Pennsylvania Patient Safety Advisory Medication Errors Occurring with the Use of Bar-Code Administration Technology ABSTRACT Studies have shown that BCMA can reduce medica- Bar-code medication administration (BCMA) systems tion errors by 65% to 86%.5,6,7 To determine the can improve medication safety by verifying that the effectiveness of its newly implemented bar-code sys- right drug is being administered to the right patient. tem, one hospital in Pennsylvania showed that the Studies have shown that BCMA technology can direct-observation accuracy rate before BCMA was reduce medication errors by 65% to 86%. But BCMA 86.5%; after BCMA, the rate rose to 97%.8 But tech- technology alone does not ensure a safe medication- nology alone does not ensure a safe medication-use use system. A number of reports submitted through system, and the process changes that accompany any PA-PSRS describe medication errors that occurred technology can introduce new sources of error.4 in organizations that used a bar-code system for administration. Some of these errors result from fail- Clinical analysts from PA-PSRS queried the data- ures to use this technology appropriately, employing base using keywords related to BCMA such as “bar workarounds or overriding alerts, disruptions in the code” and “scanned” as well as reports coded as medication administration process, and dispensing involving BCMA when reviewing individual case errors that arise in the pharmacy. Strategies to address reports. A review of medication error reports submit- problems with this technology include reviewing ted through PA-PSRS since June 2004 revealed that BCMA logs to evaluate overrides and identify system there are reports that describe potential events that weaknesses and monitoring and measuring compli- were detected and caught by BCMA technology. ance with the technology to identify and remove any However, a number of reports submitted through barriers to its appropriate use. (Pa Patient Saf Advis PA-PSRS describe medication errors that occurred 2008 Dec;5[4]:122-6.) in organizations that used a bar-coding system for administration. Some of these errors are indirectly associated with the bar-code administration system, and some are the result of issues with the use and mis- A prospective cohort study of medication errors use of this technology. by Leape et al.1 determined that 39% of errors occurred during the prescribing phase, 12% during Dispensing Node transcription, 11% during dispensing, and 38% dur- ing administration. Close to half of the errors that Some errors associated with BCMA do not originate occurred during the prescribing phase were inter- with the technology. Rather, they occur earlier in the cepted before they reached the patient; in contrast, medication-use process (i.e., dispensing phase) and only 2% of errors that occurred during the adminis- are perpetuated by bar-code verification at administra- tration phase were intercepted. Another study using tion. For example, pharmacy may mistakenly place the direct observation in 36 healthcare facilities found correct (e.g., right drug, right dose, right patient) phar- that medication administration errors occurred in macy-generated label on the wrong medication. This almost 20% of doses administered.2 Data from U.S. type of error, especially if the pharmacy-generated Pharmacopeia’s (USP’s) medication error reporting label obscures critical information on the manufac- database, MEDMARX®, indicates that an error at the turer’s label, could make its way to the patient, as the point of administration is least likely to be intercepted BCMA system would read the bar code as the correct before reaching the patient, compared to other phases medication for the patient. of the medication-use process.3 A review of medication errors associated with bar- code technology submitted to the USP MEDMARX One form of technology that may address administra- program between June and August 2006 showed tion errors is a bar-code medication administration that the most frequent cause of BCMA-related errors (BCMA) system. BCMA can improve medication was mislabeling. Sixty-five of the 128 (51%) reported safety through several levels. At the most basic level, labeling errors resulted from attaching a bar code the system helps to verify that the right drug is being associated with one product to a different product. administered to the right patient in the right dose Another 29 (22.7%) of the reports of mislabeling and at the right time. The 1999 Institute of Medicine indicated that the bar code was affixed to the wrong report To Err Is Human noted that point-of-care bar strength of the correct medication.9 coding offers a simple way to ensure that the identity and dose of the drug are as prescribed, that the drug These types of errors may occur for many reasons. is being given to the right patient, and that all of the Reports submitted through PA-PSRS demonstrate steps in the dispensing and administration processes that a wide variety of contributing factors may lead are checked for timeliness and accuracy.4 Since the to selecting the wrong product from the pharmacy late 1990s, the use of bar coding in drug administra- inventory, including