| Table 1: Degree of compliance with the Pregnancy Prevention Program in 4 reported cases of fetal exposure to isotretinoin |
|
| Measure of compliance |
Case 1 |
Case 2 |
Case 3 |
Case 4 |
|
| Patient acknowledged knowing of teratogenic risk |
Yes |
Yes |
Yes |
Yes |
| |
| Physician mentioned teratogenic risk |
Yes |
Yes |
Yes |
Yes |
| |
| Pregnancy Prevention Program was discussed with patient |
No |
No |
No |
Yes |
| |
| Physician advised patient to use 2 modes of contraception concurrently |
No |
No |
No |
No |
| |
| Patient signed consent form |
No |
No |
No |
Yes |
| |
| Patient used contraception during isotretinoin therapy |
No* |
Yes† |
Yes‡ |
Yes§ |
|
*Patient did not intend to be sexually active.
†Oral contraceptive only; used on an irregular basis.
‡Oral contraceptive only; started before isotretinoin therapy but patient already pregnant (confirmed later by pregnancy test).
§Condom only. |
