Estimating the impact of label design on reducing the risk of medication errors by applying HEART in drug administration.

HEART Label design Medication errors

Journal

European journal of clinical pharmacology
ISSN: 1432-1041
Titre abrégé: Eur J Clin Pharmacol
Pays: Germany
ID NLM: 1256165

Informations de publication

Date de publication:
29 Jan 2024
Historique:
received: 10 08 2023
accepted: 04 01 2024
medline: 29 1 2024
pubmed: 29 1 2024
entrez: 28 1 2024
Statut: aheadofprint

Résumé

Medication errors are one of the biggest problems in healthcare. The medicines' poor labelling design (i.e. look-alike labels) is a well-recognised risk for potential confusion, wrong administration, and patient damage. Human factors and ergonomics (HFE) encourages the human-centred design of system elements, which might reduce medication errors and improve people's well-being and system performance. The aim of the present study is twofold: (i) to use a human reliability analysis technique to evaluate a medication administration task within a simulated scenario of a neonatal intensive care unit (NICU) and (ii) to estimate the impact of a human-centred design (HCD) label in medication administration compared to a look-alike (LA) label. This paper used a modified version of the human error assessment and reduction technique (HEART) to analyse a medication administration task in a simulated NICU scenario. The modified technique involved expert nurses quantifying the likelihood of unreliability of a task and rating the conditions, including medicine labels, which most affect the successful completion of the task. Findings suggest that error producing conditions (EPCs), such as a shortage of time available for error detection and correction, no independent checking of output, and distractions, might increase human error probability (HEP) in administering medications. Results also showed that the assessed HEP and the relative percentage of contribution to unreliability reduced by more than 40% when the HCD label was evaluated compared to the LA label. Including labelling design based on HFE might help increase human reliability when administering medications under critical conditions.

Identifiants

pubmed: 38282080
doi: 10.1007/s00228-024-03619-3
pii: 10.1007/s00228-024-03619-3
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

