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BCMAProceedings

Bar Code Medication Administration

Selected Works from BCMA Conference,

ALARIS® Center for Medication Safety and Clinical Improvement

April 25, 2003, San Diego, CA

Philip J. Schneider, MS, FASHP, Editor

Opportunity and Evidence

Government, Associations, Organizations

Nursing Perspective

Implementation - Lessons Learned

Complementary Technologies

Roundtable Discussion

Conference Report Published by:www.alarismed.com/alariscenter

The ALARIS® Center for Medication Safety and Clinical ImprovementSan Diego, CA

2003

Inter-Professional Conferenceon Bar Code MedicationAdministration

The second conference at the

ALARIS® Center for Medicat ion Safety

and Cl in ica l Improvement in San Diego,

he ld on Apr i l 25 , 2003, brought

together a d ist inguished faculty f rom

cl in ica l pract ice , academia , industry,

organizat ions and government . Phi l ip J .

Schneider, MS, FASHP, Director of the

Lat io la is Leadership Program and

Cl in ica l Professor at the Ohio State

Univers i ty, chaired the conference and

moderated the roundtable d iscuss ion .

Nat ional ly recognized experts f rom

mult ip le d isc ip l ines focused on the

benef i ts and chal lenges of bar code

medicat ion administrat ion .

Proceedings Bar Code Medication Administration Conference

1


2

TABLE OF CONTENTS

EDITORIAL

3 Building a Safety Net for Medication Use: Challenges and Opportunities. Philip J. Schneider, MS, FASHP,The Ohio State University

OPPORTUNITY AND EVIDENCE

4 Framing the Opportunity for Bar Code Medication Administration. Philip J. Schneider, MS, FASHP, The Ohio State University

6 The Use of Bar Code Technology to Improve Medication Safety: Reviewing the Evidence. Eric Poon, MD, MPH, Brigham and Women’s Hospital

GOVERNMENT, ASSOCIATIONS, ORGANIZATIONS

8 Observations on the Proposed FDA Bar Coding Rule. Allen Vaida, PharmD, FASHP, Institute for SafeMedication Practices

10 ASHP's Approach to Advocating for Bar Code Unit Dose Medication Systems. Douglas J. Scheckelhoff,MS, RPh, FASHP, American Society of Health–System Pharmacists

12 Analysis of Impact of the Food and Drug Administration's Proposed Bar CodeLabel Requirements for Human Drug Products and Blood. Steven A. Tucker, Economist, FDA

NURSING PERSPECTIVE

15 A Nursing Perspective on Bedside Scanning Systems. Pamela F. Cipriano, RN, PhD, FAAN, University of Virginia Medical Center

17 Addressing Human Factors in Bar Code Medication Administration Systems. Emily S. Patterson, PhD,Cincinnati VA Medical Center, The Ohio State University

IMPLEMENTATION–LESSONS LEARNED

19 Tracking and Controlling UPS Packages: A Close Parallel to Drug Delivery. Wally Mrozik, President, UPS Professional Services, Inc.

21 Bar Code Medication Administration: 5 Deal Breakers, Pearls, and Perils. Geraldine A. Coyle, RN, EdD, CNAA, Martinsburg VA Medical Center

23 Impact of Bar Code Medication Administration. Thomas S. Thielke, MS, RPh, FASHP, University of Wisconsin Hospitals and Clinics

25 Documentation Bar Code Medication Administration: Lessons Learned from 3 Years of Preparation.Ray R. Maddox, PharmD, FASHP, St. Joseph’s /Candler Health System, Savannah, GA

COMPLEMENTARY TECHNOLOGIES

28 IV Infusion Pumps: The Missing Component in Bar Code Medication Administration Systems.Nat Sims, MD, Massachusetts General Hospital

30 RFID and Healthcare Applications: What comes after bar code? Irwin Thall, Manager, PrecisionDynamics Corporation

ROUNDTABLE DISCUSSION

32 BCMA as Measurement Tool

32 Impact on Nurses

33 Need for Scientific Evidence

33 The Business Case


3

Building a Safety Net for Medication Use:Challenges and Opportunities

Philip J. Schneider, MS, FASHP, Clinical Professor and Director, Latiolais Leadership Program, College of Pharmacy, The Ohio State University, Columbus, OH

Patient safety has been front andcenter among the public, providers andhealth care professionals alike since thepublication of the first report of theCommittee on Quality of Health Care inAmerica, entitled To Err is Human– Buildinga Safer Health System, in 1999. Medicationuse safety has been front and center inhospitals, however, since the 1960's, whenthe first medication error studies werepublished. As a result of this pioneeringwork, safer systems–including unit doseand IV admixture systems–were developedthat were shown to be considerably saferthan the procedures that these systemsreplaced.

To be frank, much of the impetus forthe adoption of these systems was basedon financial, not safety concerns. The fee-for-service reimbursement systems inplace at the time produced increased rev-enue to the hospitals resulting from addi-tional technology-related charges topatients for each dose dispensed.Improved safety was a bonus. Fortunately,the clinical impact of these systems wasstudied, and we now have evidence to sup-port unit dose and IV admixture systems asbest practices for safe medication use.

Times have changed. Fee-for-servicereimbursement systems are being replacedby risk-sharing systems that include co-payments, prospectively established bun-dled rates for the treatment of certainconditions, and/or capitated paymentschemes based on the number of patientsenrolled in the health plan. These newcompensation schemes have shifted thefocus from generating revenue from serv-ices provided to controlling costs. This hasresulted in a critical reexamination of pro-grams that are labor intensive and couldonly be justified through the fees thatcould be charged. Furthermore, becausesystems such as unit dose and IV admix-

ture programs are often centralized, theyare now being viewed as being unrespon-sive to the rapid changes in drug therapypresently occurring in the acute care set-ting. "Best practices" are being reexam-ined.

The new emphasis in quality improve-ment is the application of technology.Some technologies are specifically directedtoward improving medication safety.Examples include computerized prescriberorder entry (CPOE), automated dispensing,bar code identification systems, and so-called "smart" IV pumps. Most lists of rec-ommendations for changes to improvemedication use safety include the adop-tion of these innovations. Payer groups areeven proposing that some of this technol-ogy be a prerequisite for being an accept-able provider.

A critical review of the literaturereveals that the evidence supporting thesetechnologies is not as strong as the evi-dence supporting other, older systems,including unit dose and IV admixture sys-tems. Furthermore, the expense of thesenew systems is significant and poses achallenge to hospitals already financiallystrapped. The technologies often requirecultural or work changes that are difficultfor health care professionals. The chal-lenge for health care professionals andhealth care administrators is to find effec-tive ways to adopt these new, expensivetechnologies in response to public pres-sure to improve quality and safety.

The purpose of this conference was tobring together patient safety experts whoare innovators and early adopters of thesenew technologies. The focus of the meet-ing was the use of bar code technology toreduce errors in the administration ofmedications. Speakers were asked toaddress the evidence supporting the use ofthis technology, efforts to stimulate its

adoption, experiences implementing andusing bar coding in hospitals, and theapplication of bar code systems to improvethe safety of intravenous (IV) medicationadministration. Ample time was offered toattendees to ask questions of the speakersand to share their experiences with barcode medication administration (BCMA).

Despite the costs and organizationalchallenges of implementing a BCMA sys-tem, the consensus of those attending themeeting was that there is emerging evi-dence that such a system reduces errorand documents so-called “near misses.”Concerns remain regarding the laborincreases necessary to support the currenttechnology. While most of the nurses saidthat using BCMA was difficult, theyseemed to agree that they would need tofind ways to overcome those difficultiesand that the benefits of using BCMAwould ultimately make adoption of thistechnology worthwhile.

Improvements in the technology itself(size of scanners, amount of information inthe codes, and the method of coding itself)may help to speed the adoption of BCMA.Some of the issues and challenges beingexperienced by early adopters will need tobe addressed as we move to the earlymajority on the "diffusion of innovation"curve, as discussed in the opening presen-tation. The promise of integrating thisBCMA with smart infusion technology toreduce programming errors was viewedas an important application of this innova-tion.

Finally, participants emphasized care-ful evaluation of competing technologies,vendors, and products and active involve-ment of multiple disciplines–Medicine,Pharmacy, Biomed, Information Services,and most significantly, Nursing–in select-ing and implementing innovative systemsto improve patient safety.

EDITORIAL


4

The use of bar code technology inhealth care is being advocated toimprove the efficiency and safety

of medication administration. The processby which innovation spreads has beendescribed by Everett Rogers in his book,The Diffusion of Innovations.1 Theprocess starts with the creation of aconcept by innovators, followed by thespread to early adopters, early majority,late adopters, and last to laggards. Therate of adoption follows an "S-shaped"curve, i.e., starts slowly, rises quickly,and tapers off over time. In the last 40years, many innovations to improvemedication use safety have been shownto be effective and widely adopted asevidence-based practices in health care,e.g., the unit dose system, IV admixture,CPOE, and BCMA. Understanding thediffusion of these innovations may pro-vide some insight into how bar codetechnology will be adopted in healthcare to improve medication use safety.

Unit Dose SystemInnovation is not necessarily a tech-

nology. It may just be a safer way of doing

things. For example, in the unit dose sys-tem, medications are packaged in individ-ual unit packages, instead of requiringcaregivers to take medications from bulksupplies for individual patients.Medications are dispensed in as ready-to-use format as possible, and not more thana one day supply is dispensed at a time.Starting in the early 1960s, studies havedocumented error rates (deviations fromthe physician order) of 10% or more withthe traditional system, compared to 1.9%and 3.5% with a unit dose system.2

The diffusion of this innovation fol-lowed the "S-shaped" curve described byRogers. The good news is that by 1995 theunit dose system was used in 91.6% of UShospitals (see Figure 1), demonstratingthat the innovation was better than theprevious practice. The bad news is that thisdiffusion took 40 years. The diffusion ofinnovation in health care can be very slow.

IV Admixture SystemThis innovation improves safety,

because doses are prepared by a personspecially trained to prepare sterile med-ications. Like the unit dose system, each

dose is individually labeled for eachpatient, and no more than a 24-hoursupply is dispensed. Studies demonstratethe superiority of an IV admixture systemcompared to preparing sterile doses inpatient care areas.3-5 However, onceagain diffusion took 20 or 30 years (seeFigure 2).

The diffusion of both unit dose andIV admixture has been too slow. Thesesafety systems may not be sufficientlyresponsive to the acute care needs of crit-ically ill patients. This may be a factor inthe growth of new innovations, e.g.,point-of-care dispensing technology anddrug preparation at the bedside, whichcan be more responsive to the changingneeds of critically ill patients.

Hospital size may also play a role.Smaller hospitals typically have more IVadmixtures prepared at the bedside. Sinceevidence shows that this is a less safepractice, smart pumps that provide a last"test of reasonableness" for drug, dose,and infusion rate may be even moreimportant than in larger hospitals with IVadmixture programs in place.

CPOEWith this technology innovation,

orders are transferred electronically.Decision support logic provides the realvalue of CPOE by providing warnings tophysicians. CPOE has been reported to reduce the incidence of medicationerrors, preventable adverse drug events(ADEs) and potential ADEs.6 But the diffu-sion of this innovation is a little different.In the 1980's very few hospitals usedcomputer systems in the medication useprocess, and most of these were in thepharmacy. By 1998, 2% and by 2001, 4%

Key Po ints :

• Innovation has been and will continue to be needed to improve the quality and safety of medication use.

• Past experience suggests that the rate of adoption of innova-tions in health care is unacceptably slow.

• The adoption of new technology innovations that have been shown to improve medication safety is currently low.

• Methods to increase the rate of adoption of patient safety innovations are needed.

Framing the Opportunity for Bar Code Medication Administration

Philip J. Schneider, MS, FASHP, Clinical Professor and Director, Latiolais Leadership Program, College of Pharmacy, The Ohio State University, Columbus, OH


5

Framing the Opportunity for Bar CodeMedication Administration

of hospitals had CPOE in place. Largerhospitals were more likely to have CPOEthan smaller ones. In 2002, 6.9% of hos-pitals had CPOE (see Figure 3).7-9 The rateof adoption may be more rapid for CPOEthan other innovations in health care.Smaller hospitals are also adopting thisinnovation.

But there are problems with anyinnovation, including CPOE. Some sys-tems (31%) are not optimally configured,so pharmacists have to re-enter orders toa pharmacy computer system. Only 56%of CPOE systems have decision support,and half do not require prescribers them-selves to enter the orders. Only 94%require the pharmacy to check the orderprior to dispensing it.7 This sounds like ahigh number, but a reverse concern is thatmany people assume that CPOE with deci-sion support makes pharmacist review ofthe medication order unnecessary. Thus,even when an innovation diffuses morerapidly, the method of implementationmay not result in the intended benefit.

BCMAWith this innovation, medication,

patient, and the person administering themedication are scanned, reconciled, andeach dose is documented. Safety isimproved by ensuring that the rightpatient gets the right drug at the righttime. There are other ways to assure that

drug administration is safe: the identity ofthe patient can be verified by verballyquestioning the patient, the medicationorder can be double-checked, or packageintegrity can be maintained all the way tothe bedside so that there is no confusionif a nurse is interrupted. Unfortunately,despite these safe practices, nurses oftentake shortcuts. BCMA is one way to effi-ciently restore these safeguards into drugadministration. This innovation is veryearly in the adoption stage with only 2%of hospitals reporting the use of BCMAtechnology.7

To rapidly improve medication safety,it is no longer acceptable to wait 20, 30 oreven 40 years for an innovation tobecome widely adopted, when there isgood evidence that the innovation itselfhas benefit. The current rate of adoptionof many innovations is relatively low:about 7% for CPOE and 2% for BCMA.Some older innovations may be replacedby newer innovations. Unit dose and IVadmixture programs will have competi-tion from systems that are more respon-sive to urgent care needs. One innovationmay be replaced by another innovationover time.

A key question is how to enhance therate of diffusion of innovation, so that ittakes less than 30 years before a safetytechnology such as BCMA can benefitpatients.

References1. Rogers Everett M. Diffusion of Innovations. 4th

ed. New York: The Free Press;1995.2. Allen EA and KN Barker. Fundamentals of medica-

tion error research. Am J Hosp Pharm, 1990;47:555-71.

3. Thur MP, WA Miller, CJ Latiolais. Medication errors in a nurse-controlledparenteraladmixture program. Am J Hosp Pharm. 1972;29:298-304.

4. Perlstein PH, C Callison, M White, et al. Errors indrug computations during newborn intensive care. Am J Dis Child. 1979;133:376-9.

5. Taxis K and N Barber. Ethnographic study of incidence and severity of intravenous drug errors.Br Med J. 2003;326:684-7.

6. Bates DW, LL Leape, DJ Cullen, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medicationerrors. JAMA. 1998;280:1311-16.

7. Ash JS, Gorman PN, Hersh WR. Physician Order Entry in U.S. Hospitals. Proceedings /AMIA AnnualSymposium. 1998:235-39.

8. Pedersen CA, Schneider PJ, Santell JP. "ASHP National Survey of Pharmacy Practice in HospitalSettings: Prescribing and Transcribing– 2001." Am J of Health-Syst Pharm 2001; 58(23):2251-66

9. Pedersen CA, PJ Schneider, DJ Scheckelhoff. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration.Am J Health-Syst Pharm. 2003;60:52-68.

