TITLE: Electronically Generated Medication Administration and Electronic Medication Administration Records for the Prevention of Medication Transcription Errors: Review of Clinical Effectiveness and Safety DATE: 08 December 2016 CONTEXT AND POLICY ISSUES In the hospital setting, medication errors represent and significant proportion of all medical errors.1 These errors can lead to adverse drug events and can increase length of stay in hospitals.2 Errors can occur at prescription, transcription, dispensation, and administration. 3 Human error is an important factor in all stages of potential medication errors and thus information technology (IT) solutions are often sought in order to mitigate the risk of human error.4 Transcription errors can occur when patient files and medication orders are being updated from week to week and may be particularly susceptible to error due to healthcare provider fatigue (e.g. files being updated at the end of a shift). Electronic health records, computerized order entry systems, bar-code medication administration (BCMA) systems, and electronic medication administration records (eMARs) are IT solutions that are often considered in order to reduce such error.2,4 Electronically generated medication administration records (MARs), where the physician’s medication order is entered into the pharmacy system and the administration record is printed out and put into the patient file as opposed to updating by hand, and eMARs, whereby elements of the prescribing and administration process includes bar code scans and digital documentation, may be helpful in reducing transcription and administration errors. The current review seeks to examine the clinical effectiveness of electronically generated MARs and eMARs in preventing medication transcription errors in the acute care setting. RESEARCH QUESTIONS 1. What is the clinical effectiveness of the use of electronically generated medication administration records to prevent medication transcription errors in the acute care setting? Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic review s. The intent is to provide a list of sources of the best evidence on the topic that the Canadian Agency for Drugs and Technologies in Health (CADTH) could identify using all reasonable efforts within the time allow ed. Rapid responses should be considered along w ith other ty pes of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for w hich little information can be found, but w hich may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in w hich a third party ow ns copyright. This report m ay be used for the purposes of research or private study only. It may not be copied, posted on a w eb site, redistributed by email or stored on an electronic system w ithout the prior w ritten permission of CADTH or applicable copyrigh t ow ner. Links: This report may contain links to other information available on the w ebsites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the ow ners’ ow n terms and conditions. 2. What is the clinical effectiveness of the use of electronic medication administration records to prevent medication transcription errors in the acute care setting? KEY FINDINGS No studies examining the use of electronically generated medication administration records were identified and thus no conclusions can be made. Limited conclusions could be drawn regarding the effect of electronic medication administration records on the reduction of transcription errors. Based on the results of two cohort studies, the introduction of eMARs may reduce the overall rates of medication errors and may not displace errors, however the effect eMARs on transcription errors was not well reported. Further research may be warranted if the goal of introducing eMARs is to reduce transcription errors regardless of whether overall error rates are affected. METHODS Literature Search Methods A limited literature search was conducted on key resources including PubMed, The Cochrane Library, ECRI, University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2011 and November 9, 2016. Rapid Response reports are organized so that the evidence for each research question is presented separately. Selection Criteria and Methods One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1. Population Intervention Comparator Outcomes Table 1: Selection Criteria Inpatients (any age, any condition) in the acute care setting Q1 - Electronically Generated Medication Administration Records Q2- Electronic Medication Administration Record Hand transcription of medication administration records No active comparator Q1 and Q2: Effectiveness in preventing transcription errors Prevention of medication errors Patient safety Occurrence of other errors Patient harm Electronic Medication Administration Records 2 Study Designs Health Technology Assessment, Systematic Reviews, Meta-Analyses, Randomized Controlled Trials, Non-Randomized Studies