[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Notices]
[Pages 64714-64746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25133]
[[Page 64713]]
Vol. 86
Thursday,
No. 220
November 18, 2021
Part IV
Department of Justice
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Drug Enforcement Administration
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Pronto Pharmacy, LLC; Decision and Order; Notice
Federal Register / Vol. 86 , No. 220 / Thursday, November 18, 2021 /
Notices
[[Page 64714]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19-42]
Pronto Pharmacy, LLC; Decision and Order
On August 23, 2019, a former Acting Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause and Immediate Suspension of Registration
(hereinafter, OSC) to Pronto Pharmacy, LLC (hereinafter, Respondent).
Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at
1.\*A\ The OSC informed Respondent of the immediate suspension of its
DEA Certificate of Registration Number FP2302076 (hereinafter,
registration or COR) and proposed its revocation, the denial of any
pending applications for renewal or modification of such registration,
and the denial of any pending applications for additional DEA
registrations pursuant to 21 U.S.C. 824(a)(4) and 823(f), because
Respondent's ``continued registration is inconsistent with the public
interest.'' Id. (citing 21 U.S.C. 824(a)(4) and 823(f)).
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\*A\ According to Agency records, DEA removed all controlled
substances from Respondent's possession on August 29, 2019, when the
OSC was served, pursuant to the Immediate Suspension Order.
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In response to the OSC, Respondent timely requested a hearing
before an Administrative Law Judge. ALJ Ex. 3. The hearing in this
matter was conducted from January 28-29, 2020, in Tampa, Florida. On
May 5, 2020, Administrative Law Judge Mark M. Dowd (hereinafter, ALJ)
issued his Recommended Rulings, Findings of Fact, Conclusions of Law
and Decision (hereinafter, Recommended Decision or RD). On May 26,
2020, the Government and Respondent filed exceptions to the Recommended
Decision (hereinafter, Gov Exceptions and Resp Exceptions,
respectively). Having reviewed the entire record, I find Respondent's
Exceptions without merit and I adopt the ALJ's Recommended Decision
with minor modifications, as noted herein.\*B\ I have addressed each of
Respondent's Exceptions and I issue my final Order in this case
following the Recommended Decision.
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\*B\ I have made minor, nonsubstantive, grammatical changes to
the RD and nonsubstantive conforming edits. 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 in brackets, and I have included specific descriptions of
the modifications in brackets or in footnotes marked with an
asterisk and a letter. Within those brackets and footnotes, the use
of the personal pronoun ``I'' refers to myself--the Administrator.
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Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge *C 1 2 3
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\*C\ I have omitted the RD's discussion of the procedural
history to avoid repetition with my introduction.
\1\ [Footnote omitted, see supra n.*C.]
\2\ [Footnote omitted, see supra n.*C.]
\3\ [Footnote omitted, see supra n.*C.]
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The issue ultimately to be adjudicated by the Administrator, with
the assistance of this Recommended Decision, is whether the record as a
whole establishes by a preponderance of the evidence that the DEA
Certificate of Registration, No. FP2302076, issued to the Respondent
should be revoked, and any pending applications for modification or
renewal of the existing registration be denied, and any applications
for additional registrations be denied, because its continued
registration would be inconsistent with the public interest under 21
U.S.C. 823(f) and 824(a)(4).
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
1. The Respondent repeatedly issued prescriptions in violation of
the minimum practice standards that govern the practice of pharmacy in
Florida. ALJ Ex. 1 at ] 4. Specifically, from at least January 2018
through at least May 2019, the Respondent repeatedly filled
prescriptions for Schedule II narcotics in the face of obvious red
flags of drug abuse and diversion. Id. Filling these prescriptions
violated federal and Florida law, including 21 CFR 1306.04(a) and
1306.06, and Fla. Admin. Code r. 64B16-27.810.
2. In addition, the Respondent engaged in the ``manufacture'' of
controlled substances, as the Controlled Substances Act defines that
term. ALJ Ex. 1 at ] 5. The Respondent is not registered with the DEA
as a manufacturer. Id. Manufacturing controlled substances without the
appropriate registration is a violation of federal law, including 21
U.S.C. 841(a)(1) and 21 CFR 1301.13(e). Id.
Improper Dispensing
Between January 9, 2018, and May 7, 2019, the Respondent repeatedly
issued prescriptions in violation of the minimum practice standards
that govern the practice of pharmacy in Florida. ALJ Ex. 1 at ] 11.
These prescriptions presented numerous red flags of drug abuse and
diversion, including drug cocktails, early refills, excessive
dispensing of high-strength controlled substances, travelling long
distances, and cash payments. Id. at ]] 12-15, 18-19. Filling these
prescriptions violated federal and state law, including 21 U.S.C.
842(a)(1), 21 CFR 1306.04(a), and Florida Administrative Code r. 64B16-
27.810. Id. at ] 19. The OSC/ISO provided the following specific
examples of prescriptions that raised these red flags:
Drug Cocktails
3. Patient A.G.: On at least nine occasions between January 25,
2018, and April 12, 2019, the Respondent filled prescriptions issued by
the same prescriber for patient A.G. for alprazolam and oxycodone or
hydromorphone on the same date. ALJ Ex. 1, ] 12(a). Specifically, the
Respondent filled prescriptions for hydromorphone and alprazolam for
A.G. on the following four occasions: January 25, 2018; March 1, 2018;
April 12, 2018; and May 8, 2018. Id. The Respondent filled
prescriptions for oxycodone and alprazolam for A.G. on the following
five occasions: December 20, 2018; January 17, 2019; February 14, 2019;
March 20, 2019; and April 12, 2019. Id.
4. Patient B.S.: On at least five occasions between January 29,
2018, and April 22, 2019, the Respondent filled prescriptions issued by
the same prescriber for patient B.S. for alprazolam and oxycodone or
hydromorphone on the same date. ALJ Ex. 1, ] 12(b). Specifically, the
Respondent filled prescriptions for hydromorphone and alprazolam for
B.S. on the following two occasions: January 29, 2018, and May 22,
2018. Id. The Respondent filled prescriptions for oxycodone and
alprazolam for B.S. on the following three occasions: December 20,
2018; February 28, 2019; and March 26, 2019. Id.
5. Patient N.B.: On at least three occasions between September 14,
2018, and January 16, 2019, the Respondent filled prescriptions issued
by the same prescriber for patient N.B. for alprazolam and oxycodone or
hydromorphone on the same date. ALJ Ex. 1, ] 12(c). Specifically, the
Respondent filled prescriptions for hydromorphone and alprazolam for
N.B. on September 14, 2018. Id. The Respondent filled prescriptions for
oxycodone and alprazolam for N.B. on the following two occasions:
December 20, 2018, and January 16, 2019. Id.
[[Page 64715]]
6. Patient C.R.: On at least three occasions between March 6, 2018,
and July 12, 2018, the Respondent filled prescriptions issued by the
same prescriber for patient C.R. for alprazolam and oxycodone on the
same date. ALJ. Ex. at ] 12(d). Specifically, the Respondent filled
prescriptions for oxycodone and alprazolam for C.R. on March 6, 2018;
April, 19, 2018; and July 12, 2018. Id.
7. Patient J.M.: On at least five occasions between January 25,
2018, and May 16, 2018, the Respondent filled prescriptions issued by
the same prescriber for patient J.M. for alprazolam and oxycodone on
the same date. Id. Specifically, the Respondent filled prescriptions
for oxycodone and alprazolam for J.M. on January 25, 2018; March 1,
2018; April 4, 2018; April 19, 2018; and May 16, 2018. Id.
Early Refills
8. Patient A.H.: On January 22, 2019, the Respondent filled a
prescription for patient A.H. for a 30-day supply of hydromorphone 8 mg
tablets. ALJ Ex. 1, ] 13(a). The Respondent filled additional
prescriptions for A.H. for 30-day supplies of hydromorphone 8 mg
tablets on February 15, 2019 (six days early); February 27, 2019 (18
days early); and March 14, 2019 (15 days early). Id.
9. Patient M.M.: On January 3, 2019, the Respondent filled a
prescription for patient M.M. for a 28-day supply of hydromorphone 8 mg
tablets. ALJ Ex. 1, ] 13(b). The Respondent filled additional
prescriptions for M.M. for 30-day supplies of hydromorphone 8 mg
tablets on January 24, 2019 (seven days early); February 19, 2019 (four
days early); and a 28-day supply on March 15, 2019 (six days early).
Id.
10. Patient J.D.: On May 10, 2018, the Respondent filled a
prescription for patient J.D. for a 30-day supply of hydromorphone HCL
powder. ALJ Ex. 1, ] 13(c). The Respondent filled additional
prescriptions for J.D. for 30-day supplies of hydromorphone HCL powder
on May 30, 2018 (10 days early); June 15, 2018 (14 days early); and
June 30, 2018 (15 days early). Id.
11. Patient R.G.: On January 29, 2018, the Respondent filled
prescriptions for patient R.G. for a 30-day supply of oxycodone HCL
powder and a 30-day supply of alprazolam 2 mg tablets. ALJ Ex. 1, ]
13(d). The Respondent filled additional prescriptions for 30-day
supplies of oxycodone HCL powder and alprazolam 2 mg tablets for R.G.
on February 21, 2018 (seven days early); March 19, 2018 (four days
early); April 17, 2018 (one day early); and May 8, 2018 (nine days
early). Id.
12. Patient R.L.: On February 1, 2018, the Respondent filled a
prescription for patient R.L. for a 30-day supply of hydromorphone HCL
powder. ALJ Ex. 1, ] 13(e). The Respondent filled additional
prescriptions for 30-day supplies of hydromorphone HCL powder for R.L.
on February 26, 2018 (five days early); a 29-day supply on March 22,
2018 (six days early); a 30-day supply on April 17, 2018 (three days
early); and a 30-day supply on May 11, 2018 (six days early). Id.
High-Strength Controlled Substances
13. During the relevant time period, virtually all of the
prescriptions for oxycodone and hydrocodone that the Respondent
``compounded'' were for oxycodone 30 mg immediate release and
hydromorphone 8 mg immediate release, the highest strengths of these
controlled substances. ALJ Ex. 1, ] 14. Furthermore, between January
11, 2018, and July 17, 2018, 100 percent of the oxycodone tablet
prescriptions and 87 percent of the hydromorphone tablet prescriptions
(approximately 44 prescriptions total) issued by a particular
prescriber were for the highest strength available for those controlled
substances. Id.
Long Distances
14. Between September 10, 2018, and May 6, 2019, the Respondent
filled:
a. 86 prescriptions for patients with addresses in Cape Coral,
Florida, which is approximately 140 miles from the Respondent;
b. 145 prescriptions for patients with addresses in Fort Myers,
Florida, which is approximately 130 miles from the Respondent;
c. 41 prescriptions for patients with addresses in Lehigh Acres,
Florida, which is approximately 140 miles from the Respondent;
d. 15 prescriptions for patients with addresses in Immokalee,
Florida, which is approximately 150 miles from the Respondent;
e. 15 prescriptions for patients with addresses in Naples, Florida,
which is approximately 170 miles from the Respondent;
f. 11 prescriptions for patients with addresses in Opa-locka,
Florida, which is approximately 270 miles from the Respondent. ALJ Ex.
1, ]] 15(a)-(f).
15. In addition, between September 10, 2018, and May 6, 2019, over
75 percent of the prescriptions for controlled substances filled by the
Respondent were issued by prescribers whose medical practices are
located more than 150 miles away from the Respondent. ALJ Ex. 1, ] 16.
Cash Payments
16. During the relevant time period, over 90 percent of the
prescriptions for oxycodone 30 mg and hydromorphone 8 mg filled by the
Respondent were paid for with cash. ALJ Ex. 1, ] 18. In contrast, in
2018 ``approximately 11 percent of all prescriptions filled by
independently owned pharmacies . . . were paid for with cash.'' Id.
Illegal Manufacturing
17. Between January 2018 and May 2019, the Respondent was engaged
in manufacturing controlled substances, as that term is defined in the
CSA, without a separate DEA registration authorizing it to manufacture
controlled substances, in violation of 21 U.S.C. 841(a)(1) and 21 CFR
1301.13(e). ALJ Ex. 1, ] 20-28.
The Hearing
Government's Opening Statement
In its Opening Statement, Tr. 14-17, the Government stated that
through its investigation of the Respondent, the DEA obtained the
Respondent's dispensing records and patient profiles, a pharmacy expert
reviewed those records, and that review revealed suspicious patterns.
Tr. 14. Those suspicious patterns included the fact that 99 percent of
the Respondent's prescriptions were paid for in cash; over 90 percent
of the Respondent's patients travelled more than 100 miles to fill
their prescriptions; and that the Respondent dispensed a
disproportionately high volume of opioids. Id. The DEA's expert
reviewed the Respondent's records related to 11 specific patients and
found that the prescriptions filled by these patients presented
numerous red flags that could not have been resolved by a pharmacist
acting in the usual course of professional practice. Tr. 14-15. The
expert further opined that based on his review of the Respondent's
records, the Respondent made no attempt to resolve the red flags
presented by these prescriptions. Id.
In addition, the Government previewed that its evidence would show
that the Respondent unlawfully manufactured controlled substances,
specifically oxycodone and hydromorphone, without a manufacturer's
registration. Tr. 15-17. To support this allegation, the Government
intended to show that in May 2012 the Respondent's owner, Mr. Norman J.
Clement, Sr., told DEA investigators that he compounded oxycodone and
hydromorphone because it was cheaper than obtaining them from
distributors. Tr. 14-15. In conclusion,
[[Page 64716]]
the Government requested that the Respondent's registration be revoked
and any pending applications be denied because its continued
registration presents a threat to the public. Tr. 17.
Respondent's Opening Statement
In the Respondent's opening statement, Tr. 503-06, the Respondent
stated that the DEA initiated this case without objectively evaluating
the evidence. Tr. 503. The DEA did not interview any patients
identified in the OSC/ISO or the doctors who issued the prescriptions
involved in this case. Id. The DEA also did not subpoena the medical
records of the patients at issue. Id.
The Respondent argued that the Government's evidence would fail to
show that any patients involved in this case suffered adverse
consequences from the prescriptions filled by the Respondent. Tr. 504.
Furthermore, the Respondent argued that the Government's evidence would
fail to meet its burden to revoke the Respondent's registration. Id. In
the Respondent's view, the Government's case is based on the faulty
assumption that the patients must have been drug abusers because they
received treatment for chronic pain. Id. The Respondent characterized
this assumption as ``inherently unfair and inappropriate.'' Id.
The Respondent argued that the Government's assumption ignores the
Respondent's combined 90-years of pharmacy experience possessed by the
Respondent's pharmacists, as well as their professional education and
training. Tr. 505. The Respondent's evidence is expected to prove that
its pharmacists exercised appropriate professional judgment and
resolved red flags. Id. The Respondent highlighted that the
Government's evidence on red flags comes from a witness who has never
practiced in Florida. Id. Furthermore, the Respondent argued that its
evidence will show that its pharmacists' professional judgment complied
with the Florida standard of care, and that the Florida standard of
care is established by state statutes rather than an ``ivory tower
aspirational goal.'' Id.
Government's Case-in-Chief
The Government presented its case-in-chief through the testimony of
three witnesses. First, the Government presented the testimony of
Diversion Investigator Richard Albert. Tr. 24-180. Second, the
Government presented the testimony of Task Force Officer Jeffrey
Shearer. Tr. 181-94. Finally, the Government presented the testimony of
its expert, Dr. Donald Sullivan. Tr. 195-502.
Diversion Investigator (DI) Richard J. Albert, Jr.
DI Albert has been a Diversion Investigator for more than seven
years. Tr. 24-25. He is currently stationed in Tampa, Florida.
Previously, he was stationed in Nashville, Tennessee. Tr. 24. To become
a Diversion Investigator, DI Albert received training at the 12-week
basic diversion school in Quantico, Virginia. Tr. 25.
DI Albert became involved in the investigation of the Respondent in
May 2017, when he received a call from the Department of Health
regarding a pharmacy that was compounding hydromorphone and oxycodone.
Tr. 26. DI Albert and his supervisor then met with the Health
Department investigator at Respondent. Id. The Respondent's owner, Mr.
Norman J. Clement, Sr., was not present at the pharmacy, but his
daughter and wife were present. Tr. 26-27. The investigators presented
a Notice of Inspection to Mr. Clement, Sr.'s, daughter, who allowed the
investigators to inspect the pharmacy. Id. Approximately 15-minutes
into the inspection, Mrs. Clement asked the investigators to leave. Id.
The investigators complied. Tr. 27.
In September 2017, the DEA served a subpoena on the Respondent
requesting Schedule II controlled substance prescriptions, receiving
records, and batch records. Tr. 27. Government Exhibit 2 is a receiving
record sent from Auburn Pharmaceutical to the Respondent. Tr. 28; GX 2.
The DEA received this document in response to the September 2017
subpoena. Id.
Government Exhibit 3 is a receiving record for hydromorphone \4\
sent from B&B Pharmaceuticals to the Respondent. Tr. 29; GX 3. The DEA
received this document in response to the September 2017 subpoena. Id.
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\4\ Hydromorphone is a Schedule II controlled substance. Tr. 29.
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Government Exhibit 4 is a receiving record for oxycodone sent from
Fagron, Inc., to the Respondent. Tr. 31; GX 4. The DEA received this
document in response to the September 2017 subpoena. Tr. 32.
Government Exhibit 5 contains batch records for hydromorphone 8 mg.
Tr. 32-33; GX 5. A batch record documents the production of a
controlled substance and lists the ingredients in the controlled
substance. Tr. 33. The batch record is created by the person who makes
the substance. Id. The batch records indicate how many capsules were
used in the production of a particular batch. Tr. 38, 40-41. Government
Exhibit 5 documents the production of hydromorphone 8 mg. Tr. 33. The
initials ``N.C.,'' who DI Albert presumed to be the Respondent's owner,
Norman J. Clement, Sr., appear in the columns labelled ``Manufactured
By,'' ``Checked By,'' and ``Final Product Checked By.'' \5\ Tr. 35-37;
GX 5.
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\5\ During cross-examination, the Respondent's counsel directed
DI Albert's attention to page 7 and 11 of Government Exhibit 6,
which shows illegible initials in the ``Manufactured By'' column
(page 7) and the ``Checked By'' column (page 11). Tr. 150; GX 6, pp.
7, 11. DI Albert was also unable to identify the signature on page
13 of Government Exhibit 6. Tr. 151; GX 6, p. 13.
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Government Exhibit 6 contains batch records for oxycodone 30 mg.
Tr. 38-39; GX 6. The DEA received this document in response to the
September 2017 subpoena. Tr. 39.
Upon reviewing the batch records received in response to the
September 2017 subpoena, DI Albert noticed that the records listed
lactose as the only non-controlled substance ingredient. Tr. 42-43.
When he reviewed the prescriptions received in response to the
subpoena, he noticed that patients were travelling long distances to
the pharmacy. Tr. 43, 129-30.
Government Exhibit 10 is a printout of the prescription drug
monitoring program (``PDMP'') for the Respondent's dispensing from
September 2016 to June 2018. Tr. 46, 159, 162; GX 10, pp. 1, 20. This
document represents the total number of controlled substance
prescriptions that the Respondent dispensed during that 21-month time
period. Tr. 162-63. The document lists 2,360 prescriptions. Tr. 162-63.
DI Albert reviewed the Respondent's PDMP records during his
investigation. Tr. 43-44. Government Exhibits 8 and 9 also contain PDMP
printouts of the Respondent's dispensing. Tr. 49-52; GX 8-9.
DI Albert returned to Respondent in September 2018 to serve an
administrative inspection warrant (``AIW'') and subpoena. Tr. 52.
Government Exhibit 67 is the subpoena, dated September 5, 2018, that DI
Albert served on the Respondent's counsel at the time of executing the
AIW. Tr. 52-53; GX 67. The second page of the subpoena is a list of
patient names. Tr. 53; GX 67, p. 2. DI Albert did not speak with any
patients who presented at the pharmacy while the AIW was being
executed. Tr. 168. He also did not speak with any of the Respondent's
staff, including Mr. Norman J. Clement, Sr., who was instructed by
counsel to not answer any questions. Tr. 168, 173, 177.
During service of the AIW, digital forensic specialists captured
mirror
[[Page 64717]]
images of the Respondent's computer system. Tr. 54, 62, 91, 93, 134.
The Respondent used Rx30 pharmacy software. Tr. 135. DI Albert received
the information that was captured from the Respondent's system in Excel
format, but he did not know the process that the digital forensic team
used to convert that information into the format he received. Tr. 136.
DI Albert was unable to determine whether errors were made in
converting the captured images of the Respondent's system into Excel.
Tr. 136-37.
During execution of the AIW, DI Albert observed Mr. Clement, Sr.,
conduct a closing inventory of the controlled substances that the
Respondent had on-hand at the time. Tr. 54, 56, 165-66. Mr. Clement,
Sr., signed the closing inventory. Tr. 56, 58; GX 7. The closing
inventory lists 470 tablets of hydromorphone 8mg, 3,546 capsules of
hydromorphone 8 mg, hydromorphone powder, 204 tablets of oxycodone 30
mg, 574 capsules of oxycodone 30 mg, and oxycodone powder. Tr. 59, 61;
GX 7. Medications from distributors are in the form of tablets. When
medications are compounded from powder in batch at a pharmacy, the
dosage units are contained in capsules. Tr. 60.
Government Exhibit 11 is saved on a DVD. Tr. 63-64; GX 11.
Government Exhibit 11 contains records electronically downloaded from
the Respondent's computer system during execution of the AIW. Tr. 63.
Government Exhibit 12 is a report of the Respondent's dispensing
over a three-month period from November 2015 through January 2016. Tr.
68; GX 12. This document was obtained electronically during execution
of the AIW in September 2018. Tr. 69. Government Exhibit 13 was also
obtained during service of the AIW. Tr. 70; GX 13.
Government Exhibit 14 is a PDMP dispensing record for patient A.G.
Tr. 71-72; GX 14. Government Exhibit 15 is a record kept by the
Respondent for patient A.G. with information about the patient as well
as notes. Tr. 73-74; GX 15. It was electronically downloaded from the
Respondent's computer system during the AIW search. Tr. 75. The DEA
also obtained Government Exhibits 16 and 17 during the AIW search. Tr.
76-81, 140; GX 16-17. Government Exhibits 16 and 17 are dispensing
records for patient A.G. maintained by the Respondent and obtained from
the pharmacy. Id.
Government Exhibit 19 is a PDMP dispensing record for patient A.H.
Tr. 81-82; GX 19. The Government moved for the admission of Exhibits 19
through 43 and 46 through 52 as a group. Tr. 85-87. These exhibits were
either obtained from the Respondent during the AIW search in September
2018 or printed from the PDMP. Id. They relate to the specific patients
identified in the OSC/ISO. Id.
After executing the AIW at the pharmacy in September 2018, DI
Albert sent the records he obtained to a pharmacy expert, Dr. Donald
Sullivan, for review. Tr. 88. DI Albert served another subpoena on the
Respondent in May 2019. Tr. 88-89; GX 68. Attached to the subpoena is a
list of seven patients. Tr. 89; GX 68, p. 2. This subpoena requested
that the Respondent produce five categories of documents, to include
(1) patient profiles for the patients identified in the attachment; (2)
other records documenting the steps taken to avoid or resolve any
issues or red flags with prescriptions; (3) original prescriptions and
fill stickers of all prescriptions filled for patients listed in the
attachment from September 10, 2018, to May 10, 2019; (4) any pharmacist
notes evaluating potential red flags with prescriptions; (5) and any
other documentation related to the specific patients identified, such
as dispensing records, billing records, PDMP records, and medical
records. Tr. 89-90; GX 68.
DI Albert received additional documents from the Respondent in
response to the May 2019 subpoena. Tr. 94. The documents that DI Albert
received related to patients A.G. and R.B. are contained in Government
Exhibits 18 and 44. Tr. 94-98; GX 18, 44. DI Albert sent the documents
that he received in response to the May 2019 subpoena to the expert
witness for review. Tr. 118. He then began preparing the OSC/ISO. Tr.
118-19.
In his investigation of the Respondent, DI Albert calculated the
approximate distances from the cities where patients lived to the
Respondent pharmacy. Tr. 99-105, 130. DI Albert made these calculations
by using Google Maps to determine the distance from the cities of
residence to the Respondent's address. Tr. 99-101. The approximate
distances on Google Maps are contained in Government Exhibit 54.\6\ Tr.
99; GX 54.
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\6\ Although Google Maps includes estimated travel times as well
as mileage, due to the high variability of travel times, only the
mileage is being considered herein.
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DI Albert also searched for specific addresses in Google Maps. Tr.
105-12. Each of the specific addresses that DI Albert searched relate
to a specific patient. Tr. 106, 108-09, 111-12. The one-way distances
from those addresses to the Respondent are in Government Exhibits 55
through 60 and 62 through 65. Tr. 105-12; GX 55-60, 62-65.
Government Exhibit 55 shows a distance of 131 miles.\7\ Tr. 106; GX
55, p. 1. Government Exhibit 56 shows a distance of 132 miles. Tr. 109;
GX 56, p. 1. Government Exhibit 57 shows a distance of 148 miles. Tr.
110; GX 57, p. 1. Government Exhibit 58 shows a distance of 134 miles.
GX 58, p. 1. Government Exhibit 59 shows a distance of 130 miles. GX
59, p. 1. Government Exhibit 60 shows a distance of 144 miles. GX 60,
p. 1.
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\7\ The Google Maps printouts list three routes with different
distances and travel times. When speaking of the distances between
patients' homes and the Respondent, I will refer to the route with
the shortest mileage.
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Government Exhibit 62 shows a distance of 137 miles. GX 62, p. 1.
Government Exhibit 63 shows a distance of 138 miles. GX 63, p. 1.
Government Exhibit 64 shows a distance of 131 miles. GX 64, p. 1.
Government Exhibit 65 shows a distance of 138 miles. GX 65, p. 1.
Government Exhibit 61 shows the roundtrip distance from patient
M.M.'s home, to the doctor's office, to the Respondent, and then back
home. Tr. 112-18, 131, 172; GX 61. The total roundtrip distance from
M.M.'s home to the doctor's office and the Respondent, and then back
home, is 327 miles. Tr. 117, 131; GX 61, p. 1. Although DI Albert
searched for the roundtrip distance between M.M.'s home, doctor's
office, and the Respondent, he did not check to see whether M.M. filled
any prescriptions at the Respondent in Tampa on the same day that he
obtained them from the doctor in Fort Myers. Tr. 133, 171. DI Albert is
therefore not sure whether M.M. ever made the roundtrip drive that is
depicted in Government Exhibit 61. Id. If M.M. had travelled from her
home to the doctor's office and the Respondent on separate days,
however, the total travel distance would be similar to the roundtrip
distance travelled on one day.\8\ Tr. 173.
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\8\ The distance from M.M.'s home to her doctor's office is 134
miles. GX 61, p. 3. Thus, the total distance travelled if M.M. went
to the doctor and returned home on the same day would be 268 miles.
The distance from M.M.'s home to the Respondent is 38 miles. Tr.
134; GX 61, p. 6. Thus, the total distance travelled if M.M. went to
the Respondent and returned home on the same day would be 76 miles.
Added together, these distances total 344 miles. Thus, if M.M.
travelled to her doctor's office to obtain a prescription on one day
and returned home, and then travelled to the Respondent on another
day to fill the prescription and returned home, the total distance
travelled to obtain and fill that prescription would be slightly
higher (344 miles) than if she had made the roundtrip drive from
home, to the doctor's office, to the pharmacy, and back home, all in
one day (327 miles). However, during the hearing, counsel for the
Government conceded, and Dr. Sullivan confirmed, it was the distance
from the patient's home to her physician's office which represented
the red flag of long distance. Tr. 294.
