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A CALL TO ACTION:
Safeguard Drug Administration Within 2 Years!


BAR CODING OF UNIT DOSES CAN REDUCE MEDICATION ERRORS

November 2002 Second in a series of White Papers from the

Copyright © 2002 by the Institute for Safe Medication Practices. All rights reserved.

Example of an HIBCC Data Matrix Code for a Unit-Dose Package

About the Institute for Safe Medication Practices

The nonprofit Institute for Safe Medication Practices (ISMP) was formally established in January 1994, but its efforts to prevent medication errors began far earlier, in 1975. The Institute works closely with healthcare practitioners (i.e., physicians, nurses, pharmacists), regulatory agencies, healthcare institutions, professional organizations, and the pharmaceutical industry to provide education and expert recommendations to prevent adverse drug events. ISMP is governed by a volunteer board of trustees representing a cross-section of the healthcare community, including medicine, community pharmacy, health system pharmacy, consultant pharmacy, academia, nursing, the pharmaceutical industry, professional healthcare organizations, managed care, healthcare consumers, and healthcare administration.

ISMP provides independent review of all reports voluntarily submitted to the United States Pharmacopeia
(USP) - ISMP Medication Errors Reporting Program (MERP). As MedWatch partners, USP and ISMP share all information and error prevention strategies with the U.S. Food and Drug Administration. Many journals and newsletters regularly publish ISMP error advisories and safety alerts. ISMP’s own ISMP Medication Safety Alert! newsletters, available in acute care and community/ambulatory care editions, have subscribers in U.S. hospitals, community pharmacies, and ambulatory settings and in 30 countries internationally. ISMP’s web site (www.ismp.org) contains extensive information on medication errors, including a comprehensive bibliography.

Institute for Safe Medication Practices
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Fax (215) 914-1492
www.ismp.org

Publication Development
This publication was prepared for press by Calibre Publishing, Inc., and KAJ Graphics, both of Minneapolis, Minnesota. Development and distribution were made possible through an unrestricted educational grant from Abbott Laboratories, North Chicago, Illinois. The grant makes possible the related educational activity conducted by Joint Purchasing Corporation.

Continuing Education

An educational activity conducted by Joint Purchasing Corporation is available via the web site of the Institute for Safe Medication Practices (www.ismp.org). The program has been assigned ACPE #192-000-02-012-H04 and will award 1 contact hour (0.1 CEUs) of continuing pharmacy education credit.

Click here for continuing pharmacy education credit.

The views expressed herein represent those of the Institute for Safe Medication Practices and not those of the publisher, sponsor, or educational provider.

Examples courtesy of the Health Industry Business Communications Council.

Executive Summary

MEDICATION ERRORS became front page news in 1999 with the release of a report from the Institute of Medicine (IOM), which concluded that medical errors of all kinds cost as many as 98,000 American lives each year and that medicationrelated errors alone account for up to 7,000 deaths. A second IOM report issued in 2001 suggested ways in which information technology (I.T.) could contribute to a safer, more efficient, and higher quality healthcare system.

The Institute for Safe Medication Practices (ISMP) is convinced that one of the most promising technologies is a familiar one—bar coding, a type of machinereadable coding commonplace in supermarkets, department stores, and most retail settings. A bar code is a set of symbols that serves as a reference to a database entry, much in the way that a car’s license plate is linked to stored information about the vehicle and its owner. Read by devices called scanners that can be connected to computer networks, bar codes provide a highly efficient way to capture data, both more rapidly and far more accurately than keyboard entry.

Medication errors are rarely the fault of an individual healthcare professional but rather represent the failure of what can be called the medication use system. About a third of these errors are errors in drug administration; bar coding technology is likely to be especially useful for reducing the incidence of errors at that stage, particularly in acute-care facilities such as hospitals, which rely on regimented processes for administration of drugs. Thus, in the acute-care setting, ISMP sees the patient’s bedside as offering one of the greatest potentials for utilizing bar coded medications to enhance safety.

The use of bar codes is also valuable for ensuring dispensing accuracy, as well as for purchasing and inventory control. In fact, community pharmacies and mail-order pharmacies, in particular, have embraced bar coding to a much larger extent than acute-care facilities. Ultimately bar coding applications can address drug administration errors in long-term care facilities, outpatient clinics, and home care settings.