similar packaging and labeling of tion has increased. medications, pharmacy order-entry errors, look-alike Page 122 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 4—December 2008 Pennsylvania Patient Safety Advisory names, and selection of the right drug but wrong administered to a patient when only one half of a concentration. For example, consider the following tablet was ordered. reports. Nurse scanned Bumex® (bumetanide) 1 mg tab but A patient was due to have hydrogen peroxide applied forgot to break tab prior to administering 0.5 mg dose to her face. The medication was obtained from the ordered; wrong dose error. The vital signs were moni- medication room, as sent up from pharmacy. It tored and serum electrolytes were rechecked. was labeled correctly, but the bottle was magnesium Administering Node citrate. The label was placed partially covering the magnesium citrate label. This would not have been BCMA technology can improve medication safety picked up from scanning because staff scans the label. through several levels of functionality. At the most basic level, the system helps verify that the right drug Lamictal® (lamotrigine) 150 mg [orally twice daily] is being administered to the right patient in the right was ordered for a patient, but was transcribed into dose and at the right time. When one of these items the [BCMA] system as lamivudine 150 mg po bid by does not match, most systems alert the practitioner the pharmacy. Both the bar code and Pyxis scanned before administration. Alerts can also be generated correctly due to order being verified by nurse as cor- when patients do not have an active order or are aller- rect drug. Error noticed by doctor when reviewing gic to the scanned medication. However, problems medication list. may occur despite the display of an alert. Examples of reports submitted through PA-PSRS in which A patient was ordered for a “now” dose of Thorazine these alerts signaled a problem, yet an error occurred, (chlorpromazine) 25 mg. The pharmacy filled the include the following: order and dispensed Librium® (chlordiazepoxide) 25 mg. The nurse used the electronic scanner, and Nurse was assisting another nurse by giving a patient the device indicated a “wrong drug” error. The nurse a dose of insulin. The nurse scanned and adminis- looked at the drug, thought the name was correct, tered the insulin despite [BCMA] firing a “no order and overrode the device and administered the incor- in system” warning. The insulin was given to wrong rect medication. patient. Patient who was on weight-based heparin protocol Vancomycin was dispensed for a neonate in a syringe was ordered “No Bolus Ever” by the physician. labeled with the ordered dose, but with the wrong con- [BCMA] fired a “no order in system” alert, but the centration of drug. The medication scanned correctly nurse continued and administered bolus. No untow- in [BCMA], since label with correct information. ard reaction was reported. The error was discovered by pharmacy. The doses were retrieved from the floor. [Morning] dose of Avandia® (rosiglitazone) admin- istered early by the night shift nurse. Student nurse In order to maximize the safety mechanisms that noted Avandia dose on [BCMA] worksheet and BCMA technology provides, medications need to administered second dose. [BCMA] displayed appro- be packaged in unit-dose or ready-to-use formats. priate “early dose” and “exceeding maximum daily However, the availability, or lack thereof, of manufac- dose” warnings; student proceeded through warnings turer-supplied, bar-coded unit dose medications does and administered dose. not fully support this. Although the U.S. Food and Drug Administration requires bar codes on contain- Patient’s order for Cardizem® (diltiazem) 120 mg ers, it does not require that unit-dose containers be four times a day was discontinued, and the dose was available for all medications. As a result, unit-dose changed to 60 mg every six hours. The pharmacy packaging of some established products has been entered the transcribed orders into the [BCMA] sys- discontinued. Fully implementing a BCMA system, tems, awaiting confirmation by the nurse. The nurse therefore, may involve repackaging many medications administered the 120 mg dose, despite an alert from and relabeling each dose with a bar code. This may [BCMA] that stated the medication was discontin- include the purchasing of automated repackaging ued and that there were medications that required equipment, increasing pharmacy staff, providing confirmation. The nurse then confirmed orders and adequate space within the pharmacy to prepare these administered 60 mg dose within 2 hours of 120 mg medications, and implementing a verification process dose. No untoward reaction was reported. to ensure that the bar code is correct and readable by Alerts that are generated by BCMA systems often may the same scanners and database used by the nurses not be noticeable. For example, a system may generate on the patient care units. In addition, some pharma- a visual display of the alert but not provide a distinct cies do not prepare medications in a patient-specific auditory alert. If a nurse does not look at the screen ready-to-use