Exclusion Criteria Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications, or were published prior to 2011. Critical Appraisal of Individual Studies The included cohort studies were critically appraised using the SIGN-50 methodology checklist for cohort studies.5 Summary scores were not calculated for the included studies; rather, a review of the strengths and limitations of each included study were described. SUMMARY OF EVIDENCE Quantity of Research Available A total of 549 citations were identified in the literature search. Following screening of titles and abstracts, 537 citations were excluded and 12 potentially relevant reports from the electronic search were retrieved for full-text review. No potentially relevant publications were retrieved from the grey literature search. Of these potentially relevant articles, 10 publications were excluded for various reasons, while two publications met the inclusion criteria and were included in this report. Appendix 1 shows the PRISMA flowchart of the study selection. Summary of Study Characteristics Further detail regarding study characteristics is included in Appendix 2, Table A1. Study Design Both of the included studies were non-randomized, prospective, pre/post cohort studies.3,6 Country of Origin The two included studies were conducted in hospitals in the United States. 3,6 Patient Population Both studies randomly observed nurses who administered doses of medication on the units being studied.3,6 A single-centre study by McComas et al., involving 38 nurses, examined 156 cases (78 preintervention, 78 post-intervention) of medication administration to patients in a medical-oncology unit as well as hospital-wide rates of medication error.3 Data were collected over the course of 12 months. The observations were made by the principle investigator. A multi-centre study by Seibert et al., examined medication administration to patients in three matched care units (medical-surgical, telemetry, and rehabilitation) in each of two non-teaching community hospitals plus a medical-surgical intensive care unit (ICU) in one of the hospitals, Electronic Medication Administration Records 3 and an emergency department, an inpatient oncology unit, and an outpatient oncology unit in another hospital.6 Study observations were made by certified medical observers who were not involved in patient care and did not interfere with nursing activities. If an error that could cause harm was noticed by the study pharmacists, they corrected the error as discretely as possible. Data were collected over the course of 12 months. Interventions and Comparators McComas et al., examined outcomes before and after the introduction of eMAR. 3 The system used provided digital verification that the correct patient received the correct medication (correct dose, time, and route of administration) and was recorded at the bedside. Prior to the introduction of the system, nurses participated in a four hour educational session. Seibert et al., examined outcomes before and after the introduction of bar-code assisted medication administration (BCMA) plus eMAR.6 The hospital used the Meditech Magic BCMAeMAR system that included medication cards and in-room monitors with wireless scanners to digitally record the medication administered to each patient. Medications, patient bracelets, and paper orders all had machine readable bar codes. Outcomes McComas et al., examined medication efficiency as a primary outcome and medication errors as a secondary outcome.3 In this report, medication efficiency is not discussed in detail, as it is beyond the scope of this review. Medication errors comprised of prescription, transcription, dispensation, and administration errors (measured separately and combined as overall error rates). Injuries caused by medication errors were also reported. Investigators calculated descriptive statistics (frequencies, percentages, standard error of the mean, and mean) and performed t-tests and Pearson bivariate correlations in order to analyze the data. Seibert et al., examined medication administration accuracy rates (calculated by dividing the difference between opportunity for error and number of errors by 100X the opportunity for error) as a primary outcome. They defined medication errors as “any discrepancy between a prescriber’s interpretable medication order and what was administered to a patient (p. 211)”. 