In an optimally bar coded acute-care setting, a nurse would scan his or her identification badge, the patient’s identification band, and the intended drug’s bar coded label with a bar code scanner. A mismatch between the patient, the drug packaging applied during manufacturing or repackaging, and the patient’s medication record would trigger a warning, prompting the nurse to investigate the discrepancy before administering the medication. The system would also check a “rules engine” for any alerts or reminders for the nurse; it would also electronically document administration of the medication.

That kind of “error trapping” is possible only if medications are labeled with bar codes at the unit dose level—the actual unit (or dose) to be given to a patient at a specific time. Unfortunately, only about 35% of medications in a typical hospital have labels bar coded at the unit-dose level, and a far smaller percentage (less than 5%) of hospitals are now equipped to read bar codes at patients’ bedsides. This is true even though emerging studies point to the benefits of bar coding in reducing drug administration errors.

Key Challenge to Implementation

SO FAR THE PRINCIPAL OBSTACLE to widespread use of bar coding systems at the point of care is a chicken-and-egg issue: Which comes first, unit-dose medications with bar codes on their labels or the implementation by hospitals of the systems designed to read them? Hospitals and other healthcare providers have delayed buying the hardware and software necessary to process bar coded information at the bedside because manufacturers do not always provide bar coding of medications at the unit-dose level, while pharmaceutical manufacturers have delayed bar coding such labels on the grounds that so few hospitals are equipped to make effective use of them.

The U.S. Food and Drug Administration (FDA) has indicated its intent to issue regulations to break out of this cycle by requiring manufacturers to assign bar codes to the labels of medications distributed for human use. ISMP welcomes this action, believing it is long overdue.

A CALL TO ACTION

ISMP URGES THE FDA to move forward quickly, setting firm deadlines for placing bar codes on the labels of all medications, including unit doses of medications. Once this occurs, market forces can be expected to accelerate the pace of change. A major policy issue, which has both safety and cost implications, is the information content of the bar coded label. ISMP believes that, to be fully effective, bar codes should include not only the National Drug Code (NDC) number (a unique product identifier for medications), but also a manufacturer’s lot number and expiration date.

ISMP applauds those leaders in the pharmaceutical industry who have begun to act even before the FDA rule-making process is complete. We urge others to speed up the transition. At the same time, we also call on healthcare institutions to begin the necessary planning for bedside bar code scanning of medications into
their overall operations.

Bar coding is a mature technology; it has long been used to track inventories and sales of individual retail items from bread to household appliances. It is likely to be equally effective in monitoring the dispensing and administration of medications. While no technology is ever a panacea, it is inexcusable to continue to neglect this technology’s potential for preventing patient harm. If bar coding works in the retail setting, imagine what it can do in healthcare. That’s why ISMP is calling for manufacturers to provide unit-dose bar coding of medications, with a minimum of each product’s NDC number within 2 years and a more complete bar code that includes the lot number and expiration date within 3 years. ISMP is also calling on all U.S. acute-care facilities to implement bedside bar code scanning of medications within 3 years.

Medication Errors:
Harnessing Technology for Safety at the Point of Care

MEDICATION ERRORS became front page news in 1999 with the release of a compelling report from the Institute of Medicine (IOM) titled To Err Is Human: Building a Safer Health System. IOM analysts concluded that medical errors of all kinds, which occur at every stage of the healthcare process, could cost as many as 98,000 American lives each year and that medication-related errors alone account for up to 7,000 deaths. The IOM estimated the financial costs of drug-related morbidity and mortality at about $77 billion a year.
The IOM report emphasized that errors are rarely the fault of individual healthcare professionals, but instead stem from failures of a complicated healthcare system. Accidents involving drug use tend to result from a series of failures in what can be called the medication use system (see figure 1); consequently,
many errors can be reduced by carefully designed changes in how prescription drugs are prescribed, dispensed, and administered.

A second IOM report titled Crossing the Quality Chasm, issued in 2001, suggested a number of ways in which information technology (I.T.) can contribute to a safer, more efficient, and higher quality healthcare system. Crossing the Quality Chasm urged a patient-centered approach to technological investments. The end result would be what the IOM calls an “adaptive” system, in which “error trapping” technology would also improve clinical decisions, enabling them to be tailored to individual patients’ characteristics, specific conditions, and genetic makeup. (When errors cannot be completely prevented, it is desirable to automate those error-prone repetitive tasks, thus enabling recognition of errors before they are translated into accidents; the mechanism by which such errors are recognized is called “error trapping.”)

