Chances are good if you have a dermatologist he or she has a hard time getting a critical medication.
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“I see probably, in this office, about 20 Accutane patients a day,” said Dr. Liza Moore, dermatologist at Luxe Dermatology in McLean.
Accutane is commonly used to treat severe acne. Dermatologists also tell FOX 5 that it can be used as an anticancer drug in some cases.
However, Accutane is not an ordinary medicine.
iPledge became a Food and Drug Administration requirement in 2005, according to an FDA website. As a side effect, Accutane has the potential to cause serious birth defects.
The FDA has demanded that doctors and patients both agree to recognize the risks of potential birth defects; the doctors must sign, they explained the risk, the patient must promise not to be pregnant or to try to become pregnant during the regiment of a month.
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These acknowledgments are recorded in the iPledge system, the pharmacist sees this acknowledgment and dispenses the medication. Male patients must also sign on iPledge.
In 2011, a study in California determined that the program did not significantly reduce the number of children with birth defects in parents taking Accutane.
Fast forward to Monday, when an upgrade was made to iPledge – Doctors say it went wrong.
“When I got here on Monday, I couldn’t log into the system. I have two other vendors in my practice, they couldn’t log in either,” Moore said.
It’s a story FOX 5 has heard from nearly half a dozen dermatologists: They waited hours on the phone on a hotline to be able to get Accutane for their patents. Some are successful; Liza Moore didn’t.
“We weren’t even able to wait. So I have a friend who waited 5 1/2 hours, but she managed to get in the way, we couldn’t even get that far. once I dialed, I got a busy signal, ”Moore said.
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The situation sparked an emergency meeting Thursday between the FDA, an organization representing pharmacists, the American Academy of Dermatology and the company that would operate the website, according to AAD’s Dr. John Barbieri who attended the meeting. .
Barbieri said the FDA acknowledged at the meeting that this is a serious issue for patients and physicians that needs to be addressed.
The company that would operate the website told FOX 5 in a statement that they were in fact two other iPledge system contractors responsible for maintaining the website and the call center. The company also says it sympathizes with those struggling in this situation and will do what it can to find a solution.
At the time of this writing, FOX 5 has not been able to confirm who these other two contractors are.
“We asked, for example, who is really responsible for running the call center, who is responsible for the website, who do we go to and engage with to try to resolve these issues, and we didn’t really haven’t gotten a clear answer yet, ”Barbieri said.
The Food and Drug Administration released a statement on Wednesday saying it was aware of the problem.
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“We continue to work closely with the [Accutane] manufacturers to ensure that they fulfill their responsibilities to implement a properly functioning iPLEDGE REMS program and that patient care is not interrupted, ”the statement said.
Meanwhile, patients, who must see a doctor every month to get the next month’s prescription, are left behind, with many doctors unable to get into the system to get the next month’s doses.
Dr Moore says she hopes this problem will be resolved soon, or that patients may have to restart their regiments.
“Small breaks, like a day or two, are generally okay. But with this problem I have had patients because they burned out before their appointment this week, they haven’t been for a week. And that’s a problem, ”Moore said.
Dr Barbieri says he hopes, at least temporarily, a pause on iPledge’s demands while this issue is resolved so patients already on Accutane can get their doses for the next month.
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As of yet, it’s unclear if that will happen.