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Experts call for iPLEDGE program reform to reduce administrative burden

Researchers, along with the American Academy of Dermatology, have organized an iPLEDGE Workgroup to advocate for its reform with the goal of reducing administrative burden.

Since the introduction of iPLEDGE, fetal exposures to isotretinoin have continued, according to a viewpoint in JAMA Dermatology from John S. Barbieri, MD, MBA, and colleagues. There was an initial 30% decrease in isotretinoin prescriptions when the program was introduced.

The administrative burden associated with iPLEDGE can cause a delay in therapy initiation for patients with scarring acne, which may lead to permanent skin changes and reduced quality of life, according to Barbieri and colleagues.

According to previous research, 55% of adult patients, 80% of caregivers and 89% of children missed school or work because of isotretinoin-associated office visits.

Moreover, patients should be better informed on effective contraception methods and their use.

“iPLEDGE should improve the clarity of information in its educational materials regarding relative effectiveness of contraception methods; encourage the use of long-acting reversible contraception, such as intrauterine devices and subdermal implants; and provide additional information on how to obtain emergency contraception when needed,” Barbieri and colleagues wrote.

They also recommended framing contraceptive options by their rate of failure instead of their rate of success.

The researchers support removing the requirement for a secondary form of contraception, as well as a 30-day waiting period, and reducing the frequency of required confirmation/documentation of contraception counseling and method of contraception. They also wish to decrease the frequency of required pregnancy testing.

To improve the consideration for transgender patients, patients should be classified as “able to become pregnant” or “unable to become pregnant,” regardless of sex or gender. Confirmation requirements should be reduced to once every 6 months in patients unable to become pregnant, according to researchers.

“The iPLEDGE program should also explicitly allow clinicians to use flexible options for patient counseling and follow-up, including store-and-forward telemedicine, telephone or video visits, and secure messaging,” Barbieri and colleagues wrote.

“iPLEDGE has decreased access to isotretinoin and increased the burden on patients and clinicians. Physicians, patients and the FDA should together reform iPLEDGE to better enable safe and effective use of isotretinoin,” they wrote. – by Abigail Sutton

Disclosures: Barbieri reports he receives support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and partial salary support through a Pfizer fellowship grant to the trustees of the University of Pennsylvania. Please see the study for all other authors’ relevant financial disclosures.