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Published in: BMC Pediatrics 1/2019

Open Access 01-12-2019 | Care | Research article

Drug related problems in the neonatal intensive care unit: incidence, characterization and clinical relevance

Authors: Ramon Duarte Leopoldino, Marco Tavares Santos, Tatiana Xavier Costa, Rand Randall Martins, António Gouveia Oliveira

Published in: BMC Pediatrics | Issue 1/2019

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Abstract

Background

Any event involving drug therapy that may interfere in a patient’s desired clinical outcome is called a drug related problem (DRP). DRP are very common in intensive therapy, however, little is known about DRP in the Neonatal Intensive Care Unit (NICU). The purpose of this study was to determine the incidence of DRPs in NICU patients and to characterize DRPs according to type, cause and corresponding pharmaceutical conducts.

Methods

Prospective observational study conducted in the NICU at a teaching hospital in Brazil from January 2014 to November 2016. The data were collected from the records of the clinical pharmacy service, excluding neonates admitted for less than 24 h and those who had no drugs prescribed. DRPs were classified according to the Pharmaceutical Care Network Europe system and evaluated for relevance-safety.

Results

Six hundred neonates were included in the study, with mean gestational age of 31.9 ± 4.1 weeks and mean birth weight of 1779 ± 885 g. The incidence of DRPs in the NICU was 6.8% patient-days (95%CI 6.2–7.3%) and affected 59.8% of neonates (95% CI 55.8–63.8%). Sub-optimal effect (52.8%) and inappropriate dose selection (39.75%) were the most common problem and cause, respectively. Anti-infectives was the medication class most involved in DRPs. More than one-third of neonates were exposed to DRP of significant or high safety-relevance. Most of the pharmaceutical interventions were related with drug prescription, with over 90% acceptance by attending physicians.

