Quidel (San Diego) and Cholestech (Hayward, California) have joined forces to offer an Accu-Tame program to dermatologists designed to ease the process of prescribing isotretinoin for their patients while helping them comply with iPLEDGE pregnancy testing requirements as well as lipids and liver enzymes as recommended.
The iPLEDGE program is a computer-based risk management program designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA. The program strives to ensure that: no female patient starts isotretinoin therapy if pregnant; and no female patient on isotretinoin therapy becomes pregnant.
While highly effective for severe acne, isotretinoin carries a significant risk of birth defects if taken during pregnancy, according to the FDA. In addition, isotretinoin can raise the level of fats and cholesterol in the blood, and can lead to elevations of liver enzymes.
The kit contains: one box of QuickVue One-Step hCG Urine tests from Quidel, for early detection of pregnancy; one Cholestech LDX System, designed to deliver rapid results for lipids, glucose and liver enzymes; five boxes of lipid profile test cassettes; five boxes of ALT/AST test cassettes (enzymes to monitor the liver); and one box of Multi-Analyte Controls.