LAWRENCE, Kan. — A Lawrence woman is caught between the fight for a possible treatment for COVID-19 and a drug she desperately needs for her autoimmune issues.
Nancy Pistorius says her rheumatologists have prescribed the drug hydroxychloroquine for years and never, until now, had any troubling find what she considers a life-saving medication.
“My pharmacist told me she couldn’t refill my prescription because of a nationwide shortage of this drug,” Pistorius told FOX4. “She said it may take months to get more because there’s a complete national shortage and none in the warehouse.”
“I was flabbergasted when my pharmacist said she couldn’t get one of my most important drugs. I just couldn’t believe it.”
The freelance writer said her health will deteriorate without the daily medication.
“I will have widespread inflammation and pretty soon I may not be able to walk,” she said. “And it could affect other organs in my body.
“I see two different rheumatologists – one at The Mayo Clinic and KU (The University of Kansas Health System),” added Pistorius, who also has autoimmune rheumatoid arthritis. “Both said I need this drug.”
Hydroxychloroquine and chloroquine are used to treat malaria, lupus, rheumatoid arthritis, and other diseases. The Food and Drug Administration, however, just issued an emergency use authorization for the drugs to treat patients hospitalized with coronavirus or for use in clinical trials.
The FDA’s decision on Sunday came as a surprise to Pistorius, who worries the action could trigger even more shortages.
“It was a bombshell,” she said.
Although hydroxychloroquine and chloroquine are not approved treatments for COVID-19, the FDA said in a statement: “Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients.”
But the agency added this caveat: “Clinical trials are needed to provide scientific evidence that these treatments are effective.”
The FDA said the 30 million doses of donated hydroxychlorquine and one million doses of donated chloroquine will be placed in the Strategic National Stockpile (SNS) and distributed and prescribed by doctors to “hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.”
The FDA also said its action should alleviate, not accelerate, shortages of the drugs.
“Use of the donated medications is expected to help ease supply pressures for the drug,” the agency said in a statement.
Pistorius is cautiously optimistic about the FDA’s prediction.
“I hope it’s true that it will ease the demand — so that once hospitals have what they need for COVID-19 patients — there will be some left over for people who need it for their health issues.”
“I feel so sorry for the people who get that terrible disease,” she added. “And I don’t want people to die because they don’t have the drugs they need. But I’m skeptical that this is the drug they need. I’ve only seen anecdotal research (that these drugs are a possible cure for COVID-19).”
The FDA also said it’s also working with manufacturers of hydroxychloroquine and chloroquine to increase production of the drugs.
That move can’t come soon enough for Pistorius.
“I think the manufacturers (of those drugs) owe something to the people who have been taking it all along and need it badly for their health issues,” she said, adding she’s frustrated by reports that many people obtained prescriptions for the drugs because of rumors the medications could prevent COVID-19.
She blames those people, and those misleading reports, for the current drug shortages.
“I don’t understand the people taking them as a prophylactic (to prevent the disease),” she said.
Several state and national medical boards echoed her concerns. The Missouri State Board of Registration for the Healing Arts and the Missouri Board of Pharmacy said last week it had received reports about an uptick in the number of prescriptions for the drugs for “prophylactic purposes” amid the COVID-19 pandemic.
“Concerns have been raised that this activity may lead to stockpiling of medication, inappropriate use and potential drug shortages for patients with a legitimate need,” the boards said in a joint press release. “Prescribers should exercise caution and refrain from prophylactic prescribing in light of the State of Emergency.”
The American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists also warned the drugs must be written only for legitimate medical reasons.
“We are aware that some physicians and others are prophylactically prescribing medications currently identified as potential treatments for COVID-19 (e.g., chloroquine or hydroxychloroquine, azithromycin) for themselves, their families, or their colleagues,” the associations said in a joint statement. “And that some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment. We strongly oppose these actions.”
In the meantime, Pistorius continues to search for her much-needed medications.
“I was on the phone for almost two hours last night with one pharmacy,” she said Tuesday. “I found a pharmacy in Blue Springs that has some and I hope they’ll deliver to Lawrence.”
“I know I’m not the only one impacted by this,” added Pistorius, who said her next step is check online pharmacies. “There are a lot of other people in the same boat. But I only have 10 pills left.”
The Lupus Foundation of America Comments About Hydroxychloroquine Shortage.
FOX4 asked Amy Ondr, president and CEO of the Lupus Foundation of America, Heartland Chapter, about the current shortage of hydroxychloroquine. Here are her comments:
Question: What are you telling patients who need hydroxychloroquine and can no longer find any?
Answer: We are telling patients to speak with their physician to see if there is another drug that might be used to treat their lupus.
Question: Where can they get the drugs they say they desperately need?
Answer: My understanding is that mail order may be a better way to get this drug. One of our physicians was told that Express Scripts is filling mail order still. Some patients are still able to get the drug from their local pharmacy but not for a full three-month or even one-month Rx. A few patients have told me they are only being given a 14-day supply.
Question: What is your reaction to the FDA’s decision to authorize the emergency use of this drug as a possible treatment for COVID-19? Do you think that will trigger more shortages of this medication?
Answer: The U.S. Department of Health and Human Services (HHS) said in a statement that the authorization would allow for 30 million doses of hydroxychloroquine donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine donated by Bayer Pharmaceuticals to be donated to the HHS’ Strategic National Stockpile (SNS).
The HHS said that “use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is also working with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis.”
While it is encouraging for the lupus community that the HHS’ statement indicates that it will help ensure people with lupus have access to these medications, it is still unknown at this point as to exactly how the medications will get distributed and the overall impact of availability of the drugs for those who need the drugs now.