---------------------------------------------------------------------------
\*JJ\ See infra n. NN.
---------------------------------------------------------------------------
Mr. Parrado disagreed with Dr. Hamilton's assertion that the prices
on the prescriptions should be much lower than that charged by Pharmacy
4 Less. He opined that every pharmacy can determine their own prices,
which may be more expensive when filling a controlled substance
prescription based on the added work load (including checking E-FORCSE,
better maintenance of records, and additional inventories). Id. at 449.
He stated that pharmacy pricing can be very competitive. Id. at 450.
The only explanations Mr. Parrado could give for a pharmacy charging
different prices for the same medication was a potential higher cost
from a different wholesaler, the use of discount coupons, or indigent
pricing programs. Id. at 451-52. There was no evidence offered that
these exceptional circumstances existed here.
As to Mr. Parrado's claim that opioids had become scarce, difficult
to locate, and involved additional expense to the pharmacies, thus
warranting higher prices, neither party introduced documentary evidence
to support or to counter this claim. Id. at 451-52, 539. Mr. Parrado
did not offer the actual reason the Respondent charged the prices they
did, or whether the Respondent recognized their prices were
significantly higher than other like-situated pharmacies. For example,
we don't know if there was a pharmacy much closer to the patients'
homes or doctor offices charging less, from any direct evidence. We are
left with conflicting, sometimes anecdotal, evidence by Mr. Parrado and
Dr. Hamilton.
Dr. Hamilton personally surveyed pharmacy prices in his area, near
Fort Lauderdale, while Pharmacy 4 Less is located just north of
Orlando. Id. at 178. Dr. Hamilton's formula to determine average prices
by large and small pharmacies involved a survey of wholesale prices of
opioids sold to pharmacies, generally increased by 20% for pharmacy
mark up, does not rebut the justifying explanations given by Mr.
Parrado. To be more accurate, the survey should have been limited to
small pharmacies. However, Dr. Hamilton's reliance upon a GoodRx
program to determine prices charged by pharmacies for opioids does
provide objective support for his assertions that the prices charged by
Pharmacy 4 Less for the various subject opioids were considerably in
excess of what other pharmacies were charging. Id. at 177-78.
Based on a review of this record, I find that Dr. Hamilton provided
a more reliable basis in support of his opinion of unusually high
prices of opioids charged by Pharmacy 4 Less than the uncorroborated
and more anecdotal and historical explanations given by Mr. Parrado. I
do not discount the market forces cited by Mr. Parrado, although I
reject the extent to which he opined they affected the prices charged
by the Respondent.
Having found that Respondent's *[cash-paying patients at issue in
this case were paying] unusually high prices for the subject opioids,
triggering a red flag, the next inquiry is whether the Respondent
resolved the red flag. There was no evidence introduced that the
Respondent performed any inquiry or investigation as to why the subject
patients were willing to pay such high *[cash] prices for the subject
opioids. Dr. Hamilton's opinion that this red flag repeatedly went
unresolved is fully supported by this record.
[[Page 54572]]
Long Distances Traveled by Patients
Both Dr. Hamilton and Mr. Parrado agreed that long distances
traveled by patients to fill their prescriptions at Pharmacy 4 Less was
a ``red flag'' that needed to be resolved before the prescription was
filled. Id. at 209-10, 453. As to Patient A.R., Dr. Hamilton gave the
opinion that there were multiple red flags. Id. at 209. He said that
the distance from A.R.'s home to the physician was a red flag because
A.R. had to explain the reason to be going to that physician. Further,
the distance from the physician to the pharmacy is a red flag, because
it was taking A.R. even further away from A.R.'s home, approximately 50
miles from his home. A.R. needed to explain why he was traveling so far
to fill the subject prescriptions. Id. at 209-10. Dr. Hamilton first
opined that this red flag was not resolvable, but later conceded that
there may be circumstances in which it could be resolved, but that it
would need to be notated in the pharmacy file. Id. at 210.
