iPLEDGE Requirements for Female Patients

The iPLEDGE program restricts access to isotretinoin because the use of this medication during pregnancy can lead to severe birth defects. iPLEDGE is a Food and Drug Administration approved computer-based risk management program designed to ensure that:

  • No female patient starts isotretinoin therapy if pregnant
  • No female patient on isotretinoin therapy becomes pregnant

The program is designed to ensure that all female patients have a negative pregnancy test each month prior to receiving isotretinoin. This is accomplished by creating a verifiable link via the iPLEDGE website between each negative pregnancy test and the dispensing of the prescription.

  • It is iPLEDGE that makes the rules – not our practice and not your pharmacy
  • It is iPLEDGE that enforces the qualification criteria and monthly program requirements – not our practice and not your pharmacy
  • iPLEDGE will NOT change a requirement or extend a deadline under ANY circumstances, there are NO EXCEPTIONS

If our practice does not comply with iPLEDGE requirements, we risk permanent deactivation from the program, and once any practice is deactivated, iPLEDGE will not reactivate you. We do not want to lose the authority to prescribe this very valuable medication and there is nothing we can say to iPLEDGE in a phone or call or online to change a rule or requirement. PLEASE DO NOT ASK US TO DO SO.

We offer the following summary of key requirements to you to hopefully help you more easily understand and comply with iPLEDGE requirement. All of what follows can be found in the yellow iPLEDGE manual that was given to you that contained the enrollment forms (you cannot start isotretinoin without the manual).

PLEASE THOROUGHLY READ THE iPLEDGE MANUAL THAT YOU WERE GIVEN AND UTILIZE IT AS A REFERENCE WHILE TAKING ISOTRETINOIN. THE MANUAL IS ALSO AVAILABLE ON THE INTERNET AT: www.ipledgeprogram.com. IF YOU CALL WITH QUESTIONS REGARDING THE FOLLOWING REQUIREMENTS, YOU WILL BE REFERRED BACK TO THE MANUAL AND THIS DOCUMENT.

    1. GO TO A LAB THAT PARTICIPATES WITH YOUR HEALTH INSURANCE TO GET YOUR INITIAL FASTING BLOOD WORK, INCLUDING THE FIRST NEGATIVE PREGNANCY TEST.
    2. IF YOU HAVE NOT RECEIVED A PHONE CALL FROM THE OFFICE IN THE FOLLOWING 48 HOURS, CALL THE OFFICE DURING REGULAR BUSINESS HOURS MONDAY – FRIDAY SO YOU CAN BE REGISTERED IN THE iPLEDGE SYSTEM. LET US KNOW AT WHICH LAB YOU HAD BLOOD WORK DRAWN. YOU SHOULD RECEIVE A USERNAME/PASSWORD IN USPS MAIL FROM iPLEDGE IN THE NEXT 5-10 DAYS.
    3. NO SOONER THAN 30 DAYS FROM THE DATE YOU ARE REGISTERED BY OUR OFFICE, GO TO THE SAME LAB FOR YOUR 2ND PREGNANCY TEST (2ND NEGATIVE PREGNANCY TEST). THE DATE THAT YOU ARE REGISTERED IN iPLEDGE IS NOT THE DATE THAT YOU HAD YOUR LABS DRAWN. IT IS THE DATE THAT YOU RECEIVED THE PHONE CALL FROM OUR OFFICE STATING THAT YOU WERE REGISTERED. YOU CAN LOG INTO THE iPLEDGE WEBSITE TO ACCESS DUE DATES FOR BLOOD WORK IN THE CALENDAR AT ANY TIME.
    4. IF YOU HAVE NOT RECEIVED A PHONE CALL FROM THE OFFICE IN THE FOLLOWING 48 HOURS, CALL THE OFFICE DURING REGULAR BUSINESS HOURS MONDAY – FRIDAY TO BE CONFIRMED IN iPLEDGE.
    5. IF ALL BLOOD WORK IS WITHIN NORMAL LIMITS, A PRESCRIPTION CAN BE CALLED INTO YOUR PHARMACY AND A 1 MONTH FOLLOW UP APPOINTMENT WILL BE SCHEDULED.
    6. PRIOR TO EACH SUBSEQUENT MONTHLY VISIT, YOU MUST RETURN TO THE LAB FOR BLOOD WORK, IDEALLY 24-48 HOURS PRIOR TO SEEING ONE OF OUR DOCTORS.
    7. THE DAY THAT YOU GET YOUR BLOOD WORK DRAWN EACH MONTH COUNTS AS DAY 1 OF YOUR 7 DAY WINDOW. IF YOU HAVE NOT SEEN YOUR DOCTOR, LOG INTO YOUR iPLEDGE ACCOUNT TO ANSWER YOUR QUESTIONS. IF YOU HAVE NOT PICKED UP YOUR PRESCRIPTION AT THE PHARMACY BY DAY 7, YOU WILL HAVE TO REPEAT YOUR BLOOD WORK FOR A NEGATIVE PREGNANCY TEST IN ORDER TO RECEIVE YOUR PRESCRIPTION.
    8. EACH MONTH YOU WILL HAVE TO REPEAT: 
      •BLOOD WORK
      •OFFICE VISIT WITH ONE OF OUR DOCTORS
      •LOG INTO iPLEDGE ACCOUNT AND ANSWER QUESTIONS
      •PICK UP PRESCRIPTION FROM PHARMACY.

      ALL OF THESE TASKS MUST BE COMPLETED WITHIN THE 7 DAY WINDOW OR YOUR BLOOD WORK WILL BE CONSIDERED INVALID AND YOU WILL BE REQUIRED TO REPEAT YOUR BLOOD WORK. KEEP IN MIND THAT ISOTRETINOIN IS NOT COMMONLY STOCKED AT ALL LOCAL PHARMACIES. IT OFTEN HAS TO BE ORDERED. DO NOT WAIT UNTIL DAY 6 OR DAY 7 TO FILL YOUR PRESCRIPTION.
    9. SCHEDULE YOUR BLOOD WORK AND DOCTOR VISITS APPROPRIATELY. ACCORDING TO THE iPLEDGE MANUAL, FEMALE PATIENTS SHOULD IDEALLY GET LABS CHECKED ON THE 3RD DAY OF THE MENSTRUAL PERIOD EACH MONTH. AS THIS IS INCONVENIENT FOR SOME PATIENTS WHO WISH TO START ISOTRETINOIN ASAP, FEMALES CAN SCHEDULE BLOOD WORK NO SOONER THAN 28 FULL DAYS FROM THE LAST NEGATIVE PREGNANCY TEST BUT NO LATER THAN 35 DAYS FROM THAT DATE EACH MONTH.