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An Alternative Solution for the iPledge Program

Arch Dermatol. 2006;142:1055-1057.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Drug safety questions in the US pharmaceutical industry¹ have forced the Food and Drug Administration (FDA) to add isotretinoin to a mandatory risk management program and registry to minimize fetal exposure.² Justifiable regulations to minimize the teratogenic risk have been proposed in the iPledge program³ administered by Covance and the isotretinoin manufacturers. The American Academy of Dermatology⁴ has stated that the iPledge program is seriously flawed for real world application. An iPledge program needs to be developed that allows an efficient, economical solution for patient, physician, laboratory, and pharmacy participation without obtrusive, time consuming paperwork and administrative regulation.

The problem with the current system results from an inefficient reporting mechanism for adverse events of prescription drugs. Critical historical information is lost. Only 1% to 10% of estimated adverse events are reported, and most reports are fragmentary and lack key data. Physicians must take valuable time to capture, assemble, and report . . . [Full Text of this Article]

AUTHOR INFORMATION
Algie C. Brown, MD

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ABSTRACT | FULL TEXT