On April 26, Food and Drug Administration regulations mandating "the barcoding of most prescription drugs and over-the-counter drugs commonly used in hospitals and dispensed under an order" will go into full effect.
The rule is helping increase efforts to bring barcoding to the bedside, and ultimately to "close the loop" with a fully integrated medication management system that includes computerized physician order entry (CPOE) and pharmacy fulfillment applications. It also looks to further point-of-care barcoding — a system of checks and balances intended to ensure that the "Five Rights" of medication administration are always obeyed.
"We haven't stopped long enough to calculate return on investment, but we can prove a decrease in adverse events," says Janice Fraley, CIO of McLeod Health, Florence, S.C., which deployed a fully closed-loop medication administration system from Siemens Medical Solutions, Malvern, Pa., in 2005. "An adverse event requires additional cost, such as an extra test, longer length of stay and so on, up until death. We can prove we've decreased individual patient hospital expense by avoiding mistakes."
In 2001, McLeod estimated a "rate of harm" figure — defined as events resulting in temporary or permanent impairment of body function or death — of 3.5 incidents per 1,000 medication doses administered. By January, 2006, thanks to the organization's adoption of closed-loop medication management, that rate was cut tenfold, to a six-month rolling average of 0.33 events per 1,000 doses.
At Brigham & Women's Hospital, Boston, a self-designed barcode/medication administration checking (MAC) system has yielded dramatically reduced errors in dispensing medications, according to William Churchill, director of pharmacy services.
In a recent in-house study of dispensing errors, Churchill says, "We looked at incidences of dispensing errors in pharmacy in our process prior to barcoding. The old rate was 99.1 percent accurate, but that .9 percent rate was still very concerning because at a facility our size, we could still end up with more than 65,000 medication dispensing errors a year just by sheer volume. After barcode technology was employed, scanning reduced potential for errors by 85 percent."
The benefits to bedside barcoding seem so clear cut that one hospital's CIO says the team that studied the design of its barcode medication administration system — scheduled to go live in the first half of this year — didn't worry about its budget.
"We did not break down cost on this one," says Kevin Conroy, CIO of St. Francis Hospital, Poughkeepsie, N.Y. "We realized that, as a community hospital, St. Francis had to let the public know we would do whatever we had to for safety. In a year or two, it's going to be a mandate. We're excited to say we did it voluntarily."
Dual drivers, murky specifics
The FDA regulations do not mandate that hospitals adopt barcode systems, only that the manufacturers supply one. The barcode must, at a minimum, contain the drug's National Drug Code (NDC) number, which uniquely identifies the drug. For blood and blood components intended for transfusion, the final rule requires the use of machine-readable information in a format approved by the FDA. The machine-readable information must include, at a minimum, the facility identifier, the lot number relating to the donor, the product code, and the donor's ABO and Rh.
However, healthcare providers say that the FDA rule does not specifically mandate medications be barcoded at the unit-dose level, which means healthcare organization executives must improvise to find ways to make the rule truly effective.
"It has to be unit dose or it doesn't work," St. Francis CIO Conroy says. His hospital has contracted with McKesson Corporation, San Francisco, to repackage medications for St. Francis and other repackaging customers at its campus.
At McLeod Health, CIO Fraley says the organization's director of pharmacy, Natasha Nicol, began demanding unit-dose barcoding from its pharmaceutical suppliers long ago. Fraley says 75 percent of McLeod's medications are barcoded at the unit dose; the remaining 25 percent are re-packaged in-house, using the NDC number.
Fraley says she believes the FDA rules, along with market forces, will compel manufacturers to supply unit-dose barcoding, and that astute contract negotiation can prevent the passing along of re-packaging costs to hospitals. But she also says that another barcoding initiative — the Joint Commission on Accreditation of Healthcare Organization's (JCAHO) positive patient identification requirement — will be just as influential, if not more, in moving hospitals toward bedside MAC. She says patients have begun to express high rates of satisfaction in the attention McLeod pays to the issue.
Next step advice
The market for bedside MAC is still virtually wide open. According to a January, 2006 study on closed-loop medication administration systems written by market research firm KLAS Enterprises (Orem, Utah), "Only 6 percent of inpatient hospitals report barcode scanning use by between 86-100 percent of nurses at the point of care for positive patient ID."