My Fellow Osteopathic Physicians:
By now many of you have heard about an emergency regulation signed by Governor Sisolak on Monday March 23rd that essentially bans the use of hydroxychloroquine and chloroquine from being prescribed for use against the COVID-19 pandemic sweeping throughout the world today.
When reading the accompanying justification for an emergency regulation, one gets the impression that it was done due to doubts about the medications’ safety and efficacy in regard to COVID-19, along with a concern regarding a shortage of these meds for other chronic conditions. However, when I called the Board of Pharmacy (BOP) I was given a different story that squarely blamed doctors for trying to self-prescribe and deplete the supply of medications.
Thus, the BOP proposed this emergency regulation on Sunday night (March 22) and had a public hearing the next day, at which time the Governor signed the proposed regulations. Please see the link for full text:https://drive.google.com/file/d/1905SK7ox7YDaP1d-W6BjCNgJVTiIX0U/view.
For the record, the frantic pace at which this regulation was pushed through clearly excluded any input from practicing physicians or the organizations and groups that represent their patients, interests and opinions. I have confirmed thru phone calls that neither NOMA nor the Nevada State Medical Association were given any notice of this proposed regulation.
In essence, as explained to me by the BOP, this change to the Nevada Administrative Code would prohibit the writing or dispensing of the aforementioned medications for a diagnosis of COVID-19 in an outpatient setting but allow for it to be used only in an inpatient setting. Also, as per the BOP, the hospital could then prescribe or dispense the medication for that same patient as an outpatient to continue care. Otherwise, new prescriptions for use of these compounds in the rheumatologic role could continue, but an ICD-10 code would be required and supply limited to 30-days.
Like any other physician trying to practice in these trying times, I fully understand and have severe issue with anyone hoarding needed medications or protective equipment that could help someone in need. From this perspective, I understand the BOP’s position on this matter and their utterly staunch opposition to any compromise on this matter until further evidence is forthcoming for outpatient setting use of the hydroxychloroquine or chloroquine.
However, I am absolutely convinced that this rash decision by the BOP and Governor is an undeniable mistake that will prevent physicians from being able to administer a potentially curative therapy that could prevent both morbidity and mortality. My dear colleagues, this is a scope of practice issue and clearly interferes with a physician’s decision on how to treat their patients.
I wholeheartedly am in opposition to this regulation for many reasons:
First, it is my most deep and heartfelt opinion that a treatment choice should ultimately be a decision left to physicians and their patient. When you are regularly seeing a patient, you know them better and understand their nuances more than a hospitalist or other triage person seeing this patient for the first time.
Second, this deeper knowledge of said patient will result in a better capability to realize that a patient’s condition is worsening and when they really need to be hospitalized or have a specific intervention. This is especially the case with COVID-19, where a hospital triage screener is looking only at specific parameters to determine need for more acute care. Currently the recommendation outside of obvious symptoms such as dyspnea and chest pain, is that a patient who is suspected of having this illness is advised to return home to self-isolate and observe but if they worsen then return to hospital to be admitted. Clincally, since 80% of patients have limited illnesses, you are sending them home to run this course. However, with the remaining 20%, you are waiting for them to show signs of significant worsening before actually admitting to the hospital. The patient’s primary care physician is a much better judge of this deteriorating situation than a stranger who has not had as much interaction with patient. In fact, often hospital triage and ER personnel are trying to deter admissions to reduce the potential of spread of the virus and such a delay could be critical to the outcome of a patient.
Third, in my humble opinion, since it is at this stage of initial worsening as an outpatient before hospitalization, that the patient may be developing viral pneumonia, this is a critical window of therapeutic intervention. If we have a reasonably effective anti-microbial agent(s) that can be used at this point, we can limit the spread and damage of said pneumonia and likely prevent its transition into Acute Respiratory Distress Syndrome and the severe complications associated with such including the increased chance of mortality. If we wait until a patient is admitted following the need to meet all of the current admission criteria to a hospital, we may lose the opportunity to stop the complications before they start. Normally all we can do once in the hospital is give supportive care. Even if we begin using the hydroxychloroquine or chloroquine after admission, we may still miss that critical therapeutic window.
