APP, the Sole Supplier of Heparin Sodium Vials to the U.S. Market, Provides Tools and Information to Understand the Heparin Manufacturing Process
SCHAUMBURG, Ill., Dec. 5, 2008 -- APP Pharmaceuticals, LLC, currently the sole supplier of heparin sodium vials to the U.S. market, today launched a new safety initiative on the APP Web site - “Working Together for Patient Safety” (www.APPpharma.com/safety). This first phase of the program captures APP’s comprehensive efforts to ensure a safe supply of heparin for thousands of patients -- from safety and quality measures in the manufacturing process, to helping prevent medical errors in hospitals with cap, label and bar code enhancements. The launch of this initiative comes at a time when pharmacists and healthcare professionals gather at the American Society of Health-System Pharmacists (ASHP) from December 7-11, 2008 to address the newly required comprehensive management plans for heparin and other anti-coagulation medications.
“This initiative is driven by our responsibility to ensure a safe and ample supply of heparin for the thousands of patients who rely on this medication every day,” said Thomas H. Silberg, president and chief executive officer of APP Pharmaceuticals. “Our goal is to provide clinicians and the general public with an understanding of the multifaceted process that goes into the manufacturing and testing of each vial of heparin, and to provide peace of mind that heparin manufactured by APP has undergone rigorous safety and quality tests.”
The new addition to the Web site details the safety measures APP has implemented throughout its entire supply chain, including enhanced labeling and unit-of-use of barcodes to help healthcare professionals reduce medication errors, while ensuring the safe supply of heparin to the U.S. market. The site also provides an overview of how APP worked closely with the U.S. Food and Drug Administration (FDA) in stabilizing the heparin market after a massive recall of heparin products by another U.S. manufacturer. As a result, APP has implemented additional testing procedures and more than doubled its manufacturing capabilities to provide an uninterrupted supply of heparin.
APP currently plans to expand this initiative to include safety information, packaging and label enhancements for other high-alert products with the goal of providing information that may help to reduce medical errors and achieve successful outcomes with patients.
The launch of APP’s safety initiative comes one month before hospitals must establish anticoagulation management plans to meet a new National Patient Safety Goal. As of January 1, 2009, healthcare facilities accredited by The Joint Commission are required to have a comprehensive anticoagulation management plan in place to ensure a reduction in errors regarding the use of heparin and other high-alert medications. Heparin and other anticoagulants are considered high-alert medications by the Institute for Safe Medication Practices, meaning that they have the highest risk of causing injury when misused.
Featured on the site is information from The Joint Commission and the Institute for Healthcare Improvement, which hospitals will find useful as they are setting up anticoagulation management plans. These include recommended anticoagulation management protocols designed to reduce medication errors in hospitals. Prescribers will also find a list of error-prone abbreviations.
Heparin, a naturally occurring anticoagulant, is administered to reduce blood clotting during open-heart surgery and is administered for medical conditions such as acute coronary syndrome, atrial fibrillation, deep-vein thrombosis, pulmonary embolisms, and is used during dialysis to avoid clotting of blood in the dialysis filter.
About APP Pharmaceuticals
APP Pharmaceuticals, LLC, is a fully-integrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anesthetic/analgesic and critical care markets. The company offers one of the most comprehensive product portfolios used in hospitals, long-term care facilities, alternate care sites and clinics within North America and manufactures a comprehensive range of dosage formulations. Fresenius Kabi Pharmaceuticals Holding, a wholly owned subsidiary of Fresenius SE, acquired APP on September 10, 2008. Fresenius SE is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. For more information about APP, please visit the company’s Web site at www.APPpharma.com. For more information about Fresenius, please visit the company’s Web site at www.fresenius.com
The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the availability and pricing of ingredients used in the manufacture of pharmaceutical products and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in the Fresenius Kabi Pharmaceuticals Holding’s prospectus dated August 20, 2008, and other documents the company has filed with the Securities and Exchange Commission.
The information contained in this news release is as of the date of this release. APP Pharmaceuticals, LLC and Fresenius Kabi Pharmaceuticals Holdings do not assume any obligation to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
Debra Lynn Ross
Director, Corporate Communications
Hill & Knowlton
(310) 633-9413 Direct
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