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[[Page 64718]]
DI Albert was candid in conceding there were matters and facts of
which he was unaware. For example, during his investigation, DI Albert
readily conceded he did not talk to any of the 11 patients named in the
OSC/ISO. Tr. 123-24, 155. He also conceded that he did not contact the
subject prescribing doctors. Tr. 125-26, 128, 173-74, 178-80. DI Albert
also conceded that he was unfamiliar with the FDA guidelines on
compounding and that he did not receive training on compounding during
DI training. Tr. 152. He also admitted that he did not familiarize
himself with the Florida laws governing pharmacies, and that he only
applied federal law in his investigation. Tr. 152-53. DI Albert also
candidly acknowledged that he did not know the significance of the
citations to Florida law in the subpoenas that he served. Tr. 153-54.
In addition, DI Albert acknowledged that he had not done a comparison
of the Respondent's daily, weekly, and monthly dispensing volume to
other nearby pharmacies. Tr. 167-68.
DI Albert's willingness to concede these points, excepting in these
areas, bolsters his credibility. DI Albert's testimony focused
primarily on identifying exhibits and describing his investigation.
Based on my close observation of DI Albert at the hearing, my careful
review of his testimony in the transcript, and in conjunction with
other credible evidence, I find DI Albert to be a credible witness. DI
Albert presented as an impartial investigator with no direct stake in
the outcome of the case, and his testimony was straightforward,
professional, and candid. Furthermore, his testimony was also detailed
and internally consistent. For these reasons, I fully credit DI
Albert's testimony and find that his testimony merits considerable
weight in this Recommended Decision.
Task Force Officer (TFO) Jeffrey Shearer
TFO Shearer has been running a private investigation business for
the past five years. Tr. 182. Before that, he was a police officer with
the Tampa Police Department for 16 years. Id. He spent the last five-
and-a-half years of his career with the Tampa Police Department as a
task force officer working out of the DEA's Tampa District Office. Tr.
182-83. As a TFO, Mr. Shearer worked with the DEA in the Tactical
Diversion Squad on investigations related to the diversion of
controlled substances. Tr. 182.
TFO Shearer worked on an investigation of the Respondent. Tr. 183.
In May 2012, during execution of an AIW at the Respondent pharmacy, TFO
Shearer interviewed Mr. Clement, Sr., the Respondent's owner. Id. Mr.
Clement, Sr., was cooperative during execution of the AIW. Tr. 192. Mr.
Clement, Sr., was not in custody at the time and was free to leave. Tr.
183. In the interview, Mr. Clement, Sr., told TFO Shearer about his
process for manufacturing oxycodone and hydromorphone in capsules. Tr.
183-84. Mr. Clement, Sr., told TFO Shearer that he could buy a 100 gram
bottle of oxycodone powder for $1,100, enough to manufacture about
6,000 dosage units. Tr. 185. Tablets of oxycodone purchased from
commercial distributors cost roughly $2-$10 per pill. Id. Mr. Clement,
Sr., told TFO Shearer that he manufactured thousands of capsules per
batch because it was cost effective.\9\ Tr. 184-85. The batch records
that TFO Shearer reviewed in 2012 documented that Mr. Clement, Sr.,
produced thousands of pills in each batch. Id. Mr. Clement, Sr., was
not charged with a crime. Tr. 190.
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\9\ [Footnote omitted for relevance.]
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Based on listening to him testify at the hearing, and reviewing the
transcript of his testimony, I find TFO Shearer to be a credible
witness who testified in a candid, professional, and straightforward
manner. TFO Shearer testified regarding events that had occurred
approximately seven years prior to the hearing. He seemed fully capable
of recalling the majority of those events with ease, but it is not
surprising that some of his answers lacked detail. Any lack of detail,
however, did not detract from his credibility or the usefulness of his
testimony. He was honest about what he could not recall and he
presented as an impartial individual without a direct stake in the
outcome of the case. For these reasons, TFO Shearer's testimony is
credible and merits significant weight in this Recommended Decision.
Dr. Donald L. Sullivan 10
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\10\ [I agree with the ALJ's discretionary decision to allow the
Government to ask leading questions of its expert witness, over
objection by Respondent's counsel. See RD, at n.10.]
---------------------------------------------------------------------------
Dr. Sullivan is presently employed as a professor of Clinical
Pharmacy at Ohio State University College of Pharmacy, and has been for
five years. Tr. 196-97. See GX 53. Previously, he was employed at Ohio
Northern University for 17 years. Tr. 197. He obtained his Bachelor's
degree in 1990. Tr. 198. In 1991, he obtained his Master's in pharmacy
administration, and his doctorate in pharmacy administration in 1996.
Tr. 198. At Ohio State, in addition to performing research, he teaches
pharmacy practice law to all four years of students. He teaches two
courses on pharmacy operations, financial analysis, marketing, and
human resource issues. Tr. 197. His courses cover professional
standards for pharmacy personnel, including: Dispensing; record
keeping; documentation; drug utilization review; patient education and
counseling; compounding from a pharmacy practice perspective, as well
as state and federal statutes governing the practice of pharmacy. The
study of federal law comprises about 50-percent of the legal
curriculum. Tr. 197-98, 203.
He has lectured to independent pharmacies on behalf of wholesalers,
including Cardinal Health, AmerisourceBergen, HD Smith, as well as
several pharmacy organizations. Tr. 199. For the past four years, he
has presented a two-hour Continuing Education program to Florida
pharmacists on controlled substance dispensing. Tr. 199. Within the
past two-to-three years, Florida has increased the professional
requirements for pharmacists, to include validating controlled
substance prescriptions, understanding different types of diversion,
red flags for diversion, how to resolve red flags, naloxone
availability, and state and federal laws governing dispensing
controlled substances and related record keeping. Tr. 200. Dr. Sullivan
has authored five publications, consumer drug reference books, as well
as several peer-reviewed publications. Tr. 200. He has completed a
research study into community pharmacists, the resources they use in
identifying red flags, and their willingness to identify red flags of
diversion. Tr. 202. He presents training for government investigators
and attorneys. Tr. 203. He has been qualified as an expert in a
California criminal trial and in four DEA show cause hearings similar
to the instant hearing. Tr. 201, 354-55, 359.
He is a registered pharmacist in Ohio and in Florida. Tr. 198. He
has worked as a pharmacist in Ohio, but not in Florida. Tr. 198.
However, he has not worked in retail pharmacy for 20 years. Tr. 414.
His background is primarily in community pharmacy, which relates to
typical private pharmacies and chain pharmacies. Tr. 199. He has also
had experience at a pharmacy located within a mental health clinic, and
in a mail order pharmacy. Id.
Dr. Sullivan described a recent problematic trend in medication
reimbursement in which the pharmacies are sometimes being reimbursed
less than their actual costs to purchase the
[[Page 64719]]
medications. Tr. 430-31. This trend has caused small independent
pharmacies to seek niche markets. Tr. 431.
Through his education, training, and experience, Dr. Sullivan is
familiar with compounding in retail pharmacy, as well as issues related
to abuse and diversion of controlled substances, and with the
responsibilities of a retail pharmacist in the detection and prevention
of such abuse and diversion. Tr. 203. Dr. Sullivan is also familiar
with a pharmacist's corresponding responsibility under federal law, and
the standard of care and professional obligations of a pharmacist in
the state of Florida. Tr. 204. Dr. Sullivan was qualified as an expert
in the field of pharmacy and the standard of care for the practice of
pharmacy in the state of Florida. Tr. 204-05, 490.*\D\
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*\D\ Throughout the case, the Government's expert and all
parties appear to have used the phrases ``standard of care,''
``corresponding responsibility,'' and ``usual course of professional
practice'' interchangeably. Dr. Sullivan testified that in the
practice of pharmacy the phrases ``standard of care'' and ``usual
course of professional practice'' are the same. Tr. 321-22. Dr.
Sullivan's testimony regarding the requirement to resolve red flags
clearly related to Respondent's corresponding responsibility under
21 CFR 1306.04. The interchangeable use of this terminology does not
impact my ultimate finding that Respondent 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
corresponding responsibility herein.
---------------------------------------------------------------------------
Dr. Sullivan described the duties of a pharmacist in filling a
controlled substance prescription. Tr. 206. First, the pharmacist must
ensure the prescription is a ``valid prescription for a legitimate
medical purpose.'' Id. That is, the pharmacist must determine if it is
issued ``in the normal course of professional practice,'' that the
pharmacist believes the patient can safely take it, that the medication
is for an actual medical purpose, and is not being abused, misused, or
diverted. Id. These requirements are codified in both federal and
Florida law. Fla. Admin. Code r. 64B16-27.800, .810, and .831.
In reviewing a prescription, a pharmacist must first determine if
the prescription appears legal on its face; that all the information
necessary appears on the face of the prescription. Tr. 208. Then,
applying clinical expertise, the pharmacist must consider possible
over-utilization and under-utilization, where the patient is taking
more or less medication than prescribed; consider possible abuse or
misuse; whether it is serving a legitimate medical purpose; and whether
it exposes the patient to potential undue risk of side-effects, adverse
effects, or overdose. Tr. 208-09. The Florida standard of care requires
pharmacists to document their resolution of any potential issues
discovered in the pharmacist's review of a prescription. Tr. 210, 437,
489.
Dr. Sullivan was unaware that Florida had codified a definition of
``standard of care'' for healthcare workers. Tr. 438; Fla. Stat
766.102.\11\ He was unaware of the Florida Patient Bill of Rights. Tr.
462. Dr. Sullivan initially conceded there was no federal or Florida
regulation mandating where or how the resolution of red flags must be
documented. Tr. 435-37. In particular, Dr. Sullivan agreed that Florida
Administrative Code r. 64B16-27.831, Standards of Practice for the
Filling of Controlled Substance Prescriptions, subpart three, is silent
as to whether a pharmacist must document the steps a pharmacist takes
to validate a prescription. Tr. 449-50, 453-54. [However, Florida
Administrative Code r. 64B16-27.831 requires pharmacists to record
``[p]harmacist comments relevant to the individual's drug therapy,
including any other information peculiar to the specific patient or
drug,'' which Dr. Sullivan agreed would generally include the
information that is needed to resolve red flags. Tr. 488-89.]
---------------------------------------------------------------------------
\11\ The ``prevailing professional standard of care,'' is
defined under Florida law as ``that level of care, skill, and
treatment which, in light of all relevant surrounding circumstances,
is recognized as acceptable and appropriate by reasonably prudent
similar heath care providers.'' Fla. Stat. Sec. 766.102.
---------------------------------------------------------------------------
In conjunction with the precautionary evaluation described, the
pharmacist is required to maintain a ``patient profile'' for each
patient, which includes: The patient's full name, address and telephone
number, age or date of birth, gender, a list of all new and refilled
prescriptions obtained by the patient at the pharmacy, and any notes or
comments by the pharmacist particular to that patient, such as drug
allergies or contraindications. Tr. 209-10.
Dr. Sullivan explained that under federal law, the pharmacist has a
corresponding responsibility, an equal responsibility with the
prescribing physician, to determine if a prescription has been written
for a legitimate medical purpose. Tr. 210-11. That a prescription is
written by a physician does not absolve the pharmacist from ensuring
that it is for a legitimate medical purpose. Tr. 211. Common potential
concerns for a pharmacist are referred to as ``red flags.'' Red flags
include potential for diversion or abuse, patients traveling long
distances to see their physicians, or to the pharmacy 12 13
``drug cocktails commonly abused, large dosage units, payment in cash
for all or part of a patient's prescriptions,\14\ over-prescribing of
immediate release pain killers, and patients traveling in groups. Tr.
213-15, 240-41 \15\, 473-76. Traveling long distances to a pharmacy
creates the suspicion that pharmacies closer to the patient have
declined to fill that particular prescription. Tr. 220. Drug cocktails,
or drug combinations known for abuse, such as the combination opioid/
benzodiazepine, represent a ``red flag.'' Tr. 220-21; GX 66. Indeed,
the FDA issued a ``black box'' warning in August 2016, highlighting the
potential danger to the patient of this combination of medications. Tr.
221-23. Cash payment for medications is a red flag as medications are
typically expensive and normally patients will defer those costs to
their health insurance. Tr. 224-25. Dr. Sullivan testified that ``[t]he
theory behind [cash payments] is that patients are selling [the drugs]
and that's where they're getting all the cash from.'' Id. at 225. Early
refills, or early fills of new prescriptions, are suspicious as they
may suggest the patient is not taking the medication as prescribed. Tr.
224-25. Florida initiated annual CME four years previously involving
``validation and appropriate use of controlled substances.'' Tr. 235.
Florida pharmacists are taught to identify the
[[Page 64720]]
above red flags, to resolve them, and to document the resolution. Tr.
235-36.
---------------------------------------------------------------------------
\12\ Dr. Sullivan noted 90% of prescriptions filled at the
Respondent involved patients living more than 100 miles from the
pharmacy. Tr. 235.
\13\ Dr. Sullivan conceded that he was not aware of any federal
or Florida regulation limiting the distance traveled to fill a
prescription. Tr. 462.
\14\ Dr. Sullivan conceded that he was not aware of any federal
or Florida laws that prohibit pharmacies from accepting cash as
payment for prescriptions. Tr. 444.
\15\ The Government offered various statistical evidence
regarding average national prices for controlled substances, average
miles driven to the pharmacy by patients nationally, a high
percentage of Respondent's patients traveling long distances to the
Respondent's pharmacy, the relatively high percentage of the
Respondent's patients paying by cash, the high percentage of the
Respondent's controlled substance dispensations versus non-
controlled, the extremely high percentage of compounded
hydromorphone 8 mg dispensed versus the commercially available
hydromorphone 8 mg tablet dispensed by the Respondent, the extremely
high percentage of oxycodone 30 mg, and Alprazolam 2 mg (the highest
dosage units commercially produced) prescriptions issued as compared
with lower dosage units dispensed, that the Respondent dispensed
almost twice as many oxycodone 30 mg capsules as tablets. Tr. 235-
38, 241, 244-46, 250-51. This evidence was admitted as it related to
the prompting and evaluation of various red flags. It was not
admitted, and will not be considered, as probative evidence that
specific prescriptions were filled contrary to the standard of care
in Florida, which determination requires individualized proof and
individualized analysis.
---------------------------------------------------------------------------
To resolve red flags, a pharmacist should discuss the matter with
the patient, and attempt to get to know each patient. Tr. 239, 445-49;
see Fla. Admin. Code r. 64B16-27.831. The pharmacist should also
discuss the matter with the prescribing physician, which would provide
another source of input for the pharmacist. Tr. 229. However, the
prescribing physician can never be the only source of information
obtained. Tr. 229. Next, the pharmacist would review the patient's drug
record, the PDMP, to determine other medications and the strengths of
those medications, and conduct a ``prospective drug utilization
review,'' to make an independent clinical evaluation whether the
subject prescription was written for a legitimate medical purpose. Tr.
211, 227. Once the pharmacist makes his independent clinical
evaluation, the standard of care requires the pharmacist to document
his evaluation. Tr. at 210, 228, 488-89; see also Tr. 236.
If a pharmacist is unable to resolve the red flags he should
decline to fill the prescription. Tr. 228, 488. *[Omitted for
relevance.]
*[Dr. Sullivan testified that a pharmacist does not look at
individual red flags in isolation; rather, he looks at them ``as a
collective whole based on what's going on with that prescription at
that time.'' Tr. 482, 498. When asked whether you can evaluate a
prescription based on isolated red flags alone, Dr. Sullivan testified
that ``[i]t's like pieces in a puzzle, you look at everything related
to that prescription and patient.'' Tr. 498.
Dr. Sullivan testified that there are some red flags that, ``when
taken as a collective whole[,] . . . cannot be resolved.'' Tr. 481. Dr.
Sullivan testified that in these circumstances, ``no matter what the
patient tells me, what the doctor tells me, any of that, I'm still not
filling the prescription.'' Tr. 282. Dr. Sullivan testified that an
individual red flag (such as long distances traveled or cash payments)
may become unresolvable if it is combined with multiple additional red
flags. Tr. 473 (testifying that there is nothing that the patients
could have told Respondent to resolve the distance red flag in
conjunction with the other red flags); Tr. 475 (testifying that
Respondent's lack of contracts for commercial insurance does not
resolve the red flag of cash payment ``when taken into account with the
other red flags on these prescriptions''); see also Tr. 409-11
(testifying that when there are ``so many [red flags],'' a pharmacist
can make the decision not to fill a prescription without calling the
prescribing physician).]
Dr. Sullivan testified that [it is often difficult to determine
whether any individual red flag is unresolvable, because] red flags
should be evaluated in combination. Tr. 480-86, 498. However, he
testified that a single red flag could be so egregious that it was
unresolvable. Tr. 497-99.
Dr. Sullivan explained compounding, in which a pharmacist ``makes a
drug . . . from scratch . . . to meet the unique therapeutic needs of a
patient.'' Tr. 230. Typical justification for compounding may include a
patient's allergies to certain ingredients within commercially
manufactured medications, or the unavailability of a particular
medication, or strength of medication required for treatment among
commercially available medications. Tr. 230-32, 336-38. Both oxycodone
30 mg, and hydromorphone 8 mg, are commercially available. Tr. 232.
[Dr. Sullivan testified that compounding would typically be a ``very
very small'' percentage of a pharmacy's business because it is ``very
time and labor intensive. Tr. 232.]
Dr. Sullivan reviewed materials sent to him by DI Albert related to
Respondent's dispensing. Tr. 233, 349, 405-06. These materials included
the Respondent's pharmacy prescription log covering approximately three
months [GX 11], PDMP data over an eighteen-month period [GX 8-10], and
the Respondent's Prehearing Statement, which included witness
summaries. Tr. 341-43, 347-48. Dr. Sullivan did not speak with the
pharmacy customers at issue. Tr. 407, 416-18. Dr. Sullivan did not
review copies of the actual prescriptions. Tr. 348, 416, 500. Dr.
Sullivan agreed that the average 4-5 prescriptions filled at the
Respondent's pharmacy per day were much fewer than the average
community pharmacy of 190 prescriptions. Tr. 420.
Dr. Sullivan reviewed a list of prescriptions issued by Dr. L. Tr.
251; ALJ Ex. 42 \16\, p. 8. Dr. L.'s prescriptions for the highest
strength available opioid was a potential red flag for diversion or
abuse. Tr. 251-52. As to Dr. P., whose prescribing history revealed he
prescribed 65,000 doses of hydromorphone 8 mg to only 135 doses of
hydromorphone 4mg, Dr. Sullivan opined that a prudent pharmacist would
not fill Dr. P.'s prescriptions for the highest dosage of
hydromorphone. Tr. 253, 496. Similarly, Dr. Sullivan opined a
reasonable pharmacist would not fill Dr. P.'s prescriptions for
oxycodone 30 mg, as Dr. P. prescribed over 24,000 dosage units of
oxycodone 30 mg, to only 200 of the lower dosage units. Tr. 253-54.
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\16\ The Government's demonstrative exhibit will be marked as
ALJ Exhibit 42.
---------------------------------------------------------------------------
Turning to specific patients, Dr. Sullivan opined the distance
traveled by Patient A.G. from his home to the Respondent's pharmacy was
a red flag. Tr. 254; GX 55; ALJ Ex. 42, p. 10. In reviewing A.G.'s
prescription history, he was always prescribed the highest dose of
hydromorphone and of oxycodone, and except for one instance, the
highest dose of alprazolam. Tr. 254-55; GX 17; ALJ Ex. 42, p. 11. The
combination of opioid and benzodiazepine, coming even after the FDA's
black box warning, is a well-known red flag of diversion and abuse. Tr.
255-56. A review of the PDMP report revealed the dangerous combination
of the highest dosage unit of opioid along with a benzodiazepine, in
addition to early fills on April 12, 2019, representing unresolvable
red flags. Tr. 256-57, 267; GX 14; ALJ Ex. 42, p. 12.
A review of Patient A.G.'s patient profile in RX30, and of the
prescriptions and fill stickers, failed to resolve the red flags noted
or to justify the compounding done. Tr. 259, 267; GX 17; ALJ Ex. 42, p.
11. In the patient memo, it simply stated, ``Doctor OK to receive
medication in compound capsule form,'' which Dr. Sullivan testified is
insufficient to justify compounding that medication, which requires an
individualized therapeutic need. Tr. 257-59; GX 15; ALJ Ex. 42, p. 13.
See 21 U.S.C. 802(10), (15). In addition, Dr. Sullivan noted that A.G.
was prescribed both capsules and tablets of oxycodone 30 mg between
November 8, 2017, and January 25, 2018, demonstrating there was no
therapeutic need for compounding the oxycodone 30 mg. Tr. 256.
Dr. Sullivan was suspicious of the patient questionnaire used by
Respondent. Tr. 259-60; GX 18. The questionnaire questioned whether the
patient lived more than 100 miles from the pharmacy. Dr. Sullivan
interpreted the questionnaire as cover for filling prescriptions for
distant patients, rather than an effort to disclose or resolve red
flags. Tr. 259-61; GX 18. A follow-up question to the distant traveling
patients asked, ``why do you travel this distance,'' and in this case,
the patient responded, ``quick and good service.'' Tr. 262. Dr.
Sullivan opined that this reason was insufficient to resolve the red
flags. The questionnaire contained a certification to be made by the
patient, certifying that ``I am taking all of my medication
prescribed.'' Tr. 262. Dr. Sullivan deemed this certification
ineffectual in resolving the red flags of
[[Page 64721]]
early fills and of diversion. A further statement by the patient that,
``I am not selling any of my medication,'' did not alleviate any
concerns that the patient may have been diverting his medication. Tr.
262. Indeed, Dr. Sullivan suspected the question exposed a subterfuge
by the pharmacy, revealing the pharmacy believed patients were selling
their medications, and the question was designed to relieve the
pharmacy of any liability. Tr. 263. If a pharmacist believes a patient
is selling his medications, the pharmacist should not fill any further
prescriptions of that patient. Tr. 264.\17\ Dr. Sullivan was directed
to the ``Pharmacy Comment'' at the bottom of the prescriptions for A.G.
Tr. 265-66; GX 18, p. 6. The notation, ``non acute pain Uninsured
Patient'' suggested to Dr. Sullivan that whoever made the notations was
trying to signal that this medication therapy was ongoing and to
provide some justification for cash payment. Tr. 266.
---------------------------------------------------------------------------
\17\ Dr. Sullivan also questioned the prescribing protocol for
A.G., in that he was prescribed alternate monthly doses of 30 mg
oxycodone and 10 mg of oxycodone. Tr. 264; GX 18, p. 6. However, I
believe Dr. Sullivan misread the 30 mg oxycodone prescription of
October 30, 2018, as a 10 mg dosage due to a poor copy. So, his
conclusions in this regard will not be considered.
---------------------------------------------------------------------------
As to Patient A.H., Dr. Sullivan opined the 132 miles from A.H.'s
home to the Respondent pharmacy represented a red flag. Tr. 268; GX 56;
ALJ Ex. 42, p. 14. The prescriptions from January to August, 2018
contained several red flags including, highest dosage of short acting
pain-relievers, hydromorphone 8 mg and oxycodone 30 mg, and of
alprazolam 2 mg; capsules of hydromorphone being dispensed without
required therapeutic justification; and the combination of short-acting
opioids with a benzodiazepine. Dr. Sullivan deemed these unresolvable
red flags. Tr. 269. Later prescriptions for A.H. revealed significantly
early fill dates for four consecutive months. Tr. 269-71; GX 19; ALJ
Ex. 42, p. 16. Dr. Sullivan viewed this pattern of early fills as
evidence of diversion or abuse, warranting action by the pharmacist
such as refusing to fill these prescriptions. Tr. 271-72. The fact that
the prescribing physician wrote the prescriptions early does not
relieve the pharmacist's responsibility to resolve the red flag of
early fills. Tr. 272. A review of this patient's file received by Dr.
Sullivan failed to reveal any effort by the Respondent to resolve the
red flags relating to Patient A.H. Tr. 272-73. Dr. Sullivan opined
that, for the reasons discussed above, the relevant standard of care
would have caused a reasonable pharmacist operating within the usual
course of professional practice to decline filling the prescriptions
for A.H. Tr. 272-73; GX 19, 21; ALJ Ex. 42, p. 15-16.
As to Patient B.S., Dr. Sullivan opined the 132 mile distance from
B.S.'s home to Respondent represented a red flag. Tr. 273; GX 57; ALJ
Ex. 42, p. 18. The prescriptions from August 2017 to August 2018
contained several red flags including, highest dosage of short-acting
pain-relievers, hydromorphone 8 mg and oxycodone 30 mg, and of
alprazolam 2 mg; capsules of hydromorphone being dispensed without
required therapeutic justification; and the combination of short-acting
opioids with a benzodiazepine. Dr. Sullivan deemed these unresolvable
red flags. Tr. 274, 276. Dr. Sullivan noted the anti-inflammatory
ibuprofen 400 mg prescription, which he found inconsistent in
combination with the high dose of pain medication. He opined that a
once a day ibuprofen dose would have no effect in combination with such
a high dose of pain medication. Dr. Sullivan interpreted the ibuprofen
as an attempt to demonstrate that the doctor was trying an alternate
therapy as opposed to prescribing controlled substances without a
legitimate medical purpose, which Dr. Sullivan viewed as a red flag.
Tr. 275. Later prescriptions for B.S. revealed significantly early fill
dates. Tr. 275-76; GX 22; ALJ Ex. 42, p. 20. Dr. Sullivan viewed this
pattern of early fills as evidence of diversion or abuse, warranting
action by the pharmacist such as refusing to fill these prescriptions.
Tr. 276-78. A review of this patient's file received by Dr. Sullivan
failed to reveal any effort by the Respondent to resolve the red flags
relating to patient B.S. Tr. 277. Dr. Sullivan opined that, for the
reasons discussed above, he relevant standard of care would have caused
a reasonable pharmacist operating within the usual course of
professional practice would have declined to fill the prescriptions for
B.S. GX 22, 24; ALJ Ex. 42, p. 19-20.
As to Patient C.R., Dr. Sullivan opined the 134 miles from C.R.'s
home to Respondent represented a red flag. Tr. 279; GX 58; ALJ Ex. 42,
p. 22. The prescriptions from July 2017 to August 2018 contained
several red flags including, highest dosage of short-acting pain-
reliever, oxycodone 30 mg, capsules of oxycodone 30 mg being dispensed
without required therapeutic justification; and the combination of
short-acting opioids with a benzodiazepine, and the muscle relaxant
tizanidine. A July 12, 2018 prescription for morphine sulphate 60 mg
per day further heightened the danger to the patient. Tr. 280. Dr.
Sullivan deemed these unresolvable red flags. Tr. 279-82; GX 27; ALJ
Ex. 42, p. 23. A review of this patient's profile by Dr. Sullivan
failed to reveal any effort by the Respondent to resolve the red flags
relating to patient C.R. Tr. 281. Dr. Sullivan opined that, for the
reasons discussed above, the relevant standard of care would have
caused a reasonable pharmacist operating within the usual course of
professional practice to decline filling the prescriptions for C.R. Tr.
281-83; GX 27; ALJ Ex. 42, p. 23.
As to Patient J.D., Dr. Sullivan opined that the 130 miles from
J.D.'s home to the Respondent pharmacy represented a red flag. Tr. 283;
GX 59; ALJ Ex. 42, p. 23. The prescriptions from January 2018 to
September 2019 contained several red flags including, highest dosage of
short-acting pain-reliever, hydromorphone 8 mg, capsules of
hydromorphone 8 mg being dispensed without required therapeutic
justification; and the combination of two short-acting pain-relievers,
hydromorphone and methadone 10 mg, resulting in an ``extreme risk of
overdose.'' Tr. 283-84, 468; GX 30; ALJ Ex. 42, p. 26. Dr. Sullivan
deemed these red flags unresolvable and testified that a reasonable
pharmacist operating within the usual course of professional practice
would not have filled these prescriptions. Tr. 284, 288-89. Several
prescriptions filled in mid-2018 revealed unjustified early fills. Tr.
