Federal Register - October 1, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices by Publix. This evaluation included review of the drug invoices, filled prescriptions and the nature of each pharmacys overall business. Id. at 170
71. 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. Id. at 28687.
During the hearing in this matter, Dr.
Hamilton reviewed a number of materials provided to him by the DEA, including 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 also prepared an expert report in this matter based on the information and materials provided to him. GX 28.
In general, Dr. Hamilton provided detailed assessments of each of the 10
charged patients in this matter. He detailed his review of the prescriptions provided for each of the 10 charged patients and any red flags that he noticed through his review. His explanation that red flags can be resolved through a review of the prescription and some investigation, including speaking with the patient, reviewing medical history, or speaking with the prescriber, were all consistent with his ultimate opinions in this matter. His opinions in this matter were bolstered by his knowledge and experience in this field, as well as his knowledge of Florida regulation 64B
and guidance provided by the National Board of Pharmacy Association, which provide the source of pharmacy standards of care in Florida. Id. at 180, 35158.
On cross-examination, Dr. Hamiltons credibility was bolstered by his willingness to provide straightforward answers that were consistent with those opinions he had provided on direct examination. Dr. Hamilton conceded that he only reviewed the documents provided to him by the Government, but he was present throughout the hearing and was present to observe the testimony from the Respondents witnesses. He indicated, when recalled during the Governments rebuttal case, that even after hearing the testimony and opinions from the Respondents witnesses, his opinions in this matter had not changed. Tr. 1005. Further, Dr.
Hamilton demonstrated objectivity.
While Dr. Hamilton had differing opinions from Mr. Parrado in a variety of subjects, he was willing to concede areas in which he agreed with Mr.
Parrado and did not appear to form
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opinions solely to favor the Government.
Overall, I find Dr. Hamiltons testimony and opinions in this matter to be credible and reliable.
Mr. Robert Parrado, BPharm., R.Ph.
Mr. Parrado testified as the Respondents expert witness in this matter. Mr. Parrado was offered and qualified as a pharmacy expert. Id. at 431. Mr. Parrado has an extensive history in the pharmacy field. He appears to be approaching legend status in the field in Florida. He has been a licensed pharmacist in Florida since 1971. He was formerly licensed as a Consulting Pharmacist by the State of Florida until 1989. He has received numerous awards during his career. He is currently President and CEO of Parrado Pharmacy Consultants, Inc., which involves consulting with pharmacies, pharmacists, and with government agencies. Id. at 399402; RX
5. He has previously worked at several pharmacies.
From 2001 to 2004, Mr. Parrado was a member of the Florida Board of Pharmacy. From 2003 to 2009, he was on the Boards Accreditation Council in Pharmacy Education. While on the Board, Mr. Parrado also served on the Rules Committee and the Legislative Affairs Committee. During 2004, Mr.
Parrado was Chairman of the Florida Board of Pharmacy. Since 2001, Mr.
Parrado has been a perpetual member of the National Association of Boards of Pharmacy. Mr. Parrado was a member of the National Rules Committee which developed model rules for consideration by individual states. Id. at 409. For 18 months, ending in 2001, Mr.
Parrado was President-elect of the Florida Pharmacy Association. Later, Mr. Parrado served as Speaker of the House of Delegates for the Association.
Since 2014, Mr. Parrado has been guest lecturer on pharmacy law at the University of Florida College of Pharmacy. Id. at 410. As part of a recurring continuing education course, Mr. Parrado taught Resolving Red Flags, Allowing Patients to Legally Obtain Their Lawful Medical Prescriptions. Id. at 411. He has also presented to various professional organizations a course on Identifying Drug Diversion. Id. at 412. Mr. Parrado has testified as an expert witness previously, including an estimated eight or nine times as an expert called by DEA
in these administrative proceedings. Id.
at 41416.
It is undisputed that Mr. Parrado has an extensive and impressive background in the pharmacy field. In particular, Mr.
Parrado has a vast amount of experience
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in the practice of pharmacy within the state of Florida. His experience as a member of the Board of Pharmacy, including as a member of the Rules and Legislative Affairs Committees and as the Chairman of the Board, are highly instructive as to the Florida standard of care and those regulations governing Florida pharmacists. Mr. Parrado even noted that he was a co-author of Rule 64B1627.831, which is the Florida state requirement that pharmacists question prescriptions that may not be valid and only fill the prescriptions if the pharmacist is able to validate the prescription. Id. at 420.
As it has been noted, Mr. Parrado has previously testified in similar DEA
administrative proceedings. In Superior Pharmacy I and II, the Agency found that the ALJ in that matter properly qualified Mr. Parrado as an expert witness in that proceeding given his extensive experience in the pharmacy field. See Superior Pharmacy I and II, 81 FR 31,309, 31,322 n.16 2016. Mr.
Parrado was also previously certified as an expert in community pharmacy practice. Hills Pharmacy, LLC, 81 FR
49,815, 49,820 2016. The Agency also gave credit to Mr. Parrados expertise in Edge Pharmacy, 81 FR 72,092 2016. As such, I further find that Mr. Parrados background and expertise is more than sufficient to lend weight towards his testimony in this matter.
In this matter, Mr. Parrado provided generally reliable statements as to his review of the materials and his ultimate opinions. He testified that he had reviewed not only the Respondents exhibits, but also was provided and reviewed the DEAs exhibits. Tr. 432.
Mr. Parrado suggested that if he were in Dr. Hamiltons position, he would have asked the Government to provide more documentation.54 As to ultimate opinions, while Dr. Hamilton generally provided specific answers to the questions posed by the parties, Mr.
54 There was a question as to what requirement, if any, an expert witness has in requesting additional documents. Mr. Parrado indicated that it was his experience from Superior Pharmacy I and II that he should request more documents.
Respondents counsel argued that Superior Pharmacy I and II holds that if information to resolve red flags is not documented in materials provided to the expert, the additional documentation should be requested and provided to the expert if it exists. Tr. 44445. The Governments objection to the question was sustained and the parties were invited to brief this issue in their Posthearing Brief. The Government argues in its Posthearing Brief that Superior Pharmacy I and II do not stand for the argument that the Respondent asserted. Govt Posthearing Brief at 4243. Upon a review of Superior Pharmacy I and II, this Tribunal agrees with that assessment.
It was not established that Superior Pharmacy I and II have created such an obligation on the part of an expert witness to request additional documentation.
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