Notice2021-27718
Gulf Med Pharmacy; Decision and Order
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Published
December 22, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 86 Issue 243 (Wednesday, December 22, 2021)</title>
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[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Pages 72694-72735]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27718]
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Vol. 86
Wednesday,
No. 243
December 22, 2021
Part II
Department of Justice
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Drug Enforcement Administration
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Gulf Med Pharmacy; Decision and Order; Notice
Federal Register / Vol. 86 , No. 243 / Wednesday, December 22, 2021 /
Notices
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 20-06]
Gulf Med Pharmacy; Decision and Order
On November 18, 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 Gulf Med Pharmacy (hereinafter, Respondent).
Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at 1.
The OSC informed Respondent of the immediate suspension of its DEA
Certificate of Registration Number FG6290061 (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)).
In response to the OSC, Respondent timely requested a hearing
before an Administrative Law Judge. ALJ Ex. 2. The hearing in this
matter was conducted from July 20-23, 2020, from August 12-13, 2020,
and on August 20, 2020, at the DEA Hearing Facility in Arlington,
Virginia, with the parties and their witnesses participating through
video-teleconference. On November 25, 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 December 15, 2020, Respondent filed
exceptions to the Recommended Decision (hereinafter, Resp Exceptions),
and on December 28, 2020, the Government filed a response to
Respondent's exceptions (hereinafter, Gov Response). 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.*\A\ 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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*\A\ I have made minor modifications to the RD. I have
substituted initials or titles for the names of witnesses and
patients to protect their privacy and I have made minor,
nonsubstantive, grammatical changes 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 with in brackets, and I have
included specific descriptions of the modifications in the brackets
or in footnotes marked with a letter and an asterisk. 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 *<SUP>B 1 2 3</SUP>
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*\B\ I have omitted the RD's discussion of the procedural
history to avoid repetition with my introduction.
\1\ [Footnote omitted, see supra n.*B.]
\2\ [Footnote omitted, see supra n.*B.]
\3\ [Footnote omitted, see supra n.*B.]
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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. FG6290061, 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
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 March 22, 2017, until at
least August 8, 2019, Gulf Med Pharmacy repeatedly ignored obvious red
flags of abuse or diversion and filled prescriptions without exercising
its corresponding responsibility to ensure that they were issued for a
legitimate medical purpose, in violation of federal and state law,
including 21 CFR 1306.04(a) and 1306.06, and Fla. Admin. Code r. 64B16-
27.800, .810, and .831. ALJ Ex. 1.
The Order to Show Cause also alleged the following:
1. Gulf Med Pharmacy is registered with the DEA to handle
controlled substances in Schedules II-V under DEA COR No. FG6290061.
Gulf Med Pharmacy's registered address is 4106 Del Prado Boulevard
South, Cape Coral, Florida 33904. Gulf Med Pharmacy's COR expires by
its own terms on September 30, 2022.
2. Gulf Med Pharmacy's DEA COR should be revoked and any pending
application should be denied because Gulf Med Pharmacy has committed
such acts as would render its registration inconsistent with the public
interest under 21 U.S.C. 823(f). See 21 U.S.C. 824(a)(4). From March
22, 2017, until at least August 8, 2019, Gulf Med Pharmacy repeatedly
ignored obvious red flags of abuse or diversion and filled
prescriptions without exercising its corresponding responsibility to
ensure that they were issued for a legitimate medical purpose, in
violation of federal and state law. Given Gulf Med Pharmacy's
longstanding and pervasive violations of legal requirements relating to
the practice of pharmacy, Gulf Med Pharmacy's continued registration
constitutes an ``imminent danger'' as that term is defined by 21 U.S.C.
824(d).
Legal Requirements
3. 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. Pharmacists at Gulf Med Pharmacy were
permitted to fill prescriptions ``issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a). Although ``[t]he
responsibility for the proper prescribing and dispensing of controlled
substances is upon the prescribing practitioner . . . a corresponding
responsibility rests with the pharmacist who fills the prescription.''
Id. ``DEA has consistently interpreted this provision as prohibiting a
pharmacist from filling a prescription for a controlled substance when
[s]he either knows or has reason to know that the prescription was not
written for a legitimate medical purpose.'' Wheatland Pharmacy, 78 FR
69441, 69445 (2013) (internal quotation marks and citation omitted,
alteration in original).
4. In addition to complying with federal statutes and regulations,
Gulf Med Pharmacy and its pharmacists also must comply with applicable
Florida law. In particular, Florida pharmacists must ``review 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 Ann.
r. 64B16-27.810(1). Upon recognizing any of these red flags of abuse or
diversion, a Florida pharmacist ``shall take appropriate steps to avoid
or resolve the potential problems which shall, if necessary, include
consultation with the
[[Page 72695]]
prescriber.'' Id. at r. 64B16-27.810(2). Florida pharmacies must also
maintain a patient record system that documents resolution of red
flags. See id. at r. 64B16-27.800. Finally, Florida pharmacists must
comply with the standards for filling of controlled substance
prescriptions. See id. at r. 64B16-27.831 (requiring pharmacists, among
other things, to ``exercise[ ] sound professional judgment'' and
``attempt to work with the patient and the prescriber to assist in
determining the validity of the prescription''). A Florida pharmacy's
failure to comply with Florida's prescription review requirements also
constitutes a violation of the federal Controlled Substances Act. See,
e.g., Trinity Pharmacy II, 83 FR 7304, 7329 (2018) (``Thus, [Florida]
pharmacists violate Florida law if they fail to identify and resolve
the red flags that are part of the prospective drug use review set
forth in Rule 64B16-27.810. And if they knowingly fill prescriptions
without resolving these red flags during this review, then they violate
their corresponding responsibility under 21 CFR 1306.04(a).'').
5. As explained in greater detail below, a Florida pharmacy expert
retained by the DEA has reviewed numerous prescriptions filled by Gulf
Med Pharmacy and has concluded that from March 22, 2017, until at least
August 8, 2019, Gulf Med Pharmacy repeatedly filled prescriptions for
controlled substances in violation of binding minimal standards that
govern the practice of pharmacy in the State of Florida.
Cocktail Medications
6. As discussed above, both federal and Florida law require
pharmacists to identify and resolve red flags of abuse and diversion.
See paragraph 4, supra. One common red flag of drug abuse or diversion
is when a practitioner prescribes (via one or more prescriptions)
``cocktail medications.'' Cocktail medications are combinations of
controlled substances that are widely known to be abused or diverted,
and when taken together, significantly increase a patient's risk of
death or overdose. The DEA's expert reviewed numerous prescriptions
filled by Gulf Med Pharmacy, as well as Gulf Med Pharmacy's patient
profiles for the relevant patients, and concluded that Gulf Med
Pharmacy regularly dispensed cocktail medications without addressing or
resolving this red flag. For example, the DEA's expert noted that Gulf
Med Pharmacy repeatedly dispensed high doses of opioids (in the form of
hydromorphone, oxycodone, and morphine sulfate extended release) along
with high doses of other central nervous system depressant medications,
such as benzodiazepines (e.g., alprazolam, clonazepam, or diazepam) or
muscle relaxants (e.g., carisoprodol). The DEA's expert opined that
these controlled substances are dangerous when used in combination.
7. Gulf Med Pharmacy repeatedly dispensed ``cocktail medications''
without any indication that its pharmacists addressed or resolved the
fact that such prescriptions present a risk of abuse or diversion.
Examples of instances when Gulf Med Pharmacy dispensed cocktail
medications in the face of unresolved red flags include the following:
a. On at least three occasions between May 22, 2019, and July 17,
2019, Gulf Med Pharmacy filled prescriptions written on the same day by
Physician R.D. for Patient A.B. for 120 units of hydromorphone 8 mg, 60
units of morphine sulfate extended release 15 mg, and 30 units of
diazepam 10 mg.
b. On at least four occasions between February 9, 2018, and July
17, 2019, Gulf Med Pharmacy filled prescriptions written on the same
day by Physician A.N. for Patient B.Di. for 120 units of hydromorphone
8 mg, 60 units of morphine sulfate extended release 30 mg, and 60-90
units of alprazolam 1 mg.
c. On at least five occasions between December 28, 2018, and August
8, 2019, Gulf Med Pharmacy filled prescriptions written on the same day
by Physician A.N. for Patient J.B. for 120 units of oxycodone 30 mg, 60
units of morphine sulfate extended release 30 mg, and 90 units of
alprazolam 1 mg.
d. On at least four occasions between May 14, 2019, and August 6,
2019, Gulf Med Pharmacy filled prescriptions written on the same day by
Physician M.L. for Patient R.R. for 120 units of hydromorphone 8 mg, 60
units of morphine sulfate extended release 60 mg, and 30 units of
alprazolam 2 mg.
e. On at least four occasions between May 8, 2019, and August 5,
2019, Gulf Med Pharmacy filled prescriptions written on the same day by
Physician M.L. for Patient B.Da. for 120 units of hydromorphone 8 mg,
30 units of morphine sulfate extended release 30 mg, and 30 units of
alprazolam 2 mg. On February 12, 2018, Gulf Med Pharmacy also filled
prescriptions written on the same day by another physician in the same
practice--Physician D.P.--for Patient B.Da. for 150 units of
hydromorphone 8 mg, 90 units of methadone 10 mg, and 30 units of
alprazolam 2 mg.
8. According to the DEA's expert, the cocktail of an opioid, a
benzodiazepine, and carisoprodol--commonly known as the ``Trinity''
cocktail--is a particularly serious red flag because that combination
of controlled substances is highly dangerous and is widely known to be
abused and/or diverted. Gulf Med Pharmacy repeatedly dispensed Trinity
cocktail medications without any indication that its pharmacists
addressed or resolved the fact that such prescriptions present a risk
of abuse or diversion. Examples of instances when Gulf Med Pharmacy
dispensed Trinity cocktail medications in the face of unresolved red
flags include the following: Between May 30, 2019, and July 29, 2019,
Gulf Med Pharmacy filled three sets of prescriptions from Physicians
D.G. and F.M. for Patient J.R. for the Trinity cocktail. For each set
of prescriptions, Physician F.M. prescribed Patient J.R.
benzodiazepines and muscle relaxants; specifically, 30 units of
temazepam 30 mg, 30-60 units of diazepam 5 mg, and 120 units of
carisoprodol 350 mg. Meanwhile, Physician D.G. prescribed Patient J.R.
opioids; specifically, 120 units of Norco (hydrocodone-acetaminophen)
5-325 mg, 120 units of Percocet (oxycodone-acetaminophen) 5-325 mg, and
120 units of Percocet 10-325 mg.
Improper Dosing for Pain Management
9. As noted above, both federal and Florida law require a
pharmacist to identify and address red flags of drug abuse or diversion
including over-utilization and under-utilization. See 21 CFR
1306.04(a); 21 CFR 1306.06; Fla. Admin. Code. Ann. r. 64B16-27.810.
According to the DEA's expert, for a patient receiving treatment with
both long-acting and short-acting opioids, the proper pharmacologic
dosing for pain management is to use larger, scheduled doses of the
long-acting opioid to control chronic pain with smaller, as-needed
doses of the short-acting opioid for breakthrough pain. According to
the DEA's expert, this method of dosing reduces the amount of the
short-acting opioid that the patient must use in order to obtain the
same level of pain control. In contrast, the DEA's expert opined that
prescriptions that provide a larger daily dose of short-acting opioids,
rather than long-acting opioids, do not make pharmacologic sense and
thus are a red flag of drug abuse or diversion. From at least March 22,
2017, until at least August 8, 2019, Gulf Med Pharmacy repeatedly
filled prescriptions for patients receiving a much greater daily
morphine milligram equivalent dosage of short-acting opioids than long-
acting opioids. The DEA's expert also noted that each of the short-
acting or immediate release opioid prescriptions was scheduled four
times a day or every
[[Page 72696]]
six hours, even though the patient was also prescribed a scheduled,
long-acting opioid. The DEA's expert reviewed Gulf Med Pharmacy's
patient profiles for several of these patients. In the expert's view,
because these prescriptions were illogical from a pharmacological
perspective, they therefore raised a red flag. The DEA's expert further
opined that Gulf Med Pharmacy should have attempted to address or
resolve this red flag of drug abuse or diversion prior to filling these
prescriptions, but, on numerous occasions, its pharmacists failed to do
so. Examples of Gulf Med Pharmacy filling such improper prescriptions
include the following:
a. On at least 23 occasions between November 8, 2017, and July 17,
2019, Gulf Med Pharmacy filled prescriptions for Patient A.B. for 120
units of immediate release hydromorphone 8 mg (equal to 128 mg of
morphine per day), but only 60 units of morphine sulfate extended
release 15 mg (equal to 30 mg of morphine per day).
b. On at least 28 occasions between April 21, 2017, and July 17,
2019, Gulf Med Pharmacy filled prescriptions for Patient B.Di. for 120
units of immediate release hydromorphone 8 mg (equal to 128 mg of
morphine per day), but only 60 units of morphine sulfate extended
release 30 mg (equal to 60 mg of morphine per day).
c. On at least 18 occasions between January 10, 2018, and May 1,
2019, Gulf Med Pharmacy filled prescriptions for Patient S.K. for 110
units of immediate release hydromorphone 8 mg (equal to 125-128 mg of
morphine per day), but only 60 units of morphine sulfate extended
release 15 mg (equal to 30 mg of morphine per day).
d. On at least 27 occasions between March 22, 2017, and August 8,
2019, Gulf Med Pharmacy filled prescriptions for Patient J.B. for 108-
120 units of immediate release oxycodone 30 mg (equal to 162-180 mg of
morphine per day), but only 60 units of morphine sulfate extended
release 30 mg (equal to 60 mg of morphine per day).
e. On at least eight occasions between October 2, 2018, and August
6, 2019, Gulf Med Pharmacy filled prescriptions for Patient R.R. for
120 units of immediate release hydromorphone 8 mg (equal to 128 mg of
morphine per day), but only 28 units of morphine sulfate extended
release 60 mg (equal to 60 mg of morphine per day).
f. On at least eight occasions between January 16, 2019, and August
5, 2019, Gulf Med Pharmacy filled prescriptions for Patient B.Da. for
120 units of immediate release hydromorphone 8 mg (equal to 128 mg of
morphine per day), but only 30 units of morphine sulfate extended
release 30 mg (equal to 30 mg of morphine per day).
Long Distances
10. Between October 25, 2017, and August 5, 2019, Gulf Med Pharmacy
regularly filled controlled substance prescriptions for individuals who
traveled an unusual distance to obtain their prescriptions. The DEA's
expert opined that traveling long distances to obtain or fill a
controlled substance is indicative of diversion and/or abuse and that
such behavior is a red flag that must be addressed prior to dispensing.
See 21 CFR 1306.04(a); 21 CFR 1306.06; Fla. Admin. Code. Ann. r. 64B16-
27.810. Gulf Med Pharmacy did not do so, as illustrated by the
following examples of prescriptions that it filled:
11. On at least 20 occasions between November 8, 2017, and July 17,
2017, Patient A.B. traveled 45 miles round trip to obtain prescriptions
for hydromorphone 8 mg, morphine sulfate extended release 15 mg, and
diazepam 10 mg, which Gulf Med Pharmacy filled.
12. On at least five occasions between October 25, 2017, and
February 12, 2018, Patient B.Da. traveled over 48 miles round trip to
obtain prescriptions for hydromorphone 8 mg and methadone 10 mg, which
Gulf Med Pharmacy filled. On two of those trips--January 15, 2018, and
February 12, 2018--Patient B.Da. also obtained prescriptions for
alprazolam 2 mg, which Gulf Med Pharmacy also filled. Subsequently, on
at least seven occasions between February 13, 2019, and August 5, 2019,
Patient B.Da. traveled over 48 miles round trip to obtain prescriptions
for hydromorphone 8 mg, morphine sulfate extended release 30 mg, and
alprazolam 2 mg, which Gulf Med Pharmacy also filled.
13. On at least 17 occasions between January 17, 2018, and May 8,
2019, Patient R.D. traveled over 41 miles round trip to obtain
prescriptions for hydromorphone 8 mg and lorazepam 2 mg, which Gulf Med
Pharmacy filled.
Cash Payments and Price Gouging/Black Market Pricing
14. Another common red flag of abuse or diversion that pharmacists
must monitor is the use of cash payments for controlled substances
instead of insurance payments. See 21 CFR 1306.04(a); 21 CFR 1306.06;
Fla. Admin. Code. Ann. r. 64B16-27.810. According to the DEA's expert,
when a prescription for a controlled substance is electronically
processed through insurance, the insurance company will frequently
reject suspicious controlled substance prescriptions that may be
related to drug abuse or diversion, such as controlled substance
prescriptions for the same patient filled at multiple pharmacies.
Consequently, cash payments for controlled prescriptions are a red flag
of abuse or diversion because some suspect patients may choose to pay
cash in order to avoid an insurance rejection that might alert the
pharmacist to potential drug abuse or diversion. Such cash payments are
especially suspicious when the patient bills insurance for other
prescriptions, but pays cash for controlled substance prescriptions.
15. Similarly, the DEA's expert indicated that price gouging, or
charging more than the market rate for prescriptions for a controlled
substance, is a separate indicator of drug abuse or diversion. The
DEA's expert explained that price gouging is a red flag because a
legitimate patient, who could fill his or her prescription at any
pharmacy, will switch pharmacies in order to pay the fair market price
for that prescription. In contrast, the highly suspect patient can only
fill prescriptions at a suspicious pharmacy and must pay whatever price
that suspicious pharmacy sets. Consequently, patients paying inflated
prices for controlled substance prescriptions are another red flag of
drug abuse or diversion, especially when the price paid is
substantially higher than the market price available from other nearby
pharmacies. See Jones Total Health Care Pharmacy, L.L.C., 81 FR 79188,
79191 (2016). For the same reason, filling controlled substance
prescriptions at inflated cash prices shows that a pharmacy has
knowledge that it is filling prescriptions that are not legitimate, as
its inflated prices reflect a ``risk premium'' that the pharmacy
charges to account for the risk it is taking by filling illegitimate
prescriptions. See id. at 79,199-200 (``[E]ven granting that there are
no prohibitions on the prices a pharmacy can charge for controlled
substances, when those prices far exceed what other pharmacies would
charge, the Agency may properly draw the inference that the pharmacy is
charging those prices because it knows it is supplying persons who are
seeking the drugs to either abuse them or divert them to others.''). To
determine a baseline of normalcy (i.e., legitimate pricing), the DEA's
expert contacted representative pharmacies in Cape Coral, Florida, and
found that the price of 120-140 units of oxycodone 30 mg varied from
about $1.59 to $1.63 per unit, while the sale price of 120-140 units of
hydromorphone 8 mg varied from about $1.25 to $1.27 per unit.
[[Page 72697]]
16. From March 22, 2017, until at least August 6, 2019, Gulf Med
Pharmacy repeatedly filled prescriptions for oxycodone 30 mg and
hydromorphone 8 mg for patients who paid for these prescriptions in
cash at substantially inflated prices that far exceeded what other area
pharmacies charged. The DEA's expert reviewed Gulf Med Pharmacy's
patient profiles for several of these patients. The DEA's expert opined
that Gulf Med Pharmacy should have attempted to address or resolve
these red flags of drug abuse or diversion prior to filling these
prescriptions, but failed to do so. Gulf Med Pharmacy dispensed
controlled substances at inflated prices to individuals paying cash in
the following instances:
17. On at least 15 separate occasions between March 14, 2018, and
April 10, 2019, Gulf Med Pharmacy filled prescriptions for 120 units of
hydromorphone 8 mg for Patient R.D. On each occasion, Patient R.D. paid
for the prescription in cash, and on all but one occasion Patient R.D.
paid $4 per unit ($480 in total)--over three times the market rate.
18. On at least six separate occasions between February 26, 2018,
and April 22, 2019, Gulf Med Pharmacy filled prescriptions for 84 to
120 units of oxycodone 30 mg for Patient T.G. On each occasion, Patient
T.G. paid for the prescription in cash at a price of $4 per unit ($336
to $480 in total)--over three times the market rate.
19. On at least 16 separate occasions between March 7, 2018, and
May 1, 2019, Gulf Med Pharmacy filled prescriptions for 108 to 110
units of hydromorphone 8 mg for Patient S.K. On each occasion, Patient
S.K. paid for the prescription in cash at a price ranging from $3.56
per unit to $4 per unit ($392 to $432 in total)--in each case at least
two-and-a-half times the market rate, and as high as over three times
the market rate.
20. On at least 14 separate occasions between March 20, 2018, and
April 15, 2019, Gulf Med Pharmacy filled prescriptions for 90 to 120
units of oxycodone 30 mg for Patient L.V. On each occasion, Patient
L.V. paid for the prescription in cash at a price ranging from $2.50
per unit to $3.33 per unit ($300 in total)--in each case at least one-
and-a-half times the market rate, and as high as twice the market rate.
Further, Patient L.V. used insurance to pay for other prescriptions,
including prescriptions for controlled substances such as alprazolam
and zolpidem.
21. On at least 19 separate occasions between March 22, 2017, and
September 7, 2018, Gulf Med Pharmacy filled prescriptions for 108 to
120 units of oxycodone 30 mg for Patient J.B. On each occasion, Patient
J.B. paid for the prescription in cash at a price of $3.40 to $4 per
unit ($408 to $480 in total)--in each case over twice the market rate.
