Acne Patients, Especially Females, Are Required to Follow Strict Rules

Everyone who takes Accutane or its generic equivalents must comply with the unusually strict requirements of the iPledge program, which federal regulators say are designed to tightly control use of the drug and prevent pill-sharing.

All users must take blood tests that measure liver function and cholesterol levels -- the drug can disrupt both -- sign consent forms and read a lengthy booklet. They must pick up pills -- the maximum supply is for 30 days -- and schedule monthly doctor's appointments at precise intervals.

The most exacting rules apply to "FCBPs" -- females of childbearing potential, which include girls as young as 11. Here are some steps they must take:

Before the first dose :

· Start using two forms of program-approved contraception 30 days before the first dose, or state in writing that they will be continuously abstinent during the course of treatment and for 30 days afterward.

· Have two negative pregnancy tests, one of which must be performed in an approved lab.

· Take an iPledge quiz about contraception, birth defects and use of the drug.

Monthly during treatment:

· Use both forms of birth control together without fail.

· Have a pregnancy test in an approved lab.

· Take a quiz about what to do if contraception fails.

After the last dose:

· Use both forms of contraception for a month, because the drug remains in the bloodstream.

· Take another quiz.

· Undergo a final pregnancy test after the last dose and again 30 days later.

-- Sandra G. Boodman