Barcoded Medication Administration: Title and subTitle BreakA Last Line of Defense

Preventable adverse drug events (ADEs) generate an estimated $2 billion in direct hospital costs each year and are a substantial source of morbidity and mortality.¹ The 2 processes from which preventable ADEs most commonly arise are medication prescribing and administration. A physician order for penicillin for a patient with a known penicillin allergy is an example of the former, whereas the latter is illustrated by the erroneous administration of 100 units of insulin when 10 were ordered. There has been considerable attention devoted to reducing prescribing error with systematic solutions such as computerized physician order entry, electronic decision support, and pharmacist presence during physician rounds. None of these solutions, however, reduces medication administration errors, which account for 34% of preventable ADEs.²

Although occasionally attracting media attention, fines, and legal action, these errors are difficult to identify and almost never intercepted.² Traditionally, the vigilance of nurses has been the predominant protection against medication administration errors, without any systematic safeguard to ensure that the “5 rights” (right patient, right drug, right dose, right route, and right time) are achieved for billions of medication doses each year. When they do occur, errors in medication administration can be traumatic experiences for the nurses involved, with significant personal and professional consequences. Barcoded medication administration (BCMA) systems are a last line of defense against medication errors and warrant greater advocacy and implementation. Just as couriers are empowered with barcodes to track their packages to safe delivery, so too can nurses be empowered with barcodes to ensure the safe administration of medications to patients.

BCMA is a point-of-care system that requires positive patient identification and electronic verification of medications at the bedside before their administration. A BCMA system includes the following elements: the pharmacy dispenses individually packaged, barcoded medication doses to the patient's location; a nurse scans the patient's wristband and receives a list of medications to be administered; a “stop” or “go” directive, along with pertinent instructions or warnings, is provided; the nurse administers the medication; and each dose is automatically logged in the patient's electronic medication administration record.³

The central feature of BCMA is barcode labeling of medications and patient wristbands. Most are familiar with the ubiquitous 1-dimensional barcode used at supermarket checkouts, but barcode technology encompasses a range of formats that encode information in a machine-readable symbol. More complex 2-dimensional formats have the capacity to encode data such as lot number, expiration date, and unique serial numbers.³ Radiofrequency identification tags (RFIDs) are another potential candidate for point-of-care medication administration. RFIDs, which could be attached to medication packaging or even embedded in pills, wirelessly transmit encoded information to a receiver device. RFIDs have proven useful in a variety of applications, including inventory management, passport control, and electronic payment systems. However, at present, their increased unit cost and the lack of RFID labeling infrastructure in pharmaceutical manufacturing remain barriers to the use of this technology for medication administration.

BCMA systems are composed of hardware—such as mobile barcode scanners, wristband printers, and pharmacy-based medication dispensing robots—and software—such as electronic medication administration records, algorithms for error detection and warning generation, and user interfaces. Vendors and hospital networks have developed modular add-on BCMA systems that can be adapted to interface with existing electronic medical records and comprehensive electronic patient management systems that include BCMA as a core component. Most systems permit some degree of customization to facilitate implementation in different clinical settings.³

Barcodes are used widely throughout hospitals for tracking and management of linens, supplies, and other inventories. Some hospitals use barcode systems to route specimens through diagnostic laboratories, administer blood transfusions, facilitate operating room equipment counts, and administer breast milk in neonatal intensive care units. In each of these settings, barcode technology has reduced errors that had persisted despite traditional educational and organizational strategies to eliminate them.

The Veterans Administration first piloted a BCMA program in the early 1990s and by 2000 had expanded its use system-wide. Across the United States, use of BCMA increased from 1.5% of institutions in 2002 to 9.4% in 2005 (including 16% of hospitals with more than 100 beds).⁴

Several before-after studies, including results from large multi-institution hospital networks, have reported reductions in medication administration error rates of 54% to 86%.^{5 - 6} In other cases, more medication administration errors are detected after BCMA implementation: simply comparing before-and-after rates of reported administration errors can be misleading because passive reporting grossly underestimates the frequency of such errors, and BCMA increases the rate of error detection. The surveillance function of BCMA, which captures and records intercepted erroneous administrations, has found errors in as many as 1% to 2% of medication administration attempts.^{7 - 8} Of these, 12% have involved drugs with potential for serious harm and include errors such as significantly early administration (47%), lack of an existing order (27%), and expired orders (13%).⁸ If generalizable, these rates suggest that up to 200 000 errors in medication administration may be occurring each day in the United States. Although many of these errors would not cause harm, widespread BCMA implementation may prevent 84 000 ADEs per year in the United States, according to one conservative estimate.⁹ Barcode technology has also been evaluated for automated dispensing of medications in hospital pharmacies, with demonstrated reductions in dispensing errors and potential ADEs of up to 97%.¹⁰

BCMA has the potential to intercept hazardous medications or late changes to orders that arise right up to the moment of administration, enabled by a real-time interface with a patient's electronic medical record. A warfarin dose could be automatically flagged when a late laboratory result demonstrates a high international normalized ratio (INR), a phenytoin dose could be halted by a late allergy entry, or a β-blocker administration could be intercepted when the most recent vital signs have documented bradycardia.

