The SMART (System to Manage Accutane Related Teratogenicity) Program of Roche Pharmaceuticals for Isotretinoin

 

Contraindications for Accutane therapy in a woman of childbearing potential:

(1) pregnant (must not become pregnant for 1 month after taking the drug)

(2) breast feeding (must not breast feed for 1 month after taking the drug)

 

Requirements for women of childbearing potential:

(1) must comply with mandatory contraceptive measures, using at least 2 forms of effective contraception simultaneously, with at least 1 a primary form (combination oral contraceptive pills, injectable or implantable hormone, IUD, tubal ligation, vasectomy in male partner). The only exceptions are if the woman has had a hysterectomy or if she practices absolute avoidance of genital-to-genital sexual contact with a male partner.

(2) must understand and carry out instructions

(3) must have 2 negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial prescription. The first test is performed during the initial enrollment evaluation, and the second is performed during the first 5 days of the menstrual period immediately before beginning Accutane therapy.

 

Additional recommendations for female contraception:

(1) If a combined hormonal contraceptive is used as the primary contraceptive method, then St. John's Wort should be avoided since this may interfere with contraceptive effectiveness.

(2) If a combined hormonal contraceptive is used as the primary contraceptive method, then any drug that increases the metabolism of the hormones should be avoided.

(3) Oral contraceptives containing progestin-only ("minipills") should not be used.

 

There have been no documented cases of isotretinoin embryopathy occurring when the father was being treated with isotretinoin and the mother was not.

 

Requirements for anyone receiving the drug:

(1) must not donate blood while taking the drug or for 1 month after stopping therapy

(2) must not share the drug with anyone else

(3) avoid vitamin A supplements

(4) must report any mood disorders suggesting major depression

 

Each patient (male or female) receiving Accutane must present a written prescription with a yellow qualification sticker afixed before the pharmacist can dispense the drug. This is given by the prescribing physician and indicates that:

(1) the person is aware of alternative means of treating acne

(2) the patient is aware of the risks for fetal injury if taken during pregnancy

(3) the patient has received monthly pregnancy avoidance counseling (if female)

(4) the person agrees to avoid pregnancy by using effective contraception (if female)

(5) the person has had a negative pregnancy test (if female)

(6) the patient has signed the consent form.

 

The pharmacist may fill a prescription for Accutane:

(1) Only sufficient drug is prescribed for one month of therapy.

(2) The patient presents a new qualification sticker every month.

(3) The prescription must have been written within the previous 7 days.

(4) No refills are permitted. Each month a new prescription with a yellow qualification sticker must be presented.

(5) No telephone or computerized prescriptions are permitted.

(6) The patient receives an Accutane medication guide with each prescription.