Pinpointing Systemic Failures

MANY NATIONAL ORGANIZATIONS have called attention to the issues identified by IOM (see table 1), with several interdisciplinary coalitions making headway toward reaching consensus on key approaches to resolving them. The Institute for Safe Medication Practices (ISMP) began its work with preventing medication errors in 1975 and, thus, is gratified that the human and economic costs of medication errors are now receiving significant public attention.

ISMP was one of the first organizations to promote the use of an errorprevention technique called failure mode and effects analysis (FMEA) in healthcare, which can be used to pinpoint areas in the medication use system where the process is most likely to fail.(1) The effects of failure can then be predicted and effective safeguards put into place. Preventive measures include redesign of tasks, automation of error-prone operations, and education of personnel to make full use of what technology can offer. Studies show that many medication errors (39%) occur at the time prescribers order medications.(2) Accordingly, an initial ISMP white paper recommended a technology-based strategy for eliminating a major source of errors at the very beginning of the medication use system: handwritten prescriptions.(3) Medication orders written on paper pads or in patients’ charts by busy prescribers are all too often illegible or easily misinterpreted. ISMP urged prescribers, regardless of their practice setting, to replace paper-based notes with keyboard- or handheld-based input, and it continues to urge that electronic prescribing be more widely adopted.

In addition to reducing errors caused by illegible handwriting, electronic prescribing can automate the process of checking a prescription against relevant drug and patient information stored in electronic databases that otherwise may not be readily available to the prescriber. Computers can, for example, alert prescribers to patients at risk of allergic reactions to prescribed medications or who are at risk for adverse interactions with other medications. Use of computerized order entry programs have resulted in huge improvements in detecting errors; one hospital experienced a 55% reduction in errors after implementation of computerized prescriber order entry.(4)

The Last Line of Defense

ANOTHER KEY STAGE for reducing medication errors occurs near the end of the process: when the selected drugs are actually administered. Coincidentally, research suggests that the percentage of errors occurring at the medication administration stage (38%) closely reaches the proportion of errors occurring at the medication ordering stage.(2) As with prescribing errors, administration errors are not due to human carelessness, but are the result of system failure.

Nearly half of the medication errors that originate with prescriber orders are intercepted before they reach the patient (86% of them by nurses and 12% by pharmacists), but only 2% of drug administration errors are intercepted.(2) To solidify this last line of defense, ISMP sees a role at the patient’s bedside for the
scanning of medications whose labels contain a bar code—a technology so familiar as to be taken for granted when used in supermarkets, department stores, and most retail settings. (As scanning technology evolves, “machine-readable code,” a more inclusive term, is likely to be adopted, but since the term “bar code” is now more commonly recognized, it is used throughout this paper).

For more than a quarter of a century, in industry after industry, bar codes have enabled organizations to keep track of large and variable inventories and to fill orders rapidly and accurately. Tests have shown that bar coded information can achieve an accuracy rate of one error per 10 million characters, compared with
typical keyboard entry error rates of one error per 100 characters.(5) The experience of other industries suggests that implementing bar coding technology is also costeffective. Although the initial cost can be substantial, reduced errors and increased customer satisfaction typically produce rapid paybacks.
Hospitals have long recognized the value of this technology and already use it for many purposes: to label blood and laboratory samples, to manage equipment inventories, to track patients (by bar coded identification bands), and to track patients’ medical records, among other applications. Similarly, most pharmaceutical manufacturers routinely assign bar codes to product labels on their assembly line for quality checks and to bulk containers of medications before shipment. Community and mail-order pharmacies have adopted bar code scanning to ensure the correct preparation and dispensing of medications.

Nevertheless, a 1999 study indicated that only slightly more than 1% of American hospitals use bar code scanners to verify that medications are properly administered at the patient’s bedside.(6) Recently, this percentage has increased as the U.S. Veterans Health Administration has implemented bedside bar coding for drug administration in its hospitals. But, in general, it seems that bar coding is used everywhere throughout our society except where it might just do the most good—preventing patient harm. Surely that application is worth pursuing: That’s why ISMP believes that bar codes should be added to the arsenal for fighting medication errors, even though it will require coordinated action at virtually every point in the healthcare system from the manufacture of pharmaceuticals to their administration at the point of care.