284-87; GX 30; ALJ Ex. 42, p. 27. The pharmacist noted in J.D.'s
patient profile, ``NEXT FILL DATE 7/5/18!!! WATCH FILL DATES!!!!!!,''
demonstrating the Respondent knew of J.D.'s issues with early fills.
Such note is insufficient to justify filling J.D.'s prescriptions
early. Tr. 287-88; GX 29; ALJ Ex. 42, p. 28.
As to Patient J.M., Dr. Sullivan opined that the 144 miles from
J.M.'s home to Respondent represented a red flag. Tr. 289; GX 60; ALJ
Ex. 42, p. 29. The prescriptions from June 2017 to September 2018
contained several red flags including, highest dosage of short-acting
pain-relievers, hydromorphone 8 mg and oxycodone 30 mg, and of
alprazolam 2 mg; capsules of oxycodone and hydromorphone being
dispensed without required therapeutic justification; and the
combination of short-acting opioids with a benzodiazepine, and a muscle
relaxer. Dr. Sullivan deemed these unresolvable red flags. Tr. 290-91.
Dr. Sullivan noted that J.M. was prescribed both capsules and tablets
of oxycodone 30 mg between April 2018 and May 2018 demonstrating
[[Page 64722]]
there was no therapeutic need for compounding the oxycodone 30 mg. Tr.
290. A review of this patient's file received by Dr. Sullivan failed to
reveal any effort by the Respondent to resolve the red flags relating
to patient J.M. Id. Dr. Sullivan opined that, for the reasons discussed
above, the relevant standard of care would have caused a reasonable
pharmacist acting within the usual course of professional practice to
decline to fill the prescriptions for J.M. Tr. 291; GX 33; ALJ Ex. 42,
p. 30.
As to Patient M.M., Dr. Sullivan opined the distance between M.M.'s
home and the prescribing physician's office, south of Ft. Myers,
Florida, represented a red flag. Tr. 294; ALJ Ex. 42, p. 32. In
reviewing M.M.'s dispensing log, Dr. Sullivan identified many of the
same red flags as revealed by the other patient's records: high-
strength hydromorphone prescribed and dispensed; and capsules of
hydromorphone dispensed without individualized therapeutic
justification. Tr. 295; GX 36; ALJ Ex. 42, p. 33. Dr. Sullivan was also
suspicious of the .4 mg of folic acid, which he suspected was intended
to mask the opioid prescriptions. Tr. 295-96. In reviewing the
prescriptions filled from January 2019 to April 2019, Dr. Sullivan
noted that the Respondent filled both capsules and tablets of
hydromorphone, thus negating any prospect that the patient had an
individualized therapeutic need for compounded medication. Tr. 297-98;
GX 34; ALJ Ex. 42, p. 34. Dr. Sullivan was also concerned regarding a
significant break in therapy, from July 18, 2018, and January 3, 2019.
Tr. 297. Despite an almost six-month lapse in opioid therapy, the
Respondent filled a prescription for hydromorphone 8 mg, the highest
commercially available dosage. Tr. 298. If the patient had become
opioid na[iuml]ve during this lapse, there is a heightened risk of
overdose. Tr. 298. Dr. Sullivan also recognized some red flags in the
form of early fills. Tr. 299; GX 34; ALJ Ex. 42, p. 34. Dr. Sullivan
deemed the above red flags unresolvable, and testified that no
reasonable pharmacist acting within the usual course of professional
practice would have filled the subject prescriptions. Tr. 299-301.
As to Patient N.B., Dr. Sullivan opined the 137 miles from N.B.'s
home to the Respondent pharmacy represented a red flag. Tr. 301; GX 62;
ALJ Ex. 42, p. 36. The prescriptions from June 2017 to August 2018
contained several red flags, including highest dosage of short-acting
pain-reliever, hydromorphone 8 mg, capsules of hydromorphone 8 mg being
dispensed without required therapeutic justification; two separate
prescriptions for alprazolam with two separate dosage units; and the
combination of an opioid and benzodiazepine. Dr. Sullivan noted the
anti-inflammatory ibuprofen 400 mg prescription, which he found
inconsistent in combination with the high dose of pain medication. A
once a day low ibuprofen dose would have no effect in combination with
such a high dose of pain medication. Dr. Sullivan found these red flags
unresolvable. Tr. 302-03, 305-06; GX 39; ALJ Ex. 42, p. 37. The PDMP
data revealed several prescriptions filled unjustifiably early. Tr.
303-04; GX 37; ALJ Ex. 42, p. 38. Dr. Sullivan found no evidence of an
attempt to resolve these red flags. Tr. 306-07; GX 37, 39; ALJ Ex. 42,
pp. 38-39. Dr. Sullivan was concerned by the two-month gap in opioid
treatment from September 14, 2018, and December 20, 2018, potentially
producing opioid na[iuml]vet[eacute] in the patient. Tr. 304. In the
patient memo, it simply stated, ``Doctor ok patient to receive
medication in compound capsule form,'' which, according to Dr.
Sullivan, is insufficient to justify compounding that medication, which
requires an individualized therapeutic need. Tr. 306, 471; GX 38; ALJ
Ex. 42, p. 39.
As to Patient R.B., Dr. Sullivan opined the 138 miles from R.B.'s
home to Respondent represented a red flag. Tr. 307; GX 63; ALJ Ex. 42,
p. 40. Dr. Sullivan further asserted that the number of patients
traveling from the Ft. Myers area to Respondent represented a red flag
itself. Tr. 308. The coincidence of patients traveling over 100 miles
to the Respondent's pharmacy from the same proximate area represents a
pattern that the standard of care would require a pharmacist to notice
and to investigate. Tr. 309-10.
The prescriptions from June 2017 to August 2018 contained several
red flags, including highest dosage of short-acting pain-reliever,
hydromorphone 8 mg, capsules of hydromorphone 8 mg being dispensed
without required therapeutic justification; prescriptions for
alprazolam at the highest dosage strength; and the combination of an
opioid and benzodiazepine. Dr. Sullivan found these red flags were not
resolvable according to the standard of care in Florida. Tr. 311, 313,
321; GX 43; ALJ Ex. 42, p. 41. The PDMP data revealed several
prescriptions filled unjustifiably early. Tr. 311-12; GX 40; ALJ Ex.
42, p. 42. Dr. Sullivan was concerned by the two-month gap in opioid
treatment from September 12, 2018, to January 22, 2019, potentially
producing opioid na[iuml]vet[eacute] in the patient. Tr. 312, 471. Dr.
Sullivan found no evidence of an attempt to resolve these red flags.
Tr. 313; GX 41; ALJ Ex. 42, p. 41. In R.B.'s Patient Questionnaire,
R.B. gave conflicting information as to the year of her injury. Tr.
313-14. Furthermore, R.B.'s justification for traveling more than 100
miles to the Respondent's pharmacy, ``it's cheaper and they're good
people,'' does not resolve the red flag of long-distance travel. Tr.
315; GX 44. Nor does R.B.'s declaration that she is not selling her
medications resolve concerns of diversion. Tr. 315. Patient R.B.'s PDMP
report reveals she filled prescriptions at five different pharmacies,
including the Respondent's pharmacy. Tr. 316-17; GX 44, p. 5. Dr.
Sullivan views this as clear evidence of pharmacy shopping. Another
suspicious entry in the PDMP record is the payment source for an April
6, 2016 prescription for oxycodone acetaminophen, and two August 22,
2017 prescriptions for hydrocodone, which were paid for using
commercial insurance. Tr. 317-18; GX 44, p. 4. A patient alternately
paying cash and using commercial insurance is a red flag of diversion
or abuse. Tr. 318-19.
Dr. Sullivan noted prescriptions for R.B. in which it appeared the
pharmacist, by permission of the prescribing physician, changed the
prescribed ``tablet'' form of medication to compounded capsule. Tr.
319-20; GX 44, pp. 6, 8. As the ``tablet'' form was initially
prescribed, changing to compounded capsule does not appear to have been
done on the basis of an individualized therapeutic purpose. Tr. 321.
As to Patient R.G., Dr. Sullivan opined the 131 miles from R.G.'s
home to the Respondent pharmacy represented a red flag. Tr. 322; GX 64;
ALJ Ex. 42, p. 44. The prescriptions from June 2017 to September 2018
contained several red flags, including highest dosage of short-acting
pain-reliever, capsules of oxycodone 30 mg being dispensed without
required therapeutic justification; the highest strength for
alprazolam; and the combination of an opioid and benzodiazepine. Dr.
Sullivan noted the ongoing prescribing at the highest opioid dosage
suggested a red flag for the lack of individualized treatment, with
patients consistently receiving the highest dosage. Tr. 322-24, 329-30.
A further indication that there was no therapeutic justification for
the compounded capsules of oxycodone 30 mg was the two fills on August
10, 2018, for oxycodone. Tr. 324; GX 49; ALJ Ex. 42, p. 45. R.G. was
dispensed 68 tablets and 70 capsules on that same day. Tr. 324-26. Dr.
Sullivan found these red flags unresolvable. Tr. 322-23, 326,
[[Page 64723]]
328-29; GX 49; ALJ Ex. 42, p. 45. The PDMP data revealed several
prescriptions filled unjustifiably early. Tr. 326-28; GX 49; ALJ Ex.
42, p. 46. The pharmacist noted in R.G.'s patient profile, ``WATCH FILL
DATES!!!!!!,'' demonstrating the Respondent knew of R.G.'s issues with
early fills. Such note is insufficient to justify filling R.G.'s
prescriptions early. Tr. 328; GX 47; ALJ Ex. 42, p. 47. Dr. Sullivan
found no evidence of the resolution of these red flags. Tr. 329; GX 49;
ALJ Ex. 42, p. 45.
As to Patient R.L., Dr. Sullivan opined the 138 miles from R.L.'s
home to the Respondent pharmacy represented a red flag. Tr. 330; GX 65;
ALJ Ex. 42, p. 48. The prescriptions from June 2017 to September 2018
contained several red flags, including highest dosage of short-acting
pain-relievers, hydrocodone 8 mg and oxycodone 30 mg; capsules of
hydromorphone 8 mg being dispensed without required therapeutic
justification; the highest strength of alprazolam; and the combination
of an opioid and benzodiazepine. Dr. Sullivan was concerned by the
promethazine 25 mg prescription, as it acts as a muscle relaxant with
sedative qualities, thus increasing potential side effects in
combination with the opioid and benzodiazepine medications. Dr.
Sullivan noted the ongoing prescribing at the highest opioid dosage
suggested a red flag for the lack of individualized treatment, with
patients consistently receiving the highest dosage. Tr. 331-32, 329-30.
Dr. Sullivan found these red flags unresolvable. Tr. 332; GX 52; ALJ
Ex. 42, p. 49.
The PDMP data revealed several prescriptions filled unjustifiably
early. Tr. 333-35; GX 52; ALJ Ex. 42, p. 51. The pharmacist noted in
R.L.'s patient profile, ``NEXT FILL 6/10/18-10 DAYS EARLY MARCH &
APRIL-TOLD HIM THIS 5/11/18GD,'' demonstrating the Respondent knew of
R.L.'s issues with early fills. Such note is insufficient to justify
filling R.L.'s prescriptions early. Tr. 334-35; GX 51; ALJ Ex. 42, p.
52. Dr. Sullivan found no evidence of the resolution of these red
flags. Tr. 335-36; GX 50, 52; ALJ Ex. 42, pp. 49-52.
Finally, Dr. Sullivan opined that the compounding done in this case
was not legitimate, as it was outside the standard of practice. Tr.
336-38. Dr. Sullivan explained that the FDA wants pharmacists to have
the ability to compound to address the rare cases of patients with
special needs, such as allergies. Tr. 337-38. If a patient had an
allergy that required compounding, Dr. Sullivan would expect that to be
documented in the patient profile. Tr. 339. However, compounding is
also the subject of licensing and regulation. Tr. 339-40. See 21 U.S.C.
353a; Fla. Admin. Code r. 64B16-27.700, .797. Manufacturing is not
permitted under a standard community retail pharmacy license. Tr. 340.
It requires specific licensing. Id.
Dr. Sullivan noted that 95 or 96 percent of the subject
hydromorphone medication was compounded. Dr. Sullivan concluded the
extreme volume alone as proof positive that the Respondent's
compounding was not limited to patients with individualized therapeutic
needs. Tr. 337. Although the Patient Profiles reviewed contained a
category for ``allergy,'' no allergies were documented, either within
the Patient Profiles or in any of the other records reviewed. Tr. 339;
see Fla. Admin. Code r. 64B16-27.800(2). Dr. Sullivan found no evidence
that any of the subject patients receiving compounded medications were
subject to medication allergies. Tr. 339.
Expert Opinion
[Omitted for brevity.]
Dr. Sullivan was qualified as an expert in the field of pharmacy
and the standard of care for the practice of pharmacy in the State of
Florida. He gave his opinion regarding the relevant standards of care
in Florida for the practice of pharmacy, including the existence of red
flags, or generally suspicious circumstances. He also gave his opinion
regarding the parameters of lawful pharmacy compounding in light of
federal statutes and regulations governing compounding and
manufacturing. 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. Sullivan demonstrated a commanding grasp of pharmacy practice
and of the distinctions between pharmacy compounding and manufacturing.
However, there were several matters for which he had diminished
credibility. For one, he was unaware that Florida had codified the
standard of care for medical personnel. Although I later determined the
statute in question did not apply to pharmacists, it was somewhat
surprising he was unaware of it, as he teaches Florida pharmacy
law.\18\ [Text omitted.] *E 19
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\18\ However, under Florida Statute 766.102, pharmacists are not
considered ``healthcare providers.'' This Florida law defines
``healthcare providers'' as:
. . . any hospital or ambulatory surgical center as defined and
licensed under chapter 395; a birth center licensed under chapter
383; any person licensed under chapter 458, chapter 459, chapter
460, chapter 461, chapter 462, chapter 463, part I of chapter 464,
chapter 466, chapter 467, part XIV of chapter 468, or chapter 486; a
health maintenance organization certificated under part I of chapter
641; a blood bank; a plasma center; an industrial clinic; a renal
dialysis facility; or a professional association partnership,
corporation, joint venture, or other association for professional
activity by health care providers.
Fla. Stat. 766.202(4). Pharmacists are administered under
chapter 465.
*\E\ I have omitted the RD's statement that Dr. Sullivan agreed
that this statute (which does not apply to pharmacists) was
consistent with his understanding of the Florida standard of care
for pharmacists. RD, at 39. I have also deleted the RD's statement
that Dr. Sullivan ``arguably conceded an alternate generalized
standard of care for pharmacists in Florida, which is not consistent
with Florida law or regulation.'' Id. at 39-40. When Respondent's
counsel asked Dr. Sullivan whether he was aware of the statute, and
whether he agreed with the definition of the standard of care
outlined in the statute, Dr. Sullivan replied, ``Is that out of the
pharmacy statutes? I'm not familiar with that.'' Tr. 438.
Respondent's counsel stated that the definition comes from Florida
statute 766.102, and it applies to healthcare providers. Id. Dr.
Sullivan replied, ``I'll take your word for it that that's what it
says.'' Id. Their exchange continued:
Q: Okay. Do you agree that, that's the definition--the
appropriate definition of the standard of care in Florida?
A: In a broad sense, yes.
Q: Okay. And it talks about reasonably prudent healthcare
providers, correct?
A: Can you read that statement in there where it says that
again, please?
Q: Sure, I would be happy to. I'll read you the whole thing just
to make sure you have it all. ``The prevailing professional standard
of care for a given healthcare provider shall be that level of care,
skill, and treatment which, in light of all relevant surrounding
circumstances, is recognized as acceptable and appropriate by
reasonably prudent similar healthcare providers.
A: And what was the question again, please?
Q: Do you agree that that's an accurate statement of the
standard of care that applies in Florida?
A: If that's what the statute says, yes.
Tr. 438-39. During this exchange, Dr. Sullivan did not testify
that this statute outlines the standard of care for pharmacists. Dr.
Sullivan agreed--when asked whether the statute outlined ``the
appropriate definition of the standard of care in Florida''--that it
captured the standard of care in a ``[i]n a broad sense.'' Id. Dr.
Sullivan repeated several times that he was not aware of this
statute, but he would ``take [counsel's] word for it'' that he was
accurately reciting the definition from the statute. Id. I do not
find that this testimony diminishes Dr. Sullivan's credibility as an
expert in the standard of care for Florida pharmacists.
\19\ [Text omitted where footnote was included.]
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[Text omitted.] *\F\
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*\F\ I have omitted the RD's assertion that Dr. Sullivan offered
inconsistent testimony regarding unresolvable red flags. RD, at 40.
I find that Dr. Sullivan's testimony on this issue was consistent,
reliable, and supported by prior Agency Decisions. The RD found that
Dr. Sullivan's testimony was inconsistent because he ``described
several red flags as unresolvable,'' but later ``conceded that those
same red flags could be resolved. Id. Additionally, the RD states
that Dr. Sullivan ``at one point suggested no single red flag was
unresolvable, rather it was the combination of red flags which made
them unresolvable.'' Id. The RD does not cite to specific portions
of the record here, but an earlier section of the RD discusses
portions of Dr. Sullivan's testimony that the ALJ found confusing.
RD, at 24.
The ALJ primarily seemed to be concerned with Dr. Sullivan's
testimony about prescribing two immediate-release opioids
concurrently. The ALJ asked Dr. Sullivan for an example of an
unresolvable combination of red flags, and Dr. Sullivan testified
that it would be unresolvable if a patient ``brought in a
prescription for two immediate release narcotic pain killers in very
high doses.'' Tr. 228 (emphasis added). The following day, the ALJ
said to Dr. Sullivan, ``Yesterday you testified that the prescribing
of two fast-acting opioids can never be permitted,'' and Dr.
Sullivan replied, ``I'm sorry, Your Honor. If I said that, I
misspoke.'' Tr. 481. Dr. Sullivan's testimony, however, had been
that the prescribing of two immediate-release opioids in very high
doses was unresolvable. Id. at 228. Dr. Sullivan clarified that
there were instances were two immediate-release opioids could be
used together. Tr. 481. Dr. Sullivan also testified that this red
flag ``didn't apply to this case here.'' Id. at 482. I do not find
that Dr. Sullivan's testimony about immediate-release opioids
undermines his testimony about unresolvable red flags. Throughout
the hearing, Dr. Sullivan consistently testified that a pharmacist
should analyze all of the red flags with a prescription as a
``collective whole,'' rather than analyzing each red flag in
isolation, and that certain combinations of red flags may not be
resolvable ``when taken as a collective whole.'' Tr. 282, 409-11,
473, 475, 481-82, 498. Dr. Sullivan further testified that the red
flags presented by each prescription in this case were unresolvable.
As discussed in more detail below, Dr. Sullivan's testimony finds
support in prior Agency decisions, which have consistently held--
based on the credible testimony of pharmacy experts--that
prescriptions may raise red flags that are so strongly indicative of
diversion that they cannot be resolved by a pharmacist acting within
the usual course of professional practice.
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[[Page 64724]]
Dr. Sullivan deemed the questionnaire used by the Respondent as
essentially a subterfuge, designed not to reveal red flags and enable
the Respondent to assess them, but as cover for red flags already known
to exist by the Respondent. This conclusion was developed on the basis
of Dr. Sullivan's experience in reviewing pharmacies, which were found
to be operating in violation of pharmacy standards. It seemed more in
the nature of an observation of coincident patterns. This conclusion
assumes the questionnaires were never intended to assist the Respondent
in assessing red flags versus being a good faith effort to identify red
flags, which was never fulfilled. If the questionnaires were designed
to provide cover to the Respondent's illegal behavior, they fail to do
so. I did not see the questionnaires as providing any cover to the
Respondent's improper filling of prescriptions. If anything, the
completed questionnaires highlighted and documented red flags of long-
distance travel. The completed questionnaires are damning, not
exculpatory. Although not dispositive of this issue, the Government has
not alleged intentional diversion. I find Dr. Sullivan's subject
conclusion more in the nature of speculation. I don't believe the
record provides sufficient factual foundation to support this expert
opinion.\20\ I also find it inconsistent with the facts of the case.
Accordingly, on the basis of the instant record, I find Dr. Sullivan's
subject conclusion unjustified.
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\20\ [Omitted for clarity.]
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Dr. Sullivan made a similar conclusion regarding the prescribing of
non-controlled substances and of controlled substances not subject to
abuse or diversion. Again, he deemed such prescriptions as an apparent
subterfuge on the part of the prescriber, designed to mask the improper
prescribing of controlled substances highly subject to abuse and
diversion, and creating a red flag, which went unaddressed by the
Respondent. I question the sufficiency of the factual foundation for
Dr. Sullivan's expert opinion that the above prescriptions were an
apparent attempt to mask scores of improper opioid prescriptions.
[Omitted for brevity].*G 21 This finding does not affect the
probity of Dr. Sullivan's opinions as to the therapeutic effect of the
subject medications, their contraindication with other prescribed
medications, or the justification of their prescription.
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\*G\ I agree with the ALJ's conclusions about Dr. Sullivan's
testimony regarding the physicians' motivations for prescribing non-
controlled substances, so I am disregarding this testimony.
\21\ [Omitted for clarity.]
---------------------------------------------------------------------------
The Respondent made the point that Dr. Sullivan did not confer with
the subject patients or with their prescribing physicians. Dr. Sullivan
conceded that a diligent pharmacist would, as circumstances require,
attempt to resolve any red flags by discussing them with the patient
and with the prescribing physician. The Respondent argues that the fact
Dr. Sullivan did not discuss any red flags with the patients or with
the prescribers renders Dr. Sullivan's conclusions regarding red flags
questionable as Dr. Sullivan did not attempt to resolve the subject red
flags.
Although certainly the extent of Dr. Sullivan's review of relevant
material is critical to the conclusions he draws, the focus of Dr.
Sullivan's opinions relate to whether the Respondent complied with his
corresponding responsibility to resolve red flags prior to dispensing
the subject medications, and to documenting any resolution within the
file. It is neither here nor there that Dr. Sullivan could have
resolved his own concerns regarding the subject red flags by speaking
to the patients and prescribers years later. Nor is it dispositive that
Dr. Sullivan could have determined that the subject red flags were
resolvable at the time they were dispensed, if the Respondent failed to
satisfy his corresponding responsibility to resolve them. So, with the
exception of his opinion regarding the apparent red flag created by the
prescribing of non-controlled substances (discussed immediately above),
I don't view the fact that Dr. Sullivan did not speak with the subject
patients or prescribers as diminishing the probity of his relevant
opinions as to the Respondent's acts or omissions at all.
The Respondent makes the similar point regarding the fact that Dr.
Sullivan did not review copies of the physical prescriptions, as there
is evidence Respondent may have made notations relevant to resolving
red flags directly onto the prescriptions. Dr. Sullivan freely conceded
he had not been provided with copies of the prescriptions to review.
[Omitted for Relevance.] [However, because Dr. Sullivan credibly
testified that the red flags for each patient could not have been
resolved by a pharmacist acting within the usual course of professional
practice, it was unnecessary for Dr. Sullivan to review the
prescriptions.] Here, Dr. Sullivan was provided sufficient materials to
develop his opinions, which assist the factfinder to understand or to
determine facts in issue. [Citation omitted.]
[The RD does not make an explicit credibility finding on Dr.
Sullivan's testimony, aside from stating that Dr. Sullivan was provided
sufficient materials to develop his opinions and that he demonstrated a
commanding grasp of pharmacy practice and the distinctions between
pharmacy compounding and manufacturing. Based on these statements, and
based on the controlling weight that the ALJ accorded Dr. Sullivan's
unrebutted expert testimony in his legal analysis, it is evident that
the ALJ found Dr. Sullivan's opinions to be generally consistent,
reliable, and credible. I agree with that conclusion.]
Respondent's Case-in-Chief
The Respondent presented its case-in-chief through the testimony of
a single witness, Norman L. Clement, Jr. Tr. 506-57.
Norman L. Clement, Jr.
Mr. Clement, Jr., is the son of Mr. Norman Clement, Sr., the
Respondent's
[[Page 64725]]
owner. Tr. 506-07. Mr. Clement, Jr., has held a pharmacy tech license
in Florida since 2014. Tr. 507. He has worked for the Respondent since
2014. Tr. 507, 521. Mr. Clement, Jr., reported the Respondent employs
approximately four pharmacists-in-charge. Id. He described the
Respondent as a family operation. Id.
The Respondent gets few patient customers per day. Tr. 508.
Typically, the pharmacy would only see two to three patients a day,
sometimes none. Id. Four patients in one day would make for a busy day
at the pharmacy. Id. The fact that the Respondent only saw a few
patients per day meant that the staff could spend more time talking
with the patients and getting to know them. Id.
Mr. Clement, Jr., testified that the Respondent's staff always
recorded the information it collected from the patients. Tr. 509, 543.
The types of information the Respondent collected from patients
included ``personal life information,'' how treatment was progressing,
and dietary information. Tr. 509. The Respondent recorded this
information in the patient's profile. Tr. 543. Sometimes it recorded
the information on the hard-copy prescriptions. Id.
When a new patient presents at the pharmacy, the Respondent gathers
information about the patient to assist the pharmacist in making a
decision about whether to dispense to that patient. Tr. 509, 537-38,
540. The Respondent charges new patients $25 for an initial
consultation. Tr. 542. As part of this information-gathering process,
the Respondent asks patients to complete a questionnaire. Tr. 511, 537-
38, 542. The questionnaire solicits information regarding the reason
the patient is visiting the Respondent, how the patient feels, and what
caused the patient's ailment or injury. Tr. 511-12, 538, 540. Sometimes
a patient has been rejected by three to six other pharmacies before
visiting the Respondent. Tr. 538. The Respondent creates a patient
profile for all new patients and places a copy of the questionnaire in
the profile. Tr. 546-48. Notes regarding the resolution of red flags
would be contained in the patient's profile. Tr. 553. Mr. Clement, Jr.,
testified that the Respondent ``look[ed] at every aspect'' of a
prescription before filling it, and that if ``everything checks out,''
the patient is cleared to fill the prescription. Tr. 540-41. The
Respondent places a check mark on a prescription to verify it is
cleared for dispensing. Tr. 554-55.
Mr. Clement, Jr., testified that the questionnaire asks the
patients to provide details about their injury; simply claiming that
``my back pain hurts'' will not suffice. Tr. 512. The Respondent also
makes a copy of the patient's driver's license. Tr. 513, 538. Mr.
Clement, Jr., testified that the pharmacy checked the medical
legitimacy of prescriptions \22\ and called the prescribing doctor for
all controlled substance prescriptions. Tr. 538-40, 542-43, 545.
Initially, Mr. Clement, Jr., testified that the Respondent would write
down what the doctor says in the patient's profile. Tr. 543-44.
Government counsel later asked if the lack of notes about calling the
doctor meant the doctor was never called. Tr. 550. Mr. Clement, Jr.,
responded, ``Not necessarily,'' and explained that sometimes the
Respondent would write those notes on the hard-copy prescription. Tr.
550-51. The Respondent would write, ``M.D. okay'' on the prescription
to verify the doctor had been called. Tr. 550-52.
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\22\ [Omitted for clarity.]
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After reviewing the questionnaire, a staff member searches for the
patient in the PDMP to see if the patient is visiting other pharmacies.
Tr. 512-13, 538. Typically, the Respondent attaches a copy of the PDMP
reports to the patient's file. Tr. 513. The software system that the
Respondent used also produced a ``Narx'' score that informed the
pharmacy about a patient's risk of addiction. Tr. 518-19. The
Respondent and its staff used the ``Narx'' score feature when deciding
whether to fill prescriptions. Id. Sometimes after conducting this
process the Respondent has turned patients away. Tr. 512, 538, 542.
Mr. Clement, Jr.'s, primary duties at the Respondent are working
with the computer system and records. Tr. 515, 522. The Respondent uses
Rx30 software. Tr. 514. When the DEA served the OSC/ISO on the
Respondent in August 2019, it also executed a search warrant and seized
two of the Respondent's computers. Tr. 514-15, 530-31. The Respondent
also kept files on a back-up system, which was also seized by the DEA.
