iPLEDGE stands for a risk evaluation and mitigation strategy (REMS) program developed for patients who take the medication isotretinoin for acne. REMS is a set of rules and steps that applies to consumers (patients), drug manufacturers, doctors, and pharmacists to ensure that all know the risks associated with certain medications. REMS for isotretinoin iPLEDGE is a computer-based system that has been developed and mandated by the U.S. Food and Drug Administration (FDA) to ensure that no woman is or gets pregnant before or while taking isotretinoin.
Why should pregnancy be avoided while taking isotretinoin?
Isotretinoin is a drug prescribed for a severe form of acne that fails to respond to other treatment modalities. It is known to affect pregnant women by causing
- Birth defects in their fetuses such as abnormalities in the eyes, ears, mouth, or skull.
- Life-threatening problems in their babies such as severe brain damage and heart problems.
- Miscarriage.
- Preterm births.
How to register for the iPLEDGE program?
For a doctor to prescribe isotretinoin to patients and a pharmacist to dispense it, they should first be a registered member of the iPLEDGE program. Before prescribing the medication and enrolling patients in the program, the doctor will explain them the benefits and risks associated with the drug in detail. Once they understand and agree to all the terms and conditions, the doctor will ask them to sign a series of documents and steps to register for the program online. Patients should meet certain requirements during the treatment:
- Practicing two methods of contraception or practicing 100% abstinence
- Having negative pregnancy tests each month (for women of childbearing age)
- Monthly follow-ups with the doctor
- Undergoing regular blood tests whenever asked for
Once patients get registered, the doctor and pharmacist will have access to their iPLEDGE details. At every monthly visit to the doctor for the prescription (which is given only for a month at every visit), they will have to answer certain questions and perform a pregnancy test. If their pregnancy test results are negative and they agree to continue using contraception, only then the doctor will prescribe them isotretinoin for the next month. The doctor updates their test results on their iPLEDGE page, and the pharmacist checks the details before dispensing their medication.
After receiving a negative pregnancy test, they should be able to collect their isotretinoin medication from the pharmacist within 7 days. If they fail to do so, they will again have to undergo the entire monthly procedure again. This applies to women of childbearing potential. For others such as those with the male reproductive system or women with conditions because of which they cannot get pregnant, this window period extends to 30 days.
Why has the iPLEDGE program been criticized?
Some patients have criticized the program because it intruded into their privacy by asking for monthly pregnancy tests. Doctors also report issues with compliance of patients to the program because of its cumbersome nature, particularly the monthly pregnancy tests.
Despite the above concerns, the importance of the iPLEDGE program cannot be underestimated. The program has been proven to prevent birth defects in babies of women receiving isotretinoin treatment and prevent side effects of the treatment.
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Isotretinoin (marketed as Accutane) Capsule Information. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/isotretinoin-marketed-accutane-capsule-information
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