How Bar Codes Work

BAR CODES ARE machine-readable symbols composed of black and white bars and stripes; some bar codes take the form of mosaics in checkerboard or honeycomb patterns. The data encoded within these symbols usually form a string of alphanumeric characters that serves as a reference to a database entry. Think of the license plate on a car, which does not itself contain encoded information about either the vehicle or its owner, but enables such information to be efficiently located. Similarly, the bar code on a jar of peanut butter enables the proper scanning equipment to automatically look up in a supermarket database information on the product, manufacturer, shelf life, and current price.

Many varieties of bar code symbols are in common use, but all fall into one of three basic categories: Linear bar code symbols have tall printed bars of varying widths; two-dimensional (2-D) bar codes are based on matrices of printed dots or densely packed multiple rows of bars; and composite symbols combine linear and 2-D features. In all cases, coding conventions are established by standards organizations representing
broad cross-sections of industry constituencies. For example, almost all items sold in retail stores in the United States and Canada carry the symbols of the Universal Product Code (UPC) promoted by the Uniform Code Council (UCC) or sometimes an expanded code that includes European Article Numbering (EAN) Code, issued by a similar organization operating in Europe. Industry-specific codes are also common, such as those used by the U.S. Postal Service and carriers like Federal Express and United Parcel Service. Manufacturers of healthcare products, as well as hospital pharmacies, have the option of using either UCC/EAN codes or those promoted by the Health Industry Business Communications Council (HIBCC), another nonprofit standards development group.

Bar codes are read by devices called scanners. Scanners may be stationary (like those at supermarket checkout counters), but the acute-care setting benefits from portable handheld devices (wands, pens, or items resembling personal digital assistants), especially those operated via wireless networks. Once the data captured by the scanner are in the computer, a reading program not only decodes the symbols but also turns them into keyboard characters that can be read on a screen or used by other software programs, just as if the same symbols had been keyed in. The chief advantage of bar coding is that it offers a high degree of confidence that the desired information has been accurately collected and communicated—and
with a single swipe of the bar code with the scanner.

Automating the Point of Care

IT ONLY STANDS to reason that bar coding technology could enhance the safety of human patients as profoundly as it has streamlined the retail industry, especially within acute-care facilities. And, in fact, some studies are emerging that reveal positive results within hospitals that have started utilizing bar codes at the point of care.(7-9)

Of special note is research conducted by the Veterans Health Administration, which introduced a pilot program at the Colmery-O’Neil Veterans Affairs Medical Center in Topeka, Kansas, using wireless, point-of-care technology with an integrated bar code scanner.(10) The results have been impressive: From the time the program was introduced in 1995 through 1999, the test hospital administered 5.7 million doses with dramatic reductions in each of five categories of error. Analysis showed that the bar coding system had prevented more than 378,000 medication errors. Table 2 shows the reported improvements among different kinds of errors.

Implementing point-of-care bar code scanning of medications in acute-care facilities generally takes advantage of the fact that drug administration involves a highly regimented process, with nurses often serving as the last health professionals in direct contact with patients before drug administration. Nurses routinely learn the “five rights” for administering medications: right medication, right patient, right dose, right route, and right time. Thus, in the inpatient setting at least, the final chance for healthcare practitioners to identify errors that have passed through the system occurs at this crucial point.

Yet once a drug has arrived from the hospital pharmacy to the patient’s unit, a nurse must undertake an extensive set of checks:

  • determine the medication to be administered;
  • obtain the drug from storage, often from a patient’s specific medicationcassette or an automated dispensing cabinet;
  • check the drug’s label when removing it from storage;
  • check the label for accuracy against the patient’s medication administration record (drug, dose, time, and route of administration);
  • take the medication to the patient’s room;
  • positively identify the patient;
  • recheck for the right medication, right dose, right route, and right time;
  • in case of questions or concerns, call the pharmacy for verification; clarification, or substitution;
  • administer the medication; and
  • record the medication administered, including how and when, and sign that record.

Errors may occur at any of these points. The wrong medication may be obtained or a label misread. A drug intended to be administered sublingually may be administered orally. A patient’s I.D. band may be misread, or a patient may be mistaken for another one with a similar name or condition. (It is especially easy in
pediatric wards to confuse one infant or child with another.) The medication label may not be rechecked or an incorrect time may be entered into the record.