22. On at least 23 occasions between November 8, 2017, and July 17,
2019, Gulf Med Pharmacy filled prescriptions for 120 units of
hydromorphone 8 mg for Patient A.B. On each occasion, Patient A.B. paid
for the prescription in cash at a price of $3.73 to $4 per unit ($448
to $480 in total)--in each case over two-and-a-half times the market
rate, and as high as three times the market rate.
23. On at least five occasions between October 25, 2017, and
February 12, 2018, Gulf Med Pharmacy filled prescriptions for 150 units
of hydromorphone 8 mg for Patient B.Da. Subsequently, on at least six
occasions between March 13, 2019, and August 5, 2019, Gulf Med Pharmacy
filled prescriptions for 120 units of hydromorphone 8 mg for Patient
B.Da. On each of these 11 occasions, Patient B.Da. paid for the
prescription in cash at a price of $4 per unit ($480 to $600 in
total)--over three times the market rate.
24. On at least 28 occasions between April 21, 2017, and July 17,
2019, Gulf Med Pharmacy filled prescriptions for 120 units of
hydromorphone 8 mg for Patient B.Di. On each occasion, Patient B.Di.
paid for the prescription in cash at a price of $4 per unit ($480 in
total)--over three times the market rate.
25. On at least 18 occasions between December 5, 2017, and least
August 6, 2019, Gulf Med Pharmacy filled prescriptions for 120 to 168
units of hydromorphone 8 mg for Patient R.R. On each occasion, Patient
R.R. paid for the prescription in cash at a price ranging from $4 per
unit to $4.60 per unit ($480 to $672 in total)--in each case over three
times the market rate. ALJ Ex. 1.
The Hearing
Government's Opening Statement
The Government seeks to revoke the Respondent's DEA certificate of
registration, and deny any applications for renewal, or modification of
that registration because the Respondent has committed acts that render
its continued registration inconsistent with the public interest. Tr.
14-15. The testimony and evidence will show that the Respondent
repeatedly ignored red flags of abuse and diversion--many established
under prior Agency decisions--and sold prescriptions for controlled
substances without exercising their corresponding responsibility to
ensure that those prescriptions were issued in the usual course of
professional practice, and for a legitimate medical purpose.
With respect to the prescriptions that the Respondent filled for
the charged patients in this matter, the Government's expert, Dr. Tracy
Schossow, will explain that the Respondent filled prescriptions for
controlled substances for those patients in the face of multiple red
flags of abuse and diversion. Tr. 15-16. The red flags that the
Respondent ignored include filling prescriptions for patients (J.B.,
A.B., B.Da., R.D., B.Di., R.R., and L.B.) that were cocktail
combinations of opioids and benzodiazepines that are dangerous when
used in combination, and are widely known to be sought after for drug
abuse and diversion.
The Respondent also filled prescriptions for two charged patients
(J.B. and R.R.) for the Trinity drug cocktail, which is a non-
therapeutic combination of an opiate, a benzodiazepine, and muscle
relaxer, Carisoprodol, which is a known dangerous combination and used
for drug abuse and diversion.
The Respondent filled prescriptions for Patient J.R. for
benzodiazepines, which duplicated the therapeutic effects. The
Respondent also filled prescriptions for charged patients (J.B., A.B.,
B.Da., B.Di., S.K., and R.R.) for both long-acting and short-acting
opioids in combinations that do not make pharmacological sense. Tr. 16-
17. The Respondent filled prescriptions for Patient R.R. for
benzodiazepines at dosages that do not make pharmacological sense.
The Respondent filled prescriptions for charged patients (J.B.,
A.B., B.Da., R.D., B.Di., T.G., S.K., R.R., and L.B.) despite each
paying cash for controlled substances. The Respondent also sold
prescriptions for charged patients (J.B., A.B., B.Da., R.D., B.Di.,
T.G., S.K., R.R., and L.B.) for opioids despite substantial mark-ups in
price. The Respondent also filled prescriptions for charged patients
(A.D., B.Da., and R.D.) despite these patients travelling long round-
trip distances to have the Respondent's pharmacy fill the controlled
substance prescriptions.
DI will explain that the DEA executed administrative inspection
warrants and served three administrative subpoenas on the Respondent
during the investigation. Tr. 17-18. This gave the Respondent several
opportunities to provide the DEA with evidence that it identified and
resolved red flags of diversion or abuse before dispensing the charged
prescriptions. As Dr. Schossow will testify, the Respondent's records
[[Page 72698]]
indicate that it failed to address and resolve any of these red flags
of diversion or abuse, and that it failed to exercise its corresponding
responsibility to ensure that the prescriptions were issued for a
legitimate medical purpose by a practitioner acting in the normal
course of professional practice. Therefore, the Respondent violated
federal and state law when it dispensed the charged prescriptions.
Respondent's Opening
Gulf Med Pharmacy is a small, independent pharmacy in southeast
Florida. Tr. 19. Respondent contended that it has been unfairly and
inappropriately targeted by the DEA for conduct that does not violate
any Florida state or federal statues or regulations. Respondent
contended that this action is based upon the DEA's created idea about
review of prescriptions retrospectively related to some opiate
prescriptions, and combinations of those opiates and benzodiazepines.
Respondent contested that the DEA's position is not supported by
medical literature or by anything other than supposition and conjecture
on the part of the DEA's expert witness.
The Respondent will present testimony from Dr. Daniel Buffington.
Dr. Buffington is a professor associated with the University of South
Florida in the Departments of Medicine and Pharmacy. Tr. 19-20. He has
extensive experience in pharmacy practice, and will describe the
appropriateness of the Respondent's actions in filling prescriptions
defined in the Order to Show Cause, as well as the appropriateness of
the documentation related to those prescriptions.
Respondent contended that what is important in this matter is there
has been, and continues to be, a tortured and unsupportable
interpretation of the Florida Administrative Code, as it related to the
obligation of a pharmacist licensed by the state. Tr. 20. The State of
Florida has the right and obligation to control the scope and the
manner of the practice of pharmacy and medicine within the state,
consistent with the Supreme Court of the United States' precedence.
The Respondent's evidence will be direct and will show that the
attempt to characterize the distance that was traveled by the charged
patients to the Respondent's pharmacy is nothing short of manufactured.
Tr. 20. In order to make the distances seem longer, the Government
included round-trip travel as opposed to direct travel or the direct
distance between the residence of the patient and the pharmacy. Tr. 20-
21. Given the distances in south Florida, since patients are coming
from some of the barrier islands, the distance between a straight line
and coming from the barrier islands and comparing them to facilities on
the mainland, is a significant factor that was not considered by the
DEA or its expert witness.
Respondent contended that the DEA's expert witness is neither
qualified, nor capable of, having any knowledge or information to
justify opinions regarding the price paid for medications by the
patients, or on the distance, travel, or mechanism of payment. Tr. 21.
Even though it does not have any burden of proof, the Respondent will
demonstrate the fallacies of the DEA's position. Tr. 21. It also looks
forward to receiving a recommendation that Gulf Med Pharmacy's DEA
registration be reinstated and continuing to operate in its usual and
appropriate manner. Tr. 21.
Government's Case-in-Chief
Diversion Investigator (DI)
DI has been a Diversion Investigator with the DEA for three years
and has been assigned to the Miami Field Division, Western office for
most of that time. Tr. 25-27. Prior to working for the DEA, DI worked
as a transportation screening officer with the Transportation Security
Administration. Tr. 26. As a Diversion Investigator, DI is tasked with
enforcing the Controlled Substances Act, which regulates the
manufacture, distribution, possession, use, and importation of
controlled substances. Diversion Investigators also strive to prevent
the diversion of controlled substances to the streets. DI conducts
civil and criminal investigations, including administrative actions
like the current matter. Tr. 26-27. DI has attended the DEA Academy at
Quantico and has conducted approximately twelve investigations with the
DEA. Tr. 27-28, 279-81.
The investigation of Gulf Med Pharmacy was initiated because Gulf
Med Pharmacy was found to be one of the top ten purchasers of
Oxycodone, Hydromorphone, and Hydrocodone in the State of Florida. Tr.
28-29, 362.\4\ This was the impetus for the DEA inquiry, to investigate
why Gulf Med was a top purchaser of these controlled substances. Tr.
30.
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\4\ This evidence was admitted as relevant to the allegations.
The Respondent probed this evidence, but gave notice that he was
delving into this issue only on the basis the evidence was ruled to
be relevant to the existing charges, and was not consenting to
broaden the scope of the charges. The Tribunal explained to the
Respondent that it did not permit the Government to expand the scope
of the charges at the hearing, without giving timely notice to the
Respondent, so that the Respondent had an opportunity to object. Tr.
359-61.
---------------------------------------------------------------------------
DI became the case agent in approximately December 2018, after DI
2, the original case agent \5\ retired. Tr. 28, 39, 315. Upon becoming
case agent, DI reviewed the case file, which included the
administrative inspection warrant. Tr. 40-42. DI had not reviewed the
case file before he became the case agent or before the administrative
inspection warrant was served. Tr. 368-70. Based solely upon DEA
reports he later reviewed, DI confirmed that Gulf Med Pharmacy was one
of the top purchasers in Florida of these controlled substances in
2017. Tr. 362, 365-68. At the hearing, he could not confirm whether the
sole supplier of these controlled substances to the Respondent was
Cardinal. Tr. 364.
---------------------------------------------------------------------------
\5\ [Footnote omitted.]
---------------------------------------------------------------------------
Initially, DI's role in this matter was to assist the case agent
with the administrative inspection warrant. Tr. 28. The administrative
inspection warrant allows the DEA to inspect and copy records,
information, reports, files, inventories, invoices, official order
forms, prescriptions, and other documents required to be kept under the
Controlled Substances Act. Tr. 302; GX 2 at 1; see, 21 U.S.C. 880. The
warrant describes what records and information are subject to seizure,
including all of the electronic data maintained by the Respondent
pharmacy. Tr. 302-03; GX 2 at 2. In terms of the Respondent's
compliance with the Controlled Substances Act and the laws applicable
to the operation of a pharmacy, the DEA has the authority to go into
the pharmacy and seize all of the relevant electronic data. Tr. 304-06.
An administrative inspection warrant is used if the investigators
suspect that the pharmacy may deny entry to investigators presenting
with a notice of inspection. Tr. 289. When an administrative inspection
warrant is served, DI follows the instructions of his group
supervisors. Tr. 286. During an inspection, one or two agents conduct
the inspection during normal business hours. Tr. 288.
The purpose of the inspection warrant was to gather all information
relevant to the investigation, including both inculpatory and
exculpatory evidence. Tr. 281-85. The warrant was based upon an
affidavit by DI 2, the original case agent. DI did not create the
warrant and he does not know the circumstances under which it was
issued. Tr. 36-38. DI was part of the pre-inspection briefing session,
which was conducted by DI 2. Tr. 281. He was advised that the
Respondent was one of the top ten
[[Page 72699]]
purchasers of oxycodone, hydromorphone, and hydrocodone in the State of
Florida by DI 2 during the briefing before the execution of the
warrant. Tr. 370-71.
DEA investigators served an administrative inspection warrant on
Gulf Med Pharmacy on February 14, 2018. Tr. 31. DI was present when the
warrant was served on the Respondent. Tr. 33-35.\6\ The inspection of
February 14, 2018, was performed by both diversion investigators and
armed DEA special agents. Tr. 289-90. DI could not recall if any local
law enforcement were present. Tr. 290. Prior to and at the point of
service of the administrative inspection warrant, DI did not know where
the Respondent kept its records. Tr. 387. DI knew that the employees of
the pharmacy would know where the requested documents were located
within the pharmacy, including the pharmacy technician and the
Pharmacist-in-Charge. Tr. 391-92.
---------------------------------------------------------------------------
\6\ DI identified the Respondent's DEA COR. Tr. 32-33; GX 1. He
also identified the administrative inspection warrant, dated
February 14, 2018. GX 2.
---------------------------------------------------------------------------
On February 14, 2018, the DEA simultaneously served an
administrative subpoena on the Respondent through Dr. Ricard Fertil,
the pharmacist in charge of Gulf Med Pharmacy. Tr. 44-45, 57, 393-94;
GX 3; see 21 U.S.C 876. DI is familiar with administrative subpoenas,
and regularly uses them. Tr. 46. DI was present on the day it was
served and is familiar with the document. Tr. 46-49. The Respondent
produced documents in response to the subpoena, and the DEA seized
those documents from the Respondent. Tr. 64. The DEA provided a receipt
for seized documents to the Respondent through a DEA-12 form. Tr. 50-
60; GX 4. The receipt was signed by DI 2 and Mr. Ricard Fertil. DI did
not attend the closeout meeting with the Respondent following the
February 14, 2018 inspection. Tr. 356-57.
Items seized, and reflected in the receipt, included patient
profiles, reports and printouts. Tr. 61, 63-64.\7\ The investigators
also seized the original prescriptions from the date the pharmacy
opened until the date of the administrative inspection warrant. Tr.
291-92. During the service of the administrative inspection warrant,
the DEA seized all of the Respondent's prescriptions and records,
including electronic prescriptions for controlled substances. Tr. 73-
75; GX 4 at 3-4, 6.
---------------------------------------------------------------------------
\7\ DI identified the patient profiles for Patients J.B., T.G,
and L.V. Tr. 65-69; GX 5. DI also identified the patient dispensing
reports for Patient J.B., T.G., and L.V. Tr. 69-71; GX 6.
---------------------------------------------------------------------------
DI identified the prescriptions written and filled for Patient J.B.
that were seized. Tr. 75-76; GX 7. These were included in the
controlled substance prescriptions that had been filled by the
Respondent pharmacy up until the date of the inspection. Tr. 77. The
back side of the prescriptions have a filled sticker that show that the
prescriptions were filled by Gulf Med Pharmacy. Tr. 78-79; GX 7 at 2.
DI identified prescriptions for Patient A.B. that were taken from Gulf
Med Pharmacy. Tr. 80-82; GX 8. DI also identified prescriptions for
several patients filled by Gulf Med Pharmacy: Patient B.Da. (Tr. 83-85,
88-89; GX 9); Patient R.D. (Tr. 89-92; GX 10); Patient B.Di. (Tr. 95-
98; GX 11); Patient P.G. (Tr. 99-101; GX 12); Patient S.K. (Tr. 101-03;
GX 13); Patient R.R. (Tr. 111-13; GX 14); and Patient L.V. (Tr. 114-16;
GX 15).
Once the prescriptions were seized from the Respondent pharmacy,
they were placed into evidence and scanned. Tr. 93. The original
prescriptions are maintained in the custody of the DEA evidence
custodian. Tr. 94.
Once a warrant is served, the DEA investigators ask the pharmacist-
in-charge where the prescriptions are located. Tr. 86. The
investigators request a date range of prescriptions and seize them.
Here, the prescriptions were in separate folders and were categorized
by prescription number. Tr. 86-87. The folders were in various
locations, including in drawers, cabinets, boxes, and ``just out in the
open.'' Tr. 87.
A DEA technology specialist retrieved dispensing reports for the
patient profiles from the pharmacy's computer. Tr. 87-88, 292. The
technician downloaded information from the Respondent's computer
system, including patient profiles and dispensing reports. Tr. 292. The
investigators did not retrieve a mirror image of the Respondent's hard
drive. Tr. 306-07.
On the prescription for Patient S.K., there is a fill sticker,
which was printed out once the prescription was filled by the pharmacy.
Tr. 103-04; GX 13 at 2. On the fill sticker, the prescription number
was identified as N-000346, the date of the prescription, and
``PPCash'' to identify the method of payment. This shows that the
prescription was paid for with a method of payment other than by
insurance, which in this instance was cash. Tr. 104-05. This
prescription was for hydromorphone, eight milligrams. In DI's
experience, a cash method of payment for a prescription of a controlled
substance is significant, because it raises the question why a patient
would pay by cash as opposed to insurance. Tr. 106-07. This was a ``red
flag'' \8\ that the prescription may be illegitimate. Red flag methods
of payment include cash, credit, credit card, or check. Tr. 107-08.
There is no DEA regulation that prohibits a pharmacy from accepting
cash as payment for a prescription. Tr. 373-74. There is no guidance
document from the DEA that instructs pharmacists to limit the
acceptance of cash as payment for prescriptions for controlled
substances. Tr. 374. DI does not know whether patients can pay cash for
prescriptions and then submit claims to their own insurance company.
Tr. 375. He did not determine whether the charged patients had
insurance. Tr. 375.
---------------------------------------------------------------------------
\8\ A ``red flag'' serves as an indication that a ``prescription
may be illegitimate.'' Tr. 107.
---------------------------------------------------------------------------
On the prescription for Patient S.K., below the ``PPCash''
language, there is an indicator of the price paid for the prescription.
Tr. 108. The price that is paid for a controlled substance is a
significant factor because, if the price paid is two or three times
higher than a traditional price, it is an indicator that the patient is
willing to pay any cost in order to get the prescription filled. Tr.
109-110. This would be an indication that the prescription may be
illegitimate. These red flags are not only true for hydromorphone, but
for other controlled substances as well.
Apart from the prescriptions, patient profiles, and dispensing
reports previously discussed, there were no other documents pertaining
to the specific patients that either the Respondent produced pursuant
to the administrative subpoena, or that the DEA seized pursuant to the
administrative inspection warrant. Tr. 117-18, but see 358-59 (purchase
orders, invoices from suppliers, were seized during the administrative
inspection warrant).
As the Government's investigation continued, the DEA served two
additional administrative subpoenas. Tr. 118-19. The second
administrative subpoena was served on the Respondent's attorney in May
of 2019 by DI. Tr. 119-22, 350, 396; GX 16. DI was the investigator
responsible for collecting and maintaining the evidence received from
the Respondent. Tr. 350-51.
Dr. Fertil completed, and DI received, a completed copy of a
certificate of authenticity of domestic business records, along with
the documents responsive to the second administrative subpoena. Tr.
122-25; GX 18. In response to the May 2019 subpoena, the Respondent
produced hard-copy prescriptions, patient profiles, and dispensing
reports. DI did not know
[[Page 72700]]
who actually gathered the documents that were responsive to the
subpoena. Tr. 396-97. The DEA provided a receipt for these documents.
Tr. 125-28; GX 17. The second administrative subpoena required
documents dated from February 15, 2018 to May 3, 2019, which begins the
day after the end of time period of the administrative inspection
warrant. Tr. 129, 347; GX 2.
DI identified patient profile printouts for Patient R.D. (Tr. 129-
31; GX 19); Patient P.G. (Tr. 132-33; GX 20); Patient S.K. (Tr. 135-37;
GX 21); and Patient L.V. (Tr. 137-39; GX 22).
The Respondent also produced hard copy prescriptions in response to
the second administrative subpoena. Tr. 142, 348-49. The prescriptions
were for Schedule II to V controlled substance prescriptions. DI
identified prescriptions and fill stickers for Patient J.V. (Tr. 143-
46; GX 23); Patient A.B. (Tr. 146-48; GX 24); Patient B.Da. (Tr. 148-
51; GX 25); Patient R.D. (Tr. 151, 156-58; GX 26); Patient B.Di. (Tr.
158-60; GX 27); Patient P.G. (Tr. 160-62; GX 28); Patient S.K. (Tr.
163-65; GX 29); Patient J.R. (Tr. 165-70; GX 30), which includes
prescription drug monitoring reports (GX 30, pp. 16-17, 26); Patient
R.R. (Tr. 170-75; GX 31), which includes an E-FORCSE PDMP reports, a
Florida Department of Health license verification printout for Dr.
M.L., and a DEA website printout for Dr. M.L. (GX 31, pp. 19-21, 26,
31, 36, 39); Patient L.V. (Tr. 175-77; GX 32). No other documents were
produced by the Respondent pursuant to the second administrative
subpoena served in May of 2019, including dispensing reports. Tr. 178,
349-50.
A third administrative subpoena was served in August of 2019 by DI.
Tr. 179-82; GX 33. DI served the administrative subpoena on
Respondent's counsel on behalf of Gulf Med Pharmacy. Tr. 396. Ricard
Fertil produced documents in response to the third administrative
subpoena to DI. Tr. 183. DI did not know who actually gathered the
documents responsive to the third subpoena. Tr. 396-97. The Respondent
completed a certificate of authenticity of domestic business records.
Tr. 184-85; GX 34. The documents produced include patient profiles,
hard copy prescriptions, dispensing reports, and any notes for the
patients. DI identified the produced records for Patient J.B. (Tr. 186-
89; GX 35); Patient A.B. (Tr. 189-92; GX 36); Patient B.Da. (Tr. 192-
94; GX 37); Patient B.Di. (Tr. 194-96; GX 38); Patient J.R. (Tr. 196-
98; GX 39); Patient R.R. (Tr. 198-201; GX 40).
