Isotretinoin Safety & Risk Management Act of 2004 iPLEDGE

Posted on 01.14.2016

Let’s continue our review of Pharmacy Law as it relates to restricted drugs.  As a Pharmacy Technician, you will needs to know the requirements for dispensing these. Today’s focus under the Isotretinoin Safety and Risk Management Act of 2004/iPLEDGE is Accutane.

Accutane (isotretinoin) is a very effective and powerful medication to treat acne. It also has some very bad side effects, including inducing spontaneous abortion and producing adverse psychiatric affects. The act made it mandatory that all patients, practitioners, and pharmacists are registered and educated as to the side effects. The act also initiated a management program called iPLEDGE. This requires that:

  • Wholesalers distributing isotretinoin, all healthcare professionals prescribing it, all pharmacies dispensing it, and all male and female patients prescribed it, must register with the program.
  • All patients must meet qualification criteria and monthly program requirements.
  • The prescriber must counsel the patient and document in the iPLEDGE system that the patient has been counseled about the risks of isotretinoin.
  • Females of childbearing potential must select and commit to use two forms of effective contraception simultaneously for one month before, during, and for one month after isotretinoin therapy.
  • Females of childbearing potential must have two negative pregnancy tests prior to starting therapy.
  • That for each month of therapy, each female patient must have a negative result from a pregnancy test conducted by a CLIA-certified laboratory prior to receiving each prescription.
  • The prescriber must enter the female patient’s pregnancy results and two forms of contraception she has been using in the iPLEDGE system.
  • The pharmacist/pharmacy technician must obtain authorization from the iPLEDGE system via the program website or phone system prior to dispensing each isotretinoin prescription for both males and female patients.
  • Isotretinoin must be dispensed in the manufacturer packaging.

There are other drugs that, while not covered under this specific act, also fall under the category of restricted drugs. We will discuss those next time.

To learn more about this act, visit: