If you’ve had a difficult time getting your Accutane in the last few weeks, you’re not alone. A recent month-long outage of the Food and Drug Administration’s iPledge Program kept many prescription acne drug users away from their medication for weeks and sometimes even months. The outage was caused due a recent update to the system, however, the 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, first we need to know why iPledge was started in the first place. “For the past decade and a half this regulatory program has been in place to mitigate the risk of somebody being on Accutane, which includes birth defects, to make sure that we avoid prescribing it to people who are pregnant,” explains Davie, FL dermatologist Lesley Clark-Loeser, MD. “Recently the program made an update to the system that left patients, providers and pharmacists unable to get in.”
“I was personally locked out of the iPledge system for two weeks,” adds Rochester, NY dermatologist Lesley Loss, MD. “It did not recognize my login credentials, I could not reset my password and when I called daily, I got a busy signal. At one point I was on hold for seven hours, and by the end I never spoke to a human being. The system finally did something to allow providers to reset their passwords, but I would say it has taken more than six weeks for us to get everyone back on track.”
“The system is so flawed on so many levels,” notes Louisville, KY, dermatologist Tami Buss Cassis, MD. “To date, I still can’t sign in to help my patients that need their Accutane.”
“My patients have been unable to renew their prescriptions and we have been unable 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’s been a nightmare.”
Why Doctors Don’t Think It’s Needed Anymore
Just a month ago, during the outage, the American Academy of Dermatology Association reached out to the FDA and urged them to halt the program. “Once we were alerted to the fact that there would be a platform change, we called for a meeting to ask that a halt be placed on the system until we had a chance to evaluate its functionality and make sure it works correctly—with the caveat that prescribers would still adhere to the same measures of safety that they have always adhered to,” says Philadelphia dermatologist Bruce Brod, MD, who serves as the chair of the AADA Government Affairs and Health Policy Council. “We got the sense that the FDA didn’t have an appetite to completely halt the program, however we’ve been working with the program sponsors and have been communicating several key priorities to the FDA to make sure that patient access to the drugs is preserved.”
Physicians, like New York dermatologist Doris Day, MD say beyond the technical difficulties, the whole premise of the program needs revamping. “You can’t legislate 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 needs to be closely monitored by the physician,” explains Dr. Day.
According to a 2011 study published in the Journal of the American Academy of Dermatology, the iPledge has not been shown to reduce the exposure of pregnant people to Accutane, and many doctors point to this data as another reason why it’s nothing more than a cumbersome process. “If a physician is prescribing a drug, they know what risks and the benefits are and should be able to work with the patient to manage those risks,” Dr. Day says. “There are other medicines, like acitretin for severe psoriasis, that are equal in terms of risks that don’t have the same indication or signals around them. There are lots of drugs on the market with potential adverse effects, but it’s up to the physician to determine a good candidate for it and to monitor them appropriately.”
A Quality-of-Life Issue
One of the biggest challenges for doctors and patients surrounding iPledge is the frequency in which some patients need to be evaluated and issues with gaps between prescriptions. This can cause those with severe acne to go untreated or to give up on their treatment entirely. “There’s a seven-day lockout period, so if you’re a woman who’s taking it, you have to get a blood test to prove you aren’t pregnant. Then you have seven days from when the prescription is written to pick it up,” explains Dr. Day. “If you don’t, you get locked out for 30 days and there is no recourse.”
Davie, FL dermatologist Marianna Blyumin-Karasik, MD adds that the existence of the program dissuades some people who really would otherwise benefit from being on the medication because it’s such a daunting endeavor “The way the medication is so controlled is a bit extreme. Is it necessary for someone who’s not capable of getting pregnant to miss school or work? There are also costs to seeing a physician every month. It is time for them to reassess and revisit the utility of this program and programming and the facts behind it.”
Next Steps
When it comes to trying to access a drug, Dr. Brod notes that transparency is the most important factor. “Risk and mitigation programs are supposed to function to maximize safety and protect patients, but at the same time, they shouldn’t result in a disruption in reasonable access to medication,” he explains. “We want everybody to have fair and reasonable access. So, what we’re working towards are solutions and we’re eager and anxious to continue to work closely with FDA and the Isotretinoin Product Manufacturers Group (IPMG) to develop those solutions.”