Fourth, in the citation for the reason for this emergency regulation, it is noted that the medications had not had their safety and efficacy established. I would argue that these medications and related compounds have been in use for many decades (since the 1940’s) in their roles as anti-malarial agents even long before they were used in their current role as rheumatic agents. Therefore, their safety and side effect profiles are well known.
Regarding efficacy, there is always this argument that there are no controlled randomized placebo trials to refer to. People: “WAKE THE HELL UP!!!!” We are basically fighting a war against this disease, we do NOT have the luxury of time to conduct these trials where one group gets a drug and another a placebo (in fact to do this in this particular setting would be UNETHICAL!!). People are dying out there regardless of the true numbers and we have to rely on the clinical experiences of those who have already combatted this illness and review and use the most effective tools they have used to stop this. To restrict these agents currently would be akin to asking us as physicians to go into a gun fight with a knife or really nothing at all.
Right now, there are NO specifically indicated anti-microbial agents we can use for COVID-19 and even with the highest levels of supportive care in a hospital, we are only hoping on and relying on a patient’s own immune system to do the fighting. Specifically, hydroxychloroquine and chloroquine don’t just have a handful of anecdotal reports of effectiveness (sometimes with miraculous results) but have thousands of case reports of positive outcomes from doctors in the hardest hit areas all over the world. This alone should spur us to think, hey there is very likely something to this. I would argue that the sheer number of case reports with positive outcomes alone takes this evidence out of the anecdotal category to one that suggests likely beneficial outcomes. And if so, this should be enough impetus to allow for us as physicians to at least consider making a clinical decision to prescribing the same (in combination with azithromycin) especially on a compassionate (when there is no other option) basis. Another way of saying this would be “the potential benefits outweigh the risks” and given the lack of other viable agents, we as conscientious physicians should consider all that we can possibly do to help our patients with this “Novel” virus.
Additionally, other states have already begun allowing the use of these drug combinations as they have recognized the above arguments. I strongly urge the BOP and Governor Sisolak to reconsider their decision to enact these restrictive measures especially once more supply of the medications becomes available. This current emergency regulation denies our ability to put our patients’ interests first above all else which is a direct violation of the Hippocratic oath that all of us took upon graduating medical school. For these reasons and our current dire emergency circumstances, I submit there is enough evidence to show at least some level of benefit as well as known safety and as such these medications should be allowed to be prescribed for those who are specifically showing early signs of compromise with COVID-19 (suspected viral pneumonia) in an outpatient setting to potentially prevent worsening of their conditions.
Andrew Taylor Still wrote over a hundred and twenty years ago: “Let us not be governed today by what we did yesterday, nor tomorrow by what we do today, for day by day we must show progress”. Let us be true osteopaths and do what is best for our patients and make progress against this common foe of COVID-19.
What do you think? Please share your comments and even suggestions on how to address this issue with us at: Info@nevadaosteopathic.org.
Bruce Fong, DOPresident
Nevada Osteopathic Medical Association
By now, no one has been untouched by the current novel Coronavirus of 2019 (also known as SARS-Cor-2) and the disease it has been more commonly referred to as: COVID-19. Whether we or someone we know has been sickened by this or we have been affected by the rationing of everyday items (i.e.: paper products), rationing of protective supplies (hand sanitizer or gloves) or even by the rationing (diminished availability) of our ability to access our health care (due to fears of spreading this disease). It is this last item that truly gives us reason to pause.
