The U.S. Food and Drug Administration (FDA) today calls an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the flawed deployment of the program’s new gender-neutral approach. Isotretinoin risk mitigation that was launched on Monday and what can be done about it.
By most accounts, the deployment was disastrous, chaotic and a failure. Dermatologists on Twitter and elsewhere are angry and frustrated, with some calling for a temporary shutdown of the program until the bugs can be fixed.
On Twitter on Wednesday, the Academy posted: “Due to the unacceptable situation with #iPLEDGE, the @US_FDA has called an emergency meeting with AADA representatives tomorrow December 16.”
The switch to a new platform has caused frustration among doctors, pharmacists and patients. The new website crashed multiple times, with doctors and patients complaining that they were blocked or bounced off the platform when they tried to follow instructions to enter information. Calls to get someone’s help live often required hours of waiting, several said.
The new approach to the isotretinoin risk mitigation program itself is not criticized. It has been well received by dermatologists and others who have long called for the change. Instead of three risk categories (females of childbearing age, females not of childbearing age, and males), there are now two (those who can get pregnant and those who cannot). Advocates for the change have said it will make the experience more inclusive for transgender patients. The previous categories, according to some, were an obstacle to access to care.
Because isotretinoin (Absorica, Amnestimate, Claravis, others), an oral retinoid used to treat severe forms of acne, is teratogenic, with a high risk of birth defects, and has also been linked to other health problems. health, those taking the drug who are able to become pregnant should take contraceptive precautions. The FDA-mandated Risk Assessment and Mitigation Program (REMS) states that physicians, patients, and pharmacists prescribing, using, or dispensing the drug must all be registered with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by those capable of becoming pregnant.
A day of frustration
Before navigating to the new website, a new login name was required, said Ilona Frieden, MD, chair of AADA’s iPLEDGE working group and professor of dermatology at the University of California, San Francisco. “They made you create a month-day-year date of personal significance.” When she tried to log in she was blocked, she said in an interview.
The transition from the old website to the new one, which Frieden says is now administered by a different provider, went quickly. The previous website closed on December 10, and the new one launched on December 13, the first day of the new approach.
“A slower deployment would have helped,” Frieden said. While she and other dermatologists have said they’ve already offered their advice on how to ease the transition, no one seemed to want the help. “We had a listening session with the FDA,” Frieden said. That was before the meeting scheduled for today.
Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, was also frustrated with the deployment. “The week before the transition, a member of my team had to call iPLEDGE. They had a 177 minute wait to find a human.
“They want us to register patients online now instead of signing forms at the office, but the links to view, download or print don’t work,” Goldberg told Medscape.
This was after receiving information from the iPLEDGE REMS program, which stated: “The iPLEDGE REMS website will be updated to a modernized platform. All program materials and educational tools will now be available with one click. “
Goldberg also received calls from three patients who reported that they could not complete the required reproducible patient quiz to demonstrate their understanding of the risk. Without the completed quiz, required monthly, the prescription cannot be renewed.
“It’s chaotic,” said Howa Yeung, MD, assistant professor of dermatology at Emory University, in Atlanta. “The change is sudden, it’s a major change in the workflow. The process of rechecking [required] is not that difficult, but a lot of people even have a hard time logging into the platform. “
What would help? Having a human on the phone to help navigate the system, Yeung said.
The problems are delaying prescriptions for both established and new patients, Yeung said. Existing patients who can become pregnant have 7 days after their negative pregnancy test to fill their prescription. “And over the weekend the website was down,” he said, so it was a 2 day delay.
“The information we have that we have been told to use does not match what is in their database,” said Mitesh Patel, PharmD, owner of Sunshine Pharmacy in White Plains, New York, who said pharmacists are experiencing similar issues with the new platform as are doctors.
Twitter users also had a lot to say. Jack Resneck, Jr, MD, professor of dermatology at the University of California, San Francisco, tweeted: “#Accutane was basically taken off the market by the utter incompetence of @SyneosHealth hired by @US_FDA to administer the management program risks.” Resneck, also president-elect of the American Medical Association, noted the website crash, the helpline with 6-hour wait times, and patients unable to obtain the drug.
Adewole Adamson, MD, dermatologist at the University of Texas, Austin, tweeted: “Dermatologists in the US are BIG angry with the current accutane debacle caused by @SyneosHealth and @US_FDA. What a disaster for patient care!
Several have called on the FDA to immediately stop the program and let doctors manage the risk until the platform can be improved.
Are the fixes in sight?
On Tuesday, December 14, ADA President Kenneth J. Tomecki, MD released a statement expressing his disappointment with the transition. “Prior to this transition, AADA engaged the FDA and iPLEDGE administrator, Syneos Health, about the many workflow issues raised by dermatologists and how the impending changes would threaten patients’ access to medications. required. These problems have become a reality across the country. and we are working to ensure that patients can maintain safe and appropriate access to the treatment they need. “
The ADA, the statement continued, supports efforts to streamline the program while preserving patient safety and incorporating physician feedback.
“We are very much aware of the issues with the implementation of the iPLEDGE program,” FDA spokesman Charlie Kohler said in an email. “We continue to work closely with the manufacturers of isotretinoin to ensure that they are implementing a properly functioning iPLEDGE REMS program and that patient care is not disrupted. “
“Syneos Health appreciates the concern over iPLEDGE,” said Gary Gatyas, spokesperson for Syneos Health. “Although Syneos Health does not maintain the iPLEDGE system or contact center, we are doing what we can to help the responsible parties find a solution. Meanwhile, he recommended people to contact the call center.
He did not immediately respond to questions about who is responsible for maintaining the system and the call center.
Goldberg, Frieden and Yeung did not disclose any relevant financial relationship.
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