“IF EVER ONE THINKS THEY’RE TOO SMALL TO MAKE CHANGES, THEN THEY HAVE NEVER SLEPT IN A TENT WITH A MOSQUITO !!!”
REPORTED BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF RETIRED DETROIT POLICE SARGENT WALTER R. CLEMENT BS., MS., MBA., HOWARD ADELGLASS, MD., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., 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 NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
“WE ARE NOT POWERLESS, AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS, WE WILL EXPOSE THE ABUSES AND TYRANNY
JUST AS THE VIDEO WAS RECORDED BY THE CELL PHONE CAMERA OF YOUNG DARNELLA FRAZIER, BORE WITNESS TO THE MURDER OF GEORGE FLOYD THE BLOG youarewithinthenorms.com BARES WITNESS AND BOTH ALLOWS THE SYSTEM TO BE HELD ACCOUNTABLE”
THE JOURNEY
__________________________________________________________________________________
UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT
Norman Clement,
Petitioner
Case: No. 21-1262
Drug Enforcement Administration,
Respondent
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Petitioners Motion To REQUEST THis COURT UNDER HIS DISPOSITIVE MOTION TO REVIEW PATIENT CONSTITUTIONAL HEALTHCARE RIGHTs VIOLATIONS IN Pharmacist Corresponding Responsibility requirement under 21 CFR 1306.04
OUT OF A MOUNTAIN OF DESPAIR COMES A METEOR OF HOPE
Pursuant to the Court’s Order of January 09, 2022, and D.C. Circuit Rule 28(a)(1), Petitioner’s Norman Clement pro se, in Case No. 21-1262 hereby request,
STATEMENT AT ISSUE
We ask this Court to determine if a Pharmacist Corresponding Responsibility requirement under 21 CFR 1306.04 is Constitutional. We believe this provision of a law violates a person’s right under both the Eight and Fourth Amendments to seek uninhibited medical care by permitting the pharmacist to withhold medication treatment (violation of the Eight Amendment while acting outside the scope of their training and licensure that has been based on a subjected presumption (bias) and further not being required to commit his/her reasoning as part of the patient’s medical record while relying in part on enforcement tools Prescription Drug Monitoring (PDMP) and NarxCare algorithms which have not been evaluated or approved by the FDA. Thus pharmacist has become an agent of law enforcement.
We also ask this court at what point of the mile marker does and legally written Control Medication prescription become illegal to fill.
corresponding responsibility violates patientS healthcare rights and is unconstitutional
The law permits the pharmacist to violate the patient’s Fourth Amendment Rights to seek medical based on the pharmacist’s bias. The pharmacist then withholds treatment based on their bias and on a subjective presumption of wrongdoing. Neither does this law require the pharmacist to put their reasonings into writing as part of the [p]atients’ medical record as to why they’re medication treatment is being withheld. Critically, proper recording of the patient medical care record information is an absolute must requirement of corresponding responsibility of every prescribing practitioner.
PROPHET HOSEA:
“My people are destroyed
for lack of knowledge. Because you have rejected knowledge,
I will also reject you as My priests.
Since you have forgotten the law of your God, I will also forget your children.”
Drug Enforcement Agency (DEA) in its regulations (21 CFR 1306.04) which states:
“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for properly prescribing and dispensing 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.” (1)
Thus, in interpreting the regulations, a pharmacist’s position is nearly identical to the practitioner who issued the prescription, though the pharmacist did not examine the patient or review their medical records.
Therefore, the pharmacist filling a controlled substance prescription should proceed with caution and use their professional judgment to determine if a prescription for a controlled substance was issued for a legitimate medical purpose during the course of his or her usual professional practice.
However, this law has further led to abuses of patient rights and has wrong empowered and encouraged pharmacist to intimidate patients, confiscate and destroy legitimately written authorized pain control prescriptions, and then calls the prescriber to request the practitioner to lower their dosage or to prescribe and alternative pain treatments. Such actions amount to the pharmacist giving a diagnosis or a second opinion which is outside the scope of a pharmacist’s training and licensure.