Références

World Health Organization (2017) Medication without harm. No. WHO/HIS/SDS/2017.6. World Health Organization. WHO Document Production Services, Geneva, Switzerland. https://www.who.int/publications/i/item/WHO-HIS-SDS-2017.6
Elliott RA, Camacho E, Jankovic D, Sculpher MJ, Faria R (2021) Economic analysis of the prevalence and clinical and economic burden of medication error in England. BMJ Qual Saf 30(2):96–105
doi: 10.1136/bmjqs-2019-010206 pubmed: 32527980
Keers RN, Williams SD, Cooke J, Ashcroft DM (2013) Causes of medication administration errors in hospitals: a systematic review of quantitative and qualitative evidence. Drug Saf 36(11):1045–1067
doi: 10.1007/s40264-013-0090-2 pubmed: 23975331 pmcid: 3824584
Kuitunen S, Niittynen I, Airaksinen M, Holmström AR (2021) Systemic causes of in-hospital intravenous medication errors: a systematic review. J Patient Saf 17(8):E1660–E1668
doi: 10.1097/PTS.0000000000000632 pubmed: 32011427
Carayon P, Wetterneck TB, Cartmill R, Blosky MA, Brown R, Kim R et al (2014) Characterising the complexity of medication safety using a human factors approach: an observational study in two intensive care units. BMJ Qual Saf 23(1):56–65
doi: 10.1136/bmjqs-2013-001828 pubmed: 24050986
Alghamdi AA, Keers RN, Sutherland A, Ashcroft DM (2019) Prevalence and nature of medication errors and preventable adverse drug events in paediatric and neonatal intensive care settings: a systematic review. Drug Saf 42(12):1423–36. https://doi.org/10.1007/s40264-019-00856-9
doi: 10.1007/s40264-019-00856-9 pubmed: 31410745 pmcid: 6858386
Sutherland A, Phipps DL, Tomlin S, Ashcroft DM (2019) Mapping the prevalence and nature of drug related problems among hospitalised children in the United Kingdom: a systematic review. BMC Pediatr 19(1):1–14
doi: 10.1186/s12887-019-1875-y
Wilson DG, McArtney RG, Newcombe RG, McArtney RJ, Gracie J, Kirk CR et al (1998) Medication errors in paediatric practice: insights from a continuous quality improvement approach. Eur J Pediatr 157(9):769–774
doi: 10.1007/s004310050932 pubmed: 9776539
Chapanis A, Safren M (1960) Of misses and medicines. J Chronic Dis 12:103–408
doi: 10.1016/0021-9681(60)90065-5
Berman A (2004) Reducing medication errors through naming, labeling, and packaging. J Med Syst 28(1):9–29
doi: 10.1023/B:JOMS.0000021518.60670.10 pubmed: 15171066
Donaldson MS, Corrigan JM, Kohn LT (2000) To err is human: building a safer health system [cited 2021 Mar 31]. National Academies Press (US), Washington (DC). Available from: http://www.nap.edu/catalog/9728
Food and Drug Administration (2022) Safety considerations for container labels and carton labeling design to minimize medication errors. Guidance for the industry [cited 2022 Sep 12]. Office of Communications, Division of Drug Information. Center for Drug Evaluation and Research, White Oak, Maryland, United States. https://www.fda.gov/media/158522/download
Borradale H, Andersen P, Wallis M, Oprescu F (2020) Misreading injectable medications—causes and solutions: an integrative literature review. Jt Comm J Qual Patient Saf 46(5):291–8. https://doi.org/10.1016/j.jcjq.2020.01.007
doi: 10.1016/j.jcjq.2020.01.007 pubmed: 32151563
Ostini R, Roughead EE, Kirkpatrick CMJ, Monteith GR, Tett SE (2012) Quality use of medicines - medication safety issues in naming; Look-alike, sound-alike medicine names. Int J Pharm Pract 20(6):349–357
doi: 10.1111/j.2042-7174.2012.00210.x pubmed: 23134093
Kenagy JW, Stein GC (2001) Naming, labeling, and packaging of pharmaceuticals [cited 2022 Sep 12]. Am J Health Syst Pharm 58(21):2033–2041. Available from: https://academic.oup.com/ajhp/article/58/21/2033/5158502
Institute for Safe Medication Practices (2016) Special edition: tall man lettering; ISMP updates its list of drug names with tall man letters. Institute for Safe Medication Practices. Plymouth Meeting, Pennsylvania, United States [cited 2022 Sep 11]. Available from: https://www.ismp.org/resources/special-edition-tall-man-lettering-ismp-updates-its-list-drug-names-tall-man-letters
National Patient Safety Agency (2008) Design for patient safety: a guide to labelling and packaging of injectable medicines [cited 2022 Sep 11]. NPSA London. Available from: www.npsa.nhs.uk