17.5%

38.2%

61.1%

62.5%

73.8%

89.0%

91.6%

0.0% 20.0% 40.0% 60.0% 80.0% 100.0%

1975

1978

1982

1985

1987

1990

1995 6.5%

21%

44%

57% 59%

68% 70% 67%

81%

67%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

100.0%

1975 1978 1982 1985 1987 1990 1992 1994 1996

Figure 1. The Diffusion ofInnovation: Hospitals with aComplete Unit Dose System

Figure 2: The Diffusion ofInnovation: Hospitals with a

Complete IV Admixture System

FIGURE 3. The Diffusion ofInnovation: Hospitals with

CPOE Systems(excluding VA facilities)7-9

2.0

4.3

6.9

1998 2001 2002

Hospitals with CPOESystems (%)

8.0

7.0

6.0

5.0

4.0

3.0

2.0

1.0

0.0

Source: ASHP, EAHP Percentages are averages of ranges Source: ASHP. Percentages are averages of ranges


6

Medication Errors and AdverseEvents

The results of the Harvard MedicalPractice Study revealed that the mostcommon cause of adverse medical eventsin hospitalized patients was associatedwith the use of medications.1 The adversedrug events (ADEs) that are caused bymedication errors are preventable. Notonly are preventable ADEs (PADEs) poten-tially deadly, they are also extremely cost-ly. Bates et al. have reported that eachADE results in additional costs of $4500because of increased length of stay andtreatment costs.2 This figure does notinclude the cost of legal actions, re-admissions, and the suffering and loss ofproductivity incurred by patients.

Human factors studies show that themore steps that are involved in a process,the more opportunities there are forerrors to occur somewhere during theprocess. Even a cursory overview of thehospital medication use process showsthis to be a complicated process (seeFigure 1).

Leape et al. found that serious med-ication errors are most likely to occur atthe ordering and medication administra-

tion stages1 (see Figure 2). It was notedthat 61% of the serious medication errorsoccurred after the physician orderingstage. While about half of the ordering,transcribing and dispensing errors wereintercepted by the nurse before the med-ication error reached the patient, almostnone of the errors at the medicationadministration stage were caught.3

This underscores the vulnerability ofthe medication use process at the admin-istration stage.

In a study of medication administra-tion errors in 36 health care facilities,Barker et al. found that some type of med-ication administration error occurred inalmost one in five doses of medicationsadministered.4 While many of these errorswere deemed fairly harmless, 7% had thepotential to cause an ADE. In a 300-bedhospital, this translates into 40 potentialADEs per day. These errors occur after theordering process and are not addressed byCPOE.4

Impact of Bar Code Technology onMedication Errors

AAddmmiinniissttrraattiioonn EErrrroorrss.. The VeteransAdministration (VA) healthcare system

has been a pioneer in the use of bar codetechnology to improve medicationadministration safety. Johnson et al. stud-ied medication error rates based on thenumber of incident reports related tomedication errors before and afterimplementation of BCMA.5 Theyshowed that following the introduction ofBCMA, reported medication error ratesdeclined from 0.02% per dose adminis-tered to 0.0025%. This is an almost a 10-fold reduction in errors over 8 years (seeFigure 3).5

While these are impressive findings,the lack of a control group makes itimpossible to know whether improve-ments may have resulted from other fac-tors, such as other VA quality improve-ment efforts. The rates of self-reportederrors may not be reliable. Studies haveshown that 95% to 99% of ADEs andmedication errors are not documentedthrough voluntary reporting systems.6,7 Itis also unclear whether the errors thatwere prevented would have led to ADEs.

TTrraannssccrriibbiinngg EErrrroorrss.. Medicationorders, whether communicated through acomputer with CPOE or written on paper,almost always need to be transcribed to amedication administration record (MAR).Leape et al. found that errors in transcrib-ing medication orders cause 12% of allserious medication errors.3 Implementationof a system that supports an electronicmedication administration record (eMAR)automates this transcription step. In astudy performed by Mekhjian,8 9% oforders that were written on CPOE hadsubsequent transcribing errors when theMARs were examined. In the same study,Mekhjian showed that the implementationof eMAR technology completely eliminated

Key Po ints :

• Ample data exist to show that serious medication errors are common at every stage of the medication use process.

• While CPOE can reduce serious medication errors at the physician ordering stage, errors distal to the physician ordering stage may be addressed by the use of bar code technology.

• Limited evidence suggests that bar code technology mayprevent medication errors at the transcribing, dispensing, and administration stages.

The Use of Bar Code Technology to ImproveMedication Safety: Reviewing the Evidence

Eric Poon, MD, MPH, Division of General Medicine and Primary Care, Brigham and Women's Hospital, Clinical Informatics Research

and Development, Partners Information Systems, Boston, MA

these errors.8 While bar code technology wasnot explicitly studied, these results indicatethat medication transcribing errors are bothcommon and completely preventable witheMAR technology.

DDiissppeennssiinngg EErrrroorrss. Much has beendone to improve dispensing accuracy,most notably the creation of the unit dosesystem in the 1960's. While slight variationsin practices exist across different hospitals,most use a unit dose drug distribution sys-tem. In this system, a pharmacist or a phar-macy technician picks the medications offthe stock shelves according to the physicianorder. Next, a second person, usually a phar-macist, checks the accuracy of the medica-tions picked. Finally, the medications aredelivered to the patient care area.

Studies have shown the error rate forboth picking and checking to be approxi-mately 3% to 6%. Despite double-checkingprocedures at this stage, dispensing errorscan and do reach the patient care area. In theLeape study, 11% of serious ADE's were dueto dispensing errors, and only one-third ofthese errors were intercepted by nursesbefore they were administered to patients.3

The most relevant study of the impactof bar code technology on dispensing errorsin a hospital pharmacy comes from the TexasDepartment of Criminal Justice. Thisdepartment dispenses inmates' medica-tions from one central location. In aneffort to reduce errors associated with this

process, one bar code representing themedication and another representing theinmate were put on all blister packs thatwere delivered to the inmate facilities. Allbar coded medications were scanned andautomatically removed if a dispensingerror was detected. Dispensing error ratesas reported to the central facility from thereceiving prisons were compared beforeand after the implementation of the barcode system. Results showed that the thereported dispensing error rate decreasedfrom 6.3 to 3.3 per 100,000 medicationsdispensed, a reduction of 52%.9

Limitations to this study include thereliance on self-reports. It is also unclearwhether prison experience can be gener-alized to the acute hospital setting,because of different turn-around-timerequirements and different medicationtypes. In addition, the before-and-afterstudy design cannot rule out any seculartrend.

SummaryThe evidence suggests that bar code

technology holds great promise for improv-ing medication safety and efficiency.However, the evidence so far is limited by thelack of data obtained through direct obser-vation and the lack of concurrent controlgroups. More research is needed to morefully assess the impact of bar code technol-ogy on improving medication safety.

References 1. Leape LL, Brennan TA, Laird N, et al. The nature of

adverse events in hospitalized patients. Results ofthe Harvard Medical Practice Study II. NEJM.1991;324(6), 377-84.

2. Bates DW, Spell N, Cullen DJ, et al. The costs ofadverse drug events in hospitalized patients. ADEPrevention Study Group. JAMA. 1997;277(4):307-11.

3. Leape LL, Bates DW, Cullen DJ, et al. Systemsanalysis of adverse drug events. ADE PreventionStudy Group. JAMA. 1995;274(1):35-43.

4. Barker KN, Flynn EA, Pepper GA, et al. Medicationerrors observed in 36 health care facilities. ArchInt Med. 2002;162(16):1897-1903.

5. Johnson CL, Carlson RA, Tucker CL, and Willette C.Using BCMA software to improve patient safetyin Veterans Administration Medical Centers. JHealthcare Info Mgmt. 2002;16(1):46-51.

6. Flynn EA, Barker, K. N., Pepper GA, et al.Comparison of methods for detecting medicationerrors in 36 hospitals and skilled-nursing facili-ties. Am J Health-Syst Pharm. 2002;59:436-46.

7. Edlavitch SA. Adverse drug event reporting.Improving the low US reporting rates. Arch IntMed. 1988;148:1499-1503.

8. Mekhjian HS, Kumar RR, Keuhn L, et al.Immediate benefits realized following implemen-tation of physician order entry at an academicmedical center. J Am Med Inform Assoc.2002;9:529-39.

9. Carmenates J and Keith MR. Impact of automa-tion on pharmacist interventions and medicationerrors in a correctional health care system. Am JHealth-Syst Pharm. 2001;58(9);779-83.

The Use of Bar Code Technology to ImproveMedication Safety: Reviewing the Evidence


7

Figure 1. Medication Use Process Figure 2. Error Stage forSerious Medication Errors3

Figure 3. Change of ReportedError Rates Over Time6

Pharmacy

Medicationson Wards

MedicationAdmnRecord

RN Patient

Nursing Units

AAddmmiinniisstteerriinnggEErrrroorrss

TTrraannssccrriippttiioonnEErrrroorrss

OOrrddeerriinnggEErrrroorrss

DDiissppeennssiinnggEErrrroorrss

DispensingMedOrders

MD

Transcription

Administratio

Pharmacist

1993 1995 1997 1999 2001

0.0250%

0.0200%

0.0150%

0.0100%

0.0050%

0.0000%

Ordering39%

Administering38%

Transcribing12%

Dispensing11%


8

Proposed RuleIn December 2001 the Food and Drug

Administration (FDA) published a noticenotifying manufacturers and other inter-ested parties that a regulation requiringbar code identification on medicationswas being considered. In June 2002 theFDA held a public hearing to hear com-ments about the requirements thatshould be included in the regulation.Representatives from industry, healthcare, professional organizations, vendors,and patient safety advocates attended themeeting. A proposed rule was published inthe Federal Register in March 2003 withcomments being accepted until mid-June2003 (see Table 1).1

Requirements in the proposed regu-lation include:

• Linear bar code identification mustbe used on prescription drug labels, including OTC products commonly used in hospitals;

• Sample medications are excluded from the requirement;

• Bar code identification must be onthe immediate container, as well ason any outer container, and;

• At a minimum, the bar code must contain the NDC number of the medication.The FDA proposed rule also contained

bar coding requirements for blood prod-ucts and summarized the financial bene-fits resulting from decreased errors if therule were imposed.

Current Capabi l i t iesA recent article in the American

Journal of Health-System Pharmacy,"Practical guide to bar coding for patientmedication safety" by Neuenschwander etal, provides a primer on point of careBCMA.2 Linear bar codes can be read withthe available bar code scanners currentlyused in hospitals. To include bar code

identification on smaller packages, suchas small vials and ampules, it is necessaryto use reduced space symbology (RSS),which may require upgrading scannerscurrently in use. If a requirement toinclude lot number and expiration datewere also mandated, then a compositeRSS would be required on the medicationsand additional upgrading of current scan-ners would be needed.

Despite the need for hardwareupgrades in scanning devices for somecurrent users of bar coding, many patientsafety advocates and professional organi-zations are recommending that the pro-posed FDA rule include lot number andexpiration date on bar codes. Two-dimen-sional symbologies such as DataMatrixwould be ideal for including the NDCnumber, lot number, and expiration dateon all package sizes. This symbology is notconsidered a bar code but rather a digitalidentifier. Imaging scanners would benecessary to read these two-dimensionalidentifiers.

In i t ia l ResponsesMany manufacturers and group pur-

chasing alliances are already assistinghospitals in the adoption of BCMA.Several manufacturers have already com-mitted to providing bar code identifica-tion on many of their products. Labelingand packaging vendors have begun tooffer bar coding capabilities for the soft-ware used by hospitals to repackage med-ications. Group purchasing alliances havenotified manufacturers that productswhich contain bar code identification willbe preferred or even required in awardingcontracts. A recent survey by theAmerican College of Health Executives

Key Po ints :

• The FDA is proposing regulations to require that labels include specific symbology (linear bar code) with the National Drug Code (NDC) number for drugs used in acute care settings.

• Existing use of BCMA is low because of the lack of bar codes on medications and the lack of bar code scanning technology beingused in hospitals.

• Some manufacturers are printing bar codes on their products, and hospital purchasing alliances are beginning to preferen-tially award contracts for medications that have labels with barcode identification.

• Use of BCMA will have an impact on the prevention of medica-tion errors.

Observations on the Proposed FDA Bar Coding RuleAllen J. Vaida, PharmD, FASHP, Executive Director,

Institute for Safe Medication Practices, Huntingdon Valley, PA


9

Observations on the Proposed FDA Bar Coding Rule

reported that 55% of respondents saiddrug bar coding was a technology theywould consider within the next one totwo years.3 This group also felt that barcode technology would have a positiveimpact on quality and would decreaseoverall costs (see Table 2). In a surveydone by the Institute for Safe MedicationPractices (ISMP), almost 90% of respon-dents reported that they would pay extrafor medications that had bar coded unitdose medication packages, and almosthalf said they were actively consideringBCMA.4

Others have been less enthusiasticabout this technology. The PharmaceuticalResearch and Manufacturers of America(PhRMA) have already asked for an excep-tion for "small" labels. The United StatesPharmacopeia (USP) is seeking an excep-tion for vials and ampules less than 5 mL,despite the fact that some manufacturershave already begun to provide linear barcodes on these products. In addition, cli-nicians sometimes develop workaroundthat reduce the effectiveness of thistechnology (see Table 3).

Prevent ion of Errors withBar Coding

ISMP has reported many transcrip-tion, dispensing, and administrationerrors that could have been preventedwith the use of BCMA. Currently, becauseof the checks and balances in the medica-tion use system, the interception of pre-scribing errors is more than 50%, but lessthan 2% for drug administration errors.Examples of these types of potential andactual errors have been reported in theISMP Medication Safety Alert! Errorsresulting from look-alike packaging of IVsolutions and unit dose syringes could beprevented by the use of bar code identifi-cation technology to verify that the med-ication to be administered is the same asthe one on the patient's medicationadministration record. The use of bar codetechnology will not prevent all medicationerrors and it does not detect prescribingerrors, but it will have a positive impactwhen used with other technologies insafeguarding the system.

References1. Food and Drug Administration. Bar code label for

human drug products and blood: proposed rule.Fed Register. March 14, 2003;68(50):1233399-534.

2. Neuenschwander M, Cohen MR, Vaida AJ, et al.Practical guide to bar coding for patient medica-tion safety. Am J Health-Syst Pharm. 2003;60(8):768-79.

