Accutane

iPledge™ Program

All physicians that prescribe Accutane® to their patients are required by law to participate in the iPledge™ Program. Effective March 2006, the United States Food and Drug Administration has instituted, with the mandated cooperation of the Accutane® manufacturers, the iPledge™ Program. This is an enhanced risk management program designed to minimize fetal exposure to Accutane®.

This program has been implemented to prevent pregnancy among women taking Accutane®. Accutane® (Isotretinoin) can cause serious effects, including birth defects if an unborn baby’s mother takes isotretinoin. The program involves a set of steps that you, your doctor, and your pharmacist must follow for you to take isotretinoin.

Dr. Ulmer’s personal experience with Accutane® consists of well over 4,500 patients without a single patient having any permanent side effects. Occasionally, patients have had to stop this medication due to minor side effects (primarily dry lips, mild joint pains, or headaches). However, with Accutane’s® short half-life, the drug is rapidly eliminated from the body and all of these minor side effects totally resolve in a few days.

Key Information for All Accutane® Patients:

Contact with this office must be made every 30 days
- If this 30 day schedule is not maintained, the iPledge™ registry will drop the patient.
- If the patient is dropped, our office staff has to re-register the patient, with a fee in addition to the regular office visit charges.

It is recommended that the prescription be filled within seven (7) days. If the prescription is not picked up during the first seven (7) days, iPledge™ will allow another prescription to be written under the following conditions:
- Females of child-bearing potential must take another pregnancy test
- Our office will re-confirm the patient’s status in iPledge™ and re-issue a prescription
- Females of child-bearing potential will be required to log onto the website and answer questions again
- All patients will be charged a fee for re-confirmation, and females of child-bearing potential will be charged an additional pregnancy test fee if this situation occurs.

Males and Females of Non-Child-Bearing Potential:

Before You Take Accutane®:

1. You must enroll in the iPledge™ Program

During Accutane® Treatment:

1. You must have monthly counseling that will be documented in your chart.
2. Prescription and iPledge™ ID card must be taken to the pharmacy immediately after leaving the office:

A) If there is any delay due to pharmacy confusion or insurance authorization processes, you risk not being able to receive your medication in a timely manner, resulting in disruption of your treatment.
B) Accutane® prescriptions must be picked up at your pharmacy within seven (7) days of your visit to the office.
C) The seven (7) day period begins the day of your visit and ends at 8:59 pm PST (11:59 pm EST) on the seventh day.

3. If you find that you have extra Accutane® medication at the time of your regularly scheduled 30 day appointment, you still need to come for that visit (iPledge™ requires physician contact every 30 days).

After Stopping Accutane® Treatment:

1. You may not donate blood for a month after stopping Accutane® treatment.

Females of Child-Bearing Potential:

Before You Take Accutane®:

1. You must enroll in the iPledge™ Program
2. You must use 2 separate, effective methods of birth control at the same time for one month before taking Accutane® (even when one is a hormonal contraceptive method, such as birth control pills).
3. You must have negative results for 2 pregnancy tests:

A) A first test will be completed at the time that Accutane® is determined to be the appropriate treatment for you.
B) A second test will be completed during the first 5 days of your menstrual period right before you start your Accutane® therapy or as directed by your physician.

During Accutane® Treatment:

1. You must continue to use 2 separate, effective methods of birth control at the same time – at all times during Accutane® treatment.
2. You must return to the doctor and have a negative pregnancy test each month before a prescription can be filled (for only a one-month supply of Accutane®).
3. You must have monthly pregnancy counseling that will be documented in your chart.
4. You may not donate blood during Accutane® treatment.
5. Only if all of the aforementioned items are completed can an Accutane® prescription be issued. The prescription must be filled within seven (7) calendar days.
6. As soon as possible after leaving the office, you must log on to the iPledge™ website (www.ipledgeprogram.com) and answer questions to demonstrate understanding of the program.

A) It is our recommendation that this be done immediately after leaving the office (The pharmacy will not be able to fill an Accutane® prescription until the questions are answered correctly).
B) Please bring your 4-digit password with you to the office if you need assistance in logging on to the iPledge™ website.

7. As soon as you have answered your questions correctly, take your prescription and your iPledge™ ID card to the pharmacy.

A) Accutane® prescriptions must be picked up at your pharmacy within seven (7) days of your visit to the office.
B) The seven (7) day period begins the day of your visit and ends at 8:59 pm PST (11:59 pm EST) on the seventh day.

After Stopping Accutane® Treatment:

1. You must continue to use 2 separate, effective methods of birth control at the same time for one month after stopping Accutane® treatment because some of the Accutane® may remain in the body for a short period of time after stopping treatment.
2. You may not donate blood for a month after stopping Accutane® treatment.