Medication labels from the perspective of Brazilian health professionals: difficulties, level of satisfaction, and proposed improvements
DOI:
https://doi.org/10.30968/rbfhss.2022.134.0875Abstract
Objective: To evaluate health professionals’ perceptions of medication error situations associated with labeling. Methods: Crosssectional study of 1056 nurse technicians, nurses, and pharmacists interviewed in 10 Brazilian capital cities. We assessed participants’ perceptions of difficulty in differentiating or seeing information on labels, likelihood of a medication error to occur, and frequency of medication errors, including: 1) look-alike vials or labels; 2) two packages of the same medicine but of different doses; 3) ampoule labels; 4) blister pack labels; and 5) labels printed on secondary packages. Results: Most participants reported it difficult or very difficult to differentiate between look-alike vials (82.4%) and between different doses of the same medicine (82.5%). Identifying importante information on ampoules, blister packs, and secondary packages was considered difficult or very difficult by 89.9%, 64.4%, and 48.9% of participants, respectively. Approximately half of the participants reported that an error was most likely to occur in situations involving difficulty in seeing the information on an ampoule, look-alike labels, and packages of the same medicine but of different doses. Conclusion: Difficulty in at least one of the situations involving the identification or differentiation of medication labels is common among health professionals, leading to a greater likelihood of medication errors.
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References
World Health Organization (WHO). WHO Global Patient Safety Challenge: Medication Without Harm. Available in: https://www.who.int/patientsafety/medication-safety/medication-without-harm-brochure/en/. Accessed on: 7st Nov 2021.
Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health system. Washington (DC): National Academies Press 2000. Available in: https://www.ncbi.nlm.nih.gov/books/NBK225182/. Accessed on: 7st Nov 2021.
Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington (DC): National Academies Press 200. Available in: https://www.ncbi.nlm.nih.gov/books/NBK222278/. Accessed on: 7st Nov 2021.
Vincent C, Neale G, Woloshynowych M. Adverse events in British hospitals: preliminary retrospective record review. BMJ 2001;322:517-9. DOI: 10.1136/bmj.322.7285.517
Baker GR, Norton PG, Flintoft V, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ 2004;170:1678-86. DOI:10.1503/cmaj.1040498
Soop M, Fryksmark U, Koster M, et al. The incidence of adverse events in Swedish hospitals: a retrospective medical record review study. Int J Qual Health Care 2009;21:285-91. DOI:10.1093/intqhc/mzp025
7. de Vries EN, Ramrattan MA, Smorenburg SM, et al. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care . 2008;17(3):216-23. DOI: 10.1136/qshc.2007.023622.
Mendes W, Martins M, Rozenfeld S, Travassos C. The assessment of adverse events in hospitals in Brazil. International Journal for Quality in Health. Care 2009; 21(4):279-284. DOI: 10.1093/intqhc/mzp022
Sousa P, Uva AS, Serranheira F, Nunes C, Leite ES. Estimating the incidence of adverse events in Portuguese hospitals: a contribution to improving quality and patient safety. BMC Health Serv Res. 2014 18;14:311. DOI: 10.1186/1472-6963-14-311.
Bates DW. A 40-year-old woman who noticed a medication error. JAMA 2001;285:3134-40. DOI:10.1001/jama.285.24.3134
Brasil. Ministério da Saúde. Resolução da Diretoria Colegiada - RDC No 71, DE 22 DE DEZEMBRO DE 2009. Estabelece regras para a rotulagem de medicamentos. Available in: http://portal.anvisa.gov.br/documents/33880/2568070/res0071_22_12_2009.pdf/84755241-6284-48f9-a446-ec9d34841622. Accessed on: 7st Nov 2021.
Pons E, Moraes CG, Falavigna M, et al. Users’ preferences, perceptions and understanding of medication labels. Plos One 2019;14: e0212173. DOI: 10.1371/journal.pone.0212173l.
Australian Government. Department of health. Medicine labels: Guidance on TGO 91 and TGO 92. Available in: https://www.tga.gov.au/medicine-labels-guidance-tgo-91-andtgo-92. Accessed on: 7st Nov 2021.
Peterson GM, Wu MS, Beggin JK. Pharmacists’ attitudes towards dispensing errors, their causes and prevention. J Clin Pharm Ther. 1999;24(1):57–71. DOI: 10.1046/j.1365-2710.1999.00199.x.
E. Hellier, J. Edworthy, N. Derbyshire & A. Costello. Considering the impact of medicine label design characteristics on patient safety, Ergonomics.2006;49(5-6):617-30. DOI: 10.1080/00140130600568980.
European commission. Enterprise and industry directorate-general. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Available in: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf. Accessed on: 7st Nov 2021.