3. Cohen MR. It’s time to raise the "bar" in health-care. ACHE Healthcare Executive. Sept/Oct 2002.www.publicforuminstitute.org/activities/2003/mi/3-4-Cohen.ppt

4. ISMP survey shows drug companies providingfewer unit dose packaged medications. I S M PM e d i c a t i o n S a f e t y A l e r t ! March 6, 2002.www.ismp.org/MSAarticles/ CuttingPrint.htm

Table 1. FDA Proposed Rule• Federal register notice

– December 3, 2001• Public Hearing–July 2002 • Proposed rule in Federal

Register–March 14, 2003 • Comments until June 12, 2003• Effective three years following

final rule• Noncompliance would mean

adulterated or misbranded drug label

• Send comments to: www.fda.gov/dockets/ecomments

Table 2: ACHE Survey3

TTeecchhnnoollooggyy 11--22 yyeeaarrss QQuuaalliittyy IImmppaacctt ((CCoosstt IImmppaacctt))

Clinical 26% 76% (44%)ResultsOnline

Filmless 48% 74% (56%) X-rays

Drug 55% 87% (46%)Bar codes

CPOE 62% 85% (45%)

Table 3. Workarounds3

• Must prepare for implementation

• Review current processes

• Many workarounds are not unique to using bar coding but due to the workarounds we cur-rently practice


10

The American Society of Health-System Pharmacists (ASHP) is a pro-fessional membership organization

representing 30,000 pharmacists thatpractice in hospitals and health systems.Bar coding of medications to improvemedication safety has been a significantissue for ASHP members, and as a result,the organization has actively advocatedfor the inclusion of bar codes on manu-facturer packaged unit dose medications.

Members have published the benefitsof BCMA systems in ASHP's journal, theAmerican Journal of Health-SystemPharmacy (AJHP), for more than 15 years.A primer recently published in AJHP pro-vides an excellent overview of the tech-nology, symbology, and issues associatedwith implementing point-of-care systems.1

ASHP Advocacy EffortsThe first ASHP professional policy on

bar coding was approved in 1998 andactive advocacy for the inclusion of thisinformation on unit dose packages began(see Table 1). ASHP has also collaboratedwith groups such as the National

Coordinating Council on Medication ErrorReporting and Prevention (NCC MERP)and the National Alliance of HealthInformation Technology (NAHIT) on posi-tion papers and advocacy supporting theuse of bar codes. There has been workwith other stakeholder groups such as theNational Quality Forum (NQF) for theinclusion of bar codes in their safe prac-tice statements on unit dose drug distri-bution systems.

ASHP's advocacy with the Food andDrug Administration (FDA) on this issuehas been clear and consistent. ASHP cor-responded directly with the Secretary ofHealth and Human Services, TommyThompson, on the patient safety benefitsof bar coded medications in July 2001.ASHP also testified at the July 2002 FDApublic hearing on the FDA Proposed Rule,sending a strong message on the urgentneed for action. ASHP has met with theFDA Commissioner, Mark McClellan, onseveral occasions to promote the patientsafety benefits of bar coding of medica-tions. Having the proposed rule from theFDA is the culmination of many years ofadvocacy and collaboration.

ASHP Po l icyASHP's position includes three basic

elements (see Table 2).1. Medications should be electroni-

cally verifiable. `Unit dose pack-ages should be available from themanufacturer with a bar code orother mechanism that allows forelectronic verification.

2. The bar code should include theNational Drug Code (NDC) number,the lot number, and the expirationdate for the medication. Whilegreatest emphasis is on the NDCnumber and its role in verifyingaccuracy, ASHP members believethere are additional benefitsderived from having the other twodata elements.

3. Promote the rapid adoption ofpoint-of-care verification through-out health systems, so that thereare not significant delays in thediffusion of this lifesaving tech-nology.

Current Use of Bar Code DrugAdministration Systems

As summarized in Table 3, the adop-tion rate of bar code technology remainslow, with about 2% reported in the ASHPNational Survey, not including federalfacilities.2 If VA hospitals are included, thenationwide adoption rate is approximate-ly 5% to 6%, but still a relatively smallnumber.

Bar codes are currently included ononly about 35% of commercially availableunit dose packages, so hospitals choosingto implement these systems must commit

Key Po ints :

• ASHP is a strong advocate for patient safety and, as such, has worked for the inclusion of bar codes for many years.

• ASHP's position has been for the inclusion of the NDC number, lot number, and expiration date in the bar code, in addition to human-readable format.

• ASHP is also actively promoting the adoption of bar codes and point of care verification of medications in hospitals and healthsystems.

ASHP's Approach to Advocating for Bar CodeUnit Dose Medication Systems

Douglas J. Scheckelhoff, MS, RPh, FASHP, Director, Practice Leadership and Management, American Society of Health-System Pharmacists, Bethesda, MD

to repackaging the remaining doses onsite or through a third-party vendor. Thisresults in thousands of doses beingrepackaged for each hospital each day,which is a significant barrier to adoption.Having bar codes included on packageswhen they are purchased from themanufacturer will virtually eliminatethis barrier.

Unit Dose PackagingASHP members have voiced signifi-

cant concern about the declining avail-ability of drugs in unit dose packages.There is fear that this will be acceleratedby an FDA requirement for bar codes atthe unit dose package level, because somemanufacturers may not want to invest inthe re-tooling of their labeling processes.

ASHP and others recently participat-ed in a survey with the Health DistributionManagement Association (HDMA), theassociation that represents wholesalers.The survey included a question to manu-facturers whether the proposed rule on

bar coding would change their level ofunit dose packaging. Results showed that83% indicated that the FDA rule wouldnot change their product line of unit dosepackaged drugs, meaning that they wouldinclude the bar code as indicated and keepthe products available, while 11% report-ed that they would reduce their productline of unit dose packages if the proposedrule is adopted. This is a major concernsince it will require hospitals to packagethese items without the level of qualitycontrol available to manufacturers, not tomention the additional labor cost. About6% responded that they plan to increasethe availability of unit dose packaging.

Next StepsASHP will be actively promoting the

adoption of this technology as bar codesbecome available on unit dose packages.The ASHP web page is being refined toserve as a resource center for thoseimplementing bar code systems, andpractice guidelines are currently under

development. These steps, in conjunctionwith educational programs at ASHPmeetings, will provide pharmacists withthe practical tools needed to implementthese systems. There are many lessonslearned by the early adopters that can beshared to enhance and speed alongimplementation and adoption.

ASHP is encouraged that this day hasfinally come and is looking forward to thefuture as these systems evolve.

References1. Neuenschwander M, Cohen MR, Vaida AJ,

Patchett JA, Kelly J, Trohimovich A. Practicalguide to bar coding for patient medication safe-ty. Am J Health-Syst Pharm. 2003;60:768-79.

2. Pedersen CA, PJ Schneider, DJ Scheckelhoff.ASHP national survey of hospital pharmacypractice in hospital settings: dispensing andadministration–2002. Am J Health-Syst Pharm.2003;60:52-68.

ASHP's Approach to Advocating for Bar Code Unit Dose Medication Systems


11

Table 1. ASHP and Bar Codes

• AJHP and MCM since late 1980s

• First official ASHP position in 1998

• Collaboration with NCC MERP

• Membership with NAHIT

• Advocacy with FDA

• Other stakeholder groups

Table 2. ASHP and Bar Codes

• ASHP position:– Medications should be

electronically verifiable– Manufacturers should include:

• NDC• Lot Number• Expiration Date

– Encourage health-system adoptionto promote • accuracy, efficiency, safety• pharmacist involvement and

leadership

Table 3. ASHP and Bar Codes• Adoption rate remains low • High interest with ASHP members• Concern over UD availability remains• Survey with HDMA/GPOs• Actively promote adoption

– ASHP website resource center– Practice Guideline under development– Dissemination of information at

meetings– Practical tools to aid in

implementation– AJHP Primer (April 15, 2003)


12

Analysis of Impact of the Food and Drug Administration'sProposed Bar Code Label Requirements for

Human Drug Products and BloodSteven A. Tucker, Economist,

Office of Planning, Food and Drug Administration, Rockville, MD

Note: This presentation wasbased on analyses done in support of aNotice of Proposed Rulemaking pub-lished on March 14, 2003 (FederalRegister Volume 68, Number 50, pages12499-12534). The author cautionsthat agency policy decisions for finalrulemaking may be different than theestimates contained in this discussion.Also, this discussion does not representofficial policy of the Food and DrugAdministration or the Department ofHealth and Human Services. Theanalysis is subject to amendment insupport of final rulemaking. TheEastern Research Group, Inc., ofLexington, MA, collected data and con-ducted analyses under Task Order 21 ofContract No. 223-98-8002.

The objective of proposed regulations,such as the proposed bar code labelrequirements for human drug prod-

ucts and blood, is to protect public health.This proposed regulation has the objectiveof enabling the health care sector to beable to utilize technological solutions toreduce preventable adverse drug events(ADEs) associated with medication errors.

Based on the published relationshipsbetween hospital admissions and ADEs1-4

and current non-obstetric hospitaladmissions,5 we have estimated thatabout 1.25 million preventable ADEsoccur annually in American hospitals.According to these studies, between 15%4

and 49%2 of these ADEs are preventable.We used these studies to estimate that372,000 preventable ADEs occur eachyear in hospitals. We have estimated thelikelihood that over 10,000 fatalities andpermanent disabilities result from thesepreventable ADEs each year.1,6,7

The proposed regulation will requireunique product identifiers to be portrayedin linear bar codes. The National DrugCode (NDC) would identify dosages andproducts for units-of-use dispensing andadministration. The proposal does notinclude OTC drugs sold directly to con-sumers, and it does not require variableinformation to be included in the barcode.

Private markets have not establishedstandardized bar codes. This has impededthe acceptance of scanning technology inhospitals. Therefore, the FDA is proposingto require standardization to allow hospi-tals to make this investment to improvepatient safety. The regulation does notrequire hospitals to purchase this equip-ment but removes a barrier in theirinvestment decision.

The regulatory cost to manufactur-ers and labelers of drug and blood prod-ucts is the cost of changing their manu-facturing process to accommodate barcode labeling and any revisions to theircurrent labels. Some hospitals that haveinstalled systems would be required toprematurely replace equipment in orderto read reduced-space symbology (RSS)that would be used on small packages.FDA would be required to oversee com-pliance with the regulation. The expectedannualized costs of these actions are$5.1 million.

Requiring bar coded information willnot improve patient safety if hospitalswon't invest in bedside bar code readingtechnology. To estimate the expendituresneeded to acquire these systems, we esti-mated the costs of installing a computer-ized system of scanners, bar codingequipment, and patient wristbands. Thecosts estimate also includes training and

Key Po ints :

• An estimated 372,000 preventable adverse drug events occur per year in hospitals. Bar code identifiers on drug products could be expected to avert about 22% of these events.

• Hospital expenditures for bar code systems are large. An average-sized hospital is expected to pay almost $370,000 to install a BCMA system. In addition, operating and productivity costs for an average-sized hospital could cost over $300,000 per year.

• We expect the proposed regulation to accelerate the acceptanceof bar code technology by hospitals. Overall, we expect average annualized increased expenditures of $680 million for the entireindustry.

• Over 20 years, we expect over 413,000 fewer adverse drug events because of bar coded products. The average annual benefit of avoiding these events is $3.9 billion dollars in patient pain and suffering and direct treatment costs.


13

Analysis of Impact of the Food and Drug Administration'sProposed Bar Code Label Requirements for

Human Drug Products and Blood

operating costs. For an average, 191-bedhospital8,9 that currently uses pharmacycomputers that can interface with bedsidesystems, the estimated first-year costs are$369,000. The annual operating costs areestimated to be $312,000. Most of theoperating costs are incurred by expectedstaff productivity losses, mostly in nurs-ing wards (see Figure 1).

Despite these costs, hospitals havebeen accepting this technology. Accordingto the American Hospital Association(AHA), the proposed regulation is expect-ed to accelerate the acceptance of barcode systems (see Figure 2). The necessaryinvestments are expected to occur overthe next 10 years with the proposed reg-ulation rather than the next 20 years. Theestimated average annualized totalexpenditure by hospitals for the expectedaccelerated acceptance of bar code tech-nology is $680 million. This is equivalentto a one-time investment of over $7.2 bil-lion. An average hospital would haveaverage annual expenses of over$103,000 over a 20-year period.

The proposed regulation is notexpected to avoid medication errors. Barcode use is expected to increase the inter-ception rate of errors. While 38% of allerrors that result in preventable ADEs(PADEs) occur during the prescribingstage, almost 50% of prescribing errors

are currently intercepted before reachingpatients.10 In contrast, 38% of all errorsthat cause PADEs occur during the actu-al administration stage, but only 2% ofall administration errors are currentlyintercepted. Therefore, we expect bedsidebar code scanners to increase interceptionrates of errors that occur in the dispens-ing and administration stages by 50%.Overall, bar codes should result in 22.6%fewer preventable ADEs per year. For anaverage hospital, this equals avoiding12.8 ADEs per year.

The value of each avoided ADEincludes avoided direct treatment costs of$2,257,2,4,11 as well as patient pain and suf-fering. The expected loss in well-beingdue to the expected likelihood of adverseoutcomes was derived from preferencescores developed from the health eco-nomics literature.12 The expected healthloss was valued by multiplying the statedpreferences by the event's expected dura-tion and society's derived willingness-to-pay to avoid a statistical fatality fromhedonistic wage models13 as discountedby life expectancy.14 While the willingnessto pay to avoid minor toxicity is $102 perincident, avoiding permanent disability isover $2 million. The average societal ben-efit of avoiding an ADE was estimated toequal $181,600. When added to the directtreatment costs, the average value of

avoiding an ADE is almost $184,000.Avoiding 12.8 ADEs per hospital per yearimplies benefits of over $2.3 million perhospital per year from bar code utilization.

As hospitals acquire the technology,an increasing number of ADEs will beavoided. Using the same rate of accept-ance as in estimating hospital costs, overthe 20-year evaluation period we expect413,400 fewer ADEs due to accelerateduse of bar code systems. The averageannualized benefit of avoiding these pre-ventable ADEs is $3.9 billion. We expecthospitals to be able to use these systemsto generate medication administrationrecords, pharmacy reconciliationreports, and other internal records. Theexpected productivity savings of theseactivities for an average hospital wereestimated to be between $209,000 and$334,000 per year. With the rate of accel-erated acceptance, total average annual-ized savings would be between $451.5million and $721.5 million per hospitalper year.

Other internal hospital considera-tions such as reduced litigation risk,potential decreases in malpractice insur-ance rates, and efficiency gains in costcapture rates were also examined.According to data from litigationsources,15 the average pretrial settlementand jury award per ADE was slightly over

0

10

20

30

40

50

60

70

80

90

100

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Years

Per

cent

Hos

pita

ls

Figure 1. Estimated Costs forAverage Hospital to Install andOperate Bar Code Technology

Figure 2. Rate of TechnologyAcceptance by Hospitals With

and Without Regulation

Figure 3. Estimated EconomicImpacts of the Proposed

Regulation In Millions of Dollars(20 Year Period/7% Discount Rate)

Type ofImpact

DirectCosts

HospitalCosts

PatientBenefits

HealthCareEfficiency

NetBenefits

PresentValue

$53 $7,204 $41,381 $4,783 -$7,643

$34,123

AverageAnnual

$5.1 $680.0 $3,906.1 $451.5 -$721.5

$3,221.0

With Regulation

Without Regulation

Cost Element Initial Cost Annual CostScanners $48,000 $15,000

PDAs $290,000 $15,000

Bar Coding Eqmt. $4,000 <$500

Bar Coding Ops. N/A $65,000*

Patient Wristband $4,000 $1,000

Training $23,000 $6,000

Staff Productivity $209,000

Total $369,000 $312,000


14

$500 per incident. Bar code systems couldsave roughly $7,000 per hospital per yearin average litigation awards. Hospitalmalpractice insurance premiums haveincreased to as much as $18,800 per bedfrom the most recent national audit.16

Research has indicated that automatedrecord systems could increase pharma-ceutical cost capture rates from 63% to97%.17 If so, an average hospital wouldincrease revenues by $65,000 afterinstalling a bedside system.

The FDA is committed to improve-ments in patient safety while minimizingunnecessary costs to the health care sys-tem. We expect that hospital industryresponse to the bar code regulation willgenerate significant benefits (see Figure3). Net annual societal benefits in excessof $3.2 billion are in addition to internaloperating efficiencies that may beenabled. The final regulation is expectedto take public comments into considera-tion prior to publication.

References1. Bates DW, Cullen DJ, Laird N, et al. Incidence of

adverse drug events and potential adverse drugevents: Implications for prevention. JAMA.1995;274:29-34.

2. Classen DC, Pestonik SL, Evans RS, et al. Adversedrug events in hospitalized patients: Excesslength of stay, extra costs, and attributablemortality. JAMA. 1997;277(4):301-6.

3. Jha AK, Kuperman GJ, Teich JM, et al. 1998.Identifying adverse drug events. JAMA.1998;5(3):305-14.

4. Senst BL, Achusim LE, Genest RP, et al. Practicalapproach to determining the costs and fre-quency of adverse drug events in a health carenetwork. Am J Health-Syst Pharm.2001;58(12):1126-32.

5. Agency for Healthcare Research and Quality.Healthcare Cost and Utilization Project:Na t ionwide Inpa t i en t Samp le .www.ahcpr.gov/data/hcup/hcupnet.htm. June14, 2002.

6. Thomas EJ, Studdert DM, Burstin HR, et al. 2000.Incidence and types of adverse events and neg-ligent care in Utah and Colorado. Med Care.2000 Mar;38(3):261-71.

7. Kelly WN. Potential Risks and prevention, Part 1:Fatal adverse drug events. Am J Health-SystPharm. 2001;58(14):1317-24.

8. Bureau of the Census. 2000. 1997 EconomicCensus. Department of Commerce.

9. Ringold D, Santell P, Schneider PJ, et al. ASHPnational survey of pharmacy practice in acutecare settings: Dispensing and administration-1999. Am J Health-Syst Pharm. 2002;57:1759-73

10. Leape LL, DW Bates, DJ Cullen, et al. Systemsanalysis of adverse drug events. ADE PreventionStudy Group. JAMA. 1995;274(1):35-43.

11. Bates DW, Spell N, Cullen DJ, et al. The costs ofadverse drug events in hospitalized patients.JAMA. 1997;277(4):307-11.

12. Harvard Center for Risk Analysis. CUA Database:Catalog of Preference Scores. Harvard Schoolof Public Health. June 14, 2002. www.hsph.har-vard.edu/organizations/hcra/cuadatabase/intro.html.

13. Viscusi K. Fatal Tradeoffs: Public and privateresponsibilities for risk. The Oxford UniversityPress. 1992.

14. National Vital Statistics Report. 2002. Table 1:Life table for the total population: UnitedStates, 1999. 2002;50(6);March 21.

15. Jury Verdict Research. 2003. Medical MalpracticeVerdict and Settlements.

16. General Accounting Office. 1995. Impact onHospital and Physician Costs Extends BeyondInsurance. 1995;GAO/AIMD-95-169. September.

17. Lee LW, Wellman GS, Birdwell SW, Sherrin TP.Use of an automated medication storage anddistribution system. Am J Hosp Pharm.1992;49(4):851-5.

Analysis of Impact of the Food and Drug Administration'sProposed Bar Code Label Requirements for Human Drug Products and Blood

New technology promises to offerenhancements in nursing care.Nurses want to enhance speed and

accuracy of communication and haveinformation together in one location. Thisoften does not happen unless enabled bytechnology. Nurses also want to reduceerrors and reinforce a culture of safety.Nurses also need to trust technology. Asfor many health occupations facing work-er shortages in the future, reducing phys-ical effort and redundancy in the work fornursing is essential. Nurses do not tire ofcaring for patients, rather, they tire ofdealing with inefficient systems.Technology enhancements must be ableto help nurses focus their time on directpatient care.

The benefit of most technology solu-tions is improved safety. CPOE helps clar-ify hand writing and communicate essen-tial information to others. The speed ofcommunication is enhanced, as is accura-cy. CPOE helps to reduce the frequency ofprescribing errors. BCMA also reduceserrors, i.e., those associated with correct

patient and medication identification.Documentation can also be improvedwith BCMA.

There may be 30,000 to 50,000 pre-ventable deaths annually linked to theclinical use of drugs, vaccines, blood andblood products, and medical devices.1

Biologics and nutraceuticals are alsocausing concern with drug interactionsand side effects.

Barker et al studied the administra-tion of 3216 doses of medications topatients in 36 hospitals and nursinghomes in Georgia and Colorado. Theyfound a 19% medication error rate with avery large range of error rates (0% to67%). The primary types of errors werewrong time, omission, and wrong dose.2

When evaluating the magnitude of possi-ble errors, the increasing shortage ofnurses only exacerbates the concerns.One must ask the question, will there be asufficient work force to ensure accuracyand timely administration of medicationsto patients?

The imperative for safer medication

administration is clear (see Table 1). Thehuman and economic cost estimates aresignificant. It is projected that almost$180 billion dollars are spent each year asa result of morbidity and mortality relatedto drugs.

The combination of bar coding andbedside scanning achieves error reductionduring the medication administrationphase. Automating safety checks providesimprovement in the use of safe medica-tion administration practices.

The Veterans Affairs hospitals havebeen pioneers in implementing and inte-grating CPOE and BCMA with their phar-macy system. A study of 67 cases at 163centers showed that 38% of errorsoccurred during the medication adminis-tration phase. Implementation of a BCMAsystem was estimated to prevent 380,000errors over five years.3 Although it is rec-ognized that there will still be humanerror, the significant reduction in wrongmedication, wrong patient, and wrongdose with BCMA is evidence that supportsimplementation of this technology.

The challenges to implementingBCMA are the same as other issues asso-ciated with making change. Nurses, likemost other professionals, like to remain intheir comfort zone. This is even more truesince the largest component of this workforce is over 40 years old. Many nurseswere educated before technology wasreadily embraced. Making the change totrust technology and abandon paper maybe very difficult.

Organizational changes can facilitateovercoming challenges to implementingBCMA and other technologies.Organizational leaders must set expecta-

Key Po ints :

• Benefits of BCMA technology for nurses include improved speed and accuracy of communication, improved safety and error reduction, and reduced physical effort and redundancy of work.

• BCMA is not yet fully accepted but promises to improve safety through detection of errors, communication of missing doses, and safety alerts.

• Automation may create unintended consequences requiring frequentevaluation of the medication use process.

• Improvements to safety with BCMA outweigh benefits of maintaining current manual systems.

A Nursing Perspective on Bedside Scanning Systems

Pamela F. Cipriano, RN, PhD, FAAN, Chief Clinical Officer, University of Virginia Health System, Charlottesville, VA


15


16

tions for the use of technology and pro-vide support. The culture must supportchange and promote technology, and aculture of safety must be pervasivethroughout the organization.

Advantages of bedside BCMA includedetection of errors, electronic updating ofthe medication administration record,electronic communication of missingdoses, safety prompts, and automaticdocumentation of medications adminis-tered or reasons why they were not. Forthe system to work and be embraced, anumber of system characteristics areimportant. The technology-assistedprocess has to be faster than the manualprocess. Bar code scanners must be ableto read all surfaces and sizes of bar codes.Improvements in the sizes of wrist bandsand the ability of scanners to read curvedsurfaces are making the technology moreacceptable.

The interaction between nurses andtechnology at the bedside is also impor-tant. Nurses will develop "workarounds"for ineffective or inefficient systems. Thesize and portability of the equipment, andthe ease of use when standing face toface with the patient are important. Thedisplay of information must be easy toread. Institutions want to create bar codelabels for specific preparations such asthose for pediatrics.

Patterson, et. al. identified someunanticipated side effects that can occur

when introducing technology into a com-plex system.3 Even though BCMA willreduce the frequency of some failures,there can be new errors associated withthe technology.

Other technical challenges withimplementing these systems include deal-ing with emergent orders (see Table 2).There is some concern that the nurse mayskip some of the steps in BCMA whenbusy, or when the system is compromised(see Table 3). For example, if a bar codelabel cannot be scanned, a nurse will enterthe numbers manually. In situationswhere a patient has no identificationband (isolation, swollen extremities), thecomplete process of patient identificationmay be short-circuited. These all createpotential efficiency challenges to the RN,and jeopardize the safety measures of thesystem.

Another unanticipated controversywith BCMA is the 30-minute window fortiming of medication administration.Historically, little attention has beenfocused on the 30-minute pre- and post-administration window as a source ofwrong time error. Paper systems do notprovide alerts or track the frequency ofthese errors. Using a 30-minute windowto define and document wrong time errormay result in an inappropriate focus onthe time doses are given, instead of moreimportant medication issues.

Other issues surrounding bar codetechnology still must be resolved. Theneed to assure bar code readability in allsituations and to create uniform symbol-ogy, e.g., what labels will look like, howmuch information will be encoded, etc.,will drive further technology develop-ment. The ability to quantify and publishthe results of improved safety is crucial.There is a need to know how many med-ication errors are really prevented, as wellas prevented adverse drug events. Thepublic wants to know how health profes-sionals optimize care, particularly withthe use of such technology. It is equallyimportant for nurses and others to be ableto demonstrate that this technology isnot only an important step towardachieving safer patient care, but it is alsoa very responsible healthcare decision.

References1. Kohn LT, Corrigan JM, Donaldson MS (eds.). To

Err is Human: Building a Safer Health System.Nat ional Academy Press . Washington, DC.,1999.

2. Barker KN, Flynn EA, Pepper GA, et al.Medication Errors Observed in 36 Health CareFacilities. Arch Intern Med. 2002;162:1897-1903.

3. Patterson ES, Cook RI, Render ML. ImprovingPatient Safety by Identifying Side Effects fromIntroducing Bar Code Administration. J AmerMed Informatics Assn. 2002. September/October9(5); 540-53.

A Nursing Perspective on Bedside Scanning Systems

Table 1. Imperative for Safer MedicationAdministration

• CPOE– reduce prescribing errors

• BCMA–reduce administration errors– Wrong medication– Wrong patient– Wrong dose

Table 2. Technical Challenges of BCMA

• Emergent orders• Pharmacist verification of

new orders• Setting up patient record in urgent

situations and delayed documentation • Back-ups and redundancy for

down times• Medication “drops off list” after

specific time frame• Medication not available due to

automatic stop order

Table 3. Pitfalls of BCMAChallenges to RN Efficiency

• Nurses drop activities in bed side BCMA to reduce workload when busy

• Wrist band scanning can be compromised

• Patients often interrupt RN for something after wrist band scanned

• Multi-user consoles may cause delays


17

Addressing Human Factors in Bar CodeMedication Administration Systems

Emily S. Patterson, PhD, Research Physical Scientist, VA Midwest Patient Safety Center of Inquiry, Cincinnati, VAMC, Institute for Ergonomics, The Ohio State University, Columbus, OH

Adopt ing a Proact iveApproach to Pat ient Safety

The introduction of a new technolo-gy into a complex setting is never apanacea. New technologies have unantic-ipated side effects that affect technical,social, organizational, economic, cultural,and political dimensions of work. TheInstitute of Medicine report recommendsa proactive approach to patient safety,including the injunction to "examine newtechnologies... for threats to safety andredesign them before accidents occur."1

The implementation of bar code-enabledpoint-of-care medication administrationsystems eliminates some failure modes,but also creates new, potentially pre-dictable paths to adverse drug events(ADEs).2 The following question might beasked: What negative, unintended sideeffects, if any, resulting from the intro-duction of BCMA might create new pathsto ADEs?

MethodsA study of the experience of nurses

using a newly implemented BCMA systemwas conducted at a VA hospital. With thissystem, nurses are provided an alert whenthere is a mismatch between what isordered and what the nurse is about toadminister to the patient. Before imple-mentation of BCMA, 7 nurses wereobserved for a total of 21 hours during 10medication passes at one hospital. Afterimplementing BCMA, 26 nurses wereobserved for a total of 60 hours during 23medication passes at three hospitals.During the observations, time-stamped,detailed, handwritten field notes of verbaland physical behavior were recorded, tar-geting negative, unanticipated sideeffects and information captured in theelectronic patient record. The data wereanalyzed using the conceptual theoreticalframeworks from the human factors liter-ature to recognize and abstract emergingpatterns. Process tracing protocols for allof the observations were created that

detailed the activities, grouped into sever-al broad categories.3 Particularly interest-ing interaction sequences were represent-ed and analyzed as mini-cases. The mini-cases were then grouped by emergingthemes, and supplementary data from thedetailed notes based on the themes werecollated. Finally, the themes werematched to similar patterns documentedin other complex, high-consequence,socio-technical domains.

Negat ive , un intended "s ideeffects" fo l lowing BCMAimplementat ion

Five significant negative effects ofimplementing BCMA at VA hospitals wereobserved that might create new paths toADEs.4

First, nurses were sometimes sur-prised by automated actions taken by theBCMA software. For example, BCMAremoved IV medications from a patient'sprescription list four hours after thescheduled administration time, evenwhen the medication was never adminis-tered. For example, if the patient returnedto his room from a dialysis proceduremore than four hours after a scheduledadministration time, then the nurse wouldhave no indication that the medicationhad been removed and the ordered med-ication would not be administered.

Second, BCMA degraded coordina-tion between doctors and nurses com-pared to a paper-based system. BeforeBCMA was implemented, the physicianscould look quickly at the patient's bedsideat the handwritten medicationadministration record (MAR), which nolonger existed after BCMA (in some hospi-

Key Po ints :

• All new technologies, regardless of how good, will have negative, unintended consequences or "side effects" when introduced.

• The study of human factors is a body of research, largely new tohealthcare, that can help to identify side effects.

• Five side effects were directly observed when BCMA was introduced in three Veteran's Administration hospitals.

• Others can learn from the VA's experience prior to implementa-tion of new technologies by anticipating these side effects and using both medical and human factors expertise to predict and identify others.

tals). Although BCMA data were availableelectronically through the computerizedpatient record system (CPRS), for severalmonths physicians could only access aseven-day hard-coded window of dataunless they asked the nurses directly forthe information.

Third, nurses used strategies toincrease efficiency that circumvented theintended use of BCMA. For example, somenurses routinely input a patient's socialsecurity number by typing rather thanscanning the patient's bar-coded wristband, because typing was more efficient.