DI is familiar with the E-FORCSE program. Tr. 201-02, 206-08. E-
FORCSE is the Florida prescription drug monitoring program, which is a
database of controlled substance prescriptions filled, as reported by
pharmacists or pharmacies to the State of Florida. Tr. 202-03. During
the investigation, DI obtained information from the E-FORCSE database
about the prescriptions that were filled by the Respondent. He logged
onto the website and set his search query. Tr. 203-04, 206-07. A
request then generated an electronic report. The report is produced
after the database pulls all of the requested information and it is
approved by a PDMP administrator. Tr. 205. An E-FORCSE PDMP report was
generated for dates between January 1, 2018 and May 16, 2019 for Gulf
Med Pharmacy. Tr. 205-06, 208-10; GX 41. Not including the title bar,
there are 2,566 lines of data in the spreadsheet. Tr. 383. A second E-
FORCSE PDMP report was generated for dates between February 14, 2018
and August 27, 2019 for Gulf Med Pharmacy. Tr. 211-17; GX 42. Not
including the title bar, there are 2,912 lines of data in the
spreadsheet. Tr. 384. Each line of data represents a separate
prescription. Tr. 385. DI did not compare the E-FORCSE data with the
data provided by the Respondent. Tr. 385. He did not do any
investigation regarding the E-FORCSE data available prior to February
14, 2018 for the charged patients. Tr. 385-86.
During the service of the administrative inspection warrant in
February of 2018, electronic printouts of purchase orders, patient
profiles, dispensing reports, and other documents related to the
charged patients were seized from the Respondent's computers. Tr. 237.
The computers were not seized. Tr. 237-38. Copies of the software and
hard drives were not taken. DI was aware that the pharmacy uses the
PioneerRx software on their computers. During the investigation, the
DEA obtained a declaration from a representative of PioneerRx,
concerning the function of the software. Tr. 238-48; GX 48. DI received
it from PioneerRx's attorney. Tr. 239, 242.
DI never spoke to Jenny Roe directly. Tr. 343. Because DI had a
printout, he did not perform any investigation to determine what
information was in the computer system behind the tabs of information
on the computer program. Tr. 343-46; GX 5. The administrative subpoena
asked for all documents maintained in patient profiles, so if the
Respondent only provided one page, then the investigators assumed that
is all the Respondent had. Tr. 346. The Respondent is expected to
produce what is listed in the subpoena. Tr. 347.
DI is familiar with the term National Average Drug Acquisition Cost
(NADAC). Tr. 249, 255.\9\ DI first became familiar with it during the
investigation of the Respondent. Tr. 255. It is a database monitored by
the Center for Medicare and Medicaid Services, where a survey is sent
out to pharmacies throughout the country. Tr. 256. The pharmacies will
voluntarily submit acquisition costs for the drugs that they purchase
from the manufacturers. Tr. 256, 275. The Center for Medicare and
Medicaid Services is a government agency, whose role with respect to
the NADAC is to determine prices to be compensated for insurance
purposes. Tr. 256-57. The results of the survey are updated monthly and
posted online. There is data that relates to different controlled
substances. Tr. 257-58. DI reviewed the data for Oxycodone 30 mg and
Hydrocodone 8 mg. Other data available include the name of the
substance, cost per unit, NDC number, and effective date. DI identified
the NADAC results for Hydrocodone 8 mg and Oxycodone 30 mg. Tr. 259-62;
GX 44-45.\10\
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\9\ [Footnote omitted, see infra n.*P.]
\10\ Pursuant to the Tribunal's previous ruling, Government's
Exhibits 44 and 45 were not admitted. Tr. 262.
---------------------------------------------------------------------------
DI found NADAC by doing a Google search. Tr. 272. He had never
worked with it before. There is a fact sheet which explains how NADAC
gathers their information and its use. Tr. 273. DI did not communicate
with anyone at NADAC. For the Center for Medicare and Medicaid
Services, the data only applies to patients whose medications are being
paid for by Medicare or Medicaid. Tr. 273-74.
DI does not know if any of the NADAC volunteered information is
from independent pharmacies in the Fort Meyers or Cape Coral area, or
any in southeast Florida. Tr. 275. He is aware that prices are
different in terms of acquisition cost for chain pharmacies versus
independent pharmacies. Tr. 276. He does not know whether chain
pharmacies have a greater buying power than independent pharmacies, or
whether there are different reimbursements that are paid by insurance
companies compared to private pay price. Tr. 277-78. He does not know
whether independent pharmacies are reimbursed at a lower rate than
chain pharmacies. Tr. 357-58.
DI became familiar with the term ``federal upper limit'' as part of
his duties. Tr. 263. He became familiar of the term through the NADAC
database. Federal upper limit is a multiplier that the Center for
Medicare and Medicaid
[[Page 72701]]
Services uses from the NADAC average. Tr. 264-65.\11\ When the Center
determines the federal upper limit, it is provided online on their
database website. Tr. 267-68. The federal upper limit is available with
respect to particular drugs, including controlled substances. DI
reviewed the data for Oxycodone 30 mg and Hydrocodone 8 mg. DI
identified the NADAC federal upper limit results for Hydrocodone 8 mg
and Oxycodone 30 mg. Tr. 268-71; GX 46-47.\12\
---------------------------------------------------------------------------
\11\ [Footnote omitted, see infra n.*P.]
\12\ Pursuant to the Tribunal's previous ruling, Government's
Exhibits 46 and 47 were not admitted. Tr. 270-71.
---------------------------------------------------------------------------
The federal upper limit pertains to people who are not using
insurance to pay. Tr. 274. It does not matter where a person fills
their prescriptions if they are a Medicare patient. The same upper
limit of what can be charged applies. Tr. 274-75.
DI's intention through the second and third administrative
subpoenas was to obtain the same type of information and documents that
the DEA sought at the time of the administrative inspection warrant and
administrative subpoena on February 14, 2018. Tr. 293-98; GX 3, 16, 33.
DI did not draft the first administrative subpoena, but he did draft
the second and third administrative subpoenas. Tr. 308-09. He is
familiar with the process for the service of an administrative
subpoena, which includes identifying a return date for the person on
whom the subpoena is served to produce information. Tr. 310. The first
administrative subpoena directs the person to whom that subpoena is
served to respond to DI 2 by February 9, 2018. Tr. 310-11; GX 3 at 2.
The return date had already passed by five days by the time the
subpoena was served. Tr. 311. DI explained that when drafting
administrative subpoenas, the system auto-populates the date at the
bottom of the subpoena that is within two weeks or ten business days.
Tr. 312. Taking into consideration travel and getting appropriate
signatures, these subpoenas are drafted ahead of time. The date of
issue on this subpoena is the date that the document was printed and
submitted. Tr. 312-13.
The return date for the third administrative subpoena was for was
February 9, 2018. Tr. 314. The date and time for appearance auto-
populates, so it appeared that the drafter forgot to change the date,
but DI was not sure. It would be impossible for the Respondent to
timely respond to the subpoena as the Respondent did not receive it
until February 14, 2018. Tr. 314-15.
DI did not interview any of the physicians that prescribed the
charged prescriptions. Tr. 319-20. He also did not interview any of the
charged patients. Tr. 320. DI did not do any investigation to determine
the distances from the charged patients' home to the pharmacy. Tr. 377-
78. DI did not have any evidence that any of the charged patients were
abusing or diverting their medications. Tr. 321-24.\13\ He did not know
the number of patients that had been served by the Respondent prior to
February 14, 2018, and did not know what percentage of patients in the
Order to Show Cause are of the Respondent's total patients. Tr. 325-26.
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\13\ The Tribunal sustained the Government's objection as to
being outside the scope of the Government's direct examination and
that this information is irrelevant. The Tribunal found that the
Government does not require evidence of diversion or abuse to
initiate or pursue an investigation, and they do not require
evidence of diversion or improper behavior by the pharmacist to
initiate an investigation. The Tribunal permitted the Respondent to
make a proffer, but advised that the Government's theory is set out
in the Order to Show Cause and Immediate Suspension of Registration
and the Government's prehearing statements, which will serve as the
focus of the hearing. Tr. 321-23.
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DI did not receive training at the DEA Academy regarding the
Florida administrative code or Florida law. Tr. 327. In the
administrative subpoenas, DI referenced Florida Administrative Rule
64B16-27.800. Tr. 331. DI has previously read Florida Administrative
Rule 64B16-27.800. Tr. 351. He understood that investigators were
looking for the same types of profile information that the DEA
technology specialist had downloaded during the administrative
inspection warrant on February 14, 2018. Tr. 331-32.\14\
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\14\ The Tribunal sustained the Government's objection to
relevancy of the underlying Government investigation. The Tribunal
found that the focus of the hearing is not on whether there were
mistakes or missteps in the investigation, but rather on the
evidence that was seized and noticed with the allegations set out in
the Order to Show Cause. Tr. 333-39.
---------------------------------------------------------------------------
When he was assigned as the case agent, DI reviewed all of the
information that the DEA had then collected. Tr. 339. Following the
service of the second and third administrative subpoenas, he compared
the patient profiles that were seized on February 14, 2018 to the
patient profile information that was obtained in response to the second
and third administrative subpoenas. Tr. 339-40, 342-43.
DI transmitted the documents collected in response to the
administrative subpoenas to Dr. Schossow. Tr. 378. The subpoenas were
not issued at the request of the expert. Tr. 379. DI did not review any
of the information with Dr. Schossow. Dr. Schossow provided a written
report to DI before the OSC was issued, but he did not recall the exact
date. Tr. 379-80.
All of DI's interactions with Ricard Fertil and Gulf Med Pharmacy
were both pleasant and cooperative. Tr. 399.
Dr. Tracey Schossow
Dr. Schossow is a contracted expert with the Drug Enforcement
Administration. Tr. 863-64. She expects to make $15,000 on the instant
case. Tr. 879-80. She has only testified as an expert for government
agencies. Tr. 865. Although she was not averse to defending someone
charged by the Government, she has never been hired to defend anyone
charged by the Government or by the State. Tr. 876-78. Dr. Schossow is
a licensed pharmacist in the State of Florida. Tr. 404. She has a
Bachelor's of Science Degree in Pharmacy from Florida A&M, and later
received her Doctorate in Pharmacy from the University of Florida in
2001. Tr. 881. Although she has written non-peer reviewed articles, she
has not published a peer reviewed article. Tr. 939-40. She worked in
retail pharmacy for a total of fifteen years, including time as a drug
clerk and pharmacy tech for her father, who was a pharmacist. She
worked as a pharmacist in retail pharmacy for approximately twelve
years. She has also worked as a pharmacy intern, assistant manager, a
pharmacy manager, and then as a ``floater'' for other pharmacy chains.
Tr. 406-07, 417. She has worked in over 200 different pharmacies during
her retail pharmacy experience, but never one in southwest Florida. Tr.
988. However, she has not worked in a retail pharmacy since 2012. Tr.
417, 881. Since 2012, she has only worked for pharmacy benefit
managers. Tr. 883. Her last position in retail pharmacy was with Publix
Pharmacies from July 2008 to October 2012. Tr. 418, 930. She last
served a customer at a pharmacy approximately seven years ago. Tr. 880.
She has worked for ProCare, a hospice-centered company, as a
clinical pharmacist. Tr. 404, 418-19. In that capacity, she worked with
patients who were dying, and managed cocktail medications for comfort
management, while still maintaining cost effectiveness. Tr. 404-05,
419-20. She was also part of the PNT committee, which decided which
medications were non-formulary based on cost and efficacy. Tr. 405. She
additionally managed a rejection queue, where claims are rejected for
being excessively priced. Dr. Schossow offered more cost-effective
therapies.
[[Page 72702]]
Dr. Schossow presently works as a pharmacist at Florida Blue Cross/
Blue Shield. Tr. 403. As part of her duties, she reviews ``high-dollar
reports'' (meaning high cost medications) and makes sure that the
medications are being issued for a legitimate medical purpose. Tr. 403.
If she determines they are being issued for a legitimate medical
purpose, she works with the patient and provider to offer cost-
effective alternatives. Tr. 403-04. If, upon speaking to the pharmacy
and patient, she determines the medications are not for a legitimate
medical purpose, she reports those findings and opens up an
investigation through Blue Cross's fraud, waste, and abuse department
for further investigation. She also works on a team of ``complex
members'' with a nursing team and reviews medications with patients.
Blue Cross provides pharmaceutical education and offers cost-effective
alternatives to its members.
Blue Cross also submits test claims at different pharmacies,
including independent pharmacies, to determine costs at different
pharmacies in the area where patients reside. Tr. 405. Dr. Schossow did
not actually prescribe medications in these roles, but she made
recommendations to physicians based on the patient's symptoms. Tr. 406.
She was a member of an interdisciplinary team, which made medication
recommendations that the physicians generally followed. In that role,
she served as a clinical pharmacist. Tr. 406.
There are differences between a regional pharmacist and a clinical
pharmacist. Tr. 407. A regional pharmacist receives the prescriptions
from the physician. The pharmacist evaluates it, looks at the
computerized patient profile and ensures the medication is safe for the
patient before dispensing. A clinical pharmacist makes the
recommendations saved on the computer patient profile. In Dr.
Schossow's current position, she looks at all of the claims that the
patient has, from the insurance perspective. She can review all of the
medications the patient has received, and then she can make a
recommendation based on the profile, and by talking to the patient and
physician. Dr. Schossow has similar responsibilities as a regional
pharmacist, except she does not dispense medications. Tr. 407. There is
no difference in licensure between a clinical pharmacist and a
community pharmacist. Tr. 419.
Dr. Schossow has been a pharmacist for approximately twenty-six
years. Tr. 408. All of her experience is in the state of Florida. She
has experience filling approximately one million prescriptions. Dr.
Schossow also holds a consultant license in the state of Florida. The
consultant license allows her to perform additional duties, including
nursing home inspections.
Dr. Schossow has taught in the pharmacy field. Tr. 409. She taught
at a pharmacy technician school, teaching subjects including diversion,
red flags, and issues involving opioids. Tr. 409-10. She also worked at
the Veterans Administration (VA) for six years. Tr. 412. In this role,
she was a clinical pharmacy specialist and mentored residents and
interns. Tr. 412. At the VA, Dr. Schossow prescribed medication. Tr.
419. While with the VA, Dr. Schossow could prescribe medications
because she operated under the VA regulations. Tr. 422-23. However,
with the hospice and retail positions, she cannot prescribe medications
and can only make recommendations. Tr. 423. She has never had the
ability or authority to prescribe Schedule II controlled substances.
Tr. 423. At ProCare, she was a trainer in regards to high-dollar cost
rejections, including training pharmacists on these rejections, how to
handle them, and how to offer cost-effective alternatives. Tr. 412,
936-38. She also worked for Caremark, a PBM, where her role was to
control costs for contracted healthcare plans. Tr. 972-73. Dr. Schossow
conceded that, outside the realm of insurance subsidization, there is
no limit on the mark up a pharmacy can charge for medications. Tr.
1035.
Dr. Schossow is familiar with DEA regulations with respect to
dispensing of controlled substances. Tr. 408-09, 888-92, 927-28. She
has previously testified as an expert witness three times in DEA
administrative cases. Tr. 411-12, 423-24. She has been qualified each
time she has been offered as an expert. She has only testified in
administrative hearings, not in courts. Tr. 928. Her opinions have been
accepted by the DEA Administrator. Through her education and
professional experience,\15\ she is familiar with the responsibilities
of a retail pharmacist in the detection and prevention of abuse and
diversion of controlled substances. Tr. 414. She is familiar with the
standard of care \16\ and professional obligations of a pharmacist in
the state of Florida. Tr. 888-92.
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\15\ Dr. Schossow identified her curriculum vitae. Tr. 412-13;
GX 43.
\16\ The term of art, ``standard of care'' was used by the
Tribunal, the parties and sometimes witnesses as a shorthand
reference to a pharmacist's professional obligations, or acting
within the ``course of professional practice of pharmacy.'' See
Florida Statute XLVI Sec. 893.04. However, the term ``standard of
care'' is defined in Sec. 766.102, and has a different usage and
application. This distinction will be discussed in detail below.
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In the instant case, Dr. Schossow was offered as an expert in
Florida pharmacy practice and the standard of care for the practice of
pharmacy in Florida. Tr. 414, 416. She reviewed all of the exhibits in
this matter, including prescriptions, patient profiles, E-FORCSE
reports, and documents provided by Gulf Med Pharmacy. She asked the
Government to gather information that a responsible pharmacist would
look at before determining whether a prescription could be safely
filled for a legitimate medical purpose. So she asked for those items
that she would look for if she was standing in the pharmacy filling the
prescriptions. Tr. 415-16.
Dr. Schossow was qualified as an expert in Florida pharmacy
practice and the standard of care for the practice of pharmacy in
Florida.\17\ The duties of a Florida pharmacist with respect to filling
controlled substance prescriptions include exercising a corresponding
responsibility to make sure that medications are being issued for a
legitimate medical purpose by the practitioner acting within their
usual course of professional practice. Tr. 431. The pharmacist is
responsible for evaluating prescriptions based on the manufacturer's
guidelines and for the safety for the patient. Tr. 432. Florida
Administrative Rule 64B16 lists responsibilities regarding what should
be maintained in the patient record systems, including the patient's
name address, allergies, pharmacist's comments, and a Drug Use Review
(DUR) for each new prescription and refilled prescription. A DUR
includes side effects, drug interactions, whether the medication is
being clinically abused or misused, and dosages.
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\17\ The Respondent objected to the Government's offer of Dr.
Schossow as a proposed expert witness and to restriction on voir
dire as to her opinions relating to specific aspects of the standard
of care. The Tribunal overruled the Respondent's objections and Dr.
Schossow was qualified as offered. Tr. 424-27. The Tribunal noted
that the burden to qualify an expert is by a preponderance of the
evidence. Thereafter, apparent limitations to expertise will impact
the weight given to the expert's testimony.
---------------------------------------------------------------------------
Dr. Schossow is familiar with Florida Administrative Rules 64B16-
27.800, 27.810, and 27.831. Tr. 434-36, 891-92. These provisions inform
the standard of care of a pharmacist working in Florida. Tr. 434-36,
891-94, 912-16.\18\ They provide an outline of the minimal requirements
for Florida pharmacists in regards to patient safety and continuity of
care. Florida Administrative Rule
[[Page 72703]]
64B16-27.831 describes methods a pharmacist should use to validate a
prescription. Tr. 897-900. This provision also requires pharmacists to
maintain a computerized record of controlled substances dispensed,
which the Respondent did in this case as to the charged patients. Tr.
908-12. The Florida statutes define requirements for patient care and
for maintaining a patient records system. Tr. 437. These statutes
provide that the pharmacist shall ensure a reasonable effort is made to
obtain, record, and maintain certain information, including the
patient's full name, address, date of birth, gender, and prescription
list, as well as the pharmacist's comments relating to allergies, drug
interactions or any idiosyncrasies, and any conversations that the
pharmacist had with the healthcare provider in regards to the patient's
individual drug therapy. Tr. 438, 913-20. The Florida statutes also
require prescription drug review, including therapeutic
inappropriateness, which the pharmacist must address for drug therapies
that do not fall within the guidelines of the standard of care. This
ensures continuity of care with the next pharmacist reviewing the
medication protocol, as well as to assure that the medication is safe
for the patient. Tr. 927-30. These concerns include over or under-
utilization of medication, therapeutic duplications, drug interactions,
incorrect dosage forms, drug allergy interactions, and clinical abuse.
The pharmacist must take appropriate steps to resolve these issues and
to record those resolutions. Tr. 438-39, 888, 918-26. Dr. Schossow
conceded that the relevant federal regulations that she relied on to
inform the standard of care do not specifically require documentation
of the resolution of red flags. Tr. 927-28.
---------------------------------------------------------------------------
\18\ Dr. Schossow testified that the pharmacist is required to
apply the version of the regulation or statute applicable at the
time the subject prescription is filled. Tr. 896-97, 904-05.
---------------------------------------------------------------------------
A prospective drug use review is a checklist that a pharmacist
should go through when reviewing each new and refilled prescription to
ensure therapeutic appropriateness and patient safety. Tr. 439-40.
Additional concerns include therapeutic duplication, drug interactions,
correct dosages, clinical abuse and misuse, and drug allergy
interactions. Prospective drug utilization review is discussed in the
Florida Administrative Rules under section 27.810. Tr. 440-41. Upon
recognizing any therapeutic inappropriateness, the pharmacist is
supposed to take appropriate steps to resolve the issue and to record
the resolution in the patient records. It is important to document the
results of a review for continuity of care, so that when the next
pharmacist reviews the medication protocol, he will have the
information readily available and the prescription can be filled
without delay. Tr. 441-42. It also represents a safety issue. In Dr.
Schossow's opinion, the Florida standard of care requires documentation
of the resolution of these matters. Tr. 442.
Dr. Schossow is familiar with DEA regulations regarding a
pharmacist's corresponding responsibility. Tr. 442. The pharmacist has
just as much responsibility as the doctor to ensure that the medication
is for a legitimate medical purpose and that the practitioner is acting
in the usual course of professional practice. Tr. 442-43. It applies to
all pharmacists. This responsibility is in addition to all of the
requirements under the Florida rules and regulations. A pharmacist's
corresponding responsibility is not satisfied by simply verifying that
a doctor wrote the prescription. The pharmacist has an independent
responsibility to evaluate each prescription. Tr. 444.
Dr. Schossow is familiar with the phrase ``in the usual course of
professional practice.'' Tr. 444. This means that the doctor is issuing
prescriptions in an effective and safe manner and ``within his
training.'' This is a requirement for a pharmacist. ``Within his
training'' means within the scope of his practice. Tr. 444-45.
Pharmacists are required to fill prescriptions in the usual course of
their profession.