ARGUMENT
The DEA follows code 1306.04, with states, “the corresponding responsibility rests with the pharmacist who fills the prescription.” This policy is absent of medical logic unless a pharmacist has equal access to the patient’s entire medical/dental records, including treatment plane, radiographs, study models, and further conducted physical examination. They simply cannot offer a second opinion for behind a dispensing counter. Such an opinion is considered a second opinion on practicing medicine without proper credentials. More importantly, would need to request a signature from the patient to gain his or her medical record from the prescribing practitioner. Most often, the Pharmacist relies upon Prescription Drug Monitoring Program (PDMP) surveillance and the lack of regulation of PDMP platforms on opioid patient health and safety. It is, therefore, necessary to scrutinize the federal agencies vested with significant authority over controlled substance surveillance and PDMP software platform regulation: the DEA and the FDA. (1)
Prescription drug monitoring program (PDMP) predictive surveillance platforms were designed for—and funded by—law enforcement agencies. PDMPs use proprietary algorithms to determine a patient’s prescription drug misuse, diversion, and overdose risk. The proxies that PDMPs utilize to calculate patient risk scores likely produce artificially inflated scores for marginalized patients, including women and racial minorities with complex, pain-related conditions; poor, uninsured, under-insured, and rural individuals; and patients with co-morbid disabilities or diseases, including substance use disorder and mental health conditions.NarxCare algorithms factor the number of an individual patient’s prescribers and dispensers into that patient’s risk scores because the model views evidence that a patient has multiple prescribers and dispensers as a proxy for doctor and pharmacy shopping.
The model, however, does not appear to consider the myriad reasons why a patient might have multiple prescribers or dispensers unrelated to drug misuse. NarxCare certainly does not account for the surveillance platform’s role in contributing to the number of prescribers and dispensers that opioid patients accrue. (1),(2)(3)(4)(5)
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- HAVING MIRANDA RIGHTS READ BEFORE FILLING A PRESCRIPTION: THE CRIMINALIZATION OF MEDICAL PROCEDURES AND PROSECUTORIAL MISCONDUCT: CONTROL SUBSTANCE ACT (CSA) MUST BE ABOLISHED by Cathleen London https://youarewithinthenorms.com/2021/11/20/having-miranda-rights-read-before-filling-a-prescription-the-criminalization-of-medical-procedures-and-prosecutorial-misconduct-control-substance-act-csa-must-be-abolished/
2. THE LONDON BRIEFS: THE PRESCRIPTION DRUG MONITORING PROGRAM (PDMP) A BILLION DOLLAR FRAUDULENTLY DATABASE OF DOJ-DEA https://youarewithinthenorms.com/2021/12/21/the-london-briefs-the-prescription-drug-monitoring-program-pdmp-a-billion-dollar-fraudulently-database-of-doj-dea
The DEA is acting upon the citizens based on an unreasonable standard in absents of Reasonable and/or Probable Cause. Thus the pharmacist has become an agent of law enforcement rather than a healthcare provider, and even law enforcement is required to put their actions in writing. The Fourth Amendment was intended to create a constitutional buffer between U.S. citizens and the intimidating power of law enforcement.(4)(5)
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3. Jennifer Olivia, Associate Dean for Faculty Research and Development Seton Hall University School of Law; ARTICLE FEB 2022 VOLUME 110NO. 1
Dosing Discrimination: Regulating PDMP Risk Scores
https://www.californialawreview.org/print/dosing-discrimination-regulating-pdmp-risk-scores%EF%BF%BC/U.S. Food & Drug Admin., supra note 405, at 23.
These populations include women, ethnic and racial minorities, rural individuals, and socioeconomically disadvantaged patients with complex, chronic pain, OUD, and other stigmatized conditions. The FDA already has determined that PDMP scoring models pose significant risks to vulnerable patients and therefore deserve regulatory scrutiny. As a result, the agency is obligated to subject PDMP risk scoring platforms to external, peer-reviewed clinical evaluation utilizing the validation criteria outlined in the agency’s 2017 SaMD guidance.
