What is the iPLEDGE Program?
What is iPLEDGE? The iPLEDGE program is a risk evaluation and mitigation strategy (REMS). The Food and Drug Administration (FDA) may require a REMS to help ensure that a medication’s benefits outweigh its risks.
Who is required to register and use iPLEDGE?
[2][3]Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE web site in order to receive, prescribe or dispense isotretinoin. [4]
How does iPLEDGE work for men?
( Men have their own set of iPledge requirements, by the way.) As these steps are completed, they are entered into the computer-based iPledge system. Your pharmacist will access this system to receive authorization to give you your medication. You must re-qualify with iPledge every month prior to refilling your prescription.
What is the latest on the iPLEDGE REMS?
FDA approved a modification to the iPLEDGE REMS effective December 13, 2021 with system changes for health care professionals and patients..
How does the iPLEDGE program work?
The iPLEDGE system automatically checks patient qualification criteria for you. Prescriptions will be authorized only for those patients who meet all criteria. Additional fills for the prescription to achieve the desired dosage can be entered by the pharmacist immediately after the prescription is authorized.
What does iPLEDGE REMS stand for?
iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) | FDA. The .gov means it's official. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
What is the iPLEDGE system?
What is the iPLEDGE® Program*? The iPLEDGE® Program* is a computer-based risk management program that was designed to reduce risk of birth defects as well as to inform you, healthcare providers, and pharmacists about how to safely use isotretinoin and the risks that it can bring.
Why does Accutane have iPLEDGE?
The FDA and manufacturers of both brand and generic formulations of isotretinoin have since approved the iPLEDGE program in an effort to reduce fetal exposure to the drug and to prevent pregnancy during use.
Why does iPLEDGE exist?
Why iPLEDGE was Created. The program exists because a small number of women became pregnant while taking isotretinoin. Since 1988, voluntary initiatives that became more elaborate over time did not produce a noticeable change in the pregnancy rate for women taking this medication.
Who runs the iPLEDGE system?
The iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) for managing the risk of isotretinoin (also known as Accutane), a prescription medication used for the treatment of acne.
What happened to iPLEDGE?
A scheduled change to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) has led to a delay in isotretinoin prescriptions. Physicians and their teams have been unable to access the iPLEDGE site during an update to incorporate an FDA-approved modification to the iPLEDGE REMS that took effect December 13, 2021.
Is iPLEDGE required?
Everyone who uses isotretinoin, regardless of age or gender, is required to enroll in the iPledge program. Healthcare providers who prescribe isotretinoin and pharmacies that dispense it also must be registered in iPledge.
What is the purpose of the iPLEDGE program?
Answer: The iPLEDGE program is an FDA required risk management program with the goal of preventing fetal exposure to isotretinoin.
How much is Accutane a month?
How much does Accutane cost without insurance? The normal cash cost of Accutane without health insurance is $631.89 per 30, 30 Capsules Capsule though you can save money using a SingleCare Accutane coupon to pay only $192.98.
Can you have a healthy baby after Accutane?
Can I Get Pregnant During My Treatment? No. It is not suggested to attempt pregnancy one month before, during, or one month after your course of Accutane therapy. Birth defects, premature birth and loss of the fetus have all been reported in women who get pregnant while on Accutane.
How long does Accutane stay in your system?
Accutane (isotretinoin) has an elimination half-life of 21 hours, therefore it will take 5.5 x 21 hours = 115.5 hours (approximately 4.8 days) before it will be cleared from your system. Side effects may last longer. You must not become pregnant for 1 month after stopping Accutane.
What are the two types of birth control for Accutane?
Birth Control and iPLEDGE® Anyone registered as a FRP on iPLEDGE® is required to be on birth control OR be abstinent while on isotretinoin. iPLEDGE® requires TWO forms of birth control, one primary birth control and another which can be either primary or secondary.
Why do men have to do iPLEDGE?
It was put in place to prevent pregnancy in people taking isotretinoin. Taking this drug while pregnant can lead to a range of birth defects and health issues. Everyone taking isotretinoin, regardless of sex or gender, is required to register for iPLEDGE.
