Start with a healthcare professional
Accutane is the former brand name commonly used for oral isotretinoin. The FDA describes isotretinoin as a prescription medicine for severe recalcitrant nodular acne. The iPLEDGE fact sheet narrows that use to severe nodular acne that cannot be cleared by other acne treatments, including antibiotics.
A healthcare professional can discuss whether isotretinoin fits the situation. That conversation may lead to another plan, so an appointment does not guarantee a prescription.
Prescriber, patient, and pharmacy enrollment is required
Oral isotretinoin is available through the restricted-distribution iPLEDGE REMS because it is highly teratogenic and can cause severe birth defects. The program is intended to mitigate embryo-fetal risk.
The iPLEDGE fact sheet says isotretinoin can be prescribed only by an enrolled healthcare provider, dispensed only by an enrolled pharmacy, and given only to an enrolled patient who agrees to do everything required in the program. It further specifies that only enrolled and activated prescribers can prescribe and only an activated pharmacy that is enrolled can dispense.
What enrollment includes
The fact sheet describes a discussion with the doctor about isotretinoin and iPLEDGE, review of educational materials, and enrollment by the prescriber after all REMS requirements are met. The patient verifies understanding by signing the required consent or consents during enrollment.
The same source says all patients are enrolled by their prescriber and agree to follow the requirements. These are enrollment requirements, not a promise that any individual will receive a prescription.
Enrollment is a requirement, not a prescription decision
Participation by an enrolled prescriber, enrolled patient, and enrolled pharmacy is required when isotretinoin is prescribed in the U.S. The patient agrees to follow iPLEDGE requirements during enrollment.
Enrollment organizes access to this restricted-distribution medicine and helps manage embryo-fetal risk. It does not mean isotretinoin is appropriate for every person, and it does not guarantee that a clinician will prescribe it.
Frequently asked questions
Can any doctor prescribe Accutane?
No. In the U.S., only an enrolled and activated iPLEDGE prescriber can prescribe oral isotretinoin.
Can a regular pharmacy fill an isotretinoin prescription?
No. Only an enrolled and activated iPLEDGE pharmacy can dispense it.
Does an Accutane consultation guarantee a prescription?
No. An appointment does not guarantee that isotretinoin will be prescribed.
What happens during iPLEDGE enrollment?
You discuss isotretinoin and iPLEDGE, review educational materials, meet the applicable REMS requirements, verify understanding, and sign the required consent or consents before the prescriber enrolls you.
Sources
- Isotretinoin Capsule InformationU.S. Food and Drug Administration
- The iPLEDGE REMS Fact SheetiPLEDGE REMS