Patterns of medication errors involving pediatric population reported to the French Medication Error Guichet
Main Article Content
Keywords
Medication Errors, Patient Safety, Drug-Related Side Effects and Adverse Reactions, Adverse Drug Reaction Reporting Systems, Pharmacovigilance, Pharmacoepidemiology, Child, Infant, Multivariate Analysis, Retrospective Studies, France
Abstract
Background: Medication error is a global threat to patient safety, particularly in pediatrics. Yet, this issue remains understudied in this population, in both hospital and community settings.
Objectives: To characterize medication errors involving pediatrics reported to the French Medication Error Guichet, and compare them with medication errors in adults, in each of the hospital and community settings.
Methods: This was a retrospective secondary data analysis of medication errors reported throughout 2013-2017. Descriptive and multivariate analyses were performed to compare actual and potential medication error reports between pediatrics (aged <18 years) and adults (aged >18 and <60 years). Two subanalyses of actual medication errors with adverse drug reaction (ADR), and serious ADR were conducted.
Results: We analyzed 4,718 medication error reports. In pediatrics, both in hospital (n=791) and community (n=1,541) settings, antibacterials for systemic use (n=121, 15.7%; n=157, 10.4%, respectively) and wrong dose error type (n=391, 49.6%; n=549, 35.7%, respectively) were frequently reported in medication errors. These characteristics were also significantly more likely to be associated with reported errors in pediatrics compared with adults. In the hospital setting, analgesics (adjusted odds ratio (aOR)=1.59; 95% confidence interval (CI) 1.03:2.45), and blood substitutes and perfusion solutions (aOR=3.74; 95%CI 2.24:6.25) were more likely to be associated with reported medication errors in pediatrics; the latter drug class (aOR=3.02; 95%CI 1.59:5.72) along with wrong technique (aOR=2.28; 95%CI 1.01:5.19) and wrong route (aOR=2.74; 95%CI 1.22:6.15) error types related more to reported medication errors with serious ADR in pediatrics. In the community setting, the most frequently reported pediatric medication errors involved vaccines (n=389, 25.7%). Psycholeptics (aOR=2.42; 95%CI 1.36:4.31) were more likely to be associated with reported medication errors with serious ADR in pediatrics. Wrong technique error type (aOR=2.71; 95%CI 1.47:5.00) related more to reported medication errors with ADR in pediatrics.
Conclusions: We identified pediatric-specific medication error patterns in the hospital and community settings. Our findings inform focused error prevention measures, and pave the way for interventional research targeting the needs of this population.
References
2. Leape LL. Institute of Medicine medical error figures are not exaggerated. JAMA. 2000;284(1):95-97. https://doi.org/10.1001/jama.284.1.95
3. Stelfox HT, Palmisani S, Scurlock C, Orav EJ, Bates DW. The "To Err is Human" report and the patient safety literature. Qual Saf Health Care. 2006;15(3):174-178. https://doi.org/10.1136/qshc.2006.017947
4. Wittich CM, Burkle CM, Lanier WL. Medication errors: an overview for clinicians. Mayo Clin Proc. 2014;89(8):1116-1125. https://doi.org/10.1016/j.mayocp.2014.05.007
5. World Health Organization. WHO launches global effort to halve medication-related errors in 5 years. https://www.who.int/news-room/detail/29-03-2017-who-launches-global-effort-to-halve-medication-related-errors-in-5-years (accessed Sep 30, 2019).
6. Elliott RA, Camacho E, Campbell F, et al. Prevalence and economic burden of medication errors in the NHS in England. http://www.eepru.org.uk/prevalence-and-economic-burden-of-medication-errors-in-the-nhs-in-england-2/ (accessed Oct 1, 2019).
