REPORTED BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, WALTER R. CLEMENT BS, MS., MBAJELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., IN THE SPIRIT OF LOUIE LADSON RPH., MBA., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, IN THE SPIRIT OF LOUIS LADSON MBA, RPH, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
BY
FELIX BRIZUELA DO
NORMAN J. CLEMENT, RPH, DDS
“A VICTIMS OF DEA-DOJ OVERREACH INTO MEDICAL SCIENCE”
THE RED FLAGS OF ENFORCEMENT FRAUD
The entire red flag phenomenon is fabricated and is an example of how the HFPP has given the DOJ-DEA the authority to make laws, criminalize matters at will. The board of pharmacies has never given pharmacists the authority to police doctors.
Their only purpose is to fill prescriptions and warn a doctor if there is a potential interaction, intolerability. Even then, it is up to the doctor as to whether or not they want to move forward, criminalizing this aspect of medical care puts pharmacists in a tough spot.
THE PROBLEM WITH DOJ’s RED FLAG THEORY
According to the National Association of Chain Drug Store in the Amicus Curiae brief in Xiulu Ruan vs. United States Case No: 20-1410 case before the Supreme Court United States:
“There are many problems with DOJ’s “red flags” theory. It has no basis in the CSA or its implementing regulations, or even in the DEA’s Pharmacist’s Manual. It imprudently dismisses the individualized, case-by-case approach that pharmacists take when filling prescriptions in favor of a categorical approach to culpability. (10)
And it traps pharmacists in an untenable position—either face liability under the CSA for filling a facially valid prescription that raises a “red flag,” or face state-based professional liability,(11) and even civil suits,(12) for refusing to fill such a prescription.“
“But the critical point here is that § 1306.04 provides protection for pharmacists that the Court should not inadvertently eliminate: a pharmacist may only be held liable if the pharmacist “knowingly fill[s]” a “purported” prescription.
In other words, unless a pharmacist subjectively knows that a facially legitimate prescription has been prescribed for illegitimate reasons, the pharmacist should not face potential liability for dispensing medication based on that prescription.
Strict adherence to this knowledge element is critical to ensuring that pharmacists acting in good faith are not punished for filling facially valid prescriptions written by licensed and registered prescribers— a punishment that, if rendered, would chill other pharmacists from performing their duties.“
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10 See Dispensing Controlled Substances for the Treatment of Pain, 71 Fed. Reg. 52716, 52720 (Sept. 6, 2006) (noting that “each case must be evaluated based on its own merits in view of the totality of circumstances”).
11 See, e.g., Wis. Pharmacy Examining Bd., Administrative Warning, Division of Legal Services and Compliance Case No. 17 PHM 095 (Dec. 6, 2018).
12 See, e.g., First Amended Compl. ¶ 2, Fuog v. CVS Pharmacy, Inc., No. 1:20-cv-00337-WES-LDA (D.R.I. Aug. 26, 2020), ECF No. 6 (challenging “corporate-wide discriminatory practices in refusing to fill, without a legitimate basis, valid and legal prescriptions for opioid medication”); Reasor v. Walmart Stores E., L.P., No. 3:19-CV-27-CRS, 2019 WL 5597302, at *3 (W.D. Ky. Oct. 30, 2019) (defamation suit by physician asserting that “the failure to fill his patient’s prescriptions necessarily imputed illegal conduct because pharmacists are required to fill prescriptions unless the Pharmacist has reason to know of some irregularity”).
THE PHARMACIST
Pharmacists are Masters at pharmacology, the science but they’re taught very little to no clinical medicine examination, diagnostic, treatments which is not their fault or part of their licensing.
If pharmacists were to be taught clinical skills, they would have to go to medical/dental school for at least 8 years and this is not going to happen anytime soon.
“Although § 1306.04(a) regulates both prescribers and pharmacists, the two roles are far from interchangeable, including for purposes of determining potential liability. With different licenses, education, skill sets, responsibilities, and workplaces from physicians, pharmacists play a vital but distinct role in a patient’s care. (See Amicus Curiae Brief National Association Chain Drug Stores, US Supreme Court Case No. 20-1410, Ruan vs. the United States of America)
Specifically, when dispensing a controlled substance to a patient, as prescribed by a physician, a pharmacist relies on the physician’s assessment of the patient’s needs.
The pharmacist has neither examined nor diagnosed the patient and lacks the information the physician has collected on the patient’s medical situation, records, and history, including such things as x-rays, ultrasounds, lab results, and treatment plans.
The CSA recognizes pharmacists’ circumscribed role in dispensing controlled substances. It provides that pharmacists may not dispense Schedule II controlled substances “without the written prescription of a practitioner,” 21 U.S.C. § 829(a), and that they risk criminal and civil liability if they do, see id. §§ 841(a), (c), 842.
The CSA’s implementing regulations further explain that a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a).
The regulations separately provide that such a prescription “may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed” by a registered entity. 21 C.F.R. § 1306.06.“
Consistent with the division of responsibility be- tween prescribers and pharmacists, § 1306.04 limits when pharmacists may be held liable for filling controlled-substance prescriptions to situations where a pharmacist knows a prescription is illegitimate:
“The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.
