The US Food and Drug Administration (FDA) is convening an emergency meeting today with representatives from the American Academy of Dermatology Association (AADA) to discuss the flawed rollout of the new, gender-neutral approach to the isotretinoin risk mitigation program that launched Monday and what can be done to fix it.
By most accounts, the rollout was disastrous, ampicillin tablets uses chaotic, and a failure. Dermatologists on Twitter and elsewhere are angry and frustrated, with some calling for a temporary halt to the program until the bugs can be ironed out.
On Twitter Wednesday, the Academy posted: “Due to the unacceptable situation with #iPLEDGE, the @US_FDA has convened an emergency meeting with AADA representatives tomorrow, December 16.”
The switch to a new platform was met with frustration from physicians, pharmacists, and patients alike. The new website crashed repeatedly, with physicians and patients complaining they got locked out or bounced off the platform when they attempted to follow instructions to enter information. Calls to obtain support from a live person often required hours on hold, several said.
The new approach to the isotretinoin risk-mitigation program itself isn’t under fire. It was welcomed by dermatologists and others who had long requested the change. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), there are now two (those who can get pregnant and those who cannot). Advocates for the change said it will make the experience more inclusive for transgender patients. The previous categories, some contended, were a barrier to access to care.
Because isotretinoin (Absorica, Amnesteem, 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 associated with other health issues, those who take the medication who are able to get pregnant must take contraceptive precautions. The risk evaluation and mitigation program (REMS), mandated by the FDA, stipulates 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 the new website, a new log-on name was needed, said Ilona Frieden, MD, chair of the AADA’s iPLEDGE Workgroup 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 on, she got locked out, she said in an interview.
The transition from the old website to the new, which Frieden said is now administered by a different vendor, was done quickly. The previous website shut down December 10, and the new one launched December 13, the first day for the new approach.
“A slower rollout would have helped,” Frieden said. While she and other dermatologists said they offered input previously on how to make the transition go more smoothly, no one seemed to want that help. “We did have a listening session with the FDA,” Frieden said. That was before the scheduled meeting today.
Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, was also frustrated with the rollout. “The week before the transition, one of my staff had to call iPLEDGE. They had a 177-minute wait to get to a human.
“They want us to register patients online now instead of signing forms in 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 be now available to you at the click of a button.”
Goldberg also received calls from three patients who reported that they couldn’t complete the quiz that is required of patients capable of reproducing to demonstrate their comprehension about risk. Without the completed quiz, required monthly, the prescription can’t be refilled.
“It’s chaotic,” said Howa Yeung, MD, an assistant professor of dermatology at Emory University, Atlanta. “The change is sudden, it’s a major change in the workflow. The process of reverification [required] is not that hard, but a lot of people have trouble even logging into the platform.”
What would help? To have a human on the phone to help navigate the system, Yeung said.
The glitches are delaying prescriptions for established patients and new ones as well, Yeung said. Existing patients who can get pregnant have 7 days after their negative pregnancy test to get their prescription filled. “And over the weekend the website was down,” he said, so that was a 2-day delay.
“The information we have and were told to use doesn’t 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 had a lot to say, as well. Jack Resneck, Jr, MD, professor of dermatology at the University of California, San Francisco, tweeted: “#Accutane has basically been pulled from market by utter incompetence of @SyneosHealth hired by @US_FDA to administer risk mgmt program.” Resneck, also president elect of the American Medical Association, noted the crashed website, help line with 6-hour hold times, and patients unable to get the drug.
Adewole Adamson, MD, a dermatologist at the University of Texas, Austin, tweeted, “Dermatologists around the US are BIG mad about the current accutane debacle brought on by @SyneosHealth and @US_FDA. What a disaster for patient care!””
Several called for the FDA to immediately halt the program and let physicians manage the risk until the platform can be improved.
Are Fixes in Sight?
On Tuesday, December 14, AADA President Kenneth J. Tomecki, MD, issued a statement expressing disappointment about the transition. “In advance of this transition, the AADA engaged the FDA and the iPLEDGE administrator, Syneos Health, about the numerous workflow concerns raised by dermatologists and how the impending changes would threaten patient access to necessary medication. Those concerns have become a reality across the country and we’re working to ensure patients can maintain safe and appropriate access to the treatment they need.”
The AADA, the statement continues, supports efforts to streamline the program while keeping patient safety and incorporating input from physicians.
“We are very aware of the problems with the implementation of the iPLEDGE program,” FDA spokesperson Charlie Kohler said in an email. “We are continuing to work closely with the isotretinoin manufacturers to ensure that they implement a smoothly functioning iPLEDGE REMS program and that patient care is not interrupted.”
“Syneos Health appreciates the concern about iPLEDGE,” said Gary Gatyas, a spokesperson for Syneos Health. “While Syneos Health does not maintain the iPLEDGE system or contact center, we are doing what we can to help the responsible parties with a resolution.” Meanwhile, he recommended that people contact the call center.
He did not respond immediately to questions about who is responsible for maintaining the system and call center.
Goldberg, Frieden, and Yeung have disclosed no relevant financial relationships.
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