Fourth, nurses felt that timeliness ofmedication administration was greatlyincreased in priority, because BCMArequired nurses to type in an explanationwhen medications were given even a fewminutes late. Particularly in long-termcare settings, some nurses were observedto scan and pour medications for unavail-able patients so that they would appear"on time" in the record, thereby relying onmemory to administer the unlabeledmedication cup with opened, unlabeledmedications to the intended patient.

Fifth, nurses found it harder to devi-ate from the routine sequence of activi-ties with BCMA. For example, when apatient refused a medication that hadalready been automatically documentedas given when scanned, the nurses had tomanually document the change in a time-consuming process in another softwarepackage. Based on our recommendation,the software was then revised so that thenurse could easily document the changein BCMA by selecting the medication andselecting a menu option.

Lessons for SystemDes igners

Others can learn from the VA's expe-rience before implementing new tech-nologies. First, designers can avoid theuse of automation that is "strong andsilent" in that it initiates actions that arenot easily observable to its human part-ner, e.g., dropping a medication orderafter a given period of time. Second,designers can consider the impact ofintroducing new technologies not onlywith the target user population (in thiscase, nurses), but also others who interactwith them, such as pharmacists andphysicians. Third, the designers can makehuman-computer interaction and work-flow efficient, so that it is less beneficialfor users to employ "workarounds" toincrease efficiency that have undesirableconsequences. Fourth, designers shouldavoid trying to control user behaviorthrough design, such as by requiringadditional verification steps beyond whatis required with current systems. Finally,significant personnel and other resourcesneed to be allocated on a continuousbasis after implementation in order toaddress side effects when they are identi-fied and to continuously improve systemdesigns.

Bar Coding i s Not "Bad"It is not surprising that negative side

effects were identified following theimplementation of BCMA. The results ofthis study are consistent with otherresearch of technology in use in complexsettings where the consequences of fail-

ure are high. New technologies, regardlesshow "good," will have unanticipated sideeffects on the complex systems that theyare intended to support. In fact, the com-mitment exhibited by the Department ofVeterans Affairs to proactively share theirlessons learned regarding side effects is amarker of their leadership in patient safe-ty. The results from this study do not sug-gest that bar coding is bad. Rather, theresults show that bar coding is complexand that its introduction into the inter-woven fabric of technical work has far-reaching consequences. The advantagesthat bar coding provides, such as easierinput of numeric data, are purchased atthe price of trade-offs on other dimen-sions, only some of which are foreseen bydesigners.

RReeffeerreenncceess

1. Kohn LT, Corrigan JM, Donaldson MS (eds): To Erris Human: Building a Safer Health System.Washington, DC: National Academy Press,1999:150.

2. Case study: bar code system cuts medicationerrors. Briefings on Patient Safety. June2003;4(6):1-4

3. Woods DD. Process tracing methods for the studyof cognition outside of the experimental psychol-ogy laboratory. In G Klein, J Orasanu, RCalderwood (eds.), Decision Making in Action:Models and Methods Norwood, NJ: AblexPublishing Corporation, 1993;228-251.

4. Patterson ES, Cook RI, Render ML. (2002).Improving patient safety by identifying sideeffects from introducing bar coding in medica-tion administration. J Am Med Informatics Assn,9(5),540-553.


18

Addressing Human Factors in Bar CodeMedication Administration Systems

UPS has experience with the use ofbar coding, scanning, and the ben-efits of this technology to improve

the efficiency and accuracy of deliveringpackages.

For UPS it all starts with the label (seeFigure 1). There are a number of differentattributes on the label, which is an enablerfor all of the systems that have improvedpackage delivery. The UPS label includesdifferent types of bar codes, includingproprietary bar codes, which are used fordifferent reasons. It has a postal servicecode, which is important because zip codeand addresses are tracked and sorted justlike the postal service does. There is also a"maxi code," which is a proprietary codethat UPS developed to automate sorting,so that packages can be sorted at ourfacilities without human intervention.With this technology, people skilled atmemorizing zip codes are no longerneeded, which improves efficiency.

The main bar code is the UPS One Ztracking number, which identifies the cus-tomer, the service level they are providingor looking for, as well as a unique identi-fier. The unique identifier is tied into thepackage level detail (PLD). When a pack-

age is shipped, all this information istransmitted to UPS. The information isstored and transferred to different data-bases, depending upon where it is neededwithin our system. The bar code is indexedto all databases, which is how this tech-nology is used to improve efficiency andpackage delivery accuracy.

Early in 2002 a fully automated sort-ing facility, WorldPort, was opened inLouisville, Kentucky. In this facility, theonly human intervention is a person tak-ing a package off of a vehicle and puttingit on a vehicle. Sorting and all other pack-ing handling is done by automation thatindexes bar code information.

For our customers, implementationof bar code technology has meant fewerdamaged packages, fewer mis-sorts, andmore on-time deliveries. That translatesinto reduced costs to them. For example,it reduces their inventory carrying costs,because a customer can trust that a pack-age being shipped will be delivered cor-rectly. They do not need to keep extrainventory on hand in case a package isdamaged or misdirected during transit.This reduces their costs and improvestheir efficiency.

There are really two customers beingserved–the customer that pays us forshipping a package, and their customerthat is going to receive the package. Thistranslates into better customer satisfac-tion for UPS, UPS's customer, and the enduser, as well as improved loyalty to UPS(see Figure 2).

The UPS experience is important,because of general concerns about thecapital costs associated with technologyand about the implementation of scan-ning systems using bar coded informa-tion. Our experience shows that costs canbe reduced and service improved in waysthat originally might not have been con-sidered. Our customers asked us to be ableto track packages when we went into theair business in the 1980's. We have beenable improve our productivity. The morewe can improve, the better it will be forour customers and for us.

For example, the UPS TrackPad (seeFigure 3) is an application that was devel-oped to track packages within a largecampus facility. It improves accountabilityby making it possible to track a package'slocation after it has been delivered by acarrier. Customers are now using theTrackPad for other purpose beyond track-ing UPS packages. They are trackingequipment, assets, visitors, and otherpeople throughout their facilities.Conference managers and hotels cantrack packages coming in for differentmeeting participants.

In health care, a lot of valuableequipment is moved from room to roomin a hospital, depending on patient careneeds. This technology provides a way totrack equipment at any point and time to

Key Po ints :

• Bar code labels enable packages to have a large amount of use-ful shipping information.

• This information improves efficiency and accuracy of delivery and reduces inventory.

• The use of bar code labels to improve efficiency and accuracy of medication delivery would seem to be a logical application of this technology.

Tracking and Controlling UPS Packages :A Close Parallel to Drug Delivery

Wally Mrozik, President, UPS Professional Services, United Parcel Service


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determine its location and the personaccountable for it. This application of barcode and scanning technology was notpart of the original vision and illustrateshow additional opportunities to improveefficiency and reduce costs may beidentified, following technology imple-mentation.

In summary, the UPS experienceshows that the cost-savings resultingfrom the use of bar coding technology arejust as great or probably greater than thecapital costs of its acquisition and imple-mentation.

Tracking and Controlling UPS Packages :A Close Parallel to Drug Delivery

XYZ Corp.(123) 499-78604TH FLOOR1550 W ANYWHERE STREETPHOENIX AZ 85027

12 LBS 1 OF 3DWT: 12, 14, 28 O/S AH

SHIPTO:

JOHN SMITH(404) 828-4870ABC COMPANYBUILDING 3 FLOOR 4123 MAIN STREETATLANTA, GA 30328 - 3528

COD $1234.56

HAZARDOUS MATERIAL

REF # 123456789123456789123456789123456789AAA VV.VV CCCCCCCC NN.NN

GA 300 9-01UPS NEXT DAY AIRTRACKING #: 1Z123 45E 601234 56781 S

XYZ Corp.(123) 499-78604TH FLOOR1550 W ANYWHERE STREETPHOENIX AZ 85027

12 LBS 1 OF 3DWT: 12, 14, 28 O/S AH

SHIPTO:

JOHN SMITH(404) 828-4870ABC COMPANYBUILDING 3 FLOOR 4123 MAIN STREETATLANTA, GA 30328 - 3528

COD $1234.56

HAZARDOUS MATERIAL

REF # 123456789123456789123456789123456789AAA VV.VV CCCCCCCC NN.NN



F igure 3 . UPS Trackpad®

Figure 2 . How Does th i s Trans late into Customer Benef i t s?

• Time-critical documents and high-value packages can belost or delivered to the wrong department.

UPS OperationalImpacts• Fewer lost packages• Fewer late packages• Fewer damages• Fewer non-deliverable

packages• Reduction in address

corrections

When UPS service levels improve, our customers benefit as well

CustomerOperation Impacts• Reduction in call center

volume• Reduction in billing disputes

and billing adjustments• Reduction in UPS claims• Reduction in inventory levels

CustomerFinancial Impacts• Reduction in customer relationship

management costs• Reduction in carrier management costs• Reduction in inventory carrying costs• Improvement in cash flow

MaxiCode• CACH• Grand Rapids• Worldport• Bull Frogs• PFS• PAS Backup• Oak Haven• Pacific• Tilt Trays• Straight Line Sorters• Hub 2000

Routing Code• Manual Handling

IZ Tracking Number• PFS • Worldport• PAS • Oak Haven• Pacific • Tilt Trays• Straight Line Sorters

Postal BarCode• PFS• Worldport• Oak Haven• Tilt Trays• SLS• Pacific

Service Icon• Manual Handling

F igure 1 . UPS Smart Labe l

Disclaimer

The author's opinions do not neces-sarily reflect those of the Department ofVeterans Affairs. Neither the FederalGovernment nor the Department ofVeterans Affairs endorses any company ormanufacturer's products and/or services.

Deal Breaker #1–Communicat ion andAdminist rat ive Support

At the outset, planning for a complextechnology such as BCMA requires anappropriate interdisciplinary team com-prised of staff nurses, pharmacy staff,computer specialists, biomedical engi-neers, and engineering staff. The disci-pline-specific members should be changeagents and opinion leaders respected byother staff (see Table 1).

Medical center management shouldplan for and allocate substantial financialand human capital on a long-term basis.Adequate resources during planning andimplementation are required, in additionto the operational "going live" phase.

It is important to monitor the organi-zational system vital signs:

• Look at needs in each clinical area,

• Listen to problems and find solutions,

• Feel for the end user and sup-port the end user.

A significant commitment is requiredat all levels to move from a culture ofblame to a culture of safety.

Deal Breaker #2 - StaffBuy- In

Plan a vendor fair to demonstrateavailable products at the facility wherestaff can see and try out products.Develop a Requirement Analysis (RA), andduring the fair have staff provide inputthrough use of RA for product evaluation.Verify that all software is customizable tothe clinical practice at the facility, ratherthan asking nurses, physicians and phar-macists to change current acceptablepractice in order to "fit" the software.

The decision-making and implemen-tation processes should be a joint effortinvolving the planning team, contentexperts, and clinical staff.

Deal Breaker #3–EquipmentBe certain to check the durability of

hardware and input devices by checkingwith people who already use the technol-ogy. Decide on input devices (mouse ortouch screen). Decide where the laptopwill be placed on the medication cart (onan arm or tray). Test compatibility of com-ponents and battery life. Decide if thescanner will be tethered or wireless, andtest the durability of the bar code patientidentification on the wrist band.

Plan for equipment replacementevery two years, and allocate funds foradditional hardware and equipment toserve as backups for components beingserviced or repaired.

Deal Breaker #4– Tra in ing and Support

Provide end users a computer-train-ing laboratory that mirrors the practiceenvironment. Training should includeactual performance that reinforces thelaboratory learning. Around-the-clock,on-site physical support during imple-mentation on each clinical unit for oneweek is highly advisable, and individualsupport is needed during the first medica-tion administration pass.

Deal Breaker #5– OngoingSupport

Provide immediate technology assis-tance to clinicians on site via a help deskfrom 6:30 a.m. to 5:30 p.m., spanning allthree shifts. Medical staff can call on thetelephone or on a pager to reach the clin-ical informatics staff. If necessary, infor-matics staff will come to the clinician ifthe problem cannot be resolved by a tele-phone discussion. A good practice is hav-

Key Points:

• Deal Breakers for implementation and acceptance of BCMA are the lack of communication and administrative support, staff buy-in, equipment, training and support, and ongoing support.

• Perils result from staff-created workarounds when hardware, input devices and software do not perform well.

• Pearls of wisdom (lessons learned) are that documentation is available and legible; BCMA integrates the entire medication process for safer patient care; and reminders are generated for patient safety.

Bar Code Medication Administration:5 Deal Breakers, Pearls, and Perils

Geraldine A. Coyle, RN, EdD, CNAA, Associate Medical Center, Director/Nursing, Martinsburg VA Medical Center, Martinsburg, WV


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ing interdisciplinary BCMA rounds oneach unit weekly. On every unit,Pharmacy, Information ResourceManagement (IRM) staff, and InformaticsNurses approach the nursing staff usingeach medication cart on every unit toidentify hardware, software, scanning andpharmacy issues. Over time, credibility canbe built with the end users by the team.The informatics team can request links tonational software programs and can cre-ate customized products for end users.The BCMA system generates reports totrack and trend critical measures such asmissed medications and the effectivenessof PRN medications.

Per i l sHardware such as laptops, scanners,

batteries; input devices such as a mouseor touch pen; and computer software donot always integrate well or perform asexpected (see Table 2). Each componentshould be tested for performance, ade-quacy, integration and durability. Staffcreates workarounds when the com-puter response time is slow; technicalproblems with components such as lap-top, batteries or scanner are encountered;wrist bands become illegible or are miss-ing; and when scanning of the bar codedoes not perform as expected.

Pear l sDocumentation is available and legi-

ble with BCMA (see Table 3). The integra-tion of the entire medication process—ordering by CPOE, dispensing by pharma-cist, and administration by nursing staff—leads to safer patient care. Pop-up boxesand reminders also ensure patient safety.

Nursing staff uniformly supports theuse of BCMA for patient safety and theirown peace of mind. They report feelingmore secure in giving the right drug tothe right patient at the right time, at theright dose, by the right mechanism byusing this technology. BCMA does notserve as a substitute for the nurses' pro-fessional judgment. Medication admin-istration via BCMA may take up to 30%longer, which is not attributable to thelearning curve.

Bar Code Medication Administration— 5 Deal Breakers, Pearls, and Perils

Tab le 1 . Dea l Breakers

#1 – Communication and Administrative Support

#2 – Staff Buy-In

#3 – Equipment

#4 – Training and Support

#5 – Ongoing Support

Table 3 . Pear l s

• Documentation legible and available

• Entire prescribing, dispensing, and administration of medica-tions can be computerized

• Nurses support use of BCMA for patient safety and their own peace of mind

Table 2 . Per i l s

• Hardware does not integrate or perform as expected: batteries, computers, input devices

• Each component tested for adequacy integration, perform-ance and durability

The University of Wisconsin Hospitaland Clinics (UWHC) recently imple-mented BCMA as a beta site for the

McKesson Admin-Rx™. This hand-heldscanning device assures the "five rights"in drug administration. The caregiver'sidentification badge, patient's wrist band,and medication label are scanned, rec-onciled and documented. At this time,98% of all doses sent to patients have barcodes, including all IV medications.

