Federal Register - October 1, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices Administrative Code. Id. at 456. Mr.
Parrado did not recognize any violation of the Florida minimum standard of care by Pharmacy 4 Less in the documents he reviewed and interviewing the two pharmacists involved. Id. at 45658. Mr.
Parrado reviewed favorable Florida Department of Health Inspection Reports dated February 28, 2017, September 5, 2017. Id. at 47580, 546;
RX 14, 15, 16, 17. One of the documents Mr. Parrado reviewed at Pharmacy 4
Less was their biennial inventory completed April 26, 2017. Tr. 489.
Mr. Parrado disagreed with Dr.
Hamiltons opinion that 84 or 112
opioid tablets, for 30 mg of oxycodone, represented red flags, which needed to be resolved. Id. at 461
63. He did not consider these to be inordinate amounts. Id. at 463.
Mr. Parrado agreed that the simultaneous prescribing of oxycodone and buprenorphine to Patient A.V.
represented a red flag which needed to be resolved. Id. at 463. Mr. Parrado was able to resolve it by reviewing the PRM records. Id. at 464. It revealed the pharmacy had contacted the physician, who advised he was attempting to wean the patient off of the oxycodone. Id. at 46365.
In reviewing the PRM for each of the ten subject patients, Mr. Parrado found evidence that Pharmacy 4 Less contacted or attempted to contact the physician in each of ten cases to resolve red flags, and that each red flag described by Dr. Hamilton was properly resolved. Id. at 49092.
Mr. Parrado found none of the dosage units inordinately high, not even the 8
mg of hydromorphone. Id. at 491. He actually deemed 15 to 20 mg of oxycodone a very low dose, in contrast to Dr. Hamiltons assertion that those doses were relatively high. Id. at 510. As to the high prices charged, Mr.
Parrado disagreed that the subject prices were suspiciously high. Id. at 49293, 534. Mr. Parrado explained that following the crackdown on pill mills in Florida, opioids became more difficult for patients to obtain. Id. at 457, 539. They may have to travel to multiple pharmacies to even find the medication, so they would be willing to pay higher prices for them. Id. at 457, 539.
Mr. Parrado did not address the red flag described by Dr. Hamilton for the ongoing opioid prescriptions without considering a reduction in dosage, individualization. X Id. at 492.
X Though Mr. Parrado did not specifically address this red flag, he did testify generally that assuming there were red flags with every one of the patients, those red flags seemed to be resolved in every case and that he saw documentation where they had written down the resolutions. Tr. 492.
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On cross-examination, Mr. Parrado was confronted with Florida Administrative Code Section 64B16
27.800, requiring pharmacies to maintain patient records. Id. at 49596.
It specifically requires the pharmacy to provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a new or refill prescription is presented for dispensing, and requires that a reasonable effort is made to obtain, record and maintain . . . pharmacist comments relevant to the individuals drug therapy, including any other information peculiar to the specific patient or drug. Tr. 496.
Mr. Parrado indicated the red flag identified by Dr. Hamilton regarding whether patients could be opioid nave had been resolved by the subject pharmacists. Id. at 497. Mr. Parrado learned this by interviewing the pharmacists, and being satisfied with the steps they told Mr. Parrado that they generally took, including checking with the PDMP. Id. at 49699.
Mr. Parrado did not observe the ten patients increasing their dosage above the norm. Id. at 511. Most appeared to remain at maintenance levels. Id. at 51112.
As to Patient R.V., who, according to the pharmacy notes, was suffering from a neoplasm, Mr. Parrado was not concerned by a medical record from the pain doctor, which described her condition as cervicalgia resulting from a fender bender. Id. at 51622, 549; RX
34, p. 1, RX 35, p. 2.
As to Patient B.F., who Mr. Parrado testified was suffering from liver cancer, however, Mr. Parrado was unable to identify the cancer diagnosis by virtue of the diagnostic codes contained in the records. Id. at 514. However, he recalled seeing the cancer diagnosis in a medical note. Id. at 51316.
Regarding RX 22, pp. 23; GX 10, Mr.
Parrado discovered the pharmacists resolved the red flag by speaking with the subject pharmacists, who advised they confirmed they contacted the physician, who advised he was weaning the patient off of oxycodone with buprenorphine. Tr. 52225. However, in GX 10, it appears the buprenorphine was prescribed for sciatica pain. Id. at 52425. Mr. Parrado dismissed the medical codes as likely erroneous, choosing to rely on the conversation between the pharmacist and the physician. Id. at 52526. As to the nearly one year period of unchanged strength oxycodone prescriptions from April 12, 2016 to April 10, 2017, in conjunction with the buprenorphine intervention, Mr. Parrado recognized it
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to be a red flag, which would require the pharmacist to investigate by contacting the physician, pursuant to Fla. Admin.
Code 1627.810. Tr. 52627. Mr.
Parrado did not testify specifically as to whether or not this red flag was in fact resolved with a call to the physician. Tr. 527.
As to Patient R.R., who apparently suffered a broken back and fractured tibia from a car accident, Mr. Parrado was not concerned that the patient was discharged from the hospital on May 2, 2017, yet the final prescription was issued on May 30, 2017. Id. at 52728, 551; RX 32, pp. 12. Mr. Parrado did not consider a prescription issued a month after discharge unusual, and assumed the patient had not yet found another doctor. Tr. 528. Mr. Parrado was not concerned by the medical report denying any surgical history for R.R., as it was not contradictory of the above pharmacy notes, explaining a broken tibia does not necessarily require surgery. Tr. 529.
As to Patient A.E., although Mr.
Parrado reviewed the relevant medical records, which contained some obvious contradictions, including the patient claiming a pain level of 10 of 10, yet the physical examination by the physician showed no physical restrictions. Id. at 532. Mr. Parrado did not appear to have evaluated the substance of the medical records, but only the fact that the pharmacist had obtained the records and verified the patient was being treated for pain.Y Tr. 52932; RX 18, RX 19, pp. 2, 3.
As to Patient K.E.D., who was reportedly suffering from chronic pain as the result of a severe auto accident, yet the medical records deny past hospitalization, Mr. Parrado focused on the key findings of chronic pain and auto accident and not on contradictions in the medical records.
Tr. 53233, 552; RX 28, 29, p. 3.
As to Patient A.R., who apparently drove 45.4 miles one way to see his physician and to obtain his medications at Pharmacy 4 Less, Mr. Parrado did not find that distance unusual, citing the difficulty in locating pharmacies which carried opioids. Tr. 539. Mr. Parrado conceded he has testified in other cases that driving 40 miles was a red flag. Id.
at 54142. Mr. Parrado distinguished his prior testimony as the distance was also part of a suspicious pattern. Id. at 542.
Y Mr. Parrado testified, that he was not considering the medical records with specificity for their content, but was looking to see that they had gotten something from the doctor to help them resolve red flags. . . . he considered the fact that they had the medical record, and that the doctor was treating pain and that they had gotten that. Tr.
532.
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