Tr. 534-35. When the computers were eventually returned, they did not
work and the scanned copies of prescriptions had been erased.\23\ Tr.
514-15, 530-31. Mr. Clement, Jr., worked with an IT consultant and
Rx30's technical support to try to recover the prescription image files
from the computers seized by DEA. Tr. 517-18. Those recovery efforts
were unsuccessful. Id.
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\23\ Although Mr. Clement, Jr.'s, testimony about how files were
backed-up was sometimes difficult to follow, Tr. 531-36, he seemed
to indicate that the Respondent had the capability of retrieving
lost files from Rx30's system. Tr. 535-36.
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The DEA also seized a touch-screen computer monitor. Tr. 516. When
DEA returned the monitor, the screen had been shattered and it no
longer worked.\24\ Tr. 516-17, 531. The DEA also seized most of the
hard-copy prescriptions that were kept at the pharmacy.\25\ Tr. 516.
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\24\ [I have omitted, for brevity and relevance, the RD's
discussion of unfair, unequal, or uneven treatment. Respondent did
not raise any claims of unfair treatment in its Posthearing brief,
and I do not find sufficient evidence on the record to suggest that
Respondent was treated unfairly. Respondent raised concerns
prehearing that it had not received access to all of the evidence
that DEA had seized when it executed the OSC on August 29, 2019.
However, those concerns appear to have been addressed before the
hearing. Respondent also raised concerns that certain equipment that
was seized by DEA had been damaged. However, the evidence on the
record provides no indication of any sort of unequal treatment, or
any improper motive in commencing the investigation. In fact, the
evidence demonstrates that such an investigation was routine. DEA
began investigating Respondent after receiving a tip from the
Florida Department of Health in May 2017.]
\25\ Mr. Clement, Jr., testified that the Respondent has not
received back the hard-copy prescriptions seized by the DEA. Tr.
520. After testifying to this, the Respondent's counsel informed the
Tribunal, on the record, that the DEA had provided copies of the
prescriptions to counsel's office. Id.
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In general, I found Mr. Clement, Jr.'s, testimony to be somewhat
subjective. As essentially a party to the litigation, he had a clear
personal and family interest in the outcome. The Respondent's position
that the Agency has treated the Respondent unfairly was reflected in
Mr. Clement, Jr.'s, testimony. His emotional description of the manner
of the seizure of Respondent's equipment and records, and their
destruction and loss in the hands of the Agency, manifests his
partiality in this matter. However, having a personal interest in the
litigation, or manifesting an emotional commitment to your cause, are
not bars to credibility. They are simply factors to be considered. I
had some concerns with aspects of his testimony, however, which
detracted from his credibility on certain topics. For the most part,
these concerns were situations where Mr. Clement, Jr., provided
conclusory testimony, and then followed-up with more detail when
pressed by counsel.
There were also instances of inconsistency. For example, Mr.
Clement, Jr., initially testified that the Respondent's computer system
worked normally after the DEA made mirror images of the Respondent's
computer hard-drive. Tr. 522, 525. He then clarified that the
Respondent's computers did not work normally. Tr. 525-26. The computer
system started working normally again about 3-4 months after the DEA
made mirror images of it. Tr. 527.
[[Page 64726]]
Another example concerns the Respondent's efforts to call patients'
past pharmacies. At the beginning of direct examination, Mr. Clement,
Jr., testified that as part of its intake process for new patients, the
Respondent would call a new patient's past pharmacy only if the
Respondent had questions of that pharmacy. Tr. 512. Government counsel
later asked, ``Sometimes you call their past pharmacist?'' Tr. 546. He
answered, ``Yes.'' Id. Just moments later, Mr. Clement, Jr., testified
that the Respondent always called pharmacies for every new patient. Tr.
547, 549. This testimony paints an unclear picture of whether the
Respondent always called a patient's previous pharmacy or whether it
only called in certain situations.
Another example concerned the extent to which the Respondent
verified prescriptions' medical legitimacy. Mr. Clement, Jr., explained
that neither he nor the Respondent's pharmacists were qualified to read
an MRI report (or any other laboratory test). Tr. 539-40.\26\ He said
that some patients would provide a copy of their MRI report, but ``no
pharmacist needs to look at an MRI.'' Id. This testimony seems to
conflict with his testimony that the Respondent got to know its new
patients by looking into their history, background, ``pain ailments,
what they're going through, [and] sometimes treatment plans.'' Tr. 508.
If the Respondent checked a patient's background, and confirmed medical
legitimacy of the prescription, then it seems that the Respondent
merely took the patient (and his or her doctor) at their word, since
checking commonly-procured objective medical findings, such as an MRI
report, was outside the Respondent's scope of review. The fact that the
Respondent may have merely taken doctors, patients, and pharmacies at
their word is supported by Mr. Clement, Jr.'s, later testimony that a
patient is cleared to receive controlled substances if the doctor says
``yes'' and the patient's previous pharmacy says the patient is
``okay.'' Tr. 542.
---------------------------------------------------------------------------
\26\ Mr. Clement, Jr's., testimony would make sense if he was
referring to the actual x-ray or MRI, which require special training
to interpret, such as that of a radiologist, who reduces his
findings to a written report, which might then be appropriate for a
pharmacist to review.
---------------------------------------------------------------------------
There was another instance where Mr. Clement, Jr., came across as
more of an advocate for the Respondent rather than an objective
witness. In this instance, the Respondent's counsel asked Mr. Clement,
Jr., whether the Respondent had developed a niche business in the types
of patients it sees. Tr. 509-10. This seemed to be a straightforward,
unambiguous question. Mr. Clement, Jr., responded, however, by
describing, at length, the process of checking the patient's
identification, and checking the PDMP and NarcFacts. Tr. 510-11. The
Respondent's counsel then followed-up with a leading question, asking
Mr. Clement, Jr., whether the Respondent ``dispense[d] primarily to
patients who are suffering from chronic non-malignant pain?'' Tr. 511.
Mr. Clement, Jr., answered in the affirmative. Id. Mr. Clement, Jr.'s,
non-responsive answer demonstrated an eagerness to advocate the
Respondent's safety measures for screening patients and preventing
diversion, rather than answering the question about what types of
clients the Respondent serviced.
Having listened to Mr. Clement, Jr.'s, testimony at the hearing,
and having closely reviewed the transcript of his testimony, I find him
to be generally credible, with the few exceptions noted above. He
generally presented as a professional, knowledgeable, and honest
witness. I will give his testimony weight to the extent it is
internally consistent, and to the extent it is consistent with other
evidence and testimony of record.
The Government's Rebuttal Case
After each party presented its case-in-chief, the Government
presented the rebuttal testimony of DI Albert. Tr. 557-68.
DI Albert
The Government introduced DI Albert's rebuttal testimony to rebut
Mr. Clement, Jr.'s, testimony about the resolution of red flags. Tr.
559-60, 563-64. DI Albert testified about a blog post authored by Mr.
Clement, Sr.\27\ Tr. 559, 561. DI Albert downloaded this blog post from
the internet. Tr. 562. The blog post identifies its author as ``Norman
J. Clement, R.Ph, DDS.'' Tr. 563. DI Albert also downloaded an
attachment from the blog post. Tr. 564-65. The attachment is a copy of
the Government's prehearing statement in this case. Tr. 565. There are
notes written on the prehearing statement, to include the following
note on page 23:
---------------------------------------------------------------------------
\27\ Although the Government offered the title of the blog post,
``DEA's Kourt of the Kangaroo,'' the title was only admitted for
authentication purposes.
The question of the red flag issue is not an issue to [me]
because I don't challenge the physician for diagnosing and writing
prescriptions for the patients because I'm not authorized or
qualified to challenge a physician's diagnosis and treatment of his
or her patients. Therefore, on the red flag issues, the question is,
are they challenging me for filling the prescription or are they
---------------------------------------------------------------------------
challenging the physician who wrote the prescription?
Tr. 566. Neither the hard-copied blog post nor attachment were admitted
into evidence; only the oral testimony of DI Albert reading the above-
quoted paragraph. Tr. 567.
During this brief rebuttal testimony, DI Albert presented, as he
did in the Government's case-in-chief, as an honest, professional, and
impartial investigator who had no stake in the case's outcome. DI
Albert presented his rebuttal testimony in a credible and reliable
manner. Although I fully credit DI Albert's rebuttal testimony, I will
only consider his rebuttal testimony to the extent that the paragraph
he read into the record rebuts Mr. Clement, Jr.'s, testimony that the
Respondent resolved red flags.
The Facts
Stipulations of Fact
The Government and the Respondent did not agree to any stipulations
of fact.
Findings of Fact
The factual findings below are based on a preponderance of the
evidence, including the detailed, credible, and competent testimony of
the aforementioned witnesses, the exhibits entered into evidence, and
the record before me. The findings of fact are based primarily on those
proposed by the Government in its post-hearing brief. I have also
considered the findings of fact proposed by the Respondent and found
that many of those proposed findings related to matters proposed by the
Government or related to matters addressed elsewhere in this
Recommended Decision. If a proposed finding of fact is not included in
this section and is also not addressed elsewhere in this Decision, it
is because that proposed finding was not relevant to deciding this
case.
1. Respondent is registered with the DEA to handle controlled
substances in Schedules II through V under Certificate of Registration
No. FP2302076. Respondent's registered address is 1461 West Busch
Boulevard, Tampa, Florida 33612. Respondent's DEA Certificate of
Registration expires by its own terms on March 31, 2022. GX 1.
2. Oxycodone is a Schedule II controlled substance. 21 CFR
1308.12(b)(1).
3. Hydromorphone is a Schedule II controlled substance. 21 CFR
1308.12(b)(1).
4. Alprazolam is a Schedule IV controlled substance. 21 CFR
1308.14(c).
5. Morphine Sulfate is a Schedule II controlled substance. 21 CFR
1308.12(b)(1).
[[Page 64727]]
6. Methadone is a Schedule II controlled substance. 21 CFR
1308.12(c).
7. Hydromorphone 8 mg is a commercially available drug. Tr. 232.
Hydromorphone 8 mg is the highest strength of hydromorphone that is
commercially available. Tr. 248.
8. Oxycodone 30 mg is a commercially available drug. Tr. 232.
DEA's Investigation
9. After receiving a tip from the Florida Department of Health in
May 2017, DEA investigators traveled to Respondent's registered address
and presented a Notice of Inspection to the pharmacist present, who
consented to the inspection. Approximately ten to fifteen minutes
later, Respondent's owner, Norman Clement, Sr., indirectly asked the
DEA investigators to leave, which they did. Tr. 26-27.
10. In September 2017, DEA investigators served an administrative
subpoena on Respondent seeking, among other things, original Schedule
II controlled substances prescriptions, receiving records, and ``batch
records.'' Tr. 27. Government Exhibits 2 through 6 were produced by
Respondent to DEA in response to the September 2017 subpoena and were
admitted into evidence in this matter. Tr. at 27-34.
11. On September 10, 2018, DEA investigators executed an
Administrative Inspection Warrant (``AIW'') at Respondent's registered
address. Tr. 52.
12. DI Albert and Respondent's owner conducted an inventory of the
Schedule II controlled substances contained in the safe located at
Respondent's address. Tr. 56. On September 10, 2018, there were 3,546
compounded capsules of hydromorphone 8 mg; 470 commercially-produced
tablets of hydromorphone 8 mg; 574 compounded capsules of oxycodone 30
mg; and 204 commercially-produced oxycodone 30 mg tablets in the safe.
GX 7. There were also 155.2 grams of hydromorphone powder and 26 grams
of oxycodone powder. Id. There were no other Schedule II controlled
substances contained in the safe. Tr. 59.
13. During the AIW, DEA investigators attempted to inspect and copy
certain records. Tr. 56. At the time, Respondent's owner was not able
to tell the investigators where these records were located. Tr. 56-57.
As a result, one of Respondent's owner's sons (Norman Clement, Jr.) was
reached by video-teleconference on a series of mobile devices and was
able to direct the investigators to the location of various records.
Tr. 61-62; see also Tr. 521-23.
14. During the execution of the AIW, DEA investigators also served
an administrative subpoena, seeking complete copies of the ``patient
record system'' for certain specific patients. Tr. 53; GX 67.
15. During the execution of the AIW, a technician from DEA's
Digital Evidence Laboratory (SFL-9) was able to obtain copies of
electronic records from Respondent's system by ``mirroring'' the hard
drive. Tr. 62. The records obtained by the SFL-9 investigator included
information relating to patients not involved in this proceeding.\28\
Tr. 90-93. The SFL-9 provided DI Albert with electronic copies of the
records obtained during the execution of the AIW. Tr. 62-63, 94.
---------------------------------------------------------------------------
\28\ I do not agree that DI Albert's testimony supports a
finding that the SFL-9 investigator obtained a complete copy of the
Respondent's electronic records, as the Government proposed in its
post-hearing brief. Gov't PHB, p. 4, ] 16 (citing Tr. 90-93). DI
Albert's testimony supports a finding that the information
``mirrored'' from the hard-drive included patients other than the
eleven involved here, but his testimony does not support the
conclusion that the information obtained was a ``complete copy'' of
all of the Respondent's records. Tr. 90-93.
---------------------------------------------------------------------------
16. Government Exhibit 11 is a complete and accurate copy of
Respondent's dispensing log for June 1, 2017, to September 7, 2018,
which was obtained during the execution of the AIW in September 2018.
Tr. 63-66. Government Exhibits 12-13; 15-17; 20-21; 23-24; 26-27; 29-
30; 32-33; 35-36; 38-39; 41-43; 47-49, and 51 are correct and accurate
copies of documents that were obtained from Respondent's electronic
record system by the SFL-9 technician during the execution of the AIW.
Tr. 68-86.
17. During the course of the investigation, DI Albert queried the
Florida Prescription Drug Monitoring Database (E-FORCSE or PDMP) and
obtained information regarding Respondent's dispensing of controlled
substance as it was reported to the State of Florida. Tr. 44.
Government Exhibits 8-10 are accurate copies of the data obtained from
the E-FORSCE database for the dates listed. Tr. 48-51. Government
Exhibits 14, 19, 22, 25, 28, 31, 34, 37, 40, 46, and 50 are complete
and accurate copies of E-FORSCE information for certain specific
enumerated patients. Tr. 68-86. There is no evidence in the record to
indicate that the information reported by Respondent to the E-FORSCE
database is inaccurate or unreliable.
18. In May 2018, DI Albert served an additional subpoena on
Respondent seeking the complete patient record system maintained by
Respondent for certain specific patients, as well as any ``other
documentation kept by [Respondent] in connection with the filling of
prescriptions . . . for these individuals.'' Tr. 88-89; GX 68.
19. Government Exhibit 18 includes all documents and information
produced in response to the May 2018 subpoena regarding Patient A.G.
Tr. 96; GX 18. Government Exhibit 44 includes all documents and
information produced in response to the May 2018 subpoena regarding
Patient R.B. Tr. 97-98; GX 44.
20. The Respondent dispensed four to five prescriptions per day on
average. Tr. 419.
The Standard of Professional Pharmacy Practice in Florida
21. Dr. Sullivan testified that the standard of professional
practice in Florida requires that a pharmacist make sure each
prescription is valid and has been issued for a legitimate medical
purpose prior to dispensing controlled substances. Tr. 206. As part of
this evaluation, Dr. Sullivan testified that a pharmacist must first
determine whether the prescription is facially legitimate--whether it
includes all of the required information. Id. at 208. Then, Dr.
Sullivan testified that the pharmacist must attempt to determine
whether there is over-utilization or under-utilization; clinical abuse
or misuse going on; whether the prescription was issued for a
legitimate medical purpose; and whether the prescription puts the
patient at ``any potential undue risk of side effects, adverse effects,
and/or potentially overdose situations.'' Id. at 207-08; see also Fla.
Admin. Code r. 64B16-27.810 (stating that ``a pharmacist shall review
the patient record and each new and refill prescription'' to identify
potential concerns such as ``[o]ver-utilization or under-utilization,''
and ``take appropriate steps to avoid or resolve the potential
problems''); Fla. Admin. Code r. 64B16-27.831(2)(c) (``When validating
a prescription, if at any time the pharmacist determines that in his or
her professional judgment, concerns with the validity of the
prescription cannot be resolved, the pharmacist shall refuse to fill or
dispense the prescription.'')
22. [Omitted Florida law regarding the maintenance of a patient
profile, because I do not think it is relevant to the facts in this
case.]
23. Dr. Sullivan testified that a ``red flag'' is a ``warning
sign'' that ``there's something potentially wrong with the
prescription.'' Tr. 211. Specifically, it is a sign that ``the patient
may be either abusing or diverting it.'' Id. at 212. Dr. Sullivan
testified that these ``red flags'' are well-documented in the pharmacy
[[Page 64728]]
community and are known to pharmacists in the State of Florida. Id. at
211-14; 235-36.
24. Dr. Sullivan testified that some of these red flags include (1)
patients travelling long distances to the pharmacy; (2) certain drug
cocktails; (3) high dosages of immediate release pain killers; and (4)
cash-paying customers. Id. at 214.
25. Dr. Sullivan testified that the prescribing of an opioid pain
reliever and benzodiazepine at the same time is a significant red flag.
Id. at 220-21. Dr. Sullivan noted that the FDA had issued a warning in
2016 regarding the serious health risks posed by the combination of
those two medications. Id. at 220-21; GX 66. Dr. Sullivan testified
that a reasonable pharmacist acting within the usual course of
professional practice in Florida would be ``very very reluctant to
dispense that combination of drugs'' after the FDA safety warning. Tr.
223.
26. Dr. Sullivan testified that filling a controlled substance
prescription early is a red flag. Id. at 225-27. He testified that the
standard of care required a pharmacist not to fill a Schedule II
controlled substance prescription until ``the day of or day before the
medication from a previous prescription is supposed to run out.'' Tr.
270-71. While there may be legitimate reasons for a particular
prescription to be filled early in ``extreme'' and ``unusual'' cases,
there is no legitimate reason for a pharmacist to fill a Schedule II
controlled substance prescription early in multiple consecutive months.
Tr. 270-71.
27. When a pharmacist identifies one or more red flags, he must
undertake an investigation into the prescription before he can fill it.
Tr. 227. This may include speaking with the patient and/or speaking
with the prescriber. A pharmacist would also be expected to look at the
patient profile as well as apply his clinical expertise to the drug,
quantity, and strength prescribed. Id. The standard of care requires
that the pharmacist document these conversations and analyses.\29\ Tr.
227-28. [Dr. Sullivan testified that a pharmacist does not look at
individual red flags in isolation; rather, he looks at them ``as a
collective whole based on what's going on with that prescription at
that time.'' Tr. 482, 498. Dr. Sullivan testified that there are some
red flags that, ``when taken as a collective whole[,] . . . cannot be
resolved.'' Tr. 481. Dr. Sullivan testified that in these
circumstances, ``no matter what the patient tells me, what the doctor
tells me, any of that, I'm still not filling the prescription.'' Tr.
282. Dr. Sullivan testified that an individual red flag (such as long
distances traveled or cash payments) may become unresolvable if it is
combined with multiple additional red flags. Id. at 473, 475; see also
id. at 409-11.]
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\29\ [Footnote omitted.]
---------------------------------------------------------------------------
Respondent's Dispensing
Patient A.G.
28. At all times relevant to this matter, Patient A.G. resided at
411 NE 25th Ave., Cape Coral, Florida 33909. GX 15. Patient A.G.'s
residence is approximately 130 miles (one-way) from Respondent's
registered address. GX 55.
29. All of the prescriptions filled by Patient A.G. at Respondent
were paid for in cash. GX 14, 17.
30. Dr. Sullivan examined the dispensing data and the patient
profile for Patient A.G. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient A.G. was a ``red flag,'' as was the fact that Patient A.G. was
prescribed a ``cocktail of benzodiazepine and opioid'' at the highest
strengths of both medications. Tr. 254-55. Dr. Sullivan also observed
that Patient A.G. filled multiple prescriptions early. Tr. 257-59.
31. Between June 26, 2017, and August 30, 2018, Respondent filled
30 prescriptions for controlled substances for Patient A.G., including
10 prescriptions for hydromorphone 8 mg; 10 prescriptions for oxycodone
30 mg; 9 prescriptions for alprazolam 2 mg; and 1 prescription for
alprazolam 1 mg. Information regarding the controlled substances
dispensed to Patient A.G. is accurately set forth in Government Exhibit
17.
32. Between December 20, 2018, and April 12, 2019, Respondent
filled 10 prescriptions for controlled substances for Patient A.G.,
including 5 prescriptions for oxycodone 30 mg and 5 prescriptions for
alprazolam 1 mg. Information regarding the controlled substances
dispensed to Patient A.G. is accurately set forth in Government Exhibit
14.
33. Respondent maintained a patient profile for Patient A.G. The
only pharmacist note in the profile for Patient A.G. stated: ``Doctor
OK to Receive Medication in Compound Capsule Form.'' Govt. Ex. 15.
34. Dr. Sullivan testified that the notes contained the Patient
A.G.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) any of the red flags that he identified.*\H\ Tr.
258.
---------------------------------------------------------------------------
\*H\ The Findings of Fact Section discusses Respondent's efforts
to document the resolution of red flags. This discussion has minimal
relevance to my Decision, because I have concluded that the
combination of red flags presented by each prescription in this case
could not have been resolved by a pharmacist operating within the
usual course of professional practice based on the credible and
unrebutted testimony of the Government's expert. However, I have
retained this discussion to provide context for Respondent's
dispensing to each patient.
---------------------------------------------------------------------------
35. Dr. Sullivan further testified that the answers provided on the
Medical Questionnaire were not sufficient to resolve any of the
specific red flags that he identified. Tr. 260-63. [Dr. Sullivan
testified that the red flags raised by Patient A.G.'s prescriptions
were not resolvable, and that a pharmacist operating in the usual
course of professional practice would not have filled them. Tr. 256-57,
267-68.]
Patient A.H.
36. At all times relevant to this matter, Patient A.H. resided at
1001 NE 6th Place, Cape Coral, Florida 33909. GX 20. Patient A.H.'s
residence is approximately 130 miles (one-way) from Respondent's
registered address. GX 56.
37. All of the prescriptions filled by Patient A.H. at Respondent
were paid for in cash. GX 19, 21.
38. Dr. Sullivan examined the dispensing data and the patient
profile for Patient A.H. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient was a ``red flag,'' as was the fact that Patient A.G. was
prescribed a ``cocktail of benzodiazepine and opioid'' at the highest
strengths of both medications. Tr. 268-69.
39. Between January 4, 2018, and August 16, 2018, Respondent filled
11 prescriptions for controlled substances for Patient A.H., including
six prescriptions for hydromorphone 8 mg and five prescriptions for
alprazolam 2 mg. Information regarding the controlled substances
dispensed to Patient A.H. is accurately set forth in Government Exhibit
21.
40. Between September 11, 2018, and April 18, 2019, Respondent
filled at least seven prescriptions for controlled substances for
Patient A.H., including seven prescriptions for hydromorphone 8 mg.
Information regarding the controlled substances dispensed to Patient
A.H. is accurately set forth in Government Exhibit 19.
41. Respondent maintained a patient profile for Patient A.H. The
patient profile for Patient A.H. contained no pharmacist notes or
comments. GX 20. In Dr. Sullivan's opinion, Patient A.H.'s patient
profile was insufficient to resolve any of the red flags that he
identified. Tr. 272. [Dr. Sullivan testified that the red flags raised
by Patient A.H.'s prescriptions were not
[[Page 64729]]
resolvable, and that a pharmacist operating in the usual course of
professional practice would not have filled them. Tr. 269, 273.]
Patient B.S.
42. At all times relevant to this matter, Patient B.S. resided at
117 Zobora Circle, Fort Myers, Florida 33913. GX 23. Patient B.S.'s
residence is approximately 150 miles (one-way) from Respondent's
registered address. GX 57.
43. All of the prescriptions filled by Patient B.S. at Respondent
were paid for in cash. GX 22, 24.
44. Dr. Sullivan examined the dispensing data and the patient
profile for Patient B.S. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient B.S. was a ``red flag,'' as was the fact that Patient B.S. was
prescribed a cocktail of benzodiazepine and opioid at the highest
strengths of both medications. Tr. 274-75.
45. Between August 22, 2017, and August 23, 2018, Respondent filled
19 prescriptions for controlled substances for Patient B.S., including
12 prescriptions for hydromorphone 8 mg; six prescriptions for
alprazolam 2 mg; and one prescription for alprazolam 1 mg. Information
regarding the controlled substances dispensed to Patient B.S. is
accurately set forth in Government Exhibit 24.
46. Between December 20, 2018, and April 22, 2019, Respondent
filled at least nine prescriptions for controlled substances for
Patient B.S., including two prescriptions for hydromorphone 8 mg, four
prescriptions for oxycodone 30 mg, and three prescriptions for
alprazolam 1 mg. Information regarding the controlled substances
dispensed to Patient B.S. is accurately set forth in Government Exhibit
22.
47. Respondent maintained a patient profile for Patient B.S. The
patient profile for Patient B.S. contained no pharmacist notes or
comments. GX 23.
48. Dr. Sullivan testified that the notes contained in Patient
B.S.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) any of the red flags that he identified. Tr. 277.
[Dr. Sullivan testified that the red flags raised by Patient B.S.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 274, 276-77.]
Patient C.R.
49. At all times relevant to this matter, Patient C.R. resided at
2907 Jackson Street, Fort Myers, Florida 33901. GX 26. Patient C.R.'s
residence is approximately 130 miles (one-way) from Respondent's
registered address. GX 58.
50. All of the prescriptions filled by Patient C.R. at Respondent
were paid for in cash. GX 25, 27.
51. Dr. Sullivan examined the dispensing data and the patient
profile for Patient C.R. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient C.R. was a ``red flag,'' as was the fact that Patient C.R. was
prescribed a cocktail of benzodiazepine and opioid with the opioid
prescribed at the highest strength. Tr. 279-80.
52. Between July 19, 2017, and August 30, 2018, Respondent filled
13 prescriptions for controlled substances for Patient C.R., including
six prescriptions for oxycodone 30 mg, six prescriptions for alprazolam
1 mg, and one prescription for morphine sulfate 30 mg. Information
regarding the controlled substances dispensed to Patient C.R. is
accurately set forth in Government Exhibit 27.
53. Respondent maintained a patient profile for Patient C.R. The
only pharmacist note in the profile for Patient C.R. stated: ``Script
has wrong birthdate on it. Dr[.] has now update[.]'' GX 26.
54. Dr. Sullivan testified that the notes contained the Patient
C.R.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) any of the red flags that he identified. Tr. at
281.
Patient J.D.
55. At all times relevant to this matter, Patient J.D. resided at
229 NW 15th Place, Cape Coral, Florida 33993. GX 29. Patient J.D.'s
residence is approximately 130 miles (one-way) from Respondent's
registered address. GX 59.
56. All of the prescriptions filled by Patient J.D. at Respondent
were paid for in cash. GX 28, 30.
57. Dr. Sullivan examined the dispensing data and the patient
profile for Patient A.H. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient A.H. was a ``red flag,'' as was the fact that Patient A.G. was
prescribed the highest strengths of hydromorphone. Tr. 283.
58. Between January 15, 2018, and September 4, 2018, Respondent
filled ten prescriptions for controlled substances for Patient J.D.,
including nine prescriptions for hydromorphone 8 mg and one
prescription for methadone 10 mg. Information regarding the controlled
substances dispensed to Patient J.D. is accurately set forth in
Government Exhibit 30.
59. In addition, Dr. Sullivan noted that Respondent dispensed two
immediate release narcotic pain relievers (hydromorphone 8 mg and
methadone 10 mg) to Patient J.D. on March 24, 2018. Dr. Sullivan
testified that dispensing two immediate release narcotic pain relievers
on the same day was ``a red flag in and of itself.'' Tr. 283-84.
