FDA bar code regs only a starting point
Reaping the benefits of bar-coded medication will be a long, complex and costly process for American healthcare organizations.
Even as the Food and Drug Administration is expected to issue rules this month requiring that manufacturers bar-code all medications sold to hospitals, many expect the move won't quickly improve patient safety.
The regulations aren't expected to require manufacturers to bar-code all individual patient doses - that expense will fall to hospitals, at least for the near term. In addition, only a small percentage of American facilities have bar-code systems in place when patients get drugs.
But hospital executives believe the regulations, and pressure on manufacturers, will eventually make the use of bar codes more widespread.
The FDA regulations are aimed primarily at the manufacturers, said Ned Simpson, head of Applied IT Strategies, an Ann Arbor, Mich.-based consulting firm. Simpson is the chairman of the HIMSS Auto-ID and Bar Code Task Force.
"Technically, the rules don't regulate hospitals or providers," Simpson said. "It's one of the disappointments for patient safety."
The FDA regulations stipulate that manufacturers must bar-code containers with drugs, not individual doses. Hospitals that want to go to a bar-code system must bar code individual doses themselves.
The FDA estimated that it would cost manufacturers $33 million to implement the bar coding regulations, but it would cost providers $7 billion to take advantage of it. A full system necessitates bar-coding of patients' wristbands and caregivers delivering their medicine and requires interfaces between existing pharmacy, clinical and other information systems.
Simpson says that while many hospitals are interested in such systems - perhaps as many as 700 to 800 nationwide - he estimates that fewer than 100 hospitals are in the process of implementing such systems, and perhaps only 50 have bar-code systems operating.
But many hope that more pharmaceutical manufacturers can be pressured into bar-coding drugs down to the unit dose.
For example, Robert Ragan, pharmacy manager for Wesley Medical Center, Wichita, Kan., says he will selectively buy pharmaceuticals for which the hospital doesn't have contracts in order to get drugs with unit-dose bar codes.
"I think there will be a market swell toward that because people want bar coding," he said. "The market will drive unit-dose bar-coding."
Other organizations are looking to implement bar coding on intravenous solutions. While only 4 percent of medication errors relate to IV drugs, they're responsible for 80 percent of severe errors, said Steven Goulet, pharmacy information technology coordinator at St. Joseph Mercy Health System, Ann Arbor, Mich. The system will start bar-coding IV drugs this summer.