If you’ve had trouble getting your Accutane for the past few weeks, you’re not alone. A recent month-long hiatus from the Food and Drug Administration’s iPledge program kept many prescription acne medication users off their medications for weeks or even months. The outage was caused by a recent system update, however doctors who rely on it to get isotretinoin, or Accutane, to their patients say the problem goes deeper than just delays. Many believe the program is deeply flawed and needs to be evaluated to better serve patients.
Why the program stopped working
To understand what happened, we first need to know why iPledge was launched in the first place. “Over the past decade and a half, this regulatory program has been put in place to mitigate the risk of someone taking Accutane, which includes birth defects, to ensure that we avoid prescribing it. pregnant women,” says Davie, a dermatologist in Florida. Lesley Clark-Loeser, MD. “Recently, the program has made an effort to be a more gender-neutral platform, and the system update has kept patients, providers, and pharmacists out.”
“I was personally barred from the iPledge system for two weeks,” adds Rochester, NY dermatologist Lesley Loss, MD. “It didn’t recognize my login credentials, I couldn’t reset my password and when I called every day I got a busy signal. At one point I was put on hold for seven hours and in the end never spoke to a human The system finally did something to allow the vendors to reset their passwords but I would say it took us longer six weeks to get everyone back on track.
“The system is so flawed on so many levels,” notes Louisville, KY, dermatologist Tami Buss Cassis, MD. “To this day, I still can’t log in to help my patients who need their Accutane.”
“My patients have not been able to renew their prescriptions and we have not been able to enroll new patients into the system,” adds concerned Saddle Brook, NJ dermatologist Dr. Frederic Haberman. “Even after getting the required lab work and having two negative pregnancy tests. It was a nightmare.
Why Doctors Think It’s No Longer Needed
Just a month ago, during the outage, the American Academy of Dermatology Association contacted the FDA and urged them to discontinue the program. “Once we were alerted to the fact that there would be a platform change, we called a meeting to request that a shutdown be put on the system until we had the opportunity to assess its functionality and make sure it is working properly – with the caveat that prescribers would still adhere to the same safety measures they’ve always adhered to,” says Philadelphia dermatologist Bruce Brod, MD, who serves as the board’s chairman. of AADA’s Government Affairs and Health Policy.” We felt that the FDA did not want to shut down the program completely, but we have worked with the program’s sponsors and communicated several key priorities to the FDA to ensure patient access to drugs is maintained.”
Doctors, like New York dermatologist Doris Day, MD, say that beyond the technical difficulties, the whole premise of the program needs to be revamped. “You can’t legislate with common sense and common sense says that when you have a drug that has very specific issues like birth defects and possibly suicidal ideation, that has to be closely monitored by the doctor,” says Dr. Day.
According to a 2011 study published in the Journal of the American Academy of Dermatology, iPledge has not been shown to reduce pregnant women’s exposure to Accutane, and many doctors cite this data as another reason why it’s nothing more than a cumbersome process. “If a doctor prescribes a drug, they know the risks and benefits and should be able to work with the patient to manage those risks,” says Dr. Day. “There are other drugs, like acitretin for severe psoriasis, that are equal in terms of risks that don’t have the same indication or the same signals around them. There are many drugs on the market with potential side effects, but it’s up to the doctor to determine a good candidate for it and monitor them appropriately.
A quality of life problem
One of the biggest challenges for physicians and patients surrounding iPledge is the frequency with which certain patients need to be assessed and issues with gaps between prescriptions. This can cause people with severe acne to go untreated or drop out of treatment altogether. “There’s a seven-day lockdown period, so if you’re a woman taking it, you have to do a blood test to prove you’re not pregnant. Then you have seven days from writing the prescription to pick it up,” says Dr. Day. “If you don’t, you are locked out for 30 days and there is no recourse.”
Davie, FL dermatologist Marianna Blyumin-Karasik, MD adds that the existence of the program deters some people who otherwise would really benefit from being on the drug because it’s such a daunting undertaking “The way the drug is so controlled is a little extreme. Is it necessary for a person who is not able to get pregnant to miss school or work? There is also a fee to see a doctor every month. It’s time for them to reassess and review the usefulness of this program and programming and the facts behind them.
When it comes to trying to access a drug, Dr. Brod notes that transparency is the most important factor. “Risk management and mitigation programs are meant to work to maximize safety and protect patients, but at the same time they should not disrupt reasonable access to medications,” he explains. “We want everyone to have fair and reasonable access. So we are working towards solutions and we look forward and eager to continue to work closely with the FDA and the Isotretinoin Product Manufacturers Group (IPMG) to develop these solutions.
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