With Special Packaging, Sagent Gets FDA Approval For Heparin Products

Posted on 6th July 2010 by gjohnson in Uncategorized

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In a much publicized case, actor Dennis Quaid’s newborn twins were accidentally given heparin overdoses in 2007. He blames the packaging of the drug for the mishap, with 10,000 unit and 10 unit heparin vials looking so similar that nurses confused them.

Well, a heparin manufacturer has addressed that issue, and Tuesday asserted that its special labeling — with different colors for each strength of heparin – helped it to win Food and Drug Administration approval for nine of its heparin products.
http://www.fiercepharmamanufacturing.com/story/packaging-contributes-approvals-sagents-heparin/2010-07-06

Sagent said it will launch its new heparin products, the heparin sodium injection USP, immediately. In 2009 U.S. sales of heparin were about 306 million.
http://www.pharmabiz.com/article/detnews.asp?articleid=56257&sectionid=

“Attaining FDA approval of Sagent’s heparin vials is a major accomplishment for our company,” CEO Jeffrey Yordon said in a prepared statement. “Amidst the many challenges the nation’s supply of heparin has recently faced, Sagent identified and readied a reliable source for heparin and successfully navigated the FDA approval process for each of our heparin presentations. We believe that our innovative approach to the packaging and labelling of our heparin provides us with a significant advantage in the market by better meeting the requirements of patients and customers, positioning us for a successful launch.”

Sagent’s has proprietary PreventIV Measures packaging and labeling, which aids users in distinguishing between the nine presentations. Sagent’s packaging and labeling for heparin include using of a unique colour for each total strength; easy-to-read drug name, concentration and fill volumes; and cartons printed on all sides.

PreventIV Measures is Sagent’s name for what it calls its user-driven and patient-centered approach to product labeling and packaging, which considers everyone handling medication along the way in order to help prevent medication errors.

“The pace of hospital care is faster than it has ever been, requiring increased vigilance to reduce treatment errors,” Elaine Levy, system director for Pharmacy Sharp HealthCare in San Diego, California, said in a prepared statement.

“Sagent’s PreventIV Measures approach to packaging and labeling design makes it easier to differentiate drugs from others in the same class, even when the medications look or sound alike,” she said. “Further, it makes it easier to distinguish between doses, which is especially important when working with medications like heparin that have a number of concentrations and sizes. I believe that features such as those incorporated into Sagent’s products can help reduce those errors caused by selecting the incorrect medication for a patient.”

PreventIV Measures is Sagent’s comprehensive, user-driven and patient-centred approach to product labelling and packaging that is designed to help prevent medication errors. It incorporates unique label and carton designs, cap and label colours, bar coding and other features that are designed to make it easier to differentiate drugs and identify the correct dose.