7. Michel P, Quenon JL, Djihoud A, Tricaud-Vialle S, de Sarasqueta AM. French national survey of inpatient adverse events prospectively assessed with ward staff. Qual Saf Health Care. 2007;16(5):369-377. https://doi.org/10.1136/qshc.2005.016964
8. World Health Organization. WHO global patient safety challenge: medication without harm. https://www.who.int/patientsafety/medication-safety/medication-without-harm-brochure/en/ (accessed Sep 30, 2019).
9. Woo Y, Kim HE, Chung S, Park BJ. Pediatric medication error reports in Korea adverse event reporting system database, 1989-2012: comparing with adult reports. J Korean Med Sci. 2015;30(4):371-377. https://doi.org/10.3346/jkms.2015.30.4.371
10. Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001;285(16):2114-2120. https://doi.org/10.1001/jama.285.16.2114
11. Wong IC, Ghaleb MA, Franklin BD, Barber N. Incidence and nature of dosing errors in paediatric medications: a systematic review. Drug Saf. 2004;27(9):661-670. https://doi.org/10.2165/00002018-200427090-00004
12. Alghamdi AA, Keers RN, Sutherland A, Ashcroft DM. Prevalence and Nature of Medication Errors and Preventable Adverse Drug Events in Paediatric and Neonatal Intensive Care Settings: A Systematic Review. Drug Saf. 2019;42(12):1423-1436. https://doi.org/10.1007/s40264-019-00856-9
13. Smith MD, Spiller HA, Casavant MJ, Chounthirath T, Brophy TJ, Xiang H. Out-of-hospital medication errors among young children in the United States, 2002-2012. Pediatrics. 2014;134(5):867-876. https://doi.org/10.1542/peds.2014-0309
14. Jimenez A, Tran TM, Le B, Le J. Comparative cross-sectional pharmacovigilance study of medication errors in children and adults in community-based hospitals. Asploro J Pediatr Child Health. 2020;2(1):1-12. https://doi.org/10.36502/2020/asjpch.6150
15. Conn RL, Tully MP, Shields MD, Carrington A, Dornan T. Characteristics of Reported Pediatric Medication Errors in Northern Ireland and Use in Quality Improvement. Paediatr Drugs. 2020;22(5):551-560. https://doi.org/10.1007/s40272-020-00407-1
16. Cassidy N, Duggan E, Williams DJ, Tracey JA. The epidemiology and type of medication errors reported to the National Poisons Information Centre of Ireland. Clin Toxicol (Phila). 2011;49(6):485-491. https://doi.org/10.3109/15563650.2011.587193
17. Brophy TJ, Spiller HA, Casavant MJ, Chounthirath T, Smith MD, Xiang H. Medication errors reported to U.S. Poison Control Centers, 2000-2012. Clin Toxicol (Phila). 2014;52(8):880-888. https://doi.org/10.3109/15563650.2014.953168
18. Agence nationale de sécurité du médicament et des produits de santé. [Activity report 2017]. https://www.ansm.sante.fr/var/ansm_site/storage/original/application/87c97d5bef977831be05af840a2abd2c.pdf (accessed Oct 2, 2019).
19. Agence nationale de sécurité du médicament et des produits de santé. [Good pharmacovigilance practices] https://www.ansm.sante.fr/Activites/Elaboration-de-bonnes-pratiques/Bonnes-pratiques-de-pharmacovigilance/(offset)/1 (accessed Oct 2, 2019).
20. Agence nationale de sécurité du médicament et des produits de santé. [What is a medication error] https://www.ansm.sante.fr/Declarer-un-effet-indesirable/Erreurs-medicamenteuses/Qu-est-ce-qu-une-erreur-medicamenteuse/(offset)/0 (accessed Oct 2, 2019).
21. Baum T, Beretz L, Bohand X, et al. [La REMED : The review of errors related to drugs and associated devices - a method to improve the quality of care]. https://sfpc.eu/wp-content/uploads/2019/11/Manuel_de_la_remed-_jan_2013_-_version_dfinitive_300114-copie.pdf (accessed Oct 1, 2019)..
