FDA regulation may spur medical bar coding

Wireless systems seek to reduce medication errors



This month's deadline for bar coding medication could inspire a wave of wireless projects among hospitals that hope to boost patient safety. Two years ago, the Food and Drug Administration issued a rule requiring drug makers to use bar codes on medications.

The regulation calls for the computer-readable tags on the outside of containers and individual blister-wrapped cells. The bar coding rule aims to prevent medication errors, which results in more than 7,000 deaths each year, according to an Institute of Medicine report.

The FDA believes the regulation will 'allow health care professionals to use bar code scanning equipment to verify that the right drug'is given to the right patient at the right time,' according to the agency's bar coding rule. The regulation may also encourage health care organizations to pursue wireless infrastructure to automate the medication supply chain.

However, a flood of bar code projects has yet to materialize among health care providers, industry executives say. 'We have not seen the bar code issue be a huge driver in health care yet,' said Timothy Kubiak, Affinity sales manager at Westcon Group, a wireless products distributor that focuses on the health care market. Kubiak said he believes bar coding will gain momentum, adding that some hospitals have started to address Wi-Fi-based mobility applications for nurses.

Ken Kleinberg, senior director of global health care at Symbol Technologies, estimated that 7 percent to 10 percent of hospitals ' about 500 facilities nationwide ' have deployed medication bar coding applications. Kleinberg said another 500 hospitals are in the process of implementing such applications, and 500 more will start down the bar coding path in 2006.
'I think we'll see the market effectively begin to double this year,' Kleinberg said.

VA takes the lead

The Veterans Health Administration, which claims to be the country's largest integrated health care provider, ranks among the earliest adopters of medication bar coding. The Department of Veterans Affairs' bar coding push began in 1993 with a prototype system at the Colmery-O'Neil VA Medical Center in Topeka, Kan. The system's unlikely inspiration: a car rental facility at the Seattle airport.

G. Sue Kinnick, a nurse and ADP coordinator at the medical center, saw an attendant scan a vehicle bar code and wondered whether bar codes could be used to track medication, said Russell Carlson, a nursing consultant at the VA's Bar Code Medication Administration program office.

Kinnick; Chris Tucker, the hospital's pharmacy ADP coordinator; and Ray Mauer, a software developer at the medical center, helped shape the initial system. By September 1995, the medication bar coding application was deployed throughout the medical center.

The project piqued the interest of the VA's central office, which called for a nationwide release of the software, known as the Bar Code Medication Administration (BCMA) system. That implementation began in 1999, and today, all VA inpatient medical centers use BCMA, Carlson said.

'They have been way out in front of the curve,' said Ken Tighe, chief executive officer of Care Fusion, a company based in McLean, Va., that provides medication bar coding among other point-of-care applications.

Kleinberg cited the VA's medication bar coding thrust as an important driver of the FDA's bar coding rule. The VA's experience with the technology, he said, demonstrated that 'having bar codes on medicine was worth doing.'

For example, the Colmery-O'Neil VA Medical Center reduced its medication error rate by 86.2 percent from 1993, the final year it used a manual system, to 2001, according to a VA-authored article published in the Journal of Healthcare Information Management.

The reduction of medication errors has an obvious patient impact and has a financial benefit, too. As a general rule, each adverse drug event costs a hospital from $4,000 to $5,000, Kleinberg said. He said the cost stems from factors including increased hospital stays, drugs used to counteract incorrect dosages, and extra nursing and physician costs. Legal settlement expenses are not included in the estimate.

Medication bar coding also improves workflow, Carlson said. In a paper-based system, a nurse reads a document to determine what medication to administer and how often. A doctor reviews the same document to find out what medication a patient has taken and when. Then a pharmacist needs the document to conduct a pharmaceutical review.

'Everybody was after the same sheet of paper,' Carlson said.

Expanding use

The ability to boost patient safety, improve efficiency and reduce cost has compelled other health care providers to adopt medication bar coding. Users range from the $24 billion HCA health care network to smaller individual facilities, such as Beloit Memorial Hospital in Wisconsin.

The FDA regulation will spur further projects as it eliminates a classic Catch-22 scenario that impeded medication bar coding for years, observers said. Kleinberg said drug manufacturers balked at placing bar codes on medication down to the unit-dose level because hospitals lacked scanners to read them. Hospitals, for their part, questioned the value of purchasing scanners if medication lacked bar codes.

