Federal Register - October 1, 2021
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Source: Federal Register
54562
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
Pharmacy. Id. at 406. From 2003 to 2009, he was on the Boards Accreditation Council on Pharmacy Education. Id. As such, Mr. Parrado was involved in the accreditation of Florida schools of pharmacy. Id. While on the Board, Mr. Parrado was on the Rules Committee. Id. at 407. He also served on the Legislative Affairs Committee, which wrote proposed legislation for presentation to the Florida Department of Health, and for consideration by the Florida legislature. Id. During 2004, Mr.
Parrado was Chairman of the Florida Board of Pharmacy. Id. at 408. Since 2001, Mr. Parrado has been a perpetual member of the National Association of Boards of Pharmacy. Id. Mr. Parrado was a member of the National Rules Committee, which developed model rules for consideration by individual states. Id. at 40809. For 18 months, ending in 2001, Mr. Parrado was President-elect of the Florida Pharmacy Association. Id. at 409. Later, Mr.
Parrado served as Speaker of the House of Delegates for the Association. Id. at 410. Since 2014, Mr. Parrado has been guest lecturer on pharmacy law at the University of South Florida College of Pharmacy. Id. 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 taught this course at universities, to county and state pharmacy associations, and other professional organizations. Id. at 411
12. He has 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. Id. at 41416.
Mr. Parrado had last prescribed a controlled substance approximately three or four years prior to the instant hearing when working as a substitute pharmacist at Genoa Healthcare. Id. at 418. Regarding his most recent dispensing of opioids on a regular basis, Mr. Parrado estimated it to be 2011. Id.
at 419. Mr. Parrado was certified as a pharmacy expert. Id. at 431.
As relates to opioid nave patients, Mr. Parrado described various scenarios in which a patient, even one who has been dispensed opioids in the past but who has been deprived of opioids for a month or two, can become dangerously opioid nave. Id. at 433. To ensure a patient prescribed opioids is not opioid nave, Mr. Parrado described several tools available to the pharmacist. Id. at 43334. The pharmacist should ask a number of questions to alleviate
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concerns. Id. at 434. He can also reference the EFORCSE database. Id.
Mr. Parrado was critical of the limited records Dr. Hamilton reviewed to form his opinion in this case. Id. at 434. Mr.
Parrado suggested he would have asked the DEA to share more documentation with him than was shared with Dr.
Hamilton. Id. at 443.
As related to resolving red flags, Mr.
Parrado opined that in addition to consulting the EFORCSE database, a pharmacist may obtain medical records directly from the physician, or access the patient record maintenance from the Rx30 computer program. Id. at 435
36. As to Dr. Hamiltons opinion that the resolution of red flags had to be documented under Florida law, either on the prescription or somewhere else readily available to the pharmacist, Mr.
Parrado disagreed, claiming there was no such requirement under Florida law.
Id. at 434, 438. Mr. Parrado conceded documenting the resolution of red flags may represent the best practice. U Id. at 434. As to the subject documentation, Mr. Parrado observed that most pharmacists do document somewhat. Id. at 435. Most document on the back of the prescription. Id.
However, if that wasnt possible, Mr.
Parrado opined that it was acceptable to document in a card file system, or in the note field on your computer system. Id. Mr. Parrado also noted he created a computer program, called Red Flag Resolver, which would preserve such documentation on the computer server. Id. Mr. Parrado suggested diagnostic codes could be used on the prescription to demonstrate the medication was justified on the basis of the medical condition. Id.
Mr. Parrado explained that to resolve any red flag regarding immediate release medication, the physician can be consulted. Id. at 44748. Mr. Parrado noted that immediate release medications are cheaper than the extended release versions, and that the insurance company may not pay for extended release. Id. at 448.
Mr. Parrado also disagreed with Dr.
Hamiltons estimated price for each pill of oxycodone at .90 cents. Id. at 449. Mr.
U Mr. Parrado testified that there is no regulation that says you have to document . . . It may be a best practice to do that. But it does not say you have to. Tr. 434. When asked by the ALJ
whether documenting the resolution of this red flag issue might be the best practice, Mr. Parrado testified It might be, it is a good, I do it. Id. at 436. Later, Mr. Parrado testified that, you have to resolve the flag . . . . Does it say anywhere that you have to document it? No. Should you? Of course. How are you going to remember; how is your partner coming going to know, because there are many pharmacists coming in and out of the pharmacy. Id. at 438.
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Parrado suggested the price of Schedule 2 controlled substances are often inflated to accommodate the added expenses inherent in dispensing them, such as additionally scrutiny, legwork, record-keeping, and inventories. Id. Mr.
Parrado conceded that pharmacy pricing was very competitive. Id. at 44950. Mr.
Parrado explained that insurance issues can explain why a pharmacy may only accept cash payments V omitted. Id.
at 45051. Mr. Parrado explained that cash in the pharmacy business may include by credit card or even by check.
Id. at 460.
The only explanations Mr. Parrado could give for a pharmacy charging different prices for the same medication was a potential higher cost from a different wholesaler, the use of discount coupons, or indigent pricing programs.
Id. at 45152.
Regarding inordinate travel to fill a prescription, Mr. Parrado agreed it was a red flag, which needed to be resolved.
Id. at 453. But Mr. Parrado did not go on to opine as to whether or not the red flag was resolved with regard to the patient file for A.R. at issue in this case.
Id. As to the 8.5 mg prescription for hydromorphone, Mr. Parrado did not recognize it as requiring any investigation.W Id. at 454. Prescriptions for compounded medications are a normal part of pharmacy work. Id. at 45354; GX 12, p. 1718.
As to Patient B.F., who was apparently suffering from stage 3
hepatic cancer, Mr. Parrado opined that absent an inconsistent physical presentation by the patient at the pharmacy, the diagnosis itself resolved any red flag created by the large amount of opioids prescribed. Id. at 45556.
Mr. Parrado disagreed with Dr.
Hamiltons concept of the minimum standard of care, which Dr. Hamilton attributed to both the Florida Administrative Code, specifically Florida Regulation 64B, 42 and guidelines from the National Board of Pharmacy Association. Id. at 180, 351
58. Mr. Parrado understood the minimum standard of care as a violation of a law or rule of the Pharmacy Act, or of the Florida V The ALJ further found that the insurance issues can explain why a customer would pay cash. That portion of the finding is neither relevant to the alleged conduct nor did I find support for it in the record. Tr. 45051.
W Mr. Parrado did not testify in the positive or the negative regarding the need for an investigation, and he was never asked whether an 8.5 mg prescription for hydromorphone raised a red flag that needed to be resolved. Tr. 454.
42 See Wests Florida Administrative Code, Title 64. Department of Health, Subtitle 64b16, Chapter 64B1627Pharmacy Practice.
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