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After Trump touted drug for the coronavirus, Maryland warns of hoarding and ‘inappropriately’ prescribing

Jodi Steinbauer takes Plaquenil, the name brand version of hydroxychloroquine, for ailments such as lupus, rheumatoid arthritis and Sjögren’s syndrome, but now the Bowie woman can’t get her prescription filled.

After President Donald Trump began touting the decades-old drug as a potential treatment for COVID-19, the illness associated with infection by the new coronavirus, shortages of the drug started to occur and two state agencies warned doctors and pharmacists about hoarding and inappropriately prescribing hydroxychloroquine and the related chloroquine.

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Originally developed as anti-malarial drugs but also used for auto-immune disorders such as Steinbauer’s, hydroxychloroquine and chloroquine are being prescribed by doctors around the world to help treat the worst COVID-19 cases because they have shown some anti-viral properties in lab settings. The results so far are mostly anecdotal with some saying it helps and others not so much.

Its use caught the attention of Trump, and the U.S. Food and Drug Administration approved its use on an emergency basis late last month. Numerous clinical trials have begun, including one sponsored by the National Institutes of Health, but results will take months. Meanwhile, health experts warn the anti-malarial drugs haven’t been clinically proved to be effective against the coronavirus and can increase the risk of heart attacks.

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Late last month, the Maryland Board of Physicians issued an alert regarding reports that doctors were prescribing hydroxychloroquine and chloroquine “inappropriately,” and were “hoarding or stockpiling the medications for themselves, family members, friends, and coworkers without any apparent medical indication, or in anticipation of COVID-19 related illness.”

“The Board is concerned that the inappropriate prescribing and stockpiling of the medications is causing shortages of those drugs and compromising access to drug therapy for patients who are prescribed the drugs for FDA approved indications," the memo read.

Medical professionals and patients who have been prescribed chloroquine for autoimmune disorders say they’re encountering shortages of the drug at pharmacies and are turning to rationing out their own existing supplies. They’re pinning their hopes on multiple pharmaceutical manufacturers ramping up production of the drug, which is no longer patent-protected.

Steinbauer is fortunate. She doesn’t think the ramifications of a few weeks without the drug will be severe for her, but she knows others who need it more than she does.

“In one way, as a patient that’s relied on this medication, I am very grateful that they found something to help with this coronavirus,” Steinbauer said. “But I also am very nervous because for patients that are going to be affected more so than myself, that have been suffering for years with lupus, if this is the only drug that helps them with their rheumatoid arthritis, their Sjögren’s or whatever it is that they have and they’ve been taking it for so long and now it’s not available, that’s kind of not fair.

"But you also want to help people that could be dying from coronavirus. I don’t know. It’s like a double-edged sword.”

Steinbauer’s pharmacist told her the drug is on back order and it could be a few weeks before it’s available again.

Physicians and patients who rely on the drug for its approved uses hope state regulation and increased production of the drugs will rectify the shortage. But demand is likely to remain high as long as the coronavirus continues to spread and people believe it may be effective.

While the Maryland Board of Physicians issued its advisory after hearing reports about how the drug was being prescribed, the Maryland Board of Pharmacy received a consumer complaint, a state Department of Health spokesman said.

The pharmacy board subsequently issued guidance to pharmacists warning of “inappropriate and unethical prescribing by physicians for themselves, family members and friends” of several drugs, including chloroquine and the higher-dosage hydroxychloroquine, “and in high quantities to suggest hoarding or other similar stockpiling activities.”

Since those advisories, the pharmacy board did not receive any reports of shortages. State law protects the physicians board from releasing its reports.

Dr. Miriam Laufer, a professor of pediatrics at the University of Maryland School of Medicine, understands the interest in the chloroquine drugs. As head of the medical school’s Malaria Research Program, she’s an expert on the drugs.

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While she acknowledged that there’s good evidence of their anti-viral qualities, chloroquine drugs have not yet been effective on a virus in the real world.

