How To Register On Ipledge

Pregnancy
- Why should pregnancy be avoided while taking isotretinoin?
How To Register
- How to register for the iPLEDGE program?
Criticism
- Why has the iPLEDGE program been criticized?
Eye
- What Does iPLEDGE Represent? Centre

iPLEDGE stands for a risk evaluation and mitigation strategy

iPLEDGE stands for a take chances evaluation and mitigation strategy

iPLEDGE stands for a take a chance evaluation and mitigation strategy (REMS) plan adult 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 sure medications. REMS for isotretinoin iPLEDGE is a computer-based organisation that has been developed and mandated past 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 reply to other treatment modalities. It is known to affect pregnant women by causing

Nascence defects in their fetuses such as abnormalities in the eyes, ears, mouth, or skull.
Life-threatening issues in their babies such as astringent brain damage and heart problems.
Miscarriage.
Preterm births.

How to register for the iPLEDGE programme?

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. Earlier prescribing the medication and enrolling patients in the plan, the dr. 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 enquire them to sign a series of documents and steps to register for the program online. Patients should meet certain requirements during the treatment:

Practicing ii methods of contraception or practicing 100% abstinence
Having negative pregnancy tests each calendar month (for women of childbearing age)
Monthly follow-ups with the doctor
Undergoing regular blood tests whenever asked for

One time patients get registered, the physician and pharmacist will accept access to their iPLEDGE details. At every monthly visit to the physician 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 examination results are negative and they hold to continue using contraception, only then the doc will prescribe them isotretinoin for the side by side calendar month. The doctor updates their exam results on their iPLEDGE folio, and the pharmacist checks the details before dispensing their medication.

Afterward 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 take to undergo the entire monthly procedure again. This applies to women of childbearing potential. For others such as those with the male person 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 take criticized the programme because it intruded into their privacy by asking for monthly pregnancy tests. Doctors also report issues with compliance of patients to the program considering of its cumbersome nature, especially the monthly pregnancy tests.

Despite the above concerns, the importance of the iPLEDGE plan cannot be underestimated. The program has been proven to prevent nascence defects in babies of women receiving isotretinoin treatment and prevent side effects of the treatment.

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Medically Reviewed on 3/x/2021

References

The iPLEDGE Program Patient Introductory Brochure. https://www.ipledgeprogram.com/iPLEDGEUI/rems/pdf/resources/The%20iPLEDGE%20Program%20Patient%20Introductory%20Brochure.pdf

Isotretinoin (marketed every bit Accutane) Sheathing Information. https://www.fda.gov/drugs/postmarket-drug-safety-data-patients-and-providers/isotretinoin-marketed-accutane-sheathing-information