Mr. Parrado gave the opinion that while the long distance traveled
would be a red flag, it was one that could be resolved. Id. at 453. He
said that it only needed to be resolved once as long as the pharmacist
knew the patient and knew why they are coming to the pharmacy. Further,
he stated that it would not need to be re-resolved each time if the
patient was ``coming from the same place, he's seeing the same doctors,
coming to the same pharmacy.'' Id. at 453. When asked about this red
flag on cross-examination, Mr. Parrado said that from his review,
Patient A.R. appeared to have a relationship with a pharmacy that would
fill his prescriptions when it was difficult to find places to fill
prescriptions. Id. at 539. He observed that Pharmacy 4 Less had
developed a relationship with A.R., was monitoring and checking up on
him, and gave all other indications which would resolve that red flag,
in his opinion. Id. at 539.
While there appears to be no dispute that long distances traveled
can constitute a red flag, there is a dispute as to its resolution in
this matter. Mr. Parrado claimed that in his review, he believed this
red flag had been resolved. Mr. Parrado based his finding on A.R.
having developed a relationship with the Respondent and the difficulty
in locating pharmacies which carried opioids. Mr. Parrado's finding
appears to rely significantly on a scarcity of pharmacies carrying
opioids. Based on the existing record, such scarcity has not been
directly established. That the Respondent pharmacy has developed a
relationship with A.R. would certainly not justify the first few
dispensing without resolving the distance traveled red flag. In the
absence of any other evidence resolving this red flag, I credit Dr.
Hamilton's testimony that even if the red flag is resolvable, it was
not resolved in this case.
Opioid Tolerance and High Starting Dosages
I did not recognize significant disagreement between Dr. Hamilton
and Mr. Parrado regarding the red flag evident at the initial
dispensing of any significant strength of opioids. Dr. Hamilton
testified that a high initial opioid prescription is a red flag that
must be resolved. He asserted that if a starting dose is too high and a
pharmacist fails to identify the patient as being opioid na[iuml]ve to
that dosage level, the prescription could potentially prove to be
fatal. Id. at 188. While Mr. Parrado did not appear to disagree that
this is a red flag that should be resolved, he differed in his
assessment of the patients in this matter receiving high starting
dosages such that they would fail to meet the minimum standard of care.
For example, when asking about prescribing 84 pills of oxycodone 30 mg
to a patient, Dr. Hamilton testified that it would have been too high
of a starting dosage for some of the charged patients. On the other
hand, Mr. Parrado observed that there is no upper limit on the quantity
that can be prescribed to a patient or how many milligrams. He stated
that each would depend on the patient and their individual tolerance
level. Id. at 461-62. Their previous opioid medication levels would
fairly suggest their level of tolerance. Essentially, Mr. Parrado took
the position that initial subject opioid dispensing of a significant
dosage represented a red flag, which was resolvable. I do not recognize
significant conflict between the two experts in this regard.
The credibility of Ms. Mincy's testimony as relates to her
investigating the opioid naivet[eacute] of the 10 subject patients
deserves some analysis. Here, Ms. Mincy testified that she used E-
FORCSE at the pharmacy to look at patients' histories and records
before filling a prescription. Id. at 643. She indicated that she uses
it daily and prior to every fill of a new prescription of her patients.
Id. She even stated that E-FORCSE ``is the best system to resolve red
flags, in [her] opinion.'' Id. at 645. She made multiple comments about
the usefulness of the E-FORCSE system and how she uses it on a daily
basis during her work in the pharmacy. Finally, she indicated that she
uses it before she fills every controlled substance prescription. Id.
at 645-46.
The Government introduced evidence of the E-FORCSE searches
conducted by Pharmacy 4 Less between January 1, 2015, and June 6, 2017,
for the 10 charged patients in this matter. GX 38. For six patients,
A.E., B.F., K.E.D., R.R., R.V., and V.W., this exhibit shows that
Pharmacy 4 Less conducted initial opioid fills for the six patients,
but did not run a search on E-FORCSE on the corresponding date of the
fill. For example, Patient A.E. first filled a prescription on November
19, 2015, but Pharmacy 4 Less did not check E-FORCSE for Patient A.E.
until April 7, 2016. GX 38, p. 11. Apart from being able to run checks
through E-FORCSE, Pharmacy 4 Less did not introduce any evidence that
it otherwise completed or documented its resolution of any potential
red flags for Patient A.E before doing an initial fill of the
prescription. The evidence shows this to be true for Patients B.F.,
K.E.D., R.R., R.V., and V.W., as well. GX 38.
The E-FORCSE records introduced do substantiate that either Ms.
