Changes to regulatory laws regarding the prescription process surrounding painkillers have been one hurdle that rheumatoid arthritis (RA) and lupus patients have had to deal with in recent years.
Now, it may become equally difficult to obtain refills on a commonly prescribed anti-malarial drug that is also used to treat both conditions.
Hydroxychloroquine, brand name Plaquenil, is a time-tested and often-used medication that is typically a first line of defense in the treatment of autoimmune conditions such as RA and lupus.
However, manufacturers of the drug have announced a shortage that could affect thousands of patients who need Plaquenil to manage their everyday symptoms.
The Plaquenil Shortage in a Nutshell
The FDA has not yet officially added Plaquenil to the drug shortage list in the United States.
In fact, when contacted, Pittsburgh-area pharmacy Giant Eagle indicated they were not aware of a potential shortage.
A representative for the University of Pittsburgh Medical Center’s Lupus Center of Excellence said they also weren’t aware of a shortage.
“So far, we aren’t affected by it, but despite being a smaller store, I do have a lot of older patients on these medications and hope they’ll be available for them,” said Mike Bell, a pharmacy technician for Rite Aid.
The Lupus Foundation of America has issued a statement regarding the shortage, urging patients to stay tuned and to keep taking their Plaquenil as directed.
A bulletin posted on the official website for the American Society of Health-System Pharmacists (ASHP) explains that regulatory issues and an increase in demand are to blame for the shortfall.
Who’s to Blame?
Ranbaxy is a pharmaceutical manufacturer that holds a 71 percent share in the U.S. market for hydroxychloroquine.
The ASHP bulletin states that Ranbaxy’s shortage is due to a “regulatory issue,” possibly involving an overseas plant that was not up to FDA standards.
Ranbaxy officials did not return calls for comment.
Sandoz officials have cited an increased demand as cause for their shortage.
Others, such as Zydus and Mylan, cannot specify a reason for the shortage or the increase in demand.
Mylan has the drug on back order and estimates it will be available later this month. Ranbaxy and Sandoz cannot estimate a release date, but they also have versions of the medication on back order.
How Are Patients Impacted?
It seems it has taken a while for the shortage to trickle down to patients.
Some pharmacies and doctors’ offices were not aware of the shortage when contacted. Many patients in online rheumatoid arthritis forums seemed surprised to learn there’s a shortage.
Others, however, are starting to see the effects.
Lupus patient Tam Billings of Huntsville, Alabama, said, “At my last appointment, my doctor told me he’d heard of a shortage, so I got my Plaquenil prescription filled right away before I could have any issues with getting it. I wish I could have stockpiled.”
Katie Napoleon, a Cleveland, Ohio patient with RA, said, “I didn’t even know there was a shortage. Is that why my prescription cost tripled?”
It could be. As supply and demand go, a shortage in the product coupled with an increased demand could spell financial trouble for patients.
Certified integrative health coach Luanna Barker of New York says that RA and lupus patients who have to stop taking Plaquenil can focus on alternative methods of treatment in the interim, until the medication becomes available. These include an anti-inflammatory diet, yoga, acupuncture, tai chi, and reiki.
For many, though, Plaquenil will continue to be a necessity.
“Hydroxychloroquine is the mainstay of lupus therapy,” said Dr. Michelle Petri, MD, MPH, in a statement to the Lupus Foundation of America. “It prevents half of lupus flares, reduces renal and CNS lupus, reduces blood clots in half, reduces future seizures, diabetes and LDL cholesterol, and improves survival. I call it ‘lupus health insurance.’”