Apart from the requirements for pharmacists set forth by the State
of Florida and the DEA, Dr. Schossow testified that she believed that a
pharmacist's standard of care is also informed by past DEA
administrative cases.*\C\ Tr. 445-46. Pharmacists learn about the DEA
administrative decisions through mandatory CMEs and during education
seminars, including those required by Sec. 27.831. Tr. 457-62.
---------------------------------------------------------------------------
*\C\ It is noted that DEA administrative cases rely on expert
testimony to establish the standard of care.
---------------------------------------------------------------------------
Dr. Schossow is familiar with the term ``red flag.'' Tr. 446. Red
flags are circumstances surrounding a prescription that cause a
pharmacist to take pause, including signs of diversion or the potential
for patient harm. These concerns are codified under clinical abuse and
misuse within the DUR in Florida's Administrative Rule 64B16. The
section also talks about abuse under Chapter 893, in which abuse is
defined. Tr. 446. Pharmacists in the State of Florida ``must learn
three main statutes'' in order to pass the Florida Board: ``64B16, 893,
and 465.'' Tr. 449, 1004-05, 1039-40. Pharmacy students learn these
statutes for the Florida Board of Pharmacy. Chapter 893 informs the
Florida standard of care for pharmacists as it defines potential for
abuse, which relates back to 64B16. Tr. 449-50. The prospective DUR
requires that one of the things a pharmacist must review is clinical
abuse or misuse, so a pharmacist must understand what abuse means.
Florida pharmacists become familiar with red flags through their
training in pharmacy school and through their on-the-job training. Tr.
451, 888. This training includes the opioid crisis in the United
States, which led to mandatory continuing education in Florida for the
validation of prescriptions for controlled substances. Tr. 451-53. This
additional training includes, use of the PDMP, appropriate therapeutic
values for opioids, legitimate medical purpose and the laws and rules
around it, as well as protocol that addresses how to resolve red flags,
and the CDC Guidelines for Prescribing Opioids for Chronic Pain, 2016.
The CDC guidelines relating to opioid prescribing are reviewed in the
Continuing Medical Education (CME) courses. Tr. 454. The CDC guidelines
cover appropriate dosing, which is part of the mandatory CME that all
Florida pharmacists must attend every other year, as well as risks of
certain dosages of Morphine Milligram Equivalent (MME). Tr. 455. The
training covers dosing and risks to patients, as well as combining
central nervous system depressive medications that may lead to overdose
and death. Tr. 456. The training also covers dosage concerns based on
clinical studies, for which the pharmacist is responsible to know. The
standard of care requires pharmacists to remain current as to the
therapeutic appropriateness findings of these studies. The items
outlined in Florida Administrative Rule 64B16-27.810 represent red
flags. Tr. 457.
The presence of a red flag itself does not mean that a pharmacist
cannot fill a prescription. Tr. 462. Consistent with the standard of
care, a red flag means that there is a potential concern with the
prescription, which the pharmacist must address and resolve, and to
make a record of its resolution, assuming it is resolvable. Tr. 462-63,
906-07. If the pharmacist is unable to resolve the red flag, he should
not fill the prescription. Tr. 907-08. This is something that a Florida
pharmacist acting in the usual course of professional practice would do
upon encountering one or more red flags relating to a prescription. The
lack of documentation identifying and resolving of a red flag warrants
the
[[Page 72704]]
conclusion under the standard of care that the prescription was treated
as falling within the guidelines for a legitimate medical purpose and
is safe for the patient to take. Tr. 463-66.
Dr. Schossow was asked by the DEA to review material relating to
Gulf Med Pharmacy. Tr. 466, 983-84. She reviewed the front and back of
hard-copy prescriptions, the computer printouts of the patients'
pharmacy files, which included any pharmacist comments, medical records
from the pharmacy, dispensing reports, and patient profiles, including
the PDMP reports for patients. Tr. 466-71. Dr. Schossow does not know
if she received all of the relevant information from the Respondent's
computer system used to fill the subject prescriptions. Tr. 976-78.
Specifically, Dr. Schossow confirmed the screen shots of the patient
profile only depicted one of five tabs. Tr. 978; GX 19. The tab opened
in the relevant Government exhibits was the ``comment'' tab. The tab
identified as ``profile'' was not revealed. Tr. 978-79. Similarly, the
tab, ``RX history'' is not revealed. Tr. 979.
Dr. Schossow is familiar with pharmacy management software, which
maintains patient records. Tr. 471. She is familiar with how it
generally works and has worked with different systems of pharmacy
management software. However, she is not familiar with the Respondent's
system, PioneerRx. Generally, when a prescription is submitted to a
pharmacy, the technician types up the prescription, which then goes
through the system. Tr. 472. Most pharmacies perform the DUR. It is the
responsibility of the pharmacist to override it or to document that
issues revealed by the DUR were addressed. Tr. 475. Not all red flags
are flagged in the computer system, but red flags that are flagged
include major drug interactions, including central nervous system (CNS)
depressant medications that fall under an X interaction according to
the DEA and the CDC, and the FDA black box warnings on things such as
benzodiazepines combined with opioids. Tr. 476.
After a warning appears in the electronic program, that is
considered a DUR \19\ and the severity of the DUR should be addressed
by the pharmacist with either the patient or the doctor to assure
patient safety going forward and how it was resolved. There is
generally a click-through function on the program and documentation
must be provided. Tr. 476-77. For example, in the system at Walgreens,
the pharmacist has to document what they did to resolve the red flag.
If the software program does not allow the pharmacist to document in
the computer, then the pharmacist must either document in the computer
program under the patient notes or somewhere in the patient records
system, or on the prescription, as to how the DUR was resolved in terms
of patient safety, for the continuity of care for the next pharmacist.
A click-through does not count as documentation of a red flag. Tr. 477-
78. A click-through allows the pharmacist to override a DUR. For
example, at Publix, the pharmacist has a lanyard that the pharmacist
clicks to override the DUR. However, a higher level DUR requires more
documentation because of patient safety concerns. Tr. 478-79.
---------------------------------------------------------------------------
\19\ Dr. Schossow appeared to use the term DUR in place of ``red
flag'', as per the subject question.
---------------------------------------------------------------------------
A pharmacist practicing in the normal course of pharmacy practice
in Florida would record what the resolution of the red flag was for
continuity of care and to assure patient safety. Tr. 479-80. In a
pharmacy, the pharmacist is responsible for resolving any potential red
flag of abuse or diversion. Tr. 480. A pharmacy technician cannot
resolve or sign off on the resolution of a red flag.
Dr. Schossow is familiar with a combination of controlled
substances known as a ``trinity''. Tr. 480-81. A trinity is usually an
opioid like Hydromorphone or Oxycodone, plus a benzodiazepine like
Alprazolam, Temazepam, Diazepam, plus Soma or Carisoprodol, which is a
controlled muscle relaxant. Tr. 481. It is a dangerous combination. In
Dr. Schossow's experience and training, the trinity is commonly sought
by drug abusers. Tr. 482-83. A trinity is a red flag.
Patient J.B.
Dr. Schossow identified a patient medication dispensing report
printout for Patient J.B. Tr. 483-84; GX 6. The number in the quantity
column is the amount of dosage units dispensed by the pharmacy of the
controlled substance. Tr. 485. On March 22, 2017, six prescriptions
were filled. The bottom-listed controlled substance is Carisoprodol.
Tr. 485; GX 6 at 2. The prescription immediately above is Oxycodone 30
mg. Tr. 486. The prescription above that is another controlled
substance, listed as Alprazolam. Two lines above Alprazolam, Morphine
Sulfate Extended is listed. Morphine Sulfate Extended is an opioid,
Alprazolam is a benzodiazepine, Oxycodone is an opioid, and
Carisoprodol is a controlled substance muscle relaxant. Together, these
controlled substances form a trinity. Dispensing these controlled
substances on the same day represents a red flag for the pharmacy. Tr.
486-87.
Dr. Schossow noted prescriptions paid for in cash indicated a red
flag.\20\ Tr. 851-53; GX 6 at 1-2; GX 23 at 61-63. There is also an
indication of a red flag for the payment of an unusually large amount
of cash for an opioid. Tr. 852-53, GX 6 at 2. Dr. Schossow identified
prescriptions demonstrating a red flag for combining extended release
and immediate release opioids. Tr. 853-57; GX 23 at 57, 61-63, 66-69,
72-74, 77-80; GX 35 at 10, 21, 11-14, 19, 20, 24-27.
---------------------------------------------------------------------------
\20\ Dr. Schossow conceded that she was not aware whether the
charged patients, who paid cash for the subject controlled
substances, later sought reimbursement from their insurance
companies. Tr. 1036.
---------------------------------------------------------------------------
On April 19, 2017, another series of prescriptions were filled,
including Morphine Sulfate, Oxycodone 30 mg, 90 units of Alprazolam,
and Carisoprodol. Tr. 487-88; GX 6. This is a trinity combination. In
addition, the patient was also on Gabapentin and Butalbital, Aspirin,
and Caffeine, which are also additional CNS depressants, which make
this combination even more dangerous. These were prescription numbers
734 through 737; GX 6 at 2. On May 19, 2017, another series of
prescriptions were filled, including Morphine Sulfate, Oxycodone 30 mg,
Alprazolam, and Carisoprodol. Tr. 488; GX 6 at 2. This is a trinity
combination and a red flag. Tr. 488-89.
On June 16, 2017, another series of prescriptions were filled,
including Morphine Sulfate, Oxycodone 30 mg, Alprazolam, and
Carisoprodol. Tr. 489. This is a trinity combination and a red flag.
These included prescription numbers 1306, 1317, 1319, and 1321.
On July 14, 2017, another series of prescriptions were filled,
including Morphine Sulfate, Oxycodone 30 mg, Alprazolam, and
Carisoprodol. Tr. 489-90. This is a trinity combination and a red flag.
These included prescription numbers 1627, 1628, 1633, and 1634.
On August 11, 2017, another series of prescriptions were filled,
including Morphine Sulfate Extended Release, Oxycodone 30 mg,
Alprazolam 10 mg, and Carisoprodol. Tr. 490. This is a trinity
combination and a red flag. These included prescription numbers 1946,
1947, 1950, and 1951.
On September 8, 2017, another series of prescriptions were filled,
including Morphine Sulfate, Oxycodone 30 mg, and Alprazolam 10 mg. Tr.
491. These included prescription numbers 2250, 2251, and 2252. There
was no Carisoprodol issued on this date. It is still a dangerous
combination because all of those drugs suppress the central
[[Page 72705]]
nervous system and can lead to respiratory depression, overdose, and
death.
The records indicate which pharmacist actually filled the
prescription. Tr. 492. At the top of the patient record, the initial
RPH, which means registered pharmacist, lists the initials of the
pharmacist that filled the prescription. Tr. 492; GX 6 at 1.
On October 6, 2017, another series of prescriptions were filled,
including Morphine Sulfate, Oxycodone 30 mg, Alprazolam, and
Carisoprodol. Tr. 497-98; GX 6. This is a trinity combination and a red
flag. These included prescription numbers 2603 to 2606.
On November 3, 2017, prescriptions were filled, including Oxycodone
30 mg and Alprazolam. On November 6, 2017, prescriptions were issued,
including Morphine Sulfate and Carisoprodol. Tr. 498-99. This is a
trinity combination and a red flag. These included prescription numbers
3034, 3036, 3062, and 3064. It is a red flag as the medications were
dispensed so close in time.
On December 1, 2017, another series of prescriptions were filled,
including Oxycodone 30 mg and Alprazolam. Tr. 499. These included
prescription numbers 3474 and 3475. These prescriptions represent a red
flag. Tr. 500. Both of these drugs depress the central nervous system
and the Oxycodone dosage is the highest strength available, which in
itself is a red flag. These prescriptions fall under the FDA black box
warning and 2016 CDC guidelines that specifically recommend against
taking benzodiazepines with opioids. Although familiar with the 2016
CDC Guidelines, and upon which she relied in forming her opinions
herein, Dr. Schossow was unfamiliar with the clarification issued,
which clarified that the 2016 Guidelines did not apply to patients on
long-term opioid treatment. Tr. 992-94. Dr. Schossow conceded that if a
patient had been on a long-term drug regimen, that would be a
consideration of the pharmacist in conducting the DUR analysis. Tr.
1035. Dr. Schossow clarified that she had previously reviewed the CDC's
clarification to the 2016 CDC Guidelines, and noted it did not change
her opinion as it did not relate to the combination of benzodiazepines
and opioids. Tr. 1060-64.
On December 29, 2017, another series of prescriptions were filled,
including Oxycodone 30 mg, Alprazolam, Morphine Sulfate, and
Carisoprodol. Tr. 503; GX 6. These included prescription numbers 3973,
3975, 3976, and 3979. These prescriptions represent a trinity and thus
a red flag.
On January 26, 2018, another series of prescriptions were filled,
including Oxycodone 30 mg and Alprazolam. Tr. 503. These included
prescription numbers 4549 and 4550. On January 31, 2018, Morphine
Sulfate Extended Release was issued, which includes prescription number
4658. Tr. 504. These prescriptions are a combination of opioid and
benzodiazepine and thus represent a red flag.
Dr. Schossow identified the actual prescriptions for Patient J.B.
Tr. 504-05; GX 7. She did not see any resolution of red flags
documented for any of the subject prescriptions that were filled. Tr.
505-06; GX 7 at 1-69. The notation ``PDMP'' on the back of the
prescription would mean that the pharmacist checked the PDMP before
filling the prescription. Tr. 506; GX 7 at 18. This does not resolve
the red flag as there are several red flags present regarding that
prescription. Tr. 507. The red flags include the high strength of the
Oxycodone at 30 mg. The second is that the medication is over 50 mg
MME, which puts the patient at risk for CNS depression, overdose, and
death. The third red flag is the scheduling of an immediate relief
opioid. Checking the PDMP did not resolve or address any of those red
flags, but only satisfied part of the law that requires the pharmacist
to check the PDMP to ensure the patient is not doctor or pharmacy
shopping and to check the total milligram of MME. Reference to the PDMP
does not contribute to resolving any of the red flags related to the
prescription. Tr. 507-08. Dr. Schossow identified a patient computer
profile for Patient J.B. Tr. 529-30; GX 35.\21\ She did not see any
documentation or resolution of the red flags previously discussed on
the first page. Tr. 530, 857-58; GX 35, p. 1. She did not see any
documentation of red flags, or the resolution thereof, in the patient
profile, particularly under the critical comments section where the
pharmacist can fill in comments. Tr. 493-96, 504, 857-58. Nor did she
see any indication the medical records or dispensing log for J.B.
indicated the subject red flags as to J.B. were addressed, resolved or
documented. Tr. 858-59; GX 35 at 2-5, 8, 9.
---------------------------------------------------------------------------
\21\ Although both parties used the term, ``patient profile'',
Dr. Schossow confirmed the Florida subject regulations did not
define the term. Tr. 1035.
---------------------------------------------------------------------------
There were additional prescriptions of the same opioid and
benzodiazepine (Oxycodone 30mg, and Xanax) that were also red flags,
based upon the cocktail created by the controlled substances, which are
central nervous system depressants, which can cause sedation,
respiratory depression, overdose, coma, and death. Tr. 530-34; GX 35,
pp. 6-7, 10, 11-16, 21. There were additional prescriptions for
Oxycodone, Xanax, and Morphine that were red flags for the same
reasons. Tr. 533-34; GX 35 at 17-20, 22-27. Dr. Schossow did not see
any indication of red flags being documented or resolved on the
prescriptions. Tr. 534, 857-58, 860; GX 35 at 2-27.
Dr. Schossow opined that a pharmacist, acting within the relevant
standard of care, when confronted with the red flags revealed within
the subject records for Patient J.B., would not have filled the subject
prescriptions without addressing, resolving, and documenting the red
flags discussed. Tr. 859-60; GX 5 at 1.
Patient L.V.
Dr. Schossow identified a patient medication dispensing report
printout for Patient L.V. Tr. 510; GX 6 at 6. On March 2, 2017,
prescriptions for Morphine Sulfate, Alprazolam, and Oxycodone were
filled. Tr. 511. They are included as prescription numbers 308 to 310.
Dispensing these medications on the same day causes concern and serves
as a red flag as they each suppress the CNS and fall under the FDA
black box warning for risk of sedation, respiratory depression, coma,
and death.
Oxycodone is an opioid and Xanax is a benzodiazepine. Tr. 513.
Looking at fill stickers, these prescriptions were issued on February
23, 2018. Tr. 513-14; GX 23 at 2, 4. These prescriptions are a red flag
since they both depress the central nervous system and fall under the
prospective DUR for drug interaction and side effects. Tr. 514-15.
Viewing additional prescriptions, Oxycodone 30, Xanax 1 mg, and Soma
were both filled on March 21, which again, represents a trinity. Tr.
515; GX 23 at 8-10. There are two more prescriptions for Xanax and
Oxycodone 30 mg, which indicate a red flag because an opioid and
benzodiazepine were filled on the same day. Tr. 516; GX 23, p. 11, 14.
A prescription for an opioid, Oxycodone 30 mg, and a
benzodiazepine, Alprazolam 2 mg, prescriptions 5127 and 5129, are a red
flag. Tr. 520; GX 7 at 1-4. There were additional prescriptions of the
same opioid and a benzodiazepine (Oxycodone 30mg and Xanax) that were
also red flags, based upon the cocktail created by the controlled
substances, which are a central nervous system depressant, and can
cause sedation,
[[Page 72706]]
respiratory depression, overdose, coma, and death. Tr. 521-28; GX 7 at
8-9, 10-11, 14-17, 22-25, 26, 28-29, 31-36, 37, 40-42, 43, 46-47, 49,
55-59, 60-65, 66-71, 72-76, 77-82. When checking both the front and
back of the prescriptions, Dr. Schossow did not see any indications
that any of the red flags were documented or resolved as to any of the
subject prescriptions. Tr. 529.
Additional red flags for cash payments were present. Tr. 758, 767-
68, 772-74, 776, 778; GX 15 at 1-6, 7-12, 13-8, 19-21, 25, 27, 31-36,
38, 40, 43-48, 50, 52, 56, 58, 62, 64, 75-80. Red flags for the
unusually high amount of the cash payment were also present. Tr. 758-
64, 767-68, 772, 775-78; GX 15 at 8, 16, 22, 34, 50, 58, 64, 76.
An additional matter of suspicion arose in L.V.'s alternate use of
insurance to pay for benzodiazepine prescriptions in lieu of the many
cash payments for opioids, especially considering the high prices L.V.
paid for them. Tr. 768-76, 677-78; GX 15 at 30, 31-36, 42, 48, 54, 60,
71, 72, 75.
Patient A.B.
Dr. Schossow identified patient computer profiles and prescriptions
for Patient A.B. Tr. 534-35, 538; GX 8, 24. Viewing the prescriptions
in the patient profile, she found that the listed prescriptions, which
included combinations of a benzodiazepine and an opioid to create a
cocktail, which are a central nervous system depressants, again were
red flags. Tr. 535-38; GX 3 at 1-6, 7-12, 13-18, 19-24; GX 24 at 1-6,
7-12, 13-18, 19-24, 26-31, 32, 33, 35, 38, 39, 40, 42-45. These
prescriptions included additional controlled substances, including
Diazepam (a benzodiazepine), Hydromorphone, OxyContin, and Valium (a
benzodiazepine). Tr. 540-41. She did not see any of the subject red
flags documented or resolved in the prescriptions that she reviewed.
Tr. 539; GX 8.
Patient T.G.
Dr. Schossow identified a patient medication dispensing report
printout for Patient T.G. Tr. 509-10; GX 6 at 3. She also identified
the patient profile prescriptions for Patient T.G. Tr. 556; GX 12. She
identified ``ACQ Cost'' in the record, as referring to acquisition
cost. Tr. 556; GX 1 at 2. Viewing the second column, she saw an
acquisition price of $43.19. Tr. 557. Further up on the same page in
the record, there was a ``price paid'' in the same column. The price
paid was $480. This accounting occurred with additional groups of
prescriptions for this patient. Tr. 563; GX 12 at 5-8, 10. In Dr.
Schossow's opinion, the amount paid by a customer can be a red flag.
Tr. 563-65.\22\
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\22\ Dr. Schossow has experience working in retail for twelve
years in different pharmacies all over the State of Florida, but not
including southwest Florida. Tr. 564. There are regional variations
for the prices of medication, but the typical mark-up of medications
is around 20 to 25 percent. Tr. 565. Dr. Schossow is familiar with
the price of these medications during the charged period from her
time working in hospice. Tr. 566. She worked with the rejection
queue with high-cost medications for patients all over the State of
Florida. Tr. 566-67. She was the lead of the team, and a trainer for
the queue, so everyone who she trained understood normal pricing for
Oxycodone and Hydromorphone. The mark-up is about 20 percent over
the pharmacy's acquisition cost. There are slight variations
regionally in different counties and different areas of Florida, but
the typical mark-up is 20 to 25 percent over the acquisition. Tr.
569. When Dr. Schossow sees very high prices, it is a red flag.
Hospice also would not pay for it, so she would contact the pharmacy
and inquire how much they paid for it. Dr. Schossow could not
definitively quantify what the slight variations would be, but it
would typically be around 20 percent at most. Tr. 569-70. I
overruled the Respondent's objections to Dr. Schossow's testimony
and allowed her to testify about the acquisition cost and how she
determined that the price paid is much higher than what would
normally be charged in Florida, even with slight variations in
prices regionally. Tr. 571-72.
