More Than a Month After Launch, iPLEDGE Glitches Persist

More than a month after the launch of the new iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program, the operation still isn’t running smoothly for many dermatologists, pharmacists, and patients. That’s despite improvement attempts by the US Food and Drug Administration, which mandates the program to prevent fetal exposure to the teratogenic effects of isotretinoin, and by the American Academy of Dermatology Association (AADA), whose members have repeatedly asked the FDA for meetings to discuss solutions. The AADA is the legislative and advocacy arm of AAD.

When the new program launched December 13, the website crashed repeatedly, with physicians and patients complaining they got locked out or bounced off the platform when they tried to follow instructions to enter information. Hold times to talk to a live person stretched to hours.

The latest improvement attempt, announced last week by the FDA, is a tool created by the Isotretinoin Products Manufacturers Group (IPMG), the manufacturers responsible for the FDA-mandated REMS program. It is meant to allow prescribers and designees to send log-in links directly to patients’ email accounts through the iPLEDGE REMS portal, bypassing the troublesome call center.

And it’s not the answer, dermatologists said.

“The new tool does not solve issues such as prescribers or pharmacies not being able to access the site, unacceptably long call center wait times, inefficiencies caused by frequent attestation requirements for those who cannot become pregnant, patients becoming ‘locked out’ because they missed a window period through no fault of their own, among others,” said John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital and instructor in dermatology at Harvard Medical School, Boston.

The day after the FDA update about the new tool, Klint Peebles, MD, a dermatologist at Kaiser Permanente in Washington, DC, tweeted: “Lip service and empty words.” He noted that the situation has been ”disastrous from the start” as the new platform launched.

The rationale behind the launch of the new program isn’t the issue under fire. Its aim is to provide a gender-neutral approach to the risk mitigation program in place for the acne drug, to make the experience more inclusive for transgender patients. The previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) are now reduced to just two (those capable of getting pregnant and those not capable of getting pregnant).

The problem is the execution of the new platform. The transition from the old website to the new, which is said to be administered by a different vendor, was done quickly. By most accounts, the December 13 rollout was chaotic, a failure, and disastrous, triggering numerous expressions of frustration on Twitter and other social media, with some calling for the program to be halted until the bugs could be worked out.

Under the iPLEDGE program, physicians, patients, and pharmacies 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 testing for patients who can become pregnant.

AADA: More Recent Efforts to Improve the System

“We have a letter to the FDA asking for a stakeholders meeting to include us, the IPMG, and pharmacists because there are ongoing problems, though there have been some improvement in terms of certain elements,” said Ilona Frieden, MD, chair of the AADA’s iPLEDGE Workgroup and professor of dermatology at the University of California San Francisco, in an email shortly after the FDA posted the update on the new tool. “That said, there are many patients who have not gotten isotretinoin during the one month since the roll-out of the new platform.”

What still needs to be fixed? “We have ongoing concerns about the lack of transparency of the IPMG, about call center wait times, actual number of prescriptions on the hands of patients compared to the previous month, and those patients who can get pregnant who — despite complying with all of the REMS requirements — are being locked out because of the lack of timely attestation to their negative pregnancy status due to the website, not the patients themselves,” Frieden told Medscape.

“We are continuing to advocate to have decreased attestation requirements for individuals who cannot become pregnant — because this will improve the efficiency of the system for those patients for whom the REMS program goals are truly intended — those who can become pregnant, since the primary aim of the REMS program is to minimize fetal exposure.”

An AADA spokesperson said today that the IPMG has invited the AADA to a joint stakeholders meeting this coming Wednesday, along with representatives from the FDA and pharmacy industry.

Spotty Progress

“The iPLEDGE situation is as frustrating as ever,” said Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, after the FDA’s January 14 update was released. “It’s like they never tested the new website before deploying it.”

Among the issues he has experienced in his practice, he said, is an instance in which iPLEDGE swapped the first names of a mother and daughter, so it was impossible to fill the prescription. “It happened twice in the same day,” Goldberg said. The patient had to call iPLEDGE to fix this, but the call center wasn’t taking calls, he said.

In today’s technology environment, he said, he finds it hard to believe that ”we have to put up with this.”

Some have seen success. ”The tool is working fine on our end,” said Mitesh Patel, PharmD, pharmacy manager at Sunshine Pharmacy in White Plains, New York. However, he added that some doctors and patients are still having issues. He encourages dermatologists still having issues with the system to reach out to independent pharmacies that have processed iPLEDGE prescriptions and ”lean on them to assist.”

Medscape contacted CVS and Walgreens about how the system is working at their locations, but has not yet received a response. 

Goldberg, Frieden, Barbieri, and Peebles have disclosed no relevant financial relationships.

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