2007 Sustainability Report - Baxter Sustainability Report

More documents

Recommendations

Info

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
R&D and DesignSustainability PriorityBaxter will driveenhanced productstewardshipSee page 5 for a summary ofBaxter's sustainability prioritiesProduct Sustainability Review (PSR) — PSR is a two-step assessment of theenvironmental, health and safety, and other sustainability-related impacts of a productthroughout its life cycle. The assessment occurs during the early stages of the productdevelopment process. An initial screen reveals high-level sustainability risks andopportunities at the product development concept phase. A comprehensive review thenidentifies improvement opportunities across the life cycle.Beginning in 2005, Baxter has evaluated all new medical devices (ranging from intravenoussolution containers to kidney dialysis machines) reaching the concept stage of developmentusing PSR, and currently has more than 10 devices under review.Bioethics—At Baxter, bioethics issues range from animal welfare and clinical trials togenetically modified organisms. The company revised its Bioethics Policy in 2005 to reflecttechnology advancements, regulatory changes and the latest standards, using input froma geographically and functionally diverse team to ensure a broad perspective.Clinical Trials—Clinical trials play an essential role in the development of new medicalproducts and are a required part of the research process for many Baxter products. Baxterprotects the safety, privacy and dignity of clinical trial participants, as well as the integrity ofdata obtained from these studies.In 2006, Baxter adopted a new Clinical Trials policy. It defines the minimum requirementsfor clinical trials, studies and investigations involving human subjects that are sponsoredby Baxter (including but not limited to businesses, regions and functions), that useinvestigational and/or marketed medicinal products and/or medical devices. The policyapplies to all Baxter-sponsored studies worldwide.Read more about R&D and Design, including the topics described above and animal welfare,in the full report online.Materials UseBaxter carefully considers the potential environmental impacts of materials used in itsproducts and packaging. The company focuses both on the amount and the types ofmaterials used, aiming to eliminate hazardous substances wherever possible and maximizeproduct reuse, recycling and service life.Effectively tracking the materials and chemical substances used in products andmanufacturing is complex since a product may contain thousands of components fromhundreds of suppliers worldwide. To better meet this challenge, Baxter is developing anew product stewardship database to manage environmental and other informationrelated to all new products.See more information, including a timeline of Baxter Breakthrough Materials Innovations andCase Study: Materials Restrictions in the full report online.23 sustainability.baxter.com/product_responsibility
Page 1 and 2: 2007SustainabilityReportsustainabil
Page 3 and 4: Company ProfileMore online:sustaina
Page 5 and 6: “When you’re in abusiness like
Page 7 and 8: BAXTER SUSTAINABILITY PRIORITIES AN
Page 10 and 11: 8BAXTER 2007 sustainability report
Page 12 and 13: Talent ManagementTo ensure the sust
Page 14 and 15: Global InclusionSustainability Prio
Page 18 and 19: EHS 2007 Year in ReviewENVIRONMENTA
Page 20 and 21: EHS AuditsDuring an EHS audit, audi
Page 22 and 23: ProductResponsibility20BAXTER 2007
Page 26 and 27: Q&A with norbert riedel R&D at Baxt
Page 30 and 31: Supplier DiversityBaxter tries to d
Page 34 and 35: Access to HealthcareSustainability
Page 36 and 37: ight Baxter employees Kathy Wang an
Page 38 and 39: Economic ImpactsMore online:sustain
Page 40 and 41: Public PolicyMore online:sustainabi
Page 42 and 43: Summary Data TablePlease see releva
Page 44: Baxter International Inc.One Baxter

2007 Sustainability Report - Baxter Sustainability Report

Create successful ePaper yourself

Delete template?

Save as template?