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Safety, tech issues plague acne drug
Chances are good if you have a dermatologist, he or she is having a hard time getting a critical drug. Accutane is commonly used to treat severe acne. However, Accutane is no ordinary drug.
Chances are good if you have a dermatologist, he or she is having a hard time getting a critical drug.
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"I probably see, in this office, about 20 Accutane patients a day," said Dr. Liza Moore, a dermatologist at Luxe Dermatology in McLean.
Accutane is commonly used to treat severe acne. Dermatologists also tell FOX 5 it can be used as an anti-cancer drug in some cases.
However, Accutane is no ordinary drug.
iPledge became a requirement by the Food and Drug Administration in 2005, according to an FDA website. As a side effect, Accutane has the potential to cause severe birth defects.
The FDA required doctors and patients to both sign off on acknowledging the risks of potential birth defects; the doctors must sign off they explained the risk, the patient must promise to not be pregnant or try to become pregnant while on the months-long regiment.
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Those acknowledgments get logged into the iPledge system, the pharmacist sees that acknowledgment and dispenses the drug. Male patients must also sign off on iPledge.
In 2011, a study in California determined the program didn’t greatly reduce the number of children with birth defects to parents taking Accutane.
Fast-forward to Monday, when an upgrade was done to iPledge – Doctors say it’s gone wrong.
"When I got here Monday, I could not log onto the system. I have two other providers in my practice, they also could not log on," Moore said.
It’s a story FOX 5 heard from nearly a half-dozen dermatologists: They have waited on the phone for hours on a help-line to be able to get Accutane for their patents. Some get through; Liza Moore hasn’t.
"We haven’t even been able to get to the wait. So I do have a friend who waited 5 and a half hours, but she was able to get into the skew, we haven’t been able to even get that far. Every time that I’ve dialed, I’ve gotten a busy signal," Moore said.
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This situation prompted an emergency meeting Thursday between the FDA, an organization representing pharmacists, the American Academy of Dermatology and the company believed to be operating the website, according to Dr. John Barbieri with the AAD who sat in on the meeting.
Barbieri says the FDA acknowledged in the meeting this was a serious issue for patients and doctors that needs fixing.
The company believed to be operating the website tells FOX 5 in a statement that it’s actually two other iPledge system contractors responsible for maintaining the website and call center. The company also says they empathize with those struggling in this situation and will do what they can to work towards a solution.
As of this writing, FOX 5 has been unable to confirm who these two other contractors are.
"We’ve asked, like, who is really responsible for running the call center, who’s responsible for the website, who do we need to be reaching out to and engaging with to try and resolve these issues, and we really haven’t gotten a clear answer yet," Barbieri said.
The Food and Drug Administration issued a statement Wednesday saying they were aware of this issue.
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"We are continuing to work closely with the [Accutane] manufacturers to ensure that they meet their responsibilities to implement a smoothly functioning iPLEDGE REMS program and patient care is not interrupted," the statement said.
In the meantime, patients, who have to go see a doctor every month in order to get the next month’s prescription are left in the lurch with many doctors unable to get into the system to get the next month’s dosages.
Dr. Moore says she hopes this issue gets resolved soon, or patients may need to restart their regiments.
"Small breaks, like a day or two, are usually OK. But with this issue, I’ve had some patients because they ran out before their appointment this week, they’re been off of it now for a week. And that’s an issue," Moore said.
Dr. Barbieri says he hopes, at least temporarily, for a pause on the iPledge requirements while this issue gets worked out so patients already on Accutane can get their next month’s doses.
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As of now, it’s unclear whether that will happen.