Voglio sapere a riguardo di…

54576

Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
Dr. Hamiltons testimony that the drug combination red flag arises twice in this case: first, when the buprenorphine and oxycodone are prescribed together; and again, when the drug combination continues over time without tapering.
Mr. Parrado agreed with Dr. Hamilton that this drug combination is a red flag that he would have wanted to look into very carefully. Id. at 463.
However, Mr. Parrado indicated that he believed the red flag had been resolved because he found that Pharmacy 4 Less had contacted Patient A.V.s doctor, in which the doctor explained that he was trying to get A.V. off of the oxycodone by intermittently using buprenorphine.
Id. at 46364. When I asked where Mr.
Parrado had seen this red flag resolved in the records he reviewed, he stated that he had seen it in the patients record maintenance folder. Id. at 464;
RX 22, 23.
Upon a review of the evidence, I find that Patient A.V.s patient record maintenance file maintained by Pharmacy 4 Less does give some indication that Pharmacy 4 Less contacted A.V.s doctor. In the Patient Memo, it states PATIENT DCD 4/17/
17 CONTINUED DETOX WITH COM.
DRUGS FOR HIS SPECIFIC LEVEL OF
ADDICTION TAPERING PER DR. W
SEIFERTMD CONSULTED AND
RESULTED IN CONTINUED
THERAPY. RX 22, p. 1.RR However, what cannot be ascertained is when this information was entered into the system.
It is clear from at least the face of the prescriptions that Pharmacy 4 Less did not provide additional documentation beyond what is shown in the patient record maintenance file. With the impossibility of determining when this information was entered, it cannot be definitively ascertained whether Pharmacy 4 Less resolved the initial red flag at the time the prescriptions were issued or whether this information was inserted at a later time. However, even if the Respondent Pharmacy did resolve the initial red flag arising from the drug combination, there is no evidence in the record that the red flag arising from the continual prescribing of RR The Government argued in its exceptions that the ALJ improperly relied on RX 22 because the exhibit was admitted only conditionally and the condition for its admission was ultimately not met.
While I understand the Governments argument regarding reliance on the exhibit in this way, the ALJ did not rely on RX 22 standing alone, rather he relied on it as support for Mr. Parrados opinion which was that the Respondent Pharmacy had contacted the patients physician and resolved the initial red flag. Ultimately, in light of the preponderance of the evidence, RX 22 is of little importance to the finding on this red flag.

VerDate Sep<11>2014

20:19 Sep 30, 2021

Jkt 256001

the drug combination without proper tapering was resolved.
Therefore, I find that the Government has met its burden of proof as to this allegation by establishing that Respondent Pharmacy failed to resolve the red flag of arising from the long-term use of this drug combination without tapering.SS
Failure To Document Resolution of Red Flags I have presented my findings as to each of the five allegations set out by the Government as to Pharmacy 4 Lesss failure to resolve red flags. The Government has argued that not only has Pharmacy 4 Less failed to resolve these red flags, but their failure to document resolution of red flags warrants an inference that the red flag was never resolved.
As I have already discussed, Omitted. I credit Dr. Hamiltons testimony that pharmacists are required under the course of professional practice in Florida to document the resolution of red flags.TT As such, I
make my recommendation that the Administrator find Pharmacy 4 Less was required to document the resolution of red flags, and that it failed to do so.
During the hearing, Mr. Parrado provided testimony about the Florida laws and regulations that underpin the standard of care for Florida pharmacists.
As one of the individuals involved with the drafting of Florida regulations in question, he gave insightful comments about the creation and basis for the rules. However, as I noted during the hearing, Mr. Parrados comments were instructive, but not dispositive. Tr. 468.
I am foremost guided by the text of the law and regulations,UU and by the Governments expert testimony regarding the standard of care in the State of Florida.
Based upon the evidence provided, I
find that Pharmacy 4 Less has failed to document or show other evidence that demonstrates resolution of the red flags 58 as alleged by the Government in SS I

have omitted the ALJs original finding in Respondents favor based on his uncertainty over whether or not the Respondent had resolved the initial drug combination red flag as may have been documented in RX 22. The ALJ did not evaluate the red flags that arose as a result of the continued filling of the drug combination prescriptions without signs of proper tapering, and having so evaluated them, I have reached a different result.
TT See also supra Requirement to Document Resolution of Red Flags.
UU Omitted for clarity.
58 Further, the Government offered evidence that DI and the rest of his team did ask Ms. Mincy if they documented their resolution of red flags and where they did so. DI was provided documents by the Respondent at DIs request upon which records were identified that failed to indicate the resolution
PO 00000

Frm 00028

Fmt 4701

Sfmt 4703

the previous five allegations, excluding the allegation related to the initial red flag arising from Patient A.V.s prescribed drug combination.VV
Recordkeeping Violations Initial Inventory The Government has charged that Pharmacy 4 Less did not have an initial inventory in violation of 21 CFR
1304.11b. Section 1304.11b provides that every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the . . . distribution, or dispensing of controlled substances. . . .
The Government provided the testimony of DI1 that on June 6, 2017, during the on-site inspection, DI1 asked Ms. Mincy if Pharmacy 4 Less had an initial inventory. Tr. 39. When asked, Ms. Mincy could not locate the initial inventory and did not know where it was, and contacted Mr. Sprys to ask about the initial inventory. Id. at 3940.
This was done in the presence of DI1
and DI2. Tr. 39. DI1 explained to Mr.
Sprys what an initial inventory was and asked if Pharmacy 4 Less had one, to which Mr. Sprys stated that he did not.
Tr. 40. Omitted for brevity.
The Respondent did not put on any evidence to confront this allegation,WW
although the Respondent, during crossexamination of DI1, questioned whether DI1 spoke to Mr. Sprys over the telephone regarding the initial inventory. Tr. 154.
As noted, the Government has the burden of proof in these proceedings to prove the charges alleged in the OSC
and those later raised in the prehearing statements. The Government must meet its burden by a preponderance of the evidence for its burden to be satisfied as to each allegation. Here, the Government produced the testimony of DI1 that Ms. Mincy did not know where the initial inventory was, and that Mr.
Sprys indicated that the pharmacy did of red flags. This footnote was relocated for preservation after the original text to which it referenced was omitted.
VV Omitted, for brevity, the inference that Respondent Pharmacys failure to document resolution of the red flags supported a finding that the red flags were in fact not resolved. Here, there is ample evidence of red flags that were unresolved and/or undocumented.
WW In its exceptions, Respondent claimed that it opened in 2015 with zero narcotics and that this report was shown to DEA agents on initial inspection in 2015. Resp Exceptions, at 7. This assertion is not supported by the evidentiary record.
Moreover, the reference to this report is ambiguous and may or may not refer to an initial inventory, but even if an initial inventory was taken, there is no assertion that Respondent had an initial inventory during the 2017 inspection. This exception is simply without merit.

E:FRFM01OCN2.SGM

01OCN2