1. What is isotretinoin?
Answer: Isotretinoin is a prescription medicine approved for use in patients 12 years of age and older, who are not pregnant, for the treatment of severe acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Isotretinoin capsules can cause serious side effects, including birth defects. Because of the risk of severe birth defects, isotretinoin has only been available through a restricted distribution program called the iPLEDGE Program since 2005, and approved as the iPLEDGE REMS in 2010.
2. What is the iPLEDGE REMS program?
Answer: The iPLEDGE program is an FDA required risk management program with the goal of preventing fetal exposure to isotretinoin. All isotretinoin manufacturers are part of the iPLEDGE program, and health care providers and pharmacies must be registered with iPLEDGE to be able to prescribe and dispense isotretinoin to patients.
To receive isotretinoin, patients must also be enrolled in the iPLEDGE program and agree to meet all the program requirements. Program requirements vary and are determined by the patient’s risk category. iPLEDGE also includes a pregnancy registry for patients who get pregnant during isotretinoin treatment.
3. What is a Risk Evaluation and Mitigation Strategy (REMS)?
Answer: A REMS is a risk management program that uses risk minimization strategies beyond approved labeling to manage serious risks associated with a drug. Under the Food and Drug Administration Amendments Act of 2007, FDA has the authority to require a manufacturer to develop and implement a REMS when FDA finds it is necessary to ensure that the benefits of a drug outweigh its risks.
A REMS can include a Medication Guide or patient package insert, communication plan, one or more elements to ensure safe use, an implementation system, and a timetable for submission of the REMS assessments. A REMS may also include certain packaging and safe disposal technologies for drugs that pose a serious risk of abuse or overdose.
4: What are the new changes to the modified iPLEDGE REMS? Why did FDA approve this modification?
Answer: In June 2018, FDA notified the isotretinoin sponsors that a REMS modification and a labeling change would be required, replacing gender-specific language with the use of gender-neutral language throughout the label REMS risk categories. This change was based on stakeholder feedback that gender-specific language can be a barrier to access for patients who do not identify with the previous gender-specific patient categories in the iPLEDGE REMS Program.
On October 8, 2021, FDA approved a modification to the iPLEDGE REMS. As a result of this modification, patients taking isotretinoin are assigned to one of two risk categories: patients who can get pregnant and patients who cannot get pregnant. There were previously three risk categories: females of reproductive potential, females not of reproductive potential, and males.
The modification will become effective December 13, 2021, when the iPLEDGE REMS will change to a new platform and the current “switch” pharmacy management system will be removed as a method to verify authorization to dispense isotretinoin. With the changes to the pharmacy management system, pharmacists will no longer be able to use the switch system to obtain a pre-dispense authorization, known as a risk management authorization (RMA). Pharmacists need to obtain an RMA online by accessing the iPLEDGE REMS website or by telephone via the PLEDGE REMS Contact Center (866) 495-0654 prior to dispensing each isotretinoin prescription.
5: What should patients know about the changes to the iPLEDGE program?
Answer: Patients will be assigned by their health care provider into one of two risk categories: patients who can get pregnant, and patients who cannot get pregnant. Patients who can get pregnant must follow the REMS requirements to prevent pregnancy before, during, and 30 days after isotretinoin treatment. Patients who cannot get pregnant must also receive monthly counseling from their prescriber during isotretinoin therapy.
When presenting an isotretinoin prescription to the pharmacy each month, patients must also provide their iPLEDGE identification number. Patients will have the option to present a unique QR code which the pharmacy can use to navigate to the iPLEDGE website with the patient’s information pre-populated. Patients can access their unique QR code by logging into their account on the iPLEDGE REMS Website. Patients can consult their prescriber, call the iPLEDGE Contact Center at (866) 495-0654 or visit the iPLEDGE website for more information about this change.
6: What are the changes for prescribers?
Answer: Providers must assign new and existing patients into one of the two risk categories: patients who can get pregnant or patients who cannot get pregnant. Patients who can get pregnant must follow the REMS guidelines to prevent pregnancy during isotretinoin treatment.
7: How does this change impact pharmacists and authorized representatives of pharmacies?
Answer: Starting on December 13, 2021, pharmacies can no longer use the “switch” pharmacy management system as a method to verify isotretinoin dispensing or obtain a pre-dispense authorization. Pharmacists can obtain a REMS dispense authorization by accessing the iPLEDGE REMS website or by telephone via the iPLEDGE REMS Contact Center at (866) 495-0654.
Pharmacies may also choose to use QR codes presented by the patient at the time of the patient’s visit. Scanning the QR code on a pharmacy’s enabled device will navigate directly to the iPLEDGE REMS Website and pre-populate the patient’s information to verify the safe-use conditions for isotretinoin dispensing have been met.
8: Where can stakeholders go for more information and to receive answers to their questions?
Answer: More information on iPLEDGE is available at the iPLEDGE REMS website or via the iPLEDGE Contact Center at (866) 495-0654. The website includes enrollment forms and stakeholder educational materials.