60. Respondent maintained a patient profile for Patient J.D. The
only pharmacist note in the profile for Patient J.D. stated: ``Next
Fill 7/5/18!!! Watch fill dates!!!!!!'' GX 29.
61. Dr. Sullivan testified that the notes contained in Patient
J.D.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) any of the red flags that he identified. Tr. 287-
88. [Dr. Sullivan testified that the red flags raised by Patient J.D.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 284, 288-89.]
Patient J.M.
62. At all times relevant to this matter, Patient J.M. resided at
3004 30th Street SW, Lehigh Acres, Florida 22976. GX 32. Patient J.M.'s
residence is approximately 140 miles (one-way) from Respondent's
registered address. GX 60.
63. All of the prescriptions filled by Patient J.M. at Respondent
were paid for in cash. GX 31, 33.
64. Dr. Sullivan examined the dispensing data and the patient
profile for Patient J.M. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient J.M. was a ``red flag,'' as was the fact that Patient J.M. was
prescribed a cocktail of benzodiazepine and opioid with the opioid
prescribed at the highest strength. Tr. 289-90.
65. Between June 22, 2017, and September 7, 2018, Respondent filled
23 prescriptions for controlled substances for Patient J.M., including
eight prescriptions for oxycodone 30 mg; six prescriptions for
hydromorphone 8 mg; and nine prescriptions for alprazolam 2 mg.
Information regarding the controlled substances dispensed to Patient
J.M. is accurately set forth in Government Exhibit 33.
66. Respondent maintained a patient profile for Patient J.M. The
patient profile for Patient J.M. contained no pharmacist notes or
comments. GX 32.
67. Dr. Sullivan testified that the notes contained the Patient
J.M.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) any of the red flags that he identified. Tr. 290.
[Dr. Sullivan testified that the red flags raised by
[[Page 64730]]
Patient J.M.'s prescriptions were not resolvable, and that a pharmacist
operating in the usual course of professional practice would not have
filled them. Tr. 290-91.]
Patient M.M.
68. At all times relevant to this matter, Patient M.M. resided at
1145 W Walnut Street, Lakeland, Florida 22815. GX 35. The prescriptions
that Patient M.M. filled at Respondent were issued by a practitioner
located at 1670 San Carlos Blvd., Fort Myers Beach, Florida 22931. GX
36.
69. Patient M.M.'s residence is approximately 130 miles (one-way)
from the prescriber's location. GX 61. All of the prescriptions filled
by Patient M.M. at Respondent were paid for in cash. GX 34, 36.
70. Between June 6, 2017, and August 16, 2018, Respondent filled 14
prescriptions for controlled substances for Patient M.M., including 14
prescriptions for hydromorphone 8 mg. Information regarding the
controlled substances dispensed to Patient M.M. is accurately set forth
in Government Exhibit 36.
71. Between January 3, 2019, and April 16, 2019, Respondent filled
at least 5 prescriptions for controlled substances for Patient M.M.,
including 5 prescriptions for hydromorphone 8 mg. Information regarding
the controlled substances dispensed to Patient M.M. is accurately set
forth in Government Exhibit 34.
72. Dr. Sullivan examined the dispensing data and the patient
profile for Patient M.M. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient M.M. from her home to her physician was a ``red flag,'' as was
the fact that Patient M.M. was prescribed the highest available
strength of hydromorphone.\30\ Tr. 292-95.
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\30\ For reasons explained later in this Recommended Decision, I
am not accepting Dr. Sullivan's opinion that the roundtrip distance
from M.M.'s home to the prescriber's office, to the Respondent, and
back home, is a red flag, as proposed by the Government. Gov't PHB,
pp. 20-21, ] 101.
---------------------------------------------------------------------------
73. Respondent maintained a patient profile for Patient M.M. The
patient profile for Patient M.M. contained no pharmacist notes or
comments. GX 35.
74. Dr. Sullivan testified that the notes contained in Patient
M.M.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) any of the red flags that he identified. Tr. 300.
[Dr. Sullivan testified that the red flags raised by Patient M.M.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 299-300.]
Patient N.B.
75. At all times relevant to this matter, Patient N.B. resided at
2132 SE 5th Place, Cape Coral, Florida 33990. GX 38. Patient N.B.'s
residence is approximately 135 miles (one-way) from Respondent's
registered address. GX 62.
76. All of the prescriptions filled by Patient N.B. at Respondent
were paid for in cash. GX 37, 39.
77. Between June 21, 2017, and August 14, 2018, Respondent filled
19 prescriptions for controlled substances for Patient N.B., including
12 prescriptions for hydromorphone 8 mg, four prescriptions for
alprazolam 2 mg, and three prescriptions for alprazolam 1 mg.
Information regarding the controlled substances dispensed to Patient
N.B. is accurately set forth in Government Exhibit 39.
78. Between September 14, 2018, and April 10, 2019, Respondent
filled at least nine prescriptions for controlled substances for
Patient N.B., including five prescriptions for oxycodone 30 mg, three
prescriptions for alprazolam 1 mg, and one prescription for
hydromorphone 8 mg. Information regarding the controlled substances
dispensed to Patient N.B. is accurately set forth in Government Exhibit
37.
79. Dr. Sullivan examined the dispensing data and the patient
profile for Patient N.B. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient N.B. was a ``red flag,'' as was the fact that Patient N.B. was
prescribed a cocktail of benzodiazepine and opioid at the highest
strengths of both medications. Tr. 301-02, 305.
80. Respondent maintained a patient profile for Patient N.B. The
only pharmacist note in the profile for Patient N.B. stated: ``Doctor
OK Patient to Receive Medication in Compound Capsule Form.'' GX 38.
81. Dr. Sullivan testified that the notes contained in Patient
N.B.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) any of the red flags that he identified. Tr. 306.
[Dr. Sullivan testified that the red flags raised by Patient N.B.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 302-07.]
Patient R.B.
82. At all times relevant to this matter, Patient R.B. resided at
2512 Pauldo Street, Fort Myers, Florida 33916. GX 41. Patient R.B.'s
residence is approximately 140 miles (one-way) from Respondent's
registered address. GX 63.
83. All of the prescriptions filled by Patient R.B. at Respondent
were paid for in cash. GX 40, 43.
84. Between June 28, 2017, and August 16, 2018, Respondent filled
24 prescriptions for controlled substances for Patient R.B., including
12 prescriptions for hydromorphone 8 mg, 11 prescriptions for
alprazolam 2 mg, and one prescription for alprazolam 1 mg. Information
regarding the controlled substances dispensed to Patient R.B. is
accurately set forth in Government Exhibit 43.
85. Between September 12, 2018, and April 15, 2019, Respondent
filled at least 10 prescriptions for controlled substances for Patient
R.B., including five prescriptions for hydromorphone 8 mg and five
prescriptions for alprazolam 1 mg. Information regarding the controlled
substances dispensed to Patient R.B. is accurately set forth in
Government Exhibit 40.
86. Respondent maintained a patient profile for Patient R.B. The
patient profile for Patient R.B. contained no pharmacist notes or
comments. GX 41.
87. Dr. Sullivan examined the dispensing data and the patient
profile for Patient R.B. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient R.B. was a ``red flag,'' as was the fact that Patient R.B. was
prescribed a cocktail of benzodiazepine and opioid with the opioid
prescribed at the highest strength. Tr. 310-11.
88. Dr. Sullivan testified that the notes contained in Patient
R.B.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) any of the red flags that he identified. Tr. 313.
[Dr. Sullivan testified that the red flags raised by Patient R.B.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 311, 313, 321.]
Patient R.G.
89. At all times relevant to this matter, Patient R.G. resided at
1915 NE 5th Street, Cape Coral, Florida 33909. GX 47. Patient R.G.'s
residence is approximately 130 miles (one-way) from Respondent's
registered address. GX 64.
90. All of the prescriptions filled by Patient R.G. at Respondent
were paid for in cash. GX 46, 49.
91. Between June 28, 2017, and September 7, 2018, Respondent filled
29 prescriptions for controlled substances for Patient R.G., including
17 prescriptions for oxycodone 30 mg, and 12 prescriptions for
alprazolam 2 mg. Information regarding the controlled
[[Page 64731]]
substances dispensed to Patient R.G. is accurately set forth in
Government Exhibit 49.
92. Dr. Sullivan examined the dispensing data and the patient
profile for Patient R.G. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient R.G. was a ``red flag,'' as was the fact that Patient R.G. was
prescribed a cocktail of benzodiazepine and opioid at the highest
strengths of both medications. Tr. 322-23.
93. Respondent maintained a patient profile for Patient R.G. The
only pharmacist note in the profile for Patient R.G. stated: ``Watch
Fill Dates!!!!!!!!!!!!'' GX 47.
94. Dr. Sullivan testified that the notes contained in Patient
R.G.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) any of the red flags that he identified. Tr. 328.
[Dr. Sullivan testified that the red flags raised by Patient R.G.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 322-23, 326, 328-29.]
Patient R.L.
95. At all times relevant to this matter, Patient R.L. resided at
135 SW 29th Terrace, Cape Coral, Florida 33914. GX 51. Patient R.L.'s
residence is approximately 140 miles (one-way) from Respondent's
registered address. GX 65.
96. All of the prescriptions filled by Patient R.L. at Respondent
were paid for in cash. GX 50, 52.
97. Between June 21, 2017, and September 4, 2018, Respondent filled
16 prescriptions for controlled substances for Patient R.L., including
14 prescriptions for hydromorphone 8 mg, one prescription for oxycodone
30 mg, and one prescription for alprazolam 2 mg. Information regarding
the controlled substances dispensed to Patient R.L. is accurately set
forth in Government Exhibit 52.
98. Between December 27, 2018, and April 16, 2019, Respondent
filled at least five prescriptions for controlled substances for
Patient R.L., including five prescriptions for oxycodone 30 mg.
Information regarding the controlled substances dispensed to Patient
R.L. is accurately set forth in Government Exhibit 50.
99. Dr. Sullivan examined the dispensing data and the patient
profile for Patient R.L. and identified multiple ``red flags.''
Specifically, Dr. Sullivan concluded that the distance travelled by
Patient R.L. was a ``red flag,'' as was the fact that Patient R.L. was
prescribed opioids at the highest strengths available. Tr. 330-31.
100. Respondent maintained a patient profile for Patient R.L. The
only pharmacist note in the profile for Patient R.L. stated: ``Next
Fill 6/10/18--10 Days Early March & April--Told Him This 5/11/18
GD[.]'' GX 51.]
101. Dr. Sullivan testified that the notes contained in Patient
R.L.'s patient profile were insufficient to resolve (or to suggest an
attempt to resolve) the red flags that he identified. Tr. 335. [Dr.
Sullivan testified that the red flags raised by Patient R.L.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 332, 335-36.]
Compounding
102. Respondent repeatedly dispensed both commercially-available
tablet and compounded capsule forms of controlled substances to the
same patients, indicating that those patients did not have a legitimate
therapeutic need for the compounded form. See, e.g., Tr. 256, 290, 297,
321, 325, 326.
103. In May 2012, then-TFO Jeffrey Shearer conducted an interview
with Respondent's owner regarding the compounding that he was doing at
Respondent. Tr. 183.
104. Respondent's owner indicated that his formulary was designed
to ensure that the compounded product was ``essentially similar'' to
the commercially-produced product. Respondent's owner stressed that his
compounded product had the same ``bioavailability'' as the commercially
available product. Tr. 184-85.
105. TFO Shearer observed that Respondent's owner was compounding
thousands of dosage units at one time. Respondent's owner explained
that he did so because it was ``cost effective'' to produce large
volumes at the same time. Tr. 185.
106. Respondent's owner told TFO Shearer that some of his customers
did not want the compounded capsules, but that Respondent's owner
assured the patients that the capsules and the tablets were ``the same,
that they would have the same effect.'' Tr. 185-86.
Analysis
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 [and unresolvable] red flags of diversion, and in violation of
state law under the Florida Administrative Code, and state requirements
for the minimum standard of care, 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). The Government also alleges that the
Respondent engaged in a pattern of manufacturing controlled substances
without proper registration.
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). Where the Government has
sustained its burden and made its prima facie case, a respondent must
both accept responsibility for his actions and demonstrate that he 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, the 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).
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 463 (noting, on remand, that despite the respondent
having undertaken measures to reform her practice, revocation had been
appropriate because the respondent had refused to acknowledge her
responsibility under the law); Med.
[[Page 64732]]
Shoppe-Jonesborough, 73 FR 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. Consol. Edison Co. of New York v.
NLRB, 305 U.S. 197, 229 (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
Village Pharm. 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 his 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).
Analysis of Dispensing Allegations
The Government alleges that the Respondent filled numerous
prescriptions for eleven patients that raised red flags of drug abuse
and/or diversion, to include drug cocktails; early fills; traveling
long distances; prescriptions for the highest strengths of oxycodone,
hydromorphone, and alprazolam; paying in cash; and dispensing
compounded capsules without therapeutic justification. ALJ Ex. 1, pp.
4-7. The Government further alleges that [the red flags presented by
these prescriptions were so strongly indicative of drug abuse and
diversion that they could not have been resolved by a pharmacist acting
in the usual course of professional practice.]\*I\ Id. The Government
claims that by filling these eleven patients' controlled substance
prescriptions, the Respondent violated its corresponding responsibility
under 21 CFR 1306.04(a) and dispensed controlled substances outside the
usual course of pharmacy practice in violation of 21 CFR 1306.06, in
addition to Florida Administrative Code r. 64B16-27.831. Id. [Omitted
for relevance.]
---------------------------------------------------------------------------
\*I\ I have modified this paragraph to clarify that the
Government alleged that the red flags presented by the prescriptions
in this case could not have been resolved by a pharmacist acting
within the usual course of professional practice. Because the
Government presented sufficient evidence to support this allegation,
I do not need to consider the Government's alternative claim that
Respondent failed to take adequate steps under Florida and federal
law to resolve the red flags.
---------------------------------------------------------------------------
With respect to each patient, the Government presented documentary
evidence and testimony from its pharmacy expert, Dr. Sullivan, that the
Respondent filled numerous controlled substance prescriptions that
raised red flags, including drug cocktails, early fills, long distance,
highest strengths, and cash payments. The Government further presented
evidence that [the red flags presented by these prescriptions could not
have been resolved by a pharmacist acting in the usual course of
professional practice.] Finally, the Government proved the Respondent
compounded medication without therapeutic justification.
I will now turn to the evidence the Government presented for each
patient. After examining the evidence for each patient, I will
determine whether the Government has presented a prima facie case that
the Respondent filled these prescriptions in violation of federal and
state law.
Patient A.G.
From January 2018 to April 2019, the Respondent dispensed a drug
cocktail of alprazolam and oxycodone to A.G. on six occasions. GX 14.
During the same time period, the Respondent dispensed a drug cocktail
of alprazolam and hydromorphone to A.G. on three occasions. Id.
Dr. Sullivan testified that the Respondent filled several
prescriptions for A.G. before his prior month's supply of medication
ran out. Tr. 257. For example, the Respondent filled oxycodone and
alprazolam prescriptions for A.G. on January 17, 2019, the 28th day
after dispensing a 30-day supply of each drug to him on December 20,
2018 (2 days early). ALJ Ex. 42,\31\ p. 12; GX 14. The Respondent
filled an alprazolam prescription for A.G. on February 14, 2019, the
28th day after dispensing a 30-day supply on January 17, 2019 (2 days
early). Id. The Respondent filled another oxycodone prescription for
A.G. on April 12, 2019, the 23rd day after dispensing a 28-day supply
on March 20, 2019 (5 days early). Id. The Respondent also filled an
alprazolam prescription for A.G. on April 12, 2019, the 23rd day after
dispensing a 30-day supply on March 20, 2019 (7 days early). Id. These
prescriptions should not have been filled early unless the Respondent
documented a good reason for doing so. Tr. 257.
---------------------------------------------------------------------------
\31\ Because the Government structured its direct examination of
Dr. Sullivan by using the demonstrative exhibit for ease of
reference, I will cite to that document as well as the Government
Exhibit from which the information is derived. I will mark the
demonstrative exhibit as ALJ Exhibit 42. I will treat the
demonstrative exhibit similar to a summary of voluminous records
under Federal Rule of Evidence 1006. The demonstrative exhibit,
however, was never introduced into evidence, so it is being used as
a guide or aid for review of the record. Thus, the admitted evidence
trumps the demonstrative exhibit with respect to any inconsistency
between the two.
---------------------------------------------------------------------------
Patient A.G.'s home address was located about 130 miles from the
Respondent. ALJ Ex. 42, p. 10; GX 55. Dr. Sullivan opined that this
distance should have raised a red flag to a reasonable pharmacist.\32\
Tr. 254.
---------------------------------------------------------------------------
\32\ Although we do not know if A.G., in fact, travelled 131
miles from his home to the Respondent each time he filled a
prescription there, the Respondent knew he lived that far away, and
was therefore on notice of a well-established red flag of drug abuse
and/or diversion. This is true of ten of the eleven patients. The
fact that the patients lived over 100 miles away is a red flag even
if the patients did not travel that distance each time they visited
the pharmacy. The focus is on the information the Respondent knew,
and the Respondent knew the patients lived over 100 miles away
because it had their addresses on the prescriptions. According to
Dr. Sullivan, this information should have aroused the Respondent's
suspicion. The remaining patient (M.M.) lived approximately 134
miles from his prescriber's office, which represents its own red
flag of long distance travel to obtain the prescription. Tr. 291-94.
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[[Page 64733]]
From June 2017 to August 2018, the Respondent dispensed ten
prescriptions each for oxycodone, hydromorphone, and alprazolam. ALJ
Ex. 42, p. 11; GX 17. Each of these prescriptions, except for one
alprazolam prescription, was written for the highest commercially
available strength of the drug. Id.; Tr. 255. All of the oxycodone
prescriptions dispensed during this time period were for 30 mg dosage
units, the highest strength available of oxycodone. Id. All of the
hydromorphone prescriptions dispensed during this time period were for
8 mg dosage units, the highest strength available of hydromorphone. Id.
Nine of the ten alprazolam prescriptions dispensed during this time
period were for 2 mg dosage units, the highest strength available of
alprazolam. Id. Dispensing these controlled substances at their highest
strengths, especially in combination with each other, raised red flags
that required resolution. Tr. 256.
In addition to these red flags, patient A.G. paid for all of his
prescriptions in cash. GX 14; GX 17. Dr. Sullivan testified that paying
in cash is a red flag.\33\ Tr. 214.
---------------------------------------------------------------------------
\33\ The Respondent argues that it did not view cash payments as
suspicious because it did not accept insurance as a form of payment.
Resp't PHB, at 19-20, 35. I am not convinced by this argument for
two reasons. First, the Respondent did not provide any direct
evidence that the only form of payment it accepted during the
relevant time period was cash. Rather, it drove at this issue
indirectly by asking hypothetical questions such as how would the
Respondent get paid if it did not have contracts with insurance
carriers or pharmacy benefit managers. Tr. 443-44. Second, even if
the only form of payment that the Respondent accepted was cash, the
fact that a patient was willing to pay in cash should still have
aroused the Respondent's suspicion since it is a [part of the
standard of professional practice of pharmacy as testified by Dr.
Sullivan. Tr. 221-225.] The fact that the patients in this case were
willing to pay in cash was even more concerning given the other red
flags that they raised. Dr. Sullivan testified that paying in cash
for controlled substances remains suspicious when it occurs with the
other red flags involved here, even if the pharmacy did not take
insurance. Tr. 475-76. [DEA has consistently relied on the testimony
of pharmacy experts in finding that cash payments are a red flag of
diversion or abuse. See, e.g., Edge Pharm., 81 FR 72,092, 72,103,
72,111-12 (2016) (crediting Florida pharmacy expert's testimony that
paying in cash or cash equivalent, such as by credit or debit card,
creates a suspicion that a controlled substance may be abused or
diverted).]
---------------------------------------------------------------------------
Although patient A.G. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 259, 267; GX 17; ALJ Ex. 42,
p. 11. [Omitted for relevance. Dr. Sullivan testified that the red
flags raised by Patient A.G.'s prescriptions were not resolvable, and
that a pharmacist operating in the usual course of professional
practice would not have filled them. Tr. 256-57, 267-68.]
Patient A.H.
From January 2018 to August 2018, the Respondent dispensed a drug
cocktail of alprazolam and hydromorphone to A.H. on five occasions. ALJ
Ex. 42, p. 15; GX 21.
The Respondent provided three early fills of hydromorphone
prescriptions for A.H. from February to March 2019. Tr. 270-71; ALJ Ex.
42, p. 16; GX 19. The Respondent dispensed hydromorphone to A.H. on
February 15, 2019, the 24th day after dispensing a 30-day supply on
January 22, 2019 (6 days early). Id. The Respondent also dispensed
hydromorphone to A.H. on February 27, 2019, the 12th day after
dispensing a 30-day supply on February 15, 2019 (18 days early). Id.
The Respondent then dispensed hydromorphone to A.H. on March 14, 2019,
the 15th day after dispensing a 30 day-supply on February 27, 2019 (15
days early). Id. Filling three consecutive hydromorphone prescriptions
early is a red flag. Tr. 271. A pharmacist acting within the usual
course of professional practice would have either refused to fill these
prescriptions until at least the day before the prior month's supply
would have run out or refused to fill future prescriptions of the same
drug for the patient. Id.
Patient A.H.'s home address was located about 130 miles from the
Respondent. ALJ Ex. 42, p. 14; GX 56; Tr. 268. Dr. Sullivan opined that
this distance is a red flag. Tr. 268.
From January 2018 to August 2018, the Respondent dispensed six
prescriptions of hydromorphone and five prescriptions of alprazolam.
ALJ Ex. 42, p. 15; GX 21. Each of these prescriptions was written for
the highest strength of the drug. Id.; Tr. 269. All of the
hydromorphone prescriptions dispensed during this time period were for
8 mg dosage units, the highest strength available of hydromorphone. Id.
All of the alprazolam prescriptions dispensed during this time period
were for 2 mg dosage units, the highest strength available of
alprazolam. Id. Dispensing these controlled substances at their highest
strengths, especially in combination with each other, raised red flags
that required resolution. Tr. 269.
In addition to these red flags, patient A.H. paid for all of his
prescriptions in cash. GX 19; GX 21. Dr. Sullivan testified that paying
in cash is a red flag. Tr. 214.
Although patient A.H. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 272; GX 20; ALJ Ex. 42, p. 17.
[Dr. Sullivan testified that the red flags raised by Patient A.H.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 269, 273.]
Patient B.S.
From August 2017 to August 2018, the Respondent dispensed a drug
cocktail of alprazolam and hydromorphone to B.S. on five occasions. ALJ
Ex. 42, p. 19; GX 24; Tr. 274. From December 2018 to March 2019, the
Respondent dispensed a drug cocktail of alprazolam and oxycodone to
B.S. on three occasions. ALJ Ex. 42, p. 20; GX 22; Tr. 276-77.
Dr. Sullivan also pointed out the duplicative therapy that the
Respondent dispensed in January and February 2019. Tr. 276; ALJ Ex. 42,
p. 20. After dispensing a 30-day supply of oxycodone to B.S. on January
31, 2019, only five days later the Respondent dispensed a 28-day supply
of hydromorphone. Id. Then only two weeks later, the Respondent
dispensed another 30-day supply of oxycodone to B.S. Id. Oxycodone and
hydromorphone are potent immediate-release narcotic pain killers. Tr.
276. The fact that B.S. presented overlapping prescriptions for
different immediate-release opioids with duplicative therapy was a red
flag of abuse and/or diversion. Id.
Patient B.S.'s home address was located about 148 miles from the
Respondent. ALJ Ex. 42, p. 18; GX 57; Tr. 273-74. Dr. Sullivan opined
that this distance is a red flag. Tr. 273-74.
From August 2017 to August 2018, the Respondent dispensed 12
prescriptions of hydromorphone and 7 prescriptions of alprazolam. ALJ
Ex. 42, p. 19; GX 24; Tr. 274. All but one of these prescriptions was
written for the highest commercially available dosage strength of the
drug. Id. All of the hydromorphone prescriptions dispensed during this
time period were for 8 mg dosage units, the highest strength of
hydromorphone. Id. All but one of the alprazolam prescriptions
dispensed during this time period were for 2 mg dosage units, the
highest strength of alprazolam. Id. From December 2018 to April 2019,
the Respondent dispensed four
[[Page 64734]]
prescriptions of oxycodone and one prescription of hydromorphone. ALJ
Ex. 42, p. 20; GX 22; Tr. 276. All four of the oxycodone prescriptions
were written for 30 mg, the highest strength of oxycodone. Id. The
hydromorphone prescription was written for 8 mg, the highest strength
of hydromorphone. Id. Dispensing these controlled substances at their
highest strengths, especially in combination with each other, raised
red flags that required resolution. Tr. 274, 276-77.
[Text omitted.] * J 34 Id.
---------------------------------------------------------------------------
*\J\ As referenced herein, the ALJ did not find that Dr.
Sullivan's testimony regarding the ibuprofen prescriptions was
factually supported. I find it unnecessary given the strength of the
other evidence in this case to reach this issue, and therefore, I am
omitting the references to this testimony as irrelevant.
\34\ [Texted omitted where footnote was included.]
---------------------------------------------------------------------------
In addition to these red flags, patient B.S. paid for all of his
prescriptions in cash. GX 22; GX 24. Dr. Sullivan testified that paying
in cash is a red flag. Tr. 214.
Although patient B.S. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 277-78; GX 23; ALJ Ex. 42, p.
21. [Dr. Sullivan testified that the red flags raised by Patient B.S.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 274, 276-77.]
Patient C.R.
From July 2017 to August 2018, the Respondent dispensed a drug
cocktail of alprazolam and oxycodone to C.R. on five occasions. ALJ Ex.
42, p. 23; GX 27; Tr. 280. On one of these occasions, the Respondent
dispensed morphine tablets in addition to oxycodone and alprazolam. Id.
Patient C.R.'s home address was located about 134 miles from the
Respondent. ALJ Ex. 42, p. 22; GX 58; Tr. 279. Dr. Sullivan opined that
this distance is a red flag. Tr. 279.
From July 2017 to August 2018, the Respondent dispensed six
prescriptions of oxycodone. ALJ Ex. 42, p. 23; GX 27; Tr. 279-80. Each
of these six oxycodone prescriptions were for 30 mg dosage units, the
highest strength available of oxycodone. Id.
In addition to these red flags, patient C.R. paid for all of her
prescriptions in cash. GX 25; GX 27. Dr. Sullivan testified that paying
in cash is a red flag. Tr. 214.
Although patient C.R. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 281-82; GX 24; ALJ Ex. 42, p.
23. [Omitted for relevance. Dr. Sullivan testified that the red flags
raised by Patient C.R.'s prescriptions were not resolvable, and that a
pharmacist operating in the usual course of professional practice would
not have filled them. Tr. 279-83.]
Patient J.D.
On one occasion the Respondent dispensed a drug cocktail of
hydromorphone and methadone to J.D. Tr. 283-84; ALJ Ex. 42, p. 26; GX
30. Dr. Sullivan testified that taking these two immediate-release
narcotic pain killers at the same time put J.D. ``at extreme risk of
overdose.'' Tr. 284.
The Respondent provided three early fills of hydromorphone
prescriptions for J.D. from May to June 2018. Tr. 284-87; ALJ Ex. 42,
p. 27; GX 30. The Respondent dispensed hydromorphone to J.D. on May 30,
2018, the 20th day after dispensing a 30-day supply on May 10, 2018 (10
days early). Id. The Respondent also dispensed hydromorphone to J.D. on
June 15, 2018, the 16th day after dispensing a 30-day supply on May 30,
2018 (14 days early). Id. The Respondent then dispensed hydromorphone
to J.D. on June 30, 2018, the 15th day after dispensing a 30 day-supply
on June 15, 2018 (15 days early). Id. Dr. Sullivan testified that
filling three consecutive hydromorphone prescriptions early is a red
flag. Tr. 285. He testified that a pharmacist acting within the usual
course of professional practice would have either refused to fill these
prescriptions until at least the day before the prior month's supply
would have run out or refused to fill future prescriptions of the same
drug for the patient. Tr. 271.