---------------------------------------------------------------------------
Dr. Schossow's experience in the pricing of medications in Florida
reflected an approximate twenty percent mark-up from acquisition cost.
Tr. 570-72. She also did research on her own of the pricing of the
subject medications within the subject locale. She phoned pharmacists
at Walgreens and CVS and obtained the actual prices for the subject
medications.\23\
---------------------------------------------------------------------------
\23\ The Respondent objected to this hearsay evidence, and it
was ruled inadmissible as the individuals who provided the pricing
information were not identified in the Government's Supplemental
Prehearing Statement, as required by the Order for Prehearing
Statements. Tr. 572-78, 1009-10; ALJ Ex. 6.
---------------------------------------------------------------------------
Viewing Patient T.G.'s patient profile prescriptions, the type of
payment was an ``RX-lock'', which Dr. Schossow understood to mean a
cash payment. Tr. 579; GX 12 at 13-16. It applied to both
prescriptions. The method of payment and the amount paid by the
customer are red flags. This also applied to additional prescriptions
for Patient T.G.\24\ Tr. 580-83, 589-94; GX 12 at 17-20, 21-24, 25-28,
29-32, 33-34, 35-38, 39-42; GX 28 at 1-4, 5-8, 9-10, 11-12, 13-14, 15-
17. There was no documentation that the red flags relating to payments
in cash or high prices paid were flagged or addressed by the pharmacy.
Tr. 595-96; GX 5 at 2; GX 20. A pharmacist acting in the usual course
of professional practice would not have filled the charged
prescriptions without addressing those red flags and documenting the
resolution. Tr. 596-97.
---------------------------------------------------------------------------
\24\ I sustained the Respondent's objections to Dr. Schossow
speculating on the connection between the price paid for the
prescription and how the drug-seeking community is taking advantage
of using this system, including the pharmacy's reputation within the
community as without established foundation. Tr. 583-89.
---------------------------------------------------------------------------
Patient S.K.
Dr. Schossow identified the patient profile prescriptions for
Patient S.K. Tr. 597; GX 13. All of the prescriptions were paid for in
cash, which is a red flag. Tr. 597-98; GX 13, pp. 1-6. It is also a red
flag for the high amount of cash paid by the customer. Tr. 598; GX 13
at 2. There are additional concerns for these prescriptions. Looking at
the first prescription, the first concern is that the doctor is writing
for the highest dosage of immediate release Hydromorphone; the second
is that the doctor scheduled the medication, which is usually given as
a PRN (``take as needed'') dosing or breakthrough medication; and the
third is that the prescription was written for an anxiety disorder,
while Hydromorphone is not indicated for anxiety. Tr. 598-99; GX 13 at
1.
Another prescription written for this patient included concerns
that the doctor wrote a prescription for Morphine ER 15 mg, one tablet,
twice daily. Tr. 599. This prescription was concerning because the
prescription was for an opioid. It was also concerning because the
pharmacist did not address that the prescription was for an anxiety
disorder, for which Morphine is not indicated. Another concern was that
long-acting opioid prescriptions were developed by the manufacturers to
limit the number of PRN medications the patient would have to take. In
this case, the lowest dosage of Morphine was 15 mg twice a day, along
with the Hydromorphone 8 mg, which is equivalent to around 32 mg of
Morphine four times per day. It is not within the standard of care for
a low-dose Morphine to be prescribed with the highest dose of another
opioid. Tr. 599-600.
In order for a pharmacist to safely dispense medication, she must
know the dosing and how long the drug lasts in the body. Tr. 603.
Pharmacists know that Hydromorphone lasts in the body from two to four
hours, while a long-acting opioid like MS Contin lasts in the body
eight to twelve hours. Long-acting opioids were meant to reduce the
amount of immediate release opioids given. In this case, there are very
high doses of immediate release opioids, which are usually given on an
as-needed basis because they only last a short time. When working in
pain management, the doctor determines the total daily dose of the MME
and schedules that dose on the basis of the long-acting opioid; the
doctor does not
[[Page 72707]]
give more immediate release medication than a long-acting opioid. Tr.
1036-37. In this case, because the way the doctor wrote the
prescription did not make pharmacological sense, the pharmacist should
have done his due diligence to address the inappropriate dosing of the
medications. Tr. 605. Dr. Schossow did not see any documentation on the
resolution of these red flags, including the pharmacist contacting the
doctor. Improper pharmacological drug dosing is discussed in ``Florida
Rule 64B16-27.810.'' Tr. 605. The lower dose of the long-acting opioid
with the higher doses of the short-acting opioid is a red flag. Tr.
606. This is something the pharmacy should have addressed.
The first two prescriptions for the patient are opioids and the
third prescription is for Clonazepam, which is a benzodiazepine. Tr.
606; GX 13 at 1-6. Taken together, these prescriptions represent a
cocktail, which is a red flag. Additional prescriptions given to the
patient indicate red flags for cash payments, the high price paid by
the patient, the dosages of the medications, improper medications for
listed conditions, and cocktail combinations. Tr. 606-11, 612-24, 626-
40; GX 13 at 7-12, 13-18, 19-24, 25-30, 31-36, 37-42, 43-48, 49-54, 55-
60, 61-66, 67-72, 73-78; GX 29 at 1-6, 7-12, 13-18, 19-24, 25-30, 31-
33, 34-39, 40-45, 46-49, 50-53, 54-57, 58-61, 62-65, 66-69, 70-73, 74-
79.
A Florida pharmacist operating within the standard of care should
have resolved the red flags and documented that resolution that were
identified for Patient S.K. for subsequent pharmacists to assure
continuity of care and patient safety, assuming the red flags were
resolvable. Tr. 640-41. Looking at the patient profile, there was
nothing in the patient profile or prescriptions for Patient S.K. to
suggest that any sort of investigation was done or that the red flags
were addressed, resolved, or documented. Tr. 641; GX 21. A reasonable
pharmacist acting in the usual course of professional practice would
not have filled these prescriptions without addressing, resolving, and
documenting such resolution of the red flags. Tr. 641.
Patient R.R.
Dr. Schossow identified the patient profile prescriptions for
Patient R.R. Tr. 641-42; GX 14. The prescriptions present red flags for
cash payment. Tr. 642; GX 14 at 1-7. They also indicate a red flag for
high prices paid by the patient. Tr. 642; GX 14 at 2. They also
indicate a red flag for cocktail medications. An additional
prescription is for Alprazolam or Xanax 2 mg, which is the highest
strength available. Tr. 643; GX 14 at 5-6. This drug is called ``Xany
Bars'' on the street, and is a highly sought-after diverted medication.
Although it is not usual to dose this medication to half a tablet, it
raises a red flag with this particular drug that the instructions were
to dispense 30, which is the entire tablet. The pharmacist should
address why the patient is prescribed 2 mg in order to take half a
tablet of a highly sought-after medication, when Xanax 1 mg is
available. Tr. 643-44. Dr. Schossow has never seen Xanax directions
like this. This prescription represents a red flag with respect to the
nature of the dispensing order of the controlled substance. Tr. 644-45.
The additional prescriptions issued to the patient demonstrated these
red flags, including red flags for clinical abuse use under Florida
Regulation 810,\25\ inappropriate clinical and therapeutic dosing, and
extended release opioids combined with immediate release opioids. Tr.
645-47, 648-66, 666-73; GX 14 at 8-13, 14-19; GX 31 at 1-6, 7-12, 13-
18, 22-25, 27-28, 29-30, 32-33, 34-35, 37-38, 40-41, 42-47, 48-51, 52-
55, 56-59, 60-63, 64-69, 70-75; GX 40 at 8-11, 12-13, 14-15, 16-19, 20-
23, 24-29, 30-31.
---------------------------------------------------------------------------
\25\ Florida Administrative Rule 64B16-27.810.
---------------------------------------------------------------------------
A Florida pharmacist operating within the standard of care should
have acknowledged the therapeutic inappropriateness of the
prescriptions, and should have contacted the patient or the provider
and recorded the resolution of those red flags, if they were
resolvable. Tr. 673. Dr. Schossow believed all red flags herein were
resolvable. Tr. 1038, 1068. Dr. Schossow did not see any indication on
the prescriptions for Patient R.R. that any specific red flags were
identified or documented or resolved on any of the prescriptions. There
is nothing in the patient profile to suggest that an investigation was
done or that the red flags were identified, resolved or documented in
the patient profile. Tr. 673; GX 40 at 1. The critical comments listed
did not address or show how the red flags or DURs were resolved. Tr.
673-74. None of the documents in the dispensing log address the red
flags for the prescriptions. Tr. 674; GX 40 at 2-7. Based on a review
of the prescriptions, the patient profile, or any other documents for
Patient R.R., Dr. Schossow opined that a reasonable pharmacist acting
in the usual course of profession practice would not have filled the
charged prescriptions without addressing, resolving, and documenting
the red flags for this patient. Tr. 674.
Patient R.D.
Dr. Schossow identified the patient profile prescriptions for
Patient R.D. Tr. 675-76; GX 10. She noted that Ativan is a
benzodiazepine. Tr. 676. The prescriptions indicate a red flag for
cocktail medications. Tr. 676; GX 10 at 1-4. They also indicate a red
flag for payment of cash for controlled substance prescriptions. They
further indicate a red flag for the high amount of cash paid for
controlled substances. Dr. Schossow explained that one of the
medications is Hydromorphone 8 mg, which is the highest dosage of
medication commercially available for this medication. Tr. 677.
Although the prescribing physician said the medication was not only for
anxiety, but also to manage hypertension, this medication does not
treat anxiety or hypertension. This is very dangerous because there
were no records that the pharmacist attempted to contact the physician
to discuss the red flag. Tr. 677.
There was an additional red flag present with Patient R.D. Tr. 678.
The red flag involved long distances traveled by the patient. Tr. 678-
79; GX 10 at. 1-2. Dr. Schossow looked up the address of the doctor,
the patient, and the pharmacy, which she characterized as an abnormally
long distance. Additionally, there were other pharmacies that were very
close. Dr. Schossow had concerns with the patient traveling longer than
necessary to get to the Respondent pharmacy and then paying ``double
the amount'' for the prescription. Tr. 679. A community pharmacist
knows her community and the area around it, so this presents a safety
issue. Tr. 682, 1032. Dr. Schossow would defer to a local community
pharmacist's knowledge of the subject area. Tr. 1032. For example,
central nervous system depressant drugs suppress the central nervous
system and cause drowsiness, dizziness, and profound sedation,
including a warning on operating heavy machinery. If a patient can
drive across the street to obtain her medication versus driving
further, it is safer for the patient. Tr. 950-53.
Dr. Schossow did not suggest that distance is a reason not to fill
a prescription, but it is a reason to ask more questions and clear up
concerns. Tr. 682-83, 954-58. In this case, there was no such
documentation. Dr. Schossow mapped all of the relevant cities and
determined the route that the patient used. The patient lived very far
west, had to cross over three bridges to get to the prescribing
physician, and then crossed over another bridge to get
[[Page 72708]]
to the pharmacy. These prescriptions issued to Patient R.D. thus
presented a red flag for distance. Tr. 684; GX 10 at 1-4.
The additional prescriptions issued to the patient demonstrated the
previously discussed red flags. Tr. 685-701; GX 10 at 5-8, 9-12; GX 26
at 1-4, 5-8, 9-12, 13-16, 17-20, 21-23, 24-27, 28-31, 32-35, 36-39, 40-
43, 44-47, 48-51, 52-55, 56-59.
A Florida pharmacist operating within the standard of care must
make a reasonable effort to address each red flag for therapeutic
appropriateness through either the patient and/or the physician,
document if the red flag is resolved, and maintain those records. Tr.
701. Looking at the patient profile and prescriptions, there is nothing
to suggest that an investigation or assessment was done of any of the
red flags identified by Dr. Schossow. Tr. 701-02; GX 10, 19, 26. In the
patient profile, the comments in the critical comments popup box do not
address the red flags identified by Dr. Schossow. Tr. 702; GX 19. Based
on her review of the prescriptions and patient profile, Dr. Schossow
opined that a reasonable pharmacist acting in the usual course of
professional practice would not have filled the prescriptions for
Patient R.D. without addressing, identifying, resolving, and
documenting the red flags observed and charged by the Government. Tr.
702.
Patient J.R.
Dr. Schossow identified the patient profile prescriptions for
Patient J.R. Tr. 702-03; GX 30. The prescriptions issued to the patient
present a red flag for cocktail combinations or a trinity. Tr. 703; GX
30, p. 47-54. The prescriptions contain two benzodiazepines,
Carisoprodol or Soma, and an opioid, Hydrocodone. Tr. 703-04. The
prescriptions also indicate another red flag that falls under
Regulation 810 \26\ of the DUR for therapeutic duplication. Tr. 704; GX
10 at 49-50, 53-54. Therapeutic duplication means two drugs that are in
the same class, and thus act in the same way. With Patient J.R., there
are two medications that are benzodiazepines and they are both long-
acting benzodiazepines. They are Temazepam and Diazepam. This
represents a dangerous combination. The two medications duplicate
effects and are therapeutically inappropriate because they can compound
the side effects of each other. These side effects include CNS
depression, leading to respiratory depression, pronounced sedation,
overdose, and death. Tr. 704-05. Additional prescriptions to Patient
J.R. also indicated these red flags. Tr. 705-07; GX 30 at 55-60, 61-68.
---------------------------------------------------------------------------
\26\ Florida Administrative Rule 64B16-27.810.
---------------------------------------------------------------------------
Patient J.R. was prescribed additional trinity cocktails. Tr. 708-
09; GX 39 at 3-4, 13-14, 31-34. The patient received an opioid, the
muscle relaxer Carisoprodol, and two long-acting benzodiazepines. Tr.
710. The prescriptions also indicated a red flag of therapeutic
duplication of benzodiazepines. Tr. 710; GX 39 at 31-34. Additional
prescriptions indicated these red flags. Tr. 710-16; GX 39 at 2, 7-10,
11-12, 15-16, 35-38.
A Florida pharmacist operating within the standard of care should
have made a reasonable effort to contact the patient and/or the doctor
and inquire about the therapeutic inappropriateness of the medication,
the risk involved in taking the medications together, and if the
therapeutic inappropriateness was resolvable, to document the
resolution and maintain those records. Tr. 716-17. There is nothing in
the patient profile or prescriptions that suggests that an
investigation was done of any of the red flags or that the red flags
were resolved. Tr. 717; GX 39 at 1. A reasonable pharmacist acting in
the usual course of professional practice would not have filled the
prescriptions for Patient J.R. without addressing, resolving, and
documenting the red flags that have been charged by the Government. Tr.
717.
Patient B.Di.
Dr. Schossow identified the patient profile prescriptions for
Patient B.Di. Tr. 718-19; GX 11. Prescriptions indicated a red flag for
cash payment for controlled substance prescriptions. Tr. 719; GX 11 at
1-6. There is also an indication of a red flag for the payment of an
unusually large amount of cash for an opioid. Tr. 719; GX 11 at 2. The
prescriptions taken together represent a red flag for cocktail
medications with respect to opioids and benzodiazepines. Finally, the
prescriptions for Dilaudid 8mg and MS Contin 30 mg, extended release,
indicate a red flag for opioid dosing. Tr. 719-20; GX 11 at 1, 3.
Additional prescriptions indicated the previously discussed red flags.
Tr. 720-43; GX 11 at 7-12, 13-18, 19-24, 25-30, 31-36, 37-42, 43-48,
49-54, 55-60; GX 27 at 1-6, 7-12, 13-18, 19-23, 24, 26-27, 29-30, 32-
35, 36-39, 41-42, 43-44, 46-49, 50-55, 56-61, 62-67, 68-73, 74-79, 80-
83, 86-93; GX 38, pp. 5-6, 7-10, 11-14, 15-16, 17-18, 19-20, 21-22.
A Florida pharmacist operating within the standard of care should
have addressed each red flag of concern, documented it appropriately in
his patient record, and maintained those records. Tr. 743-44. There is
nothing in the patient profile or in the prescriptions to suggest that
any sort of investigation or resolution was made or attempted or
documented with respect to the identified red flags. Nothing in the
patient profile indicated that any of the prescriptions were reviewed.
A reasonable pharmacist acting in the usual course of professional
practice would not have filled the prescriptions for Patient B.Di.
without first addressing, resolving, and documenting the specific red
flags identified by Dr. Schossow. Tr. 744.
Patient B.Da.
As to Patient B.D.a., prescriptions indicated a red flag for cash
payment for controlled substance prescriptions. Tr. 745-46; GX 9 at 1-
6. There is also an indication of a red flag for the payment of an
unusually large amount of cash for an opioid. Tr. 745; GX 9 at 4. The
prescriptions taken together represent a red flag for cocktail
medications with respect to opioids and benzodiazepines. Finally, the
prescriptions demonstrate a red flag for long distance travel, with the
patient traveling from Bokeelia, Florida. Tr. 745-46; GX 9 at 1-6.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 746; GX 9 at 7-12. The
prescriptions taken together represent a red flag for cocktail
medications with respect to opioids and benzodiazepines. Finally, the
prescriptions demonstrate a red flag for long distance travel. Tr. 747;
GX 9 at 7-12.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 747; GX 9 at 13-18. There is
also an indication of a red flag for the payment of an unusually large
amount of cash for an opioid. Tr. 747; GX 9 at 14. The prescriptions
taken together represent a red flag for cocktail medications with
respect to opioids and benzodiazepines. Finally, the prescriptions
demonstrate a red flag for long distance travel, with the patient
traveling from Bokeelia, Florida. Tr. 748; GX 9 at 13-18.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 748; GX 9 at 19-24. There is
also an indication of a red flag for the payment of an unusually large
amount of cash for an opioid. Tr. 749; GX 9 at 20. The prescriptions
taken together represent a red flag for cocktail medications with
respect to opioids and benzodiazepines. Finally, the prescriptions
demonstrate a red flag for long distance travel, with the patient
traveling from Bokeelia, Florida. Tr. 749; GX 9 at 19-24.
Additional prescriptions indicated a red flag for cash payment for
controlled
[[Page 72709]]
substance prescriptions. Tr. 749; GX 9 at 25-30. There is also an
indication of a red flag for the payment of an unusually large amount
of cash for an opioid. Tr. 749; GX 9 at 30. The prescriptions taken
together represent a red flag for cocktail medications with respect to
opioids and benzodiazepines. Tr. 749; GX 9 at 25-30. Finally, the
prescriptions demonstrate a red flag for long distance travel, with the
patient traveling from Bokeelia, Florida. Tr. 748.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 750; GX 25 at 1-3. The
prescriptions taken together represent a red flag for cocktail
medications with respect to opioids and benzodiazepines. Tr. 751; GX 25
at 1-3. The prescriptions demonstrate a red flag for combining extended
release and immediate release opioids. Tr. 751; GX 25 at 1-3. Finally,
the prescriptions demonstrate a red flag for long distance travel, with
the patient traveling from Bokeelia, Florida. Tr. 748.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 752; GX 25 at. 7-12. The
prescriptions taken together represent a red flag for cocktail
medications with respect to opioids and benzodiazepines. Tr. 752; GX 25
at 8. The prescriptions demonstrate a red flag for combining extended
release and immediate release opioids. Tr. 752; GX 25 at 7-12. Finally,
the prescriptions demonstrate a red flag for long distance travel, with
the patient traveling from Bokeelia, Florida. Tr. 748.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 752; GX 25 at 13-18. The
prescriptions taken together represent a red flag for cocktail
medications with respect to opioids and benzodiazepines. Tr. 752; GX 25
at 13-18. The prescriptions demonstrate a red flag for combining
extended release and immediate release opioids. Tr. 752; GX 25 at 13-
18. Finally, the prescriptions demonstrate a red flag for long distance
travel, with the patient traveling from Bokeelia, Florida. Tr. 748.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 752; GX 25 at 19-24. There is
also an indication of a red flag for the payment of an unusually large
amount of cash for an opioid. Tr. 752; GX 25 at 22. The prescriptions
taken together represent a red flag for cocktail medications with
respect to opioids and benzodiazepines. Tr. 752; GX 25 at 19-24. The
prescriptions demonstrate a red flag for combining extended release and
immediate release opioids. Tr. 753; GX 25 at 19-24. Finally, the
prescriptions demonstrate a red flag for long distance travel, with the
patient traveling from Bokeelia, Florida. Tr. 748.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 753; GX 37 at 24-25, 28-31.
