Download iPLEDGE is a Go

The United States Food and Drug Administration (FDA) has approved changes to the
iPLEDGE Program. The following changes will be effective in early December 2007.
What are the changes for female patients of childbearing potential?
 Change in the start of the 7-day prescription window for Female Patients of
Childbearing Potential
 Elimination of the 23-day lock-out period for Female Patients of Childbearing
Potential
 The exception is for female patients of childbearing potential who did
not pick up their first prescription; the next CLIA certified pregnancy
test to start the 7 day prescription window over again must be at least
19 days after the CLIA based pregnancy test that started the previous
7 day prescription window.
 If a female patient of childbearing potential has chosen male latex condom as one
of her two required methods of contraception, it can be used with or without
spermicide.
Currently, for female patients of childbearing potential, the start of the 7-day prescription
window is the date of the office visit. Whether a prescription was picked up or not, a
female patient of childbearing potential may not start the qualification process for another
prescription until 23 days after the end of their 7-day prescription window. Also, the
iPLEDGE program currently requires the use of spermicide if a male latex condom is one
the two chosen methods of contraception for female patients of childbearing potential.
What are the changes for female patients not of childbearing potential and male
patients?
 The prescription window for female patients not of childbearing potential and
male patients will be changing from 7 days to 30 days from the date of the office
visit.
How will this change affect prescribing procedures?
The prescribing procedures and qualification criteria for isotretinoin will remain the same
for all patients. The elimination of the 23-day lock-out period will allow all patients
(including female patients of childbearing potential) the ability to have a new prescription
filled after the prescription window has expired. There are generally no restrictions
regarding the timing of office visits. One notable exception is that female patients of
childbearing potential who do not fill and pick up their first month of therapy prescription
in their first 7-day prescription window, must wait at least 19 days from their most recent
pregnancy test until getting their next pregnancy test. This is based on the requirement
that the most recent pregnancy test prior to beginning therapy must be conducted in the
first 5 days of her menstrual cycle. In addition, both the patient and prescriber must
complete the qualification process again to ensure the patient has met all qualification
criteria.
The change for female patients not of childbearing potential and male patients is that the
prescription window will be for 30 days from the office visit. The start of the
prescription window for male and female patients not of childbearing potential continues
to be the date of the office visit.
What are the actions required for Female Patients of Childbearing Potential after
this change?
Follow these steps to start the qualification process for the next 7-day prescription
window
1. The patient starts the qualification process by getting a pregnancy test. The date
of the specimen collection will be the start of the 7-day prescription window.
2. The prescriber confirms patient counseling and enters pregnancy results into the
iPLEDGE system as one step by selecting the option to Confirm Patient
Counseling. You must have the pregnancy test results before you can confirm
patient counseling in the system.
3. The patient must answer her comprehension questions in the iPLEDGE system.
This can not be done until you confirm patient counseling and enter the pregnancy
results.
Are there specific actions needed for Female Patients of Childbearing Potential who
are in a 7-day prescription window when this change was made?
Yes, however, the specific action that is needed for a patient depends on what action has
already been completed.

For patients that have been confirmed in the iPLEDGE system but do not
have pregnancy test results entered in the iPLEDGE system.
1. The prescriber obtains pregnancy test results for patient.
2. The prescriber enters pregnancy results into the iPLEDGE system.
This requires you to confirm patient counseling again and enter
pregnancy results into the iPLEDGE system as one step by
selecting the option to Confirm Patient Counseling.
3. If the patient has already answered her monthly comprehension
questions, she will be “Qualified to Receive Drug”, otherwise she
must still answer her questions in order to become “Qualified to
Receive Drug”.

Patients that have been confirmed in the iPLEDGE system and have
pregnancy test results entered into the iPLEDGE system require no action
by the prescriber for this prescription.
How will this change affect prescription authorization procedures?
Pharmacists must continue to authorize every isotretinoin prescription using the
iPLEDGE system. No other action is required.
Are there additional program enhancements?
There are additional program enhancements that impact all prescribers and patients.
 Web Navigation Updates
 Step by step patient registration
 Removal of the HIPPA checkbox from patient registration
 Password message upon registration completion
 One step to confirm counseling and enter pregnancy result for female
patients of childbearing potential
 Manage Patients screen easier to use
 More information provided at completion of actions
 Enhance Display of Patient Data, Key Dates, Patient Status, etc.
 Patient Status screen shows critical information for female patients of
childbearing potential:
– Current Patient Status
– Progress in current 7-day prescription window
– 7-day prescription window expiration
– Next step(s)
– Previous prescriptions filled
– Allowable start date for next prescription
– Direct links to required actions directly from Patient Status screen
Using the Patient Status screen, you can determine if your patient filled the
previous prescription. A missing prescription fill when you know the patient
filled the prescription indicates a non-compliant pharmacy. Please call 866-4950654 to assist iPLEDGE in addressing the non-compliant pharmacy.
 Enhanced Prescription Denial Messages
 A new Action Required List
 This is a reminder list of specific actions that are required for your
patients, but have not occurred in iPLEDGE. For example, the system
will remind you to obtain post therapy pregnancy tests for patient that
have completed therapy but are missing their pregnancy test results.
 If you have required actions, this list will be presented to you after you log
in.
The iPLEDGE system will now provide more informative messages to the pharmacist
and prescriber when a prescription authorization is denied, such as Patient needs to
answer her comprehension questions in the iPLEDGE system.
How Can I Prepare For These Changes?
If you are registered with the iPLEDGE program, watch your mailbox in late November
for more information from the iPLEDGE program about these changes and for new
versions of the iPLEDGE educational materials. These materials will replace your
existing materials.
Go to the iPLEDGE website, www.iPLEDGEprogram.com in late November to see the
notification box containing a link to the “What’s New” document detailing these changes
or to read the updated Frequently Asked Questions (FAQs).
If you are not registered in the iPLEDGE program or if you are registered and you need
to activate your registration, visit the program website at www.ipledgeprogram.com or
call the automated phone system at 1-866-495-0654.
You should also refresh your knowledge of the iPLEDGE program requirements for
prescribers by reviewing the package insert.