Patient J.D.'s home address was located about 130 miles from the
Respondent. ALJ Ex. 42, p. 25; GX 59; Tr. 283. Dr. Sullivan opined that
this distance is a red flag. Tr. 283.
From January 2018 to September 2018, the Respondent dispensed nine
prescriptions of hydromorphone. ALJ Ex. 42, p. 26; GX 30; Tr. 283-84.
Each of these nine hydromorphone prescriptions were for 8 mg dosage
units, the highest strength available of hydromorphone. Id.
In addition to these red flags, patient J.D. paid for all of her
prescriptions in cash. GX 28; GX 30. Dr. Sullivan testified that paying
in cash is a red flag. Tr. 214.
Although patient J.D. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 287-88; GX 29; ALJ Ex. 42, p.
28. [Omitted for relevance. Dr. Sullivan testified that the red flags
raised by Patient J.D.'s prescriptions were not resolvable, and that a
pharmacist operating in the usual course of professional practice would
not have filled them. Tr. 284, 288-89.]
Patient J.M.
From June 2017 to September 2018, the Respondent dispensed a drug
cocktail of alprazolam and oxycodone to J.M. on five occasions. ALJ Ex.
42, p. 30; GX 33; Tr. 289-90. During the same time period, the
Respondent dispensed a drug cocktail of alprazolam and hydromorphone to
J.M. on three occasions. Id.
Patient J.M.'s home address was located about 144 miles from the
Respondent. ALJ Ex. 42, p. 29; GX 60; Tr. 289. Dr. Sullivan opined that
this distance is a red flag. Tr. 289.
From June 2017 to September 2018, the Respondent dispensed nine
prescriptions of alprazolam, eight prescriptions of oxycodone, and six
prescriptions of hydromorphone. ALJ Ex. 42, p. 30; GX 33; Tr. 289-90.
All of these prescriptions were for the highest strength available of
the drug. All of the nine alprazolam prescriptions were for 2 mg dosage
units, the highest strength of alprazolam. Id. All of the eight
oxycodone prescriptions were for 30 mg dosage units, the highest
strength of oxycodone. Id. All of the six hydromorphone prescriptions
were for 8 mg dosage units, the highest strength of hydromorphone. Id.
In addition to these red flags, patient J.M. paid for all of her
prescriptions in cash. GX 31; GX 33. Dr. Sullivan testified that paying
in cash is a red flag. Tr. 214.
Although patient J.M. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 290; GX 32; ALJ Ex. 42, p. 31.
[Dr. Sullivan testified that the red flags raised by Patient J.M.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 290-91.]
Patient M.M.
The Respondent provided three early fills of hydromorphone
prescriptions for M.M. from January to March 2019. Tr. 299-300; ALJ Ex.
42, p. 34; GX 34. The Respondent dispensed hydromorphone to M.M. on
January 24, 2019, the 21st day after dispensing a 28-day supply on
January 3, 2019 (7 days early). Id. The Respondent also dispensed
hydromorphone to J.D. on February 19, 2019, the 26th day after
dispensing a 30-
[[Page 64735]]
day supply on January 24, 2019 (4 days early). Id. The Respondent then
dispensed hydromorphone to J.D. on March 15, 2019, the 24th day after
dispensing a 30-day supply on February 19, 2019 (6 days early). Id. Dr.
Sullivan testified that filling three consecutive hydromorphone
prescriptions early is a red flag. Tr. 285, 300. He testified that a
pharmacist acting within the usual course of professional practice
would have either refused to fill these prescriptions until at least
the day before the prior month's supply would have run out or refused
to fill future prescriptions of the same drug for the patient. Tr. 271,
300.
Patient M.M.'s home address was located about 38 miles from the
Respondent. GX 60, pp. 5-6; Tr. 292-93. The concern about the distance
M.M. would have had to travel, however, was the distance from his home
to the prescribing doctor's office. Tr. 293-94. Patient M.M.'s home was
located about 134 miles from the office of the doctor who issued him
controlled substance prescriptions. GX 61, pp. 1-3. Dr. Sullivan opined
that the distance from M.M.'s home to the doctor's office is a red
flag.\35\ Tr. 292-94.
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\35\ I am not accepting Dr. Sullivan's testimony that the
roundtrip distance from M.M.'s home to the doctor's office, and then
to the Respondent, and then back home, is a red flag. Tr. 293. There
was no evidence M.M. ever made that round trip. The 38 miles from
M.M.'s home to the Respondent is not overly suspicious on its face.
I believe the Government withdrew its allegation as to that
distance. I will, however, accept Dr. Sullivan's testimony that the
134 miles from M.M.'s home to the doctor's office is a red flag. Tr.
294.
---------------------------------------------------------------------------
From June 2017 to August 2018, and from January to April 2019, the
Respondent dispensed 14 and 5, respectively, hydromorphone
prescriptions to patient M.M. ALJ Ex. 42, p. 33-34; GX 34; GX 36; Tr.
295. All of these 19 prescriptions were for 8 mg dosage units, the
highest strength of hydromorphone. Id.
Dr. Sullivan also pointed out the red flag raised by M.M.'s
prescriptions for folic acid 0.4 mg. Tr. 295-96; ALJ Ex. 42, p. 33; GX
36. From June 2017 to August 2018, the Respondent dispensed folic acid
0.4 mg to M.M. on eight occasions. Id. Folic acid is a vitamin and 0.4
mg of folic acid is a dose that could be obtained over-the-counter
without a prescription. Tr. 295. Dr. Sullivan opined that it is common
for doctors who unlawfully prescribe controlled substances to add low
doses of non-controlled medication to make their controlled substance
prescribing appear legitimate. Id. For the same reasons I gave earlier
with respect to B.S., however, I do not accept Dr. Sullivan's testimony
in this regard.
Dr. Sullivan also observed a concerning lapse in M.M.'s opioid
prescriptions from July 2018 to January 2019. Tr. 297-98; ALJ Ex. 42,
p. 34; GX 34. After M.M. filled a hydromorphone prescription in July
2018, M.M. did not present another prescription until January 2019,
when she presented a prescription for 8 mg dosage units of
hydromorphone, the highest strength of that drug. Id. The seven-month
lapse in hydromorphone prescriptions followed by a prescription for the
highest strength of hydromorphone should have raised a red flag because
returning abruptly to such a high dose after not taking it for seven
months would have put M.M. at ``heightened risk for overdose.'' Id.
In addition to these red flags, patient M.M. paid for all of her
prescriptions in cash. GX 34; GX 36. Dr. Sullivan testified that paying
in cash is a red flag. Tr. 214.
Although patient M.M. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 300-01; GX 35; ALJ Ex. 42, p.
35. [Dr. Sullivan testified that the red flags raised by Patient M.M.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 299-300.]
Patient N.B.
From June 2017 to August 2018, the Respondent dispensed a drug
cocktail of alprazolam and hydromorphone to N.B. on six occasions. ALJ
Ex. 42, p. 37; GX 39; Tr. 302. From September 2018 to January 2019, the
Respondent dispensed a drug cocktail of alprazolam and oxycodone to
N.B. on two occasions, and a cocktail of alprazolam and hydromorphone
on one occasion. ALJ Ex. 42, p. 38; GX 37; Tr. 305.
The Respondent provided two early fills of prescriptions for N.B.
from January to March 2019. Tr. 303-04; ALJ Ex. 42, p. 38; GX 37.
First, the Respondent dispensed oxycodone and alprazolam to N.B. on
January 16, 2019, the 27th day after dispensing a 30-day supply of each
drug on December 20, 2018 (3 days early). Id. Then, the Respondent
dispensed oxycodone to N.B. on March 13, 2019, the 19th day after
dispensing a 28-day supply on February 22, 2019 (9 days early). Id. A
pharmacist acting within the usual course of professional practice
would have either refused to fill these prescriptions until at least
the day before the prior month's supply would have run out or refused
to fill future prescriptions of the same drug for the patient. Tr. 271,
300, 304.
Patient N.B.'s home address was located about 137 miles from the
Respondent. ALJ Ex. 42, p. 36; GX 62; Tr. 301. Dr. Sullivan opined that
this distance is a red flag. Tr. 301.
From June 2017 to August 2018, the Respondent dispensed 12
prescriptions of hydromorphone to N.B. ALJ Ex. 42, p. 37; GX 39; Tr.
302. All of these 12 hydromorphone prescriptions were for 8 mg dosage
units, the highest strength of hydromorphone. Id. In addition, the
Respondent also dispended four prescriptions of alprazolam in 2 mg
dosage units, the highest strength of alprazolam. Id. Dr. Sullivan also
pointed out that on one occasion the Respondent dispensed alprazolam to
N.B. in 2 mg and 1 mg dosage units. Id. He testified that aking the
same controlled substance in two different strengths is a red flag. Id.
[Text omitted, see supra n.*J.]
Dr. Sullivan also observed a concerning two-month gap in N.B.'s
opioid prescriptions in October and November 2018. Tr. 304-05; ALJ Ex.
42, p. 38; GX 37. N.B. presented a prescription for hydromorphone in
September 2018 and then presented an oxycodone 30 mg prescription in
December 2018, but did not present any opioid prescriptions to the
Respondent in October and November. Id. Dr. Sullivan testified that not
taking opioids for two months and then starting up again on the highest
strength of oxycodone is concerning and puts the patient at heightened
risk of overdose. Tr. 297-98, 304-05. This lapse in filling opioid
prescriptions raises a red flag. Id.
In addition to these red flags, patient N.B. paid for all of her
prescriptions in cash. GX 37; GX 39. Dr. Sullivan testified that paying
in cash is a red flag. Tr. 214.
Although patient N.B. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 306-07; GX 38; ALJ Ex. 42, p.
39. [Omitted for relevance. Dr. Sullivan testified that the red flags
raised by Patient N.B.'s prescriptions were not resolvable, and that a
pharmacist operating in the usual course of professional practice would
not have filled them. Tr. 302-07.]
Patient R.B.
From June 2017 to August 2018, the Respondent dispensed a drug
cocktail of alprazolam and hydromorphone to R.B. on twelve occasions.
ALJ Ex. 42, p. 41; GX 43; Tr. 311.
The Respondent provided one early fill of hydromorphone to R.B. On
February 18, 2019, the Respondent dispensed hydromorphone to R.B. on
[[Page 64736]]
February 18, 2019, the 27th day after dispensing a 31-day supply of
hydromorphone on January 22, 2019 (4 days early). ALJ Ex. 42, p. 42; GX
40; Tr. 312.
Patient R.B.'s home address was located about 138 miles from the
Respondent. ALJ Ex. 42, p. 40; GX 63; Tr. 307. Dr. Sullivan opined that
this distance is a red flag. Tr. 307.
From June 2017 to August 2018, the Respondent dispensed 12
prescriptions of hydromorphone and 12 prescriptions of alprazolam to
R.B. ALJ Ex. 42, p. 41; GX 43; Tr. 311. All of the 12 hydromorphone
prescriptions were for 8 mg dosage units, the highest commercially
available strength of hydromorphone. Id. Eleven of the 12 alprazolam
prescriptions were for 2 mg dosage units, the highest strength of
alprazolam. Id.
As with patients M.M. and N.B., Dr. Sullivan also observed a
concerning three-month gap in R.B.'s opioid prescriptions in October,
November, and December 2018. Tr. 312; ALJ Ex. 42, p. 42; GX 40. R.B.
presented a prescription for hydromorphone in September 2018 and did
not present another hydromorphone prescription to the Respondent until
January 2019.\36\ Id. A three-month lapse in opioid treatment renders
the patient opioid na[iuml]ve and puts the patient at heightened risk
of overdose upon resumption of opioid treatment. Tr. 297-98, 304-05,
312. This lapse in filling opioid prescriptions raises a red flag. Id.
---------------------------------------------------------------------------
\36\ Patient R.B.'s PDMP report indicates that the hydromorphone
prescription he received from the Respondent in September 2018 was
for a 120-day supply. GX 40; ALJ Ex. 42, p. 42. If that were true,
the gap in opioid prescriptions from September 2018 to January 2019
would not raise any concern because the September 2018 prescription
would have lasted four months. That number, however, must have been
incorrectly reported to the PDMP. In fact, the September 2018
prescription was written for a 30-day supply, not 120-days as
reported in the PDMP. This becomes evident by comparing the PDMP
report to the actual prescription, which is one of the few hard-copy
prescriptions in evidence. The PDMP report indicates that the Rx
number for the September 2018 hydromorphone prescription (10th from
the top) is 5011489 and was issued by Dr. L. GX 40. The
corresponding prescription bearing the same Rx number on the fill
sticker is located at Government Exhibit 44, pages 6-7 (prescription
at top right corner). That prescription was written by Dr. L. for
120 tablets of hydromorphone 8 mg, to be taken one tablet every 6
hours (or 4 tablets per day). GX 44, p. 6. A 120-tablet prescription
with these instructions would last one month, not four months. Thus,
R.B.'s three month lapse in filling opioid prescriptions at the
Respondent remains a concern that the Respondent should have
addressed.
---------------------------------------------------------------------------
Dr. Sullivan also observed that R.B.'s PDMP report revealed
evidence of pharmacy shopping, which Dr. Sullivan considered
significant. Tr. 316-17. The PDMP report showed that R.B. filled
controlled substance prescriptions at five different pharmacies, to
include the Respondent. Tr. 316-17; GX 44, p. 5.
In addition to these red flags, patient R.B. paid for all of her
prescriptions that were filled by the Respondent in cash. GX 40; GX 43.
Dr. Sullivan testified that paying in cash is a red flag. Tr. 214.
Although R.B. always paid in cash at the Respondent, she used insurance
to purchase controlled substance prescriptions at other pharmacies on
three occasions. GX 44, pp. 4-5; Tr. 317-19. Dr. Sullivan noted that a
patient does not break the law by alternating between paying in cash
and using insurance. Tr. 319. It is, however, another red flag that a
pharmacist should resolve. Tr. 318-19. When a pharmacist evaluates the
red flag raised by a patient paying in cash for controlled substances,
it would be relevant to consider the fact that the patient was using
insurance to fill prescriptions at another location. Tr. 318.
Although patient R.B. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 313; GX 41; ALJ Ex. 42, p. 43.
[Dr. Sullivan testified that the red flags raised by Patient R.B.'s
prescriptions were not resolvable, and that a pharmacist operating in
the usual course of professional practice would not have filled them.
Tr. 311, 313, 321.]
Patient R.G.
From June 2017 to September 2018, the Respondent dispensed a drug
cocktail of alprazolam and oxycodone to R.G. on twelve occasions. ALJ
Ex. 42, p. 45; GX 49; Tr. 322-24.
The Respondent provided multiple early fills of prescriptions for
R.G. from February to May 2018. Tr. 326-28; ALJ Ex. 42, p. 46; GX 49.
The Respondent dispensed alprazolam and oxycodone to R.G. on February
21, 2018, the 23rd day after dispensing a 30-day supply of each drug on
January 29, 2018 (7 days early). Id. The Respondent again dispensed
alprazolam and oxycodone to R.G. on March 19, 2018, the 26th day after
dispensing a 30-day supply of each drug on February 21, 2018 (4 days
early). Id. The Respondent then dispensed alprazolam to R.G. on April
17, 2018, even though the doctor instructed that the prescription
should not be filled until April 20, 2018 (3 days early). Id. The
Respondent dispensed oxycodone to R.G. on May 8, 2018, the 21st day
after dispensing a 30-day supply of oxycodone on April 17, 2018 (9 days
early). Id. A pharmacist acting within the usual course of professional
practice would have either refused to fill these prescriptions until at
least the day before the prior month's supply would have run out or
refused to fill future prescriptions of the same drug for the patient.
Tr. 271, 300, 304, 328.
Patient R.G.'s home address was located about 131 miles from the
Respondent. ALJ Ex. 42, p. 44; GX 64; Tr. 322. Dr. Sullivan opined that
this distance is a red flag. Tr. 322.
From June 2017 to September 2018, the Respondent dispensed 17
prescriptions of oxycodone and 12 prescriptions of alprazolam to R.G.
Tr. 322-24; ALJ Ex. 42, p. 45; GX 49. All of these 29 prescriptions
were for the highest strength of the drug. Id. All of the 17 oxycodone
prescriptions were for 30 mg dosage units, the highest strength of
oxycodone. Id. All of the 12 alprazolam prescriptions were for 2 mg
dosage units, the highest strength of alprazolam. Id.
In addition to these red flags, patient R.G. paid for all of his
prescriptions in cash. GX 46; GX 49. Dr. Sullivan testified that paying
in cash is a red flag. Tr. 214.
Although patient R.G. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 328-29; GX 47; ALJ Ex. 42, p.
47. [Omitted for relevance. Dr. Sullivan testified that the red flags
raised by Patient R.G.'s prescriptions were not resolvable, and that a
pharmacist operating in the usual course of professional practice would
not have filled them. Tr. 322-23, 326, 328-29.]
Patient R.L.
From June 2017 to September 2018, the Respondent dispensed a drug
cocktail of alprazolam and hydromorphone to R.L. on one occasion. ALJ
Ex. 42, p. 49; GX 52; Tr. 331.
The Respondent provided four early fills of hydromorphone to R.L.
from February to May 2018. Tr. 333-34; ALJ Ex. 42, p. 51; GX 52. First,
the Respondent dispensed hydromorphone to R.L. on February 26, 2018,
the 25th day after dispensing a 30-day supply of hydromorphone on
February 1, 2018 (5 days early). Id. The Respondent dispensed
hydromorphone to R.L. again on March 22, 2018, the 24th day after
dispensing a 30-day supply of hydromorphone on February 26, 2018 (six
days early). Id. Then the Respondent dispensed hydromorphone to R.L. on
April 17, 2018, the 26th day after dispensing a 30-day supply of
hydromorphone on March 22, 2018 (4 days early). Id. The Respondent also
dispensed hydromorphone to R.L. on May 11, 2018, the 24th day after
[[Page 64737]]
dispensing a 30-day supply of hydromorphone on April 17, 2018 (6 days
early). Id. Filling four consecutive hydromorphone prescriptions early
is a red flag. Tr. 271, 285, 300, 334. A pharmacist acting within the
usual course of professional practice would have either refused to fill
these prescriptions until at least the day before the prior month's
supply would have run out or refused to fill future prescriptions of
the same drug for the patient. Tr. 334.
Patient R.L.'s home address was located about 138 miles from the
Respondent. ALJ Ex. 42, p. 48; GX 65; Tr. 330. Dr. Sullivan opined that
this distance is a red flag. Tr. 330.
From June 2017 to September 2018, the Respondent dispensed 14
prescriptions of hydromorphone, one prescription of oxycodone, and one
prescription of alprazolam to R.L. Tr. 331-32; ALJ Ex. 42, p. 49; GX
52. All of these 16 prescriptions were for the highest strength of the
drug. Id. All of the 14 hydromorphone prescriptions were for 8 mg
dosage units, the highest strength of hydromorphone. Id. The oxycodone
prescription was for 30 mg dosage units, the highest strength of
oxycodone. Id. The alprazolam prescription was for 2 mg dosage units,
the highest strength of alprazolam. Id. From December 2018 to April
2019, the Respondent dispensed five prescriptions of oxycodone to R.L.
in 30 mg dosage units, the highest strength of oxycodone. Tr. 331-32;
ALJ Ex. 42, p. 50; GX 50.
In addition to these red flags, patient R.L. paid for all of his
prescriptions in cash. GX 50; GX 52. Dr. Sullivan testified that paying
in cash is a red flag. Tr. 214.
Although patient R.L. presented prescriptions to the Respondent
that raised multiple red flags of drug abuse and/or diversion, the
Respondent filled each prescription. Tr. 334-36; GX 51; ALJ Ex. 42, p.
52. [Omitted for relevance. Dr. Sullivan testified that the red flags
raised by Patient R.L.'s prescriptions were not resolvable, and that a
pharmacist operating in the usual course of professional practice would
not have filled them. Tr. 332, 335-36.]
Analysis of Dispensing Evidence for All Eleven Patients
[Analysis omitted for brevity and relevance.] *K \37\
\38\ \39\ \40\ \41\ \42\ \43\
---------------------------------------------------------------------------
*K I disagree with the ALJ's decision not to credit
Dr. Sullivan's testimony that the red flags in this case could not
have been resolved by a pharmacist operating in the usual course of
professional practice. Because the ALJ did not credit this
testimony, his analysis centered on whether Respondent had
adequately resolved the red flags with each prescription and whether
Respondent had adequately documented the resolution of red flags.
RD, at 90-100. The ALJ concluded that he was unable to determine
that Respondent had violated its corresponding responsibility for
the majority of the prescriptions, because Dr. Sullivan testified
that red flags may be resolved in the patient profile or on the face
of the prescription, and the Government did not admit copies of the
majority of the prescriptions into evidence. Id. Instead, the ALJ
found that Respondent had violated Florida law--which the ALJ
interpreted as requiring pharmacists to resolve red flags in the
patient profile--and therefore, that Respondent had dispensed
controlled substances outside the usual course of professional
practice, in violation of 21 CFR 1306.06. In its Exceptions,
Respondent argued that the ALJ's interpretation of Florida law was
incorrect, because it does not require pharmacists to document the
resolution of red flags. Resp Exceptions, at 8-17.
As discussed in more detail above, it is not necessary for me to
resolve this conflict. Because Dr. Sullivan offered credible and
unrebutted expert testimony that the prescriptions in this case
presented unresolvable red flags of drug abuse and diversion, and
that these prescriptions would not have been filled by a pharmacist
acting within the usual course of professional practice, I have
concluded that Respondent violated Florida and federal law. Thus, I
need not determine whether Respondent made adequate attempts under
Florida law to resolve red flags and document their resolution.
Therefore, I have omitted the RD's discussion of Florida and federal
law requirements for documenting the resolution of red flags. I have
also omitted the RD's discussion of whether Respondent adequately
documented the resolution of red flags in this case.
This section also included a discussion of Florida requirements
for conducting a drug utilization review of each controlled
substance prescription. This discussion has been incorporated into
the section below summarizing the evidence under Factors Two and
Four of the public interest analysis.
\37\ [Text omitted where footnote was included.]
\38\ [Text omitted where footnote was included.]
\39\ [Text omitted where footnote was included.]
\40\ [Text omitted where footnote was included.]
\41\ [Text omitted where footnote was included.]
\42\ [Text omitted where footnote was included.]
\43\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------
[As discussed in more detail infra, the Government's evidence
showed that Respondent repeatedly filled controlled substances
prescriptions for eleven patients that raised numerous red flags of
drug abuse and diversion. These red flags included early fills, long
distances traveled, cash payments, dangerous drug cocktails, and high-
strength narcotics. Dr. Sullivan offered credible and unrebutted expert
testimony that, for each of these customers, these red flags could not
have been resolved by a reasonable pharmacist acting within the usual
course of his professional practice. Thus, by filling these
prescriptions, Respondent violated its corresponding responsibility and
filled prescriptions outside the usual course of professional practice,
in violation of 21 CFR 1306.04 and 1306.06. Respondent also violated
Florida law, which requires pharmacists to ``exercise[ ] sound
professional judgment,'' to conduct a prospective drug use review
before dispensing a controlled substance, and to take appropriate steps
to avoid or resolve problems with the prescriptions. Fla. Admin. Code
rs. 64B16-27.831, 64B16-27.810.]
Analysis of Unlawful Manufacturing Allegation
Finally, the Government alleges that the Respondent engaged in
``manufacturing'' controlled substances, as that term is defined in the
CSA, without a separate DEA registration authorizing the manufacture of
controlled substances, in violation of 21 U.S.C. 841(a)(1) and 21 CFR
1301.13(e). ALJ Ex. 1, ] 20-28. Specifically, the Government alleges
that the Respondent compounded oxycodone and hydromorphone capsules in
such large quantities that this activity constituted manufacturing
rather than permissible compounding for individual patients. Id.
DEA regulations require registrants to obtain a separate
registration for each regulated business activity in which they engage.
21 CFR 1301.13(e). Section 1301.13(e) provides ten separate business
activities, to include manufacturing and dispensing.\44\ Id. at
(e)(1)(i), (iv). Each business activity is ``deemed to be independent
of each other.'' 21 U.S.C. 1301.13(e). In other words, a registration
for one activity does not authorize the registrant to engage in another
activity. Id. To engage in both dispensing and manufacturing, a
registrant would need to apply for and obtain separate registrations
for each activity. No person or entity may engage in a regulated
business activity ``until the application for registration is granted
and a Certificate of Registration is issued by the Administrator to
such person [or entity].'' 21 CFR 1301.13(a).
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\44\ Although not relevant to this case, the other business
activities include distributing, reverse distributing, research
(Schedule I), research (Schedules II-V), narcotic treatment
programs, importing, exporting, and chemical analysis. 21 U.S.C.
1301.13(e)(1).
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Requiring separate registrations for manufacturing and dispensing
is more than mere formality. In fact, the CSA imposes stricter
requirements on manufacturers than dispensers, not to mention a
different standard for issuing a sanction. Wedgewood Village Pharm., 71
FR 16,593, 16,594 (2006); compare 21 U.S.C. 823(a) (setting forth six
public interest factors for manufacturers of Schedule I and II
controlled substances), with 21 U.S.C. 823(f) (establishing five
similar, yet different, public interest factors for practitioners,
which includes pharmacies engaged in dispensing). Additionally, the CSA
imposes higher
[[Page 64738]]
standards for recordkeeping, reporting, and security on manufacturing
than it does on dispensing. 71 FR 16,594. Manufacturers are also
required to obtain a registration annually, whereas dispensers are only
required to obtain a registration every three years. Id. (citing 21
U.S.C. 822(a)(1)-(2)).
The Respondent is registered with the DEA as a ``retail pharmacy.''
GX 1. Pursuant to this registration, the Respondent may dispense
controlled substances in Schedules II-V. Id.; 21 CFR 1301.13(e)(1)(iv).
The Respondent's registration as a retail pharmacy authorizing it to
engage in the regulated activity of dispensing does not permit the
Respondent to manufacture controlled substances; thus, any
manufacturing it performed would be unlawful. To prevail on its claim
that the Respondent manufactured controlled substances, the Government
must show by a preponderance of the evidence that the Respondent
engaged in an activity that met the CSA's definition of
``manufacturing.''
Although the CSA does not define what the term ``to compound''
means, it does define ``manufacture.'' *L Wedgewood Village
Pharm. v. DEA, 509 F.3d 541, 543 (D.C. Cir. 2007) (noting the CSA does
not define ``compounding''). ``The term `manufacture' means the
production, preparation, propagation, compounding, or processing of a
drug or other substance, either directly or indirectly or by extraction
from substances of natural origin, or independently by means of
chemical synthesis or by a combination of extraction and chemical
synthesis, and includes any packaging or repackaging of such substance
or labeling or relabeling of its container.'' 21 U.S.C. 802(15)
(emphasis added). Importantly, the CSA includes compounding in its
definition of manufacturing. Id. Not all compounding, however, is
considered to be manufacturing. The definition of manufacturing ``does
not include the preparation, compounding, packaging, or labeling of a
drug or other substance in conformity with applicable State or local
law by a practitioner as an incident to his administration or
dispensing of such drug or substance in the course of his professional
practice.'' Id. [Omitted.] \45\ \46\
---------------------------------------------------------------------------
*\L\ Respondent argues in its Exceptions that it was permitted
to compound under the definition of ``dispense'' in the CSA. Resp
Exceptions, at 17-22. However, as the ALJ stated,
[u]nder the CSA, ``dispense'' means ``to deliver a controlled
substance to an ultimate user or research subject by, or pursuant to
the lawful order of, a practitioner, including the prescribing and
administering of a controlled substance and the packaging, labeling
or compounding necessary to prepare the substance for such
delivery.'' 21 U.S.C. 802(10) (emphases added).