6 They further divided errors into target errors (i.e., errors that should have been caught by the bar code system), opportunity for errors (doses that were ordered), total number of opportunities for error (i.e., number of doses given plus those omitted) and total errors (i.e., errors that were observed – included missed doses, administration of an unauthorized medication, a wrong dose, incorrect route of administration, and incorrect timing of dose). They distinguished between other errors and “wrong-time errors” by defining the latter as the administration of the correct drug at the correct dose more than 60 minutes before or after the scheduled time. Chisquare (with Yates correction) statistics were calculated and the level of significance was set at 0.05. Summary of Critical Appraisal The two included studies had similar strengths.3,6 Both of the studies had clearly focused questions, clearly defined outcomes and reliable exposure assessment. A primary limitation of both studies is the presence of an observer when the medication administration systems were being used and doses were being administered. It is unclear Electronic Medication Administration Records 4 whether the presence of the trained observers had an effect on the intervention and behaviour of nurses. In the single-center McComas study,3 while nurses performing medication administration were randomly observed, the total number of cases observed was reported, not the total number of opportunities for medication error, which may represent an inaccurate estimate. It was unclear whether or not the study was adequately powered to detect meaningful differences. The multi-centre Seibert study6 included a sample size that was sufficiently powered to detect meaningful differences (based on an a priori calculation), randomly observed the nurses administering doses, and observed various units within the hospital and therefore observed a wide range of patient types and medication types. They also presented the number of opportunities for error alongside the administration accuracy rates. However, authors did not discuss the limitations of their own methodology or study. There was no acknowledgement of factors such as the effect of an observer on behaviour or the limitations of a cohort design. While both studies 3,6 randomly observed the nurses administering doses, the cohort design may limit the ability to make causal conclusions regarding the interventions being studied. Factors such as educational initiatives, increased profile of reducing errors, or other hospital or cultural factors could have influenced the rates of medication administration errors in ways that were not accounted for. Further detail regarding critical appraisal is included in Appendix 3, Table A2. Summary of Findings What is the clinical effectiveness of the use of electronically generated medication administration records to prevent medication transcription errors in the acute care setting? No relevant studies were identified regarding the use of electronically generated MARs to prevent medication transcription errors in the acute care setting. What is the clinical effectiveness of the use of electronic medication administration records to prevent medication transcription errors in the acute care setting? With respect to overall medication error rates, the results of the single-centre McComas study3 showed a statistically significant decrease from 11.0 errors per month before the introduction of eMAR to 5.3 per month following the introduction of eMAR (P = 0.034).3 Injuries caused by medication error decreased from 0.67 per month to 0.33 per month after the introduction of eMAR (P value not reported). The separate effect sizes of error rates for prescription, transcription, dispensing, and administration error rates were not provided and were only reported in graph-form. Based on visual interpretation of the graph presented in the publication, prescription, transcription, and dispensing errors decreased by at least or more than half between the pre- and post-eMAR periods. Administration error rates, which were the highest of the error rate types both before and after eMAR, also decreased, but by proportionally less than the others. Overall accuracy rates of medication administration rates of the multi-centre Seibert study6 were reported by hospital and by hospital unit. There was a statistically significant increase in overall accuracy rate following the introduction of BCMA-eMAR for the first hospital both when wrong- Electronic Medication Administration Records 5 time errors were included (89% vs. 90%; P = 0.002) and excluded (92% vs. 96%; P <0.001). For the second hospital, there was no significant difference following the introduction of BCMAeMAR when wrong-time errors were included (89% vs 91%; P = NR) but was significantly increased when they were not included (93% vs. 96%; P = 0.015). Patient harm was not reported. Authors did report that new medication errors were not reported. Rates for the different units in each hospital are presented in Appendix 4, Table A3. Limitations The small number of studies and the lack of Canadian studies are both limitations to the generalizability and applicability of this review to the Canadian context. While a variety of units within hospitals were examined in the studies, because of the limited number of studies, it is unclear if the results are valid in other hospitals or types of hospitals. The lack of reporting specific effect sizes and information regarding transcription errors as a part of medical errors and of eMAR separate from BCMA further limits the ability to draw conclusions. CONCLUSIONS AND IMPLICATIONS FOR DECISION OR POLICY MAKING No relevant studies were identified regarding the use of electronically generated MARs to prevent medication transcription errors in the acute care setting. Based on the results of two non-randomized cohort studies, the use of eMAR may lead to reductions in overall rates of medication administration errors.3,6 Medication transcription errors were included in overall error rates in both of the included studies, however, despite a reduction in transcription errors, the effect size was not reported in one of the studies 3 and the second did not specifically report transcription error rates, however they did conclude that error rates decreased and errors were not displaced.6 Therefore, no firm conclusions can be made regarding the effect of the introduction of eMAR on the reduction of transcription errors. Additionally, as one of the studies included both eMAR and BCMA, it is unclear what the impact of eMAR alone was. As information technologies may be introduced together (such as eMAR with BCMA), and some eMAR systems include bar code technology, this may not be an issue. One study concluded that eMAR did not lead to new errors or the displacement of medication administration errors. 6 Further research regarding the impact of eMAR on transcription errors may be warranted if the goal of introducing eMAR is to reduce transcription errors regardless of whether overall error rates are affected. As no information regarding electronically generated MARs was identified, if there is interest in introducing the technology, further research regarding how this type of record may have an impact on transcription errors is warranted. PREPARED BY: Canadian Agency for Drugs and Technologies in Health Tel: 1-866-898-8439 www.cadth.ca Electronic Medication Administration Records 6 REFERENCES 1. Gorbach C, Blanton L, Lukawski BA, Varkey AC, Pitman EP, Garey KW. Frequency of and risk factors for medication errors by pharmacists during order verification in a tertiary care medical center. Am J Health Syst Pharm. 2015 Sep 1;72(17):1471-4. 2. Berdot S, Roudot M, Schramm C, Katsahian S, Durieux P, Sabatier B. Interventions to reduce nurses' medication administration errors in inpatient settings: a systematic review and meta-analysis. Int J Nurs Stud. 2016 Jan;53:342-50. 3. McComas J, Riingen M, Chae KS. Impact of an electronic medication administration record on medication administration efficiency and errors. Comput Inform Nurs. 2014 Dec;32(12):589-95. 4. Stultz JS, Nahata MC. Preventability of voluntarily reported or trigger tool-identified medication errors in a pediatric institution by information technology: a retrospective cohort study. Drug Saf. 2015 Jul;38(7):661-70. 5. Methodology checklist 3: cohort studies [Internet]. Edinburgh (UK): Scottish Intercollegiate Guidelines Network (SIGN); 2011 Mar. [cited 2016 Dec 1]. Available from: http://www.sign.ac.uk/methodology/checklists.html 6. Seibert HH, Maddox RR, Flynn EA, Williams CK. Effect of barcode technology with electronic medication administration record on medication accuracy rates. Am J Health Syst Pharm. 2014 Feb 1;71(3):209-18. Electronic Medication Administration Records 7 APPENDIX 1: Selection of Included Studies 549 citations identified from electronic literature search and screened 537 citations excluded 12 potentially relevant articles retrieved for scrutiny (full text, if available) 0 potentially relevant reports retrieved from other sources (grey literature, hand search) 12 potentially relevant reports 10 reports excluded: -irrelevant intervention (6) -irrelevant outcomes (1) -irrelevant study type (2) -published in language other than English (1) 2 reports included in review Electronic Medication Administration Records 8 APPENDIX 2: Characteristics of Included Publications Table A1: Characteristics of Included Clinical Studies First Author, Publication Year, Country, Study Name McComas, 3 2014, USA Seibert, 2014, 6 USA Study Design; Study Objectives Patient Characteristics Interventio n(s) Comparator( s) Prospective Cohort (pre/post); to determine the impact of the implementation of eMAR on medication administration efficiency and medication errors. Prospective cohort (pre/post); to determine the effect of the combination of barcodeassisted medication administration (BCMA) and eMAR on medication administration errors. 