- Must be registered with the iPLEDGE program by the prescriber
- Must understand that severe birth defects can occur with the use of isotretinoin by female patients
- Must be reliable in understanding and carrying out instructions
- Must sign a Patient Information/Informed Consent (for all patients) form that contains warnings about the potential risks associated with isotretinoin
- Must fill the prescription within 7 days of the office visit
- Must not donate blood while on isotretinoin and for 1 month after treatment has ended
- Must not share isotretinoin with anyone, even someone who has similar symptoms
Isotretinoin is contraindicated in female patients who are pregnant. In addition to the requirements for all patients described above, female patients of childbearing potential must meet the following conditions:
- Must NOT be pregnant or breast-feeding
- Must comply with the required pregnancy testing at a CLIA-certified laboratory
- Must be capable of complying with the mandatory contraceptive measures required for isotretinoin therapy, or commit to continuous abstinence from heterosexual intercourse, and understand behaviors associated with an increased risk of pregnancy
- Must understand that it is her responsibility to avoid pregnancy one month before, during and one month after isotretinoin therapy
- Must have signed an additional Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form, before starting isotretinoin, that contains warnings about the risk of potential birth defects if the fetus is exposed to isotretinoin
- Must access the iPLEDGE program via the internet (www.ipledgeprogram.com) or telephone (1-866- 495-0654), before starting isotretinoin, on a monthly basis during therapy, and 1 month after the last dose to answer questions on the program requirements and to enter the patient’s two chosen forms of contraception
- Must have been informed of the purpose and importance of providing information to the iPLEDGE program should she become pregnant while taking isotretinoin or within 1 month of the last dose
The Responsible Site Pharmacist must register the pharmacy by signing and returning the completed registration form. After registration, the Responsible Site Pharmacist can only activate the pharmacy registration by affirming that they meet requirements and will comply with all iPLEDGE requirements by attesting to the following points:
- I know the risk and severity of fetal injury/birth defects from isotretinoin.
- I will train all pharmacists, who participate in the filling and dispensing of isotretinoin prescriptions, on the iPLEDGE program requirements.
- I will comply and seek to ensure all pharmacists who participate in the filling and dispensing of isotretinoin prescriptions comply with the iPLEDGE program requirements described in the booklet entitled The iPLEDGE Program Pharmacist Guide for Isotretinoin.
- I will obtain isotretinoin product only from iPLEDGE registered wholesalers.
- I will not sell, buy, borrow, loan or otherwise transfer isotretinoin in any manner to or from another pharmacy.
- I will return to the manufacturer (or delegate) any unused product if registration is revoked by the manufacturer or if the pharmacy chooses to not reactivate annually.
- I will not fill isotretinoin for any party other than a qualified patient.
- be trained by the Responsible Site Pharmacist concerning the iPLEDGE program requirements.
- obtain authorization from the iPLEDGE program via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) for every isotretinoin prescription. Authorization signifies that the patient has met all program requirements and is qualified to receive isotretinoin.
- write the Risk Management Authorization (RMA) number on the prescription.
- in no more than a 30-day supply
- with a Sotret Medication Guide
- after authorization from the iPLEDGE program
- prior to the “do not dispense to patient after” date provided by the iPLEDGE system (within 7 days of the office visit)
- with a new prescription for refills and another authorization from the iPLEDGE program (No automatic refills are allowed)
A Sotret Medication Guide must be given to the patient each time Sotret is dispensed, as required by law. This Sotret Medication Guide is an important part of the risk management program for the patients.
Sotret must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE program. Only FDA-approved Sotret products must be distributed, prescribed, dispensed, and used. Patients must fill Sotret prescriptions only at US licensed pharmacies.
- The iPLEDGE Program Guide to Best Practices for Isotretinoin includes: isotretinoin teratogenic potential, information on pregnancy testing, and the method to complete a qualified isotretinoin prescription.
- The iPLEDGE Program Prescriber Contraception Counseling Guide includes: specific information about effective contraception, the limitations of contraceptive methods, behaviors associated with an increased risk of contraceptive failure and pregnancy and the methods to evaluate pregnancy risk.
- The iPLEDGE Program Pharmacist Guide for Isotretinoin includes: isotretinoin teratogenic potential and the method to obtain authorization to dispense an isotretinoin prescription.
- The iPLEDGE program is a systematic approach to comprehensive patient education about their responsibilities and includes education for contraception compliance and reinforcement of educational messages. The iPLEDGE program includes information on the risks and benefits of isotretinoin which is linked to the Medication Guide dispensed by pharmacists with each isotretinoin prescription.
- Female patients not of childbearing potential and male patients, and female patients of childbearing potential are provided with separate booklets. Each booklet contains information on isotretinoin therapy including precautions and warnings, a Patient Information/Informed Consent (for all patients) form, and a toll-free line which provides isotretinoin information in 2 languages.
- The booklet for female patients not of childbearing potential and male patients, The iPLEDGE Program Guide to Isotretinoin for Male Patients and Female Patients Who Cannot Get Pregnant , also includes information about male reproduction and a warning not to share isotretinoin with others or to donate blood during isotretinoin therapy and for 1 month following discontinuation of isotretinoin.
- The booklet for female patients of childbearing potential, The iPLEDGE Program Guide to Isotretinoin for Female Patients Who Can Get Pregnant , includes a referral program that offers female patients free contraception counseling, reimbursed by the manufacturer, by a reproductive specialist; and a second Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form concerning birth defects.
- The booklet, The iPLEDGE Program Birth Control Workbook includes information on the types of contraceptive methods, the selection and use of appropriate, effective contraception, the rates of possible contraceptive failure and a toll-free contraception counseling line.
- In addition, there is a patient educational DVD with the following videos —“Be Prepared, Be Protected” and “Be Aware: The Risk of Pregnancy While on Isotretinoin” (see Information for Patients).
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