Gulf Med Pharmacy; Decision and Order

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.

*

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.

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge

*

B 1 2 3

*

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.]

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

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

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.

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

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.

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

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

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

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

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.

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.

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

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.

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.

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 § 893.04. However, the term “standard of care” is defined in § 766.102, and has a different usage and application. This distinction will be discussed in detail below.

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.

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

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 § 27.831. Tr. 457-62.

*

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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

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

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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.

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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.

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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.

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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

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.

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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.

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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,

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.

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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.

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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.

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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.

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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

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,

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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.

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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

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

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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.

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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

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-

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.

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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.

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.

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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.

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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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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.

Dr. N.

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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.

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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.

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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.

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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.

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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.

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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

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.

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.

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

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.

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

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

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.

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.

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.

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

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.

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.

45

Dr. Buffington testified that it is “particularly offensive to infer the opposite.” Tr. 1139.

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,

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 i

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