Abbott promises bar codes on injectables, IV drugs
Human drug and biologic products need to be bar-coded — quickly, health care groups told the Food and Drug Administration (FDA) in a July 26 public meeting.
"This is a high-urgency public health and safety issue. The time for action is now," testified Kasey K. Thompson, PharmD, director of the Center on Patient Safety of the American Society of Health-System Pharmacists (ASHP) in Bethesda, MD. He told the FDA, which has been considering this action for years, that there is a great need for this long-overdue step.
"The American public expects and deserves safeguards such as bar code medication verification at the bedside," Thompson tells Drug Utilization Review. "It is very important for the FDA to stay focused on publishing a proposed rule by November 2002. Further delays are unacceptable."
The FDA is considering mandating standardized bar-coding of drug products as a means of reducing medication errors. "Research cited by the Institute of Medicine three years ago estimated that up to 100,000 patients die in the United States every year from preventable medical errors in hospitals alone," said Lester M. Crawford, Jr., DVM, PhD, deputy commissioner of the FDA, in an opening statement.
Bar-coding of drug products has proved to be successful in several cases, he said. For example, the Veterans Administration hospital in Chicago estimates that its bar-coding system has prevented almost 380,000 medication errors in a five-year period. A hospital in New Hampshire also registered an 80% reduction in medication errors, and a medical center in Colorado reduced its medication error rate by more than 70%, both as a result of their use of bar-coding.
Say yes to bar-coding
ASHP was just one of several health care groups that supported the use of standardized bar-coding on drug products. Improved patient care and safety, as well as increased work force productivity and satisfaction, are some of the potential benefits of bar-coding pharmaceuticals, testified John Combes, MD, senior medical advisor for the American Hospital Association (AHA) and The Hospital and Healthsystem Association of Pennsylvania. The lack of standards and uniformity in bar-coding technology has slowed its use in hospitals, he explained.
The AHA supports the FDA’s effort to require a bar code on drug products down to the unit-of-use packaging, he said, but stakeholders need to identify what products should be labeled and what data should be included. Bar-coding technology can enhance patient safety by ensuring there is real-time verification of the correct patient, medication and dose, he added.
Drug manufacturers, however, said adding bar codes to drug products is not an easy task. According to press reports, the Pharmaceutical Research and Manufacturers of America industry group testified that drug makers support bar codes, but it would take two to three years to add even simple bar codes to existing labels.
Pharmacist concerns continue
Thompson says he thinks the meeting was "a positive step in the right direction," but he says some issues still need to be worked out prior to a proposed rule being published, such as whether the pharmaceutical industry will support the inclusion of NDC (National Drug Code), lot number, and expiration date, or just the NDC. "ASHP supports the inclusion of all three elements [NDC, lot, and expiration date]," he says.
Another issue is the trend of fewer medications being made available by pharmaceutical manufacturers in unit-dose packages.
"The disturbing decrease in the availability of products in unit-dose packages has a negative effect on patient safety and threatens the effectiveness of bar code verification systems at the bedside," Thompson says. "New opportunities for errors to occur are introduced when hospital pharmacy departments have to repackage into unit-dose from bulk." For example, repackaging bottles of 1,000 tablets into 1,000 single-unit packages with bar codes inserted by the hospital pharmacy results in "1,000 new opportunities for a mistake to be made.
"This takes pharmacists away from direct patient care responsibilities," he says.
Repackaging and bar-coding at the hospital level is cost-prohibitive for many small to mid-size hospitals, he adds. "The bottom line: A prerequisite to bar-coding is a complete and effective unit-dose drug distribution system," Thompson says.
It’s still unknown whether the FDA will recommend a standard symbol such as Reduced Space Symbology (RSS) or just specify elements that need to be included in the bar code.
"Whichever standard gets adopted, it must work with commercially available scanners used by hospitals and health systems and must support the seamless connectivity and integration of current computer systems with the bar-coding system in hospitals and health systems," Thompson says.
Abbott commits to bar-coding
Abbott Laboratories in Abbott Park, IL, isn’t waiting for the word from the FDA on bar-coding. The company pledged in July to affix unit-of-use bar codes to all of its hospital injectable pharmaceuticals and IV solutions product lines by early 2003, as part of what it calls a "comprehensive, industry-leading initiative to help reduce medication errors and enhance patient safety in hospitals." Abbott says it already has bar-coded about 45% of its more than 1,000 injectable pharmaceuticals and IV solutions products and projects it will have 70% of these products bar-coded by the end of the year.
Approximately one-quarter of Abbott’s injectables and IV solutions will use RSS technology, which allows for a miniaturized bar code to be applied to single-unit containers as small as a pen cap.
Pharmacists may be encouraged by this kind of action, but Thompson says he doesn’t think the struggle is over yet. "We should reserve the celebration until we see a workable regulation from the FDA requiring pharmaceutical manufacturers to place bar codes on all pharmaceutical product packages, down to the unit-dose level, that contain NDC, lot number, and expiration date," he says. "Once we get that, we will have good reason to celebrate an important new safeguard to help protect patients from harm resulting from preventable medication errors."