156 cases (78 pre, 78 post) of medication administration activities in the medical oncology unit. introduction of eMAR pre-eMAR Medical errors were examined hospitalwide 3 matched patient care units in each of two community, nonteaching hospitals (medical surgical, telemetry, rehabilitation), plus a medical-surgical ICU, an emergency department, an inpatient oncology unit, and an outpatient oncology unit in one hospital. BCMA plus eMAR pre-BCMA plus eMAR; voluntary reporting of errors during that period Clinical Outcomes Primary outcome: medication administration efficiency Secondary: medication errors (prescription, transcription, dispensation, and administration errors) Rate of medication administration a errors. (Nurses who administered at least one medication to adult patients in one of the selected units during the study period observation times were randomly observed) AB = Alberta; BCMA = bar-code-assisted medication administration; eMAR = electronic medication administration record; ICU = intensive care unit; MAO = medication administration omission a Authors defined this as: “any discrepancy between a prescriber’s interpretable medication order and w hat was administered to a patient. Drug administration more than 60 minutes before or after the scheduled time w as considered a w rong-time error” Electronic Medication Administration Records 9 APPENDIX 3: Critical Appraisal of Included Publications Table A2: Summary of Critical Appraisal of the Included Cohort Studies Using the Sign 50 tool 5 Sign 50 Item First Author, Year McComas 3 Seibert6 The study addresses an appropriate and clearly focused question y y The two groups being studied are selected from source populations that c/s c/s are comparable in all respects other than the factor under investigation. The study indicates how many of the people asked to take part did so in n n each of the groups being studied. The likelihood that some eligible subjects might have the outcome at the n n time of enrolment is assessed and taken into account in the analysis? What percentage of individuals or clusters recruited into each arm of the n/a n/a study dropped out before the study was completed? Comparison is made between full participants and those lost to follow -up, n/a n/a by exposure status. The outcomes are clearly defined y y The assessment of outcome is made blind to exposure status n n Where blinding was not possible, there is some recognition that n n knowledge of exposure status could have influenced the assessment of outcome. The measure of assessment of exposure is reliable. y y Evidence from other sources is used to demonstrate that the method of n/a n/a outcome assessment is valid and reliable. Exposure level or prognostic factor is assessed more than once y y The main potential confounders are identified and taken into account y n adequately in the design and analysis Confidence intervals are provided n n Taking into account clinical considerations, your evaluation of the . The authors do not discuss the limitations of methodology used, and the statistical power of the study, do you think There is no indication of the number of their studies. there is clear evidence of an association between exposure and outcome? medication administration occurrences – while there was random observation of Direct observation could have influenced the medication administration from the day actions of the staff. and night shift, it is unclear if this was a The fact that multiple types of units that deal significant portion of the number of with many types of medications were observations. The presence of the observed increases the generalizability of the observer could have influenced study. administration behaviour. This was a single-centre and single-unit study, Sample size was calculated. which may limit generalizability for the efficiency results. The medication error Electronic Medication Administration Records 10 Table A2: Summary of Critical Appraisal of the Included Cohort Studies Using the Sign 50 tool 5 Sign 50 Item First Author, Year McComas 3 Seibert6 results were hospital-wide, thus the single-centre lack of generalizability applies but it may be slightly more generalizable than the efficiency results due to being hospital-wide. Full results for the type of medication administration errors are reported in graphical form only, and P values are not reported. Summarize the author’s conclusions. Add any comments on your own After adjusting for confounders, eMAR There were significant decreases in assessment of the study, and the extent to which it answers your question neither increased nor decreased medication administration errors (increases in and mention any areas of uncertainty raised above. This section is very medication administration efficiency. medication accuracy) following the important and will appear on the evidence table. After the implementation of eMAR there introduction of BCMA-eMAR when compared was a ‘marked’ decrease in the monthly with voluntary reporting. BCMA-eMAR did not number of medication error events (over introduce a new type of error and the multiple categories of errors) and of frequency of errors that were preventable by medication error injuries. the technology decreased significantly. BCMA = bar code medication