For well-recognized potent human teratogens, pharmacovigilance efforts may also encompass the monitoring of unintended pregnancy exposures to evaluate and inform methods for improving pregnancy prevention.
MONITORING FOR PREGNANCY
EXPOSURES AND PREGNANCY PREVENTION FOR KNOWN HUMAN TERATOGENS
For
well-recognized potent human teratogens,
pharmacovigilance efforts may also encompass the monitoring of unintended
pregnancy exposures to evaluate and inform methods for improving pregnancy
prevention. An example of one such effort is the S.T.E.P.S. program (System for
Thalido-mide Education and Prescription Safety), which is intended to prevent
pregnancy exposures to thalido-mide (http://www.celgene.com/). Using a
comprehen-sive system of drug dispensing through registered clinicians and
through registered pharmacies as well as careful education and monitoring of
women who are treated with thalidomide and have the potential to become
pregnant, this program has to some extent allowed a known high-risk teratogen
to be marketed in the United States for the first time.
Similarly,
isotretinoin, another high-risk terato-gen, has been monitored for many years
initially through the Pregnancy Prevention Program, which was superseded in
some regions with the expanded S.M.A.R.T. program (System for Management of
Accutane Related Teratogenicity). As of March 2006, in the United States, this
effort has been increased to a level in many respects comparable with the
thalido-mide prevention program. The new iPLEDGE risk-management program is
aimed at preventing the use of isotretinoin during pregnancy. To obtain the
drug, in addition to registering with iPLEDGE, patients must comply with many
key requirements that include completing an informed consent form, obtaining
coun-seling about the risks and requirements for safe use of the drug and, for
women of childbearing age, comply-ing with necessary pregnancy testing and
birth control methods (https://www.ipledgeprogram.com/). As part of iPLEDGE,
pharmacovigilance for pregnancies that may occur despite the enhanced
prevention program will contribute to the evaluation and improvement of these
efforts to maintain access to the drug while preventing these high-risk
exposures.
Related Topics
TH 2019 - 2024 pharmacy180.com; Developed by Therithal info.