RD, at 105. Respondent has not demonstrated that there was a
lawful order of a practitioner to prepare the substance for such
delivery to fall under the definition of ``dispense.''
\45\ [Text omitted where footnote was included.]
\46\ [Text omitted where footnote was included.]
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*\M\ The thrust of the Respondent's argument is that because the
CSA does not define compounding, the appropriate question is whether
the Respondent complied with Florida law and other federal laws. Resp't
PHB, at 37-38. The Respondent argues that it engaged in anticipatory
compounding (i.e., compounding before receiving a prescription), which
is permissible under Florida law and the Food, Drug, and Cosmetic Act
(hereinafter, FDCA).*\N\ Id. at 37-41. Florida law provides that lawful
compounding includes ``[t]he preparation of drugs or devices in
anticipation of prescriptions based on routine, regularly observed
prescribing patterns.'' Fla. Admin. Code r. 64B16-27.700(1)(a).*\O\
[However, as explained herein, the facts on the record do not support a
finding that Respondent was compounding in this manner, nor do they
support a finding that Respondent was compounding within the usual
course of the professional practice of pharmacy in order to meet the
CSA's manufacturing exemption.] [Text omitted.] \47\
---------------------------------------------------------------------------
*\M\ RD's discussion was relocated.
*\N\ The RD contained an analysis of the FDCA requirements in
rebuttal of Respondent's assertion, but declined to make a finding
as to whether Respondent was in compliance. RD, at 107-09. As the RD
noted, the FDCA does not have a direct impact on DEA's
interpretation of the CSA manufacturing provision. Id.
*\O\ Even if Florida law were controlling in this case, there is
no evidence that Respondent's compounding was permissible under
Florida law. Although Florida Law permits what the Respondent
describes as ``anticipatory compounding,'' there are plain language
restrictions in the regulation that require the preparation to be in
anticipation of prescriptions. As described herein, the facts of
this case contradict the Respondent's claim that its compounding was
in compliance with this law. Respondent also cited to Fla. Admin.
Code r. 64B16-27.700(1)(c) that permits ``the preparation of
commercially available products from bulk when the prescribing
practitioner has prescribed the compounded product on a per
prescription basis,'' but the evidence shows that Respondent
typically contacted the physicians for permission to substitute
compounded capsules when the prescriptions were written for tablets.
The Respondent has presented no evidence or argument to support that
physicians were specifically prescribing the compounded product,
which appears to be what is required by this section of Florida
code. Furthermore, there is no evidence that this section, or the
other section of the Florida code, permits the Respondent to
compound without an individualized patient need in accordance with
the usual course of professional practice.
\47\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------
*\P\ The clearest evidence that the Respondent manufactured, rather
than compounded for individual patients, comes from the closing
inventory conducted by DI Albert and Mr. Clement, Sr., in September
2018. Tr. 52, 54, 56, 165-66; GX 7. The closing inventory documented
the number of controlled substances the Respondent had on hand at the
time. Id. DI Albert observed Mr. Clement, Sr., conduct the inventory
and Mr. Clement, Sr., signed off on it. Tr. 56, 166.
---------------------------------------------------------------------------
*\P\ RD's discussion was relocated.
---------------------------------------------------------------------------
The closing inventory shows that on September 10, 2018, the
Respondent had 3,546 compounded capsules of hydromorphone 8 mg on hand
and 574 compounded capsules of oxycodone 30 mg on hand. GX 7, p. 1.
These capsules were sitting in a safe when they were counted. Tr. 56.
Several thousand capsules sitting in a safe is not consistent with
compounding for an individual patient's therapeutic needs as an
incident to dispensing [nor is it consistent with anticipated
prescriptions based on routine prescribing patterns as described in
Florida law]. It is consistent with manufacturing capsules in bulk and
storing them until a prescription is presented.
The Respondent argues that no evidence of record proves that it
``produced significantly large quantities of any drug.'' Resp't PHB, at
41. Whether the 4,120 capsules stored in the Respondent's safe on
September 10, 2018, constitutes a ``significantly large'' quantity is
beside the point. Whether the Respondent produced a large or small
amount of compounded capsules, however, is relative, and my finding on
this allegation has nothing to do with the amount of capsules produced.
[Omitted.] \48\
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\48\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------
This is especially true when the Respondent typically filled only
two to four prescriptions per day. Tr. 508. The rough math shows that
four thousand compounded capsules could be enough for two weeks of
dispensing. Considering that a month's supply of oxycodone would be
roughly 112 tablets (GX 18, p. 6) and a month's supply of hydromorphone
would be roughly 120 tablets (GX 44, p. 6), the Respondent had enough
oxycodone capsules on hand to fill approximately 5 prescriptions and
enough hydromorphone capsules on hand to fill about 29 prescriptions.
Together, this would approximate the number of prescriptions the
Respondent typically saw over the course of two weeks. This lends
further support to my conclusion that the amount of compounded capsules
the Respondent had on hand on September 10, 2018, is [more
[[Page 64739]]
consistent with manufacturing than dispensing compounding within the
scope of the CSA.]
In addition to the closing inventory, the Government also points to
statements made by Mr. Clement, Sr., in 2012. Gov't PHB, at 46. In May
2012, during execution of an administrative inspection warrant (AIW) at
the Respondent pharmacy, TFO Shearer interviewed Mr. Clement, Sr., the
Respondent's owner. Tr. 183. Mr. Clement, Sr., was not in custody at
the time and was free to leave. Id. In the interview, Mr. Clement, Sr.,
told TFO Shearer about his process for manufacturing oxycodone and
hydromorphone in capsules. Tr. 183-84. Mr. Clement, Sr., told TFO
Shearer that he could buy a 100 gram bottle of oxycodone powder for
$1,100, enough to manufacture about 6,000 dosage units. Tr. 185.
Tablets of oxycodone purchased from commercial distributors cost
roughly $2-$10 per pill. Id. In other words, $1,100 worth of powder
could produce at least $12,000 worth of dosage units. Mr. Clement, Sr.,
told TFO Shearer that he manufactured thousands of capsules per batch
because it was cost effective. Tr. 184-85. The batch records that TFO
Shearer reviewed in 2012 documented that Mr. Clement, Sr., produced
thousands of pills in each batch. Id. Mr. Clement, Sr., also told TFO
Shearer that he persuaded patients to take capsules even if they did
not want them because capsules have the same effect as tablets.\49\ Tr.
185-86.
---------------------------------------------------------------------------
\49\ While reliable hearsay statements may be admissible in
these administrative proceedings, Mr. Clement, Sr.'s, statements to
TFO Shearer in 2012 are not hearsay. They enjoy enhanced credibility
as they would qualify as statements by a party opponent and would,
therefore, be excluded from the definition of hearsay. Fed. R. Evid.
801(d)(2). [Respondent argues that this conversation was six or
seven years ago and to rely on it would be arbitrary and capricious.
Resp't Exceptions, at 3. This conversation lends further support for
a finding that has other support in the record. Also, I note that
Respondent did not refute this evidence through the testimony of Mr.
Clement, Sr.]
---------------------------------------------------------------------------
Although these statements were made in 2012, they demonstrate that
the Respondent had a system in place to compound thousands of capsules
at a time. Tr. 184-85. These statements also demonstrate that the
Respondent's motive for mass-compounding thousands of capsules per
batch was cost effectiveness, rather than patients' unique therapeutic
needs. Tr. 184-86. These statements provide additional support to the
conclusion that the Respondent's compounding was cost-driven rather
than patient-driven, and that the Respondent was, therefore,
manufacturing and not compounding as the CSA understands those terms.
The Government also points to the batch records obtained pursuant
to the 2017 subpoena. Gov't PHB, at 46; Tr. 27. A batch record
documents the production of a controlled substance and lists the
ingredients in the controlled substance. Tr. 33. The batch record is
created by the person who makes the substance. Id. The batch records
indicate how many capsules were used in the production of each batch.
Tr. 38, 40-41. The batch records in Government Exhibit 5 document the
production of hydromorphone 8 mg. The batch records in Government
Exhibit 6 document the production of oxycodone 30 mg. The hydromorphone
batch records show that the Respondent ``compounded'' from 600 to 2,400
capsules per batch, with 1,200 capsules being the most frequently
occurring quantity. See generally GX 5. The oxycodone batch records
show that the Respondent ``compounded'' from 600 to 1,800 capsules per
batch, with 1,200 capsules being the most frequently occurring
quantity. See generally GX 6. These numbers are consistent with the
number of compounded capsules found during the 2018 closing inventory
and with Mr. Clement, Sr.'s, statements to TFO Shearer in 2012. [When
viewed with the other facts,] these numbers are also consistent with
manufacturing rather than [dispensing] compounding.
Furthermore, the Respondent's dispensing records also demonstrate
that the patients for whom the Respondent compounded oxycodone and
hydromorphone did not have valid therapeutic needs for compounded
medication. Dr. Sullivan explained that the definition of compounding
in the practice of pharmacy is to ``make[ ] a drug . . . from scratch,
make it in a finished form from an unfinished form, to meet the
individual, unique therapeutic needs of a patient.'' Tr. 230.
Compounding would be necessary, he continued, if the patient had an
allergy to the commercially available version or if the patient needed
a unique dose or strength that was not available in the mass-produced
product. Tr. 230-31. [Omitted. Dr. Sullivan also testified that the
dosage units dispensed in GE-11, at 7, demonstrated that 90,179 dosage
units of the compounded 8 milligram hydromorphone capsules. Tr. 248. He
testified that ``[t]here cannot be that many patients that need to have
compounded hydromorphone 8 milligram tablets to meet the unique
therapeutic needs of the patient. In [his] opinion, that's
manufacturing.'' Tr. 249; see also Tr. 250 (same for oxycodone).]
Dispensing records, however, show that the Respondent dispensed
both commercially manufactured tablets and compounded capsules to the
same patient. The fact that the Respondent dispensed both commercially
available tablets and compounded capsules of the same controlled
substances to the same patients indicates that the patients lacked
``unique therapeutic needs'' for the compounded version. Tr. 231, 256.
For example, the Respondent dispensed seven prescriptions of oxycodone
30 mg tablets to patient A.G. from June 2017 to August 2018. ALJ Ex.
42, p. 11. During that same time period, the Respondent also dispensed
to A.G. three prescriptions of oxycodone 30 mg compounded capsules. Id.
A note dated March 13, 2017, in A.G.'s profile states that a doctor
approved dispensing medication to A.G. in compounded capsules. GX 15,
p. 1; ALJ Ex. 42, p. 13. After March 2017, however, the Respondent
continued dispensing both tablets and compounded capsules to A.G. ALJ
Ex. 42, p. 11. Thus, even if a doctor approved of A.G. taking
compounded capsules, it was not for a therapeutic or medical reason
because he continued to alternate between capsules and tablets. [Dr.
Sullivan testified that nothing in the record demonstrated that there
was a therapeutic need for the compounded medication. Tr. 258-59].
In another example, the Respondent dispensed both tablets and
compounded capsules to patient R.G. to fill the same oxycodone
prescription. GX 49; Tr. 325-26. Dr. Sullivan opined that R.G. clearly
had no valid therapeutic need for compounded capsules since he also
took the tablet form of the same drug. Tr. 326. Patient R.G. also
received oxycodone in capsules on 15 occasions from June 2017 to
September 2018, and in tablets on 2 occasions during the same time
period. ALJ Ex. 42, p. 45. As Dr. Sullivan observed, the fact that the
Respondent dispensed oxycodone to R.G. in both capsule and tablet
forms, and dispensed capsules and tablets together on one occasion,
demonstrates that the Respondent was not compounding for R.G. in
response to a unique therapeutic need for compounded capsules. Tr. 325-
26. Furthermore, no profile for any of the patients documents an
allergy or other reason that would have necessitated compounded
capsules. Tr. 339; GX 15, 20, 23, 26, 29, 32, 35, 38, 41, 47, 51.
Dr. Sullivan pointed out numerous other instances where the
Respondent's dispensing history demonstrated that patients lacked
legitimate therapeutic justification for compounded capsules. From
January 2018 to December 2018, the Respondent dispensed compounded
capsules of hydromorphone 8 mg to A.H. on eight occasions: January 4;
[[Page 64740]]
February 15; March 5; April 3; May 2; August 16; September 11; and
December 5. ALJ Ex. 42, pp. 15-16; GX 19; GX 21. The Respondent then
dispensed tablets of hydromorphone 8 mg to A.H. on the following five
occasions in 2019: January 22; February 15; February 27; March 14; and
April 18. Id. The fact that the Respondent dispensed capsules of
hydromorphone to A.H. on eight occasions in 2018 and then tablets of
hydromorphone on five occasions in 2019 demonstrates that A.H. had no
unique therapeutic justification that required the Respondent to
compound hydromorphone capsules for him. Tr. 255-56, 258-59, 269.
Dr. Sullivan noted a lack of therapeutic justification to compound
hydromorphone for B.S. since he received hydromorphone in both tablets
and capsules. Tr. 274. From August 2017 to August 2018, the Respondent
filled 12 hydromorphone prescriptions with compounded capsules for
B.S.: August 22, 2017; September 27, 2017; October 18, 2017; November
15, 2017; December 12, 2017; January 4, 2018; January 29, 2018;
February 28, 2018; March 26, 2018; April 23, 2018; May 22, 2018; and
August 24, 2018. ALJ Ex. 42, p. 19; GX 24. On February 5, 2019, the
Respondent filled a hydromorphone prescription for B.S. with tablets.
ALJ Ex. 42, p. 20; GX 22. The fact that the Respondent dispensed
hydromorphone tablets to B.S. in 2019 shows that B.S. had no unique
therapeutic justification that required the Respondent to compound
hydromorphone capsules for him on 12 occasions in 2017 and 2018. Tr.
255-56, 258-59, 269, 274.
The Respondent dispensed oxycodone capsules and tablets to C.R.,
indicating that there was no valid therapeutic reason for the
Respondent to compound oxycodone capsules for her. Tr. 255-56, 258-59,
269, 274, 279-80. On July 19, 2017, and October 26, 2017, the
Respondent filled oxycodone prescriptions for C.R. with compounded
capsules. ALJ Ex. 42, p. 23; GX 27. The Respondent then filled four
oxycodone prescriptions for C.R. with tablets: March 6, 2018; April 19,
2018; July 12, 2018; and August 28, 2018. Id.
Dr. Sullivan observed that J.M. alternated between tablets and
capsules of oxycodone, demonstrating that there was no valid
therapeutic need for the Respondent to compound oxycodone capsules for
her. Tr. 290. First, the Respondent dispensed oxycodone tablets to J.M.
on January 25, 2018, and then filled J.M.'s next oxycodone prescription
with compounded capsules on March 1, 2018. ALJ Ex. 42, p. 30; GX 33;
Tr. 290. The next month the Respondent switched back to oxycodone
tablets on April 4, 2018, followed by oxycodone capsules on April 19,
2018, and then switched back again to tablets on May 16, 2018. Id. The
fact that the Respondent alternated between dispensing oxycodone
tablets and capsules to J.M. demonstrates that there was no valid
therapeutic reason for the Respondent to compound oxycodone capsules
for her. Tr. 255-56, 258-59, 269, 274, 279-80, 290.
Dr. Sullivan observed that the Respondent dispensed oxycodone
tablets and compounded capsules to M.M. Tr. 295, 297. From June 2017 to
August 2018, the Respondent filled 14 oxycodone prescriptions for M.M.
with compounded capsules. Tr. 295, 297; ALJ Ex. 42, pp. 33-34; GX 34;
GX 36. From January 2019 to April 2019, the Respondent filled five
oxycodone prescriptions for M.M. with tablets. Id. The fact that the
Respondent dispensed compounded oxycodone capsules to M.M. for over a
year and then switched to dispensing oxycodone tablets to her for
several months demonstrates that there was no valid medical reason for
the Respondent to have compounded oxycodone for her. Tr. 255-56, 258-
59, 269, 274, 279-80, 290, 295, 297.
Dr. Sullivan observed that the Respondent compounded hydromorphone
capsules for N.B. without any apparent therapeutic justification. Tr.
302. From June 2017 to August 2018, the Respondent filled twelve
hydromorphone prescriptions for N.B. with compounded capsules. ALJ Ex.
42, p. 37; GX 39.
Dr. Sullivan pointed out that the Respondent compounded
hydromorphone capsules for R.B. without any apparent medical
justification. Tr. 311, 319-20. From June 2017 to January 2019, the
Respondent filled 14 hydromorphone prescriptions for R.B. with
compounded capsules. GX 40; GX 43; ALJ Ex. 42, pp. 41-42. At least
three of those prescriptions were originally written for tablets and
were substituted for capsules by the Respondent. Tr. 319-20; GX 44, pp.
6-7. The Respondent then dispensed hydromorphone tablets to R.B. on
three occasions from February to April 2019. ALJ Ex. 42, p. 42; GX 40.
The fact that the Respondent dispensed tablets and capsules of
hydromorphone to R.B., switching prescribed tablets to capsules,
demonstrates that there was no valid therapeutic reason for the
Respondent to compound hydromorphone for R.B. Tr. 311, 319-21.
Lastly, Dr. Sullivan noted that the Respondent compounded capsules
of hydromorphone for R.L. without any apparent medical justification.
Tr. 331; ALJ Ex. 42, p. 49; GX 52. From June 2017 to September 2018,
the Respondent filled 14 hydromorphone prescriptions for R.L. with
compounded capsules. Id.
[Contrary to the Respondent's contention, due to the credible and
unrebutted testimony of the Government's expert witness, Respondent's
compounding cannot fall into the CSA's exception to the definition of
manufacturing ``in conformity with applicable State or local law by a
practitioner as an incident to his administration or dispensing of such
drug or substance in the course of his professional practice.''
*Q 21 U.S.C. 802(15). Dr. Sullivan's testimony was clear
that the compounding here was outside the course of professional
practice, because there was no individualized therapeutic need for the
compounded capsules, as evidenced by the quantities dispensed and the
alternating of compounded capsules and commercially available product
and the lack of documentation or other support demonstrating any
individualized need. Further, as described above, Respondent's reliance
on Florida law is unavailing for many
[[Page 64741]]
reasons. Although Florida law permits compounding based on routine,
regularly observed prescribing patterns, there is nothing in Florida
law to suggest that this anticipation would negate the professional
practice of pharmacy requirement for there to be individualized
therapeutic need, which the record has repeatedly demonstrated was
lacking with regard to these compounded capsules.*R See Fla.
Admin. Code r. 64B16-27.700(1)(a).]
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*Q In finding that Respondent engaged in
manufacturing, the ALJ relied primarily on a statutory
interpretation of ``incident to'' and determined that the
compounding in this case would not be considered ``incident to'' the
dispensing. RD, at 103-06. I find that it is unnecessary to rely on
a statutory interpretation of ``incident to'' in this case, because
the evidence on the record clearly establishes that this compounding
was not in the course of professional practice, which the statute
states plainly is required for the exception to the manufacturing
definition to apply. In analyzing this issue, the ALJ discussed the
Agency's decision in Wedgewood, which clarifies that to use a
dispensing registration for compounding the important consideration
is that the compounding is ``for a specific patient on a patient by
patient basis.'' Id. (citing Wedgewood Village Pharm., 71 FR 16,593,
16,595 (2006)). It is noted that Wedgewood was appealed and
remanded, based primarily on the Agency's interpretation of
distribution--not manufacturing, Wedgewood Village Pharmacy v. DEA,
509 F.3d 541, 550-52 (D.C. Cir. 2007) and therefore, that the
Agency's interpretation in Wedgewood regarding what constitutes
manufacturing remains intact; however, I also find it unnecessary to
rely on prior Agency interpretation in this case, because, again,
the statute is clear regarding the requirement that such compounding
must be in the course of professional practice. My conclusions rely
on Dr. Sullivan's testimony that patients must have a specific need
for compounded capsules and other support in the record that the
usual course of professional practice requires such a need. As
discussed in more detail herein, the record does not demonstrate
that Respondent's customers had individualized needs. The RD also
provided examples where courts, including the Supreme Court, have
defined the term ``compounding'' to require individualized patient
need. RD, at 105, n.45, and 116. Although not in the context of the
CSA, these interpretations further support Dr. Sullivan's credible
and unrebutted testimony regarding the course of the professional
practice and the lack of individualized need for compounded capsules
in this case.
*R Although stated in a different context, there is
further support for this finding in Department of Health, Petitioner
v. Discovery Experimental and Development, Inc., Respondent
Discovery Experimental and Development, Inc., Petitioner, 2003 WL
1921003 (April 18, 2003), where a Florida Administrative Law Judge
stated that Fla. Admin. Code r. 64B16-27.700 ``requires patient
specific compounding of medicinal drugs, on a per prescription basis
where there is an established patient-physician relationship, and
the patient has been made aware that a pharmacist will prepare the
compounded drug.'' Id. at n.14). Although the portion of the Florida
regulation cited to by Respondent would permit advance preparation
of compounded drugs under state law, there is no evidence that
Florida intended it to permit a pharmacy to compound drugs without a
specific therapeutic need. In fact, the Government's expert opined
that such compounding is not within the course of professional
practice of pharmacy, and in his opinion, constitutes manufacturing.
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In sum, the evidence paints a picture of a pharmacy mass-
compounding bulk quantities of oxycodone and hydromorphone in thousands
of capsules per batch. The evidence further reveals the Respondent's
motive for doing so: Profit rather than patient need. The evidence
shows that the Respondent's ``compounding'' was not incidental to the
act of dispensing and was not in the course of its professional
practice. [Omitted]. Thus, the Respondent engaged in manufacturing
thousands of controlled substance dosages over a period of several
years without the proper registration. For these reasons, the
Government's allegation that the Respondent illegally manufactured
controlled substances is SUSTAINED. ALJ Ex. 1, pp. 8-10, ] 20-28.
[Although I find that this constitutes a separate violation of federal
law, which I consider under Factor Four below, I also find that there
is more than enough evidence of other violations in this case to
support a sanction of revocation, even if I had not sustained this
allegation.]
Government's Burden of Proof and Establishment of a Prima Facie Case
[In order to make a prima facie case that a ground for revocation
of Respondent's registration exists, the Government must demonstrate
that Respondent's continued registration is inconsistent with the
public interest]. [Text omitted for clarity.].
Public Interest Determination: The Standard
Pursuant to 21 U.S.C. 823(a)(4) (2006 & Supp. III 2010), the
Administrator \50\ may revoke a DEA Certificate of Registration if the
Registrant has committed such acts as would render its registration
inconsistent with the public interest. Evaluation of the following
factors have been mandated by Congress in determining whether
maintaining such registration would be inconsistent with ``the public
interest'':
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\50\ This authority has been delegated pursuant to 28 CFR
0.100(b) and 0.104 (2008).
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(3) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
``These factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Any one or a combination
of factors may be relied upon, and when exercising authority as an
impartial adjudicator, the Agency may properly give each factor
whatever weight it deems appropriate in determining whether a
registrant's registration should be revoked. Id. (citation omitted);
David H. Gillis, M.D., 58 FR 37,507, 37,508 (1993); see also Morall v.
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005); Henry J. Schwarz, Jr.,
M.D., 54 FR 16,422, 16,424 (1989). Moreover, the Agency is ``not
required to make findings as to all of the factors,'' Hoxie v. DEA, 419
F.3d 477, 482 (6th Cir. 2005); see also Morall, 412 F.3d at 173, and is
not required to discuss consideration of each factor in equal detail,
or even every factor in any given level of detail. Trawick v. DEA, 861
F.2d 72, 76 (4th Cir. 1988) (holding that the Administrator's
obligation to explain the decision rationale may be satisfied even if
only minimal consideration is given to the relevant factors, and that
remand is required only when it is unclear whether the relevant factors
were considered at all). The balancing of the public interest factors
``is not a contest in which score is kept; the Agency is not required
to mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest.'' Jayam Krishna-Iyer,
M.D., 74 FR 459, 462 (2009).
Factors Two and Four: Experience in Dispensing, and Compliance With
Applicable State, Federal, or Local Laws Relating to Controlled
Substances
The Government seeks the revocation of the Respondent's COR based
primarily on conduct most appropriately considered under Public
Interest Factors Two and Four.\51\ The Government has also raised one
allegation under Factor Five.
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\51\ 21 U.S.C. 823(f)(2), (4). There is nothing in the record to
suggest that a state licensing board made any recommendation
regarding the disposition of the Respondent's DEA COR (Factor One).
Likewise, the record contains no evidence that the Respondent has
been convicted of (or charged with) a crime related to controlled
substances (Factor Three).
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[Factors Two and Four are often analyzed together. See, e.g., Fred
Samimi, M.D., 79 FR 18,698, 18,709 (2014); John V. Scalera, M.D., 78 FR
12,092, 12,098 (2013). Under Factor Two, the DEA analyzes a
registrant's ``experience in dispensing . . . controlled substances.''
21 U.S.C. 823(f)(2). Factor Two analysis focuses on an applicant's acts
that are inconsistent with the public interest, rather than on an
applicant's neutral or positive acts and experience. Randall L. Wolff,
M.D., 77 FR 5106, 5121 n.25 (2012) (explaining that ``every registrant
can undoubtedly point to an extensive body of legitimate prescribing
over the course of [the registrant's] professional career'') (quoting
Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009)). Similarly, under
Factor Four, the DEA analyzes an applicant's compliance with federal
and state controlled substance laws. 21 U.S.C. 823(f)(4). Factor Four
analysis focuses on violations of state and federal laws and
regulations. Volkman v. DEA, 567 F.3d 215, 223-24 (6th Cir. 2009)
(citing Gonzales v. Oregon, 546 U.S. 243, 272, 274 (2006)); see Joseph
Gaudio, M.D., 74 FR 10,083, 10,090-91 (2009).] *S 52
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*S For brevity and keeping with recent cases, I have
removed the RD's legal analysis of Factors Two and Four and replaced
it with this text.
\52\ [Text omitted where footnote was included.]
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Standard of Care as to Charged Violations *T
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*T This section was modified to clarify the analysis
of a pharmacist's corresponding responsibility under 21 CFR
1306.04(a).
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[According to the CSA's implementing regulations, ``[a]
prescription for a controlled substance may only be filled by a
pharmacist, acting in the usual course of his professional practice.''
21 CFR 1306.06.
[[Page 64742]]
Further, a controlled substance prescription must be ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). While
the ``responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner . . . a
corresponding responsibility rests with the pharmacist who fills the
prescription.'' Id. The regulations establish the parameters of the
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pharmacy's corresponding responsibility.
An order purporting to be a prescription issued not in the usual
course of professional treatment . . . is not a prescription within
the meaning and intent of . . . 21 U.S.C. 829 . . . and the person
knowingly filling such a purported prescription, as well as the
person issuing it, shall be subject to the penalties provided for
violations of the provisions of law relating to controlled
substances.
Id. ``The language in 21 CFR 1306.04 and caselaw could not be more
explicit. A pharmacist has his own responsibility to ensure that
controlled substances are not dispensed for non-medical reasons.''
Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730
(1990) (citing United States v. Hayes, 595 F.2d 258 (5th Cir. 1979),
cert. denied, 444 U.S. 866 (1979); United States v. Henry, 727 F.2d
1373 (5th Cir. 1984) (reversed on other grounds)). As the Supreme Court
explained in the context of the CSA's requirement that schedule II
controlled substances may be dispensed only by written prescription,
``the prescription requirement . . . ensures patients use controlled
substances under the supervision of a doctor so as to prevent addiction
and recreational abuse . . . [and] also bars doctors from peddling to
patients who crave the drugs for those prohibited uses.'' Gonzales v.
Oregon, 546 U.S. 243, 274 (2006).