Mincy or Mr. Sprys checked the E-FORCSE database for the initial opioid
dispensing for the following subject patients: A.R. on March 16, 2016;
A.V. on April 21, 2016; B.N. on January 22, 2016; and K.Y.D. on
February 4, 2016. See GX 38; RX 21, p. 4, 23, p. 3, 27, p. 3, 31, p. 7.
However, Ms. Mincy conceded there was no documentary evidence that
indicated that any of the subject ten patients started at lower doses
of opioids, including oxycodone and hydromorphone, and worked their way
up because they become opioid tolerant. Tr. 815-16. To the extent that
Mr. Parrado credited Ms. Mincy's and Mr. Sprys' claims that they
checked E-FORCSE to resolve opioid na[iuml]vet[eacute] for the six
patients noted above, this significantly diminishes Mr. Parrado's
opinion.
The E-FORCSE records further belie Ms. Mincy's claim that she
checked the E-FORCSE prior to filling each prescription. Tr. 645-46; GX
38. According to my math, of the 190 charged dispensed prescriptions
within the subject record, the Respondent checked the E-FORCSE database
31 times, or 16.3% of the time. Ms. Mincy later testified that she
checked E-FORCSE for each Schedule 2 prescription, and only recently
began checking it for all controlled substance prescriptions. This
significantly diminishes Ms. Mincy's reliability as a witness.
[[Page 54573]]
Findings as to Allegations
The Government alleges that the Respondent's COR should be revoked
because the Respondent failed to ensure that it only filled
prescriptions issued for legitimate medical purposes, and within the
course of professional practice, in violation of its corresponding
responsibility, and repeatedly filled prescriptions in the face of
obvious red flags of diversion, and its registration would be
inconsistent with the public interest, as provided in 21 U.S.C.
824(a)(4) and 21 U.S.C. 823(f), and in violation of state law under the
Florida Administrative Code and state requirements for the minimum
standard of care.
In the adjudication of a revocation or suspension of a DEA COR, DEA
has the burden of proving that the requirements for such revocation or
suspension are satisfied. 21 CFR 1301.44(e) (2010). Where the
Government has sustained its burden and made its prima facie case, a
respondent must both accept responsibility for her actions and
demonstrate that she will not engage in future misconduct. Patrick W.
Stodola, M.D., 74 FR 20,727, 20,734 (2009). 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).
Where the Government has sustained its burden, that registrant must
present sufficient mitigating evidence to assure the Administrator that
he can be entrusted with the responsibility commensurate with such a
registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008).\*KK\
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\*KK\ Text omitted for brevity.
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The Agency's conclusion that ``past performance is the best
predictor of future performance'' has been sustained on review in the
courts, Alra Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as
has the Agency's consistent policy of strongly weighing whether a
registrant who has committed acts inconsistent with the public interest
has accepted responsibility and demonstrated that he or she will not
engage in future misconduct. Hoxie, 419 F.3d at 482-83; see also Ronald
Lynch, M.D., 75 FR 78,745, 78,754 (2010) (holding that the Respondent's
attempts to minimize misconduct undermined acceptance of
responsibility); George C. Aycock, M.D., 74 FR 17,529, 17,543 (2009)
(finding that much of the respondent's testimony undermined his initial
acceptance that he was ``probably at fault'' for some misconduct);
Krishna-Iyer, 74 FR at 463 (noting, on remand, that despite the
respondent's having undertaken measures to reform her practice,
revocation had been appropriate because the respondent had refused to
acknowledge her responsibility under the law); Med. Shoppe-
Jonesborough, 73 FR at 387 (noting that the respondent did not
acknowledge recordkeeping problems, let alone more serious violations
of federal law, and concluding that revocation was warranted).
The burden of proof at this administrative hearing is a
preponderance-of-the-evidence standard. Steadman v. SEC, 450 U.S. 91,
100-01 (1981). The Administrator's factual findings will be sustained
on review to the extent they are supported by ``substantial evidence.''
Hoxie, 419 F.3d at 481. The Supreme Court has defined `substantial
evidence' as such relevant evidence as a reasonable mind might accept
as adequate to support a conclusion. Consolidated Edison Co. of New
York v. National Labor Relations Board, 305 U.S. 197, 229, 59 S.Ct.
