The FDA has modified its iPLEDGE Risk Evaluation and Mitigation Strategy (REMS), which was first implemented in 2005 to help prevent fetal exposure to isotretinoin, a prescription medication for the treatment of severe acne.
The acne medicine has been connected to severe side effects, including birth defects and is only available through the iPLEDGE program.
Starting Dec. 13, 2021, the agency will modify its website with changes directed at health care providers, pharmacies and patients.
Health care providers will see that there are now two risk categories — patients who can get pregnant and those who cannot get pregnant. “Health care providers must assign and confirm their currently enrolled patients’ risk category for each patient upon their first login into the iPLEDGE REMS website on or after Dec. 13. 2021,” the agency wrote in an email statement on the update. “The iPLEDGE REMS Prescriber Guide describes the qualification criteria for determining the reproductive potential of a patient.”
Importantly, patients whose current prescriptions will expired on Dec. 11-12, 2o21 are “instructed to obtain their prescription before 11:59 p.m. (Eastern) on Dec. 10, 2021.”
Patients are being given the same information noting that they will be assigned to one of the two categories and will also “have the option of presenting a unique QR code at the pharmacy on their smartphone instead of providing their iPLEDGE identification number.” This code can be found when they log into the iPLEDGE website.
For pharmacists, the changes are as follows:
“The REMS administrator has changed, and the current ’switch’ pharmacy management system is being removed as a method to verify authorization to dispense isotretinoin. With the changes to the pharmacy management system, pharmacists will no longer use the switch system to obtain a pre-dispense authorization, known as a risk management authorization (RMA). Starting on December 13, 2021, all pharmacists must obtain an RMA prior to dispensing isotretinoin by accessing the iPLEDGE REMS website or the iPLEDGE REMS Contact Center.
“Pharmacies will not be able to obtain an RMA number to dispense isotretinoin between December 11-12, 2021. Isotretinoin manufacturers anticipate the phone and internet systems for the modified iPLEDGE will be available on Dec. 13, 2021,” the FDA noted.
The iPLEDGE REMS website provides more information or interested parties can contact the iPLEDGE REMS Contact Center at 866-495-0654.
The FDA website “Questions and Answers on the iPLEDGE REMS” also has more information.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 105
Topic ID: 75,105,730,105,191,41,925
