Denying Prescriptions for Hydroxychloroquine Can Be Life-Threatening for Lupus Patients: Multiple Rheumatologists Weigh In

After a BuzzFeed News story went viral about a lupus patient who could not get her prescription for hydroxychloroquine filled by her doctor, who is part of the Kaiser Permanente health care network, the Global Healthy Living Foundation took action to see what was happening.

Hydroxychloroquine (Plaquenil) is a commonly prescribed — and critically important — medication for rheumatologic conditions such as lupus and rheumatoid arthritis (RA). It is currently being studied as a treatment for hospitalized COVID-19 patients, which is leading to a nationwide shortage.

We emailed Kaiser for comment about their policy, and this is what they wrote back:

The safety and well-being of our patients have always been Kaiser Permanente’s top priorities. When it comes to the availability of plaquenil, there’s currently a severe nationwide shortage of this drug, which historically has been used to treat lupus, rheumatoid arthritis and malaria patients. 

Today, this drug has been identified as possibly having an impact in the treatment of severely sick COVID-19 patients who are hospitalized. As we face the real possibility of running out of the drug for everybody if we don’t take steps to mitigate the shortage, Kaiser Permanente, like other health care organizations across the country, has had to take steps to control the outflow of the medication to ensure access to severely sick patients, including both COVID-19 and those with acute lupus.  

Extensive experience and research show that hydroxychloroquine builds up in the body and continues to work for an average of 40 days even after the last dose is taken. By then, we expect the drug manufacturers to have ramped up production to meet the increased demand. Until then, we are no longer refilling routine prescriptions to ensure we have adequate supply to care for our sickest patients.

Without taking this necessary action, we could collectively run out of this medication. As such, we are focusing on taking the necessary steps to ensure the safety for our patients. Kaiser Permanente physicians and pharmacists are also working together on an evidence-based approach to identify alternative therapies for patients with lupus.

We followed up by asking for them to share the “extensive research” and got this response:

This is all we are releasing at this time, Jessica [name of our media relations staffer].

What Rheumatologists Say About This Hydroxychloroquine Policy

“Restricting lupus, rheumatoid arthritis, and other rheumatology patients from accessing hydroxychloroquine is wrong,” says Michael Putman, MD, a rheumatologist at Northwestern University School of Medicine and founder and host of the EBRheum podcast. “The data on taking this medication for conditions like lupus is very strong, while the data for using it to treat COVID-19 is of low quality. This is a panicked decision, not a rational one.”

“I do not feel that it is ethical to deprive lupus and RA patients of a known organ-saving medication to use an unproven remedy in COVID-19 patients,” says rheumatologist Robin K. Dore, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA.

“Lupus patients should not have the drug withdrawn, especially when there is no evidence yet that these drugs work in this virus,” says Lee Simon, MD, a rheumatologist and research scientist who has served as Division Director of Analgesic, Anti-inflammatory, and Ophthalmologic Drug Products at the U.S. Food and Drug Administration (FDA). “The studies [on hydroxychloroquine and COVID-19] are now just being done, we will know in about one to two months.”

All of the rheumatologists we spoke to — including some of the top lupus researchers and clinicians in the country — had many concerns and issues with policies like this one from Kaiser. For one thing, we could not find any extensive research that shows patients will do fine because the drug has a long half-life.

Concerns About Hydroxychloroquine Half-Life

“Hydroxychloroquine indeed has a long half-life, but saying everyone will do well for 40 days is misleading,” says George Stojan, MD, assistant professor of medicine in the division of rheumatology at the Johns Hopkins University Medical School and the co-director of the Hopkins Lupus Center.

He explains: “Half-life is the time required for the blood levels of hydroxychloroquine to reduce to half of its initial value. 1,000 ng/ml is the target blood hydroxychloroquine concentration (500 to 2,000ng/ml is considered therapeutic). [The Kaiser statement] assumes that all patients have blood levels between 1,000 and 2,000 ng/ml or more at the time when hydroxychloroquine is stopped so that their blood levels remains in a therapeutic range for the entire 40 days.”