The FDA rule breaks a 'log jam in the use of bar coding in health care,' said Kleinberg, who participates in the Healthcare Information and Management Systems Society's automatic identification and bar coding task force.

The VA, which has a head start in bar coding, now seeks to increase its use of the technology. The department has embarked on its Bar Code Expansion project, which aims to provide a wider range of bar code applications for wireless handheld computers.

The VA awarded a contract, announced in February, to Patriot Technologies, a service-disabled veteran-owned small business. Patriot Technology's team includes Care Fusion, EDS, Symbol and Zebra Technologies. The latter is a bar code printer company.

Care Fusion, the application developer, provides its wCareMed software, which uses bar code scanning to support medication administration. Other Care Fusion products covered under the contract include wCareCollect, which addresses the specimen collection process, and wBloodCare, which verifies blood products before a transfusion.

The software runs on a Symbol handheld computer, which incorporates a bar code scanner. The device is ruggedized for use in health care. Symbol's PPT8800 mobile computer withstands drops on concrete, Kleinberg said. The device is sealed so it may be cleaned with disinfectant without adverse results.

'That type of abuse would kill a standard PDA,' Tighe said.

As for wireless communication, the Symbol handheld devices come equipped with integrated 802.11 radios.

The VA's bar coding system also includes a security regimen. Any wireless environment calls for security. Health care providers have the added duty of protecting patient data and complying with the Health Insurance Portability and Accountability Act requirements.

Bill Hartwell, vice president of Symbol's federal government systems, identified encrypted solutions certified under Federal Information Processing Standards as critical parts of the package. In the VA's case, Fortress Technologies provides the necessary Layer 2 encryption, he added.

When put into practice, the handheld device provides wireless access to a hospital's electronic medication administration record system. That system details the medication and dosage scheduled for a given patient. A nurse scans a bar code on a patient's wristband and scans the bar code on the medication to be administered.

The system then checks the 'five rights': Is the right patient receiving the right medication at the right dosage through the right route of administration at the right time?

The benefits of automation aside, Carlson emphasized that a bar code medication system fails to replace a nurse's clinical judgment. A computer augments nurses' practice, but they still have to perform their own checks, he explained.

The pursuit of bar coding

Hospitals following bar coding's pioneers should have a fairly easy go of it, at least on the technology side. That's particularly the case for providers equipped with robust wireless networks, industry executives say.

'If the infrastructure is in place already'putting a bar coding medication solution on top isn't difficult to do,' said Maryam Esfarjani, senior associate at Booz Allen Hamilton.

'The technology is relatively easy to implement if [health care providers] have the foundation,' Kubiak added.

For an increasing number of hospitals that foundation will consist of an 802.11g network, Tighe said. The 802.11g technology provides higher bandwidth than the widely used 802.11b.

Organizations lacking wireless infrastructure face an extra step but may find favorable pricing as they prepare to field a network. Kleinberg said the cost of wireless technology has dropped dramatically, enabling a 200-bed hospital to install a network for $50,000 to $150,000.

He said the cost of the wireless network represents a relatively small portion of the overall investment in a bar code medication administration application. Kleinberg estimated the total expenditure, including hardware, software and services, from $400,000 to $2 million depending on the size of the facility.

The availability of commercial applications is another plus for hospitals considering a bar coding initiative. The FDA regulation and other patient safety efforts 'have created an increase in the vendors that'are providing the bar coding technologies,' said Chris Ghion, a principal at Booz Allen Hamilton.

Kleinberg noted several companies with bar code medication administration installations including Cerner Bridge Medical, Eclipsys, McKessson and Siemens. Debbie Daspit, director of solution management at Cerner Bridge Medical, said bar coding interest has increased in the past six months. 'I think the industry recognizes the time to do it is now,' she said.

Culture, however, may prove to be the more daunting obstacle for bar code adopters. 'The biggest challenge is changing the work process for caregivers,' Kubiak said. Nurses accustomed to written charts will have to learn a new interface, he said.

Some nurses have used a paper-based system for 10 or more years, Carlson said. 'It's really hard to give up something that has been ingrained that long,' he added.

Carlson said some hospitals didn't want to abandon paper entirely and tried to run a bar code-driven system in parallel. The dual system caused greater issues, he said. For example, nurses found discrepancies between a medication order viewed on a computer system and one on a paper record. The former is updated in real time, but the latter requires several levels of human intervention before it can be updated.

The upshot: A hospital must change 'business processes and business practices when going from a paper system to a computerized system,' Carlson said.

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