The Society of Dermatology Physician Assistants has been notified by members that FDA-approved modifications to the iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) implemented December 13, 2021, have caused a negative impact on patient care. SDPA requests immediate action from the FDA to remedy this unacceptable situation, which is preventing dermatology PAs and other healthcare professionals from prescribing isotretinoin, an important medication for the treatment of severe recalcitrant nodular acne.

We ask that our patients’ access to this important medication be restored as quickly as possible, whether that requires a reversal to the previous system or an expedited fix to the new one. Communication from the FDA on their plan of action is needed now in either case.

Prior to implementing the new system, the FDA was repeatedly warned by the dermatology community that the proposed changes did not reflect clinical practice and would stymie patient care. The FDA’s response did not adequately address the real-world, practical issues faced by dermatology PAs when they treat patients using isotretinoin.

Feedback from SDPA members includes the following comments submitted December 15, 2021:

• “It has been a nightmare for our office and the interruption in therapy for patients can be detrimental to their treatment outcome. With wait times of 2-3 hours minimum to speak to someone with iPLEDGE, most offices do not have the resources to devote a staff person to waiting on the phone, leading to further delays. Even though I had my staff watch the video iPLEDGE released, my staff still did not feel adequately prepared for the changes and what was required on the provider’s side of things.”
• “This has been a nightmare. My patients are unable to fill their prescriptions.  I have been calling iPLEDGE all day long, but have been unable to reach them because all circuits are busy. I receive an error message when I am entering the correct information. My only recourse is to speak with a human.” 

According to the FDA, the goals of the iPLEDGE REMS are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions. REMS, which includes all FDA-approved isotretinoin products, provides a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used. 

SDPA will continue to monitor the situation and will collect additional comments from its members.

The Society of Dermatology Physician Assistants (SDPA) is a 501c6 non-profit professional organization composed of members who provide dermatologic care or have an interest in the medical specialty of dermatology. Its Fellow members are PAs who provide medical services with the collaboration of a board-certified dermatologist. Founded in 1994, the SDPA currently has over 4,000 members. SDPA is the largest specialty organization in the American Academy of Physician Assistants (AAPA).

Comments...

Mariah K. Evans (Lefforge) says...

Posted Tuesday, December 21, 2021

In addition to the fact that many providers, patients, and pharmacies are unable to gain access, the new 7 day window it quotes is actually 8 days, it no longer gives the official end of the 30 day lockout and does not show the calendar to verify when pt can fill or get pregnancy test, and there is no option to transfer a patient who was registered under another office in to my list of patients.