Bedside bar coding systems linked with other important technology systems (e.g., a pharmacy information system, computerized prescriber order entry) hold promise for eliminating all of these errors. In such a scenario, a physician or other prescriber would directly enter an order into a computer. The order would immediately be available to the pharmacy to check and verify, then be released to the medication administration record available to the nurse.

A nurse or other healthcare practitioner administering medications would scan his or her identification badge, the patient’s I.D. band, and the intended drug’s label with a bar code scanner (see figures 2 and figure 3). A mismatch with the patient’s band, the bar code applied to the drug packaging, and the patient’s medication profile would trigger a warning, prompting the practitioner to investigate the discrepancy before
administering the medication. (The system would also check a “rules engine” for possible interactions with any other medications the patient is taking, as well as suggest parameters that may be necessary to monitor before and/or after administering the medication.) If a proper match is made, the drug, dosage, and time of administration would all be entered automatically into the patient’s electronic medical record.

This real-time system enables instant updates for everyone in the medication use loop. Additional benefits are also significant, including streamlined workflow, notifying nurses of unadministered medications, and reductions in time documenting and annotating charts.

Point-of-care bar code scanning, then, confirms the patient’s identity, matches that identity with his or her medication profile in the pharmacy information system, checks for any alerts or reminders for the nurse, electronically records the action in an online medication administration record, and stores the data for later aggregate analysis. The patient’s bar coded I.D. band must, of course, be applied by the hospital, normally at the point of admission when an identification number is entered into a database. The bar coded label for the medication can be applied by the manufacturer, by a repackager of bulk medications, or by the dispensing pharmacy. (The pharmacy information system must be integrated or interfaced with the point-of-care bar coding system.) Bioidentification systems, such as iris scanning and fingerprinting, which now are used outside of healthcare, will be available in the near future to better identify healthcare practitioners and patients.

Bar Coded Unit Doses

ERROR TRAPPING by bedside medication bar code scanning is feasible only if both the patient’s I.D. band and the unit dose of medication to be administered have been labeled with bar codes. The term “unit dose” means a single dose to be taken by a patient at a specific time. It should not be confused with “unit of use,” a term applied to medication packages, which may be used for a course of therapy. For example, a seven-day course of therapy for one patient may be dispensed in one unit-of-use package.

From a patient safety perspective, the superior approach for implementing bar codes on pharmaceutical products is for manufacturers to supply them on unit-dose packaging. Drug manufacturers can and do implement quality control procedures that are far more stringent and accurate than those available to most
healthcare institutions. Moreover, a general rule of error prevention applies here: The more steps involved in a process, the greater the chance for error to occur. Each repackaging step that a hospital must incorporate into the system will therefore increase the possibility of error in the dispensing process.(11)

With the availability of a lot number and expiration date on medications, healthcare providers will be able to easily track drug recalls and prevent the inadvertent administration of expired drugs. A recent vaccine recall, for example, necessitated one large healthcare system to devote hundreds of staff-hours to manually review written logs of information in order to retrieve stored medication and identify patients who may have received the medication.

Equally important, bedside bar code scanning of unit-dose medications permits analysis of “near misses”—situations where a mismatch between a medication label and a patient I.D. band enables a nurse to avert an error. Because no error actually occurs, these near misses would normally never be reported. Automated point-of-care error trapping records this valuable information, enabling analysts to make appropriate system-wide procedural changes. The analysis of this information must focus on system failures and not individuals. ISMP believes that the identity of the person who administered the medication should not be used in error analysis.

A recent survey reported in ISMP’s ISMP Medication Safety Alert! showed that many hospitals were experiencing a decrease in availability of unit-dose medications from manufacturers.(12) ISMP strongly recommends that hospitals obtain the majority of products in unit-dose or ready-to-use packaging whenever possible from manufacturers. This includes oral as well as intravenous products. Hospital pharmacies should review their formulary product line and utilize products that are available in unit dose. The ISMP survey also revealed that hospitals are willing to pay extra for unit-dose products. The possibility for error when preparing medications in-house far exceeds the added cost of obtaining, for instance, prefilled syringes and premixed intravenous solutions.

For all these reasons, the bar coding of unit doses of medications for use in bedside bar code scanning of medications has been endorsed by the American Hospital Association, the American Society of Health-System Pharmacists, the American Pharmaceutical Association, and the American Medical Association—in
fact, by most of the organizations listed in table 1.