4. THE DEA-DOJ BOGUS OPIOID HOAX: “PRESCRIPTION MEDICATIONS ARE NOT RESPONSIBLE FOR OPIOID SO-CALLED PANDEMIC,” COURTS HAVE RULED: https://youarewithinthenorms.com/2021/11/27/the-dea-doj-opioid-hoax-prescription-medications-are-not-responsible-for-opioid-so-called-pandemic-courts-have-ruled/
5. THE MEDICAL “JIM CROW” HOW GOVERNMENT ALLOWS YOUR PHARMACY TO LEGALLY DISCRIMINATE AND VIOLATE YOUR CONSTITUTIONAL RIGHTS: A PODCAST WITH CATHLEEN LONDON MD., 3RD YEAR LAW U.MAINE, https://youarewithinthenorms.com/2021/11/22/the-medical-jim-crow-how-government-allows-your-pharmacy-to-legally-discriminate-and-violate-your-constitutional-rights-a-podcast-with-cathleen-london-md-3rd-year-law-u-maine/
The Uncomfortable Pharmacists
The practice of the “uncomfortable pharmacist” in withholding treatment of a patient by altering or denying medications is both dangerous and unacceptable in the field of medicine; it has resulted in patients’ suicide. However, what further makes these Pharmacists even more dangerous is their opinions and reasoning are based on the foundation of CDC’s flawed Unscientific Opioid prescribing Guidelines which were developed under unreliable data.
Furthermore, pharmacists’ attitudes have their etiology in a belief that they have a corresponding responsibility which in fact, requires them to operate within the field of medicine in giving a second opinion; thus undermining the diagnosis and treatment plan of the prescribing practitioners.
Its origins are grounded in positioning hospital medical politics and “power-hungry egos” to elevate the pharmacy profession out from images of just being in the basement of a hospital dispensing and compounding to a clinical role on the healthcare team.
In these cases, the pharmacist acts by using no sound scientific materials to support their “uncomfortable foundation.”
- The pharmacist does no physical examination on the patients.
- The pharmacist reviews nor orders any lab work.
- The pharmacist reviews nor orders additional radiographs and views no progress report.
- The pharmacist further fails by entering nothing into writing as to the decision of how they determine the prescription(s) to be illegitimate and why they’ve interjected themselves into the practitioner-patient relationship by withholding or denying patients their medications.
The respective regulatory bodies, including the various “Boards” of Pharmacy, Medicine, Dentistry, Nursing, etc., clearly outline the ‘scope of practice for each of those disciplines. The orderly flow of a prescription “from” the doctor to the patient – via the Pharmacist – clearly outlines where the ‘diagnosis’ has to come from.
It is statutorily the purview of the pharmacist to ‘inspect and assure that the drug that is being given is safe and has no known incompatibilities with the patient and its holistic environment. It is not the purview, nor is the pharmacist trained to ‘challenge the physician’s diagnosis and to do so verbally or otherwise with the patient.
It erodes the ‘doctor-patient relationship and destroys the patient’s confidence in his/her physician. At the very least, it is ‘unethical’ and may very well be a HIPPA violation and beneath the standard of care as a pharmacist. Any healthcare provider that is licensed to ‘prescribe’ is governed by the set of conditions and circumstances under which a prescription can be written.