22. WHO Collaborating Centre for Drug Statistics Methodology. International language for drug utilization research ATC/DDD. https://www.whocc.no (accessed Sep 30, 2019).
23. Rishoej RM, Almarsdóttir AB, Christesen HT, Hallas J, Kjeldsen LJ. Medication errors in pediatric inpatients: a study based on a national mandatory reporting system. Eur J Pediatr. 2017;176(12):1697-1705. https://doi.org/10.1007/s00431-017-3023-8
24. World Health Organization. WHO expert committee on specifications for pharmaceutical preparations. [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_970/en/ (accessed Sep 30, 2019).
25. Mehndiratta S. Strategies to reduce medication errors in pediatric ambulatory settings. J Postgrad Med. 2012;58(1):47-53. https://doi.org/10.4103/0022-3859.93252
26. Conroy S, Sweis D, Planner C, et al. Interventions to reduce dosing errors in children: a systematic review of the literature. Drug Saf. 2007;30(12):1111-1125. https://doi.org/10.2165/00002018-200730120-00004
27. Gates PJ, Meyerson SA, Baysari MT, Westbrook JI. The Prevalence of Dose Errors Among Paediatric Patients in Hospital Wards with and without Health Information Technology: A Systematic Review and Meta-Analysis. Drug Saf. 2019;42(1):13-25. https://doi.org/10.1007/s40264-018-0715-6
28. Yin HS, Parker RM, Sanders LM, et al. Pictograms, Units and Dosing Tools, and Parent Medication Errors: A Randomized Study. Pediatrics. 2017;140(1):e20163237. https://doi.org/10.1542/peds.2016-3237
29. Størdal K, Wyder C, Trobisch A, Grossman Z, Hadjipanayis A. Overtesting and overtreatment-statement from the European Academy of Paediatrics (EAP). Eur J Pediatr. 2019;178(12):1923-1927. https://doi.org/10.1007/s00431-019-03461-1
30. Bosley H, Henshall C, Appleton JV, Jackson D. A systematic review to explore influences on parental attitudes towards antibiotic prescribing in children. J Clin Nurs. 2018;27(5-6):892-905. https://doi.org/10.1111/jocn.14073
31. Bénard-Laribière A, Jové J, Lassalle R, Robinson P, Droz-Perroteau C, Noize P. Drug use in French children: a population-based study. Arch Dis Child. 2015;100(10):960-965. https://doi.org/10.1136/archdischild-2014-307224
32. Santell JP, Hicks RW, McMeekin J, Cousins DD. Medication errors: experience of the United States Pharmacopeia (USP) MEDMARX reporting system. J Clin Pharmacol. 2003;43(7):760-767. https://doi.org/10.1177/0091270003254831
33. Miller MR, Robinson KA, Lubomski LH, Rinke ML, Pronovost PJ. Medication errors in paediatric care: a systematic review of epidemiology and an evaluation of evidence supporting reduction strategy recommendations. Qual Saf Health Care. 2007;16(2):116-126. https://doi.org/10.1136/qshc.2006.019950
34. Kaushal R, Goldmann DA, Keohane CA, et al. Adverse drug events in pediatric outpatients. Ambul Pediatr. 2007;7(5):383-389. https://doi.org/10.1016/j.ambp.2007.05.005
35. Ameer A, Dhillon S, Peters MJ, Ghaleb M. Systematic literature review of hospital medication administration errors in children. Integr Pharm Res Pract. 2015;4:153-165. https://doi.org/10.2147/iprp.s54998
36. Kahn S, Abramson EL. What is new in paediatric medication safety?. Arch Dis Child. 2019;104(6):596-599. https://doi.org/10.1136/archdischild-2018-315175
37. Manias E, Kinney S, Cranswick N, Williams A. Medication errors in hospitalised children. J Paediatr Child Health. 2014;50(1):71-77. https://doi.org/10.1111/jpc.12412