Anticipated benefits for UWHC inimplementing BCMA technology includeimproved administration accuracy, doc-umentation accuracy, and nursing satis-faction. Implementing BCMA "closed theloop" on all of the automation installed todate, and we have used this extensively inpublic relations. Patients report increasedconfidence in the care they receive, andFinance is working toward 100% accuracyin charges.

Medication Error StudyIn a 28-bed hematology unit, which

has extensive medication use with manyhigh-risk medications, medication admin-istration accuracy was observed before

and after implementation of BCMA.Baseline error rate pre-BCMA was 9.09%,which was reduced by 87% post-BCMA(see Figure 1). Is is estimated that 11,518errors per year are eliminated on this oneunit. Wrong dose and wrong dosage formwere eliminated entirely, and omitteddoses and wrong time were greatlyreduced. While wrong drug errors werereduced by only 51%, many of theseerrors were not serious (e.g., a verbalorder not yet entered into the systemwhen the drug was administered, so thatdrug administration was recorded as anerror).

It was found that 3.2% of doses wereerrors that were intercepted by the BCMAsystem (near misses). The nurses saw indi-vidual near misses on their scanners, andit was very revealing to see that therewere 4,600 near misses per year. Morethan half the averted errors were under-doses, about a quarter were the wrongdrug, and overdoses and wrong patienterrors were each less than 10% (seeFigure 2). The study also showed thatBCMA forces compliance with existingpolicies for nurses to witness the admin-istration of high-alert medications, check

patient ID band, and document dosesimmediately after administration. Pre-BCMA, checking the wrist bands occurredwith only about 30% of patients. Thestudy also showed that this system doesnot allow a common bad practice ofpreparing medications for multiplepatients at one time.

Challenges with implementation ofthis system included software problemsthat resulted from the early stage ofdevelopment and that required extensivework with the company. It was a chal-lenge for the pharmacy to bar code allmedications. This required improving theefficiency of the packaging operation.Computer-system interfaces are always achallenge to overcome, and this has alsobeen true at UWHC.

Nursing issues included budgeting afull-time project manager and two tothree part-time staff to assist with theproject. Having nurse champions on thestudy unit proved very helpful. Spendingenough time in training and re-trainingprovided helpful lessons before expandingto other units.

There were also challenges with themedical staff. Training sessions werescheduled for all physicians, but many didnot participate. This resulted in frustrationwhen they were unable to use the scan-ners. The medical staff now uses the sys-tem quite well, although the attendingphysicians still present challenges. A web-page system is being developed to accessinformation that will make the systemmore user-friendly for physicians.

The nurse project coordinators havedone a good job in preventingworkarounds, such as taping extra barcode wristbands on the walls by the med-icine cabinet to avoid having to scan

Key Po ints :

• Implementation of BCMA reduced the rate of medication administration errors 87%, from 13,340 administration errors per year to 1,822 administration errors per year.

• 3.2% of doses (4,657 annually) were "near misses," i.e., were intercepted by the BCMA system.

• Nursing satisfaction data showed a 42% improvement post-BCMA.

• UWHC will be a beta site for integrating BCMA with smart infusion technology to avoid IV medication errors.

Impact of Bar Code MedicationAdministration

Thomas S. Thielke, MS, RPh, FASHP, Vice President Professional and Support Services,University of Wisconsin Hospitals and Clinics, Madison, WI


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patients' wrist bands. The system nowdocuments when and where a second barcode is printed. When an extra bar code isprinted, nurses now check to see what ishappening, give people immediate feed-back, and eliminate that practice whennecessary. Management engineering andnursing staffs have assisted withredesigning workflow to improve thesystem.

Nurs ing Sat i s fact ion StudyA survey (see Figure 3) showed a 42%

improvement in nurses' satisfactionfollowing implementation of the BCMAsystem. The greatest improvements beforeand after implementing BCMA were seenin "Easy to determine what meds are due"(48% improvement) and "View MedAdministration History" (67% improve-ment). "Efficiency" received the lowestratings. The administration process takesa bit longer with BCMA, but the processof planning medication administration issignificantly less, so that overall efficiencymay not be reduced.

Next steps are to continue to monitorand tighten practices and to explore newareas to implement bar code checks, suchas in the laboratory, phlebotomy, and theoperating room. Another goal is to linkerrors detected by BCMA to the web-based electronic error-reporting systemso that medication safety information isavailable in a more timely manner. Effortsto improve the software and reportingcapabilities will continue. Lastly, integra-tion of the ALARIS Medical Systems®Medley™ Medication Safety System with

the Guardrails® Safety Software with theAdmin-Rx™ is planned. IV infusion errorsare often more significant medicationerrors, as shown by pre-installation data.Implementation of the new smart pumptechnology is expected to reduce the fre-quency of IV infusion errors, improve IVadministration documentation, and pro-vide the pharmacy system with betterinformation on the status of infusiondevices.

Figure 3. Pre versus Post Admin-Rx Nursing Satisfaction

Wrong Dose

Wrong Dosage Form

Omitted Doses

Wrong Time

Wrong Drug

100%

100%

92%

77%

51%

Figure 1. Medication Error Reduction11,518 errors avoided annually on one unit

87%

Post Admin-Rx data is based on 17 days of data collected in February, 2002

1,822 adminerrors /year

9.09%

Overall medication error rate

Pre Admin-Rx Post Admin-Rx

1.21%

13,340 adminerrors /year

Figure 2. Near-MissesIntercepted by Admin-Rx

As a % of Doses Scanned3.2% of doses (4,657 annually)

Based on 17 days of data collected in February, 2002

Wrongpatient 8%

Overdose 9%

Underdose 57%

Wrong drug26%

5

4

3

2

1

Easy toPlanShift

Efficiency Safety Easy to trackmed admin

times

Easy todeterminewhat meds

are due

View MedAdminHistory

Excellent

Very good

Acceptable

Poor

Unacceptable

Pre-Admin Rx Post-Admin Rx

42%Improvement

48%Improvement

67%Improvement

OverallSatisfaction

Impact of Bar Code Medication Administration

St. Josephs/Candler Health System(SJC) is a 3-hospital acute care sys-tem located in Savannah, Georgia.

SJC is a long-term Pyxis client and hasparticipated in the development of sever-al innovations in automation developedby the company. In April 1999 SJC and thecompany initiated an agreement to devel-op the Pyxis Veri-5 product at CandlerHospital, one of SJC's acute care hospitals.Pyxis Veri-5 is an automated system inte-grated with Pyxis MedstationRx 2000 thatuses bar codes to identify drugs, patients,and persons who administer medicationsat the bedside. Pyxis Veri-5 electronicallydocuments medication administrationand provides alerts when errors may beabout to occur. The pilot project was con-ducted on a 14-bed oncology medical/sur-

gical unit. Hand-held Pyxis bar code scan-ners communicate directly by radio fre-quency to unit-based Pyxis cabinets inreal-time. Patient medication and clinicalinformation resides in the MeditechMedical Information System that isinterfaced to the Pyxis console in thepharmacy.

Important Lessons LearnedThe developmental project at SJC

provided a number of important insightsfor future implementation of BCMA at oursite. During this time both our employeesand Pyxis personnel refined andredesigned various mechanical, technical,and procedural aspects of the Veri-5device and our drug administrationprocesses.

Implementation is a long and oftendifficult process. BCMA requires thedevelopment of processes to assure thatall medications, patients, and appropriatecaregivers are bar coded for electronicident i f i ca t i on a t the beds ide .Unfortunately, there are few, if any, sys-tems that address all of the variables nec-essary to make this possible. Many med-ications are not provided in bar codepackaging; institutions must either pur-chase unit dose packaging equipment oroutsource this process. Patient identifica-tion using bar coded wrist bands may alsopresent problems with difficulty in read-ing the band, particularly on pediatricpatients. Several vendors are marketingthis innovative technology, includingcompanies that sell "stand-alone" systemsand those that are part of "integrated"institution-wide medical informationsystems (MIS). Product selection deci-sions are best made using a pre-defined,objective process for evaluating availabletechnology.1

Data coordination and integrationis necessary. While the use of bar codes atthe bedside to improve medication safetyis just beginning to be implemented inhospitals, electronic storage of dataimportant to making this process worksmoothly is already stored in various for-mats in multiple information systems.Medications are purchased electronicallyusing drug identification symbologydeveloped by drug distributors and resi-dent in inventory management systems inhospitals; this symbology is often a barcode on a box containing multiple dosesof a specific drug. Since there is currentlyno industry standard for bar code content

Bar Code Medication Administration:Lessons Learned from 3 Years of Preparation

Ray R. Maddox, PharmD, FASHP, Director, Clinical Pharmacy, Research & Pulmonary Medicine, St. Josephs/Candler Health System, Savannah, GA

Key Po ints :

• Implementation of a BCMA system is technically and procedurally difficult and requires support from administrative, medical, and nursing leadership.

• BCMA requires integration between multiple electronic databases, including patient medical information, pharmacy medication/profile system, drug inventory purchasing/manage-ment, drug packaging devices, and automated drug dispensing hardware.

• Implementation of an electronic medication record in institutions should probably precede the initiation of BCMA.

• Lack of bar code product packaging standards for oral and injectable medications complicates full-scale implementation of this technology in institutions.

• BCMA is a patient care improvement that significantly affects the work flow of nurses and does not reduce time associated with medication administration.


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on doses of drugs, those companies thatare currently packaging unit doses in barcoded packaging are not using uniformsymbology, and there is not uniform con-tent for the bar codes (see Table 1). Thesame generic product made by differentcompanies may have different bar codes.1

The BCMA system must be able to recog-nize multiple sources of the same genericdrug and automatically update the elec-tronic drug identifier for the bedside barcode database; this function is most effi-ciently done using the inventory manage-ment system at the time of receipt ofdrugs from the supplier. Medicationadministration information recorded atthe bedside needs to flow electronically tothe medication administration record (e-MAR); however, the e-MAR may reside ina different computer system in the hospi-tal that may require development of aninterface between the BCMA and MIS sys-tems. Currently some integrated MIS ven-dors market BCMA software; however,these systems may not be as user-friend-ly to the nurse as other "stand-alone"options; there may be internal conflictbe tween In fo rmat ion Se rv i ce sDepartments and clinical users about thechoice of integrated MIS vs stand-alone,best-of-breed BCMA systems.

An electronic medication administra-tion record (e-MAR) is essential to the suc-cessful implementation of BCMA. The pri-mary intent of BCMA is to improve med-

ication safety using technology; animportant additional benefit is its positivecontribution to documentation of med-ication administration. Because docu-mentation of clinical events, includingdrug administration, form the basis forfuture clinical interventions, including theadministration of doses of drugs, the e-MAR should be implemented at least con-currently, and preferably before, BCMA.The structure, flow, and access of elec-tronic drug administration data must beresolved before BCMA can function suc-cessfully.

Until drug manufacturers and pack-agers bar code all products in a uniformformat, institutions must develop theirown individual solutions. A minority oforal and parenteral doses have labels thatinclude bar codes. Doses compounded atthe hospital need to be identified with abar code by an internal process. Variousalternatives are available for creating barcodes for medication labels including on-site automated packaging equipment thatmay be stand-alone or integrated withdispensing machines; outsourcing ofunit dose packaging to local "niche"companies or large distributor/pack-agers; devices intended for small volumepackaging at the site; and pharmacyinformation systems that may print barcodes on labels of preparations com-pounded at the site.

BCMA is primarily a tool used bynurses to assure the "5 Rights" of medica-tion administration and dramaticallyaffects their work processes (see Table 2).Nurses are committed to assuring thatthe 1) right medication is given to the 2)right patient at the 3) right time in the 4)right dose by the 5) right route. However,one or more of these "rights" are fre-quently violated, resulting in up to 40%of all medication errors occurring at thebedside by the nurse or person adminis-tering medications. BCMA is interposedbetween the nurse and the patient toimprove this process and reduce errorsthereby assuring the "5 Rights." Manynurses have a difficult time conceptual-izing how BCMA, which takes more timeand is an apparently less efficientprocess, will help them do their job bet-ter. If given the opportunity, nurses willfind ways to circumvent steps in BCMAthat will negate the inherent safety fea-tures of this technology. BCMA willrequire a redesign of workflow for nurs-es; therefore, it is imperative that theyare intimately involved in the design,selection, implementation, and evalua-tion of this technology as it is incorpo-rated into patient care. Appropriate rep-resentation will include staff, managers,administrators, and opinion leaders inthe nursing department.

Documentation Bar Code Medication Administration–Lessons Learned from 3 Years of Preparation

Lessons Learned

• Implementation is a very long process

• Is technically and procedurally difficult

• Pharmacy and IS agendas may conflict regarding use of technology as a tool

• Beware of false claims by vendors

• Use an objective process to evaluate available technology1

Coordination with IS

• BCMA requires data integration

• “Best-of-breed” vs Integrated

Systems

• Cooperation of MIS vendor(s)

• “Best-of-breed” decisions directly

conflict with many IS priorities

BCMA is an important innovationthat will improve medication safety ininstitutions. Our experience suggests thatimplementation of BCMA is complex,multifaceted and complicated by unre-solved issues concerning product packag-ing, data integration and system integra-tion/interfacing.

References1. Kremsdorf R. Medication safety tools 2003 eval-

uation of vendor offerings for computerizedphysician order entry and medication admin-istration. 5 Rights Consulting, Inc, January 24,2003.

Table 1 . Log i s t ica l I s sues• Maintenance of electronic bar

code files• Integration of electronic drug

identifiers into a single database(inventory management, charge-file, Pyxis identifier)

• Multiple bar codes from manufac-turers for the same generic product

• Some hospital locations may notparticipate: ED, PACU, OR

Table 2 . Nurs ing I s sues• Recognition by nursing that

patient safety improves andBCMA is beneficial to the nurse

• The “5-Rights” do not alwaysoccur in the manual system

• Med documentation does notalways occur in the manualsystem

• Electronic verification is not atime saver

• Requires significant changes innursing work processes

• Workarounds will develop–requires constant nursingmanagement


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Documentation Bar Code Medication Administration–Lessons Learned from 3 Years of Preparation

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IV Infusion Pumps: The Missing Component in BarCode Medication Administration Systems

Nat Sims, MD, Cardiac Anesthesiologist, Massachusetts General Hospital; Physician Advisor, Partners Biomedical Engineering, Boston, MA

"Smart" Infusion PumpsOver 10 years ago, significant efforts

were made to create BCMA systems thatwould include IV infusion pumps toaddress IV medication errors; however,these attempts were not commerciallysuccessful. More recently, smart infusionpumps have been introduced to addressthe source of most IV errors, thoseassociated with device programming.Computerized smart infusion pumps con-tain specialized software that allows eachhospital to program their devices withcustomized drug libraries developed fromtheir own best practice guidelines (seeTable 1). At a minimum, the library shouldcover all medications that are delivered bycontinuous infusion and include the drugname, available concentrations, dosingunits, and minimum/maximum dose lim-its. The drug library is also structured bypatient type or patient care areas (e.g.,

NICU, PICU, AICU, ED, etc.) When the care-giver turns on the device, he/she identifiesthe patient care area and selects the drugand concentration from the hospital-for-mulated library now installed in the smartpump, thus removing many of the oppor-tunities for error. The smart pumps alsoprovide continuous quality improvement(CQI) reports of use to the hospital to sup-port improvements to best practice.

