Bar coding is making rapid headway hospitals as the FDA looks to mandate bar codes on drugs and some buying groups will purchase only bar-coded products.
Once the preserve of grape jelly jars, potato chip packages, and cold remedies, the lowly bar code is now being heralded as a giant step forward in the fight to protect patients from medication errors. Even Uncle Sam is convinced such a technological safety net must be constructed. The question is whether those bar codes will ever make it to the bedside.
The biggest boost for bar codes came last winter when the Food & Drug Administration let it be known that mandating bar codes on human drugs and biologicals is on the agency's to-do list. The notice was published in the Dec. 3, 2001, issue of the Federal Register. But the actual proposed rule won't be issued for comment until late this fall at the earliest, said spokeswoman Crystal Rice. An outside contractor's evaluation of the economic costs of bar-coding is not due until this month. The proposed rule will then have to be sent to the secretary of the Department of Health & Human Services before it can be published in the Federal Register, she said.
The FDA announcement was music to the ears of ASHP, which had urged the agency to make the move to bar codes. In addition to patient safety, ASHP touts the additional benefits of more efficient drug purchasing, storage, and distribution. Such efficiencies give pharmacists more time to counsel patients and monitor drug therapies.
"Bar-coding and bedside scanning are extremely high priorities for ASHP," said Kasey Thompson, Pharm.D., director of ASHP's Center on Patient Safety. "It's exciting to have the FDA announce that it's actually drafting regulations. ASHP is trying to rally the troops around the issue. In addition to advocacy and consensus building, we're also preparing health-system pharmacists for implementation and use of bar-coding and scanning technology."
While the FDA gets its regulatory ducks in a row, some private healthcare enterprises are forging ahead onto the bar-code frontier. A few days after the FDA signaled its intentions, two large buying groups, Novation and Premier Inc., put the pharmaceutical industry on notice that the day is fast approaching when contracted products must be bar-coded at the unit-of-use level.
Novation's pro-bar-code stance is "not negotiable," said John Riddick, Novation's director of quality assurance/regulatory affairs and supplier certification. The Irving, Texas, group purchasing organization represents 2,300 members and affiliates of VHA Inc. and the University HealthSystem Consortium, as well as 5,400 members of the HealthCare Purchasing Partners International. The GPO manages purchases of more than $17 billion annually. And, by 2004, suppliers will have to toe the bar-code line by applying machine-readable bar codes at the unit-of-use level.
"Our primary thrust is patient safety and prevention of errors," Riddick told Drug Topics. "We want to do everything we can to prevent mix-ups, and we feel that machine-readable bar codes will do that."
Bar-coding got another seal of approval last month at the annual meeting of the National Association of Boards of Pharmacy. The house of delegates approved a resolution urging NABP and state pharmacy boards to encourage drug companies to supply medications, where appropriate, in standardized unit- of-use packages with bar codes containing the drug ID, lot number, and expiration date.
There is some question about what should be bar-coded. The FDA's current thinking is that bar codes will be required down to the unit-dose level. Health systems would also prefer that the zebra stripes be placed on each individual dose in order to bring the safety net right to the patient's bedside. Scanning the unit dose just before administration helps ensure that the right patient is getting the right medication at the right time.
However, the FDA and many health-system pharmacy leaders share the concern that when faced with a mandate, drug companies will throw the unit-dose baby out with the bar-code bath water. The push for bar codes from the FDA, patient advocates, pharmacy associations, and large purchasing groups may tip the scale away from unit dose. The pharmaceutical industry had already been retreating from such packaging. Now the concern is that drug companies will offer only bulk containers, leaving it up to their customers to repackage the medications into unit doses.
There is some evidence that the reversion to bulk packaging is, in fact, happening. There has been a decline in the number of products available in unit-dose form during the past five years, according to 76% of the respondents in a survey of hospital R.Ph.s recently conducted by the Institute for Safe Medication Practices (ISMP).
"A key issue in hospitals is that bar codes be included on all product packages, specifically unit doses," said Thompson. "We're seeing real concern with pharmacists and institutions about the decreasing availability of drugs in unit-dose packaging. It's something our phones are ringing about. We don't have quantifiable data to do hard advocacy yet, but we soon will, and this will be a significant issue."
Unit-dose packaging has been held hostage by a Catch-22, said Peter Mayberry, executive director of the Healthcare Compliance Packaging Council. In the mid-'90s, drug manufacturers offered 95% of their products in a hospital unit-dose format. But when cost-conscious hospitals realized how much more expensive such products were, they switched to bulk containers. So the less hospitals bought unit-dose packages, the fewer products manufacturers put in unit-dose format.
"Pharmaceutical manufacturers are cutting back on products that were historically available in hospital unit-dose format," said Mayberry. "If hospitals aren't buying those products because they're too expensive, then I could conclude hospitals are prepared to sacrifice safety for cost savings. I find that extremely difficult to believe."
Not only does repackaging bulk medications into unit-dose form take time and money, it's an invitation to errors. Hospitals in the ISMP survey estimated that repackaging could lead to an error rate as high as 10%. "I don't think anyone is urging that hospitals repackage drugs in the pharmacy because there can still be mistakes," said Mayberry. "Plus, the hospital pharmacists are as strained as can be right now. Another scenario would be to use wholesalers that provide packaging services. Or they could use repackaging organizations. That's about where we are."
Another unanswered question is what information should be encoded in those black and white bar-code stripes. FDA bar codes would have to include certain information, such as the NDC number, but the agency is still mulling over whether to also require the lot number and expiration date.
Mandating the use of expiration dates and lot numbers would be troublesome, not to mention expensive, for drug companies, said Novation's Riddick. Instead of just configuring the bar code once for the drug product's NDC, the information would have to be changed with every new lot.
The amount of information that can be stored on a bar code is also a hurdle. Technology exists to create miniscule bar codes that can still be read by scanners, but hospitals as a rule don't yet have such sophisticated readers, Riddick said. "We've had a lot of discussion with the FDA about a potential glitch with very, very small vials where there's no room for anything else," he said. "One of our suppliers put bar codes on some of its smallest vials, but the FDA told them they can't do that because it has negative effects on the readability of the labels. Small vials are going to be a challenge for us, and we're not sure how we're going to handle that."
And then there's the inevitable bottom line issue of how much it all costs. The FDA has estimated that bar-coding would cost the pharmaceutical industry between $500 million to $1.5 billion over a 10-year period. The wide swing stems from unknown factors, such as how much it would cost to require various pieces of information, whether all or just some drugs and biologicals would have to be bar-coded, and possible changes in labeling operations.
Cost is one of the tough issues yet to be resolved, but ASHP's Thompson believes the bar-code technology will be implemented. "Our last survey showed only about 1.1% of hospitals utilize bar-coding at the bedside," he said. "And there are issues to work through. However, they will probably be minimal in the grand scheme of things, especially in terms of how many lives could be saved by bar-code scanning at the bedside."
Carol Ukens. Bar codes weave safety net for patients.