Following President Donald Trump’s touting of anti-malaria drug chloroquine (and its analog hydroxychloroquine) as a potential “game changer” in treating Wuhan coronavirus, several states instituted what were initially reported as “bans” on using the anti-virals. But other than the response by Michigan Gov. Gretchen Whitmer — a response so inept it screamed of partisan pandering and required a prompt walk-back by the novice Democrat’s administration — the states all acted within the realm of reasonableness in carving out standards to prevent hoarding of the drugs.
The Las Vegas Sun spurred the narrative that states were banning doctors from prescribing hydroxychloroquine and chloroquine to coronavirus patients by reporting that Nevada’s Democratic Gov. Steve Sisolak had done it. The Nevada outlet later issued a correction to clarify that the governor’s restriction didn’t apply to patients hospitalized with COVID-19.
But the correction still failed to capture the complete story. In Nevada, the governor’s COVID-19 Medical Advisory Team and the State Board of Pharmacy recommended the governor sign an emergency regulation governing the prescription of chloroquine and hydroxychloroquine “due to the hoarding and stockpiling” of the drugs, which could result in a shortage for those currently using the medications to treat rheumatoid arthritis or lupus.
With this goal in mind, Nevada promulgated an emergency regulation restricting chloroquine and hydroxychloroquine prescriptions for coronavirus patients and all new COVID-19 diagnoses from that point forward. Significantly, the emergency regulation does “not apply to a chart order for an inpatient in an institutional setting or to an existing course of treatment for a diagnosis made before the effective date of the regulation.”
Striking a Balance
The reality of the Nevada regulation is much different than originally reported. But while Nevada’s approach is within the bounds of reason, Ohio’s approach seems sounder.
In Ohio, Gov. Mike DeWine authorized the State Board of Pharmacy to file an emergency rule governing the prescribing of chloroquine or hydroxychloroquine, but unlike Nevada’s regulation, Ohio does not limit the use of the drug to a hospital setting. Rather, Ohio’s emergency rule provides:
No prescription for chloroquine or hydroxychloroquine may be dispensed by a pharmacist or sold at retail by a licensed terminal distributor of dangerous drugs unless all the following apply:
(1) The prescription bears a written diagnosis code from the prescriber; and
(2) If written for a COVID-19 diagnosis, the diagnosis has been confirmed by a positive test result, which is documented on the prescription and both of the following apply:
(a) The prescription is limited to no more than a fourteen-day supply; and
(b) No refills may be permitted unless a new prescription is furnished.
Ohio’s regulations also prohibit using the drugs preventatively or to treat patients supposed to have COVID-19 who have not been diagnosed, unless the Board of Pharmacy later approves such use in a resolution.
Given the burden on hospitals during the pandemic and the limited number of beds, Nevada’s approach of restricting the use of the anti-virals to a hospital setting is less than ideal. Moreover, research indicates that the hydroxychloroquine and azithromycin combination proves more effective if given prior to severe lung impairment, and other countries are using this combination to treat mild cases of coronavirus in at-risk populations. Under these circumstances, Ohio’s approach, which allows doctors to prescribe hydroxychloroquine to treat confirmed COVID-19 patients without requiring hospitalization, seems a more appropriate balance.
Texas and Idaho also adopted regulations to prevent hoarding and ensure availability of these drugs for rheumatoid arthritis and lupus patients. Texas’s rule provides:
No prescription or medication order for chloroquine, hydroxychloroquine, mefloquine, or azithromycin may be dispensed or distributed unless all the following apply: (1) the prescription or medication order bears a written diagnosis from the prescriber consistent with the evidence for its use; (2) the prescription or medication order is limited to no more than a fourteen (14) day supply, unless the patient was previously established on the medication prior to the effective date of this rule; and (3) no refills may be permitted unless a new prescription or medication order is furnished.
Idaho’s temporary rule governing limitations on the drug dispensing mirrors Texas’ language.
Unlike the clarity in Ohio’s rule, the language Texas and Idaho used creates an ambiguity concerning whether hydroxychloroquine can be dispensed for a coronavirus diagnosis, as both rules require “a written diagnosis from the prescriber consistent with the evidence for its use.” Do Texas and Idaho consider there to be evidence supporting the use of hydroxychloroquine in treating the Wuhan coronavirus?
In response to an inquiry, the Texas State Board of Pharmacy shared with me an excerpt from the guidance it issued for dispensing drugs in compliance with its emergency hydroxychloroquine rule: “The rule does not prevent a physician from prescribing one of these drugs for an off-label use.” The intent of the rule, according to the board’s guidelines, is to prevent hoarding and to make sure all patients that need the drugs have access to them, including COVID-19 patients.
Nicole Chopski, executive director for the Idaho Board of Pharmacy, told me Idaho’s intent was likewise to “prevent stockpiling,” and that “pharmacists are expected to use their professional judgement for each scenario they encounter.” Chopski said the Idaho rule was created to evolve as the evidence changes, considering new information emerges every day about using the anti-malaria drug to treat coronavirus.
Texas and Idaho’s rules thus provide flexibility for doctors to prescribe and pharmacies to fill hydroxychloroquine prescriptions for COVID-19 patients.
In sharp contrast to the balanced approach these states took to respond promptly to hoarding concerns, Michigan Gov. Whitmer’s administration bungled the challenge. Rather than promulgate an emergency rule or regulation, the state dispatched a letter to “Licensed Prescribers & Dispensers.”
The letter threatened investigative and administrative action against doctors and pharmacists, implying prescribing hydroxychloroquine or chloroquine to treat COVID-19 patients was inappropriate. “These are drugs that have not been proven scientifically or medically to treat COVID-19,” the letter intoned, before suggesting that medical professionals turn in their colleagues for prescribing the drugs to Wuhan virus patients.
Less than a week after issuing the daunting letter, Whitmer’s administration issued a “clarification,” noting a national concern that the drugs were being prescribed “without a legitimate medical purpose.” The letter left unanswered, however, whether Whitmer’s team believed there was a “legitimate medical purpose” to prescribe hydroxychloroquine off-label for coronavirus patients. Within her own state, leading hospitals such as Henry Ford Hospital and the University of Michigan have adopted hydroxychloroquine into their protocols for treating hospitalized coronavirus patients.
When I asked for clarification, David Harns, the spokesman for the Department of Licensing and Regulatory Affairs, said, “Prescribers and dispensers have a responsibility to apply the best standards of care and use their clinical judgment when prescribing and dispensing these and any other drugs to treat patients with legitimate medical conditions. Hoarding and stockpiling drugs for one’s own personal use is inappropriate.”
Harns’ comments suggest Whitmer’s administration had backtracked from its original position but remains unwilling to acknowledge the possible therapeutic benefit of the drug Trump has been touting. Of course, whether hydroxychloroquine will prove a game-changer remains to be seen, but the evidence continues to accumulate. Sadly, evidence also continues to mount that some governors aren’t up to the challenges the coronavirus is throwing their way.