form—for example, breaking tablets in for any alerts after scanning a patient’s wristband half before unit-dosing the products for “half-tablet” and/or bar-coded medications, errors will ensue. orders or providing patient care areas with bulk Additionally, the alerts are not hard-stops, meaning bottles of liquid medications from which a nurse is that the system does not physically stop a practitioner required to measure a dose. In the following report from proceeding with scanning or administering a submitted through PA-PSRS, a whole tablet was medication. The alert is merely a warning that may or Vol. 5, No. 4—December 2008 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Page 123 Pennsylvania Patient Safety Advisory may not require a simple key stroke (e.g., hitting the of the 85 facilities under the Hospital Corporation “Enter” key on a keyboard) to override. One Pennsyl- of America facilities using BCMA in June 2004, vania facility submitted the following report through only 64% of patient armbands were scanned and PA-PSRS that illustrates this. only 86% of medication labels were scanned.10 Many A nurse drew up a medication for a patient in another reports submitted through PA-PSRS suggest that some room and mistakenly administered the medication to medications and patient armbands continue to not [another] patient. The [nurse] scanned each medica- be scanned. tion; however, the nurse went into the wrong room, A nurse found Brevibloc® (esmolol) to be infusing scanned the patient’s bar code, and did not check the instead of a heparin infusion as ordered. Heparin screen prior to giving medication to the patient. The was ordered to be resumed, and the nurse started screen did verify that it was the wrong patient. The wrong infusion. The nurse did not scan medication. patient received three incorrect medications. Nurse connected peripherally inserted central catheter Problems have also occurred when other processes line to central venous pressure transducer as ordered surrounding medication administration have broken but used a heparin flush bag on patient with HIPA down. Although the steps directly involved with (+) [sic] history instead of normal saline flush. Nurse the scanning of the medication and patient may be did not scan heparin bag into [BCMA] prior to completed, errors can be introduced if distractions administration so allergy alert could not fire. occur or medications are laid down after the scan- ning process. Patients in Pennsylvania have received Phenylephrine drip [was found] infusing at the incorrect medication or dose due to these types 35 mL/hour instead of ordered insulin drip at of process breakdowns, as evident from the following 7 units/hour (35 mL/hour). When hanging new bag PA-PSRS reports. of insulin, nurse failed to scan bar code into [BCMA] and hung wrong medication. There was no adverse Nurse pulled Unasyn® (ampicillin and sulbactam) effect to blood pressure or glucose noted. 1.5 mg to hang for patient’s dose. She scanned the medication and the patient’s wristband appropri- Altace® (ramipril) was given in the morning by ately. The nurse put down the medication on the the nurse but was not scanned or documented into medication cart to answer a call bell. She returned [BCMA] system. Later, another nurse noted that the to the medication cart within approximately five medication was still profiled for administration on minutes, took the medication into the wrong patient [BCMA], and she also administered the medication, room, and hung on wrong patient. which resulted in an extra dose error. Nurse removed morphine syringe for patient-controlled The patient’s bedtime medications were given but analgesia (PCA) to change the PCA pump since were not immediately recorded into the [BCMA] sys- the previous syringe was empty. The doctor wrote tem because the nurse was suddenly called to a code an order for “sodium bicarbonate [intravenous] IV blue elsewhere. Another staff member, in an effort push x1.” The nurse scanned the sodium bicarbon- to assist, checked to see if the patient’s medications ate per protocol, but after scanning the patient and were given, saw that they had not been scanned, and the medication, the nurse picked up PCA morphine assumed they were not given. The medications were syringe and administered morphine to patient instead administered a second time at bedtime resulting in an of the sodium bicarbonate. The nurse began to scan extra dose. the morphine PCA syringe to change PCA and then Why practitioners choose not to use this technology realized that morphine was given. when giving medications is a key question to ask in A patient with diabetes was to receive 4 units of order to maximize the impact BCMA can have on regular insulin per sliding scale insulin coverage, but medication safety. To determine the factors that influ- the patient received 10 units of regular insulin and enced the bar-code verification undertaken by nurses 20 units of NPH insulin that was intended to be during medication administration, one Dutch hospi- given to the patient’s roommate. The nurse drew both tal asked the nurses why the bar-code system was not insulin doses from the automated dispensing cabinet always