Home Infusion Therapy: Product Profile

• By Rex Hansen, Patrick Meeker
• Jul 01, 2003

Recent reports have shown that medication errors in home infusion are common and threaten patient safety. According to the United States Pharmacopeia (USP) Medication Errors Reporting Program (MER), of all the medication errors reported between May 1992 and June 1999, home health care errors were more likely to involve patient harm compared with all other errors reported.

Current staff shortages in health care only add to the problem of medication errors in home infusion. A study involving a home infusion company found that medication errors increase as the workload increases and that infusion pump related errors were significantly higher than other types of errors. Electronic infusion devices were identified as being involved in 13 percent of medication errors reported in the home care setting.

The drug regimen most often reported in home care medication errors is anti-infective therapy (22 percent). The number of patients receiving anti-infective therapy in 2001 was 315,000 up from 255,000 in 1999. Reasons for this growing trend include reduced length of hospital stay when a patient is discharged to receive home infusion anti-infective therapy and patients preferring outpatient intravenous therapy due to quality of life reasons.

With fewer home health care providers bearing the burden of heavier workloads, technology is an essential element in reducing human error and the risk of medication errors. The Food and Drug Administration's (FDA) new Home Health Care Committee, featuring representatives from CMS, JCAHO, Department of Veterans Affairs, National Science Foundation and the Health Resources and Services Administration (HRSA), recently held a meeting to discuss the need for safe, user-friendly medical technology that can be used in the home.

For the home health care provider, intravenous delivery of anti-infective therapy can be a complicated, time consuming, labor-intensive process. Since anti-infective drugs are not stable in solution, the drug and diluent must be mixed just prior to infusion so that the drug does not lose its potency. In a home care setting, the mixing of intravenous medication can be challenging and dangerous.

Many anti-infective intravenous medication delivery devices are difficult to use, increasing the risk of injury to patients. They often require a health care provider to connect the drug and diluent prior to infusion, leading to the risk that the diluent could be infused into the patient without the drug being mixed. Delivering anti-infective therapy in this manner also could potentially lead to contamination and mixing errors.

Other delivery devices require the drug and diluent solution to be maintained at a certain temperature and thawed prior to infusion. The need to refrigerate and thaw anti-infective intravenous medication can be inconvenient, time-consuming and messy in a home health care setting.

A new anti-infective intravenous drug delivery technology from B. Braun Medical Inc. has been developed to reduce the risk of medication errors, and simplify the process of anti-infective infusion therapy in both the hospital and in home health care.

The Duplex" Drug Delivery System is designed to reduce the risk of medication errors and ease of use. It consists of a pre-filled, PVC-free, DEHP-free, latex-free IV bag containing proper doses of drug and diluent in different compartments separated by a quick release seal. The caregiver simply squeezes the bag to mix the drug and diluent just prior to administration.

"Duplex is an ideal technology for home health care infusion therapy," said Shauna Daly, product director, Drug Delivery, B. Braun Medical Inc. "Home health care providers often work in a fast-paced, high-stress environment where their time with each patient is limited. The Duplex System provides a safe, easy, efficient way to delivery anti-infective intravenous drug therapy."

"Since the drug and diluent and pre-filled in the IV bag, there is no risk of mixing errors, contamination, or the possibility of delivering the diluent without the drug," Daly said. "The health care provider can activate the drug just prior to delivery to minimize wastage. This method also reduces the time needed to prepare the drug. There is less labor involved in mixing the intravenous anti-infective drug therapy since there is no need to attach vials or connect the drug and diluent prior to infusion. The health care provider can activate the drug just by folding and gently shaking the IV bag."

The design of the Duplex System also addresses two patient safety issues raised by the FDA-barcode labeling to reduce the risk of medication errors, and a DEHP-free construction to eliminate the potential dangers of DEHP exposure.

The FDA recently announced an initiative to develop a regulation on barcode labeling for human drug products to reduce the number of preventable drug errors in the United States. The Duplex System is equipped with a UCC/EAN-128 barcode that references the final admixture and can be used to reduce medication errors, track inventory and facilitate reimbursement tracking.

The Duplex System is PVC-free, DEHP-free and latex-free for added patient safety. In its recent public health notification about DEHP, the FDA suggests using PVC-free, DEHP-free alternatives during a number of medical procedures for neonates, peripubertal males, pregnant or lactating women, and adults undergoing certain procedures. Di(2-ethylhexyl) phthalate (DEHP) is a chemical compound used to make polyvinyl chloride products like intravenous bags and tubing soft and pliable. DEHP has been classified as a Group B2, probable human carcinogen by the U.S. Environmental Protection Agency (EPA).

"Through its People, Products and Programs Safety Initiative, B. Braun is dedicated to improving the safety of both patients and practitioners," said Daly. "The Duplex System is a key product in this initiative since it was designed to reduce the risk of medication errors and eliminate the potential dangers of DEHP exposure. B. Braun offers a full line of basic intravenous solutions in PVC-free and DEHP-free IV containers. "We are striving to improve the quality of healthcare across the board - from the hospital to the home care setting."

B. Braun currently offers Cefazolin in the Duplex System. A second cephalosporin drug, Cefuroxime, will be available this summer.

This article originally appeared in the July 2003 issue of HME Business.