Safety

Patient safety is at the core of everything Baxter does. The company was founded in 1931 on its ability to produce safe intravenous (IV) solutions for hospitals at a time when IV therapy was considered a last resort. Most hospitals were not equipped to prepare their own IV solutions, and those that tried often produced solutions that were inconsistent in quality and caused adverse reactions in patients. Baxter solved this problem by mass-producing IV solutions in glass-vacuum containers under carefully controlled conditions and shipping them to hospitals ready for use.

Today, patient safety remains a driving force at Baxter. The company’s approach to ensuring patient safety has several key aspects:

Each of Baxter’s businesses – Medication Delivery, BioScience and Renal – has a long history of leadership in improving the safety of its products and the therapies in which they are used. This section contains examples of some of these efforts as well as other means by which the company commits itself to patient safety worldwide.

 

Reducing Bloodstream Infections

In 1971, Baxter introduced the first flexible, plastic IV bag. As the first “closed system” IV container, the solution in the bag remains fully sealed and sterile during administration, never coming in contact with outside air. Open systems, on the other hand, require the container to be “vented” to enable the solution to flow smoothly during administration, leaving open the possibility of air contaminants getting into the solution and subsequently infecting the patient.

While studies have shown the success of closed system IVs in reducing bloodstream infections, many hospitals, particularly in developing countries, continue to use open systems, often sourced from small local suppliers. The lower cost of these products, however, can be outweighed by the cost of complications associated with bloodstream infections.

Baxter works with governments and healthcare providers to help conduct studies, set standards and implement conversion to closed IV systems in a number of markets outside the United States in order to improve public health. One such market is Brazil, where the ministry of health mandated that all of the country’s nearly 8,000 hospitals convert from open- to closed-system IVs by March 2009.

Patients also can acquire bloodstream infections when medication is administered through an IV catheter, into which pathogens – disease-causing microorganisms – can be introduced. Some can be deadly, including treatment-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), which causes nearly 20,000 deaths a year in the United States alone, according to the U.S. Centers for Disease Control and Prevention. In 2008, Baxter launched the first needle-less IV connector with an antimicrobial coating that has been shown through in vitro testing to kill at least 99.99 percent of common pathogens known to cause catheter-related bloodstream infections, including MRSA, within the device.

 

Reducing Medication Errors

The Institute of Medicine in the United States estimates that medication errors injure more than a million individuals each year, and that 7,000 of those die each year as a result. Other research shows even greater mortality statistics in other countries.

Baxter helps reduce medication errors in a number of ways. The company’s premixed IV drugs are ready to use so hospital pharmacists do not have to prepare these critical drugs themselves. Baxter was the first company to work with other pharmaceutical firms to premix their drugs in IV solution, and is the only manufacturer of frozen premixed drugs for compounds not stable at room temperature.

For IV drugs that must be administered in a very specific dose or have other special requirements, Baxter operates pharmacy compounding centers in some countries. These centers provide patient-specific premixed drugs for hospitals. Hospital pharmacies transmit prescriptions electronically from the hospital pharmacy to the Baxter compounding center, where pharmacists and technicians prepare the solutions under sterile conditions and deliver them to the hospital ready to administer to the patient.

Baxter also continues to improve product packaging and labeling to reduce the potential for medication errors. Baxter was the first to introduce a readable bar code for clear, flexible IV bags, which present challenges for conventional bar-code technology. Most recently, Baxter has introduced distinctive labeling particularly for medications most likely to cause serious harm if mis-administered.

Baxter’s Medication Delivery business also helps hospitals reduce medication errors through its Connections portfolio. Focusing on three key human factor principles – simplification, streamlining and standardization – the portfolio offers a variety of programs that reduce variability of processes to create a safer environment. These programs, administered by Baxter clinical experts, identify and address gaps between current practices and the latest national standards, including the Joint Commission on Accreditation of Healthcare Organizations, National Patient Safety Foundation and the United States Pharmacopia.

 

Improving the Safety of Hemophilia Therapy

When people with hemophilia began contracting HIV from blood products in the early 1980s, Baxter was the first to develop a heat-treatment process that killed blood-borne viruses, including HIV, which might be present in source plasma. A few years later, Baxter introduced an even safer manufacturing process for plasma-derived factor VIII – the clotting protein missing from the blood of people with hemophilia A – that used monoclonal antibodies to select factor VIII, and only factor VIII, from the plasma, and added a solvent/detergent treatment step as an extra measure of safety.

Then in 1992, Baxter introduced the first genetically manufactured, or recombinant, factor VIII, produced in cell culture rather than derived from plasma, further reducing the risk of transmission of blood-borne viruses. This remained the industry standard until 2003, when Baxter introduced ADVATE, the first recombinant factor VIII processed without any blood additives, eliminating viral transmission risk from such additives.