FILE - In this Thursday, April 9, 2020 file photo, a chemist displays hydroxychloroquine tablets in New Delhi, India. Scientists in Brazil have stopped part of a study of the malaria drug touted as a possible coronavirus treatment after heart rhythm problems developed in one-quarter of people given the higher of two doses being tested. Chloroquine and a similar drug, hydroxychloroquine, have been pushed by President Donald Trump after some early tests suggested the drugs might curb coronavirus entering cells. (AP Photo/Manish Swarup, File)
FILE - In this Thursday, April 9, 2020 file photo, a chemist displays hydroxychloroquine tablets in New Delhi, India. Scientists in Brazil have stopped part of a study of the malaria drug touted as a possible coronavirus treatment after heart rhythm problems developed in one-quarter of people given the higher of two doses being tested. Chloroquine and a similar drug, hydroxychloroquine, have been pushed by President Donald Trump after some early tests suggested the drugs might curb coronavirus entering cells. (AP Photo/Manish Swarup, File)(Manish Swarup/AP)

“Even though in the laboratory they seem to inhibit viral entry or viral replication, when they’ve done studies in people, it’s never worked,” Laufer said.

Still, under the FDA’s emergency use order, doctors are trying them and a host of other methods for treating their most high-risk patients with COVID-19 symptoms and in clinical trials to test their effectiveness for treating the illness.

The drug is mainly being used for patients in hospitals “at high risk for poor outcomes from COVID-19,” said Sara Keller, an assistant professor of infectious diseases at the Johns Hopkins School of Medicine who is doing observational research on COVID-19. It’s not being used on patients at high risk for known chloroquine side effects, such as those with heart issues.

Doctors aren’t using chloroquine drugs outside hospital settings, say in clinics or outpatient treatment, for prevention, Keller said

Johns Hopkins is "emphasizing in our guidance to doctors and other clinicians to also take some of [the treatment] criteria into account so that patients who have actually been on this for years and really need it to control their lupus, for example, can still access it,” she said.

“We’ve been worried about this for a couple weeks, and it has basically made us more assertive, I guess, in our guidance,” Keller said.

Added Laufer: “I think everybody realizes you don’t want to trade in the use of a drug that has no proven benefit in exchange for not treating people who actually need it and there is proven benefit.”

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Several lawmakers have been asking the state to release racial data on coronavirus cases in Maryland.

The Lupus Foundation of America joined the Arthritis Foundation last month to petition state pharmacy boards with a list of measures they hoped would ensure patients with longstanding treatment plans involving hydroxychloroquine continue to get access to the drug.

There’s also hope that drug makers will flood the market with supplies of hydroxychloroquine given the attention on the drug as a potential COVID-19 treatment. The FDA website lists updates from nine pharmaceutical companies on their chloroquine back orders, with some noting that they’re continuing production to fill longstanding orders and others supplementing their production for COVID-19 purposes.

Concordia Pharmaceuticals, which makes the brand name Plaquenil, reports a limited supply available, with the next shipment due to go out in June. Other companies report increased production of generic versions.

On its website, the Lupus Foundation of America said patients were finding it difficult to have Plaquenil prescriptions filled. Its advisories to patients note that they should work with their doctors and pharmacies on securing an extended supply, but warn that there’s no alternatives. The foundation also directed people to an online pharmacy, Honeybee Health, that has Plaquenil in stock for patients with lupus or rheumatoid arthritis.

Steinbauer, who is active in the annual Walk to End Lupus Now in Baltimore through the Lupus Foundation, said she knows of around 10 people who could not get their prescriptions re-filled because of the shortage.

Some, like her, can manage for a time without it. Others are in more dire situations, Steinbauer said, with physicians instead putting them on Prednisone until their Plaquenil is available.

One person who couldn’t have their prescription filled, she said, called her to see if she had any extra during a flare-up.

“There are going to be people — I’m sure she’s not the only one — that are suffering right now, that need it,” Steinbauer said.

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