Monitoring for Pregnancy Exposures and Pregnancy Prevention for Known Human Teratogens

| Home | | Pharmacovigilance |

Chapter: Pharmacovigilance: Drug Safety in Pregnancy

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high-risk terato-gen, has been monitored for many years initially through the Pregnancy Prevention Program, which was superseded in some regions with the expanded S.M.A.R.T. program (System for Management of Accutane Related Teratogenicity).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.

Contact Us, Privacy Policy, Terms and Compliant, DMCA Policy and Compliant

TH 2019 - 2022 pharmacy180.com; Developed by Therithal info.