Baxter remains committed to improving hemophilia therapy. The company is pursuing several technologies to increase the amount of time factor VIII remains active in the bloodstream. This would result in fewer intravenous infusions for patients, a significant improvement in convenience. Baxter also is investigating non-intravenous forms of administration, and applying its proprietary protein-free technology to develop a recombinant factor IX therapy for people with hemophilia B.

 

Lowering Peritonitis Rates in Dialysis Patients

In 1978, Baxter introduced continuous ambulatory peritoneal dialysis (CAPD) – a self-administered home therapy – as the first practical alternative to clinic-based hemodialysis in treating end-stage kidney disease, or irreversible kidney failure. In CAPD, patients manually infuse solution through a surgically implanted catheter into their abdominal cavity, where the solution draws waste and excess fluid across the peritoneum (or abdominal membrane) that would normally be removed by healthy kidneys. Patients then drain and discard the solution. Patients perform solution exchanges several times a day.

When CAPD was introduced, peritonitis – an infection of the peritoneum – was common in patients, due in part to patient handling of the connection site. If not treated promptly or properly, peritonitis could require hospitalization or surgery.

In 1978, peritonitis rates averaged about one in three patient months on the therapy. Baxter then began introducing a series of innovations to make solution-exchanges easier for patients and reduce handling of the connection site. An important improvement occurred when Baxter introduced “twin bag” container systems in the late 1980s, which combine infusion and drainage in a single closed system. Enhanced training and patient support provided by Baxter clinical care coordinators also has had an impact.

By 1990, peritonitis rates in many PD programs had dropped to approximately one in 35 patient months. Today, PD programs in some countries boast peritonitis rates as low as one in 70 patient months.

Baxter continues to advance the safety of peritoneal dialysis through automated peritoneal dialysis systems, which perform solution-exchanges for patients overnight. The company’s future home dialysis systems are being designed to further improve user experiences and patient safety.

 

Addressing Product Safety Issues

Baxter may determine that products manufactured or marketed by the company do not meet company specifications, published standards or regulatory requirements. When Baxter identifies a quality or safety issue with one of its products, it investigates and takes appropriate corrective action, such as withdrawal of the product from the market, correction of the problem at the customer location, notice to the customer of revised labeling and/or other actions.

For example, in January 2009, Baxter sent an Urgent Device Correction letter to customers about quality issues related to its COLLEAGUE Volumetric Infusion Pump, an electronic device that controls the flow of IV drugs to patients. The letter notified customers of conditions that may cause the device to stop infusing and steps to take to address an interruption of therapy. It also contained information on hazards associated with improper cleaning, and a higher than expected occurrence of damaged battery messages with certain versions of the product’s software. For more information on Baxter's efforts to address quality issues involving COLLEAGUE, see Baxter's website at www.baxter.com.

Another example involves heparin sodium injection, a commonly used anticoagulant, or blood thinner. In late December 2007, Baxter began receiving reports indicating an increased rate of allergic-type reactions in the United States associated with its heparin vial products. Baxter recalled all heparin vials and formed a team to look for differences between lots that were associated with adverse events in the field and lots not associated with those events.

Working in cooperation with the FDA, Baxter developed new tests with additional screening methods that identified the presence of over-sulfated chondroitin sulfate (OSCS), a contaminant that had been chemically modified to avoid detection through standard, globally recognized quality tests. The OSCS was introduced during the raw material processing stage, before it reached Baxter or its supplier, in what appeared to be a deliberate attempt to alter a critical medication. Subsequently, this contaminant was discovered in heparin made by more than a dozen other companies in nearly a dozen countries. Baxter has begun implementing steps to reduce the risk of a similar event while planning to re-enter the U.S. heparin vial market.

 

Complying with Government Regulations

Baxter's operations and products are subject to extensive regulation by numerous governmental agencies, both within and outside the United States. In the United States, the federal agencies that regulate the company's facilities, operations, employees, products (their manufacture, sale, import and export) and services include: the FDA, the Drug Enforcement Agency, the Environmental Protection Agency, the Occupational Health and Safety Administration, the Department of Agriculture, the Department of Labor, the Department of Defense, Customs and Border Protection, the Department of Commerce, the Department of Treasury and others.

The FDA in the United States, as well as other governmental agencies inside and outside the United States, administer requirements covering the testing, safety, effectiveness, manufacturing, labeling, promotion and advertising, distribution and post-market surveillance of Baxter's products. The company must obtain approval or clearance from the FDA before it can market and sell most of its products in the United States. Other countries have similar pre-market registration requirements. Even after the company obtains regulatory approval to market a product, the product and the company's manufacturing processes are subject to continued review by regulatory authorities.