There is also an indication of a red flag for the payment of an
unusually large amount of cash for an opioid. Tr. 753; GX 37 at 29. The
prescriptions taken together represent a red flag for cocktail
medications with respect to opioids and benzodiazepines. Tr. 753; GX 37
at 28-31. The prescriptions demonstrate a red flag for combining
extended release and immediate release opioids. Tr. 754; GX 37 at 28-
31. Finally, the prescriptions demonstrate a red flag for long distance
travel, with the patient traveling from Bokeelia, Florida. Tr. 748.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 754; GX 37 at 18-19, 22-23, 26-
27. There is also an indication of a red flag for the payment of an
unusually large amount of cash for an opioid. Tr. 754; GX 37 at 27. The
prescriptions taken together represent a red flag for cocktail
medications with respect to opioids and benzodiazepines. Tr. 754; GX 37
at 28-31. The prescriptions demonstrate a red flag for combining
extended release and immediate release opioids. Tr. 754; GX 37 at 28-
31. Finally, the prescriptions demonstrate a red flag for long distance
travel, with the patient traveling from Bokeelia, Florida. Tr. 748.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 755; GX 37 at 8-9, 16-17, 20-
21. The prescriptions taken together represent a red flag for cocktail
medications with respect to opioids and benzodiazepines. Tr. 755; GX 37
at 8-9, 16-17, 20-21. The prescriptions demonstrate a red flag for
combining extended release and immediate release opioids. Tr. 755; GX
37, pp. 8-9, 16-17, 20-21. Finally, the prescriptions demonstrate a red
flag for long distance travel, with the patient traveling from
Bokeelia, Florida. Tr. 748.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 755; GX 37 at 10-15. There is
also an indication of a red flag for the payment of an unusually large
amount of cash for an opioid. Tr. 755; GX 37 at 11. The prescriptions
taken together represent a red flag for cocktail medications with
respect to opioids and benzodiazepines. Tr. 756; GX 37 at 10-15. The
prescriptions demonstrate a red flag for combining extended release and
immediate release opioids. Tr. 756; GX 37 at 10-15. Finally, the
prescriptions demonstrate a red flag for long distance travel, with the
patient traveling from Bokeelia, Florida. Tr. 748.
Dr. Schossow opined that a pharmacist, acting within the relevant
standard of care, when confronted with the red flags revealed within
the subject records for Patient B.D.a., would have investigated the
therapeutic appropriateness of the subject prescriptions by contacting
the prescribing physician or patient, document if the red flags were
resolvable, and to maintain that documentation. Tr. 756. Nothing in the
patient profile, prescriptions nor medical records suggest any
investigation to identify, resolve or document the subject red flags.
Tr. 756-57; GX 37 at 1, 4-8.
Patient L.V.
Dr. Schossow identified prescriptions revealing the red flag for
cocktail medications with respect to opioids and benzodiazepines. Tr.
791, 794, 796, 797, 798-807; GX 32 at 1-8, 9-16, 25-28, 37-42, 44-51,
53-60, 61-68, 69-74, 75-80, 83-90, 91-98, 101-08, 109-114, 117-124.
Additional prescriptions indicated a red flag for cash payment for
controlled substance prescriptions. Tr. 794, 796-807; GX 32 at 9-16,
23, 24, 25-28, 37-42, 44-51, 53-60, 61-68, 69-74, 75-80, 83-90, 91-98,
101-108, 109-114, 117-124. Dr. Schossow noted a further red flag with
some prescriptions paid for by cash, while others were paid for by
insurance. Tr. 792-93, 794; GX 32 at 6, 8, 9-16. There is also an
indication of a red flag for the payment of an unusually large amount
of cash for an opioid. Tr. 793-807; GX 32 at 2, 10, 24, 26, 37, 47, 54,
64, 70, 75, 84, 94, 102, 110, 120.
Dr. Schossow opined that a pharmacist, acting within the relevant
standard of care, when confronted with the red flags revealed within
the subject records for Patient L.V., would not have filled the subject
prescriptions without addressing, resolving and documenting the red
flags discussed. Tr. 812-13. Nothing in the patient profile,
prescriptions nor medical records suggest any investigation to
identify, resolve or document the subject red flags. Tr. 808-09, 812-
13; GX 5 at 3; GX 6 at 5-6; GX 22.
Patient A.B.
Dr. Schossow identified prescriptions demonstrating a red flag for
combining extended release and immediate release opioids. Tr. 813-16,
819-823, 825, 827-28, 830, 831, 832, 833-34, 835-41, 842-43, 845-48; GX
8 at 1-4, 7-10, 13-16, 19-22; GX 24 at 1-4, 7-10, 13-16, 26-
[[Page 72710]]
29, 32-33, 37-38, 40-41, 44-47, 50-53, 56-59, 62-63, 68-71, 74-77, 80-
83, 86-89, 92-95; GX 36 at 17-20, 21-24, 27-30. Additional
prescriptions indicated a red flag for cash payment for controlled
substance prescriptions. Tr. 814, 820-21, 823, 827, 828, 830, 831-34,
836-41, 843, 845-47, 848-49; GX 8 at 1-4, 7-10, 13-16; GX 24 at 1-4, 7-
10, 26-29, 32-33, 37-38, 40-41, 44-47, 50-53, 56-59, 62-63, 68-71, 74-
77, 80-83, 86-89, 92-95; GX 36 at 17-20, 21-24, 27-30. There is also an
indication of a red flag for the payment of an unusually large amount
of cash for an opioid. Tr. 816-17, 820, 821-23, 825-27, 828-29, 830-32,
833-37, 839, 841, 842-44, 845-47, 848-49; GX 8 at 2, 8, 14, 20; GX 24
at 10, 20, 27, 32-33, 38, 47, 51, 53, 59, 63, 71, 77, 83, 87, 95; GX 36
at 20, 24, 30. Finally, the prescriptions demonstrate a red flag for
long distance travel, with the patient traveling from Bokeelia,
Florida. Tr. 748, 816-17, 820-21, 822, 824, 826, 827, 829-30, 832-37,
838-40, 841-44, 847, 848-50; GX 8 at 2, 8; GX 24, p. 4, 7-10, 13-16,
26-29, 33, 41, 44-47, 51, 53, 59, 63, 71, 77, 83, 87, 95; GX 36 at 17-
20, 21-24, 30.
Nothing in the patient profile, prescriptions nor medical records
suggest any investigation to identify, resolve or document the subject
red flags. Tr. 844-45; GX 36 at 1-12. Dr. Schossow opined that a
pharmacist, acting within the relevant standard of care, when
confronted with the red flags revealed within the subject records for
Patient A.B., would not have filled the subject prescriptions without
addressing, resolving and documenting the red flags discussed. Tr. 850-
51.\27\
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\27\ 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 the 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.
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Respondent's Case-in-Chief
The Respondent presented its defense through the testimony of five
witnesses: Dr. Daniel Buffington, L.V., J.R., Dr. N., and Dr. Ricard
Fertil.
J.R.\28\
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\28\ The testimony of patients of the Respondent was relevant as
relates to information they shared with the Respondent prior to the
filling of prescriptions, the protocols employed by the Respondent
in filling prescriptions, the reasons they traveled some distance to
fill their prescriptions, and as relates to the Respondent's
experience in filling prescriptions under 21 U.S.C. 823(f)(2). Any
patient testimony relating to the efficacy of their physician's
treatment and prescribing, whether their physician performed
consistent with professional standards, and whether the Respondent's
professional performance was consistent to professional standards
will not be considered herein. See ALJ Exs. 11, 14.
---------------------------------------------------------------------------
J.R. lives in Cape Coral, Florida and is a disabled Vietnam
veteran. Tr. 1310. He has service-connected disabilities as a result of
back problems, including four back surgeries, eye cancer, and suffers
from post-traumatic stress disorder. Tr. 1310-1313. Dr. D. has been his
pain management doctor for three or four years. Tr. 1313. J.R. began
seeing Dr. D. at his practice in Fort Myers, but Dr. D.'s practice has
since moved to Naples, Florida. Tr. 1314. Despite Dr. D.'s relocation,
J.R. drives to Dr. D.'s new office. Tr. 1314-15. Dr. D. has prescribed
J.R. Oxycodone, hydrocodone, and extended-release morphine sulfate. Tr.
1315. J.R.'s primary care doctor, Dr. M., also prescribed J.R.
diazepam, temazepam, and carisopridol, also known as Soma. Tr. 1316.
J.R. was a customer with Gulf Med Pharmacy for about two or three
years. Tr. 1317. J.R. provided the pharmacy a disk with his MRI from
the VA. Tr. 1317. Prior to becoming a customer at Gulf Med, J.R. filled
his prescriptions with Walgreens. Tr. 1318. Walgreens failed to provide
him with a prescription after a surgery so he went to the closest
pharmacy that could fill his prescription, Gulf Med. Tr. 1318. Gulf Med
is even closer than Dr. D.'s office in Naples, Florida. Tr. 1319. Gulf
Med always answered his questions to his satisfaction and provided him
with written or printed materials like brochures or informational
material for his opioid prescriptions. Tr. 1319. J.R. discussed
information regarding his medical history, treatment, and prescriptions
with Gulf Med staff that he had previously discussed with his doctors.
Tr. 1320. He spoke with Mr. Fertil about medication he was taking and
the ways he could wean himself off some medications and Mr. Fertil
appeared very knowledgeable about this. Tr. 1321. J.R. did in fact
taper off some of his medicines.
L.V.
L.V. lives at 1103 Northeast 32nd Terrace in Cape Coral, Florida
and serves as a billing manager for Charlotte Compassionate Care. Tr.
1292. She suffers from anxiety, cervical disc degeneration,
cervicalgia, lumbar or lumbrosacral disc degeneration, lumbago, partial
tear of a rotator cuff, chronic pain syndrome, breast cancer and was
diagnosed with COVID-19 in July 2020. Tr. 1293-94, 1298. She is a
patient of Dr. N. in Fort Myers, Florida. Tr. 1194. Dr. N. prescribed
certain medications to L.V. including 30 milligrams of oxycodone and
extended-release MS Contin 60 milligram and L.V. had previously been
prescribed alprazolam or Xanax. Tr. 1294.\29\ L.V. was previously a
customer of Gulf Med, but could not recall how many years she was a
customer there. Tr. 1301. She had gone to a different pharmacy,
Myerlee, but changed to Gulf Med because there was a delay in Myerlee
filling her prescriptions, which caused her a lot of pain for weeks at
a time until the prescriptions were filled. Tr. 1301-02.
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\29\ At this point in the testimony the Respondent's counsel
asked L.V. if she had ever discussed the risks associated with
taking an opioid and a benzodiazepine together. Tr. 1294. The
Government's counsel objected based on relevance and that the
information was not provided in the Respondent's prehearing
statement. Tr. 1295. The Tribunal sustained the objection of
relevance, see Tr. 1295, and after reviewing the Respondent's first
Supplemental Prehearing Statement, overruled the Government's second
objection about the testimony being unnoticed. Tr. 1298. The
Respondent's counsel next asked if L.V. takes her medications as
prescribed, the Government's counsel objected, and the Tribunal
sustained the objection based on relevance. Tr. 1298-99.
---------------------------------------------------------------------------
L.V. had tried using other pharmacies. Tr. 1302-03. Walgreens told
her to never come back to the pharmacy after putting her name in the
computer and Publix told her that it could not run the prescriptions
through her insurance and it would not fill her prescriptions. Tr.
1303. She then went to Gulf Med, where her prescriptions were filled in
a timely fashion at a reasonable price. Tr. 1303. She selected Gulf Med
over other pharmacies because it always had her medications at cheaper
prices. Tr. 1305. Gulf Med also provided her with informational
materials/brochures regarding the prescriptions it was dispensing to
her, which included a CDC pamphlet about prescription opioids. Tr.
1306. Based on discussions with her physician, Dr. N., she learned that
Dr. N. had been in contact with Gulf Med regarding her prescriptions.
Tr. 1307.
[[Page 72711]]
Dr. N.\30\
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\30\ Dr. N. is a treating physician of one of the charged
patients. His relevant testimony is limited to his interactions with
the Respondent prior to the filling of the subject prescriptions and
as relates to the Respondent's experience in dispensing controlled
substances. 21 U.S.C. 823(f)(2); ALJ Ex. 11.
---------------------------------------------------------------------------
Dr. N. has been a licensed physician since 1979 and is licensed in
New York, New Jersey, Massachusetts, Connecticut, and Florida. Tr.
1324-25. He completed his residency at Mount Sinai in New York and
currently practices in Fort Myers, Florida with a specialty in pain
management and anesthesiology. Tr. 1325.
Dr. N. is aware of what an FDA black box warning is.\31\ Dr. N.
treated a patient by the name of L.V., but could not recall how long he
treated her or what medications he prescribed her. Tr. 1327. It has
been in Dr. N.'s practice in the past to include an ICD-10 diagnosis
code on prescriptions he writes for his patients, which is a diagnosis
that Dr. N. gave for the patient. Tr. 1327-28.\32\
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\31\ At this point in the testimony, the Respondent's counsel
asked Dr. N. about the black box warning pertaining to the
prescribing of a combination of drug therapies and whether Dr. N.
prescribed certain medications. Tr. 1325-26. The Government's
counsel objected to both questions and the Tribunal sustained both
objections noting that the relevance of Dr. N.'s testimony was
limited to his interaction with the pharmacy. Tr. 1326.
\32\ After reviewing the Government's Exhibit 15, Page 1, Dr. N.
noted that the prescription in the exhibit was for 30 milligrams of
oxycodone and instructed the patient to take the medication up to
four times per day only when necessary to alleviate breakthrough
pain. Tr. 1330-31; GX 15 at 1. Government's Exhibit 15 on Page 3 is
for MS Contin, 60 milligrams. Tr. 1331; GX 15 at 3. Page 5 of
Exhibit 15 depicts a prescription for Xanax. Tr. 1331; GX 15 at 5.
MS Contin and oxycodone are opiate medications and Xanax is a
benzodiazepine. Tr. 1331.
---------------------------------------------------------------------------
Dr. N. could not recall whether pharmacies ever contacted him or
his office to verify prescriptions or ask questions about some of the
drug therapies he prescribed to his patient. Tr. 1332. Dr. N. is not
familiar with Gulf Med Pharmacy and could not recall whether he or his
staff communicated with Gulf Med Pharmacy or its staff about verifying
prescriptions or drug therapies. Tr. 1333.
Dr. Daniel Buffington
Dr. Daniel Buffington is a pharmacist practicing in Tampa, Florida.
Tr. 1081, 1087. Dr. Buffington received his PharmD degree from Mercer
University in Atlanta, Georgia and then completed a post-doctorate
degree residency and fellowship in clinical pharmacology at Emory
University. Tr. 1079. He has practiced as a pharmacist for over thirty
years. Tr. 1078, 1087.
Dr. Buffington has training in conducting drug diversion
investigations and has worked with attorneys general, states attorneys'
offices, the DEA, and local law enforcement. Tr. 1159. He helped these
agencies identify how healthcare investigations are different from
other investigations involving drug gangs or illicit drug sales. Tr.
1159-60. Dr. Buffington is active with the National Association of
Investigators and Drug Diversion Investigators, which is a
multidisciplinary organization that aids healthcare professionals in
understanding how to conduct and design investigations and look for
healthcare fraud, drug divergence, and substance abuse. Tr. 1160.
Dr. Buffington currently practices as a pharmacist in Tampa,
Florida at a practice where patients are referred who are typically
prescribed high-risk medications. Tr. 1080-85. Dr. Buffington also
provides consulting services to pharmacists, medical practitioners,
healthcare facilities and organizations, and law enforcement agencies.
Tr. 1080, 1085, 1087, 1091. This includes consulting with practices in
both Southeast and Southwest Florida. Tr. 1097. Dr. Buffington has
served in several capacities as a pharmacist, including direct
dispensing roles, administrative roles, and as a medication safety and
review officer. Tr. 1088. Although it is unclear how many prescriptions
Dr. Buffington has dispensed in the last year or five years, he has
experience making determinations about whether or not a particular
prescription should be filled for a controlled substance based on the
legitimacy or medical reason for its prescription. Tr. 1088-89.
Dr. Buffington also serves on the faculty at the University of
South Florida's Colleges of Medicine and Pharmacy where he teaches
toxicology, pharmacy law, and other healthcare administration and
practice management aspects. Tr. 1076, 1096. He has served as a guest
lecturer or taught pharmacy law at the University of Florida, Florida
A&M, Nova, Southeastern, Palm Beach, Mercer University, Marshall
University, and the University of Pittsburgh. Tr. 1097. Through
teaching these courses, Dr. Buffington must review applicable Florida
administrative code provisions and is therefore familiar with Florida
Administrative Rules 4B16-27.800, 64B16-27.810, and 64B16-27.831. Tr.
1098. Dr. Buffington is also familiar with the standard of care that
applies to pharmacists in the State of Florida as the standard of care
relates to these administrative code provisions, and corresponding
statutes of the federal Controlled Substances Act. Tr. 1099.\33\
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\33\ Dr. Buffington testified that the Federal Controlled
Substances Act does not have jurisdiction over the practice of
pharmacy in Florida. Tr. 1099.
---------------------------------------------------------------------------
Dr. Buffington reported he has testified as an expert witness on
over 300 occasions in state, federal, and administrative proceedings.
Tr. 1077-78, 1083, 1094. Dr. Buffington reported he has previously
testified in DEA administrative hearings before a DEA Administrative
Law Judge, but could not recall when or the names of any participants.
Tr. 1230. He has appeared as an expert with respect to the Florida
standard of care in a DEA administrative proceeding, but is unsure if
his testimony was credited by the DEA administrator in a final opinion.
Tr. 1230-31.\34\
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\34\ During cross-examination, the Government questioned Dr.
Buffington regarding his CV. Tr. 1201-1209. Dr. Buffington stated
that he was not admonished in a district court case in Ohio and his
testimony was not stricken for failing to include his legal
experience as part of his CV. Tr. 1208. Instead, Dr. Buffington
asserts that there was an issue with an Ohio court where the
opposing counsel claimed that Dr. Buffington's CV did not follow
Federal Rule 26 formatting and opposing counsel petitioned the court
for more detail. This updated information for Dr. Buffington's CV
was not provided by the deadline and therefore the testimony was
withheld and not permitted. Tr. 1209. Unlike the Government
counsel's assertion that the district court had found that this was
the third time Dr. Buffington failed to disclose legal testimony,
see Tr. 1210, 13-14, Dr. Buffington asserts that instead there was
simply a formatting issue and the court requested for him to include
more detail in another case with the same parties, and that the
corrected report was done but was missing a case. Tr. 1214.
---------------------------------------------------------------------------
In approximately February 2020, Dr. Buffington was contacted by a
firm representing Gulf Med Pharmacy and reviewed documents in the
instant case including copies of prescriptions, dispensing logs, and
PDMP data that was produced by the DEA as well as all exhibits offered
by both parties in this case. Tr. 1076-77. This included the Order to
Show Cause, the Government's Prehearing Statements, and other documents
such as CDC guidelines, statutes, administrative rules, and stakeholder
challenges. Tr. 1198-99. He also reviewed different statutes and
regulations, including Florida statute 766.102, which includes
pharmacists in the definition of a ``healthcare practitioner.'' Tr.
1233-34. Dr. Buffington also wrote the summaries of his testimony in
concert with counsel. Tr. 1198. He spent approximately ten to fifteen
hours preparing for this hearing. Tr. 1201.
Dr. Buffington testified that the standard of care in Florida does
not require a pharmacist to document in writing any specific resolution
of ``red
[[Page 72712]]
flags'' \35\ and in fact, he testified that the term ``red flags'' is
not mentioned in the Florida regulatory documents or the DEA guidance
documents, but rather is a DEA slang term.\36\ Tr. 1100, 1124, 1145.
Dr. Buffington testified that Florida Code 64B16-27.810 merely states
what exercise a pharmacist is supposed to perform professionally in the
process of evaluating the prescription, not what is required
documentation. Tr. 1100. Dr. Buffington stated that the standard of
care for a pharmacist in Florida is based on the level of care that a
reasonable pharmacist would use in like circumstances and reasonable
pharmacists could disagree about what the requirements are for
documentation of prescriptions in the state of Florida. Tr. 1101, 1249.
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\35\ [Omitted for brevity.]
\36\ Dr. Buffington noted that these items should be referred to
as ``yellow flags'' or ``yellow lights'' as opposed to ``red flags''
because these are things that should be factored and considered. Tr.
1124.
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Dr. Buffington testified that Florida's guidelines are clear that a
pharmacist must exercise his or her professional judgment in evaluating
each prescription and such judgment should have the patient's safety
and therapeutic outcomes in mind. Tr. 1101-02, 1135.\37\ He testified
that, based on a review of all the prescriptions identified in the
Government's exhibits that were admitted into evidence, as well as
Respondent's exhibits, the pharmacists at Gulf Med Pharmacy complied
with the applicable standard of care as it relates to documentation of
the resolution of red flags and the DEA provided no substantive
evidence to presume otherwise. Tr. 1109, 1112. Furthermore, Dr.
Buffington testified that Florida Administrative Rule 64B-27.810
provides categories of elements that pharmacists would consider in
their determination of both legally validated and clinically validated
prescriptions based on the record they had while performing
prescription fulfillment and dispensing, and the code does not state
that a written report is required. Tr. 1110.
---------------------------------------------------------------------------
\37\ Dr. Buffington's analysis was a direct contradiction to Dr.
Schossow's testimony regarding her analysis of the guidelines for a
pharmacist in Florida.
---------------------------------------------------------------------------
Dr. Buffington testified that Rule 64B16-27.800 specifically
requires that the pharmacist provide the full name, address, phone
number, age, date of birth, gender, and the refill details as well as
any related information provided by the healthcare professional. Tr.
1111. Furthermore, he testified that it is in the pharmacist's
professional judgment as to what is relevant to address and/or record
because there is no specific Florida pharmacy law that clearly states
what steps are required for each patient. Tr. 1111.