Estock JL, Murray AW, Mizah MT, Mangione MP, Goode JS, Eibling DE (2018) Label design affects medication safety in an operating room crisis: a controlled simulation study. J Patient Saf. https://doi.org/10.1097/PTS.0000000000000176
doi: 10.1097/PTS.0000000000000176 pubmed: 25760652
Hignett S, Carayon P, Buckle P, Catchpole K (2013) State of science: human factors and ergonomics in healthcare. Ergonomics 56(10):1491–1503. https://doi.org/10.1080/00140139.2013.822932
doi: 10.1080/00140139.2013.822932 pubmed: 23926898
Carayon P, Xie A, Kianfar S (2014) Human factors and ergonomics as a patient safety practice. BMJ Qual Saf 23(3):196–205
doi: 10.1136/bmjqs-2013-001812 pubmed: 23813211
World Health Organization (2021) Global patient safety action plan 2021–2030: towards eliminating avoidable harm in health care. World Health Organization. Macro Graphics Pvt. Ltd., India.  https://iris.who.int/bitstream/handle/10665/343477/9789240032705-eng.pdf?sequence=1
Holden RJ, Abebe E, Russ-Jara AL, Chui MA (2021) Human factors and ergonomics methods for pharmacy research and clinical practice. Res Soc Adm Pharm 17(12):2019–2027
doi: 10.1016/j.sapharm.2021.04.024
Chui MA, Holden RJ, Russ AL, Abraham O, Srinivas P, Stone JA et al (2017) Human factors in pharmacy. Proc Hum Factors Ergon Soc 2017:666–70. https://doi.org/10.1177/1541931213601653
doi: 10.1177/1541931213601653
Sutherland A, Phipps DL (2020) The rise of human factors in medication safety research. Jt Comm J Qual Patient Saf 46(12):664–6. https://doi.org/10.1016/j.jcjq.2020.08.012
doi: 10.1016/j.jcjq.2020.08.012 pubmed: 32952063
Sutherland A, Jones MD, Howlett M, Arenas-Lopez S, Patel A, Franklin BD (2022) developing strategic recommendations for implementing smart pumps in advanced healthcare systems to improve intravenous medication safety. Drug Saf 45(8):881–889
doi: 10.1007/s40264-022-01203-1 pubmed: 35838875 pmcid: 9283846
Vosper H, Hignett S (2018) A UK perspective on human factors and patient safety education in pharmacy curricula. Am J Pharm Educ 82(3):227–239
doi: 10.5688/ajpe6184
Goel S, Joseph A, Neyens DM, Catchpole K, Alfred M, Jaruzel C et al (2022) A user-centered approach to designing secondary anesthesia medication labels. Proc Hum Factors Ergon Soc Annu Meet 66(1):2127–2131
doi: 10.1177/1071181322661100
Stanton NA, Salmon PM, Rafferty LA, Walker GH, Baber C, Jenkins DP (2013) Human factors methods: a practical guide for engineering and design, 2nd edn. CRC Press Taylor & Francis Group, Florida, United States of America, pp 1–627
Sujan MA, Embrey D (2020) Huang H (2017) On the application of Human Reliability Analysis in healthcare: opportunities and challenges. Reliab Eng Syst Saf 194:106189. https://doi.org/10.1016/j.ress.2018.06.017
doi: 10.1016/j.ress.2018.06.017
Read GJM, Shorrock S, Walker GH, Salmon PM (2021) State of science: evolving perspectives on ‘human error.’ Ergonomics 64(9):1091–114. https://doi.org/10.1080/00140139.2021.1953615
doi: 10.1080/00140139.2021.1953615 pubmed: 34243698
Lyons M, Adams S, Woloshynowych M, Vincent C (2004) Human reliability analysis in healthcare: a review of techniques. Int J Risk Saf Med 16(4):223–237
Embrey DE (1986) SHERPA: a systematic human error reduction and prediction approach. Paper presented at the International Topical Meeting on Advances in Human Factors in Nuclear Power Systems. International Topical Meeting on Advances in Human Factors in Nuclear Power Systems. Knoxville, TN (USA)
Ashour A, Phipps DL, Ashcroft M (2022) Predicting dispensing errors in community pharmacies: an application of the Systematic Human Error Reduction and Prediction Approach (SHERPA). PLoS One 17(1 January):1–17
Lane R, Stanton NA, Harrison D (2006) Applying hierarchical task analysis to medication administration errors. Appl Ergon 37(5):669–679
doi: 10.1016/j.apergo.2005.08.001 pubmed: 16182230
Williams JC (1986) Heart - a proposed method for achieving high reliability in process operation by means of human factors engineering technology. 9th Advances in Reliability Technology Symposium. University of Bradford, United Kingdom
Pandya D, Podofillini L, Emert F, Lomax AJ, Dang VN (2018) Developing the foundations of a cognition-based human reliability analysis model via mapping task types and performance-influencing factors: application to radiotherapy. Proc Inst Mech Eng Part O J Risk Reliab 232(1):3–37
