Raise
the Bar
Proposal for uniformity in bar coding medicine aims to
improve accuracy and speed delivery
By Scott Mace
May 23, 2003
A few stripes on the side of a drug bottle or packet sounds like a simple thing to agree upon and implement. But the Food and Drug Administration recently broke a stalemate by ordering mandatory use of such bar codes and a standard way to represent information about drugs in a bar code.
To the select number of nurses who've already implemented bar coded medicine, the improved accuracy and delivery speed of drugs has been stunning.
"It has caught errors we didn't even know we were making," said Peg Spisak, RN, director of quality and risk management and patient safety officer at Ohio Valley General Hospital in McKees Rocks, Pa.
Ohio Valley's pilot use of bar coded medications went live Sept. 18, 2001, using McKesson Corp.'s Admin-RX, with which bedside nurses scan patient wristband and medication bar codes into a handheld terminal that communicates to a wireless hospital network where electronic medical records are kept.
"Busy nurses make mistakes without realizing it," Spisak said. "Now, if someone tried to take this away, we'd have a problem."
However, many nurses still rely on paper charts to administer the "five rights" (right medication, right patient, right dose, right route, at the right time), as the lack of standards and concerns over the cost of technology and training have kept many drug companies from placing bar codes on most medicines.
A rash of stories on medication errors in the United States prompted a call for a federal role. Department of Health and Human Services Secretary Tommy Thompson announced March 13 a proposed rule requiring bar codes on drug labels, similar in appearance to the bar codes present for years on retail products.
The proposed rule would apply to prescription drugs, excluding physician samples, and to over-the-counter drugs commonly used in hospitals and dispensed pursuant to an order. The rule would apply to drug manufacturers, repackers, relabelers and private-label distributors of drugs. The proposal would require the bar code to contain, at a minimum, the drug's National Drug Code number, a unique number that identifies each drug, its dosage form and its strength.
The nurses interviewed for this story welcomed the FDA move.
The FDA intends to make the rule effective three years after it publishes a final rule. However, some drugs already have bar codes, and some firms have announced their intention to place bar codes on their drugs sooner.
Health care providers are under no obligation to implement systems to read and record the information contained on the bar codes. However, hospitals such as Ohio Valley have acted as vanguards in doing so.
Veterans Administration hospitals have adopted bar coding for pharmaceutical products used at patients' bedsides, according to Jerry Phillips, associate director of the FDA's Office of Drug Safety.
"We use this as a role model," Phillips said.
Several national hospital purchasing alliances, including Premier Inc., Novation and Amerinet, plan to preferentially award contracts to those pharmaceutical companies that provide bar coded medications, said Allen Vaida, executive director of the Institute for Safe Medication Practices in Huntingdon Valley, Pa.
"What really drives the market is what people will buy, and the good sign is that the purchasing alliances are on board," Vaida said.
Today, 30 percent to 35 percent of drugs already have bar codes. However, firms use different, incompatible standards. So even as hospitals print bar codes for medications that don't have them, they also may have to print bar codes to replace incompatible ones.
The FDA's mandate replaces such conflicting standards with a unified one that permits extensions to a basic set of information. The 90-day public comment period that ends June 13 is also an invitation for advocates of extended information to argue for its inclusion and standardization. For instance, the Institute for Safe Medication Practices wants each drug's expiration date and lot number to be required and standardized across all FDA-mandated drug bar codes.
Other health care providers are concerned that the regulations will encourage pharmaceutical companies to continue a recent trend in which some drugs are packaged in bulk instead of single doses. Hospital pharmacies can divide such packages into smaller containers and apply new bar codes, which adds to drug costs.
"There are reasons why unidose packaging is decreasing, having to do with [pharmacy company] marketing and cost reasons," Phillips said. "It's really our hope at the FDA that we don't see a decrease in unit-of-use packaging. We hope we'll see the opposite, that the industry will see a great patient safety need for this and will rise to the occasion."
One thing that seems certain is that different hospitals will introduce bar coded medications in different ways. At Central Washington Hospital in Wenatchee, Wash., the pharmacy was using a McKesson robotic drug distribution system 2½ years ago, said Connect-RX coordinator Paul Stringham, RN.
"We chose to test [the bar coded meds] on a rehab and OB unit," Stringham said. The hospital started there "mainly because the rehab unit was on separate ID systems from the hospital, requiring a discharge and readmittance, which cut out confusion between the old and new systems. The OB unit, of course, had a high turnover rate, with new mothers coming and going at the rate they do, so this let us see how the bar codes worked with a high rate of discharge."
By contrast, Ohio Valley General Hospital started with the most intense pilot possible, the critical care suite.
"I wanted to see virtually everything that could happen to the system while we had the support of the company [McKesson] during the first days," Spisak said. "I'm glad we did, though apparently everyone else is afraid to do their ICU. I get conference calls to have our ICU nurses talk through other ICU nurses" from other hospitals that are adopting bar coding. "Some [nurses] are afraid that bar code scanning will stop them from reacting quickly, giving stat medications."
Central Washington's Stringham notes that in some of the hospital's fastest-paced areas, such as the ER and recovery rooms, bar codes still are not used at the bedside because bar code generation normally routes through the hospital pharmacy. However, the pharmacy is able to do all the checks and input stat orders into the system shortly afterward to keep records accurate.
Bar coded medication delivery appears to enhance quality of care. Now, organizations are starting to quantify cost savings and returns on investments. Often, the bar coding is part of a total upgrade to a paperless electronic medical record-keeping system.
The FDA estimates its proposed rule, when finalized, will result in more than 413,000 fewer adverse drug events over 20 years. The present value of avoiding related hospital stays and patient pain and suffering is estimated to be about $41.4 billion, discounted at 7 percent. Hospitals are expected to realize a present value from $4.8 billion to $7.6 billion in savings related to record-keeping and reporting activities.
In addition, the FDA expects that hospitals could avoid litigation associated with preventable adverse events, reduce malpractice liability insurance premiums and increase receipts with more accurate billing procedures.
Stringham sees quantifiable savings, too. "Every drug error in the hospital has an average cost of $2,500 to $3,500 for that patient," he said.
Still, a transition awaits most nurses.
"It's something new between the nurse and the patient," said Mary Beth Navarra, RN, director of automation planning at McKesson Automation in Pittsburgh. "But if the patient said his incision is bothering him and wants to know the last time he had his pain medication, if that history is on a paper chart, there's a delay while the nurse has to go back to that paper. The nurse with the handheld device can say, 'Sure, I can tell you right now.' "
In addition, Navarra said, a patient's electronic medical record can tell the nurse if a physician has discontinued a medication that morning, something that busy nurses might not notice on a paper chart.
"The goal of point-of-care bedside scanning is to provide that safety net," Navarra said.
While the up-front costs of implementing a paperless system are considerable, ever-present drug bar coding also could have benefits far beyond hospitals, including long-term care, home health care and nursing home situations, Navarra said.