Hydroxychloroquine (Plaquenil) Shortage Causing Concern

Updated March 24, 2020 –

People who take hydroxychloroquine (Plaquenil) are increasingly having trouble getting a refill from their retail or mail order pharmacy. Doctors are getting questions about this after news about the potential for the drug to help shorten the course of COVID-19 was broadly reported on March 19. Erin Fox, an associate adjunct professor of pharmacology at the University of Utah and an expert in drug shortages, says four of the eight suppliers of the drug report normal supplies. The others report back orders. 

The drug, originally approved for malaria in 1955, has been approved for decades as a disease-modifying antirheumatic drug to treat rheumatoid arthritis (RA) and systemic lupus erythematosus and is used in the treatment of juvenile idiopathic arthritis (JIA).             

Fox says that the sudden high demand comes from people and clinics that want to use hydroxychloroquine for COVID-19 prevention or treatment, although the drug is not approved for either indication, and there is limited evidence to support its use in COVID-19. Researchers are preparing to launch rigorous studies of its safety and effectiveness. Despite that, people and clinicians are putting their hope in hydroxychloroquine (and chloroquine, a closely related drug).

But that is leaving many people who have lupus, RA and JIA without the medication they depend on and may have been taking for years.

State boards of pharmacy in Nevada, Ohio, Texas and Idaho have established new rules to control the run on the drug, requiring a diagnosis for an indicated disease be written on the prescription. If the diagnosis is COVID-19, further restrictions apply, such as a 14-day supply limit, no refills and other measures intended to stop hoarding and maintain an adequate supply for patients who have been taking the drug for indicated uses.

Jenny Wai, chief pharmacist, Ohio Board of Pharmacy, says of her state’s new emergency rule, “I hope we have stopped the bleeding now.”

Several manufacturers have pledged to donate tens of millions of doses of hydroxychloroquine, or Plaquenil, the brand version, or chloroquine. The pharmaceutical manufacturer Novartis Sandoz has increased its donation pledge from 20 million doses to as many as 130 million doses, which includes both its current stock and supply expected from increased production through May. Access to the donated supply is controlled by the Department of Health and Human Services (HHS). “Any requests from new customers go to HHS,” says Linda Krystek, from Novartis customer operations department. She says the company is referring to HHS the many requests it is receiving from health organizations, hospitals and doctor offices.

Michelle Petri, MD, a rheumatologist at Johns Hopkins University School of Medicine, in Baltimore, says she would never want her patients to stop a disease-modifying drug or reduce frequency or doses to conserve pills. “Systemic lupus erythematosus patients cannot ‘ration’ their drug, as that would lead to subtherapeutic hydroxychloroquine blood levels and loss of efficacy,” she says.

“It should not be forgotten that SLE is the fifth or sixth leading cause of death in African-American and Hispanic-American young women. Hydroxychloroquine is the only SLE treatment shown in multiple studies to improve survival in SLE.”