An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. [§] 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.21 C.F.R. § 1306.04(a) (emphasis added).
A pharmacist violates this provision only if the pharmacist “knowingly fill[s]” a “purported” prescription—i.e., a prescription that was not written, “in the usual course of professional treatment.”
So pharmacists should never ever be held liable for a physician’s action. the law still holds that the final decision is up to the doctor, not the pharmacist.
So why should the pharmacist have any responsibility? If there is some idiot out there who doesn’t know what they’re doing, they need to be held fully responsible not the pharmacist.
ACCORDING TO DEA DIVERSION CONTROL
In reference to opiates, I keep emphasizing, that it is a fact that when it comes to prescribing opiates, there is no ceiling effect. According to Thomas Prevoznik, DEA Deputy Assistant Administrator, 02/12/2021, letter to Richard A Lawhern Ph.D.:
“The Controlled Substances Act (CSA) and its implementing regulations established a closed system of distribution to ensure appropriate medical care and to maintain the integrity of the system through an accountability process. One of the most important principles underlying the CSA and its implementing regulations is that to be valid, every prescription for a controlled substance must be based on a determination by an individual practitioner, that the dispensing of the controlled substance is for a legitimate medical purpose in the usual course of professional practice. United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a).
Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States.
1. DEA has not promulgated any new regulations regarding the treatment of pain.
2. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient.
3. DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716.
While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.”
THE OPIATES
Opiates are the only pain medications that can be titrated to a patient’s response, which the FDA made very clear depends on the patient’s own physiology. In fact, if you dig deep, and play steps is on things like indication, ops are the only drugs indicated for chronic pain management.
The package inserts for acetaminophen, ibuprofen, and naproxen clearly limit the time that these prescriptions can be written, and they do have a ceiling effect.
The DEA and FBI have taken it upon themselves to define these drugs as an alternative to chronic pain management for which they are not approved.
I will try the patience with a fungus ball, aspergillosis causing severe visceral pain on 800 mg of oxycodone a day, he was fully functioning at a high-end executive level. Of course, the majority, who are uneducated will call this misuse, but in reality, it is a therapeutic intervention to suit the needs of the patient.
Carol D Pilkington1957 – 2015
Patients are going to die. It is incredibly stupid the whole doctors and pharmacists are liable for a patient’s death. I had a patient with lupus, Francis myelitis, CDIP who had it for years. She was so far gone, that she really did not respond to IVIG, ended up dying 6 months later.
Perhaps I should have gone to jail for not performing magic. Chronic pain patients are chronically ill patients. I’ve said multiple times, posted multiple times that chronic pain falls into the category of chronic disease. You cannot have chronic pain without having a chronic disease. Ultimately, these very ill individuals will die of their chronic disease.
And no one beholds, the FBI and the DA are quick to jump on the doctor and say they died because of you. I had a lady with chronic neuropathic diabetic pain, for the 15% ejection fraction. I kept her alive for 5 years and was comfortable with oxycodone 20 mg three times a day.
Ultimately, she perished she was on the transplant list but never made it. Of course, this a******DEA and FBI agents climbed all over me claiming that I killed her with a prescription opiate. They never followed up on this, perhaps cuz they realized how asinine their theory was.
And, it is a fact, an unequivocal fact that they’re at the very least 50 million chronic pain patients in this country alone. At its peak, there were only 4300 pain doctors and not all of these prescribed opiates.
Do the math. 20,000 prescriptions are very very low and not fulfilling the needs of those chronic disease patients. But, to the DA and FBI, it is a crime if you address it properly.
LOW HANGING FRUIT
FOR NOW, YOU ARE WITHIN
THE NORMS
REFERENCE
This article by Norman Clement nails it. Aside from physicians prescribing good faith, which the doj has stripped doctors of without due process, and without the authority, then there’s the issue of regulatory agencies, making laws.
There is a reason we have a legislative branch of government, both local, state and national. Judges, through judicial misconduct have allowed this very dirty, crooked and unconstitutional behavior.
I myself was reported by a pharmacist for something minor which the doj made a huge deal of, but the pharmacist themselves would probably faced severe consequences. In other words they were bullied. Pharmacists know that they do not have diagnostic or interventional authority.
They can only advise physicians on drugs, warn them of things like drug interactions, they can question an indication, they can only refuse to fill after a discussion with the physician.
The da, doj have given themselves legislative authority, they are literally breaking the laws and forcing the pharmacies to do this. Pharmacies that do not do as you’re told, face criminalization and jail time. What a conundrum.
Other physicians and myself, are in disagreement about the potential outcome of the ruan versus USA case.
Yes, the question to be bought up in front of the court is physicians prescribing in good faith. We prescribe you a medication, based on a history, physically examination. If the patient diverts a prescription, sells it, abuse it, or even overdoses it is not our responsibility.
However, I do feel that the supreme Court will dig deeper. I do feel the question of non legislative authorities literally creating criminal rules enforcing prosecution and criminalization will come into question.
Because even if they decide only on good faith, it still leaves the pharmacies open to litigation, and criminal prosecution. The doj, the DEA do not have the authority to do this.
Sandra Sam Newman
Oddly, the DOJ has violated our Constitution with zero oversight. Zero. 😡😡😡😡🇺🇸🇺🇸