Dr. Buffington reviewed Florida Administrative Rule 64B16-27.831 as
it relates to validating a prescription in the retail setting. Tr.
1112. He testified that the administrative code requires that there
must be a valid or eligible prescription to move forward and that if
the pharmacist has specific concerns (that does not necessarily mean a
red flag), then the pharmacist could resolve any issues by speaking to
the prescriber or the patient or taking consultation with the
prescription drug monitoring program. Tr. 1112-13, 1122. Furthermore,
he testified that if a pharmacist learns that a physician is writing a
prescription for non-legitimate purpose or ill-intent by the patients,
then the pharmacist has a duty to report this to the Florida Department
of Public Health. Tr. 1113.
Dr. Buffington testified that there are pharmacy software programs
that identify potential issues through an alert system. Tr. 1113-14. He
testified that an alert is not inherently a stop and is a pop-up
message that prompts the pharmacist to consider something at the time,
but the pharmacist may accept or move past the prompt. Tr. 1114. He
testified that when a pharmacist ``clicks through'' the pop-up prompt,
the software program records this through a ``click tracking'' program.
Tr. 1114, 1115. He testified that this click tracking is a key way to
track individual activity. Tr. 1114. He testified that when a person
has a prescription for both a benzodiazepine and opiate, an alert does
not require a stop because these prescriptions are routinely prescribed
together. Tr. 1115-16. He testified that it routinely happens that
different prescribers prescribe medications that interact and although
a pharmacist with concerns should have an assessment with a patient and
a provider, there is no requirement set forth in the Florida
administrative code that requires such concerns be put in writing. Tr.
1118.
Dr. Buffington testified that as to the specific software program
used by Gulf Med, PioneerRx, there are certain boxes that must be
clicked, called pathways, in order to fill a prescription. Tr. 1239. He
testified that the PioneerRx system allows someone to run a specific
report to see how long a pharmacist spent on a particular pathway
click. Tr. 1240. Although Dr. Buffington does not recall seeing a
report being run, he thinks he saw a ``time change.'' He testified that
whether a pharmacist spent ten minutes or five seconds on a particular
box looking at a pathway, however, is irrelevant to the instant case
given that there is not a single requirement for documentation
formatting and the documentation may not have transpired during that
pathway.
Dr. Buffington testified that opiates and benzodiazepines, or Class
II drugs in general, are routinely prescribed together and although
such a combination is not always justified, there is no default
presumption that the two drugs cannot be prescribed together. Tr. 1115-
16, 1241. Furthermore, he testified that even if two sets of Class II
prescriptions are prescribed, this would not be a hard stop. Tr. 1116.
[Omitted. See infra n.*L.]
Dr. Buffington testified that if a pharmacist receives a
prescription for an opiate, benzodiazepine, and a muscle relaxant,
there must be an analysis of clinical oversight. Tr. 1118-19. In
particular, he testified that the first analysis would be to evaluate
for duplicity and whether other muscle relaxants have been prescribed
and whether such an addition should be communicated with the prescriber
or assessed with the patient based on the pharmacist's professional
judgment. Tr. 1119-20.
Furthermore, Dr. Buffington testified that even a black box warning
does not serve as a stop if the pharmacist consults with the patient
and the E-FORSCE data demonstrates that a patient has been on a certain
treatment regimen for a significant period of time. Tr. 1118. He
testified that if a muscle relaxant is prescribed with an opiate and
benzodiazepine, the analysis as a clinician changes and a pharmacist
would then need to make a professional judgment. Tr. 1119-20. Dr.
Buffington testified that pursuant to Section 1306.04 of the Controlled
Substances Act,\38\ the physician has certain responsibilities and
makes decisions based on the needs of the patient and selecting a
medication by name, product formulation, and dose. Tr. 1120. [Omitted
discussion of confusing testimony purporting to interpret federal and
state law.] *\D\
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\38\ 21 CFR 1306.04.
*\D\ Dr. Buffington's testimony addressed the level of intent
required for a violation of 21 CFR 1306.06, which is outside of his
expertise as a pharmacy expert.
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Dr. Buffington testified that although the combination of three
controlled substances--colloquially known as the ``holy trinity'' or
``trinity'' \39\--heightens a risk to a patient, there is the same risk
when combining many types of
[[Page 72713]]
medications including over-the-counter medications. Tr. 1243. He
testified that the circumstance of prescribing this combination of
prescriptions alone would not automatically raise a reasonable
suspicion. Tr. 1265-68. Therefore, he testified that there is need and
merit to evaluate and counsel the patient, but it is not necessarily
inappropriate to prescribe three controlled substance together as it is
commonplace for physicians to prescribe this combination. Tr. 1243-44.
Dr. Buffington testified that it is a clinical question as to whether
there is inappropriate use as opposed to a law enforcement question.
Tr. 1253-54. Furthermore, he testified that although these three
combined substances can also produce a high by illicit drug use,
alcohol use and other base medications can have the same effect and
this is irrelevant to the case. Tr. 1255. Furthermore, he testified
that the practice of prescribing these three drugs together is
declining based on the research that Carisoprodol is of less utility.
Tr. 1255. Dr. Buffington testified that even if ``red flags'' are an
inference to things that a pharmacist should look at and evaluate,
these are not something that should be counted and a person is in
trouble if his count hits a threshold. Tr. 1254. In Dr. Buffington's
view, this would be a disingenuous attempt at an investigation.\40\
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\39\ According to Dr. Buffington, the slang term, ``trinity,''
refers to an opiate, a benzodiazepine, and Carisoprodol being
prescribed to one patient at the same time. Tr. 1255.
\40\ At this point in the testimony the Tribunal directed Dr.
Buffington not to give his opinion about whether the investigation
was appropriate as he had not been qualified to give that opinion.
Tr. 1254. The Tribunal reiterated that this not a criminal matter,
but rather an administrative proceeding, and directed Dr. Buffington
to focus on his expertise as it relates to pharmacy practice and to
pharmacy law. Tr. 1254-55.
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Dr. Buffington compared the Florida Administrative Codes to the
federal regulations and the Controlled Substances Act, noting that the
statute is very clear that the responsibility of the prescriber or the
dispenser is to knowingly demonstrate that a prescription was written
or dispensed for an appropriate purpose whereas the Florida law speaks
to the duty of the pharmacist and the requirement to report. Tr. 1120.
Furthermore, he testified that ``combination therapy'' or ``multidrug
regimen'' \41\ are routine and the Respondent in this case had not
failed in its responsibility nor was there evidence that the Respondent
breached its standard of pharmacy practice with regards to such
medications. Tr. 1121-22.
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\41\ Respondent's counsel referred to ``cocktail medications''
when questioning Dr. Buffington, however, Dr. Buffington asserted
that this was a ``colloquial'' or ``slang'' term, and the proper
terminology was ``combination therapy'' or ``multidrug regimen''.
Tr. 1121, 1122.
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Dr. Buffington testified that the quantity of the dosage of a
product formulation should not itself be a ``red flag'' because
pharmacists will instruct patients to take multiples of whatever that
formulation is at the time of dosing which makes product formulation an
irrelevant basis of a ``red flag.'' \42\ Tr. 1124-25. He testified that
even lower dosages carry the possibility of adverse side effects. Tr.
1125. He testified that it is not a deviation from a Florida
pharmacist's standard of care or corresponding responsibility to fill a
prescription that includes a long-acting or extended release opiate
(some of which are twelve or twenty-four hours) along with an immediate
release for breakthrough pain. Tr. 1129-30.\43\
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\42\ Dr. Buffington specifically disagreed with Dr. Schossow's
opinion that there should be an inference of an alert or caution if
a medication is prescribed at a magnitude or dose in relation to
product formulation that the manufacturer produces. Tr. 1123. In
fact, Dr. Buffington described such an inference as ``preposterous''
and stated that it is a complete misrepresentation to make such an
inference. However, when later prompted by the Tribunal regarding
his critique of Dr. Schossow, Dr. Buffington declined, stating that
he did not come to testify about Dr. Schossow's findings, but rather
to testify about his own findings in the case. Tr. 1248.
\43\ Dr. Buffington testified that the long-acting release are
also supposed to provide baseline relief, not 100%. Tr. 1129. Dr.
Buffington also described that aggravated pain could occur, which
can be triggered by things such as a patient's lifestyle and can
vary from patient to patient and even with one patient. Tr. 1129-30,
1248.
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Dr. Buffington testified that there were no breaches of the
pharmacist's responsibilities or that the pharmacist had breached a
duty. Tr. 1131-32.\44\ Specifically, he testified that there was no
evidence presented in this case that a pharmacist in the State of
Florida at Gulf Med Pharmacy was knowingly aware. Tr. 1134. He
testified that Gulf Med also did not ``turn a blind eye'' or ``bur[y]
[its] head in the sand'' when Gulf Med pharmacists were presented with
issues due to red flags because the Florida pharmacy statutes, and
administrative rules require a pharmacist use professional judgment and
there is no requirement that this needs to be documented. Tr. 1135.
---------------------------------------------------------------------------
\44\ Respondent had posed a question asking whether there was
any evidence that the Respondent pharmacist deviated or violated the
Florida standard of care for a pharmacist as to over- or
underutilization, therapeutic duplication, drug disease
contraindications, drug-drug interactions, incorrect drug dosage or
duration of drug treatment, drug allergy interactions, or clinical
abuse or misuse. Tr. 1132
---------------------------------------------------------------------------
Dr. Buffington testified that there is no restriction on the
distance a patient may travel to a pharmacy and there are in fact now
mail order pharmacists. Tr. 1136. Furthermore, he testified that a
patient travelling a distance of thirty miles is not a reason to cause
a pharmacist pause because many people like to stay engaged with a
particular practitioner or the pharmacy is near their work or
doctor.\45\ Tr. 1138-39. Furthermore, he testified that the Florida
Administrative Code does not require a pharmacist to identify or
document the distance a patient travelled to their doctor or the
pharmacy. Tr. 1141.
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\45\ Dr. Buffington testified that it is ``particularly
offensive to infer the opposite.'' Tr. 1139.
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As to payment, Dr. Buffington testified that there is nothing that
prohibits a patient from paying in cash and even when a patient pays in
cash, this is reported through PDMP and E-FORCSE. Tr. 1144-45. He
testified that there is no circumventing the system when a patient pays
in cash. Tr. 1145. He testified that E-FORCSE data includes the name of
the prescriber, the prescriber's address, the name of the patient, the
patient's address, the price that was paid, the date the prescription
was issued, and the date it was filled, and the manner of payment. Tr.
1145, 1274. He testified that a pharmacist must evaluate many other
data elements including a patient's response to medications and medical
history. Tr. 1145. Furthermore, he testified that a patient may pay
with cash because there is a better pathway for their out-of-pockets
costs, including a discount plan. Tr. 1146. He testified that even
paying for an opioid prescription with cash would not change this
analysis. Tr. 1151-52.
Dr. Buffington testified that there are also many variables
pharmacists consider when choosing how much to charge a patient.\46\
Tr. 1147. In Dr. Buffington's view, a pharmacy is like any other
business and requires sufficient practice revenue and pricing tables
evolve. Tr. 1148. He testified that cash price is usually higher
because there is counter-contract similar to Medicaid or Medical
programs that will contract at a reduced price.
---------------------------------------------------------------------------
\46\ At one point Dr. Buffington stated that payment options
were unique to each pharmacy; however, he later went on to state
that he ``amend[ed] the comment,'' and in fact the pricing was
``almost universal.'' Tr. 1147.
---------------------------------------------------------------------------
Dr. Buffington testified that pharmacies must also take into
consideration their overhead costs including rent, payroll, taxes, and
utilities. Tr. 1149. Furthermore, he testified that whether Gulf Med
has a debt or rent against the building is a nonissue because nothing
regulates what a physician charges for a medical service, a surgery, a
hospital admission,
[[Page 72714]]
or what a pharmacy charges for a particular dispensed medication. Tr.
1151. Dr. Buffington testified that after reviewing the acquisition
price and sales price on the pill stickers, there was no apparent
evidence of inappropriate practice based on the fee structure for the
cash paying patients. Tr. 1152.
Dr. Buffington testified that the analysis would not change if a
person paid in cash, had a combination of drugs, and drove 30 to 50
miles. Tr. 1153. He testified that once a pharmacist finds the
prescription to be fillable the first time based on certain factors,
each time after that, there is no longer a red flag.\47\ Dr. Buffington
testified that pharmacists use their professional judgment in deciding
whether to fill it, while complying with Florida Rule 64B17-831. Tr.
1155.
---------------------------------------------------------------------------
\47\ Furthermore, Dr. Buffington noted that there is no evidence
in the record providing how often a pharmacist at Gulf Med did not
fill a particular prescription. Tr. 1154.
---------------------------------------------------------------------------
Based on his education, training, and experience, Dr. Buffington
reviewed the information in this case and did not see any evidence that
would support the inferences made by the Government. He testified that
no formal metrics were used and he felt that DEA ``attempt[ed] to
manifest or fabricate information from pharmacy records that are
incomplete or descriptive of things that they're trying to infer.'' Tr.
1161. Dr. Buffington did not see any red flags, noted that there was
other attainable information, and that all the prescriptions charged by
the Government and issued by the Respondent are within the standard of
care and the scope of professional practice of Florida law as to
Florida pharmacies. Tr. 1162, 1241, 1277-78. In particular, Dr.
Buffington noted that there were additional fields in the PioneerRx
database referred to as Medication Therapy Management and that there
were multiple other tabs and therefore further additional information
that the investigator can request and consider as a factor. Tr. 1163-
64.\48\ [However, as discussed in more detail below, Respondent was
served with three subpoenas that required the production of all
documents that contained any discussion or resolution of red flags.
Thus, Dr. Buffington's testimony that there might have been additional
materials resolving red flags is not entitled to any weight. Further,
there is no evidence that Dr. Buffington reviewed any additional tabs
and thus his testimony as to whether there could be information on such
other tabs is entirely speculative.] As to the legality, Dr. Buffington
testified that there is a three-step process: (1) Presuming legality of
a prescription absent evidence to the contrary, (2) the pharmacist
validates that the order is valid based on data points and data
elements, and (3) doing a Prospective Drug Review. Tr. 1278.
---------------------------------------------------------------------------
\48\ Dr. Buffington analogized his review of the record to that
of a puzzle and the missing tabs equated to missing pieces of the
puzzle. Tr. 1163-64.
---------------------------------------------------------------------------
Dr. Buffington has also worked with the Florida Department of
Health and Board of Pharmacy in developing regulations relating to
pharmacy practice. Tr. 1164. At one point, Dr. Buffington served on the
national association of the American Pharmacists Board of Trustees,
where he had a dialogue with the DEA to express that healthcare
professionals feel like they are part of the solution and although the
term ``red flag'' has merit, flags are not metrics and are only things
to consider. Tr. 1164-65. According to Dr. Buffington, despite pleas
from healthcare professionals, no guidance material has been published
for pharmacists since the 2010 Pharmacists Manual and in fact the term
``red flags'' is not even in the manual. 1165-66.
Dr. Buffington testified that there is no requirement that a
pharmacist learn about DEA administrative decisions or be familiar with
or read the Federal Register as the DEA does not have jurisdiction over
pharmacy practice. Tr. 1168-69. Although Dr. Buffington testified that
the DEA administrator's findings are binding upon DEA registrants, he
believes that this does not include every pharmacist and such findings
would relate to criminal issues rather than the scope of practice. Tr.
1237. Furthermore, he testified that the DEA is law enforcement and has
jurisdiction over criminality, not medical decision-making and
pharmacologic decision-making over the use of medications. Tr. 1245.
Dr. Buffington testified that the second aspect of the mandatory CE
or assessment ``b'' is using the Prescription Drug Monitoring Database,
which Dr. Buffington incorporates into his class. Tr. 1169. Dr.
Buffington is familiar with the types of data that E-FORCSE maintains,
serves as a consultant with the team that manages the E-FORCSE system
in Florida, and covers the types of data that E-FORCSE includes in his
continuing education course. Dr. Buffington testified that the third
assessment, ``c'', is the assessment of prescriptions for therapeutic
value, which requires the practitioners involved in dispensing the drug
to use their professional judgment in assessing risk and reviewing a
patient's historical response to a medication in deciding whether a
drug should be dispensed. Tr. 1169-71, 1175. Dr. Buffington testified
that unless there is a known drug allergy or an actual drug
interaction, the pharmacist does not need to document his process in
dispensing prescriptions. Tr. 1171. Furthermore, Dr. Buffington
testified that a pharmacist does not always have the opportunity to
speak directly with a patient because a caregiver or family member may
bring the prescription, the prescription is called in and the patient
is not present, or the prescription may be mailed to a patient. Tr.
1172. Dr. Buffington testified that in these instances, and especially
with the current pandemic, such events do not minimize the opportunity
to call and have a direct dialogue with a patient and practitioners
should touch point to discuss concerns instead of just refusing a
prescription. Tr. 1173.
Dr. Buffington testified that pharmacists must also learn how to
detect whether a prescription is not based on a legitimate medical
purpose, which can be done through communicating with a prescriber,
evaluating and having a discussion with the patient, and putting down
the patient's diagnosis \49\ in the records. Tr. 1178. Dr. Buffington
also noted that even if a prescription is outside of the FDA-approved
list, pharmacologically, using such a prescription is fine as long as
the pharmacist has supporting clinical rationale. Tr. 1174-75. Dr.
Buffington testified that Florida Administrative Rule 64B16-27.831 is
the law and rule related to prescribing and dispensing of controlled
substances, which does not require that pharmacists be educated on DEA
administrative decisions, because this would be based on criminal
issues and not on something in terms of delivery of healthcare
services, which is dictated on the a state level. Tr. 1176-77.\50\
---------------------------------------------------------------------------
\49\ Dr. Buffington noted that in his review of the universe of
prescriptions for this case, although it is not required, some of
the prescribers routinely include diagnostic codes on the
prescriptions. Tr. 1175-76.
\50\ See Gonzalez v. Oregon, 546 U.S. 243, 270-72 (2006), for
context.
---------------------------------------------------------------------------
Dr. Buffington testified that the next section is proper patient
storage and disposal of controlled substances which discusses how a
patient is supposed to store and dispose of controlled substances and
requires healthcare professionals to record the receipts, the transfer,
and the destruction of controlled substances. Tr. 1177. Dr. Buffington
testified that the next section of Florida Administrative Rule 64B16-
27.831 relates to protocols for addressing and resolving problems
[[Page 72715]]
recognized during the drug utilization review, including but not
limited to, drug-drug interactions, side effects, high-dose and low-
dose guidelines, which is new to the CE as of June 2018. Tr. 1177-78.
Dr. Buffington testified that the mere presence of a dosage range is
not a rate limiter for dispensing a prescription, but rather a
pharmacist must use his professional judgment. Tr. 1178. Dr. Buffington
does not advise pharmacies to document any resolution of these DUR-
related issues because there is no requirement to do so and each
pharmacy has a process within their own facility to convey from peer to
peer. Tr. 1178-79.
Dr. Buffington testified that the protocol for addressing and
resolving issues relating to drug utilization review are limited to
drug-drug interactions, side effects, and high-dose and low-dose
guidelines. Tr. 1179. He testified that such issues must rise to the
level of needing resolution in a pharmacist's professional judgment,
not that something just occurred. Dr. Buffington testified that Section
H requires pharmacists to be educated on the availability of NARCAN or
naloxone for overdose treatment. He testified that Section I relates to
pharmacists initiating counseling with patients who have opioid
prescriptions, which makes it imperative for there to be an open
dialogue between the pharmacist and patient. He testified that Section
J relates to available treatment resources for opioid physical
dependence, addiction, misuse, or abuse. Tr. 1181. Dr. Buffington
testified that Respondent pharmacists at Gulf Med were not providing
copies of the CDC pamphlet to patients receiving opioid prescriptions,
but there is no legislative mandate that the pharmacists give that
particular document to patients. Tr. 1181-82. Dr. Buffington testified
that there was a legislative change in 2019 that requires pharmacists
to develop and/or produce or distribute a patient education pamphlet so
the CDC's pamphlet would be an acceptable tool to satisfy that
requirement. Tr. 1182.
Dr. Buffington testified that when a prescription is dispensed, a
label is produced and given to the patient as an educational resource.
Tr. 1182-83. He testified that this labeling is in response to an OBRA-
90 mandate that serves as an additional trigger to see if a patient has
any questions and leaves with information that improves their health
outcomes and safety. Tr. 1185. He testified that the software also
generates educational information about warning signs, side effects,
drug interactions, and how to store and protect medication. At this
point in the testimony, the Respondent's counsel discussed that there
is a Critical Comments box in the lower right-hand corner on page 1 of
Government's Exhibit 39 which includes a data field for pop-ups and
went through several patients. Tr. 1185-1192; GX 39. Dr. Buffington
testified that for patient J.R., among the critical comments listed for
various dates, the signature or the directions for the use of the
prescriptions were verified by the pharmacist with the prescriber. Tr.
