Do Your PART Program
The Do Your PART program was developed to reinforce the importance of pregnancy prevention in patients receiving acitretin by providing information on risks of fetal exposure to the drug and to help prevent pregnancy.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)
Patient must complete and sign a Patient Agreement/Informed Consent form detailing risks of potential birth defects, contraceptive failure, and alcohol ingestion, and importance of pregnancy prevention during and after drug discontinuance. A Soriatane Patient/Contraceptive Counseling Referral form also is provided, allowing for a free initial contraceptive counseling session and pregnancy testing. A Medication Guide for all patients and a patient survey for women of childbearing potential also are included.
Prior to issuing the initial prescription for acitretin, pregnancy should be excluded by 2 negative serum or urine tests (the second test should be performed during the first 5 days of the menstrual period immediately prior to initiation of acitretin therapy). Pregnancy should be excluded by monthly testing during therapy and every 3 months after therapy discontinuance. Initial testing should be performed by a clinician.
To enhance compliance with pregnancy testing, a limited supply of acitretin should be prescribed.
Pregnancy must be prevented by simultaneous use of 2 forms of reliable contraception (unless the patient is absolutely abstinent, has undergone a hysterectomy, or is postmenopausal) for at least 1 month prior to therapy initiation, during therapy, and for at least 3 years following cessation of therapy.(See Advice to Patients.)
For detailed information regarding the program's requirements, the manufacturer's prescribing information should be consulted; prescribers should contact the manufacturer to obtain information on materials available for the program. To obtain further information regarding contraception options, patients should contact the Birth Control Counseling line at 800-739-6700.