CORRECTED-UPDATE 2-APP Pharma unveils plans to safeguard heparin

(Changes date of recall in first paragraph to early 2008 instead of late 2007. Makes clear in paragraph 12 that APP imports its raw materials to make heparin from China.) (Adds more about the Web site in paragraph 5)

By Debra Sherman

CHICAGO Dec 5 (Reuters) - APP Pharmaceuticals LLC, the sole provider of heparin in the United States, said it was taking steps to ensure a safe supply after at least 81 deaths and hundreds of other adverse events led to a competitor's recall of the blood thinner in early 2008.

Heparin is widely used to reduce blood clotting during open heart surgery and to treat many medical conditions, including acute coronary syndrome, atrial fibrillation, deep-vein thrombosis and pulmonary embolisms. Another common use is to avoid clotting of blood in dialysis filters.

But the product came under intense scrutiny last year after high-profile product recalls by Baxter International (BAX.N), which bought a contaminated supply from China, and after reports of medical errors and overdosing.

APP, which manufactures injectable drugs for the oncology, anti-infective, anesthetic/analgesic and critical care markets, said it was launching a website (www.APPpharma.com/safety) as the first phase of its plan to improve safety.

The site details safety measures APP has implemented through its supply chain, including enhanced labeling and unit-of-use of barcodes to help eliminate medication errors, the company said. The website also provides an overview of how APP works with the U.S. Food and Drug Administration in stabilizing the heparin market.

The unit of Germany's Fresenius SE FREG_p.DE plans to expand the initiative to include safety information, packaging and label enhancement for other "high-alert" products, which have the highest risk of causing injury when misused.

"We want this patient safety concept applied to all of our products," APP Chief Executive Thomas Silberg said in an interview. "We make some pretty serious medicines."

In 2001, APP became the first company to use barcodes, large lettering and color-coded stoppers on vials, Silberg said.

MEDIA ATTENTION

The problem of heparin overdosing gained great attention in 2007 when Cedars-Sinai Medical Center in Los Angeles gave the newborn twins of actor Dennis Quaid 1,000 times the intended dose of heparin, nearly killing the babies. The error occurred in part because the packaging of high- and low-dose heparin was similar.

Contamination of the drug caused Baxter, which bought its supplies from China, to recall the product about a year ago.

A report published in the Dec. 4 issue of the New England Journal of Medicine confirmed that the problems stemmed from a man-made chemical that was added to batches of the drug imported from China.

Before the recall, Baxter and APP each had about 50 percent of the U.S. market. After the recall, APP had to double its manufacturing capacity to supply the U.S. market. The company has two plants in the United States and one in Puerto Rico. APP imports its raw material from another Chinese supplier, which Silberg characterized as "high quality."

"We could produce more heparin if we needed to," Silberg said.

He noted that heparin had returned to a normal supply chain only a couple of weeks ago. Bypassing wholesalers, APP had been shipping the product directly to hospitals to keep them from overstocking it.

"We wanted to make sure that when a hospital needed it, they got it," Silberg said.

APP's heparin initiative comes one month before U.S. hospitals must establish anticoagulation management plans to meet new federal safety requirements.

On Jan. 1, healthcare facilities accredited by the U.S. Joint Commission must have a comprehensive anticoagulation management plan in place to ensure a reduction in errors from the use of heparin and other high-alert medications. (Reporting by Debra Sherman; Editing by Lisa Von Ahn)