Stacks Image 2024

iPLEDGE Program for Isotretinoin


Access to the iPLEDGE program is available online (www.ipledgeprogram.com). The iPLEDGE program requires the following:
• All patients who receive isotretinoin in the United States must participate in the ipledge program. There are no exceptions. The US government mandates this.
• As required by the iPledge program, all patients who receive isotretinoin may not receive more than a 30 day supply of isotretinoin. This means that isotretinoin patient must plan on monthly appointments with their dermatologist. Just to be clear, no refills are given with isotretinoin prescriptions. Monthly visits are required for all patients under the iPledge program.
• Patients may not donate blood during isotretinoin therapy and for one month after discontinuing therapy.
• Once a woman has had her first menstrual period, she is considered to be of childbearing potential. Female patients who have passed menopause or who have had their reproductive organs surgically removed are treated like male patients under the iPledge program. However, female patients who have had their tubes tied are still considered to be of reproductive potential.
• All patients have a specific period of time in which they can fill and pick up their prescription. This is called the “prescription window” and its start and end dates depend on whether the patient is a female of reproductive potential.
• For female patients of reproductive potential: The prescription window is 7 days, and starts on the date that the urine or blood sample is taken for a pregnancy test. This date is counted as DAY 1. To determine the end date of their 7-day prescription window, these patients should add 6 days to the date of the blood or urine sample being taken. It is generally recommended that the prescription be attempted to be picked up on DAY 1 just in case there are any insurance issues that delay things.
• For male patients and for female patients who cannot get pregnant: the prescription window is 30 days, and starts on the date the prescriber enters as the date of the office visit. This date is counted as DAY 1. To determine the end date of their 30-day prescription window, these patients should add 29 days to the date of their office visit.
• After 11:59 p.m. Eastern Time on the last day of the prescription window, the patient can no longer fill and pick up their prescription, and must start the process over to get a new prescription window.
• Female patients of childbearing potential who do not fill and pick up their first prescription in their first 7-day prescription window must wait at least 19 days from their most recent pregnancy test until getting their next pregnancy test. This is based on the requirement that the most recent pregnancy test prior to beginning therapy must be conducted in the first 5 days of her menstrual cycle.
• To receive monthly prescriptions, a female patient of childbearing potential must also answer questions in the iPLEDGE system about the program requirements and pregnancy prevention. Answering these questions can only take place after the prescriber has confirmed counseling, and entered the pregnancy test result and the patient’s 2 forms of contraception (or reliance on abstinence) into the system. In addition to answering the questions, the patient must also enter the 2 forms of birth control she is using (or indicate that she is relying on abstinence).
• All female patients of childbearing potential must select and commit to the use of two forms of birth control for at least one month prior to starting isotretinoin therapy, during therapy, and for one month after therapy. The forms of contraception that meet these requirements are specified by the iPLEDGE program.
• Typically, most heterosexual women aged 13 or older select a form of hormonal contraception as their primary method of contraception. This can include birth control pills, the NuvaRing, or patch. An intra-uterine device placed by a gynecologist or primary care provider, also called an IUD, can also serve as a primary contraception method.
• Typically, male latex condoms are chosen as the secondary form of contraception.
• Current data indicated that 26% of American women have had sexual intercourse prior to their 15th birthday.
• All female patients of childbearing potential must have two negative urine or blood pregnancy tests before receiving the initial prescription. These two tests must be at least 19 days apart, and the second test must fall in the first 5 days after the start of the menstrual period.
• For each month of therapy and one month after completing therapy, female patients must return to their physicians for evaluation, counseling, education, and a pregnancy test.

To summarize, female patients who have the ability to become pregnant must:
• Have an initial pregnancy test, which may be performed in the prescriber’s office
• Be counseled on contraception requirements
• Use 2 forms of contraception together for sexual intercourse for 1 month before, during, and for 1 month after treatment with isotretinoin
• There is a 30 day mandatory waiting period during which female patients of childbearing potential must be using both chosen forms of birth control before they are eligible to begin treatment with isotretinoin.
• Have a second pregnancy test, after being on 2 effective forms of contraception for 1 month and before starting isotretinoin therapy. This second pregnancy test must be at least 19 days after the initial pregnancy test.
• Fulfill monthly requirements before receiving each prescription:
– Have a serum or urine pregnancy test
–Answer online questions about the iPLEDGE requirements and pregnancy prevention (you will register online and get a username and password)
– Enter into the iPLEDGE system the 2 forms of contraception being used
• Have a pregnancy test right after their last dose
• Continue using 2 forms of contraception for 1 month after their last dose
• Have a pregnancy test 1 month after their last dose