Thus it is illegal to prescribe for a person that the prescriber has not conducted the ‘chain of authority that would qualify them to write a prescription: history and physical examination, formulation of a diagnosis, and discussion such with the patient as well as the proposed manner of treatment in a culturally sensitive and ethically appropriate manner; and provision of an opportunity for the patient to ‘question and discuss alternative forms of treatment; etc. (5),(6)(7)
Once the licensed prescribing practitioner has met all of those as mentioned above and other ‘requirements to write a prescription, then and then ONLY should a healthcare practitioner write a prescription. Furthermore, as stated above, a pharmacist IS NOT AUTHORIZED TO WRITE CONTROL PRESCRIPTIONS by any health regulatory board. The pharmacist has ‘no reason and more importantly, the pharmacist has ‘no power’ to question or interrogate each provider on ‘each prescription’ that is received as long as the ‘safety, efficacy and convenience’ of the medications being prescribed meet the standards of Medication Dispensing. Any given medication can be and certainly will be given for multiple different diagnoses and it is not even feasible for the pharmacist to ‘contact and question’ each and every diagnosis for pain control. (8) (9)
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ibid-3
6. DEA GESTAPO ACTIONS DESTROYS PHYSICIANS CAREERS AND CHRONIC PAINS PATIENTS LIVES: WE MUST RESIST BEING DEFILEDhttps://youarewithinthenorms.com/2021/12/09/dea-gestapo-actions-destroys-physicians-careers-and-chronic-pains-patients-lives-we-must-resist-being-defiled/
7. “RACIAL BIAS IN PAIN CARE PROTECTED AFRICAN AMERICANS,” CONCLUDED ANDREW KOLODNY, MD., TOP U.S. GOVERNMENT EXPERT AND “AMERICA’S MOST DANGEROUS PSYCHIATRIST” https://youarewithinthenorms.com/2021/12/13/racial-bias-in-pain-care-protected-african-americans-concluded-andrew-kolodny-md-top-u-s-government-expert-and-americas-most-dangerous-psychiatrist/
8. THE WRONG ARMS OF THE LAW: STATE ATTORNEYS-GENERALS, DOJ-DEA: FRAUDULENT DATA UNDERMINES HEALTHCARE CAUSING THOUSANDS OF PATIENTS DEATHS:https://youarewithinthenorms.com/2021/12/15/the-wrong-arms-of-the-law-state-attorneys-generals-doj-dea-fraudulent-data-undermines-healthcare-causing-thousands-of-patient-death/
9. HFPP SECRET ALGORITHM UNIQUELY TARGETED “OLDER WHITE PHYSICIANS,” BASED ON ASSETS, AGE, AND SPECIALTY IN MASSIVE GOVERNMENTAL OVERREACH: PT-2 https://youarewithinthenorms.com/2021/12/01/hfpp-secret-algorithm-uniquely-targeted-older-white-physicians-based-on-assets-age-and-specialty/
10. CRUCIFIED ON THE BLUE CROSS: THE STORY OF DRALVES GENE EDWARDS, DO.; PRACTICING MEDICINE WHILE BLACK AND THE RACIAL PROFILING OF PHYSICIANS OF COLOR IN AMERICAhttps://youarewithinthenorms.com/2021/12/08/crucified-on-the-blue-cross-the-story-of-dralves-gene-edwards-do-practicing-medicine-while-black-and-the-racial-profiling-of-physicians-of-color-in-america
THE AMERICAN MEDICAL ASSOCIATION CONCERNS
The American Medical Association has noted these abuses in its June 16, 2020, letter to Deborah Dowell, MD, MPH Chief Medical Officer National Center for Injury Prevention and Control U.S. Centers for Disease Control and Prevention 4770 Buford Highway, NE Atlanta, GA 30341 which stated
“We are concerned that such a careful approach to identifying the precise combination of pharmacologic options could be flagged on a prescription drug monitoring program as indications wrongly interpreted as so-called “doctor shopping” and cause the patient to be inappropriately questioned by a pharmacist.
The AMA strongly supports a pharmacist carrying out his or her corresponding responsibility under state and federal law, but the past few years are rife with examples of patients facing what amounts to interrogations at the pharmacy counter as well as denials of legitimate medication.
Pain is a complex and subjective experience initiated by an unpleasant (or noxious) stimulus associated with actual or potential tissue damage. Pain is a primitive response that motivates us to withdraw from the source that is causing the pain and protect the body from further damage. The unpleasant feeling associated with pain is also stored in our memory so that we can avoid similar situations in the future. While seemingly intimidating, its understanding is not all that difficult.
Over prescribing has no definition, is not a medical term, and has not been proven that substance exposure alters any aspect of the “opioid crisis.” In fact, patients on long-term opiate therapy for pain stabilization are the least likely to overdose. Richard Lawhern PH.D.“Morphine Milligram Equivalent Daily Dose (MMEDD) is not a useful measure in defining limits on opioid dosage and as such, it has been repudiated by the American Medical Association(AMA). Its major utility is as a rough guide to the clinician in making a safe transition from one opioid to another.”
