iPLEDGE is a Food and Drug Administration-approved, restricted distribution program that is designed to prevent pregnancies in females who are taking isotretinoin and to prevent pregnant females from taking isotretinoin. Used by dermatologists to treat severe acne, isotretinoin is teratogenic and must not be used by pregnant women. There is an extremely high risk that a deformed infant will result if pregnancy occurs while a female patient is taking isotretinoin, even for a short period of time.
All prescribers of, patients taking and pharmacists dispensing isotretinoin must enroll in and follow the rules of the iPLEDGE program.
FDA institutes new iPLEDGE non-compliance policy
Effective July 16, 2012, the iPLEDGE program instituted a non-compliance policy, which was approved as a component of the Isotretinoin Risk Evaluation and Mitigation Strategy (REMS). It sets forth the principles by which non-compliance by iPLEDGE stakeholders will be evaluated. The policy consists of tiered levels based on severity and/or accumulation of non-compliance complaints. The tiers include:
- Notice of non-compliance: Issued to a stakeholder for an action that demonstrates a lack of understanding of the program and requires stakeholders to be re-educated about the program requirements.
- Warning: Issued to a stakeholder who fails to comply with one or more fundamental elements of the risk program and requires stakeholders to comply with all corrective actions required by the Isotretinoin Product Manufacturers Group (IPMG).
- Permanent deactivation: Stakeholders are permanently removed from the program and will not be allowed to prescribe isotretinoin to existing or future patients; no corrective action can be taken.
The iPLEDGE program has been operating under the framework of this non-compliance policy since the program's inception in 2006. Review the details of the non-compliance action policy here.