He adds: “In a study done in our center, only 2 percent of patients had levels of 2,000 ng/ml or more; 44 percent of patients had levels below 500 ng/ml. I think a significant number of patients will definitely be at risk of potential flares without hydroxychloroquine for such prolonged periods of time.”

Lupus patients deprived of hydroxychloroquine could go down to a dosage that is no longer considered therapeutic within a week or two, depending on the individual, says Alfred H.J. Kim, MD, PhD, assistant professor of medicine at Washington University School of Medicine and director of the Washington University Lupus Clinic in St. Louis, Missouri.

“There is no evidence that hydroxychloroquine will continue to have its favorable effects on, for instance, rheumatoid arthritis or lupus, for this extended 40- day period of time after discontinuation,” says Andrew Concoff, MD, executive vice president, chief value medical officer for United Rheumatology, a rheumatology care management organization that serves more than 600 independent rheumatologists across the U.S. “Furthermore, the converse of this argument is also true: After the medication is stopped, it will take an extended period of time after the drug is restarted before it again has favorable effects.  All of this is of particular concern in lupus, where the use of hydroxychloroquine has been demonstrated to improve survival.”

Potentially Life-Threatening Consequences

“Lupus patients need to stay on hydroxychloroquine to prevent complications,” says Dr. Putman. “There is very, very good evidence that staying on this medication prevents flares and stopping this medication can cause flares.”

Let’s not let the word “flare” be misleading, either. Flares of rheumatic diseases like lupus can require hospitalization, lead to damage of major organs such as the kidneys, heart, lungs, and brain, and even be life-threatening for some people.

“For some very high-risk patients, stopping hydroxychloroquine can lead to potentially fatal complications,” says rheumatologist Leah Alon, MD, who practices in New York City. “Lupus patients with anti-phospholipid syndrome — a condition in which there are antibodies that cause blood clots to form in the legs, lungs, and brain, causing fatal strokes, pulmonary embolism, and other complications — need to take hydroxychloroquine every day. It is vital to prevent death.”

She continues, “for some rheumatology patients, hydroxychloroquine is the only medication they can take to treat their condition. It is one of the few rheumatic drugs that is not associated with an increased risk of cancer, so it is often preferred for patients who also have cancer. It is safe during pregnancy and thus is often the safest choice for lupus or RA patients who are pregnant.”

Lots of Questions About Hydroxychloroquine Drug Rationing

All of the rheumatologists we spoke to agreed that patients currently on hydroxychloroquine for rheumatologic conditions should ideally continue taking their medication without any interruption or change in dosage.

“It is very important for patients who take it for rheumatic conditions to maintain a steady-state dosage. The dose has to be correct or else the medication is not effective,” says Dr. Alon.

But if shortages are literally evaporating the medication from patients’ lives, clinicians who treat lupus and RA patients are discussing the best ways to help patients stay safe and avoid complications. In some cases — though everyone agreed this is less than ideal and needs to happen on a case-by-case basis with a patient and their provider — it may be best to ration your current prescription rather than running out and not taking it at all.

“We don’t want patients to have to reduce their dosage,” says Dr. Putman. “But it may be the case that taking half your Plaquenil now is better than taking none in a week or two from now.”

“Rationing is not a good thing. It is not a solution. But it may be something you need to discuss with your doctor,” he says.

If there is no hydroxychloroquine available in the U.S., “we don’t have a choice,” says Michelle Petri, MD, Director, Hopkins Lupus Center. “Some doctors are telling patients to reduce their dose to stretch it out.”

What to Do If You Take Hydroxychloroquine for a Rheumatologic Condition

“Patients should continue their hydroxychloroquine for as long as they have it at the prescribed dose and inform their rheumatologist if they cannot get it refilled,” says rheumatologist Gary Feldman, MD, medical director of Pacific Arthritis Care Center in Los Angeles. “Then individual patients can figure out with their doctors how to handle the situation with substitute medications or other strategies. Hopefully, we can get the production of hydroxychloroquine up in the next several weeks and get a system to specifically supply our patients with the drug they need and we know works for them.”

Experiencing Issues Accessing Hydroxychloroquine? Tell Us

If you are a patient living with a chronic illness and are having trouble getting access to hydroxychloroquine (Plaquenil), we want to hear from you. Click here to share your story with us.

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