General requirements:
(1) The drug can only be prescribed by physicians trained in the proper use of thalidomide and registered as an authorized prescriber.
(2) Dispensing of thalidomide is tightly controlled.
(3) No other alternative therapy is available for the patient.
(4) All patients must have received oral and written warnings of the teratogenic risks to an exposed fetus and of potential adverse effects of therapy.
(5) All patients must have received oral and written warnings about the risk of possible contraception failure.
(6) All patients must acknowledge these warnings and provide consent in writing.
(7) All patients must complete the enrollment survey form.
(8) If the patient is from 12 to 17 years of age, then the parent or legal guardian must read the material and agree to ensure compliance with the restrictions.
Instructions for women:
(1) A woman of childbearing potential must use 2 forms of contraception at the same time if she engages in heterosexual contact. These must be started 4 weeks prior to starting thalidomide therapy, all during its use, and for 4 weeks after discontinuation.
(2) The woman should have a negative pregnancy test with a sensitivity of at least 50 mIU/mL HCG within 24 hours of starting therapy. A pregnancy test is repeated every week for the first month, then monthly thereafter. If the woman's cycle is irregular then pregnancy testing should be performed every 2 weeks.
(3) If pregnancy occurs during therapy, then the drug must be stopped immediately. The patient should be referred to an obstetrician experienced in reproductive toxicity and the case should be reported.
(4) Pregnancy testing should be performed if the patient misses her period or has abnormal menstrual bleeding.
(5) The patient should be familiar with emergency contraceptive methods that are available.
where:
• The forms of contraception should include at least 1 highly effective method (IUD, birth control pills, implants, tubal ligation, vasectomy of partner) and 1 other effective method (latex condom, diaphragm, cervical cap).
• A woman is not considered childbearing if she has had a hysterectomy, if she has been postmenopausal for at least 24 months, or has not had a period for at least 24 consecutive months.
Instructions for men:
(1) The man must always use barrier contraception (latex condom) when having sexual intercourse with a woman of childbearing potential, even if the patient has undergone a vasectomy.
(2) The patient should not donate sperm.
Features of the prescriptions:
(1) They cannot be issued by telephone.
(2) They must be filled within 7 days.
(3) During the first month the dispensed amount should allow for only 7 days of therapy at a time. Afterwards the dispensed amount should allow for only 4 weeks of therapy.
(4) No automatic refills are permitted.
(5) The pharmacist should verify patient enrollment in the STEPS program.
(6) The patient should provide a signed consent form which is retained by the pharmacist.