used. The five most frequently cited reasons for and had properly labeled the syringes by bar coding not verifying bar codes were difficulties in scanning them. Prior to administering the insulin, she scanned bar codes on the medication labels, lack of awareness the patient and the syringe. She then obtained an of bar codes on medication labels, delays in responses alcohol swab, picked up the wrong syringe, and from the computerized system, shortage of time, and administered the wrong dose to the patient. The nurse administration of medication before prescription.11 immediately realized her mistake and notified the Workarounds and Overrides physician. A workaround is a method of accomplishing an Failure to Scan Medications activity when the usual system/process is not work- The effectiveness of bar coding technology in safe- ing well.12 While a workaround provides a temporary guarding patients is limited by the extent to which it solution to the immediate problem, it is also an indi- is correctly and consistently used at the bedside by cation that the system may need improvement. To each clinician administering medications. In a study save time, nurses may work around the safety features Page 124 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 4—December 2008 Pennsylvania Patient Safety Advisory of a BCMA system. For example, nurses may type the patient’s Social Security number (which can be Failure Modes in the BCMA Process used as a patient identifier) into the system rather than scanning the patient’s wristband. This avoids Examples of failure modes that can occur during the bar-code medication administration (BCMA) perceived difficulties (e.g., a damaged bar code, the process include the following: curvature of the band on patients with small wrists) ■ Medication does not come packaged as bar- in scanning the wristband. Other examples of work- coded unit-dose product arounds used to identify patients include keeping a ■ Pharmacy does not scan products arriving in second set of printed patient wristbands on a ring for scanning in the medication room or patient bedside pharmacy for readability or affixing the patient wristband to the bedside rather ■ Pharmacy applies correct label with bar code than on the patient to expedite scanning (e.g., when a to wrong product new IV bag is hung and the patient is asleep). ■ Drugs not available in ready-to-use unit-doses for nurse (e.g., tablets not broken in half) Like automated dispensing cabinets (ADCs), BCMA ■ Nurse fails to scan patient systems allow overrides in case medications need to be ■ Nurse fails to scan medication administered in an emergency. All caregivers admin- istering medications must understand that using an ■ Bar code on patient and/or medication is override bypasses the important safety checks. One unreadable workaround identified by the Institute for Safe Medi- ■ Patient wristbands are not on patients but cation Practices (ISMP) that led to an error involved other locations (e.g., clipboards, med rooms) an order for digoxin elixir, which was stocked on the ■ Nurse overlooks alert displayed on patient care unit as a 60 mL (0.05 mg/mL) multidose computer screen bottle (the usual dose is 0.125 to 0.25 mg [2.5 to ■ Nurse overrides alert without investigating 5 mL]).13 The nurse misinterpreted the dose of digoxin its cause elixir as 60 mL. In addition, she accidentally retrieved a bottle of doxepin (an antidepressant) from unit stock and attempted to administer a 60 mL dose of what she thought was digoxin. Scanning the bar code on the bottle of doxepin generated an error window on the ■ Monitor and measure compliance with the tech- electronic medication administration record screen nology to identify and remove any barriers to the stating “drug not on profile,” but the nurse did not safe and appropriate use of BCMA. investigate the warning. Instead, she manually entered ■ Conduct focus groups and satisfaction surveys to the doxepin national drug code (NDC), overriding the solicit nursing feedback. digoxin NDC that had been entered by the pharmacy. The result was administration of 60 mL doxepin to ■ Conduct executive rounds and direct observation the patient. of medication administration to help identify and correct workarounds. Keeping an open door policy Another example of a workaround includes a failure will allow staff opportunities to discuss barriers to scan every tablet or capsule included in a patient’s and workarounds. The nurse executive should dose. A number of reports have been submitted encourage staff participation in the continuing by Pennsylvania facilities that illustrate this at-risk process improvement activities that follow the behavior. implementation period.10 A nurse withdrew the incorrect amount of ■ Dispense patient-specific doses with bar codes Dolophine® (methadone) tablets from the ADC whenever possible. This includes half tablets, oral and administered the medication. The nurse scanned syringes that contain the exact dose of an oral solu- one tablet and manually entered the prescribed dose tion, and IV syringes that contain the patient’s in [BCMA] instead of scanning each individual exact dose. tablet until the total prescribed dose was