Key Challenge to Implementation

SINCE THE POTENTIAL of bar coding at the point of care to reduce medication errors is well accepted, why is it not already in common use in hospitals? The answer involves what analysts for the Healthcare Information and Management Systems Society (HIMSS) have referred to as a classic chicken-and-egg problem(13):
  • Hospitals and other healthcare providers have delayed investments in scanners, networks, and supporting software until pharmaceutical manufacturers routinely apply bar codes to individual packages of prescription medications. At present only about 35% of medications in a typical hospital
    have labels containing a bar code at the unit-dose level.(11) Automating the point-of-care would require hospital pharmacies to apply bar coded labels (or arrange for them to be applied by a repackager) to roughly two-thirds of their inventory.
  • Pharmaceutical manufacturers have delayed incurring the cost of applying bar codes to individual medication packages on the grounds that fewer than 5% of hospitals are equipped to scan unit doses at the point of care. Why, manufacturers ask, should we apply bar code labels when there is no market advantage to doing so as long as so few end users are equipped to read them?

Concern about capital expenses is understandable, given the costs of retooling healthcare facilities and pharmaceutical warehouses; one estimate places the total costs for adding bar codes to all product packages to be in excess of $1 billion.(14) Uncertainty about standards also has delayed investments by both providers and manufacturers. Manufacturers naturally want to use the standards that will satisfy the needs of most customers, both in the foreseeable future and over the long term. Providers need assurance that the hardware and software they buy will be able to read the codes that most, if not all, manufacturers use.
Setting standards involves two issues, the first of which is the information content of the bar coded label. ISMP believes that the bar coded label on unit-dose packages should include:

  • a unique product identifier,
  • a lot number, and
  • the drug’s expiration date.

The unique product identifier should be the National Drug Code (NDC) number for manufacturer-supplied products and manufacturer-repackaged products. For products that are patient-specific and prepared or compounded by the hospital, ambulatory site, or outside vendor, the provider would place an identifier to enable the identification of the ingredients or unique dose of the medication. This would include bar codes placed on intravenous solutions with patient-specific additives, partial doses of medications, pediatric doses, extemporaneous preparations, etc.

The lot number and expiration date should be supplied on the bar code from the manufacturer. For patient-specific doses, prepared by the provider as described above, the provider should include an internal lot number and expiration date.

Each of these items is important in administering the right drug in the right dose to the right patient. Although there is widespread consensus among healthcare stakeholders that bar codes should include the NDC, it is not as widely held, especially among many manufacturers, that the other two elements are necessary.
However, incorporating them into any bar coding scheme is often technically feasible and also critical for reducing medication errors to the fullest extent. In the case of product recalls, for example, lot numbers and expiration dates facilitate the tracing of medications that are on pharmacy shelves, were used in filling prescriptions, or have already been administered to patients. The time frame for implementation of these requirements may be different, but they are all necessary nonetheless.

A second standards-related issue involves the symbology in which content is encoded, including the choice between UCC/EAN or HIBCC codes. The amount of information carried within a bar code and the size of the label onto which it must fit affect the choice of symbology. Minuscule labels (e.g., those on ampules of 5 mL or smaller) may require codes that must be read by imaging scanners. One promising option is reduced-space symbology (RSS), which one manufacturer says can be added to vials and ampules as small as 2 mL; in fact, it will use RSS to bar code some of its injectable product line. Scanners capable of reading RSS are widely available, or current scanners may be enhanced via minor upgrades. The adoption of technology such as data matrix codes will require imaging scanners, which will further increase costs for hospitals, yet data matrix codes will most likely be the symbology of choice in the future.

Human and Technical Challenges

OTHER CHALLENGES to implementation include the ability of vendors to offer a bar coding solution that is easily incorporated into the acute-care facility’s current I.T. system, the facility’s ability to install and maintain the system, and human factor issues.

Human factors cannot be minimized. For example, ISMP has published in ISMP Medication Safety Alert! numerous reports of “work arounds” with the use of bedside bar coding. Preprinted cards with commonly used medications and their bar codes often are developed because some scanners may not be readily capable of reading curved surfaces (e.g., intravenous solutions, ampules, wristbands). This practice defeats
the goal of electronically verifying the actual medication at the time of administration.

