Latest News

FDA OKs iPLEDGE change for gender-neutral language


 

FDA elaborates

The modification includes important changes for doctors, pharmacists, and patients alike, according to the FDA.

Health care providers must assign and confirm their currently enrolled patient’s risk category when they first log in to the IPLEDGE REMS website on or after Dec. 13, the effective date. They should be sure any patient whose prescription RMA (iPLEDGE authorization) expires on Dec. 11-12 is told to obtain their prescription before midnight, Eastern time, Dec. 10.

Pharmacists will be affected, too, since the iPLEDGE REMS changed to a new platform vendor and the current “switch” pharmacy management system will be removed as a method to verify authorization to dispense isotretinoin. With these changes, as of Dec. 13, pharmacists can’t use the switch system to obtain a predispense authorization, or RMA (risk management authorization). They will need to obtain an RMA online by accessing the iPLEDGE REMS website or via telephone to the PLEDGE REMS center, 866-495-0654, before dispensing the prescription.

Patients, beginning Dec. 13, will have the option of presenting a unique QR code at the pharmacy on their smartphone rather than providing the iPLEDGE identification number. The code can be accessed by logging into their account on the iPLEDGE REMS website.

Patients with an isotretinoin prescription RMA that expires Dec. 11-12, must obtain the prescription before 11:59 p.m. Eastern time on Dec. 10. If the RMA expires before the prescription is picked up, the patient must begin the authorization process all over again.

Dr. Safer, Dr. Yeung, and Dr. Peebles have no relevant disclosures.

More information on the update and the isotretinoin REMS program is available on the FDA website.

Pages

Recommended Reading

Shortcomings identified in study of acne videos on TikTok
MDedge Family Medicine
Light-based technologies emerging as promising acne treatments
MDedge Family Medicine
Expert calls for paradigm shift in lab monitoring of some dermatology drugs
MDedge Family Medicine
Emerging treatments for molluscum contagiosum and acne show promise
MDedge Family Medicine
LGBTQ patients face unique skin risks
MDedge Family Medicine
In Black patients, acne scarring might not mean what you think
MDedge Family Medicine
Isotretinoin benefits similar in overweight, obese adolescents, and those in normal weight range
MDedge Family Medicine
Study eyes impact of isotretinoin on triglycerides, other lab measures
MDedge Family Medicine
Study estimates carbon footprint reduction of virtual isotretinoin visits
MDedge Family Medicine
Study highlights impact of acne in adult women on quality of life, mental health
MDedge Family Medicine