June 19, 2024

unic power

health life

Patients going weeks without isotretinoin after website overhaul

13 min read

Jessica Soohoo, a 20-year-old student in New Jersey, was supposed to start her sixth and final month of isotretinoin acne treatment in December. Isotretinoin is the generic name for Absorica, Claravis and others, and is still frequently referred to by its former brand name Accutane. 

Soohoo dutifully followed all the usual procedures to get her medication, including taking a pregnancy test. But this month, she had trouble logging into the iPledge website to check the required digital boxes. And when she finally got in, it gave her an error message and told her to contact her dermatologist. 

Her dermatologist couldn’t help and directed her to the iPledge customer service line. When she called, however, no one picked up for hours at a time. If she got an answer, it was an automated message saying the call center was too busy.

After an overhaul to the iPledge website last month, patients on isotretinoin across the country are complaining that tech issues like these are making it impossible for them to access their medication. 

Nearly a month later, Soohoo still doesn’t have her prescription 

“The main problem is the fact that they can’t pick up their calls ever. It would just be nice to have someone to contact to know something is going to be worked on, but they don’t really let anyone know anything,” Soohoo told TODAY.

Isotretinoin is used to treat severe acne, including in cases where other medications have failed, the American Academy of Dermatology explains. But it’s also a known teratogen, as the U.S. Food and Drug Administration makes clear, meaning it can cause birth defects if taken during pregnancy. That’s why anyone who takes isotretinoin — whether they can become pregnant or not — has to go through a risk-management procedure aimed at pregnancy prevention called iPledge. 

The FDA requires that isotretinoin patients use iPledge as part of a Risk Evaluation and Management Strategy to prevent fetal exposure to the medication. (People who take other medications also have to abide by similar REMS requirements, but iPledge is unique to isotretinoin.) And it falls to the Isotretinoin Producers Manufacturing Group — the companies that make the drug — to run the website.

But over the weekend of Dec. 10, just a few days before Soohoo tried to refill her prescription for what should have been the last time, the iPledge website went through an overhaul. Doctors and patients say it’s been nearly unusable since. And, without iPledge, patients are forced to delay going on the medication or to stop taking it during what is meant to be a consistent treatment period.

Patients can’t log in, doctors can’t verify their patients and call centers have hours-long wait times

The issues have inspired TikTok videos (including one from Dr. Pimple Popper), at least three change.org petitions calling for a halt to iPledge and a patient-created guide to troubleshooting the website. 

It’s hard to know exactly how widespread the problems are, but the drug statistics website ClinCalc estimates there are around 350,000 isotretinoin patients in the U.S. every year. And a Dermatology Times poll found that, as of Jan. 6, almost two-thirds of the poll’s respondents were still locked out of their iPledge accounts. 

“Anyone who was on Accutane during the month of December was affected by this,” Dr. Evan Rieder, assistant professor in the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine, told TODAY. “Everyone was affected.”

But those trying to use the site say there still haven’t been any significant improvements. The FDA shared a statement in late December, acknowledging and addressing the issues. 

“Given the magnitude of the issues that iPledge  participants are currently facing, FDA has communicated to the IPMG a potential temporary solution to support isotretinoin patients during the transition to the new iPledge  website and we have been prompting the IPMG to work with prescribers and pharmacies to put in place this temporary solution as quickly as possible,” the statement read, in part.

The FDA also said it has “strongly encouraged the IPMG to work with the American Academy of Dermatology Association  and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition to the modified iPledge program.”

For its part, the IPMG told TODAY in a statement that it has begun implementing strategies to help fix the issues. “We appreciate the feedback we have received from the patient, prescriber and pharmacist communities and we are working — collaboratively with the FDA and stakeholders contributing to solutions — to help resolve the current situation, as quickly as possible,” the IPMG said. 

“We have taken multiple immediate actions to alleviate technical issues, handle call volumes and reduce wait times. We have added staff at the contact center and outbound call campaigns are continuing. We have added features to the site to address login issues,” the full IPMG statement continued. “There is more work to be done; however, we are focused on getting there. We encourage iPledge users to visit the website as enhancements are rolled out regularly.”

TODAY asked IPMG if it could share any other specific actions it would be taking to address the issues patients and providers were reporting, as well as when IPMG hopes to have the issues resolved. But IPMG responded that it had “nothing further to add” at the time.

As of Friday, the iPledge site does have one noticeable new feature: It now allows providers to directly assist some patients having login issues through the site, making it possible for them to bypass the call center. 

But depending on when patients were slated to start or renew their isotretinoin prescriptions, they may have already gone a week — or weeks — without the medication. Being forced to go without it and experiencing anxiety about when it will finally be available has both physical and mental health effects for patients, said dermatologists who spoke to TODAY.

