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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
Long Distances Traveled by Patients Both Dr. Hamilton and Mr. Parrado agreed that long distances traveled by patients to fill their prescriptions at Pharmacy 4 Less was a red flag that needed to be resolved before the prescription was filled. Id. at 20910, 453. As to Patient A.R., Dr. Hamilton gave the opinion that there were multiple red flags. Id. at 209. He said that the distance from A.R.s home to the physician was a red flag because A.R. had to explain the reason to be going to that physician. Further, the distance from the physician to the pharmacy is a red flag, because it was taking A.R. even further away from A.R.s home, approximately 50 miles from his home. A.R. needed to explain why he was traveling so far to fill the subject prescriptions. Id. at 20910. Dr.
Hamilton first opined that this red flag was not resolvable, but later conceded that there may be circumstances in which it could be resolved, but that it would need to be notated in the pharmacy file. Id. at 210.
Mr. Parrado gave the opinion that while the long distance traveled would be a red flag, it was one that could be resolved. Id. at 453. He said that it only needed to be resolved once as long as the pharmacist knew the patient and knew why they are coming to the pharmacy. Further, he stated that it would not need to be re-resolved each time if the patient was coming from the same place, hes seeing the same doctors, coming to the same pharmacy.
Id. at 453. When asked about this red flag on cross-examination, Mr. Parrado said that from his review, Patient A.R.
appeared to have a relationship with a pharmacy that would fill his prescriptions when it was difficult to find places to fill prescriptions. Id. at 539. He observed that Pharmacy 4 Less had developed a relationship with A.R., was monitoring and checking up on him, and gave all other indications which would resolve that red flag, in his opinion. Id. at 539.
While there appears to be no dispute that long distances traveled can constitute a red flag, there is a dispute as to its resolution in this matter. Mr.
Parrado claimed that in his review, he believed this red flag had been resolved.
Mr. Parrado based his finding on A.R.
having developed a relationship with the Respondent and the difficulty in locating pharmacies which carried opioids. Mr. Parrados finding appears to rely significantly on a scarcity of pharmacies carrying opioids. Based on the existing record, such scarcity has not been directly established. That the Respondent pharmacy has developed a
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relationship with A.R. would certainly not justify the first few dispensing without resolving the distance traveled red flag. In the absence of any other evidence resolving this red flag, I credit Dr. Hamiltons testimony that even if the red flag is resolvable, it was not resolved in this case.
Opioid Tolerance and High Starting Dosages I did not recognize significant disagreement between Dr. Hamilton and Mr. Parrado regarding the red flag evident at the initial dispensing of any significant strength of opioids. Dr.
Hamilton testified that a high initial opioid prescription is a red flag that must be resolved. He asserted that if a starting dose is too high and a pharmacist fails to identify the patient as being opioid nave to that dosage level, the prescription could potentially prove to be fatal. Id. at 188. While Mr.
Parrado did not appear to disagree that this is a red flag that should be resolved, he differed in his assessment of the patients in this matter receiving high starting dosages such that they would fail to meet the minimum standard of care. For example, when asking about prescribing 84 pills of oxycodone 30 mg to a patient, Dr. Hamilton testified that it would have been too high of a starting dosage for some of the charged patients.
On the other hand, Mr. Parrado observed that there is no upper limit on the quantity that can be prescribed to a patient or how many milligrams. He stated that each would depend on the patient and their individual tolerance level. Id. at 46162. Their previous opioid medication levels would fairly suggest their level of tolerance.
Essentially, Mr. Parrado took the position that initial subject opioid dispensing of a significant dosage represented a red flag, which was resolvable. I do not recognize significant conflict between the two experts in this regard.
The credibility of Ms. Mincys testimony as relates to her investigating the opioid naivete of the 10 subject patients deserves some analysis. Here, Ms. Mincy testified that she used E
FORCSE at the pharmacy to look at patients histories and records before filling a prescription. Id. at 643. She indicated that she uses it daily and prior to every fill of a new prescription of her patients. Id. She even stated that E
FORCSE is the best system to resolve red flags, in her opinion. Id. at 645.
She made multiple comments about the usefulness of the EFORCSE system and how she uses it on a daily basis during her work in the pharmacy. Finally, she indicated that she uses it before she fills
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every controlled substance prescription.
Id. at 64546.
The Government introduced evidence of the EFORCSE searches conducted by Pharmacy 4 Less between January 1, 2015, and June 6, 2017, for the 10
charged patients in this matter. GX 38.
For six patients, A.E., B.F., K.E.D., R.R., R.V., and V.W., this exhibit shows that Pharmacy 4 Less conducted initial opioid fills for the six patients, but did not run a search on EFORCSE on the corresponding date of the fill. For example, Patient A.E. first filled a prescription on November 19, 2015, but Pharmacy 4 Less did not check E
FORCSE for Patient A.E. until April 7, 2016. GX 38, p. 11. Apart from being able to run checks through EFORCSE, Pharmacy 4 Less did not introduce any evidence that it otherwise completed or documented its resolution of any potential red flags for Patient A.E before doing an initial fill of the prescription.
The evidence shows this to be true for Patients B.F., K.E.D., R.R., R.V., and V.W., as well. GX 38.
The EFORCSE records introduced do substantiate that either Ms. Mincy or Mr. Sprys checked the EFORCSE
database for the initial opioid dispensing for the following subject patients: A.R. on March 16, 2016; A.V.
on April 21, 2016; B.N. on January 22, 2016; and K.Y.D. on February 4, 2016.
See GX 38; RX 21, p. 4, 23, p. 3, 27, p.
3, 31, p. 7. However, Ms. Mincy conceded there was no documentary evidence that indicated that any of the subject ten patients started at lower doses of opioids, including oxycodone and hydromorphone, and worked their way up because they become opioid tolerant. Tr. 81516. To the extent that Mr. Parrado credited Ms. Mincys and Mr. Sprys claims that they checked E
FORCSE to resolve opioid navete for the six patients noted above, this significantly diminishes Mr. Parrados opinion.
The EFORCSE records further belie Ms. Mincys claim that she checked the EFORCSE prior to filling each prescription. Tr. 64546; GX 38.
According to my math, of the 190
charged dispensed prescriptions within the subject record, the Respondent checked the EFORCSE database 31
times, or 16.3% of the time. Ms. Mincy later testified that she checked E
FORCSE for each Schedule 2
prescription, and only recently began checking it for all controlled substance prescriptions. This significantly diminishes Ms. Mincys reliability as a witness.

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