INSIDE : inside.mc.duke.edu

May 05, 2008 Volume 17 No. 5

1 of 1

Safety first with child doses of Heparin

The Problem

Most harmful pediatric medication errors are caused by improper doses, due, in part, to the fact that there are few standard unit-dose medications for children. Doses for children are calculated based on the specific weight of each child. This creates room for error because physicians and nurses often have to complete mathematical calculations to determine how much medicine a child should receive.

Some pediatric-specific medications and formulations are available, but these products are often packaged in vials or injectables that look very similar to adult concentrations and formulations. Though the products look very similar, the content is completely different. Further, since medications are supplied in different formulations, nurses are forced to do math to convert the dose that is ordered (in mg) to the appropriate does in mL, based on the formulation of medicine that is in stock.

Karen Frush, M.D., chief patient safety officer, said the major problem is not the lack of care or intelligence of nurses and physicians but rather, “the system sets them up to make errors.”

The Solution

“One solution is to develop national standard pediatric formulations, with standard labeling and packaging, but that will take a lot of work,” Frush said.

What Duke is doing:

• Limiting the drug formulations it purchases. For example, Duke is limiting the formulations of Heparin and other medicines it purchases, in an effort to standardize the formulations available to clinicians.

• Creating awareness of the high-risk factors involved. Duke hosts patient safety seminars that inform staff about the problems associated with dosing children’s medicines and ways to insure safety.

• Utilizing IT systems, such as the computerized physician order entry system, that provides physicians with pre-calculated dosages, based on the child’s weight.

Rapid Response
Duke’s swift action insures safety amid Heparin recall

By Erin Pratt

print/ email

In January, when the Food and Drug Administration issued the first of several product recalls for Heparin, a blood thinning medication, Duke University Health System leaders reacted promptly.

They learned that tainted batches of Heparin were being implicated in the deaths of patients around the country, and they wanted to act before any Duke patients could be harmed.

That message came to Duke through a Web-based recall system known as Risk and Safety Management Alert System (RASMAS).

Through RASMAS, the procurement department receives the first alert of a recall and immediately researches Duke’s purchasing history of the product. Procurement staff then send a message directly to specific front-line employees ordering the removal of the items from Duke’s pharmacy shelves. RASMAS receives 4000 alerts each year and 30 percent of these alerts result in pulled medications.

Heparin is widely used at Duke, and this recall had the potential to affect many patients. That prompted Duke to escalate the recall alert to involve the Senior Recall Team. This team, comprised of seven members of leadership from Medical Affairs, Patient Safety, Risk Management and Procurement, immediately initiates a comprehensive plan to explore related safety issues throughout the health system.

“These people are so engaged,” said Brooke Berson, director of clinical resource management and member of the Senior Recall Team. “They can make a real difference, very quickly. It helps to have such high level involvement.”

Duke’s Heparin recall was further compounded by the use of Heparin through Duke HomeCare & Hospice (DHCH).

“This presented a real problem because it was no longer as easy as pulling Heparin from the shelf,” Berson said. The Senior Recall Team had to develop a plan for safely retrieving the Heparin, used by 500 patients at their homes, and then deliver new, safe Heparin back to the patients.

DHCH obtained sufficient quantities of Heparin from another supplier, which enabled them to replace all recalled Heparin. DHCH is now transitioning to a new Heparin vendor.

Duke’s quick response to the recall allowed for a thorough investigation and communication of a plan of resolution within 24 hours.

“Our Heparin supply is sound, and safe,” said Michael Cuffe, M.D., vice president for medical affairs and member of the Senior Recall Team. The recall team continues to monitor the FDA’s investigation into the tainted supplies of Heparin, which is currently blamed for 81 deaths in the U.S. and hundreds of allergic reactions.

Berson said the team was happy with the response to the recall because “everything we hoped for and more with this RASMAS program has come through. That is the real success.”