I.T. vendors must be evaluated for their products’ ability to interface and/or integrate with the acute-care facility’s current I.T. system. The ease of maintaining the system and its database is equally important. Maintaining one drug database for the provider is ideal, although not always feasible. (Over time, because a bar code is an index to a database, hospital information officers will want to eliminate, if possible, the necessity of maintaining more than one database with links to other software.) A number of I.T. vendors have focused their energies on offering bar coding solutions for the healthcare industry (see table 3). Many of their products enable the bar coding software to integrate with application suites already used within hospitals, such as billing and the collection of clinical data.

Indeed, because the real value of bar codes lies in their ability to reference stored information, the choice of computer software, as well as hardware, is crucially important. Newer scanners read codes in multiple formats, and many older ones can be reprogrammed to do so.

Providers may find it useful to complete a readiness assessment for a bar coded administration system. One such assessment is under collaborative development by ISMP, the Health Research and Education Trust, and the American Hospital Association, which should be available by the first quarter of 2003.

It is worth noting that the transition from a paper-based system to an electronic system for managing the administration of medication will require staff education. In particular, all healthcare practitioners should be consulted on system design, workflow analysis, and hardware selection. Put simply, systems that are difficult to use will not be used. Practitioners need to understand exactly how bar coding contributes to patient safety so that they will not, for example, defeat the technology’s purpose by administering a medication first and then scanning in its label, as if they were completing an after-the-fact record on a paper chart. If the need for any of these work arounds are encountered, they should be immediately shared with the entire team in order to make system enhancements.

Progress Under Way

FORTUNATELY, THE PROSPECTS for rapid implementation of point-of-care bar coding systems may be better than the preceding paragraphs imply.

In July 2002, the U.S. Food and Drug Administration (FDA) announced its intent to issue rules requiring bar codes on packaging of prescription drugs, as well as its intent to release those proposed regulations by the end of the calendar year. Whatever the scope of those rules and of the timetable by which they must be implemented, the FDA initiative seems sure to catalyze both manufacturers and providers. Once the FDA provides manufacturers with implementation deadlines and a framework for decisions—i.e., standards for bar code information content and performance criteria for electronic data interchange—the “Who goes first?” basis for delays will vanish. At that point, even admittedly complex technical issues, such as those involving choices among symbologies, seem likely to be resolved by market forces.

This phenomenon has been witnessed in other industries. About 20 years ago in the American retail sector, for example, bar coding became almost universal after Safeway and Wal-Mart announced that they would no longer buy from suppliers who did not bar code individual items. Soon thereafter, bar codes began to appear on unit packaging of everything from chewing gum to children’s toys.

The healthcare industry is fragmented, and no single buyer has the kind of market-moving muscle that many large retail organizations enjoy. Nevertheless, the U.S. Veterans Health Administration has announced that it prefers its 173 hospitals, when purchasing medications, to purchase those whose unit doses have been labeled with bar codes. Similar messages by other large healthcare systems should provide a major competitive incentive for manufacturers to accelerate the investments and develop the production lines that packaging unit doses of medications with bar codes will require. (Several Internet web sites monitor such activities; see table 4.)

Some pharmaceutical manufacturers have not waited for FDA regulatory action to begin adding bar codes to unit doses of important categories of medications. For example, Abbott Laboratories announced in the summer of 2002 that it would affix bar codes to all of its hospital injectable pharmaceuticals and I.V. solutions by early 2003. Similarly, Baxter Healthcare Corporation currently applies bar codes to about
70% of its premixed products, including many of its I.V. products.

Finally, although ISMP’s recommendations for capitalizing on bar coding technology focus on the reduction of medication errors in the inpatient setting, applications also can address drug administration errors in long-term care facilities, as well as outpatient clinics, home care settings, and community pharmacies. For
example, as widespread adoption drives down the cost of scanning technology, it seems likely that it will become cost-effective to equip homebound patients and caregivers with scanners linked to online databases. Elderly patients and their caregivers, often challenged to read fine-print text labels or confused by look-alike medication bottles, will be educated to scan a label to verify compliance; the scanner can set off an alert if a medication is not taken, taken too often, or taken in conjunction with one that may risk complications.

A CALL TO ACTION

ISMP BELIEVES that mounting evidence, combined with an almost inescapable inference based on the experience of other industries, suggests that bar coding has the potential to reduce errors in medication administration. And the organization is encouraged that the FDA appears ready to demonstrate leadership in requiring bar coded labeling on human drug products.

