Mandatory Physician & All Female Patient Isotretinoin Registry
females diagnosed by
the dermatologistsregistered to have severe
recalcitrant nodular acne and are going to be put on isotretinoin
enroll into this algorithm /
2. Childbearing potential and Not of Childbearing potential to be decided by the registered prescriber as per guidelines in the PI.
pregnancy test is done as a screener in the prescriber’s office
and under supervision of a staff member.
If this test is positive, the patient is not eligible for the product.
Consultation and Registration of the female patient occurs
happens at the same visit.
During the consultation the registered dermatologists will walk
the patient through the need for isotretinoin, the risks associated with
treatment and all procedures as outlined in the isotretinoin risk management
program. Both subsets of female population, childbearing and non-childbearing
potential, will be qualified and registered as per their requirements.
information to include specific information to uniquely identify the patient.
information to have basic fields like patient name, address, SS#, doctor’s name
and other specific information to uniquely identify the patient.
Transmission of registration information from registered doctors ’office to the
registry and back.
7. The Registry will be a single registry for all manufacturers. Registry will assign a patient identification number (PIN) which can uniquely identify the patient in all future transactions.
conclusion of the registration and consultation, the patient
(childbearing potential only) is required to get a serum pregnancy
test done. This test
is a confirmatory test and is done on a date derived from the guidelines in the
qualificat The prescriber will enter the re-qualification information into the system.
be sent by the lab to the dermatologists and their offices in turn send it to
the registry.L are
transmitted. 1. Patient
visits the dermatologists with the pregnancy results in place.
11. For Eligible
patients a prescription for 30 days of isotretinoin and a
qualification sticker is affixed to the prescription.
12. Patient takes prescription to pharmacy.
, LOT #, etc…