A Bad Decision in Desperate Times
My Fellow Osteopathic Physicians:
By now many of you have heard about an emergency regulation signed by Governor Sisolak on Monday March 23
rd
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:
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:
Sincerely Yours;
Bruce Fong, DO
President
Nevada Osteopathic Medical Association