How do I find my iPLEDGE number?
Answer: More information on iPLEDGE is available at the iPLEDGE REMS website or via the iPLEDGE Contact Center at (866) 495-0654.
Why do you need two forms of birth control on Accutane?
You must understand that any form of birth control can fail. Therefore, it is very important to decrease the risk of accidental pregnancy by using two forms of birth control at all times.
Why is the IPledge program important?
The program has been proven to prevent birth defects in babies of women receiving isotretinoin treatment and prevent side effects of the treatment .
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.
What is the iPledge program?
iPledge was developed by the Food and Drug Administration (FDA) in an effort to protect against preventable birth defects and other pregnancy-related side effects of isotretinoin. The intent of the iPledge program is to provide a system of checks and balances to reduce the chance of fetal exposure to this drug. 1 .
How long does a prescription last with iPledge?
You will only get enough medication to last the one month between the required visits . The pharmacist filling your prescription must also verify through the iPledge system website (or over the phone) that all criteria have been met. Your pharmacist must obtain authorization before giving you the medication.
What are the requirements for the iPledge program?
Requirements of the iPledge program include using two methods of contraception or practicing 100 percent abstinence during treatment, having negative pregnancy tests each month (for women of childbearing potential), seeing a doctor monthly, and submitting to regular blood tests as needed. 1
Is the iPledge program intrusive?
There has been some criticism of the iPledge program, with some patients viewing the monthly pregnancy test requirement as unnecessarily intrusive and a potential disrupt ion of their privacy . Healthcare providers have raised concerns that the program is too cumbersome and difficult for patients to adhere to, particularly the monthly pregnancy tests. Very little information is available on how patient data is stored in the iPledge program, which has also raised patient privacy concerns.
What is the iPledge program?
It is a “shared system” REMS, meaning that it includes all FDA-approved isotretinoin products. It provides a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used.
What is the FDA's iPledge?
iPLEDGE Update (10/2007): FDA is providing an update about iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin (a drug to treat severe recalcitrant nodular acne). FDA approved several changes to the program. See IPLEDGE Update
When was iPledge approved?
iPLEDGE Update (10/22/2010): Today, FDA approved iPledge as a Risk Evaluation and Mitigation Strategy (REMS) in accordance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). This approval does not substantively change the program for patients, prescribers, dispensers, and wholesalers for approved uses of isotretinoin. FDAAA required the conversion to REMS of those RiskMAPs approved before FDAAA was enacted that contained certain features such as those of the iPledge program requiring prescriber and pharmacist certification, and documentation of safe use conditions before the drug can be dispensed, including pregnancy testing and agreement to use contraception.
Can prescribers interact with iPledge?
Prescribers will not be able to interact with the iPLEDGE Program,
What is the FDA's iPledge program?
The iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) for managing the risk of isotretinoin (also known as Accutane), a prescription medication used for the treatment of acne. Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE web site in order to receive, ...
Who is responsible for the Ipledge program?
The iPLEDGE program was put into place a group formed by the companies that manufactured the drug at the time – Roche, Mylan, Barr, and Ranbaxy – called the Isotretinoin Products Manufacturing Group (IPMG); they are responsible for iPLEDGE and they hired Covance to manage it.
How long was the Ipledge held up?
Although eventually resolved, the older concerns proved valid in 2003 when the launch of iPLEDGE was held up for three years while objections from women's rights, patient's rights, physician's rights and pro-choice lobbyists were debated in committee.
What are some criticisms of the Ipledge website?
Some criticisms of the iPLEDGE website include that the website does not clearly identify who administers the site, despite being a mandatory program that requires the submission of private information about medical patients. The terms of use and legal disclaimer section of the site do not clearly identify the legal entity running the program or describe how the private information of the patients is secured. The terms of use for the site is phrased as a contract between "you" and "the sponsors of the Site" (which it defines as synonymous with "iPLEDGE"), without clearly saying who "the sponsors of the Site" includes.
How long does it take to get a password for iPledge?
After they have been registered in iPLEDGE by their doctor, they will receive their password in the mail after 5–10 business days. Patients are classified either as females of child-bearing potential (FCBPs), females not of child-bearing potential (FnCBPs), or males.