38. Maaskant JM, Eskes A, van Rijn-Bikker P, Bosman D, van Aalderen W, Vermeulen H. High-alert medications for pediatric patients: an international modified Delphi study. Expert Opin Drug Saf. 2013;12(6):805-814. https://doi.org/10.1517/14740338.2013.825247
39. Wahr JA, Shore AD, Harris LH, et al. Comparison of intensive care unit medication errors reported to the United States' MedMarx and the United Kingdom's National Reporting and Learning System: a cross-sectional study. Am J Med Qual. 2014;29(1):61-69. https://doi.org/10.1177/1062860613482964
40. Kuitunen T, Kuisma P, Hoppu K. Medication errors made by health care professionals. Analysis of the Finnish Poison Information Centre data between 2000 and 2007. Eur J Clin Pharmacol. 2008;64(8):769-774. https://doi.org/10.1007/s00228-008-0496-4
41. Bundy DG, Shore AD, Morlock LL, Miller MR. Pediatric vaccination errors: application of the "5 rights" framework to a national error reporting database. Vaccine. 2009;27(29):3890-3896. https://doi.org/10.1016/j.vaccine.2009.04.005
42. Rees P, Edwards A, Panesar S, et al. Safety incidents in the primary care office setting. Pediatrics. 2015;135(6):1027-1035. https://doi.org/10.1542/peds.2014-3259
43. McD Taylor D, Robinson J, MacLeod D, MacBean CE, Braitberg G. Therapeutic errors among children in the community setting: nature, causes and outcomes. J Paediatr Child Health. 2009;45(5):304-309. https://doi.org/10.1111/j.1440-1754.2008.01462.x
44. Kamboj A, Spiller HA, Casavant MJ, Chounthirath T, Hodges NL, Smith GA. Antidepressant and antipsychotic medication errors reported to United States poison control centers. Pharmacoepidemiol Drug Saf. 2018;27(8):902-911. https://doi.org/10.1002/pds.4554
45. Briars LA. The Latest Update on Over-the-Counter Cough and Cold Product Use in Children. J Pediatr Pharmacol Ther. 2009;14(3):127-131. https://doi.org/10.5863/1551-6776-14.3.127
46. Walsh KE, Roblin DW, Weingart SN, et al. Medication errors in the home: a multisite study of children with cancer. Pediatrics. 2013;131(5):e1405-e1414. https://doi.org/10.1542/peds.2012-2434
47. Walsh KE, Mazor KM, Stille CJ, et al. Medication errors in the homes of children with chronic conditions. Arch Dis Child. 2011;96(6):581-586. https://doi.org/10.1136/adc.2010.204479
48. Parand A, Garfield S, Vincent C, Franklin BD. Carers' Medication Administration Errors in the Domiciliary Setting: A Systematic Review. PLoS One. 2016;11(12):e0167204. https://doi.org/10.1371/journal.pone.0167204
49. Dunn SL, Arslanian-Engoren C, DeKoekkoek T, Jadack R, Scott LD. Secondary Data Analysis as an Efficient and Effective Approach to Nursing Research. West J Nurs Res. 2015;37(10):1295-1307. https://doi.org/10.1177/0193945915570042
50. Zhan C, Smith SR, Keyes MA, Hicks RW, Cousins DD, Clancy CM. How useful are voluntary medication error reports? The case of warfarin-related medication errors. Jt Comm J Qual Patient Saf. 2008;34(1):36-45. https://doi.org/10.1016/s1553-7250(08)34006-9
51. Smith, J. Building a safer NHS for patients: improving medication safety. London: Department of Health; 2004.
52. Jeffe DB, Dunagan WC, Garbutt J, et al. Using focus groups to understand physicians' and nurses' perspectives on error reporting in hospitals. Jt Comm J Qual Saf. 2004;30(9):471-479. https://doi.org/10.1016/s1549-3741(04)30055-9