The Need for Bar CodesAlthough the smart infusion pumps

can prevent most programming errors,they are still dependent on the caregiverto select the correct drug and concentra-tion from the library. Combining smartpumps with bar code drug/concentrationrecognition could address this issue (seeTable 2). In addition to selecting the cor-rect medication, this approach would onlyrequire a single bar code label on the IV

container. This label can be the manufac-turer's label, and the major manufacturersof pre-mix IV medications have or soonwill include a bar code label on the IV con-tainer. For IV admixtures that are preparedby pharmacy, the bar code identifying thedrug/concentration can be generated aspart of the pharmacy-applied label. Ineither case, scanning the bar code selectsan entry in the drug library of the smartpump.

A variation on this application is toinclude the patient's name as a bar codelabel on the IV container. The patient's barcode wrist band can be scanned to assignthe patient to the infusion device, andadding a bar code label of the patient'sname to the IV container can ensure thatthe drug was intended for the patient towhom it is about to be infused. In thisimplementation the patient wrist bandneed only be scanned at initial pump setup, and the caregiver would not have toscan the patient for every new IV dose.

In either case, the adoption of smartpumps with drug libraries and dose limits,combined with drug/concentration andthe option to include the patient's name,provides a pathway to addressing manyof the most serious medication errors. Amajor advantage of this system is the fitwith current drug distribution practices.This IV pump bar code system will func-tion effectively in hospitals that dependheavily on access-controlled drug cabi-nets or in traditional admixture programswhere each IV dose is dispensed directlyfrom pharmacy. It is also an initial firststep that introduces a small change incaregiver practice, can eliminate signifi-cant sources of IV pump programming

Key Po ints :

• BCMA involving IV infusion pumps was a significant, but unsuccessful, infusion device industry initiative over 10 years ago.

• The current bar code systems do not address the complex issues related to IVs and device programming.

• Efforts to address BCMA involving infusion devices are currently underway through collaborative research and development between infusion device manufacturers and early innovators in barcode medication systems.

• The emerging IV applications of bar coding cover a wide spec-trum from recognition of the drug and concentration to full programming of the infusion device.

• Adding BCMA in combination with the new "smart" IV pumps holds great promise in reducing both errors and harm associated with IV pump errors.

errors, and does not depend on a wirelessinfrastructure and multiple system inter-faces. Currently, there are no commercial-ly available smart pumps that have inte-grated the bar code reader and the druglibrary, but development is proceeding ata rapid pace.

Higher level of InnovationThe above combination of bar code

recognition with smart pumps has obvi-ous advantages (see Table 3), but there arelimitations to this system. The earlyadopters of BCMA technology envisionintegrating the infusion devices into theirexisting bar code system. Rather thanusing a separate infusion device bar codereader for the IV medications, their desireis to use the same scanning technologyfor oral medications and IVs. This can be aPDA with a built-in scanner or laptopcomputer with a tethered scanner. Sincethese systems require a wireless infra-structure and interfaces to ADT, pharma-cy, and possibly other computer systems,adding the IVs and pump programming is

viewed as a logical next step to their cur-rent system. The industry is responding tothis opportunity, and research and devel-opment (R&D) will soon lead to commer-cially available products. The potential forfurther reducing IV errors includes real-time communication from the pharmacyinformation system directly to the infu-sion devices either to program the rate ordose, or to confirm that the programmingis consistent with physician's order. A barcode system built into a smart pump pro-vides protection for when the bar code isnot available, such as with STAT medica-tions, system interruptions, and otherunscheduled or emergency events. Thewireless connection to the infusionpumps also will feed infusion data direct-ly into the electronic medical record(eMAR), thus significantly reducing nurs-ing time currently spent in documenta-tion of infusions administered. It also pro-vides pump manufacturers with a meansto update data sets wirelessly and thuseliminates the need to physically find andupdate every infusion device.

SummaryThe initial attempts to link BCMA and

IV infusion pumps many years ago failedto become commercial successes.However, a convergence of new technolo-gy, manufacturer-applied bar code labels,and the medication safety culture hasaccelerated R&D in this area. Smart infu-sion pumps combined with bar coderecognition provide hospitals with newopportunities to address both errors andharm. Hospitals will have options andtechnology-upgrade paths that until nowhave existed only for the oral and othernon-IV medications.

IV Infusion Pumps: The Missing Component in BarCode Medication Administration Systems


29

Table 1. Smart Infusion PumpCharacteristics

• Comprehensive drug library with:

– Drug name, including indication or other modifier

– Available standardized concentrations

– Non-editable dose rate units

– Other clinically useful guidance

– Soft/hard dose rate limits

• for continuous and bolus infusions

• Hospitals ‘own’, edit, and update libraries

• Libraries are ‘care-area-specific’

• All programming errors and resolution are logged and downloadable

Table 2. Non-NetworkedSmart Pump with Bar Coding

• Pump has “on-board label reader”– ‘Built-in’, ‘on tether’, or

‘short-range wireless’• Works together with drug library • Scan of IV drug container

– Selects correct entry in drug library– Ensures correct drug/concentration

in pump• Optional patient-smart pump link

– Ensures drug dispensed for specific patient

– Adds patient ID to ‘dose alert logs’• Pump logs downloaded periodically for

analysis

Table 3. Fully NetworkedSmart Pump with Bar Coding

• Shares bar code scan system with non-IV doses– Caregiver appliance with ‘real-time’

networked PDA/scanner functionality– Pump is also networked (directly or

via appliance)– Scan: patient, caregiver, drug,

pump channel – Server confirms ‘5 rights’ to permit

infusion– Ensures active order, right library

entry/programming– Populates medication administration

record (eMAR)– Provides Pharmacy window to

bedside (remote monitoring)• Pump’s drug library is utilized as ‘back

up system’ for STATs and verbal orders


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There is currently an increasedemphasis on patient safety, drugmarking, verification of medication

administration, improving the “fiverights,” improving surgical site informa-tion, and safer transfusions. These all havesignificant implications for positivepatient identification.

Current Bar Code I s suesThere are two ways to print a bar

code on a patient identification band (seeFigure 1). One is in a "picket fence" stylethat it wraps around the wrist. Oneproblem with this approach is that theidentification band becomes unreadablebecause it is too long. The other is the"ladder" style, where the information isprinted up and down on the wristband.The problem with this approach is there isnot enough space to print enough data.For example, for an eleven character barcode such as a social security number, it isvery difficult to put that in that spaceacross the wrist band.

When users encounter these prob-lems, they resort to key entry orworkarounds, such as carrying around bar

code cards with patient ID numbers.When this happens, there are increasedchances for errors.

Another problem is that the bar codeidentification on the wristband may notbe readily available. It may be under thepillow because that is where the patient'shand is while sleeping. Or it may be undera patient who has rolled onto his or herside or under the covers because it is coldin the room. The nurse has to wake thepatient up, find the wrist, find where theband is, find the bar code on the band,and turn on the lights. All of this canincrease patient discomfort.

What i s RF ID?RFID stands for "radio frequency

identification." It is an auto-identifica-tion technology, which includes barcodes, biometrics, voice recognition,magnetic stripe, on the back of creditcards, and RFID.

RFID has attributes that as a technol-ogy cover all of the different uses of barcodes (see Figure 2). It comprises a pieceof silicon–a chip, similar to one in a com-puter or in a PDA–that is attached to an

antenna. Data can be stored on the chipand communicated wirelessly. RFID isnon-linear, so there are not issues withthe location of the bar code or the wristband, because the data can be obtainedthrough radio wave transmission thatgoes through and around the humanbody. The read/write capability is anotherimprovement over bar code technology.(see Figure 3). Data can both be retrievedfrom and sent to the RFID device. When abar code is applied to a wristband and anyinformation in the bar code needs to bechanged, a new wristband would need tobe printed. The RFID wrist band can beupdated by sending data wirelessly.

RFID will be used to connect thepatient to the flow of data within thehospital. As the patient moves throughthe continuum of care, patient informa-tion can be stored and updated on thewristband, creating a dynamic databasethat travels with the patient.

The amount of data that can bestored on an RFID is increasing. Currently256 characters can be stored on a wrist-band. Information on a band can belocked and encrypted, so it cannot bechanged or read by unauthorized person-nel. The following information might allbe stored on a band: patient name, med-ical record number, social security num-ber, date of birth, doctors' names, admis-sion date, event number, a DNR instruc-tion, surgical site, blood type, height,weight, body surface area, insurance code,and allergy alert. Even with all of thisinformation, there is still room to storemore data and a place to hold data thatwill be updated, such as last medicationgiven, last EKG taken, or last pulse oxime-try reading.

Key Po ints :

• Bar code use for patient identification and medication administra-tion is growing.

• Although bar codes reduce medical errors, workarounds are emerg-ing because of the difficulties and added workload associatedwith bar code scanning.

• Radio frequency identification (RFID) provides non-linear site scanning, read / write data transfer, updating of patient data on thewrist, and increased information at the bedside.

RFID and Healthcare Applications: What comes after bar code?

Irwin Thall, Manager, Healthcare Market Development, Advanced Marketing and Technology, Precision Dynamics Corporation, San Fernando, CA

The RFID wristband is part of a sys-tem. This system could be accessed by ahand-held device no bigger than a PDA orby terminals connected to the HIS system.Data are collected by the system fromthe wristband and sent to the host sys-tem. The host system can verify thetransactions and then return updatedinformation to the wristband, completingthe loop.

Advantages for Hea l thcareRFID technology can prevent data

entry and collection errors, improve sys-tem efficiency, reduce forms processingtime, improve tracking of labor and sup-plies, and improve communicationsbetween doctors, nurses and patients.

RFID and Healthcare Applications: What comes after bar code?

Figure 3. RFID Patient ID Band System

1. Smart Band enters RF field2. RF signal powers tag3. Smart Band transmits ID, plus data4. Reader/writer captures data5. Reader/writer sends data to computer 6. Computer determines action and

sends data to reader/writer 7. Reader/writer updates Smart Band

ISSUES:Band 1

BC too longCurvature hard to scan

Band 2Not enough room for dataMultiple scans

Both BandsBC not readily accessibleNeed 2 hands for 1st time read

PROBLEMS:Band 1

Can’t scan Key entry required

Band 2Hard angles to scanKey entry used

Both BandsWork arounds createdNot enough hands

RESULTS:Potential increase in medical errors due toincorrect patient ID

SOLUTION:RFID Wrist Band

Figure 2. What is a SmartWrist Band?

• Inlet is sealed in an economical, non-transfer-able wrist band.

• Unlike bar code, RFID provides an “over-the-air” interface. Line-of-Sight communication isnot necessary (Read/Write through andaround bedding, clothing, and the humanbody).

• Read/Write capability allows for data transferto and from host systems and data storage(i.e. blood type, allergic reaction warning,instructions/DNR, surgery site).

• Part of a system that connects the caregiver,and the patient and the medication to thehospital system


31

Figure 1. Bar Code ID Bands


32

ROUNDTABLE DISCUSSION SUMMARY

How useful is BCMA as apatient safety measurementtool?Participants agreed that the primaryrationale for BCMA is to improve medica-tion safety. In addition, BCMA can poten-tially serve as a patient safety measure-ment tool. The following points were dis-cussed:

• BCMA can produce an accurate recordof deviations from physician orders

• These data can be useful as a medica-tion safety measurement tool

• These data include a record of all medication errors detected and prevented(near misses), some of which would haveresulted in patient harm

• The importance of minimizing processvariation in medication administration toimprove medication safety was debated

• For this information to be useful, anon-punitive culture of improvement isneeded

Need technology with a great databaseThomas S. Thielke, MS, RPh, FASHP,University of Wisconsin Hospitals andClinics: "If we're selecting vendors inmedication administration–smart pumps,CPOE, BCMA, or other technologies–Ithink the most effective systems arethose that have a great database that isreadily retrievable, so you can take theinformation to your P and T committeesor QI committees to continuously seewhat's happening, so you can go back andrevamp the system to make it better– inaddition to determining whether you arereally making a difference over time."

Patient, nurse have to come firstEmily S. Patterson, PhD, Cincinnati VAMedical Center, The Ohio State University:"There have been hundreds of requests forchange to BCMA, and I'd say about a thirdof them have been for better reporting,better tracking, and more user-friendlyreports. I have assigned those all a rela-

tively low priority level, because we needto keep in mind that in terms of opera-tion, the end user, the nurse has to betaken care of first. Until there is wide-spread user adoption and the removal offrequent "workarounds", the data inreports will not be accurate."

We have to remember that the patientwho's being taken care of is the first pri-ority with this system–that's the driverfor putting it in. Those other things cancome along for the ride, but only if you donot ask the nurse to type in more data, ifyou do not slow it down, and if you don'tpunish the nurse based on timelinessdata. Trying to get a "two-for-one" withthe system in ways that make nurses domore work for others' benefits makes thesystem less likely to be quickly adopted.

What is the impact ofBCMA on nurses?

It was noted that decisions to adoptnew technologies often do not adequate-ly involve the clinicians that must use it.Participants noted the following impactof BCMA on nurses:

• BCMA does NOT improve nursing pro-ductivity, particularly with systems withslow response time

• It takes time for nurses to learn to useand accept BCMA technology

• BCMA results in nurses placing higherpriority on following medication ordersaccurately, instead of on meeting otherurgent clinical patient care needs thatmay be more important

• Workarounds reflect a need for nurs-es to use clinical judgement when admin-istering medications

• Nurses are more likely to acceptBCMA if the systems are designed aroundtheir work and they are involved in theselection of a system

• Improvements in technology are like-ly to speed adoption of BCMA by nurses

Preventing major errorsRebecca Long, RN, MS, CNS, CCRN, SanDiego VA Medical Center: "For thosemajor errors such as wrong patient,wrong med, or errors that can be verycritical, we are seeing those being pre-vented. Most of the nurses are gettingon board for bar coding due to this errorprevention."

Over time, nurses are more satisfiedwith BCMA Wendy Wittwer, RN, BSN, St. Mary’sHospital Medical Center, Madison, WI:"Nursing satisfaction studies done at ourhospital pre and post-implementationshow that nurses are far more satisfiedwith the BCMA system than without it-similar to the University of Wisconsinfindings. These studies also show that thelonger the system is in place, the moresatisfied nurses are. Given some time toget through the process change, nursingdefinitely understands and appreciatesthe value of the system helping them todeliver safer patient care."

Nurses accept BCMA as part of work-ing in our hospitalMarilyn J. Cushing, RNC, MSN, MBA,Piedmont Hospital, Atlanta, GA: "Thenurses in our community hospital reallydidn't like it at the beginning. But we'vebeen ‘live’ in all of our units including crit-ical care for over a year, and staff reallyaccept it now a lot better than they did. Ido not believe that it's improved produc-tivity: it takes nurses longer to initiallycheck and verify medications entered bypharmacy against the doctor's order.There are still some issues with pharma-cy getting the orders in quickly, so thatnursing can give the meds with the orderalready in the system. But new peoplecoming in are told this is the way we dobusiness and they just accept it. They maynot like it, they may wish that they werenot using the technology, but they acceptit as part of working in our hospital."


