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Quick response, teamwork protected patients during heparin recall

By Deborah Epstein

From the July ACP Hospitalist, copyright © 2008 by the American College of Physicians

On Feb. 11, 2008, the FDA alerted the public that tainted heparin from China had reached the United States. Baxter HealthCare, which produces about half of the U.S. heparin supply, recalled all of its U.S. vial-based products, and a few other manufacturers followed suit. The massive recall left hospitals scrambling to maintain seamless care for anticoagulation, dialysis and cardiology patients. Pharmacists did most of the heavy lifting, but nurses and physicians played important roles as well.

First responders

Pharmacists first rushed to remove tainted product from their inventories. Then the frantic search for other heparin suppliers began.

“Our senior inpatient pharmacist worked hard to identify distributors with products that had not been recalled,” said Suzanne Watnick, MD, medical director of dialysis at the Portland VA Medical Center in Portland, Ore. The center provides over 6,000 inpatient and outpatient dialysis treatments per year. “As a precaution, we decided to minimize heparin use in a way that would not adversely affect our patients,” Dr. Watnick said. “We changed to citrate rather than heparin for dialysis catheter locks and used less heparin during dialysis when possible.”

“Because we worried about running out, we overpurchased to the point that we are still overstocked. There was never a gap in supply,” said Butch David, director of pharmacy at Banner Good Samaritan Medical Center in Phoenix. After physically searching 170 dispensing cabinets, pharmacists found no contaminated products in the 770-bed tertiary care hospital. To stave off a shortage, the center turned to other manufacturers that provide heparin products. “Distributors can keep large quantities of heparin on hand because it’s a low-cost item,” Mr. David said.

At Henry Ford Hospital, a 900-bed tertiary care center in Detroit, heparin is mainly used as prophylaxis for deep venous thrombosis (DVT), but it’s also used for dialysis and cardiology patients to prevent blood clots. APP Pharmaceuticals met most of Henry Ford’s supply needs almost immediately, and while the hospital did not decrease use or dosages, administrators decided to change the protocols for DVT prophylaxis. For about a month, physicians could use enoxaparin instead of heparin at their discretion. “From the patient viewpoint, it was a seamless transition,” said Ed Szandzik, director of pharmacy.

The recall had a major impact on Harborview Medical Center in Seattle, according to Beverly Sheridan, pharmacy director. “We received the notice late in the day, and our search left us with only multiple-dose vials,” she said. The center administers heparin to approximately 150 patients, many of them three times a day. The pharmacy had to locate a new supplier, draw every dose into single-dose syringes, and ensure the new products fit into the dispensing cabinet. But these workarounds presented new challenges.

“We began seeing sticks among nursing,” Ms. Sheridan said, “so we created an instructive video on using the syringe holders.” Eventually, the hospital bought products with attached needles to avoid safety and training issues, and patient therapies didn’t change. The center now has adequate heparin supplies.

“The main issue for us was that the FDA gave no warning that a total recall was expected,” Ms. Sheridan said.

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Calls for reporting, close monitoring

As pharmacists monitored hospital supplies, physicians and nurses monitored patients. In its heparin alert, the FDA called on clinicians to watch patients receiving heparin closely and report all adverse events to MedWatch, the FDA’s online system. This “watching and waiting” was the only course available to hospitals, explained Jonathan Himmelfarb, MD, director of nephrology and kidney transplantation at Maine Medical Center in Portland, Maine, and chair of the public policy board of the American Society of Nephrology.

“Manufacturers must use sophisticated instruments to test products, which hospitals cannot do,” he said. “All we can do is alert staff to assess patients closely, as the FDA advises.” His center, which performs 5,000 inpatient dialysis treatments each year, did not change heparin protocols for dialysis.

At Portland VA Medical Center, said Dr. Watnick, “We alerted staff to maintain a high level of suspicion for possible reactions during dialysis.” Outpatients stay at the VA center for five to 15 minutes after completing dialysis and are warned about possible reactions, she said.

Reporting events is key to public safety, according to experts. “The most important message for clinicians is to report adverse effects [for all drugs] to the FDA,” said Lynda A. Szczech, MD, associate professor at Duke University Medical Center in Durham, N.C. “Fewer than 1% of events are currently reported.”

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Next steps

Because the contaminant involved in the current recall had been chemically modified, it wasn't detected with the standard quality tests that Baxter and its supplier perform on every batch of heparin, said Erin Gardiner, a company spokesperson. Baxter and the FDA have announced new advanced quality tests, using nuclear magnetic resonance and capillary electrophoresis, which have been shared globally for all heparin manufacturers, she noted.

The FDA’s drug shortage list now includes multiple- and single-dose vials of heparin and large-volume infusion solutions. Baxter will not resume production until this incident has been thoroughly analyzed, additional safeguards have been put in place, and appropriate active pharmaceutical ingredients are available, Ms. Gardiner said.

In the meantime, heparin supplies remain sufficient, mainly because other manufacturers’ products are available, Dr. Szczech said, but safety remains an open question. Many clinicians and suppliers remain concerned about future contamination, Dr. Watnick noted.

“Baxter apparently did not know they were using the contaminated ingredient, and it could happen to other manufacturers,” she said.

Dr. Himmelfarb agreed. “The concern is whether future problems arise with other heparin suppliers,” he said. “The heparin situation has heightened awareness of drug safety in general.”

Deborah Epstein is a freelance writer in Ringwood, N.J.

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ACP Hospitalist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP. All published material, which is covered by copyright, represents the views of the contributor and does not reflect the opinion of the American College of Physicians or any other institution unless clearly stated