Norman Clement RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, JOSEPH SOLVO ESQ., MARTIN NDJOU, RPH., WALTER L. SMITH BS., MS., TYRONE HUMBLES, SHELLEY HIGHTOWER PHARMD, ALFRED EVANS RPH., MS., ADRIENE EDMUNDSON, LYNN MICHELLE CLARK, BELINDA PARKER-BROWN, REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BRAHM FISHER ESQ., JOSEPH WEBSTER MD., ESTER HYATT PHD., BRAHM FISHER ESQ., MICHELE ALEXANDER, DEBRA LYNN SHEPHERD, BS., CUDJOE WILDING, BERES E. MUSCHETT, STRATEGIC ADVISOR
Norman J Clement, Aaron Howard, Lynn Michelle Clark, Rick Fertil demand the return of our DEA pharmacy Control Substance Registrations Immediately.
“WE ARE PHARMACISTS NOT DRUG DEALERS”
The American Medical Association June 16, 2020:
“The nation no longer has a prescription opioid-driven epidemic. However, we are now facing an unprecedented, multi-factorial, and much more dangerous overdose, and the drug epidemic is driven by heroin and illicitly manufactured fentanyl, fentanyl analogs, and stimulants. We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens. This is why the AMA continues its aggressive advocacy efforts in support of patients with pain and those with a substance use disorder as well as broad support for harm reduction policies and practices that address the wide range of factors affecting patients. “
The nation’s opioid epidemic has never been just about prescription opioids, and we encourage CDC to take a broader view of how to help ensure patients have access to evidence-based comprehensive care that includes multidisciplinary, multimodal pain care options as well as efforts to remove the stigma that patients with pain experience on a regular basis. CDC has a great opportunity to demonstrate its commitment to patients with pain through a detailed re-examination of the CDC Guideline, and the AMA urges CDC to work with physicians and patients to ensure that the revisions support patients with pain and the physicians who care for them.”
“While the AMA understands that the apparent goal of the CDC Guideline was to reduce opioid prescribing, we believe the proper role of CDC is to improve pain care. It follows that a dedicated effort must be made to undo the damage from the misapplication of the CDC Guideline.“
The CDC Guideline has harmed patients
The AMA writes:
It is clear that the CDC Guideline has harmed many patients10—so much so that in 2019, the CDC authors11 and HHS issued long-overdue, but greatly appreciated, clarifications that states should not use the CDC Guideline to implement an arbitrary threshold:
Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond its recommendations. A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal
The AMA writes:
Accordingly, the CDC Guideline could be substantially improved in three overarching ways. First, by incorporating some fundamental revisions that acknowledge that many patients experience pain that is not well controlled, substantially impairs their quality of life and/or functional status, stigmatizes them, and could be managed with more compassionate patient care.
Second, by using the revised CDC Guideline as part of a coordinated federal strategy to help ensure patients with pain receive comprehensive care delivered in a patient-centric approach. And third, by urging state legislatures, payers, pharmacy chains, pharmacy benefit management companies, and all other stakeholders to immediately suspend the use of the CDC Guideline as an arbitrary policy to limit, discontinue or taper a patient’s opioid therapy.
The AMA further writes:
“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. 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.” (7)
” 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.”
THE DECEPTIVE ENFORCEMENT ADMINISTRATION (DEA)
When understanding the level of corruption of the DEA one needs only to ask themselves two fundamental questions.
A. How long has the DEA been around?
B. How long have pain and anxiety been around?
DEA’s evidence always relies upon exaggerations on numbers of “pills” and street language such as “pill mills,” “Holy Grails,” and “Cocktails,” not on medical disease states, clinical conditions, or medical terminology. Through the use of Junk Science, the DEA has been waging a clandestine campaign of disinformation to sway the public into believing prescribed narcotic analgesic medications are indeed dangerous drugs and their high dosages are red flags indicating abuse and trafficking which have contributed to the so-called opioid crisis around America.
