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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
various capacities at Publix, including Pharmacist, Assistant Manager of the Pharmacy, and Pharmacy Manager. GX
27. He also served as a fixer, or a temporary Pharmacy Manager, who would clean up pharmacies. Tr. 169.
Dr. Hamilton later transitioned to a Pharmacy Supervisor, in which he oversaw up to 4045 H pharmacies, in hiring, firing and daily operations. Tr.
170. Additionally, Dr. Hamilton evaluated stand-alone, independent pharmacies for purchase by Publix Supermarkets. Id. at 170. This evaluation included review of the drug invoices, the filled prescriptions, and the nature of the pharmacys overall business. Id. at 17071. In order to spend more time with his young family, Dr. Hamilton decreased his responsibilities with the company, gave up his supervisory role, and now serves as a Pharmacy Manager of a single pharmacy with Publix. Id. at 28687.
In connection with the investigation into Pharmacy 4 Less, Dr. Hamilton reviewed the materials sent to him by the Government, which included prescriptions front and back, related patient medical notes, and patient addresses. Id. at 177, 38081.
Additionally, Dr. Hamilton reviewed prescription pricing via GoodRx. Id. at 17778. Dr. Hamilton noticed red flags in connection with the reviewed prescriptions. Id. at 178. Red flags are concerns resulting from the review of the prescription. Id. at 17879. These concerns can be resolved through some investigation by the pharmacist, such as speaking with the patient, reviewing the medical history, or checking with the prescriber. Id. at 179. Dr. Hamilton noted that the resolution of the red flag had to be documented in the file as part of the Florida Standard of Care,I
noting, if its not documented, theres no evidence that . . . it was resolved or a phone call was made, or an answer was given. Id. at 17981, 306, 318, 337, 100611, 1016.28
H Amended
pursuant to Tr. 170.
the case, the Governments expert and all parties appear to have used the phrases standard of care and corresponding responsibility and standard of pharmacy practice interchangeably. The testimony regarding the requirement to resolve red flags is clearly related to Respondent Pharmacys corresponding responsibility under 21 CFR 1306.04. The interchangeable use of this terminology does not impact my ultimate finding that Respondent Pharmacy failed to resolve red flags in contravention of Respondents corresponding responsibility under 21 CFR 1306.04 and outside the usual course of professional practice in violation of 21 CFR 1306.06. For consistency purposes, I will use the language regarding standard of care to encompass the standard of pharmacy practice and corresponding responsibility herein.
28 Omitted for clarity. The ALJ found that the Government did not allege a separate violation I Throughout
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Dr. Hamilton indicated the source of pharmacy standards in Florida included Florida Regulation 64B, 29 and guidance from the National Board of Pharmacy Association. Id. at 180, 351
58. Dr. Hamilton noted these standards are enforced by the Board of Pharmacy in Florida. Id. at 180.
Dr. Hamilton explained that if the prescription involved a controlled substance, that in itself was a red flag.
Id. at 182. The strength of medication and the duration of the medication therapy was a concern, which needed to be addressed. Id. The pricing structure of the controlled substance represented a concern, as well as the distance of travel. Id. at 182, 36061.
Dr. Hamilton noted red flags in a prescription to Patient A.E., for 84
tablets of 8 mg. of hydromorphone. Id.
at 18384; GX. 6, pp. 12, GX. 5; RX 18, pp. 12, RX 19.30 Dr. Hamilton noted that 8 mg was the highest dosage made of hydromorphone, a Schedule 2
controlled substance. Tr. 184. Further, the number of dosage units prescribed, 84, was also concerning. Id. at 184. Dr.
Hamilton noted that, based on the records, the first red flag involving a dangerously high dosage level, had not been resolved. Id. at 186. Dr. Hamilton noted the absence of any information relating to the patients prescribing history suggesting the patient was acclimated to this significant dosage, and not opiate nave to this dosage.
Id. at 18890, 31617. Dr. Hamilton indicated the Florida standard of care required the starting date of the prescribed medication to be disclosed on the face of the prescription or in a note readily available to the pharmacist.
Id. at 18687, 35051, 39294. Dr.
Hamilton acknowledged that a pharmacist had access to the Florida PDMP, or EFORCSE database, which regarding the documentation of the resolution of red flags, but instead chose to consider such lack of documentation as an inference supporting a finding that the red flag was not resolved. In this case, I find that the Governments expert credibly testified that documenting the resolution of red flags was required by the standard of professional practice in Florida. Furthermore, the issue of whether documentation was required by the standard of practice in Florida was thoroughly addressed by both parties at the hearing. See id.
17981, 43438, 100708. I find that it is unimportant to find an independent violation related to the lack of documentation, because such lack of documentation already supports the overall finding that Respondent filled these alleged prescriptions in violation of its corresponding responsibility and outside the usual course of professional practice in Florida.
29 See Wests Florida Administrative Code, Title 64. Department of Health, Subtitle 64b16, Chapter 64B1627Pharmacy Practice.
30 Dr. Hamilton compared GX 5 with RX 18.

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contained prescribing history. Id. at 34849.
Dr. Hamilton noted that an identical prescription for hydromorphone was issued to A.E. for two more consecutive months. Tr. 19192; GX 6, pp. 36. Dr.
Hamilton noted the Florida standard of care regarding individualization required that the pharmacist consider whether an extended high dosage of controlled medication should be continued or should be reduced. Tr.
19293. Dr. Hamilton expected to see a reduction in dosage over time, or an explanation by the pharmacist for continuing to dispense the same high dosage. Id. at 101314. Dr. Hamilton noted there was no evidence that any reevaluation of the patients continued need for this strong medication had been made. Id. at 193. The fact that the patient was on immediate release tablets further heightened the red flag. GX
28, p. 6. Dr. Hamilton explained that immediate release tablets typically addressed acute versus chronic or longterm conditions, as suggested here by ongoing prescriptions for hydromorphone. Tr. 19394, 101314.
This red flag was not resolved on the face of the prescription, or in the medical notes. Tr. 194; GX 5, GX 6, pp.
56. Dr. Hamilton was also concerned by the cash purchase of the prescription and the extremely high prices paid, of $5.95 per pill. Tr. 194, 199; GX, 28, p.
6.
Dr. Hamilton explained that medications are typically priced at the average wholesale price plus 20%. Tr.
195. Dr. Hamilton explained that the appropriate price J of 8 mg. of hydromorphone was $1.50 per tablet.
He cautioned that this was an approximation by reviewing pharmacy prices in his area, both of big chain pharmacies as well as independents. Id.
at 195, 326, 33031. Dr. Hamilton opined that prices per pill from wholesalers would be fairly consistent across the state. Id. at 195, 101113.
However, he noted that, at the retail level, the purchase of just a few pills could result in an extremely high price per pill versus the purchase of a large number of pills. Tr. 198.
On rebuttal, Dr. Hamilton compared versions of the same medical records as to A.E. See GX 5 and RX 18, 19. After pointing out differences in the two versions, and granting the reliability of the Respondents versions, Dr. Hamilton opined that considering the GX 18, 19
version, his previous opinions as to A.E.s dispensing remained the same.
Tr. 95765. As related to the differences J Dr. Hamilton referred to it as the market retail price. Tr. 195.

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