obtained. ■ Scan all medications upon arriving in the phar- macy to verify that the bar code is part of the Risk Reduction Strategies current database, and scan medications before New technology will not be a panacea for medication dispensing. errors, but it can provide safeguards not possible with ■ Develop a mechanism to alert pharmacy when fully manual processes. Organizations may consider there is a problem scanning medications on the some of the following steps to maximize BCMA’s patient care units. impact on medication safety. ■ Computer screens that display patient information, ■ Analyze BCMA logs, and evaluate all overrides to including allergies and medication lists, should be identify system weaknesses and areas in need of positioned so that they can be easily viewed and process improvement. read by nurses. Vol. 5, No. 4—December 2008 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Page 125 Pennsylvania Patient Safety Advisory ■ Bar-code label equipment, including printers and 4. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is batteries, must be continually checked for accuracy human: building a safer health system. Washington (DC): and readability and undergo routine preventive National Academy Press; 1999. maintenance by information technology (IT) or 5. Malcolm B, Carlson RA, Tucker CL, et al. Veterans biomedical staff.13 Affairs: eliminating medication errors through point-of- ■ Do not have healthcare clinicians view the verifica- care devices. Paper presented at: Healthcare Information tion that BCMA provides as a nice but unnecessary and Management Systems Society Conference; 2001 feature. The alerts that arise from the system Apr; Dallas (TX). Vol. 2 (Session 73): 218–26. should not be allowed to be bypassed without 6. Puckett F. Medication-management component of a serious consideration. For every error like those point-of-care information system. Am J Health Syst Pharm described above, many more have been prevented 1995 Jun 15;52(12):1305-9. because BCMA has been employed. There is little doubt that BCMA can save lives if properly imple- 7. Johnson CL, Carlson RA, Tucker CL, et al. Using mented and used appropriately. BCMA software to improve patient safety in Veterans Administration Medical Centers. J Healthc Inf Manage ■ For those organizations that plan on introducing 2002 Winter;16(1):46-51. BCMA into their facilities, conduct a readiness assessment or other proactive risk assessment 8. Paoletti RD, Suess TM, Lesko MG, et al. Using bar-code to gain commitment and create enthusiasm for technology and medication observation methodology for safer medication administration. Am J Health Syst Pharm BCMA, identify challenges and plan accordingly, 2007 Mar 1;64(5):536-43. and remedy process problems before implemen- tation. A bar-code readiness assessment tool is 9. Cochran GL, Jones KJ, Brockman J, et al. Errors pre- available free of charge from ISMP. To obtain a vented by and associated with bar-code medication copy, visit: http://www.ismp.org/selfassessments/ administration systems. Jt Comm J Qual Patient Saf 2007 barcoding.asp. May;33(5):293-301. ■ Establish a multidisciplinary team, including nurs- 10. Englebright JD, Franklin M. Managing a new ing, IT, and pharmacy staff, as well as frontline medication administration process. J Nurs Adm 2005 practitioners, to determine best practices and guide Sep;35(9):410-3. implementation. 11. van Onzenoort HA, van de Plas A, Kessels AG, et al. Notes Factors influencing bar-code verification by nurses dur- 1. Leape LL, Bates DW, Cullen DJ, et al. Systems analysis ing medication administration in a Dutch hospital. Am J of adverse drug events. ADE Prevention Study Group. Health Syst Pharm 2008 Apr 1;65(7):644-8. JAMA 1995 Jul 5;274(1):35-43. 12. Workaround. Whatis.com [Web site]. 2003 May 29 2. Barker KN, Flynn EA, Pepper GA, et al. Medication [cited 2005 Jun 10]. TechTarget. Available from Internet: error observed in 36 health care facilities. Arch Intern http://whatis.techtarget.com/definition/ Med 2002 Sep 9;162(16):1897-903. 0,,sid9_gci868091,00.html. 3. Hicks RW, Cousins DD, Williams RL. Summary of infor- 13. Grissinger MC, Cohen H, Vaida Al. Using technology mation submitted to MEDMARX in the year 2002. [annual to prevent medication errors. Chapter 15. In: Cohen report]. Rockville (MD): USP Center for the Advance- MR, ed. Medication errors. Washington (DC): American ment of Patient Safety, 2003. Pharmacists Association; 2007:431-44. Page 126 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 4—December 2008 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 5, No. 4—December 2008. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). Copyright 2008 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. To see other articles or issues of the Advisory, visit our Web site at http://www.patientsafetyauthority.org. Click on “Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the PA-PSRS program, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the PA-PSRS program or the Pennsylvania Patient Safety An Independent Agency of the Commonwealth of Pennsylvania Authority, see the Authority’s Web site at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.