BCMA automatically generates an accurate electronic medication administration record, improving both patient care and hospital invoicing. When barcodes include medication lot number and expiration dates, BCMA can facilitate recalls, prevent the use of expired drugs, and help to identify and investigate adverse events related to defects or contamination of drugs. This final attribute may become increasingly important with a worldwide pharmaceutical supply chain, as exemplified by the recent series of heparin contaminant−related adverse drug reactions that has been widely reported in the media.

BCMA requires a significant investment in technology, infrastructure, and training. Pharmacies must have equipment to dispense barcoded doses, patient care areas must be equipped with mobile barcode readers, and information systems must integrate the technology. In addition, barcodes must appear on patient wristbands and on every dose of medication in unit-dose packages. In 2003, the Food and Drug Administration (FDA) estimated that the initial BCMA start-up cost for an average 191-bed hospital would be $377 000, with annual operating and maintenance costs of $315 000.⁹ With nationwide implementation, annual health care expenditures of $680 million could result in an estimated $3.9 billion in annualized public health benefit. Potential gains in hospital efficiencies may add a further $450 million to $720 million to this $3.2 billion annual net benefit.⁹ Cost analyses focused solely on the pharmacy dispensing process suggest that the investment in a barcode system are offset in 5 to 10 years by the avoidance of hospital costs caused by preventable ADEs.¹¹

In a development that could have had a tremendous influence on facilitating BCMA, the FDA in 2004 mandated that by 2006 all drugs sold to hospitals be labeled with barcodes.¹² Despite calls by health care stakeholders, the rule made no provision to require unit-dose packaging. As a result, hospitals using BCMA today must resort to costly and potentially error-prone repackaging for a large proportion of medications. Furthermore, this legislation requires only that the national drug code, encoding product and dose, appear on labels in a linear barcode format. Although this strategy might have been reasonable to streamline implementation, more sophisticated barcode technology can encode other important information such as lot number and expiration dates.

Nurses have been some of the greatest proponents of this technology, but BCMA has the potential to disrupt nursing routines. Cumbersome workstations, frequent disconnections, power losses, sluggish software, and degraded, missing, or unreadable barcodes may all contribute to error, inefficiency, and frustration. Such deficiencies also may lead to workarounds that subvert BCMA's safety benefits, such as scanning a wristband attached to the patient's bed instead of the patient's wrist or scanning an empty medication package instead of the actual medication to be administered. The electronic surveillance of medication administration times may cause nurses to excessively focus on accurate administration times at the expense of other important nursing duties. Despite these concerns, limited data show high nursing satisfaction with BCMA¹³ and no change in the time spent on medication administration or on other patient care tasks.

Like any technologic solution, BCMA could lead to new sources of error. Potential problems include excessive warnings of limited merit,⁸ mislabeled medications, or patients to whom the wrong wristband is attached.¹⁴ Mislabeling can be minimized by avoiding medication repackaging, and misidentification can be mitigated by continuing to use a second patient identifier and designing rigorous procedures to error-proof the process of patient wristband application. Special consideration is required for implementation in critical care units, for emergency delivery of doses of medications, and for the management of system downtime.

When stakeholders convened with the FDA in 2002, there was a clear consensus on the potential safety benefits of BCMA. The available evidence supports this view, although it is limited in scope and largely observational. Six years later, the health care system remains far from realizing the potential safety improvements that BCMA promises. The lack of universal availability of the necessary raw material—barcoded single-unit dose medications—has been a major contributor to this delay. Drug manufacturers should be required to offer all medications in single-unit dose format, with barcode labeling. Barcoding requirements should expand to include lot number and expiration date, and hospitals should be required to implement barcoding as a preferred form of positive patient identification.

Technology is not static, and novel solutions will eventually prove superior to barcodes. Any legislation related to BCMA must be sufficiently flexible to allow new advances to be developed and implemented.¹⁵ However, although care must be taken to avoid hindering progress, the health care system can no longer afford to defer the solution at hand. Moreover, funding agencies should prioritize research into BCMA implementation strategies to optimize its benefits and minimize potential downsides, as well as support efforts to develop new and more effective electronic medication administration technologies.

Nurses have long served as the last line of defense against medication errors. The health care system must wait no longer to provide them, and all patients, with the systematic safety net that they deserve.