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In an attempt to prevent birth defects, Hoffmann-La Roche and the Food and Drug Administration are phasing in an enhanced version of the drug company's Pregnancy Prevention Program for Women on Accutane to more than 375,000 dermatologists, primary care prescribes and pharmacists in the United States.
After April 10, pharmacists will be allowed only to fill Accutane (isotretinoin) prescriptions with a yellow sticker on them, an indication from the woman's doctor that she is not pregnant. The program is called System to Manage Accutane Related Teratogenicity, or SMART.
Each month, female patients must have a negative pregnancy test and receive contraception counseling from the prescriber before receiving a new Accutane prescription. If the patient meets these qualifications or is male, the prescriber can write a prescription for a one-month supply of Accutane, affix one of the yellow Accutane Qualification Stickers and date it. Prescriptions must be filled within seven days of the qualification date on the sticker.
COPYRIGHT 2002 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2002 Gale Group
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