Does the Ipledge program require participation?
The iPLEDGE Program requires the participation of both males and FnCBPs, and this has been a subject of criticism over the course of the program's lifetime. Dermatologist Ned Ryan said "They [the FDA and drug manufacturers] want a wide net, understandably. But this is completely over the top."
Why is iPledge required?
This program was put in place to prevent birth defects caused by isotretinoin. 1 . You'll need to enroll in iPledge to get your prescription; it's a requirement for everyone who is prescribed isotretinoin medications like Absorica, Amnesteem, Claravis, and Sotret. Because of the high risk of birth defects in babies whose mothers take isotretinoin, ...
Who is included in the iPledge?
This includes young people who have not started menstruating yet , and even those assigned female at birth who have had their tubes tied. ( Men have their own set of iPledge requirements, by the way.)
How often do you have to re-qualify for iPledge?
Your pharmacist will access this system to receive authorization to give you your medication. You must re-qualify with iPledge every month prior to refilling your prescription. If you are a person who can get pregnant, no matter how slight the chances, you are required to:
Can you skip the iPledge?
You will also confirm the two birth control methods you are using. And no, you can't skip this step . Your pharmacist can't fill your prescription until you have completed all necessary steps.
Why Pregnancy Must Be Avoided While Taking Isotretinoin
Isotretinoin and Ipledge Program Registration Basics
- iPledge was developed by the Food and Drug Administration (FDA) in an effort to protect against preventable birth defects and other pregnancy-related side effects of isotretinoin. The intent of the iPledge program is to provide a system of checks and balances to reduce the chance of fetal exposure to this drug.1 Everyone who uses isotretinoin, rega...
Meeting The Requirements For Qualification
- Learning about isotretinoin and its side effects is just the beginning of the iPledge program. You must also meet certain requirements before you will be qualified to receive your medication. Requirements of the iPledge program include using two methods of contraception or practicing 100 percent abstinence during treatment, having negative pregnancy tests each month (for peo…
Criticism of The Program
- There has been some criticism of the iPledge program, with some patients viewing the monthly pregnancy test requirement as unnecessarily intrusive and a potential disruption of their privacy. Healthcare providers have raised concerns that the program is too cumbersome and difficult for patients to adhere to, particularly the monthly pregnancy tests. Very little information is availabl…
The Bottom Line
- Despite concerns raised about the iPledge program, the current rules still require anyone taking isotretinoin to register and submit to this monitoring. Ultimately, the program has been a proven system for preventing devastating birth defects and harmful side effects of Accutane (before it was discontinued in 2009) and other isotretinoin drugs.
Overview
The iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) for managing the risk of isotretinoin (also known as Accutane), a prescription medication used for the treatment of acne. Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE web site in order to receive, prescribe or dispense isotretinoin.
Process
Once a doctor decides a patient is a candidate for isotretinoin, they will counsel the patient to ensure they understand the drug and the potential side effects. Once the patient signs the necessary paperwork, their doctor will give them a patient ID number, ID card, and program educational materials. After a patient has been registered in iPLEDGE by their doctor, they receive their password in the mail within 5–10 business days.
Background and history
Some dermatologists have praised isotretinoin for its ability to treat severe acne, with current research calling it "a drug of choice" with "immense promise … in reducing dermal irritation and increasing the therapeutic performance, thus resulting in an efficacious and patient-compliant formulation". However, there have also been many reports and studies criticizing the negative side effects of isotretinoin have been published over the years.
Criticisms
Criticisms of the iPLEDGE program include the following:
When the Program launched in March 2006, there were many complaints about how difficult it was to use the system. Launch and pre-launch difficulties were common with the system jointly built by the drug manufacturers with the assistance of Covance, Inc, and approved by the FDA. Glitches with the website and long hold times were rampant at the time, and became a focus of …
External links
• ipledgeprogram.com The official iPledge program web site.
• REMS document
• FDA press release about the program
• Information from the CDC CDC and the March of Dimes Isotretinoin and other retinoids during pregnancy