Early studies have shown some promise for the use of Plaquenil (hydroxychloroquine sulfate) to treat COVID-19. Plaquenil is currently used to prevent and treat malaria in addition to treating lupus and rheumatoid arthritis. While Plaquenil is not yet an FDA-approved treatment option for the novel coronavirus, some physicians have begun prescribing the medication, raising concerns about a shortage of the medication for those patients who need it to treat chronic conditions.
SECTION 1: Plaquenil drug shortage
From an official standpoint, Plaquenil is currently only approved by the FDA for prescription treatment of conditions such as malaria, lupus, and rheumatoid arthritis. The United States government has approved Plaquenil for compassionate use (i.e. treatment of severely ill patients with no other recourse) and endorses further evaluation of its use for all coronavirus patients. It has not been formally approved for treatment of patients with the novel coronavirus. However, some doctors are choosing to prescribe Plaquenil off-label for this purpose.
Our pharmacy has received an unprecedented number of phone calls from doctors seeking information regarding Plaquenil dosing for COVID-19. Many prescribers have reported feeling pressure to prescribe this drug as a precautionary measure by their patients.
We are urging prescribers to be vigilant of the potential risks associated with families hoarding this medication in their homes without valid diagnosis. There are many patients who require Plaquenil to both prevent and treat malaria in addition to treating lupus and rheumatoid arthritis. We are concerned that the increasing demand for Plaquenil during the COVID-19 outbreak could lead to decreased availability of the drug for those patients who need it to treat chronic conditions.
Already, some wholesalers have reported a shortage of the drug Plaquenil due to the increasing number of prescriptions written for its use as an unofficial, non-FDA-approved treatment option for COVID-19. Additionally, a shortage of Aralen (chloroquine phosphate), the medication from which Plaquenil is derived, was recently reported by the FDA.
As demand for this prescription medication increases, supply is being limited. Traditional big chain pharmacies are restricted to purchasing prescription medications from one of the three primary wholesalers (Cardinal, AmerisourceBergen Corporation, or McKesson Corporation). This is due to their contracts with Pharmacy Benefit Managers (PBMs), industry middlemen that negotiate contracts between pharmacies, wholesalers, and manufacturers. As demand has increased for Plaquenil, these primary wholesalers are limiting the amount that pharmacies can purchase.
While chain pharmacies have additional capital and leverage to buy extra supplies and manipulate pricing, smaller independent pharmacies will be particularly impacted during a drug shortage.
Pharmacies that are not beholden to the insurance adjudication system, like Honeybee, are in a unique position because we do not work with PBMs. Therefore, we are not restricted to purchasing from a singular wholesaler and instead have access to a wider supply of medications and smaller wholesalers. This allows us to circumvent any supply restrictions imposed by the three main primary wholesalers.
SECTION 2: What is Plaquenil?
Plaquenil (hydroxychloroquine sulfate) is an anti-rheumatic, anti-malarial, antiparasitic, and immuno-modulatory prescription medication. In the 1950s, Plaquenil was approved by the FDA to prevent and treat malaria. Later, it was also approved to treat lupus and rheumatoid arthritis. The precise mechanism by which Plaquenil exhibits activity against Plasmodium (malaria) is not known, but it is theorized that it prevents the malaria parasite from breaking down hemoglobin in red blood cells. For lupus and rheumatoid arthritis, which are autoimmune diseases, Plaquenil works by modulating the body’s immune system.
Plaquenil can have rare, but serious, health consequences, including but not limited to:
- Irreversible eye damage, including blindness
- Cardiac failure and irregular heartbeats
- Severe rash and photosensitivity
- Muscular weakness, atrophy, and abnormal muscle reflex and control
It also commonly causes the following side effects:
- Dizziness and headache
- Lack of appetite, weight loss, nausea, vomiting, diarrhea, and abdominal pain
- Hair and skin discoloration and hair loss
Generally, serious health consequences tend to manifest with daily doses exceeding the maximum daily dose of 400 mg and increased duration of therapy (such as one to five years). That being said, side effects and serious consequences can still occur with shorter drug therapy durations and lower doses. The safety of the drug also depends on a variety of other health factors, including but not limited to any underlying conditions the patient might have and other drugs they are taking.
As with any prescription medication, it is up to the patient, their doctor, and their pharmacist to decide if the benefits outweigh the risks.
SECTION 3: Early findings on the treatment of COVID-19 with Plaquenil
Researchers are actively studying the safety and efficacy of Plaquenil in treating COVID-19. Because this treatment option is still in early stages of testing, human studies have so far been limited to small sample sizes. Furthermore, because human studies started in February or March of 2020, there is virtually no information available regarding recurrence of COVID-19 or need for longer-term treatment. As of March 2020, there is no concrete evidence that Plaquenil can cure or treat the new coronavirus in people. Here, we summarize initial findings from available studies on Plaquenil’s efficacy in treating patients with the coronavirus.
As of March 19, 2020, the use of hydroxychloroquine in treatment of the coronavirus is being studied in 9 trials registered in the Chinese Clinical Trials Registry and 3 trials registered with the U.S. National Laboratory of Medicine’s ClinicalTrials.gov.
On February 19th, a Chinese research group released findings from a study on over 100 patients treated with chloroquine, the medication from which hydroxychloroquine is derived. While they did not release specifics of their results, they claimed that the drug is “superior to the control” in treating the infection.
On March 17th, a research group in France released results of a study involving 20 coronavirus patients treated with Plaquenil (600 mg daily). After 6 days of treatment, 70% of the Plaquenil patients tested negative for the virus, compared to 12.5% of the control group.
Another report, published by Elsevier in March, discussed recommendations from Korean physicians. They endorsed the use of chloroquine (500 mg twice daily) or hydroxychloroquine (400 mg once daily) in treating elderly coronavirus patients or those with underlying conditions and more serious COVID-19 symptoms.
While evidence from human studies is limited, this systematic review of in vitro studies (i.e. studying samples outside the human body) concludes that chloroquine “seems to be effective” in treating the coronavirus infection.
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