Related Experiment Videos
A risk management program aimed at preventing fetal exposure to isotretinoin: retrospective cohort study
T Craig Cheetham1, Richard A Wagner, Gene Chiu
1Pharmacy Analytical Service Kaiser Permanente, Downey, California 90242, USA. craig.t.cheetham@kp.org
Background:
Preventing fetal exposure to isotretinoin is an important public health goal. Since approval of isotretinoin (1982), the Food and Drug Administration has implemented several unsuccessful risk management programs aimed at preventing fetal exposure. The Kaiser Permanente isotretinoin risk management program included electronic capture of all isotretinoin prescriptions and the documentation of pregnancy testing with each dispense.
Objective:
Our aim was to analyze the success of Kaiser Permanente's program at improving pregnancy testing rates and reducing fetal exposure.
Methods:
This was a retrospective cohort study.
Results:
Pregnancy testing rates improved after implementation of the Kaiser Permanente program. However, the rate of fetal exposure to isotretinoin did not change (0.21% before vs 0.23% after, P = .85). LIMITATIONS/CONCLUSION: In this study, linking a negative pregnancy test to isotretinoin dispensing did not reduce fetal exposures. Patient failure to use two contraceptive methods was the most common reason for fetal exposure. These results have important implications for iPLEDGE, the new isotretinoin risk management program mandated by the Food and Drug Administration.
Related Concept Videos
01:27Acne Infection
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...