2007 Sustainability Report - Baxter Sustainability Report

Quality and SafetyBaxter's reputation is built on the quality of its products. Baxter's quality systems applyacross the product life cycle, including design, development, manufacturing, sterilization,labeling, packaging, handling, distribution and promotion. If Baxter identifies a quality orsafety issue with one of its products, it investigates and takes appropriate corrective action,such as notifying customers, correcting the problem, and/or withdrawing the productfrom the market.See more information, including Case Study: Reducing Medication Error through New DrugSafety Packaging for High Alert Medications, in the full report online.Q&A WITH PETER ARDUINI HEPARIN CONTAMINATIONIn early January 2008, doctors inBaxter’s pharmacovigilance group,who routinely monitor safetyinformation related to Baxter products,detected an unusual increase inallergic-type reactions in the UnitedStates associated with heparinsodium injection, a commonly usedanticoagulant (blood thinner). Baxtersubsequently recalled all of its U.S.heparin vial products and identifieda contaminant. Following the highlypublicized recall, more than a dozenother companies in nearly a dozencountries reported similar heparincontamination issues.Peter J. ArduiniCorporate Vice President and President ofBaxter's Medication Delivery BusinessWhat happened with Baxter’s heparin?It appears that a deliberate and sophisticated product tampering took place on a globalscale. A contaminant was added to heparin in the raw material stage, long before it reachedBaxter or its supplier. That contaminant is linked with allergic-type reactions, includingpotentially dangerous drops in blood pressure. Patient safety is our number one priority, andwe deeply regret the impact this has had on patients.How did this happen?We’re still not sure. We think it may have been motivated by money—substituting cheaperingredients into the heparin active pharmaceutical ingredient raw materials that mimicthe real thing. This was a fairly sophisticated endeavor because the contaminant was virtuallyidentical to heparin, was designed to evade sophisticated quality tests and to be virtuallyindistinguishable from the real drug.What is Baxter doing about it?Baxter saw the issue first, recalled our product, identified the contaminant and developedthe tests that are now in use worldwide to screen for the contaminant. We believe that ouractions have helped to avert an even broader and more serious worldwide crisis.How will Baxter make sure a situation like this doesn’t happen again?We are working with government and industry to analyze and improve upon the currentsystem of heparin production. A fundamental issue is the need for visibility deeper intoour supply chain to allow us to better predict emerging risks of the type that occurred here.Also, Baxter has formed a new Threat Analysis Team. The team of scientists will reviewour entire product portfolio and strive to "think like the bad guys," those who wouldcontaminate or sabotage a product, and determine how to best protect the company andour customers against those threats.In the meantime, we will not sell another vial of heparin until we have helped to create asystem in which quality and safety are secured. And that system must include all steps ofthe manufacturing process, in all countries around the world. Baxter plans to be an integralpart of creating new processes and strengthened regulation that helps secure all heparin,regardless of country of origin or manufacturer.For more information on the Baxter heparin recall, including a detailed timeline of related events,Congressional testimony from Baxter CEO Bob Parkinson, and video of Parkinson addressing Baxteremployees about heparin, visit www.baxter.com.22 BAXTER 2007 sustainability report | Product Responsibility