administration c/s = can’t say; eMAR = electronic administration record; n/a = not applicable; no = no; y = yes Electronic Medication Administration Records 11 APPENDIX 4: Main Study Findings and Author’s Conclusions Table A3: Summary of Findings of Included Studies Main Study Findings Author’s Conclusions McComas, 20153 Total time (mean; SD) for medication After adjustment for confounding variables administration (including preparation, (such as using multiple machines, administration, documentation, and distractions, and interruptions), eMAR did distractions/interruptions): not result in increased or decreased pre-eMAR: 11.3 ± 8.4 minutes medication administration efficiency. post-eMAR: 14.4 ± 10.2 minutes There was a statistically significant reduction in medication errors following the mean difference: +3.1 implementation of eMAR. t = 2.080; P = 0.039 Medication administration error rates were Medication errors (mean): the most frequent error rates both before hospital-wide medication error events: and after eMAR introduction. o pre-eMAR: 11.0/month o Computerized order entry and baro post-eMAR: 5.3/month code-assisted medication o P = 0.034 administration were not part of the medication error-related injuries (mean): protocol. o pre-eMAR: 0.67/month Authors concluded that quality of care o post-eMAR: 0.33/month improved. Prescription, transcription, and dispensing errors decreased by at least or more than half between the pre- and post-eMAR periods.a Administration error rates, which were the highest of the error rate types both before and after eMAR, also decreased, but by proportionally less than the others.a Seibert, 20156 Hospital 1 – overall accuracy: Medication accuracy rates were pre-BCMA-eMAR: 89% significantly improved following the introduction of BCMA-eMAR. post-BCMA-eMAR: 90% New medication errors were not introduced P = 0.0015 when wrong-time errors were excluded, BCMA-eMAR and direct observation were more effective in preventing errors than pre-rate was 92% and post-BCMAvoluntary reporting. eMAR rate was 96% (P = 0.000008) Hospital 2 – overall accuracy: no significant change in overall accuracy when wrong-time errors were included (89% vs 91%) when wrong-time errors were excluded. pre-BCMA-eMAR rate was 93%, postrate was 96%; P = 0.015 Hospital 1 – Units: Medical-Surgical Electronic Medication Administration Records 12 Table A3: Summary of Findings of Included Studies Main Study Findings Author’s Conclusions o no significant change in accuracy after introduction of BCMA-eMAR when wrong-time errors were included (88% vs. 93%) or excluded (93% vs. 96%) Telemetry o significant decrease in medication accuracy rates after introduction of BCMA-eMAR when wrong time errors were included: 94% vs. 88%; P = 0.04 o rates remained unchanged when wrong-time errors were excluded (94% vs. 94%) Rehabilitation o no significant change in accuracy after introduction of BCMA-eMAR when wrong-time errors were included (86% vs. 85%) o rates were significantly lower when wrong-time errors were excluded: 90% vs. 94%; P = 0.004 Inpatient oncology o medication accuracy rates increased from 89% to 94% (P not significant) o when wrong-time errors were excluded, the results remained not statistically significant Outpatient oncology o medication accuracy rates remained unchanged o when wrong-time errors were excluded, the rates were 97% pre- and 98% post-BCMAeMAR (P = 0.006) Emergency department o medication accuracy rates increased from 86% to 95% following BCMA-eMAR (P = 0.0015) o when wrong-time errors were excluded, the rates were 87% Electronic Medication Administration Records 13 Table A3: Summary of Findings of Included Studies Main Study Findings Author’s Conclusions and 99% (P = 0.000002) Hospital 2 – Units: Medical-surgical o no significant change in accuracy after introduction of BCMA-eMAR when wrong-time errors were included (89% vs. 92%) or excluded (94% vs. 93%) Telemetry o no significant change in accuracy after introduction of BCMA-eMAR when wrong-time errors were included (89% vs. 89%) o when wrong-time errors were excluded, the rates were 93% vs. 98%; P = 0.006 Rehabilitation o accuracy rates significantly increased after the introduction of BCMA-eMAR both when wrong-time errors were included (87% vs. 94%; P = 0.0005) and excluded (92% vs 97%; P = 0.002) ICU o medication accuracy rates decreased from 94% to 89% following BCMA-eMAR when wrong-time errors were included (P = 0.004) and when wrong-time errors were excluded (96% to 88%; P = 0.003) BCMA = eMAR = electronic medication administration record; ICU = intensive care unit a Results w ere presented in a bar-graph form; numerical error rates and P values w ere not reported. The authors do, how ever, report that the rates are statistically significantly lower following the implementation of eMAR. Electronic Medication Administration Records 14
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