Medical Technology

iPLEDGE Rollout: As Frustration Mounts, FDA Agrees to Help

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched December 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request — and get — an emergency meeting on December 16 with the US Food and Drug Administration (FDA), which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ”the FDA and HHS [US Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ”reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ”was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Frieden said. No timeline for solving the issues was provided, so on Tuesday, December 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Frieden told Medscape Medical News.

While Frieden sees progress, ”we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Frieden said. “In the meeting last week [December 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told Medscape that he received a follow-up survey from United BioSource LLC about the new website. Medscape contacted that company to confirm it runs the website, but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception, but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence, but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following last week’s Medscape story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Frieden and Goldberg have no relevant disclosures.

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