There’s really no substitute for isotretinoin

“Isotretinoin is the gold standard medication in the treatment of scarring and nodular cystic acne, and it’s really like our last line of defense,” Rieder said.

Not only can isotretinoin treat severe acne, but it can also help prevent the scarring that often comes with the painful pimples — and make it significantly less likely that the acne will ever return, Rieder said. 

“It’s really our best option for trying to prevent scarring, which is a permanent mark left behind from acne and can impact people for the rest of their lives,” Dr. John Barbieri, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, told TODAY. 

Isotretinoin is also used to treat other skin conditions, including a group of issues that primarily affect children called ichthyoses, Barbieri said. It can also be used preventively in people who have a high risk for skin cancer. And, outside of dermatology, it’s sometimes used in the treatment of neuroblastomas in children, he said.

Although some patients come in with the type of acne that can only be treated with isotretinoin, many other patients try various other treatment options before resorting to isotretinoin, Dr. Rita Khodosh, vice chair of dermatology at the University of Massachusetts. 

For instance, Anna Lucking, a 22-year-old esthetician in Maple Grove, Minnesota, told TODAY that she’s “someone who’s spent thousands of dollars on my face before even thinking about Accutane.” Having dealt with acne since the eighth grade that only became more severe and painful over the years, Lucking tried chemical peels, cortisone injections, laser treatments and more before going through the process to start isotretinoin in mid-November. 

After the iPledge system update, however, Lucking told TODAY that it was nearly three weeks before she could get through to someone at the call center to reset her password and allow her to log into the website.

It took Anna Lucking three weeks to finally get set up in the iPledge system.Courtesy Anna Lucking

In some cases, the oral medication can come with side effects, the AAD explains. Those might include dryness and a temporary worsening of acne colloquially called “purging.” 

And if taken while pregnant, the medication can also cause birth defects. That’s where the iPledge system comes in: Each month, patients have to fill out questionnaires using iPledge about their mental health and, if they can become pregnant, the two forms of birth control they’re required to be on. 

With past versions of this process, a patient could fill out the initial consent forms on paper and take a monthly pregnancy test. Then, the patient’s negative test results would be uploaded to electronic health records, allowing the pharmacist to give the patient the medication. When the iPledge system was implemented in 2006, it introduced additional digital requirements for the patient and provider. 

Among the most recent changes to the iPledge site is the incorporation of gender-neutral language in the questions. But on the tech side, the new version of iPledge is essentially nonfunctional for many patients and providers. 

A flawed system, now nearly unusable

Chelsea Robarge Fife has been trying to get isotretinoin for her 16-year-old daughter Cristie since October, before the December changes to the iPledge site. They went through the initial steps: two negative pregnancy tests 30 days apart, bloodwork and a mountain of paperwork. But when it came time to pick up the prescription, the pharmacy told Robarge Fife that she and her daughter needed to fill out iPledge information online. 

Patients are supposed to receive login information for the website through their email or the mail, but Robarge Fife told TODAY that she never received it. After a conversation with Cristie’s dermatologist, Robarge Fife turned to the call center. She’s called dozens of times, been on hold for upwards of five hours, and only once had her call go through — to an automated message.

“We’re just kind of left to their mercy and their staffing issues as to whether we’re going to be able to get the prescription filled,” Robarge Fife said. 

When asked about Robarge Fife’s experience, IPMG again told TODAY it had “nothing further to add.”

If patients don’t pick up their isotretinoin prescription within a week of the negative pregnancy test, it gets sent back and they need to take another test. So Robarge Fife missed Cristie’s initial prescription window and had to go through the process again. Now, months later, she’s still dealing with login issues and her daughter doesn’t have the medication.

“I’m a leukemia survivor and I had a bone marrow transplant and I didn’t have to jump through these kinds of hoops,” she said. “It’s been more work for me to get my kid’s acne taken care of than it was for me to go through cancer treatment.”

For the system to work, all three parties — the patient, their prescribing doctor and the pharmacist — need to be able to access iPledge. If any one of them can’t get in, the patient can’t get isotretinoin. This timing was always precarious with isotretinoin, especially for those patients who can become pregnant. The changes to iPledge made the process even more challenging.

“It’s been more work for me to get my kid’s acne taken care of than it was for me to go through cancer treatment.”

said Chelsea Robarge Fife

When Victoria Guillemard first tried to log into the new iPledge system right before Christmas, it wouldn’t let her, she told TODAY. After three days, she was finally able to log in, but her doctor still didn’t have access. “So even though he knows and he’s able to see that I am not pregnant, he can’t report it to the iPledge website, which means that my pharmacist couldn’t fill the prescription,” she explained. 

Guillemard ended up going five days without isotretinoin, which was long enough that she experienced purging symptoms again when she restarted the medication — despite the fact that she’d already been using it for five months. 