1184. Dr. Buffington testified that on May 15, 2019, patient J.R. was
also given the CDC pamphlet. On August 5, 2019, the pharmacist
requested clarification or verification of the prescription with the
provider. Tr. 1184-85; GX 39 at 5. Dr. Greshler prescribed Oxycodone
acetaminophen, a combination tablet, and the pharmacist wrote a note
saying ``per M.D. patient prior dose was ineffective. Need to start
oxy/acet 10/325'' and ``Spoke to Rochelle. Patient was told to increase
his dose to 10 milligrams per M.D.'' with the ten milligrams referring
to the first active ingredient, Oxycodone. Tr. 1186; GX 39 at 5. There
is also a prescription from Dr. Mikovic for morphine extended release,
fifteen milligram tablet with a note saying ``new regimen is added to
help, current therapy is not sufficient.'' Tr. 1178-92; GX at 7. Dr.
Buffington testified that there is only a minimal requirement for a
pharmacist so such a note would be an acceptable note. Tr. 1187; GX at
7. Dr. Buffington testified that continuity of care information is also
available to pharmacies even in different pharmacies for particular
patients. Tr. 1188.
There was also a prescription from a physician, Gilberto Acosta,
for an Oxycodone and acetaminophen combination for five milligrams of
Oxycodone and 325 milligrams of acetaminophen with a note that said
``doctor wants to add long-acting MS Contin with short Percocet 5.''
Tr. 1190. Based on the dispensing log, the patient also received
diazepam, a benzodiazepine typically used for management of anxiety and
muscle spasms as well as temazepam, another benzodiazepine, which is
used as a sleep aid. Tr. 1191. Dr. Buffington testified that such a
prescription is not uncommon, but would necessitate counseling of the
patient to watch for over drowsiness in the morning from the temazepam
and to limit the diazepam used during the day. Tr. 1191-92. Based on
Dr. Buffington's review of the universe of prescriptions that were
provided in this case, there were no prescriptions that caused him any
concerns. Tr. 1192.
Dr. Buffington testified that there is nothing unusual or
inappropriate in a patient using insurance to pay for one prescription
and not another because the patient may have an access issue, scope of
benefit and coverage issue, difference in out-of-pocket cost at one
pharmacy, and other reasons. Tr. 1193. Furthermore, Dr. Buffington
believes that the prices that Gulf Med charged for prescriptions such
as Oxycodone or Hydromorphone were not surprising or astonishing
numbers and even if there was a high value there would be no regulatory
problem because that is the patient's prerogative. Tr. 1194.
Furthermore, there was nothing that Dr. Buffington reviewed that caused
him any concern about whether or not Gulf Med and its pharmacists were
exercising their corresponding responsibility or violating the
applicable standard of care based upon any of the dosing instructions
included in any of the prescriptions. Tr. 1193-94, 1995-96.
Dr. Buffington disagreed with Dr. Schossow's testimony regarding
driving under the influence of a benzodiazepine and an opiate as there
was no way to determine whether or not the patient was the person who
was driving and that there is no clinical expectation that combining
these two drugs would in fact impair someone's ability to drive or
impact their cognitive status. Tr. 1194-1195. Dr. Buffington testified
that although it is possible, it would be disingenuous to infer that
putting the two drugs together would be an incorrect behavior. Tr.
1195, 1241. In fact, he testified that the FDA does not say in the
black box warning that both drugs cannot be used together and it is not
inappropriate to prescribe them together. Tr. 1195, 1243. Dr.
Buffington testified that once a prescription is dispensed, the
pharmacist cannot control if a person is going to independently abuse
something. Tr. 1277.
Dr. Ricard Fertil
Dr. Fertil is a licensed pharmacist in Florida. Tr. 1337. He
attended FIU for undergraduate school. He attended and received his
doctorate of pharmacy degree from Florida A&M in 2003. Tr. 1336-37.
During his attendance at Florida A&M, he performed internships and
externships at area hospitals including Jackson Hospital, Texas
Hospital and Hollywood Memorial Hospital. Tr. 1337-38. He also trained
at CVS and Publix pharmacies in Florida. Tr. 1338. All of his training
and experience as a pharmacist has been in Florida. Tr. 1339.
[[Page 72716]]
Following his licensing, he worked at CVS and Publix Pharmacies,
retail chain pharmacies. Tr. 1339. Later, he worked at independent
pharmacies in Southwest Florida for eight or nine years. Tr. 1339-40.
While at independent pharmacies, he was involved in setting the prices
for medications dispensed to customers. Tr. 1340. He was also involved
in negotiating contracts with pharmacy benefits managers in setting
rates of reimbursement. Tr. 1341.
Dr. Fertil is the pharmacist in charge at Gulf Med Pharmacy. Gulf
Med operates with a single pharmacist and a pharmacy technician. Tr.
1370-71. He was involved with software venders, and in setting up the
PioneerRx software for Gulf Med, including setting the pricing formulas
within the software. Tr. 1341-42.
Dr. Fertil described the layout of Gulf Med. Located within a
building formerly housing a bank, Gulf Med has a drive-through window
to service customers. It also has separate rooms for compounding
medications, and a consultation room, where HIPAA-protected matters are
discussed with the patient in private, and where the pharmacist
exercises his professional judgement in determining whether to fill
each separate prescription. Tr. 1334-35, 1367-68, 1397-98. Dr. Fertil
is unfamiliar with the term, ``red flag.'' Tr. 1395. The pharmacist
reviews the diagnosis and medical history with the customer. Distance
traveled by the customer would only concern Dr. Fertil if they traveled
from outside the County, although he was unaware of any law restricting
the filling of a prescription on the basis of distance traveled. Tr.
1406-07. Dr. Fertil did not view payment by cash as a suspicious
circumstance, nor would it cause him to decline filling a prescription.
Tr. 1408-10. If the customer is opiate na[iuml]ve, as determined by a
review of the E-FORCSE, the pharmacy has a policy not to fill the
prescription. Tr. 1346-47. The pharmacist determines if the
prescription contains the statutorily required components. Tr. 1351-52.
The PioneerRx software also prompts the pharmacist as to required
components and alerts. Tr. 1352-56; RX 13-22. Review of the E-FORCSE
database, which the pharmacist does for every controlled substance
prescription presented, also reveals whether the customer is doctor-
shopping. Tr. 1347-50, 1357-58; RX 1-11. When directed to review three
controlled substance prescriptions for B.D.a., Dr. Fertil confirmed
none contained any notations that the E-FORCSE had been referenced. Tr.
1418-21. Dr. Fertil explained that no documentation was necessary, and
that his signature on the prescription was proof that he checked the E-
FORCSE. When asked if he ever noted PDMP on the prescriptions, he
confirmed that sometimes he wrote PDMP to confirm that he checked the
PDMP, but that sometimes he simply signed the prescriptions, also
confirming that he checked the PDMP. Tr. 1419-20. Ultimately, Dr.
Fertil explained that there was no set way that he confirmed on the
prescription that he checked the PDMP. Sometimes he would note
``verified E-FORCSE'', sometimes he put a check mark or initials. Tr.
1423. The pharmacist will also consult with the prescribing physicians
as needed. Tr. 1349-50.
Dr. Fertil confirmed that he discussed with the charged patients,
J.R. and L.V. their restrictions presented for their prescriptions for
combinations of medications of opioids, benzodiazepine and a muscle
relaxant, the risks of this combination, including the sedative effect.
Tr. 1360-61. Further, the patients were questioned as to whether they
were experiencing any of the noted side effects of the drug
combinations, and were provided written warnings, including drug
interactions, abuse and side effects, produced by the PioneerRx
software system and stapled to their receipts. Tr. 1361-64. Dr. Fertil
confirmed that he used his professional judgement in resolving some of
the alerts of the PioneerRx software and in filling the subject
prescriptions. Tr. 1362-63. Dr. Fertil explained that Gulf Med had a
much smaller volume of prescriptions than the large chain pharmacies,
permitting the pharmacist to spend more time and attention with
patients than at the chain pharmacies. Tr. 1363.
Dr. Fertil was present when the Administrative Inspection Warrant
was served on Gulf Med., on February 14, 2018. Tr. 1364-65, 1372. He
also received the Administrative Subpoena requiring ``patient profile''
information. Tr. 1365, 1372-73. Dr. Fertil cooperated and worked with
the DEA computer technician to retrieve the information DEA required.
Tr. 1365, 1369, 1373-74, 1379. The DEA technician also worked with a
representative of PioneerRx to obtain the information required. Tr.
1365. The DEA technician operated the PioneerRx software in obtaining
the information sought, and printed the documents in question. Tr.
1367, 1377. The documents printed by the DEA Technician included
``screen shots'' of the first tab of the ``patient profiles.'' Tr.
1425-29; GX 5, 19, 20, 21, 22, 35, 36, 37, 38, 39, 40. Whereas, RX 13-
22 represents an Excel spreadsheet reflecting information from all five
tabs of the same document. Tr. 1428-29.
When the DEA made further requests for patient profile information,
Dr. Fertil produced the same type of information as they retrieved
during their first request. Tr. 1365-66, 1381-95. Dr. Fertil could not
remember whether he read the May, 2019 subpoena, which required the
``patient profiles'' and patient medication records for the charged
patients, so he could not confirm that the documents he provided in
response to the subpoena were complete. Tr. 1388-89. Dr. Fertil had
great difficulty recalling receiving the third subpoena in August,
2019. Tr. 1391. He could not recall reviewing the subpoena to determine
what documents were being requested or what documents were provided in
response to the subpoena, despite attempts to refresh his memory. Tr.
1390-95. Although Dr. Fertil could not remember what documents he
provided in response to the second and third subpoenas, he was adamant
the documents provided were the same type of documents the DEA seized
during service of the first administrative subpoena. Tr. 1392-94.
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.
I. Background
1. Respondent is registered with the DEA to handle controlled
substances in Schedules II through V under DEA COR No. FG6290061 at
4106 Del Prado Boulevard, South, Cape Coral, FL 33904. DEA COR No.
FG6290061 will expire by
[[Page 72717]]
its own terms on September 30, 2022. GX 1
2. DEA lists Ambien (zolpidem tartrate) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(54).
3. DEA lists Ativan (lorazepam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(30).
4. DEA lists hydromorphone as a Schedule II controlled substance
under 21 CFR 1308.12(b)(1)(vii).
5. DEA lists methadone as a Schedule II controlled substance under
21 CFR 1308.12(c)(15). DEA lists MS Contin (morphine sulfate extended
release) as a Schedule II controlled substance under 21 CFR
1308.12(b)(1)(ix).
6. DEA lists Klonopin (clonazepam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(11).
7. DEA lists Norco (hydrocodone-acetaminophen) as a Schedule II
controlled substance under 21 CFR 1308.12(b)(1)(vi).
8. DEA lists oxycodone as a Schedule II controlled substance under
21 CFR 1308.12(b)(1)(xiii).
9. DEA lists Percocet (oxycodone-acetaminophen) as a Schedule II
controlled substance under 21 CFR 1308.12(b)(1)(xiii).
10. DEA lists Restoril (temazepam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(50).
11. DEA lists Soma (carisoprodol) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(6).
12. DEA lists Valium (diazepam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(16).
13. DEA lists Xanax (alprazolam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(2).
II. DEA's Investigation Into Respondent
14. On February 14, 2018, DEA investigators executed an
administrative inspection warrant (``AIW'') on the Respondent, pursuant
to which DEA seized the hardcopies of controlled substance
prescriptions that Respondent had dispensed from its opening through
the date the AIW was executed. GX 2; Tr. at 34-35. On the same date,
the DEA also served an administrative subpoena on Respondent seeking,
(a) copies of Respondent's patient profiles for certain listed
individuals; (b) copies of ``[a]ny and all other records . . .
maintained pursuant to the requirements of Florida Statutes and Florida
Administrative Code 64B16-27.800 documenting the steps taken to avoid
or resolve any issues with the prescriptions presented by'' those same
listed individuals; and (c) copies of ``[a]ny other documentation kept
by'' the Respondent ``in connection with the filling of prescriptions
or providing medical treatment'' for those named individuals, including
dispensing logs or reports, for those listed individuals. GX. 3; Tr. at
45. Government Exhibits 2 and 3 are true and correct copies of the AIW
and administrative subpoena, respectively, that DEA served on
Respondent on February 14, 2018. Tr. at 35,41-42,64-65.
15. Government Exhibit 5 contains true and correct copies of the
patient profiles for Patients J.B., T.G., and L.V. produced by
Respondent pursuant to the administrative subpoena served on February
14, 2018. Tr. at 65-69. Government Exhibit 6 contains true and correct
copies of the dispensing logs for Patients J.B., T.G., and L.V.
produced by Respondent pursuant to the administrative subpoena served
on February 14, 2018. Tr. at 69-71. Government Exhibits 7-15 contain
true and correct copies of the prescriptions Respondent dispensed to
Patients J.B., A.B., B.Da., R.D., B.Di., T.G., S.K., R.R., and L.V.,
respectively, that the DEA seized pursuant to the AIW served on
February 14, 2018. Tr. at 76-103, 111-16. The DEA did not seize any
other documents pertaining to Patients J.B., A.B., B.Da., R.D., B.Di.,
T.G., S.K., R.R., and L.V. pursuant to the AIW served on February 14,
2018, beyond those reflected in Government Exhibits 5-15; nor did
Respondent produce any other documents pertaining to those same
patients pursuant to the administrative subpoena served on February 14,
2018, beyond those reflected in Government Exhibits 5-15. Tr. at 117-
18.
16. The DEA provided Respondent a receipt for the items that were
seized by DEA during the execution of the AIW on February 14, 2018, or
that were produced by the Respondent pursuant to the administrative
subpoena served that same day. Government Exhibit 4 is a true and
correct copy of the warrant return filed pursuant to the AIW served on
February 14, 2018, and contains as an attachment a true and accurate
copy of the receipt provided to the Respondent. Tr. at 52-59.
17. In May 2019, DI served a second administrative subpoena on
Respondent seeking, inter alia, (a) hardcopies of controlled substance
prescriptions that Respondent had dispensed from February 15, 2018,
through May 3, 2019; (b) copies of Respondent's patient profiles for
certain listed individuals; and (c) copies of ``[a]ny and all records .
. . maintained pursuant to the requirements of Florida Statutes and
Florida Administrative Code 64B16-27.800 for Patient Records,
documenting the steps taken to avoid or resolve any issues with the
prescriptions presented by'' those same listed individuals ``reflecting
efforts by the pharmacist to exercise their corresponding
responsibility to assess the validity'' of controlled substance
prescriptions dispensed to those listed individuals. Gov't Ex. 16; Tr.
at 119. Government Exhibit 16 is a true and correct copy of the
administrative subpoena that DEA served on Respondent in May 2019. Tr.
at 120-21.
18. DI has conducted approximately twelve (12) investigations while
employed by DEA. Tr. 27-28.
19. With its production of documents in response to the May 2019
administrative subpoena, the Respondent also produced a signed
certificate of authenticity of domestic business records. Tr. at 123-
24. Government Exhibit 18 is a true and correct copy of the signed
certificate of authenticity of domestic business records produced by
the Respondent with its production of documents in response to the May
2019 administrative subpoena. Tr. at 124.
20. Government Exhibits 19-22 contain true and correct copies of
the patient profiles for Patients R.D., T.G., S.K., and L.V.,
respectively, produced by Respondent pursuant to the administrative
subpoena served in May 2019. Tr. at 129-38. Government Exhibits 23-32
contain true and correct copies of the prescriptions Respondent
dispensed to Patients J.B., A.B., B.Da., R.D., B.Di., T.G., S.K., J.R.,
R.R., and L.V., respectively, that the Respondent produced pursuant to
the administrative subpoena served in May 2019. Tr. at 143-77. The
Respondent did not produce any other documents pertaining to Patients
J.B., A.B., B.Da., R.D., B.Di., T.G., S.K., J.R., R.R., or L.V.,
pursuant to the administrative subpoena served in May 2019 beyond those
reflected in Government Exhibits 19-32. Tr. at 178.
21. The DEA provided Respondent a receipt for the items that were
produced by the Respondent pursuant to the administrative subpoena
served in May 2019. Tr. at 126-27. Government Exhibit 17 is a true and
correct copy of the receipt provided to the Respondent. Tr. at 127.
22. In August 2019, DI served a third administrative subpoena on
Respondent seeking, with respect to Patients J.B., A.B., B.Da., B.Di.,
J.R., and R.R., (a) hardcopies of controlled substance prescriptions
that Respondent had dispensed to those patients from May 3, 2019,
through August 9, 2019; (b) copies of Respondent's patient profiles for
those patients; and (c) copies of ``[a]ny and all records . . .
maintained pursuant to the requirements of Florida Statutes and Florida
Administrative
[[Page 72718]]
Code 64B16-27.800 for Patient Records, documenting the steps taken to
avoid or resolve any issues with the prescriptions presented by'' those
patients ``reflecting efforts by the pharmacist to exercise their
corresponding responsibility to assess the validity'' of controlled
substance prescriptions dispensed to those patients. Gov't Ex. 33; Tr.
at 179.
23. Government Exhibit 33 is a true and correct copy of the
administrative subpoena that DEA served on Respondent in August 2019.
Tr. at 179-82.
24. With its production of documents in response to the August 2019
administrative subpoena, the Respondent also produced a signed
certificate of authenticity of domestic business records. Tr. at 184.
Government Exhibit 34 is a true and correct copy of the signed
certificate of authenticity of domestic business records produced by
the Respondent with its production of documents in response to the
August 2019 administrative subpoena. Tr. at 184-85.
25. Government Exhibits 35-40 contains true and correct copies of
the patient profiles, prescriptions, and other responsive documents for
Patients J.B., A.B., B.Da., B.Di., J.R., and R.R., respectively, that
Respondent produced pursuant to the administrative subpoena served in
August 2019. Tr. at 186-201. The Respondent did not produce any other
documents pertaining to Patients J.B., A.B., B.Da., B.Di., J.R., or
R.R. pursuant to the administrative subpoena served in August 2019
beyond those reflected in Government Exhibits 35-40. Tr. at 187, 190-
91, 193, 195, 197- 98, 200-01.
26. During the course of the investigation, DI queried the Florida
Prescription Drug Monitoring Database (``E-FORCSE'') and obtained
information regarding Respondent's dispensing of controlled substance
as it was reported to the State of Florida. Tr. at 205-216. Government
Exhibits 41-42 are true and correct copies of the data obtained from
the E-FORSCE database for the dates listed. Id. There is no evidence in
the record to indicate that the information reported by Respondent to
the E-FORSCE database is inaccurate or unreliable.
27. Subsequent to Respondent's Second Supplement Prehearing
Statement, which concerned information retrieved from the PioneerRx
pharmacy management software used by the Respondent, DEA obtained a
declaration from J.R., Vice President of PioneerRx, concerning the
functioning of that software. Tr. at 238-40. Government Exhibit 48 is a
true and correct copy of the declaration of J.R. Tr. at 242-48.
28. DI testified that use of cash to pay for a prescription for
controlled substances and the willingness of a customer to pay a
higher-than-market price to purchase said medications are ``red flags''
that a prescription may be illegitimate. Tr. 106-107; 109-110. However,
he later testified that there is no DEA regulation prohibiting a
pharmacy from accepting cash as payment for prescriptions for
controlled substances. Tr. 373-374.
III. The Government's Expert
29. Tracey J. Schossow, a pharmacy expert retained by DEA, is a
clinical pharmacist at Florida Blue Cross Blue Shield. In that
capacity, she reviews medications prescribed to Blue Cross members to
ensure, among other things, that the medications are being issued for a
legitimate medical purpose, and to provide cost-effective alternatives
for prescribed medications where appropriate. Dr. Schossow holds both a
bachelor's degree in pharmacy and a doctorate in pharmacy. She is a
licensed pharmacist in Florida and also holds an additional Florida
license as a consultant pharmacist. Tr. at 403-04, 408; GX 43.
30. Dr. Schossow has 26 years of experience as a pharmacist, with
12-years' experience as a retail pharmacist and the remainder as a
clinical pharmacist. Immediately prior to her current role, Dr.
Schossow was a clinical pharmacist for ProcareRx, a hospice-centered
pharmacy benefits manager (``PBM''). While at ProcareRx, Dr. Schossow
worked with hospice patients and managed medications for those
patients, including opioids, benzodiazepines, and muscle relaxants.
Additionally, Dr. Schossow served on the committee that managed which
medications were on the ProcareRx formulary based on cost and efficacy
considerations, and she also managed the queue for high-cost claims
submitted by the hospices and ran test claims for the PBM to determine
costs at different pharmacies across the State of Florida. Tr. at 404-
08; GX 43.
31. Through her education and experience, Dr. Schossow has gained
specialized knowledge regarding the practice of pharmacy, including the
costs charged by pharmacies for controlled substance medications, the
standard of care for dispensing controlled substances in the State of
Florida, the obligations of a retail pharmacist in the detection and
prevention of abuse and diversion of controlled substances, and a
pharmacist's corresponding responsibility under federal law. Tr. at
411-14.
32. Dr. Schossow has previously been accepted by this Agency as an
expert witness on three occasions. Tr. at 412, 423-24.
33. Dr. Schossow was accepted by the Tribunal as an expert in in
the field of pharmacy and the standard of care for the practice of
pharmacy in the State of Florida. Tr. at 427.
34. Dr. Schossow was unfamiliar with any clarification issued by
the Center for Disease Control (``CDC'') regarding its 2016 opiate
[…truncated; see source link]Indexed from Federal Register on December 22, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.