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01-01-2007 | Current Opinion

Can We Ensure the Safe Use of Known Human Teratogens?

The iPLEDGE™ Test Case

Authors: Dr Margaret A. Honein, Jill A. Lindstrom, Sandra L. Kweder

Published in: Drug Safety | Issue 1/2007

Abstract

Minimising the public health burden of isotretinoin-induced teratogenicity has been a challenge for 24 years, the duration of availability of isotretinoin in the US for the treatment of severe, recalcitrant nodular acne. Although the teratogenicity of this drug is well known and risk-management programmes had been implemented, preventable fetal exposures continued to occur, largely as a result of the lack of sufficient controls within the programmes themselves. The manufacturers of isotretinoin implemented a new risk-management programme, iPLEDGE™, in March 2006. iPLEDGE™ is a comprehensive distribution system that includes mandatory registration of patients, healthcare providers, pharmacies, and wholesalers. It allows real-time linkage of pregnancy-test results for verification prior to the dispensing of isotretinoin. Although the challenges of implementing a closed distribution system for a very widely used medication have been extensive, the potential public health benefits from preventing fetal exposure to isotretinoin are substantial.

SMART™: System to Manage Accutane-Related Teratogenicity® (Roche); SPIRIT™: System to Prevent Isotretinoin-Related Issues of Teratogenicity (Mylan); IMPART™: Isotretinoin Medication Programme: Alerting you to the Risks of Teratogenicity (Ranbaxy); ALERT™: Adverse Event Learning and Education Regarding Teratogenicity (Barr).

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Title: Can We Ensure the Safe Use of Known Human Teratogens?
The iPLEDGE™ Test Case
Authors: Dr Margaret A. Honein
Jill A. Lindstrom
Sandra L. Kweder
Publication date: 01-01-2007
Publisher: Springer International Publishing
Published in: Drug Safety / Issue 1/2007
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI: https://doi.org/10.2165/00002018-200730010-00002

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Can We Ensure the Safe Use of Known Human Teratogens?

The iPLEDGE™ Test Case

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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