The iPLEDGE Program is a computer-based risk management program designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA. The program strives to ensure that:
This enhanced program is a SINGLE pregnancy risk management program for prescribing and dispensing all isotretinoin products (brand and generic products). The iPLEDGE Program requires registration of all wholesalers distributing isotretinoin, all healthcare professionals prescribing isotretinoin, all pharmacies dispensing isotretinoin, and all male and female patients prescribed isotretinoin. This program is designed to create a verifiable link between the negative pregnancy test and the dispensing of the isotretinoin prescription to the female patient of reproductive potential. The iPLEDGE Program requires that all patients meet qualification criteria and monthly program requirements. Before the patient receives his/her isotretinoin prescription each month, the prescriber must counsel the patient and document in the iPLEDGE system that the patient has been counseled about the risks of isotretinoin.
There are also additional qualification criteria and monthly requirements for females of reproductive potential.
As part of the ongoing risk management of isotretinoin products, it is crucial that a female of reproductive potential selects and commits to use two forms of effective contraception simultaneously for one month before, during, and for one month after isotretinoin therapy. She must have 2 negative urine or blood (serum) pregnancy tests with a sensitivity of at least 25 mIU/ml before receiving the initial isotretinoin prescription. The first pregnancy test is a screening test and can be conducted in the prescriber's office. The second pregnancy test must be done in a CLIA-certified laboratory according to the package insert. Each month of therapy, the patient must have a negative result from a urine or blood (serum) pregnancy test conducted by a CLIA-certified laboratory prior to receiving each prescription.
Each month, the prescriber must enter the female patient's pregnancy results and the 2 forms of contraception she has been using in the iPLEDGE system. The iPLEDGE system verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE system via the program web site or phone system prior to dispensing each isotretinoin prescription for both male and female patients.