The AMA urges CDC to provide strong guidance and support for physicians and pharmacists to work together rather than jumping to conclusions about a patient’s PDMP report.” ” Clinicians are encouraged to have open and honest discussions with their patients so as to avoid stigmatizing the decision to start, continue, or discontinue opioids or non-opioid therapy. This discussion also must account for the treatment options accessible to the patient based on their health condition, social determinants of health (e.g. transportation, employment, childcare responsibilities, race, gender, age) and insurance coverage.”
Far less attention, however, has been directed at the significant role federal and state regulators played in the overdose crisis, including the FDA, DEA, Centers for Disease Control and Prevention (CDC), Office of National Drug Control Policy (ONDCP), and state medical and pharmacy licensing boards.[94]
Detailing these agencies’ collective contributions to our ever-worsening drug overdose epidemic, however, would fill the pages of a hefty text and exceed the concerns of this Article.
Under the Controlled Substance Act, the DEA is charged with preventing the diversion of legal drugs into the illicit market by maintaining strict control over the availability of controlled substances. This extends to CSA-regulated prescription opioids, which are monitored “through quotas, registration, record keeping, reporting, and security requirements.”
FDA HAS NOT APPROVED NARXSCORE OR PDMP SOFTWARE
Considerable evidence also demonstrates that PDMP risk scores disparately impact specific patient groups experiencing “a critical situation or condition.”[5] The FDA has already determined that PDMP scoring models pose significant risks to vulnerable patients and deserve regulatory scrutiny. As a result, the agency is obligated to subject PDMP risk scoring platforms to external, peer-reviewed clinical evaluation utilizing the validation criteria outlined in the agency’s 2017 SaMD guidance. (7)(8)
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[7]
U.S. Food & Drug Admin., supra note 405, at 23.
8. “LET THEM DIE-OFF” UNITED STATES GOVERNMENT EXPERT ANDREW KOLODNY, MD., THE MOST DANGEROUS PSYCHIATRIST IN AMERICA AND EXPOSING “THE OPIOIDGATE MEDICAL SCANDAL” https://youarewithinthenorms.com/2021/12/04/let-them-die-off-united-states-government-expert-andrew-kolodny-md-the-most-dangerous-physician-in-america-and-exposing-the-opioidgate-medical-scandal
Conclusion
I am a pharmacist/dentist dispensing FDA approved medication Narcotic Analgesic Medication and not a drug street dealer.
The government has a legitimate interest in deterring the diversion and misuse of controlled substances, especially amid the illicit drug overdose crisis. But a standard for criminal liability that overly deters and may cause medical professionals to act against their best medical judgment due to fear of oversight has a chilling effect on their willingness to care for patients in pain and even encourage them to engage in self-protective practices that risk the safety and endanger the lives of a patient receiving pain care.
WHEREFORE, WE REQUEST UPON THIS COURT:
- Grant this motion and reverse these findings and decision of the Administrative Court, return and restore all privileges of the DEA Control Registration Certificates of Pronto Pharmacy LLC.
- Further, Dismiss the Decision of the Administrative Judge Mark Dowd in agency case No: 19-42, Federal Registry filed 1927282 on December 20, 2021with extreme prejudice.
- Return all Files, Equipment, and Medication to Pronto Pharmacy Llc and its owner Norman J Clement of Tampa, Florida.
- I’ve lost my life savings by reward damages and penalties of amounts greater than $187 million U.S. dollars.
RESPECTFULLY SUBMITTED
March 7, 2022
Norman J Clement
Norman J Clement, pro se
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on March 7, 2022, a true and correct copy of the foregoing was electronically filed via ECF and/or served via e-mail upon the following:
I, Norman J Clement, hereby certify that I’ve electronically filed and agree to utilize jointly the foregoing Respondent’s Notice of Filing the Certified List of the Record with the Clerk of the Court for the United States Court of Appeals for the District of Columbia Circuit, by using the appellate CM/ECF system, on March 7, 2022. I certify further that Petitioner is pro se, and that service will is accomplished by electronic mail to
Anita Gay, Esq United States Department of Justice
Criminal Division/ Narcotic and Dangerous Drugs Section
145 N Street, NE, Room 2E-404 Washington, D.C. 20002
(202) 353-7629 anita.gay2@usdoj.gov
Norman J Clement
Norman J Clement pro. se
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