National Patient Safety Agency THHRC. Design for patient safety: A guide to the graphic design of medication packaging. Second Edtion. London, UK: National Health Service; 2007. Available in: http://www.hhc.rca.ac.uk/cms/files/npsa-design-for-patient-safety-.pdf. Accessed on: 7st Nov 2021.
National Patient Safety Agency THHRC. Design for patient safety: A guide to labelling and packaging of injectable medicines. Edition 1. London, UK: National Health Service; 2008. Available from: http://ezdrugid.org/EZDrugID/Strategies_files/NHSInjectableMedLabels.pdf. Accessed on:7st Nov 2021.
U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Safety considerations for product design to minimize medication errors. Guidance for Industry. Available in: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm331810.pdf. Accessed on: 7st Nov 2021.
Government of Canada. Good Label and Package Practices Guide for Prescription Drugs. Available in: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/pubs/medeff/guide/2016-label-package-practices-pratiques-etiquetage-emballage-rx/glppg-gbpee-rx-eng.pdf. Accessed on: 7st Nov 2021.
Hellebek A, Schytte-Hansen S, Fischer H, et al. Patient safety in drug label design: analysis of reported adverse events before and after introducing a new label design. Eur J Hosp Pharm Sci Pract 2013;20:212-17.
Cohen MR. ISMP Medication error report analysis – Cross contamination with insulin pens; Look-alike vials; Kids and medication patches; New look-alike name pair; Preventing dosing errors with methotrexate injection. Hosp Pharm 2008;43:445–47. DOI:10.1310/hpj4306-445
Institute for Safe Medication Practices Canada (ISMP Canada). Labelling and packaging: an aggregate analysis of medication incident report. Available in: https://www.ismp-canada.org/download/LabellingPackaging/ISMPC2013_LabellingPackaging_FullReport.pdf. Accessed on: 7st Nov 2021.
Taneja N, Wiegmann DA. The role of perception in Medication Errors : Implications for Non-Technological Interventions. Med J Armed Forces India 2004;60(2):172-6. DOI:10.1016/S0377-1237(04)80112-6
Phillips J, Beam S, Brinker A, et al. Retrospective analysis of mortalities associated with medication errors. Am J Health Syst Pharm 2001;58:1835-41. DOI: 10.1093/ajhp/58.19.1835
Government of Canada IC. Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products. Government of Canada, ISMP Canada; 2018. Available in: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/reports-publications/medeffect-canada/good-label-package-practices-guide-nonprescription-drugs-natural-health-products-guidance/ goodlabel-st package-practices-guide-non-prescription-drugs-natural-health-products-eng.pdf. Accessed on: 7st Nov 2021.
Institute of Medicine. Preventing medication errors. Available in: https://www.nap.edu/catalog/11623/preventing-medication-errors. Accessed on: 7st Nov 2021.
Orser BA, Chen RJ, Yee DA. Medication errors in anesthetic practice: a survey of 687 practitioners. Can J Anaesth 2001;48:139-46. DOI:10.1007/BF03019726
Llewellyn RL, Gordon PC, Wheatcroft D, et al. Drug administration errors: a prospective survey from three South African teaching hospitals. Anaesth Intensive Care 2009;37:93-8. DOI: 10.1177/0310057X0903700105
Abeysekera A, Bergman IJ, Kluger MT, et al. Drug error in anaesthetic practice: a review of 896 reports from the Australian Incident Monitoring Study database. Anaesthesia 2005;60:220-7. DOI:10.1111/j.1365-2044.2005.04123.x
Larmene-Beld KHM, Alting EK, Taxis K. A systematic literature review on strategies to avoid look-alike errors of labels. Eur J Clin Pharmacol 2018;74(8):985-99. DOI:10.1007/s00228-018-2471-z
Hellier E, Tucker M, Kenny N, Rowntree A, Edworthy J. Merits of using color and shape differentiation to improve the speed and accuracy of drug strength identification on over-thecounter medicines by laypeople. J Patient Saf . 2010;6(3):158-64. DOI: 10.1097/pts.0b013e3181eee157.
Endestad T, Wortinger LA, Madsen S, Hortemo S. Package Design Affects Accuracy Recognition for Medications. Human factors. 2016;58(8):1206-16. DOI: 10.1177/0018720816664824.
Gupta B, Gupta SK, Suri S, et al. Efficacy of contrasting background on a drug label: A prospective, randomized study. J Anaesthesiol Clin Pharmacol 2015;31:230-3. DOI:10.4103/0970-9185.155154
ISMP Updates its List of Drug Name Pairs with TALL Man Letters. Available in: https://www.medscape.com/viewarticle/736754. Accessed on: 7st Nov 2021.
Filik R, Purdy K, Gale A, Gerrett D. Drug name confusion: evaluating the effectiveness of capital (“Tall Man”) letters using eye movement data. Soc Sci Med. 2004; 59:2597–601. DOI: 10.1016/j.socscimed.2004.04.008.
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