Onofrio R, Trucco P (2018) Human Reliability Analysis (HRA) in surgery: identification and assessment of Influencing Factors. Saf Sci 110(August):110–123
doi: 10.1016/j.ssci.2018.08.004
Ward J, Teng YC, Horberry T, Clarkson PJ (2013) Healthcare human reliability analysis - by heart. Contemp Ergon Hum Factors 2013(March):287–8
Castiglia F, Giardina M, Tomarchio E (2010) Risk analysis using fuzzy set theory of the accidental exposure of medical staff during brachytherapy procedures. J Radiol Prot 30(1):49–62
doi: 10.1088/0952-4746/30/1/004 pubmed: 20220212
Chadwick L, Fallon EF (2012) Human reliability assessment of a critical nursing task in a radiotherapy treatment process. Appl Ergon 43(1):89–97
doi: 10.1016/j.apergo.2011.03.011 pubmed: 21530940
Beirouti M, Kamalinia M, Daneshmandi H, Soltani A, Dehghani P, Fararooei M et al (2022) Application of the HEART method to enhance patient safety in the intensive care unit. Work 72(3):1087–1097
doi: 10.3233/WOR-205338 pubmed: 35634817
Garnica S, Aristizabal A (2017) Making safer medicines: improving labeling and packaging to prevent medication errors. Drug Saf 10:1018–1018
Humphreys P (1988) Human reliability assessors guide: an overview. In: Sayers BA (ed) Human factors and decision making: their influence on safety and reliability. Elsevier applied science, Amsterdam, The Netherlands
Caro-Rojas A (2020) Caracterización de estrategias metacognitivas en un ambiente de prueba de errores de medicación y sus implicaciones educativas para la medicación segura [Internet]. Thesis [cited 2023 May 29]. Available from: https://repository.javeriana.edu.co/handle/10554/51975
Lyons M (2009) Towards a framework to select techniques for error prediction: supporting novice users in the healthcare sector. Appl Ergon 40(3):379–395
doi: 10.1016/j.apergo.2008.11.004 pubmed: 19091307
Williams J, Bell JL (2015) Consolidation of the error producing conditions used in the Human Error Assessment and Reduction Technique (Heart). Saf Reliab 35(3):26–76
doi: 10.1080/09617353.2015.11691047
Kirwan B, Kennedy R, Taylor-Adams S, Lambert B (1997) The validation of three human reliability quantification techniques THERP, HEART and JHEDI: Part II - results of validation exercise. Appl Ergon 28(1):17–25
doi: 10.1016/S0003-6870(96)00045-2 pubmed: 9414337
Williams J, Bell JL (2017) Consolidation of the generic task type database and concepts used in the Human Error Assessment and Reduction Technique (HEART). Saf Reliab 36(4):245–278
doi: 10.1080/09617353.2017.1336884
Bell JL, Williams JC (2018) Evaluation and consolidation of the HEART human reliability assessment principles. Adv Intell Syst Comput 589:3–12
doi: 10.1007/978-3-319-60645-3_1
Hayes C, Jackson D, Davidson PM, Power T (2015) Medication errors in hospitals: a literature review of disruptions to nursing practice during medication administration. J Clin Nurs 24(21–22):3063–3076
doi: 10.1111/jocn.12944 pubmed: 26255621
Erdmann TR, Garcia JHS, Loureiro ML, Monteiro MP, Brunharo GM (2016) Profile of drug administration errors in anesthesia among anesthesiologists from Santa Catarina. Brazilian J Anesthesiol (English Ed [Internet]) 66(1):105–110. https://doi.org/10.1016/j.bjane.2014.06.011
doi: 10.1016/j.bjane.2014.06.011
Endestad T, Wortinger LA, Madsen S, Hortemo S (2016) Package design affects accuracy recognition for medications. Hum Factors [Internet] 58(8):1206–16. https://doi.org/10.1177/0018720816664824
doi: 10.1177/0018720816664824 pubmed: 27591209
Gupta B, Gupta SK, Suri S, Farooque K, Yadav N, Misra M (2015) Efficacy of contrasting background on a drug label: a prospective, randomized study. J Anaesthesiol Clin Pharmacol 31(2):230–233
doi: 10.4103/0970-9185.155154 pubmed: 25948907 pmcid: 4411840

Auteurs

Carlos Aceves-Gonzalez (C)

Universidad de Guadalajara, Guadalajara, Mexico. c.aceves@academicos.udg.mx.

Angela Caro-Rojas (A)

International Society of Pharmacovigilance, London, UK.

John A Rey-Galindo (JA)

Universidad de Guadalajara, Guadalajara, Mexico.

Luz Aristizabal-Ruiz (L)

Vitalis Lab, Bogota, Colombia.

Karen Hernández-Cruz (K)

Vitalis Lab, Bogota, Colombia.

Classifications MeSH