206, 217 (1938). While ``the possibility of drawing two inconsistent
conclusions from the evidence'' does not limit the Administrator's
ability to find facts on either side of the contested issues in the
case, Shatz v. U.S. Dep't of Justice, 873 F.2d 1089, 1092 (8th Cir.
1989); Trawick, 861 F.2d at 77, all ``important aspect[s] of the
problem,'' such as a respondent's defense or explanation that runs
counter to the Government's evidence, must be considered. Wedgewood
Vill. Pharmacy v. DEA, 509 F.3d 541, 549 (D.C. Cir. 2007); Humphreys v.
DEA, 96 F.3d 658, 663 (3rd Cir. 1996). The ultimate disposition of the
case must be in accordance with the weight of the evidence, not simply
supported by enough evidence to justify, if the trial were to a jury, a
refusal to direct a verdict when the conclusion sought to be drawn from
it is one of fact for the jury. Steadman, 450 U.S. at 99 (internal
quotation marks omitted).
Regarding the exercise of discretionary authority, the courts have
recognized that gross deviations from past agency precedent must be
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in
application does not, standing alone, render a particular discretionary
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (D.C. Cir. 2008)
(citing Butz v. Glover Livestock Comm'n Co., 411 U.S. 182, 188 (1973)).
It is well-settled that since the Administrative Law Judge has had the
opportunity to observe the demeanor and conduct of hearing witnesses,
the factual findings set forth in this recommended decision are
entitled to significant deference, Universal Camera Corp. v. NLRB, 340
U.S. 474, 496 (1951), and that this recommended decision constitutes an
important part of the record that must be considered in the
Administrator's decision. Morall, 412 F.3d at 179. However, any
recommendations set forth herein regarding the exercise of discretion
are by no means binding on the Administrator and do not limit the
exercise of that discretion. 5 U.S.C. 557(b) (2006); River Forest
Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney
General's Manual on the Administrative Procedure Act 8 (1947).
Red Flags of Diversion
The Government has alleged that Pharmacy 4 Less failed to resolve
and document ``red flags'' of diversion outside the usual course of
professional practice (21 CFR 1306.06) and the pharmacy's corresponding
responsibility (21 CFR 1306.04(a)) and in violation of meeting the
Florida minimum standard of care under Florida law.
High Starting Dosages
The Government has alleged that Pharmacy 4 Less routinely filled
Schedule 2 controlled substances for patients with high starting
dosages, including both the dosage being prescribed and the number of
tablets being prescribed.
The Government presented evidence by Dr. Hamilton that the initial
starting dosages for at least six of the charged patients (Patients
A.E., B.F., K.E.D., R.R., R.V., and V.W.) were too high and potentially
fatal to opioid na[iuml]ve patients. Dr. Hamilton gave his opinion that
the starting dosages for these charged patients were too high given the
nature of the patients' medical records and other documents that he had
reviewed. Mr. Parrado appeared to agree with Dr. Hamilton that it is
necessary to determine whether a patient is opioid na[iuml]ve and that
it should be factored into the determination of what a proper starting
dosage would be, but disagreed that the starting dosages were
necessarily too high. Both experts agreed that in order to determine if
a patient is opioid na[iuml]ve, a pharmacist can check E-FORCSE, talk
to the patient, consult with the prescribing doctor, or take other
steps the pharmacist determines to be necessary.
Here, Ms. Mincy testified that she used E-FORCSE at the pharmacy to
look at patients' histories and records before
[[Page 54574]]
filling a prescription. Tr. 643. She indicated that she uses it daily
and prior to every fill of a new prescription of her patients. Id. She
even stated that E-FORCSE ``is the best system to resolve red flags, in
[her] opinion.'' Id. at 645. She made multiple comments about the
usefulness of the E-FORCSE system and how she uses it on a daily basis
during her work in the pharmacy. Finally, she indicated that she uses
it before she fills every controlled substance prescription. Id. at
645-46.
The Government introduced evidence of the E-FORCSE searches
conducted by Pharmacy 4 Less between January 1, 2015, and June 6, 2017,
for the 10 charged patients in this matter. GX 38. For the six patients
previously mentioned, this exhibit shows that Pharmacy 4 Less condu
[…truncated; see source link]Indexed from Federal Register on October 1, 2021.
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.