As frustration mounts, FDA agrees to help

More than a week after rolling out the new gender-neutral approach to the isotretinoin risk mitigation program, frustration and problems remain a problem, according to dermatologists, pharmacists and patients.

When the new website and call center launched on December 13, hours of wait and repeated website crashes were reported as the norm, not the exception, prompting the American Academy of Dermatology Association (AADA) to request – and obtain – an emergency meeting Dec. 16 with the United States Food and Drug Administration (FDA), which enforces the Risk Assessment and Mitigation Strategy (REMS) for isotretinoin due to the teratogenicity of the acne drug.

At this meeting, ” the FDA and the HHS [US Department of Health and Human Services] recognized the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution, ”said Ilona Frieden, MD, chair of AADA’s iPLEDGE working group and professor of dermatology at the University of California in San Francisco, in an email interview. At the meeting, ADA representatives described the severe impact on patients’ access to treatment resulting from these problems. The ADA also “reiterated our call for a temporary hiatus from the program while stakeholders work to resolve pressing issues with the platform.” she said.

The new approach, which aims to make the experience more inclusive for transgender patients, reduces the previous three risk categories (women of childbearing age, non-childbearing women, and men) to just two (those capable of becoming pregnant. and those who are not). able). The program requires that physicians, patients, and pharmacists who prescribe, use, or dispense the drug be registered, with requirements that include the use of two forms of effective contraception and regular pregnancy tests by patients at risk of becoming pregnant. .

With reduced or no access during technological issues, access to the drug has been delayed for some patients. And dermatologists, pharmacists and their staff have reported grueling wait times to try to reach the call center when the website has problems.

While the FDA agreed to help find a solution, it noted that the solution “has to be found with dermatologists and pharmacists who are in the field and who go through the program every day,” Frieden said. No timeline for resolving the issues has been provided, so on Tuesday, December 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Frieden said. Medscape Medical News.

As Frieden sees progress, “We are disappointed that this situation continues to drag on for more than a week later, with more and more patients losing access to the medications they need every day. While some prescribers were able to log into the portal and enter the required information, confirming some patients, large gaps remain, she said. Patients and pharmacists are still reporting difficulty getting online. When this happens and they try to reach the call center, there are often hours of waiting, dropped calls, or a message saying to call back.

IPLEDGE’s administrator is Syneos Health, but Syneos spokesperson Gary Gatyas said the company is not maintaining the system or the contact center.

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

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

A dermatologist operating the new website who successfully registered as a supplier told Medscape that he had received a follow-up investigation from United BioSource LLC about the new website. Medscape has contacted that company to confirm that it operates 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 teenage daughters fill out forms by attesting that they would use abstinence for contraception, but couldn’t figure out how answer another question. As a result, their responses were interpreted as patients saying they practiced abstinence, but did not commit not to have sexual contact with a partner capable of impregnating them. Goldberg therefore received an automated message from the iPLEDGE program indicating that the responses did not match.

And in the comments section after last week’s Medscape article on the problematic deployment, one reader offered a suggestion to reduce call center wait times: choose the Spanish option.

Frieden and Goldberg have no relevant disclosure.

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