Even people who can’t get pregnant are negatively impacted by the site’s issues. For 16-year-old Ryan, who falls into this category, isotretinoin was the last resort after two years of antibiotic treatments, his mom Adrienne Dunfee told TODAY.

After five months on isotretinoin, Victoria Guillemard’s phone is full of selfies.Courtesy Victoria Guillemard

He’d been on the medication for two full months when the iPledge update happened, which locked his dermatologist out of the system. The two were unable to get Ryan’s prescription before going away on vacation, leaving him without the medication for more than a week.

“It seems like it was this incredibly glitchy system to begin with, it transitioned overnight to a system that was even worse and it’s just completely overloaded the call center,” Dunfee said. 

On the provider side, Rieder said he’s been locked out of the system at random times, which made it impossible to do the correct consent procedures with patients going on isotretinoin for the first time. “They gave me a new login and a new password, which didn’t work,” he said. “And then you call the service line and you’re on hold for like six hours or you can’t get through at all.” 

The end result is that some patients haven’t been able to get their medication for a week or more. Outside of a few exceptions, “they basically abruptly shut off the dispensation of isotretinoin for all the patients in the United States,” Reider said. 

Acne — and acne treatment — can affect mental health too

“I always tell people acne is a three-part disease: It’s medical, it’s cosmetic and it’s psychological,” said Rieder, who is board-certified in both dermatology and psychiatry. “You have to deal with the psychology of having your skin not in an ideal state when you’re having acne. And then if you have acne scarring, those psychological scars can be with you indefinitely.”

Among these patients, a forced break or delay in isotretinoin treatment can cause frustration and anxiety about whether or not they’ll ever be able to get back on a medication that feels like a lifeline. 

“I’ve been dealing with this for the past almost three weeks now. I have just been in tears,” Lucking said. “It has drained my mental health. I feel insecure about my skin when I should feel comfortable in my skin.”

Dunfee recalled Ryan asking her every day whether she’d heard from his doctor or the pharmacy. “He’s very cognizant of the fact that he was supposed to be taking this medicine and wasn’t able to. It’s just adding to that normal teenage stress,” Dunfee said.

Soohoo didn’t realize how much her skin was affecting her mental health until it started to clear up. “I just remember that it was a lot harder to wake up in the morning and like wash your face and look at yourself,” she said. For Guillemard, the changes were subtle as well. She went from not taking a photo of herself in two years to a phone “full of selfies,” she said. 

“I know people look at it as just an acne medication, but I think it’s very life-changing,” Soohoo added.

Unpredictability and a lack of transparency 

“This rollout was a total disaster for practitioners and patients alike,” Rieder said. But it’s not clear exactly who is responsible for the changes to the website or which third-party contractors, if any, IPMG has running the site’s operations. 

“There’s really been a lack of transparency,” Barbieri said, adding that while he’s heard horror stories from his patients and others online, there’s no way to know how the issues have affected prescription numbers or the call center wait times for instance. Answers to questions like these are “really critical information to be able to monitor the progress of any intervention that we’re taking to try to address this issue,” said Barbieri, who is part of the AAD’s iPledge workgroup, which has met with the FDA to offer guidance on the program. “We know nothing about what’s happening,” he said.

The AAD’s workgroup doesn’t know much about the people at IPMG they’re supposed to be collaborating with. “We’d love to work with those people, but we don’t know who they are and we don’t have a way to contact them directly,” Barbieri said. In fact, he and the workgroup have proposed several potential solutions such as temporarily pausing use of the iPledge site, for instance, or pausing it for patients who can’t get pregnant to free up call center staff for those who can.

“It’d be great if the IPMG and the FDA could be more transparent in terms of engaging with key stakeholders,” he continued. “As dermatologists, we’re eager and ready to work together to try to address this issue and we’d love to be more involved in the process and have more access to what’s going on.”

The iPledge site right now is “really touch and go,” Rieder said. Some days he can log in and get things going, but other days he can’t — and he’s resorted to keeping a running list of patients who still need access to their medication.

People look at it as just an acne medication, but I think it’s very life-changing.”

said jessica soohoo

“I’m just really frustrated and sad that nobody seems to want to help these patients. And I feel very powerless because no matter how hard we try, there are many patients we can’t help,” Khodosh said. “To have a website stand between you and this life-altering medication that you really need is just beyond frustrating.”

In her department, dermatologists who are locked out of the system have had some success in transferring their patients to others who do have access, she said. But it’s a workaround that takes time and effort and still doesn’t help everyone.

“This is all a bureaucratic failure,” said Guillemard, who is also days away from graduating law school with a focus on health care compliance. 

To some, treating acne may seem less significant than other medical issues. “But these are the things that matter to teenagers. These are things that cost money. These are things that take time,” Robarge Fife said. “It just feels like a system that’s broken at the expense of patients.”


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