ISMP believes that manufacturers’ labels should include a bar code with the NDC number, lot number, and expiration date. The NDC number should be an immediate requirement, with implementation within 2 years. If the FDA decides to allow a somewhat longer lead time for adding lot numbers and expiration dates to the bar codes, the regulations should contain a firm timetable of 3 years for full compliance. ISMP also recommends that healthcare providers in the acute-care setting implement bar coding technology for bedside drug administration within 3 years.

ISMP believes that the final FDA regulation should encourage manufacturers to adopt symbologies currently utilized in most healthcare settings. The marketplace will dictate further changes as new technology is introduced. ISMP also calls upon the FDA to be ready to assist manufacturers in approving labeling changes on unit-dose products in order to permit space for bar codes.

ISMP applauds leaders in the pharmaceutical industry who have begun to act even before the FDA rule-making process is complete. We recognize that manufacturers have difficult decisions to make about technical standards, equipment orders, and production processes, among other choices. We call on industry leadership to make these decisions as rapidly as possible to speed up the transition to packaging labeled for safety.

We also urge healthcare providers, especially acute-care facilities, to begin the necessary planning for integrating point-of-care bar code scanning of medications into their overall operations. This will require that hospital pharmacists, medical directors, nurses, administrators, and I.T. officers analyze workflows, evaluate hardware and software options, and plan and execute staff education.

In summary, bar coding is a mature technology whose benefits have been amply demonstrated in virtually every other American industry. Surely it ought to be equally effective in enhancing the dispensing and administration of medications. While no technology is a panacea, it is inexcusable to continue to neglect
this particular technology’s potential for saving human lives, especially in light of recent evidence-based studies. If bar coding can succeed in the retail setting, imagine what it can do in the healthcare setting.
That’s why ISMP is calling for manufacturers to provide unit-dose bar coding of medications, with a minimum of the product’s NDC number within 2 years and a more complete bar code that includes the lot number and expiration date within 3 years. And that’s why ISMP is calling for implementation of bedside bar code scanning within U.S. acute-care facilities within 3 years.


References

  1. Cohen MR, Senders J, Davis NM:
    Failure Mode and Effects Analysis: A novel approach to avoiding dangerous medication errors and accidents. Hosp Pharm 1994;29:319-330.
  2. Leape LL, Bates DW, Cullen DJ, et al:
    Systems analysis of adverse drug events. JAMA 1995;274:35-43.
  3. Institute for Safe Medication Practices:
    A Call to Action: Eliminate Handwritten Prescriptions Within 3 Years! ISMP, Huntingdon Valley, PA,
    April 2000.
  4. Bates DW, Leape LL, Cullen DJ, et al:
    Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA 1998;280:1311-1316.
  5. Yang M, Brown MM, Trohimovich B, et al:
    The effect of barcode-enabled point of care technology on medication administration errors. April 2001. Available at: www.mederrors.com/resource_main_set.html
  6. American Society of Health-System Pharmacists: National survey of pharmacy practice in acute care settings:
    dispensing and administration, 1999. Am J Health-Syst Pharm 2000;57;1759-1775.
  7. Meyer GE, Brandell R, Smith JE, et al:
    Use of bar codes in inpatient drug distribution. Am J Hosp Pharm 1991;48:953-966.
  8. Hokanson JA, Keith MR, Guernsey BG, et al:
    Potential use of bar codes to implement automated dispensing quality assurance programs. Hosp Pharm 1985;20:327-337.
  9. Puckett F:
    Medication-management component of a point-of-care information system. Am J Health-Syst Pharm 1995;52:1305-1309.
  10. Malcom B, Carlson RA, Tucker CL, et al:
    Veterans Affairs: Eliminating medication errors through point-of-care devices. Technical paper for the 2000 Annual HIMSS Conference. Submitted November 30, 1999.
  11. U.S. Food and Drug Administration:
    Bar code label requirements for human drug products, hearing record from a public meeting held on July 26, 2002. Available at: www.fda.gov
  12. Institute for Safe Medication Practices:
    ISMP Medication Safety Alert!, March 6, 2002.
  13. Simpson NJ:
    Advocacy White Paper: Bar coding for patient safety. Presented at the 2001 Annual HIMSS Conference. Available at: www.himss.org/content/files/whitepapers/wp_barcoding.pdf
  14. Tribble DA:
    Bar coding a must for patient safety [letter to the editor, with editorial response]. Am J Health-Syst Pharm 2002; 59(7):667-668
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