In fact, DEA is the single most heinous government agency whose tactics have increased the cost of medication and healthcare all across America by misinterpreting the purpose and roles of medications needed to treat acute, chronic, neuropathic, and psychological pain.
Healthcare Providers are assumed by DEA to be lacking due diligence if they don’t prove beyond a shadow of a doubt that they have addressed any red flags, but in DEA court tribunals the agencies hardly ever produce evidence of real diversion. They rely on suspicions and glitzy non-scientific presentations.
From data published by CDC, we know that opioids are prescribed three to six times more often among seniors over age 62 than they are to youth under age 19. But overdose-related mortality in youth is three to six times higher than in seniors. Mortality has been stable for the past 17 years in seniors while it has skyrocketed in youth. More basically, there is simply no cause-and-effect relationship between State-by-State prescribing rates versus overdose mortality. Although mortality overall has risen sharply since 2010, it remains below national average in States with the highest medical prescribing rates.
In short, the basic premises of the 2016 CDC guidelines on prescription of opioid analgesics to adults with chronic non-cancer pain are wrong. And CDC KNOWS they are wrong!
Higher overdose mortality from 2010-2020 is a direct outgrowth of socioeconomic factors and the invasion of illegal Fentanyl into US street markets. We also know from State-level analysis of Prescription Drug Monitoring Programs data that when a prescription-type opioid is found in postmortem toxicity screens, it is likely to be only one substance among several, including illegal or diverted drugs and alcohol. Our “drug crisis” is driven by illegal drugs, not prescriptions.
Doctors who treat pain are NOT at fault in the opioid crisis. They never were. CDC policy seeking to force restrictions on opioid prescribing — at a huge and growing cost to patients — must change NOW, not a year from now.
See charts below:
I look forward to receiving a commitment from CDC to independently repeat the data analysis reported above with publication of your results.
STOP PERSECUTING DOCTORS FOR LEGITIMATELY PRESCRIBING OPIOIDS FOR CHRONIC PAIN
According to Richard Lawhern, June 19, 2020 article, “STOP PERSECUTING DOCTORS FOR LEGITIMATELY PRESCRIBING OPIOIDS FOR CHRONIC PAIN” in STAT+ online news states:
The damage to healthcare providers and the chronic pain patient population is devastating and the DEA never takes into account the clinical needs of the patients. It’s as if they have criminalized pain management without the benefit of clinical knowledge.
“Doctors should have gotten the message by now that deserting patients is a violation of medical practice standards, not to mention human rights. But they haven’t. On the contrary, they’ve been hearing about other doctors who got raided by Drug Enforcement Agency swat teams, their patients terrorized, medical records seized, and practices ruined by announcements in local news media. Compounding such brutal tactics, chain pharmacies have compiled high prescriber lists, blacklisting “top prescribing” physicians and denying prescription pain medication to their patients.”
The American Medical Association States:
As a starting point, the AMA points to the well-received recommendation from the U.S. Health and Human Services Pain Management Best Practices Interagency Task Force7 that patients experiencing pain need to be treated as individuals, not according to one-size-fits-all algorithms and policies that do not take individual patient’s needs into account. A similar statement was made by the CDC in 2016 when it published the CDC Guideline, where the authors plainly stated that:
The recommendations in the guideline are voluntary, rather than prescriptive standards. They are based on emerging evidence, including observational studies or randomized clinical trials with notable limitations. Clinicians should consider the circumstances and unique needs of each patient when providing care.”8 (emphasis added)
Yet, the CDC Guideline also included multiple arbitrary dosage and quantity recommendations that have been consistently misapplied by state legislatures, national pharmacy chains, pharmacy benefit management companies, health insurance companies, and federal agencies. Early on, the AMA feared9 that the arbitrary opioid analgesic dosage and quantity thresholds appearing in the CDC Guideline would cause unintended consequences when used to severely limit individual treatment decisions made by physicians.
We believe it is instructive to detail some of the specific effects the CDC Guideline has had on patients and policies to highlight the urgent need for CDC to revise the CDC Guideline.
FOR NOW, YOU ARE WITHIN THE