BCMA can create operational barriers to careGeraldine A. Coyle, RN, EdD, CNAA,Martinsburg VA Medical Center: "WithBCMA, our nurses have noticed that theLPN who used to give us more help withmedication administration, doesn't giveus nearly that amount of help, particular-ly in long term care. For example, if theservers are slow and she has to wait forthe ‘go’ message-got the right patient,got the right med, it's a go-she is waiting10 seconds between every medication. Ingeriatrics, patients can have 14 differentkinds of medications. You are standingthere going gray waiting for just onepatient, and you've got 20 patients."

Technology has to be integratedCarol Dueck, Director, Clinical HealthInformation, Scarborough General Hospital,Toronto, Ontario: "Especially the criticalcare people-they do want bar coding, andthey want the technology, but they want itintegrated, and they want it to be part of thediscussion at the table before it gets built."

Has to work for nursing at the point ofcareWendy Wittwer, RN, BSN: "The bottomline in all of this, and I hear it from nurs-es all of the time–it has to work for nurs-ing. They are at the end of the line. Theyare the last person who could catch amistake. That is why the best place to usetechnology is at the point of care."

Must be process-drivenRebecca Long, RN, MS, CNS, CCRN: "Weneed to have the process drive the tech-nology, and not the technology drive theprocess."

Is there a need for scientificevidence to support imple-mentation of BCMA?

In health care, the emphasis has beenon evidence-based medicine and basingdecisions on scientific proof. This evi-

dence is often lacking for patient safetytechnologies, including BCMA. The partic-ipants debated the need for scientific evi-dence for patient safety innovation, mak-ing the following points:

• Ideally, the use of a system thatchanges work and incurs significant costsshould be based on scientific evidence

• Other industries use hunches andjudgement to make quality improvementdecisions

• Early adopters are likely to use hunch-es and judgement in deciding to useBCMA before scientific evidence support-ing its use is available

• Later adopters are likely to await sci-entific or anecdotal evidence from earlyadopters before making a decision aboutBCMA

Evidence-based medicine (EBM) can be limitingChuck Denham, MD, Healthcare Concepts,Inc., Austin, TX: "We also need to considerthe 'force multiplier' effect of couplingcomplementary technologies: What per-formance impact does adding bar code to asmart pump now give us that may multiplythe benefits? Simply put, instead of 3 plus3, we may be getting a 3 x 3 in impact."

Common sense: significant changeThomas S. Thielke, MS, RPh, FASHP: "If wehave three or four well done studies ofBCMA and you see these huge differencesin error rates, I think it's very compelling-to where common sense tells us that evenif the reported error rate isn't entirelyaccurate, it's a really significant change."

Do study results transfer?Thomas S. Thielke, MS, RPh, FASHP: "Thereare some studies with good data, but wehave to make sure that the technology weare using is similar to what's been used inthe studies at Vanderbilt or Brigham andWomen’s Hospital, and not the kind of turn-key systems that can't really do thejob and achieve similar results."

Ken Barker, PhD, Auburn University:"Hospitals are still so dissimilar and stillknow so little about their own systems.Just because i t works at Br ighamand Women's Hospital, University ofWisconsin, or these other outstandingplaces doesn't at all guarantee success ordeserve generalization to the other hospi-tal situations. Our real problem is the needfor better technology evaluations at theindividual hospital level, or certainly atthe system level, to follow up on thesestudies. Yes, it worked in our leading hos-pitals. Now, will it work in the VA? Will itwork in a 200-bed hospital that's not yetcomputerized?"

FDA interested in diffusion of technology, not a specific approach Steven A. Tucker, Economist, FDA: "TheFDA is extremely interested in the diffu-sion of technology. We don't feel that weare necessarily backing bar coding overany other patient safety initiative. Thiswas one we could do now through themanufacturing sector. We hope that it willhelp, and not necessarily hinder any otherspecific outcomes."

What is the business case?It was agreed that new patient safety

technologies are expensive and posechallenges to hospitals that operateunder financial constraints. Participantsdiscussed the following considerations inmaking a business case for BCMA:

• Acquisition of any technology needsto be compared to other technologies as itrelates to potential impact on safety, easeof implementation, and cost

• Even with the same technology, notall products or vendors are the same

• Not all errors pose the same risk; needto focus on errors that cause harm

• Cost savings from adverse drugevents prevented (cost of treatment,increases in length of stay)

• Reduced costs for litigation


33

• Decreased liability claims

• Increased reimbursement

• Impact on nurses

• Improved image of the hospital to thepublic

Must impact errors that cause harmNat Sims, MD, Massachusetts GeneralHospital: "There are many options toapply technology to address medicationerrors, but the real opportunity is toaddress the errors that cause harm.Taking harm out of the system should beour first priority."

Enable best practiceChuck Denham, MD: "We should alwaysstart with the best or better practice thatdelivers known performance impact andthen apply the best combination of prod-ucts, services, and technologies thatenable that practice. Technologies shouldalways be seen as enabling a best practice,not a substitute for a practice."

Is bar coding the best approach?Calvin Franz, PhD, Senior Economist, ERG,Inc., Lexington, MA: "In our bar codingstudy, a 1% decrease in nurse produc-tivity nationwide is $300-400 million peryear. As an economist, it seems obvious tome that the bar coding will improvepatient safety, but if it is costing us half abillion dollars a year, then that might bemoney could be invested into anothersystem that would give us greater 'bangfor the buck.' We keep researching to seeif there are cheaper ways of improvingpatient safety, since capital is so scarcefor hospitals."

Overly rapid diffusion could jeopardizethe innovationPhilip J. Schneider, MS, FASHP, The OhioState University: "Putting an emphasis orpressure on healthcare providers to dif-fuse innovation before the environment isready or the technology is ready, we couldend up jeopardizing the innovation itselfby trying to stimulate it too quickly."

Insurance discounts, cost savingsF. Andrew (Drew) Gaffney, MD, FACC,Vanderbilt University Medical Center: "Asingle malpractice insurance carrier, StateVolunteer Mutual Insurance Company,covers approximately 90% of the physi-cians in the state of Tennessee. They'vestarted a discount program for surgeonswho take a special course related to safe-ty. The area of safety is called ‘crewresource management,’ an aviation basedcommunication and leadership coursethat teaches team members to speak upwhen a problem is recognized or identi-fied. We are in the process of implement-ing that same program at Vanderbilt. Weare self-insured but use actuarial data toset our malpractice rates for our differ-ent groups of physicians. Our self-insur-ance trust is funding Crew ResourceManagement training for over 600 physi-cians, nurses, and other care givers as partof a large scale pilot safety project. Wehope to have insurance discounts in placefor the coming year for those physiciansand departments that complete the safetytraining and demonstrate incorporation ofthe training into their medical practice.

"Just to put into context the magni-tude of medical malpractice, medicalerrors, and resultant risk managementexpenses, we looked at what we were set-ting aside for actual and potential claimson an annual basis and converted thosedollars back to gross revenue, i.e. howmuch revenue was ‘lost,’ given that mal-practice claims expenses really come froman organization's bottom line. Theamount of lost revenue can easily run intothe hundreds of millions of dollars annu-ally. It's virtually impossible to get thiskind of information in the public sector,but each institution has its own data. It'smoney that is is essentially thrown awaybecause most of the medical errors lead-ing to claims are preventable. Whenyou're talking about numbers this mas-sive, it becomes much easier to make theargument to administrators that safety

measures and safety programs are costeffective, not to mention benefits of notactually causing harm to our patients."

Errors that cause harm are IVChuck Denham, MD: "There are errors,harm, and errors that cause harm. Errorsthat cause great harm are in the IV area—they are really dramatic and there is agreat return on investment in reducingthem. The speed to impact is better withsmart pumps than anything we haveseen."

Grab every opportunityKen Barker, PhD: "Any of these efforts thatattempt to give us a good rationalapproach to improving even part of theprocess are well worthwhile. For instance,if we don't decide that it's the time for allkinds of bar code applications, and we dodecide that it's time for to move ahead oninfusion safety, I think that's a very rea-sonable thing for us to do-that is, to grabevery opportunity we have at processimprovement and move forward. There isso much room for improvement, we canhardly go wrong."

Decisions based on philosophy and missionGeraldine A. Coyle, RN, EdD, CNAA: "TomThielke's CEO wanted the University ofWisconsin to be the safest hospital in thestate. So you have a vision and a philoso-phy and a lot of the decisions about whatto do and how to do it, what to buy andwhen to buy it, are grounded in your phi-losophy of care and the mission of yourmedical center."


34



ALARIS Medical Systems, Inc.Worldwide Headquarters, 10221 Wateridge Circle, San Diego, California 92121-2772

Fax: 1-858-458-7760Customer Service: 1-800-482-4822Website: www.alarismed.com/na ©2

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SPEAKERSPamela F. Cipriano, PhD, RN, FAAN Chief Clinical OfficerUniversity of Virginia Medical CenterCharlottesville, VA

Geraldine A. Coyle, RN, EdD, CNAAAssociate Medical Center Director for Nursing and EducationMartinsburg VA Medical CenterMartinsburg, WV

Ray R. Maddox, PharmD, FASHPDirector of Clinical Pharmacy, Research and Respiratory CareSt. Joseph's/Candler Health SystemSavannah, GA

Wally Mrozik. PhDUPS Professional Service, Inc.PresidentAtlanta, GA

Emily S. Patterson, PhDResearch Physical Scientist, VA Midwest Patient Safety Center of Inquiry, Cincinnati,VAMC, Institute for Ergonomics, The Ohio State University, Columbus, OH

Eric Poon, MD, MPHDivision of General Medicine and Primary CareBrigham and Women's HospitalClinical Informatics Research and Development, Partners Information SystemsBoston, MA

Douglas J. Scheckelhoff, MS, RPh, FASHPDirector, Practice Leadership and ManagementAmerican Society of Health-System PharmacistsBethesda, MD

Philip J. Schneider, MS, FASHPDirector of Latiolais Leadership ProgramClinical Professor, The Ohio State UniversityColumbus, OH

Nat Sims, MDCardiac Anesthesiologist, Massachusetts General Hospital;Physician Advisor, Partners Biomedical Engineering, Boston, MA

Irwin ThallManager, Healthcare Market DevelopmentAdvanced Marketing and Technology (AMAT)Precision Dynamics CorporationSan Fernando, CA

Thomas S. Thielke, MS, RPh, FASHPVice President Professional and Support ServicesUniversity of Wisconsin Hospitals and ClinicsMadison, WI

John TourvilleDirector, PharmacyChildren's Medical Center of DallasDallas, TX

Steven A. TuckerEconomistOffice of Planning, FDARockville, MD

Allen J. Vaida, PharmD, FASHPExecutive DirectorInstitute for Safe Medication PracticesHuntingdon Valley, PA

ATTENDEESEric Balmir, PharmDNew York Methodist Hospital, New York, NY

Kenneth N. Barker, PhDDirector, Center for Pharmacy Operations and DesignsAuburn University, Auburn, AL

Larry G. Bettesworth, PharmDDirector of Pharmacy, Sacred Heart Medical CenterSpokane, WA

Rhonda Collins, RNC, MSNVice President–Women's & Children's ServicesBaylor University Medical Center, Houston, TX

Marilyn J. Cushing RNC, MSN, MBANursing Informatics SpecialistPiedmont Hospital, Atlanta, GA

Charles R. Denham, MDCEO, Health Care Concepts, Inc., Austin, TX

Cathy Denning, RN, MSNSenior Clinical Manager- Safety, NovationInving, TX

Carol DueckDirector of Clinical Health InformationScarborough General HospitalToronto, Ontario

Jim Eskew, RPh, MBADirector of Pharmacy, Clarian Health PartnersIndianapolis, IN

Calvin Franz, PhDSenior Economist, ERG, Inc.Lexington, MA

Blair FraterSharp Healthcare, San Diego, CA

F. Andrew (Drew) Gaffney, MD, FACCProfessor of Medical Administration and MedicineAssociate Dean, Clinical Affairs(Patient Safety and Risk Management)Vanderbilt University Medical CenterNashville, TN

Regina Izu, RN, PHN, MSN, APNScripps HealthCardiac Care Center (6 E/W)Medical/Oncology (7W)La Jolla, CA

Elaine LevySharp HealthcareSan Diego, CA

Rebecca Long, RN, MS, CNS, CCRN, AACNNational Board of Directors, AACN Clinical Nurse Specialist/Academic EducatorVA Healthcare System–San DiegoSan Diego, CA

G. Bernard Meyer von Bremen, PharmDAssociate Director of Pharmacy ServicesClinical Support and Pharmacy Automation InstitutionalReview Board, ChairMedical Center of Central Georgia, Macon, GA

Mike Millard, MS, RPhDirector of Pharmacy, PeaceHealthSacred Heart Medical Center, Eugene, OR

Mark NeuenschwanderPresident, The Neuenschwander CompanyBellevue, WA

Matthew R. Pike, RPhMedi-Span US Product File ManagerIndianapolis, IN

Gina Pugliese, RN, MSVice President, Premier Safety InstituteMacon, GA

Tim RitterSr. Project Engineer, Emergency Care Research Institute (ECRI)Plymouth Meeting, PA

Lynne Royer-WilloughbyDirector of Medical InformaticsCommunity Health Network, Indianapolis, IN

Andy C. Seger, RPhSr. Research Pharmacist, Brigham and Women's HospitalDivision of General Medicine and Primary CareBoston, MA

Ned Simpson, Director, TCS Life Sciences and HealthcareAnn Arbor, MI

Erin SparnonProject Engineer, Emergency Care Research Institute (ECRI)Plymouth Meeting, PA

William A. SpoonerSenior Vice President and CIOSharp Healthcare, San Diego, CA

David UPresident and CEOInstitute for Safe Medication Practices CanadaSunnybrook & Women's College Health Sciences CentreToronto, Ontario

John VanEeckhout, PharmDVice President, Clinical ServicesChild Health Corporation of AmericaShawnee Mission, KS

Matthew B. Weinger, MDDirector, San Diego Center for Patient SafetyDirector, Anesthesia Ergonomics Research LaboratoryProfessor of AnesthesiologyUniversity of California, San Diego School of MedicineSan Diego, CA

Nancy Weiss, RNMayo Clinic, Rochester, MN

Wendy Wittwer, RN, BSNMedPoint Coordinator, St. Mary's Hospital Medical CenterMadison, WI

ALARIS Medical Systems, Inc.Joseph CondursoDirector, Marketing Applications

Sally Graver Writer

Gamble HeffernanDirector, The ALARIS® Center for Medication Safety and Clinical Improvement

Claudia Russell Division Vice President, Marketing and Strategic Dev.

David Schlotterbeck President and CEO

Geoff Siegel Division Vice President, Product Development

Jake St. PhilipVice President and General Manager, North America

Tim Vanderveen, PharmD, MSExecutive Clinical Director, The ALARIS® Center forMedication Safety and Clinical Improvement

bar code medication administration - bd · curve, as discussed in the opening presen-tation. the...

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