Opinion: Michigan shouldn't rule out potentially lifesaving COVID-19 drugs
A recent letter sent to doctors and pharmacists across the state of Michigan sparked a great deal of controversy over the perceived threat of disciplinary action for anyone caught prescribing or dispensing certain drugs to treat the coronavirus (COVID-19). This was followed by a second letter that partially walked back the threatening tone of the first letter by implying that the first letter was only intended to prevent the hoarding of medication.
Like many other physicians, I understand and completely agree with the need to conserve critical medications during pandemics and all other situations that necessitate such care.
However, the original letter from the Michigan Department of Licensing and Regulatory Affairs (LARA) was like a punch in the gut — telling medical providers we cannot adhere to the longtime FDA practice of allowing off-label prescriptions and commanding we turn in our colleagues, to name just two points addressed in the letter.
Given this highly unsettling time and politically charged environment, the letter unfortunately became tangled in a lot of partisan political bickering. Continuing this track will solve nothing. Therefore, let’s bring this issue back to the one fundamental goal on which we all agree: saving lives.
Doing so requires clarifying one point made in the original LARA letter.
In it, the state indicated that Plaquenil (hydroxychloroquine), a drug commonly used to treat lupus, is not scientifically validated to treat COVID-19. Though technically correct, they went on to state that to fill a prescription for hydroxychloroquine prescribing physicians were required to have a “valid” diagnosis. The proceeding statement would seem to indicate that they did not consider COVID-19 to be one. According to the first letter, failing to do so could subject the physician or pharmacist to “administrative act” by the licensing department.
This seemed to be an attempt to obstruct the growing practice of prescribing hydroxychloroquine to treat COVID-19, a disease with no known treatment. Though this use is not yet conclusively proven or FDA approved, hydroxychloroquine has a growing wealth of data supporting that it may be effective in treating COVID-19. Thus, if the early data is born out, LARA could have been restricting the use of a drug that may prove to be lifesaving.
After receiving significant blowback for the tone and implicit threats contained within the letter, LARA sent the second letter. This follow-up letter appeared to attempt to clarify that the first letter was intended to prevent hoarding of hydroxychloroquine. Hoarding is widely discouraged as it could deprive lupus patients of this much needed drug.
The problem is that LARA attempted to protect the supply of hydroxychloroquine by also suggesting that it was not a valid “off-label” treatment for COVID-19. It seemed to pit the interest of lupus sufferers against those of COVID-19 suffers for whom it may prove that this medication was equally as needed.
My proposal to prevent hoarding would be, rather than prohibiting the dispensing of hydroxychloroquine based on diagnostic code, instead temporarily require a diagnostic code for the quantity dispensed. This would be a valid approach to preserve the limited supply as it would discourage hoarding and limit the quantity dispensed to those quantities appropriate for use given the diagnosis.
For example: 14 pills of hydroxychloroquine 200mg could be dispensed for a diagnosis of COVID-19 as this would adhere to the recommendation of Epocrates, which is one of the most reputable drug reference guides.
Conversely, though many lupus patients have been unable to obtain a three-month supply of hydroxychloroquine during this shortage and given the potentially equally valid use among COVID-19 patients, they may be asked to accept refills of a one-month supply at a time until the shortage resolves.
Thus, by enacting a diagnosis based dispensing approach, we could achieve protection of both patient groups while limiting hoarding until the supply is replenished.
More broadly, as only a very small amount of hydroxychloroquine may be needed to prevent potentially life-threatening COVID-19 complications, appropriate use and limited dispensing may have minimal impact on the supply of hydroxychloroquine for lupus sufferers while reducing the burden on our health care system. This is due to the fact that the current evidence supports that hydroxychloroquine may prevent viral entry into cells and replication.
Thus, early treatment of COVID-19 patients as outpatients may prevent progression of the disease, reducing the strain on hospitals and minimizing the need for ventilators. If true, this could have substantial economic implications as a reduction in costly hospitalization may be achievable inexpensively as hydroxychloroquine is generally very affordable ($10 for 30 pills via goodrx.com).
I highly encourage Gov. Gretchen Whitmer, with her authority over LARA, to consider this approach instead of attempting to claim invalid the use of hydroxychloroquine for COVID-19. Though using hydroxychloroquine to treat COVID-19 is not yet fully proven, there is currently more data supporting that it does work than supporting that it does not work.
I believe with this approach we could both protect those for whom this is a proven and established treatment while offering others what could be a lifesaving therapy.
Chad Savage, M.D., is the founder of the direct primary care practice YourChoice Direct Care in Brighton. He is also a policy fellow with the Docs4PatientCare Foundation, a physician-run foundation aimed at improving the doctor-patient relationship.