Conn. Patients Say Unproven Use Of Drugs For COVID-19 Leaves Them Without Chronic Disease Treatments
Alisha Scott recently had a telemedicine appointment with her doctor, who prescribed a refill of a medication called hydroxychloroquine.
She’s been taking the antimalarial medication for years to manage lupus, an autoimmune disease.
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“It really is a maintenance drug,” said Scott, who lives in Bloomfield. “What it does for us is it’s an immunosuppressant, so it weakens the immune system, which suppresses the reaction of our own immune system attacking our bodies’ tissues, which makes it possible for us to try to fight off other illnesses.”
Scott said she’s never had a problem getting it -- until now.
“I got the call from CVS with the automated message saying, you know, ‘we are out of stock of that medication. We are going to contact your physician for an alternative,’” she said. “I don’t even recall if I’ve ever before gotten the message about this particular drug not even being in stock.”
Scott said she and other Connecticut residents in the lupus community are struggling to find this medication since it’s been lauded as a possible treatment for COVID-19. The efficacy of this drug and others for the pandemic virus is largely unproven -- and debated within the medical community.
But even so, there have been national reports of shortages, inappropriate ordering and hoarding of medication.
“It’s been scary,” Scott said. “It’s been scary for a lot of people, and it’s very heart-wrenching for me to talk to people that really need it and need it to actually live a productive life.”
COVID-19 Drug Research
Scientists and physicians are looking at antimalarial drugs like chloroquine and hydroxychloroquine, an antiviral called remdesivir and an antibiotic called azithromycin as possible treatments for the coronavirus that causes COVID-19.
Much of the drug research is in early stages, and no medications have been approved by the U.S. Food and Drug Administration specifically for the pandemic virus, but some are still being given to hospitalized patients.
Jeffrey Aeschlimann, an associate professor at UConn School of Pharmacy and UConn Health, said that’s happening through federal clinical trials, or a federal expanded access program.
“Their main goal is to take a drug that at least has some early potential safety benefit but hasn’t yet made it through the big trials, and get it to patients that may benefit from it as fast as possible,” he said, “but yet there’s still safeguards to try and collect data on what happened to those patients who got it under expanded access.”
Supplies of hydroxychloroquine and chloroquine that come from the Strategic National Stockpile can now be given to hospitalized COVID-19 patients when a clinical trial is not available.
Aeschlimann said hydroxychloroquine in particular is also being used through off-label use, which is a common practice. It happens when the FDA approves a drug for a certain disease, like lupus, and researchers later find that it may have therapeutic benefits for a different condition.
“Once the FDA approves a drug, any licensed health care provider can prescribe that drug for an unapproved use if, in their expert opinion, there’s data available that’s scientifically rigorous that it can be medically appropriate for that patient,” Aeschlimann said.
Prescription Misuse And Hoarding
But that has also led to physicians and other health care professionals nationally who are writing prescriptions outside hospital settings for these unproven COVID-19 medications for themselves, their families and friends, even when they’re not sick.
“We were hearing reports outside the state before it happened here, and unfortunately, it has happened here,” said Nathan Tinker, CEO of the Connecticut Pharmacists Association.
Tinker said it seems that cases of hoarding and inappropriate prescribing are happening only to a small degree in Connecticut, but it’s still unsettling. He knows of at least one case in which an eye doctor requested 180-count fills of hydroxychloroquine for each of five family members.
A pharmacy intern flagged the order, and it was eventually reported to state drug authorities, Tinker said.
“I’m sure that the reasons that were not necessarily in and of themselves malicious -- they were to protect, you know, family and so forth,” he said, “but it’s still outside of the realm of both ethics and the law in terms of what you can do.”
Rodrick Marriott, director of state Drug Control, said a worldwide event like a pandemic will inevitably affect the availability of prescriptions. Until production catches up with a spike in demand, Marriott said some areas will experience temporary shortages.
And yes, he said, there will be instances of inappropriate prescribing.
“It is an unfortunate circumstance,” Marriott said. “It’s not a unique circumstance in that when we have the situations like this, you do see some of that from time to time.”
That’s why Tinker said pharmacists have a greater responsibility to spot suspicious orders and ultimately make sure patients with chronic diseases get these medications.
“This speaks, again, to the importance of the role that pharmacists can play, and being the ones in the community are often closest to those communities, they have a better chance of identifying, engaging and intercepting,” he said.
Complaints of suspicious prescribing can be reported to the state Department of Consumer Protection.