FDA Plans to Strengthen Monitoring of Accutane. Part 2

Under the new restrictions, manufacturers of isotretinoin will be
required to keep grounds of not only physicians who prescribe the drug,
but also the pharmacies that dispense the drug and the patients who use
it.

In accession to registering in a central database, the regulations
require affidavit of the people before a patient’s low black and white
is filled: Ending of case pedagogy on the potential difference risks of
the drug by the prescribing physician.
Cogent evidence of a recent film pregnancy test before dispensing the
drug.
Completed informed consent, educational activity, and risk
establishment selective information by the participant role.

For
subsequent refills, substantiation of monthly case educational
activity, repeat denial pregnancy tests, and ongoing risk direction
will also be required.

The new risk minimization proceeding
plan (RiskMAP) for isotretinoin calls for the drug’s manufacturers to:
Establish and maintain the database.
Varan sales of the drug exterior approved channels, such as on the
Internet.
Develop procedures to reminder and evaluate RiskMAP conformity.Evaluate
the potency of the software system in reduction influence to the drug
during pregnancy.

This is a part of article FDA Plans to Strengthen Monitoring of Accutane. Part 2 Taken from "Acne Isotretinoin Accutane" Information Blog