Following its
approval for therapeutic use in 1998, a program was established that required all clinicians,
pharmacists, and patients that receive thalidomide to enroll in a specific program (System for
Thalidomide Education and Prescribing Safety, STEPS). The population at risk for the
potential teratogenic effects of thalidomide (all women of childbearing age) were required to
use two forms of birth control, and also have a negative pregnancy test within 24 hours of
beginning therapy, and periodically the patients registered with the STEPS program, 6000
were females of childbearing age. Remarkably, after 6 years of use, only one patient actually
received thalidomide during her pregnancy. She initially tested negative at the beginning of
therapy; on a subsequent test she was identified as positive, and the drug was stopped. The
pregnancy ended up as a miscarriage (Uhl et al., 2006).