Isotretinoin: Information for Pharmacy Technicians About Getting Authorization to Dispense

For Isotretinoin, (trade names: Amneesteen, Sotret, Claravis, Accutane, and other names) the prescriber and the patient must register on the iPledge website.

This medication is used to treat severe acne, including acne that causes deep cysts and nodules, both of which can be quite painful.

Isotretinoin is known to cause:

  • Stillbirth,
  • Miscarriage
  • Serious Birth Defects, ("Isotretinoin: Overview", 2020)

when a female who is taking the drug becomes pregnant.  In order to prevent these unacceptable birth defects, it is required for women who are of childbearing age to take and receive two negative pregnancy test results.  Women who decide to start taking Isotretinoin must agree to take monthly pregnancy tests and also use two different types of birth control so as to prevent pregnancy while on the acne medication.  Women who decide to initiate treatment with this medication must also commit to follow up vistis with their prescriber for monitoring.  Taking in to account the serious and dangerous side effect profile (as listed above) the FDA considers Isotretinoin "high risk".  

The iPledge website is part of the Food and Drug Administration (FDA) of the United States government.  ("iPledge REMS", 2020).

Once the pharmacy technician or pharmacist has been presented with a prescription for Isotretinoin, he or she must go to the iPledge website and get permission to dispense the drug from the iPledge REMS (Risk Evaluation and Mitigation Strategies) Program.

According to Wikipedia, "As of 2018, there are 74 medications subject to REMS monitoring. 62% of these include "elements to assure safe use". These typically require clinicians or health care institutions to become certified prior to prescribing." ("Risk Evaluation and Mitigation Strategies", 2020).

The prescriber and the patient must have already registered on the website in order for the pharmacy to be given authorization from the FDA to dispense it.

Once the pharmacy has received authorization to fill the medication from the iPledge website, the prescription can be filled.

However, the patient has only 7 days from the date the prescription was given to the pharmacy to pick up the medication from the pharmacy.

Once you get the authorization for fill a prescription on, if you forget to write down the authorization number on the prescription, all is not lost.

You can call iPledge at the phone number on their website and speak with a iPledge representative. They will be happy to assist you and have that information.

You can also call them if you have entered an incorrect days supply or quantity.

If you have entered incorrect information and realize it, you may have to reverse the authorization.

You will need to enter the risk management number on the website and then you can go back and get authorized again, this time with a new authorization number.

Be sure to enter the correct information this time!


iPledge REMS. (2020). Retrieved 19 October 2020, from

Isotretinoin: Overview. (2020). Retrieved 19 October 2020, from

Risk Evaluation and Mitigation Strategies. (2020). Retrieved 19 October 2020, from

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