Fear has played a larger role than anything in the loss or diminished ability to be able to obtain healthcare for ourselves. All across our nation and the world, strict protocols and outright quarantines (no matter what you call it) force most doctors and facilities to turn away many patients who would normally be treated. Although I personally agree that “social distancing” and isolation are good methods to help limit the spread and ultimately speed up the dying off of this virus; the fear of greatly exaggerated death rates and outright falsehoods of social media bloggers have created mass panic and worry among the majority of the public.
Many so-called leaders at all levels including local and state have ridden on this fear and have declared the need for isolation by forcing closed many “non-essential” businesses, leaving many Americans in particular out in the cold worrying about what will occur next. Furthermore, these leaders have massively failed to calm their constituents about the true reason behind these forced isolations and instead have subscribed to the fear-mongering and lack of factual evidence that is so prevalent about COVID-19.
The true reason for the isolations and social distancing is to protect those of our population who are vulnerable to more serious consequences of this illness (typically those over 60 years old and/or those with pre-existing chronic medical conditions including chronic lung diseases, diabetes, hypertension, low immune states or possibly any other severely debilitating chronic illness). The vast majority of people who contract this disease (generally considered greater than 80%) will NOT need hospitalization or even significant medical care. Of those hospitalized, most will require supportive care typically for viral pneumonia and a small percentage of these patients will require intubation and ventilator for acute respiratory distress syndrome. It is from this latter group that unfortunately a percentage of these patients will die. Therefore, I state with most certainty and confidence that if most of us were to be exposed to this virus, that we would experience none to very mild symptoms or at worst suffer a flu-like illness but then RECOVER. We should NOT be so fearful of this illness which is likely to kill far fewer of us than a typical influenza virus that occurs every year. Although it is our duty to protect the vulnerable members in our society, we also should not have to sacrifice our own health and well-being to do so.
The combination of fear and government forced closures of businesses as well as essentially forced isolation have had an unexpected consequence; many people at large are now unable to access their healthcare to maintain themselves and their health in general even if their issues don’t involve COVID-19 at all. Many doctors’ offices have been forced to close or curtail their operations due to outright fear of the disease or due to a lack of patients willing to venture out to be seen. This unforeseen consequence will result in the worsening of many patients’ chronic states as well as a general downturn in peoples’ ability to maintain themselves and in particular their immune systems in a time when we need that very immune system to keep us healthy and help us avoid serious consequences should we contract COVID-19.
We here at Sierra Integrative Medical Center, feel that this is an unacceptable situation and have committed ourselves to trying to stay open to provide a safe and efficient environment to provide you with your medical needs.
The traditional role of our integrative treatment center is to provide the best in therapies to bolster the immune system to fight diseases naturally and non-toxically. We offer treatments such as oxidative therapies and high dose vitamin C infusions that have traditionally had an anti-viral effect while enhancing immune system functionality. Although currently, there is no proven specific treatment for the novel corona virus, we feel that bolstering your immune system will play a large role in helping to try to prevent the illness or if you do contract it, you will have a means to likely lessen the severity and duration of said illness. Research at the National Institutes of Health have shown that vitamin C even in small doses can achieve this effect in the common cold (of which other corona viruses make up a large number of the causative agents).
Additionally, as an internist, I can address any other medical needs you may have should you have any difficulties in seeing your own physician or in being able to access care. I have deeply researched many aspects of the COVID-19 illness and have recently been lecturing various bodies regarding the same, trying to promote calm and profess factual evidence and dispel the plethora of falsehoods and rumors that create panic. I have encouraged my staff in regard to standing strong and steadfast against this disease and all the challenges that have arisen from it. Furthermore, we have revamped our infection control protocols to help ensure a safe and clean environment for you all here at our facility.
Again, we here at Sierra Integrative Medical Center send you all our prayers and well wishes in this difficult time but encourage you to seek us out to help provide for your medical needs as needed. May GOD bless you all and see all of us through this trial soon.
BRUCE K. FONG, D.O., H.M.D.
Sierra Integrative Medical Center
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