To prove a pharmacist violated his or her corresponding
responsibility, the Government must show that the pharmacist acted with
the requisite degree of scienter. See 21 CFR 1306.04(a) (``[T]he person
knowingly filling [a prescription issued not in the usual course of
professional treatment] . . . shall be subject to the penalties
provided for violations of the provisions of law relating to controlled
substances.'') (emphasis added). DEA has also consistently interpreted
the corresponding responsibility regulation such that ``[w]hen
prescriptions are clearly not issued for legitimate medical purposes, a
pharmacist may not intentionally close his eyes and thereby avoid
[actual] knowledge of the real purpose of the prescription.''
Bertolino, 55 FR 4730 (citations omitted); see also JM Pharmacy Group,
Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR 28,667,
28,670-72 (2015) (applying the standard of willful blindness in
assessing whether a pharmacist acted with the requisite scienter).
Pursuant to their corresponding responsibility, pharmacists must
exercise ``common sense and professional judgment'' when filling a
prescription issued by a physician. Bertolino, 55 FR 4730. When a
pharmacist's suspicions are aroused by a red flag, the pharmacist must
question the prescription and, if unable to resolve the red flag,
refuse to fill the prescription. Id.; Medicine Shoppe-Jonesborough, 300
F. App'x 409, 412 (6th Cir. 2008) (``When pharmacists' suspicions are
aroused as reasonable professionals, they must at least verify the
prescription's propriety, and if not satisfied by the answer they must
refuse to dispense.'').
Finally, ``[t]he corresponding responsibility to ensure the
dispensing of valid prescriptions extends to the pharmacy itself.''
Holiday CVS, 77 FR 62,341 (citing Med. Shoppe--Jonesborough, 73 FR 384;
United Prescription Servs., Inc., 72 FR 50,397, 50,407-08 (2007); EZRX,
L.L.C., 69 FR 63,178, 63,181 (2004); Role of Authorized Agents in
Communicating Controlled Substance Prescriptions to Pharmacies, 75 FR
61,613, 61,617 (2010); Issuance of Multiple Prescriptions for Schedule
II Controlled Substances, 72 FR 64,921, 64,924 (2007) (other citations
omitted)). The DEA has consistently held that the registration of a
pharmacy may be revoked as the result of the unlawful activity of the
pharmacy's owners, majority shareholders, officers, managing
pharmacist, or other key employee. EZRX, L.L.C., 69 FR 63,181; Plaza
Pharmacy, 53 FR 36,910, 36,911 (1988). Similarly, ``[k]nowledge
obtained by the pharmacists and other employees acting within the scope
of their employment may be imputed to the pharmacy itself.'' Holiday
CVS, 77 FR 62,341.
In this matter, the Government did not allege that Respondent
dispensed the prescriptions at issue having actual knowledge that the
prescriptions lacked a legitimate medical purpose. Instead, the
Government alleged that Respondent violated its corresponding
responsibility by filling prescriptions that raised red flags that were
so strongly indicative of drug abuse and diversion that they could not
have been resolved by a pharmacist acting in the usual course of
professional practice. ALJ Ex. 1, pp. 4-7. Agency decisions have
consistently found that prescriptions with similar red flags were so
suspicious as to support a finding that the pharmacists who filled them
violated their corresponding responsibility because they had actual
knowledge of, or were willfully blind to, the prescriptions'
illegitimacy.*U Additionally, DEA has consistently held,
based on the credible testimony of pharmacy experts, that prescriptions
may raise red flags that are so strongly indicative of diversion that
they cannot be resolved by a pharmacist acting within the usual course
of professional practice, and should not be filled.*V DEA
has also held that a pharmacist who fills prescriptions that present
unresolvable red flags engages in knowing diversion of controlled
substances.*W]
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*U See, e.g., Pharmacy Doctors Enterprises d/b/a Zion
Clinic Pharmacy, 83 FR 10,876, 10,898, pet. for rev. denied, 789 F.
App'x 724 (11th Cir. 2019) (long distances; pattern prescribing;
customers with the same street address presenting the same
prescriptions on the same day; drug cocktails; cash payments; early
refills); Hills Pharmacy, 81 FR 49,816, 49,836-39 (2016) (multiple
customers presenting prescriptions written by the same prescriber
for the same drugs in the same quantities; customers with the same
last name and street address presenting similar prescriptions on the
same day; long distances; drug cocktails); The Medicine Shoppe, 79
FR 59,504, 59,507, 59,512-13 (2014) (unusually large quantity of a
controlled substance; pattern prescribing; irregular dosing
instructions; drug cocktails); Holiday CVS, 77 FR 62,316, 62,317-22
(2012) (long distances; multiple customers presenting prescriptions
written by the same prescriber for the same drugs in the same
quantities; customers with the same last name and street address
presenting virtually the same prescriptions within a short time
span; payment by cash); East Main Street Pharmacy, 75 FR 66,149,
66,163-65 (2010) (long distances; lack of individualized therapy or
dosing; drug cocktails; early fills/refills; other pharmacies'
refusals to fill the prescriptions).
*V See, e.g., Pharmacy Doctors Enterprises, 83 FR
10,286, 10,888 (2018) (crediting expert testimony that certain red
flags were ``not resolvable''); The Medicine Shoppe, 79 FR 59,504,
59,507-08 (2014) (same); Holiday CVS, LLC, 77 FR 62,316, 62,319
(2012) (same); cf. Edge Pharmacy, 81 FR 72,092, 72,112 n.54 (2016)
(noting that ``many of the prescriptions presented unresolvable red
flags'').
*W The Medicine Shoppe, 79 FR at n.10.
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[Text omitted for brevity.]*X
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*X I have omitted, for brevity, text regarding the
legal standard requiring a nexus between the state laws that have
been violated and the CSA's purpose of preventing drug abuse and
diversion. I find that the Florida laws in this case are
sufficiently related to controlled substances to be considered in my
public interest analysis, and that my consideration of these state
law violations bears a rational relationship to the core purpose of
the CSA. See Salman Akbar, M.D., 86 FR 52,181, 52,194-95 (2021)
(citing 21 U.S.C. 823(a)(4); Judulang v. Holder, 556 U.S. 42, 63
(2011)).
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The Government has introduced a preponderance of evidence to prove
that the Respondent dispensed numerous controlled substance
prescriptions for at least eleven patients that raised red flags of
drug abuse and/or diversion. These
[[Page 64743]]
red flags included early fills, long distances traveled, cash payments,
dangerous drug cocktails, and high-strength narcotics, among others.
[Dr. Sullivan offered credible and unrebutted testimony that these red
flags could not have been resolved by a reasonable pharmacist acting
within the usual course of his professional practice. Therefore, I find
that the Respondent filled prescriptions for controlled substances that
the pharmacists knew were not prescribed for legitimate medical
purposes, or were willfully blind to such, in violation of their
corresponding responsibility under 21 CFR 1306.04(a) and outside the
usual course of professional practice in violation of 21 CFR
1306.06.*Y
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*Y I have omitted the RD's discussion of Respondent's
efforts (or lack thereof) to document a resolution of the red flags
in this case.
---------------------------------------------------------------------------
Further, the Government introduced evidence that Respondent
violated Florida law by repeatedly filling prescriptions that raised
unresolvable red flags. Florida law and the Florida standard of care
require a pharmacist to conduct a prospective drug use review before
dispensing a controlled substance. Tr. 211, 227-28; Fla. Admin. Code r.
64B16-27.810. This includes ``review[ing] the patient record and each
new and refill prescription presented for dispensing'' to identify,
among other things, ``[o]ver-utilization or under-utilization,''
``[t]herapeutic duplication,'' ``drug-drug interactions,'' and
``[c]linical abuse/misuse.'' Fla. Admin. Code r. 64B16-27.810. After
conducting this review, the pharmacist must ``take appropriate steps to
avoid or resolve the potential problems.'' Id. The purpose of the
prospective drug use review is to identify red flags that require
resolution before dispensing a controlled substance. Tr. 207-08, 211.
Additionally, Florida law requires pharmacists to ``exercise[ ] sound
professional judgment,'' review each prescription ``with each patient's
unique situation in mind,'' and ``attempt to work with the patient and
the prescriber to assist in determining the validity of the
prescription.'' Fla. Admin. Code r. 64B16-27.831.
Respondent violated Fla. Admin. Code rs. 64B16-27.810 and 64B16-
27.831 by repeatedly filling prescriptions that presented unresolvable
red flags. Based on Dr. Sullivan's credible expert testimony, as
supported by Florida law and prior Agency Decisions, a pharmacist
acting in accordance with Florida law would have declined to fill these
prescriptions after conducting a prospective drug use review.]
The Respondent failed to rebut or discredit the Government's case.
The Respondent did not introduce any documentary evidence and it only
offered the testimony of a single witness, who failed to convincingly
rebut the Government's evidence. In light of the record as to this
factor, I find that the Government has overwhelmingly proven that the
Respondent failed to comply with federal and state law with respect to
its corresponding responsibility for the prescriptions in evidence.
Furthermore, I find that the Government has sponsored a
preponderance of evidence to show that the Respondent engaged in
unlawful manufacturing of controlled substances without the proper DEA
registration, in violation of 21 U.S.C. 841(a)(1) and 21 CFR
1301.13(e). Thus, the Government has introduced evidence against the
Respondent with respect to two aspects of the controlled drug supply
chain, dispensing and manufacturing. The totality of this evidence
demonstrates a concerning lack of compliance with applicable federal
and state law that poses a significant risk of diversion and threatens
public health and safety. This evidence further demonstrates a lack of
commitment on the Respondent's part with respect to its federal and
state controlled substance obligations. Therefore, I find that this
factor significantly favors revoking the Respondent's
registration.*Z
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*Z As found herein, there is substantial record
evidence that Respondent dispensed controlled substances
prescriptions outside the usual course of the professional practice
in Florida and in violation of its corresponding responsibility and
in violation of state law. There is also substantial record evidence
that Respondent manufactured controlled substances outside the usual
course of professional practice and without the proper registration.
I, therefore, have concluded that Respondent engaged in misconduct
that supports a determination that its registration is inconsistent
with the public interest. See Pharmacy Doctors Enterprises d/b/a
Zion Clinic Pharmacy, 83 FR 10,876, 10,903 (2018).
For purposes of the imminent danger inquiry, my findings also
lead to the conclusion that Respondent has ``fail[ed] . . . to
maintain effective controls against diversion or otherwise comply
with the obligations of a registrant'' under the CSA. 21 U.S.C.
824(d)(2). At the time the Government issued the OSC, the Government
had clear evidence that Respondent repeatedly filled prescriptions
that presented a combination of red flags that could not have been
resolved by a pharmacist acting in the usual course of professional
practice, which establishes ``a substantial likelihood of an
immediate threat that death, serious bodily harm, or abuse of a
controlled substance . . . [would] occur in the absence of the
immediate suspension'' of Respondent's registration. Id.
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[Section omitted for brevity and relevance.] *AA 53 54
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*AA The Government argued that I should consider
under Factor Five that ``Respondent's business consisted almost
entirely of dispensing controlled substances to customers who
exhibited one or more significant red flags.'' Gov't Posthearing, at
39-40. The ALJ declined to consider this conduct under Factor Five.
RD, at 130-31. I find that the Government has provided substantial
evidence related to Factors Two and Four to support my finding that
Respondent's continued registration is inconsistent with the public
interest and that the appropriate remedy in this case is revocation.
Therefore, I decline to consider the Government's evidence under
Factor Five.
\53\ [Text omitted where footnote was included.]
\54\ [Text omitted where footnote was included.]
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Acceptance of Responsibility
With the Government's prima facie burden having been met, the
Respondent must present sufficient mitigating evidence to assure the
Administrator that it can be entrusted with the responsibility
incumbent with such registration. Medicine Shoppe-Jonesborough, 73 FR
364, 387 (2008); Samuel S. Jackson, 72 FR 23,848, 23,853 (2007).*\BB\
As past performance is the best predictor of future performance, DEA
has repeatedly held that where a registrant has committed acts
inconsistent with the public interest, the registrant must accept
responsibility for its actions and demonstrate that it will not engage
in future misconduct. ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th
Cir. 1995); Medicine Shoppe, 73 FR 387; see also Hoxie v. DEA, 419 F.3d
477, 483 (6th Cir. 2005) (reasoning that ``admitting fault'' is
``properly consider[ed]'' by DEA to be an ``important factor[]'' in the
public interest determination). Likewise, in making the public interest
determination, ``this Agency places great weight on a registrant's
candor, both during an investigation and in [a] subsequent
proceeding.'' Robert F. Hunt, 75 FR 49,995, 50,004 (2010); Hoxie, 419
F.3d at 483.
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*BB This sentence was relocated for clarity, and text
was omitted for brevity.
---------------------------------------------------------------------------
Although correcting improper behavior and practices is very
important to establish acceptance of responsibility, conceding
wrongdoing is critical to reestablishing trust with the Agency. Holiday
CVS, L.L.C., 77 FR 62,316, 62,346 (2012); Daniel A. Glick, D.D.S., 80
FR 74,800, 74,801 (2015).
The Respondent has not unequivocally accepted responsibility for
the proven violations. In fact, the Respondent has not tendered any
acceptance of responsibility at all, whether equivocal or unequivocal.
The Respondent's owner and pharmacist-in-charge never testified at the
hearing in order to accept responsibility. Instead, the Respondent's
sole witness, a pharmacy tech, never admitted that the Respondent
committed any wrongdoing. The Respondent's post-hearing brief is silent
on this issue. Resp't PHB, p. 29, ] (i); p. 32, ] (ii); p. 36, ] (iii).
[In its
[[Page 64744]]
opening statement, Respondent previewed its failure to accept
responsibility]. Respondent argued that the Government had failed to
satisfy its burden; accused the DEA of never intending to clearly or
objectively evaluate the evidence; attacked the credentials of the
Government's expert; claimed that the Respondent exercised appropriate
judgment when dispensing the relevant controlled substance
prescriptions in compliance with Florida law; and complained about the
so-called ``ivory tower aspirational'' standard the DEA is imposing on
its conduct. Tr. 503-05. In other words, the message from the
Respondent's post-hearing brief and its opening statement is that it
has done nothing wrong. These sentiments are inconsistent with a
registrant that is remorseful for misconduct and determined to regain
the Agency's trust. By failing to accept responsibility, the Respondent
has failed to overcome the Government's prima facie case. In addition
to failing to accept responsibility, the Respondent has also failed to
offer any evidence of remediation.
Egregiousness and Deterrence
*CC The egregiousness and extent of an applicant's
misconduct are significant factors in determining the appropriate
sanction. See Jacobo Dreszer, 76 FR 19,386, 19,387-88 (2011)
(explaining that a respondent can ``argue that even though the
Government has made out a prima facie case, his conduct was not so
egregious as to warrant revocation''); Paul H. Volkman, 73 FR 30,630,
30,644 (2008); see also Gregory D. Owens, 74 FR 36,751, 36,757 n.22
(2009). [Likewise, DEA considers its interest in deterring future
misconduct by both the registrant as well as other registrants. David
A. Ruben, M.D., 78 FR 38363, 38364 (2013).]
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*CC Omitted for brevity.
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I find that the proven misconduct is egregious and that deterrence
considerations weigh in favor of revocation. The proven misconduct
involves repeated instances of dispensing high-strength schedule II
controlled substances despite the presence of well-known signs of drug
abuse and diversion. The proven misconduct also involves repeat
instances of failing to follow state law and state standards of
practice [by filling prescriptions that presented unresolvable red
flags].*DD Respondent repeatedly dispensed high-strength
schedule II opioids, sometimes dangerously combined with high-strength
benzodiazepines, to patients who raised multiple red flags of
diversion. [These red flags included paying in cash, filling
prescriptions early, filling dangerous combinations of high-strength
narcotics and benzodiazepines, and traveling between two and five
hundred miles round trip to Respondent. The Government's expert
credibly testified that the rationales that the patients offered for
traveling such extraordinary distances should have concerned the
pharmacists. Patient A.G. wrote on his questionnaire that he traveled
two hundred and eighty miles roundtrip for ``quick and good service,''
GX 18; and Patient R.B. wrote that she traveled the same distance
because ``[i]t's cheaper and [she has] found that they are good
people.'' GX 44, at 1. Dr. Sullivan testified that the red flags raised
by these prescriptions were so strongly indicative of drug abuse and
diversion that a pharmacist acting in the usual course of professional
practice would not have filled them. Respondent's decision to
repeatedly turn a blind eye to these red flags] constitutes egregious
misconduct because it allowed for the potential of unchecked diversion
of controlled substances into illegitimate channels.
---------------------------------------------------------------------------
*DD Paragraph modified for consistency with my
finding that the prescriptions in this case presented a combination
of red flags that could not have been resolved by a pharmacist
acting in the usual course of professional practice.
---------------------------------------------------------------------------
[Omitted for brevity.] *EE
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*EE I have omitted, for brevity, the RD's statements
that revocation is the appropriate remedy notwithstanding the lack
of evidence related to Factors One, Three, and Five. As discussed in
more detail above, the Agency is ``not required to make findings as
to all of the factors,'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall, 412 F.3d at 173, and is not required to
discuss consideration of each factor in equal detail, or even every
factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76
(4th Cir. 1988).
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In addition to the severity of the Respondent's dispensing
misconduct, the Respondent also unlawfully manufactured thousands of
capsules of schedule II controlled substances without being registered
with the DEA as a manufacturer. As noted earlier, registered
manufacturers of controlled substances are held to higher standards
than practitioners with respect to recordkeeping, reporting, security,
and frequency of renewing registration. Thus, manufacturing controlled
substances without the DEA's blessing enabled the Respondent to produce
thousands of dosage units of controlled substances over several years
in the absence of regulatory monitoring. As with unlawful dispensing,
unlawful manufacturing is an egregious violation and warrants the
revocation of registration.
I further find that deterrence considerations weigh in favor of
revocation. Allowing the Respondent to retain its COR despite the
proven misconduct would send the wrong message to the regulated
community. Imposing a sanction less than revocation would create the
impression that registrants can maintain DEA registration despite
repeatedly [ignoring glaring red flags of drug abuse and diversion],
and despite engaging in a regulated activity without obtaining approval
from the DEA to engage in that activity. Revoking the Respondent's COR
communicates to registrants that the DEA takes all failings under the
CSA seriously and that severe violations will result in severe
sanctions.
Advice of Counsel
When the DEA executed an AIW at the Respondent in September 2018,
the Respondent's owner and pharmacist-in-charge, Mr. Clement, Sr.,
refused to speak to DI Albert upon advice of counsel to not answer any
questions. Tr. 168, 173, 177. The Respondent has an absolute right to
seek advice of counsel, and no adverse inference from obtaining advice
of counsel may be drawn. It does not provide, however, any defense to
actions taken, including failing to eventually respond to DEA inquiries
following consultation with counsel, or lack of cooperation with the
DEA's investigation.
Loss of Trust
Where the Government has sustained its burden and established that
a registrant has committed acts inconsistent with the public interest,
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).
There is no evidence that suggests the Respondent has learned any
lessons from its misconduct. As just discussed, the Respondent does not
appear to believe it has done anything wrong. [Text omitted for
clarity.] The Respondent's failure to accept responsibly and present
remediation evidence has convinced this Tribunal that the DEA cannot
trust Respondent with the obligations of a DEA registration. [Omitted
for relevance.] *FF
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*FF I have omitted the ALJ's discussion of
Respondent's failure to cooperate with DEA investigators during
inspections. Although cooperation with law enforcement can be
relevant to sanction determinations, it is not necessary for me to
consider this evidence in this case. I find that revocation is the
appropriate remedy based on the egregiousness of Respondent's
conduct and its failure to accept responsibility.
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[[Page 64745]]
Recommendation
Considering the entire record before me, the conduct of the
hearing, and observation of the testimony of the witnesses presented, I
find that the Government has met its burden of proof and has
established a prima facie case for revocation. Furthermore, I find that
the Respondent has not accepted responsibility, or presented sufficient
evidence demonstrating that the Agency can entrust it with a COR.
Therefore, I recommend that the Respondent's DEA COR No. FP2302076
should be revoked, and that any pending applications for modification
or renewal of the existing registration, and any applications for
additional registrations, be denied.
Signed: May 5, 2020.
Mark M. Dowd,
U.S. Administrative Law Judge
The Respondent's Exceptions *GG
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*\GG\ Jack Folson, Jr., who identifies himself as a clinical
pharmacist in Westland, Michigan, filed a document on June 9, 2020,
titled Amicus Brief Concerning the Standard of Practice in Pharmacy,
Law and Decision of the Administrative Law Judge. Mr. Folson states
that Respondent retained him to review the trial transcript and the
RD, and he outlines his disagreements with the RD and Dr. Sullivan's
testimony. The ALJ issued an Order Regarding Respondent's Amicus
Brief on June 10, 2020. Order, at 1. The Order stated that
Respondent had already filed the one set of exceptions it was
entitled to file, and that the Amicus Brief was essentially a second
set of exceptions that was filed after the May 26, 2020 deadline.
Id. The ALJ also noted that the Amicus Brief repeatedly cites to
materials outside of the record and includes unsworn expert
testimony. Id. at 2. I agree with the RD's conclusion that the
Amicus Brief is a set of untimely exceptions that is not permitted
by the agency's adjudicative process. Id. at 2. Further the Brief
presented evidence that was not on the record of the hearing, which
I cannot consider, because doing so would, among other things,
deprive the Government of an opportunity to address Respondent's
representations and prevent a full credibility assessment. See Lisa
Hamilton, 84 FR 71,465, 71,466 n.3 (2019). Therefore, I do not
consider the Amicus Brief in my Decision.
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On May 26, 2020, Respondent filed its exceptions to the Recommended
Decision. DEA regulations require that Exceptions ``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, Respondent's Exceptions not
only fail to comply with this regulatory requirement, but they also
lack evidentiary support in the Administrative Record. Additionally,
some of Respondent's Exceptions repeat arguments that were already
raised in Respondent's Posthearing Brief, and were adequately addressed
by the ALJ in the adopted Recommended Decision.
Exceptions #1 and 2
In the first two Exceptions, Respondent argues that the ALJ erred
in concluding that approximately thirty of the documents that the
Government admitted into evidence were accurate and reliable. Resp
Exceptions, at 5-8. These documents consist of: (1) Dispensing data,
prescription records, and other patient records that DEA downloaded
from Respondent's computers during the September 2018 AIW; and (2)
dispensing data that DEA obtained from Florida's controlled substance
dispensing database, E-FORSCE. Id. Because all of these records were
generated by Respondent, and Respondent has not identified any specific
concerns with the accuracy of these records, I find that these
Exceptions are without merit.
The only record evidence that Respondent identifies as potentially
undercutting the reliability of these records is Mr. Clement, Jr.'s
testimony that Respondent's computers were inoperable when DEA returned
them after the search warrant was executed in August of 2019, which
precluded Respondent from confirming the accuracy of the records that
DEA downloaded. Resp Exceptions, at 6-7 (citing Tr. 515, 517-18).
Respondent also argues that DEA did not present ``sufficient evidence
to prove the accuracy or reliability of the[se] records,'' because DI--
who laid the foundation for each document--did not download the records
from Respondent's computers himself, and therefore could not attest to
whether any errors were made when the records were
extracted.*HH Id. at 5-6 (citing Tr. 62-65, 134-36).
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*HH Respondent also argues that the Government did
not adequately authenticate these records, but Respondent waived
this objection by failing to raise it in writing prior to the
hearing and failing to show good cause for not raising it prior to
the hearing. See 21 CFR 1316.59; see also Tr. 64-68. Moreover,
Respondent has not raised any noteworthy objections to the
authenticity of these records.
---------------------------------------------------------------------------
Respondent, however, has not identified any inconsistencies or
errors in the documents that would cause me to question their
reliability. For example, Respondent has not identified any particular
prescriptions that it believes it did not dispense, or patients to whom
it did not dispense.*II Moreover, Respondent has not
identified any discrepancies between the E-FORSCE dispensing records,
which DEA obtained directly from E-FORSCE, and the dispensing records
that DEA downloaded from Respondent's computers. It is reasonable for
DEA to rely on these records as evidence of Respondent's dispensing,
because these are all records that Respondent is required to generate
under Florida *JJ and federal law.*KK
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*II The one error that Respondent identifies in the
PDMP data does little to undercut the reliability of the PDMP data,
and in fact, it elucidates the suspicious nature of Respondent's
dispensing. Resp Exceptions, at 7 (citing RD, at 86 n.36). The PDMP
indicates that Respondent prescribed a 120-day supply of
hydromorphone to Patient R.B. in September 2018, when in fact the
prescription was for a 30-day supply. RD, at 86 n.36. This PDMP
error highlights an unexplained lapse in Patient R.B.'s opioid
prescriptions, because this patient did not fill another
hydromorphone prescription for four months after receiving the 30-
day supply. Id.
In questioning the PDMP data, Respondent also states that ``the
Government's own expert acknowledged that there are errors in the
PDMP data.'' Resp Exceptions, at 7. Respondent cites to Dr.
Sullivan's testimony--in response to the question of whether he has
``ever encountered . . . a data entry error'' in the PDMP--that he
``know[s] that there are data entry errors in the PDMP. Potential
errors.'' Id. This testimony is not specific enough to undermine the
reliability of the PDMP data, especially because Respondent is
required by state law to accurately report each controlled substance
that it dispenses to E-FORSCE. See Fla. Stat. Sec. 893.055(3)(a)
(2019) (requiring certain information to be reported to E-FORSCE
each time a controlled substance is dispensed, including the date
the prescription was filled; the patient's name and other
identifying information; and the name, quantity, and strength of the
controlled substance dispensed).
*JJ See Fla. Stat. Sec. 893.055(3)(a).
*KK See generally 21 CFR 1304.04; see also Tr. 492
(DI's testimony that pharmacists must keep accurate dispensing
logs).
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Exception #3
Respondent next argues that the RD's conclusion that Florida law
and the Florida standard of care require pharmacists to document the
resolution of red flags ``was based upon a clear error of law, and thus
arbitrary and capricious.'' Resp Exceptions, at 8-17. Respondent argues
that the RD's conclusion that Respondent violated 21 CFR 1306.04(a) and
1306.06 was dependent on his erroneous conclusion that Florida law
requires documentation, and therefore, Respondent argues that these
conclusions should be overturned. Id.
I do not need to address this Exception because I have concluded
above, based on Dr. Sullivan's credible and unrebutted expert
testimony, that the prescriptions that Respondent dispensed raised red
flags that could not have been resolved by a pharmacist acting within
the usual course of professional practice. I have also concluded that,
by filling these prescriptions, Respondent violated its corresponding
responsibility because the pharmacists knew these controlled substances
were not prescribed for
[[Page 64746]]
legitimate medical purposes, or were willfully blind to such, in
violation of their corresponding responsibility under 21 CFR
1306.04(a), and Respondent dispensed controlled substances outside the
usual course of professional practice, in violation of 21 CFR
1306.04(a) and 1306.06. Because the red flags were unresolvable, I find
that it is irrelevant whether Respondent took adequate steps under
Florida law to document any attempts to resolve the red flags.
Exception #4
Respondent's final Exception restates, nearly verbatim, arguments
that it made in its Posthearing brief. Compare Resp Exceptions, at 17-
21 with Resp Posthearing, at 36-41. I find that the RD adequately
addresses these arguments, and I agree with the RD's conclusion that
Respondent engaged in illegal manufacturing. I therefore find that this
Exception is without merit.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of
Registration No. FP2302076 issued to Pronto Pharmacy, LLC. Pursuant to
28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and
21 U.S.C. 823(f), I further hereby deny any pending applications for
renewal or modification of this registration, as well as any other
pending application of Pronto Pharmacy, LLC for registration in
Florida. Pursuant to the authority vested in me by 21 U.S.C. 824(f), as
well as 28 CFR 0.100(b), I further order that all controlled substances
seized pursuant to the Order of Immediate Suspension of Registration
are forfeited to the United States. This Order is effective December
20, 2021.
Anne Milgram,
Administrator.
[FR Doc. 2021-25133 Filed 11-17-21; 8:45 am]
BILLING CODE 4410-09-P