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Volume XXVI , Number 1                                                             Winter 2001/2002


A PRESCRIPTION FOR ACCUTANE ~ Can I fill it?

by Steve Morse, R.Ph.
Director of Professional Services

The Food and Drug Administration (FDA) recently announced significant changes to the Accutane risk management program for pregnancy prevention. The new program, called S.M.A.R.T.™ (System to Manage Accutane Related Teratogenicity), was developed by Accutane’s manufacturer, Hoffman-LaRoche, Inc., in consultation with FDA. The program is designed to enhance the safe and appropriate use of Accutane.

Practitioner’s wishing to prescribe Accutane must document their knowledge of the measures to minimize fetal exposures to Accutane. Upon receipt of this documentation, the prescriber will receive special yellow self-adhesive Accutane Qualification Stickers from Roche. All prescriptions for Accutane must have the yellow sticker attached beginning April 10, 2002. This sticker indicates to the pharmacist that the patient is "qualified" according to the new requirements.


Important Information for Pharmacists

To be in compliance, as of April 10, 2002, pharmacists must:

• Dispense Accutane only to those patients who present an Accutane prescription with a completed yellow Accutane Qualification Sticker attached.

• Refuse to refill without a new prescription containing the yellow Accutane Qualification Sticker.

• Dispense Accutane to patients only if the prescription is presented within seven (7) days of the date of qualification listed on the yellow sticker.

• Dispense Accutane only after receiving a new prescription with a yellow Accutane Qualification Sticker attached.

• Decline telephoned or computerized requests for a new prescription for Accutane.

• Provide a copy of the Accutane Medication Guide to all patients with each prescription.

 

FAQs

• Can I refill a prescription for Accutane?

• Can I refill a prescription for Accutance issued before the start date of April 10, 2002?

• Can I fill a prescription for Accutane from a Mexican or Canadian physician?


Answers - No, No, and No.

As of April 10, 2002, pharmacists must receive a new, written prescription with the yellow sticker attached each time a prescription for Accutane is dispensed.

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