Process came in handy when hospital had heparin shortage

Pharmacy had 48 hours to make changes

A North Carolina hospital pharmacy recently demonstrated the importance of having a good performance improvement (PI) strategy readily available when the pharmacy had to act quickly in February due to an IV heparin shortage.

"There was a national heparin shortage as the manufacturer changed from the old formulation to a new formulation," says Lynn Eschenbacher, PharmD, MBA, clinical manager at WakeMed Health & Hospitals in Raleigh, NC.

WakeMed's manufacturer was Hospira for the IV bags of heparin. Hospira attributed the shortage of heparin vials to supply and demand issues, according to the American Society of Health-System Pharmacists (ASHP). Hospira announced in January, 2010, that all large-volume heparin sodium in dextrose 5% premix solutions and one presentation of heparin sodium in 0.45% sodium chloride would be unavailable through the end of March, 2010. The company also reported it was working to implement new manufacturing procedures associated with the new USP reference standard for heparin products.

The WakeMed pharmacy had managed the potential shortage by measuring the hospital's daily use of heparin, analyzing its needs, and monitoring product supply.

Then something unexpected happened: One day in mid-February, 2010, the hospital's heparin distributor said it had no more old product and the new product wouldn't be available until April, 2010.

The current IV heparin bags were on national back order and there were only a few of the current IV bags left in the hospital, Eschenbacher says.

"We quickly had to develop a plan, and we pulled together a team that included the vice president of patient safety, chief medical officer, medical director of the laboratory, pharmacy, and nursing," she says.

The team had 48 hours to implement a process improvement (PI) plan and prevent the heparin shortage from impacting patient care.

These questions had to be answered:

  • How many heparin bags were left?
  • How will the hospital make the transition?
  • Where would the hospital find the new formulation when its usual distributor reported the bags being backordered until April, 2010?
  • How would they change out materials in dispensing machines?
  • How would they educate nurses and physicians about the formulation change?

Quickly, the team assigned people to handle different parts of the PI project.

The pharmacy buyer called different distributors until finding a company that could deliver the new product immediately. Another person was in charge of the physical operational change and making certain stickers were put on every new vial of heparin, Eschenbacher says.

"I went to a nursing leadership meeting and educated nursing directors and supervisors about the new product," she says. "The new heparin product looks different from the old formulation, and we didn't want nurses to worry that they were administering the wrong medication."

Eschenbacher also worked with the hospital's public relations department to send hospital staff an Intranet message and to put a notice about the heparin switch in the hospital's weekly newsletter.

"I sent a follow-up e-mail to all nurses, as well, and I did this within 24 hours," Eschenbacher says.

The PI process worked. WakeMed obtained the new heparin before running out of the old product, the staff was educated, and the change-over went smoothly.

As a final part of the performance improvement process, the hospital will monitor the change and ensure the new product is safe for patients.

"We're going to gather blood samples from 30 patients to verify there is no potency difference between the new heparin and the old formulation," Eschenbacher says.

Pharmacists will collect information from using activated factor Xa and aPTT tests. Then they'll send those results to physicians within two or three weeks, she adds.

"If the tests are okay, then we'll let them know," she says. "If there is a change, and there's not the same correlation then we'll have to develop a new tool to measure heparin potency and change order sets and re-educate the hospital staff."

Another PI action will be to distribute the phone number of the medical director of laboratories to hospital staff, asking them to notify the medical director if anyone identifies a problem or unexpected issue with heparin use, Eschenbacher says.

"We've assured that all the old products are taken out, we've put the new products in place, and we've communicated that if anybody has any questions, this is what we've done," she adds.