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.
QUESTION
What percentage of the human body is water? See AnswerIsotretinoin (marketed as Accutane) Capsule Information. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/isotretinoin-marketed-accutane-capsule-information
Top What Does iPLEDGE Stand For? Related Articles
Common Medical Abbreviations & Terms
Doctors, pharmacists, and other health-care professionals use abbreviations, acronyms, and other terminology for instructions and information in regard to a patient's health condition, prescription drugs they are to take, or medical procedures that have been ordered. There is no approved this list of common medical abbreviations, acronyms, and terminology used by doctors and other health- care professionals. You can use this list of medical abbreviations and acronyms written by our doctors the next time you can't understand what is on your prescription package, blood test results, or medical procedure orders. Examples include:
- ANED: Alive no evidence of disease. The patient arrived in the ER alive with no evidence of disease.
- ARF: Acute renal (kidney) failure
- cap: Capsule.
- CPAP: Continuous positive airway pressure. A treatment for sleep apnea.
- DJD: Degenerative joint disease. Another term for osteoarthritis.
- DM: Diabetes mellitus. Type 1 and type 2 diabetes
- HA: Headache
- IBD: Inflammatory bowel disease. A name for two disorders of the gastrointestinal (BI) tract, Crohn's disease and ulcerative colitis
- JT: Joint
- N/V: Nausea or vomiting.
- p.o.: By mouth. From the Latin terminology per os.
- q.i.d.: Four times daily. As in taking a medicine four times daily.
- RA: Rheumatoid arthritis
- SOB: Shortness of breath.
- T: Temperature. Temperature is recorded as part of the physical examination. It is one of the "vital signs."
How Long Does a Miscarriage Last?
A miscarriage is the loss of a pregnancy within the first 20 weeks of conceiving. It’s also called pregnancy loss or spontaneous abortion. Every miscarriage is different, and the experience varies from person to person.
Miscarriage
Miscarriage is the medical term for the spontaneous loss of pregnancy from conception to 20 weeks gestation. Risk factors for a woman having a miscarriage include cigarette smoking, older maternal age, radiation exposure, previous miscarriage, maternal weight, illicit drug use, use of NSAIDs, and trauma or anatomical abnormalities to the uterus. There are five classified types of miscarriage: 1) threatened abortion; 2) incomplete abortion; 3) complete abortion; 4) missed abortion; and (5 septic abortion. While there are no specific treatments to stop a miscarriage, a woman's doctor may advise avoiding certain activities, bed rest, etc. If a woman believes she has had a miscarriage, she needs to seek prompt medical attention.
Pregnancy: Multiple Births, Twins, Triplets, and More
Multiple births occur when a woman bears twins, triplets, or even more babies during pregnancy. More multiples are born today thanks to assisted reproductive technology (ART), including in vitro fertilization using fertility drugs. Women carrying multiples often give birth via C-section.