IPLEDGE

iPLEDGE

The iPLEDGE program is a risk management distribution program in the United States, designed to prevent fetal exposure to isotretinoin, a medication used primarily to treat severe acne. Isotretinoin is a potent teratogen, meaning it can cause severe birth defects if taken during pregnancy. The iPLEDGE program is mandated by the U.S. Food and Drug Administration (FDA) and is a critical component of the safe prescribing and dispensing of isotretinoin.

Background

Isotretinoin, known by brand names such as Accutane, Claravis, and others, is an oral retinoid that is highly effective in treating severe nodular acne. However, due to its teratogenic effects, it poses significant risks if used during pregnancy. The iPLEDGE program was established to mitigate these risks by ensuring that patients, prescribers, and pharmacists adhere to strict guidelines.

Program Requirements

The iPLEDGE program requires that all patients, prescribers, and pharmacies register and comply with specific requirements:

For Patients

- Registration: Patients must register with the iPLEDGE program and agree to comply with its requirements. - Pregnancy Testing: Female patients of childbearing potential must undergo regular pregnancy testing before, during, and after treatment. - Contraception: Female patients must commit to using two forms of contraception simultaneously or abstain from sexual intercourse. - Monthly Requirements: Patients must answer questions about the program and confirm their understanding of the risks each month before receiving a prescription.

For Prescribers

- Registration: Prescribers must register with iPLEDGE and agree to comply with its requirements. - Patient Counseling: Prescribers must counsel patients on the risks of isotretinoin and the importance of adhering to the program requirements. - Prescription Authorization: Prescribers must authorize prescriptions through the iPLEDGE system, confirming that all requirements have been met.

For Pharmacies

- Registration: Pharmacies must register with iPLEDGE and agree to comply with its requirements. - Prescription Verification: Pharmacies must verify that the prescription is authorized by iPLEDGE before dispensing isotretinoin. - Dispensing Limitations: Pharmacies can only dispense a 30-day supply and must ensure that the prescription is filled within a specific time frame after authorization.

Impact and Controversy

The iPLEDGE program has been effective in reducing the number of pregnancies exposed to isotretinoin. However, it has also faced criticism for being cumbersome and difficult to navigate for both patients and healthcare providers. Some argue that the program's complexity can lead to delays in treatment and increased administrative burden.

Also see

- Isotretinoin - Teratogen - Acne treatment - FDA regulations