Conclusion

DRP are common in NICU, predominating problems of sub-optimal treatment, mainly due to inappropriate dose selection.
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Literature
2.
go back to reference van den Bemt PMLA, Egberts TCG, De Jong-Van den Berg LTW, Brouwers JRBJ. Drug-related problems in hospitalised patients. Drug Saf. 2000;22:321–33.CrossRef van den Bemt PMLA, Egberts TCG, De Jong-Van den Berg LTW, Brouwers JRBJ. Drug-related problems in hospitalised patients. Drug Saf. 2000;22:321–33.CrossRef
3.
go back to reference Kunac DI, Kennedy J, Austin N, Reith D. Incidence, preventability, and impact of adverse drug events (ADEs) and potential ADEs in hospitalized children in New Zealand: a prospective observational cohort study. Paediatr Drugs. 2009;11:153–60.CrossRef Kunac DI, Kennedy J, Austin N, Reith D. Incidence, preventability, and impact of adverse drug events (ADEs) and potential ADEs in hospitalized children in New Zealand: a prospective observational cohort study. Paediatr Drugs. 2009;11:153–60.CrossRef
4.
go back to reference Ohta Y, Sakuma M, Koike K, Bates DW, Morimoto T. Influence of adverse drug events on morbidity and mortality in intensive care units: the JADE study. Int J Qual Health Care. 2014;26:573–8.CrossRef Ohta Y, Sakuma M, Koike K, Bates DW, Morimoto T. Influence of adverse drug events on morbidity and mortality in intensive care units: the JADE study. Int J Qual Health Care. 2014;26:573–8.CrossRef
5.
go back to reference Tasaka Y, Yasunaga D, Tanaka M, Tanaka A, Asakawa T, Horio I, et al. Economic and safety benefits of pharmaceutical interventions by community and hospital pharmacists in Japan. Int J Clin Pharm. 2016;38:321–9.CrossRef Tasaka Y, Yasunaga D, Tanaka M, Tanaka A, Asakawa T, Horio I, et al. Economic and safety benefits of pharmaceutical interventions by community and hospital pharmacists in Japan. Int J Clin Pharm. 2016;38:321–9.CrossRef
6.
go back to reference Garrouste-Orgeas M, Philippart F, Bruel C, Max A, Lau N, Misset B. Overview of medical errors and adverse events. Ann Intensive Care. 2012;2:2.CrossRef Garrouste-Orgeas M, Philippart F, Bruel C, Max A, Lau N, Misset B. Overview of medical errors and adverse events. Ann Intensive Care. 2012;2:2.CrossRef
7.
go back to reference Rashed AN, Neubert A, Tomlin S, Jackman J, Alhamdan H, AlShaikh A, et al. Epidemiology and potential associated risk factors of drug-related problems in hospitalised children in the United Kingdom and Saudi Arabia. Eur J Clin Pharmacol. 2012;68:1657–66.CrossRef Rashed AN, Neubert A, Tomlin S, Jackman J, Alhamdan H, AlShaikh A, et al. Epidemiology and potential associated risk factors of drug-related problems in hospitalised children in the United Kingdom and Saudi Arabia. Eur J Clin Pharmacol. 2012;68:1657–66.CrossRef
8.
go back to reference Rashed AN, Wilton L, Lo CCH, Kwong BY, Leung S, Wong ICK. Epidemiology and potential risk factors of drug-related problems in Hong Kong paediatric wards. Br J Clin Pharmacol. 2014;77:873–9.CrossRef Rashed AN, Wilton L, Lo CCH, Kwong BY, Leung S, Wong ICK. Epidemiology and potential risk factors of drug-related problems in Hong Kong paediatric wards. Br J Clin Pharmacol. 2014;77:873–9.CrossRef
9.
go back to reference Ibrahim N, Wong ICK, Tomlin S, Sinha MD, Rees L, Jani Y. Epidemiology of medication-related problems in children with kidney disease. Pediatr Nephrol. 2015;30:623–33.CrossRef Ibrahim N, Wong ICK, Tomlin S, Sinha MD, Rees L, Jani Y. Epidemiology of medication-related problems in children with kidney disease. Pediatr Nephrol. 2015;30:623–33.CrossRef
10.
go back to reference Birarra MK, Heye TB, Shibeshi W. Assessment of drug-related problems in pediatric ward of Zewditu memorial referral hospital, Addis Ababa, Ethiopia. Int J Clin Pharm. 2017;39:1–8.CrossRef Birarra MK, Heye TB, Shibeshi W. Assessment of drug-related problems in pediatric ward of Zewditu memorial referral hospital, Addis Ababa, Ethiopia. Int J Clin Pharm. 2017;39:1–8.CrossRef
11.
go back to reference Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp MD, Federico F, Goldmann DA. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001;285:2114–20.CrossRef Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp MD, Federico F, Goldmann DA. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001;285:2114–20.CrossRef
12.
go back to reference Fernandez-Llamazares CM, Calleja-Hernández MA, Manrique-Rodríguez S, Pérez-Sanz C, Durán-García E, Sanjurjo-Sáez M. Prescribing errors intercepted by clinical pharmacists in paediatrics and obstetrics in a tertiary hospital in Spain. Eur J Clin Pharmacol. 2012;68:1339–45.CrossRef Fernandez-Llamazares CM, Calleja-Hernández MA, Manrique-Rodríguez S, Pérez-Sanz C, Durán-García E, Sanjurjo-Sáez M. Prescribing errors intercepted by clinical pharmacists in paediatrics and obstetrics in a tertiary hospital in Spain. Eur J Clin Pharmacol. 2012;68:1339–45.CrossRef
13.
go back to reference Allegaert K, van den Anker JN. Adverse drug reactions in neonates and infants: a population-tailored approach is needed. Br J Clin Pharmacol. 2015;80:788–95.CrossRef Allegaert K, van den Anker JN. Adverse drug reactions in neonates and infants: a population-tailored approach is needed. Br J Clin Pharmacol. 2015;80:788–95.CrossRef
14.
go back to reference Sorrentino E, Alegiani C. Medication errors in the neonate. J Matern Fetal Neonatal Med. 2012;25:83–5.CrossRef Sorrentino E, Alegiani C. Medication errors in the neonate. J Matern Fetal Neonatal Med. 2012;25:83–5.CrossRef
15.
go back to reference Rodieux F, Wilbaux M, van den Anker JN, Pfister M. Effect of kidney function on drug kinetics and dosing in neonates, infants, and children. Clin Pharmacokinet. 2015;54:1183–204.CrossRef Rodieux F, Wilbaux M, van den Anker JN, Pfister M. Effect of kidney function on drug kinetics and dosing in neonates, infants, and children. Clin Pharmacokinet. 2015;54:1183–204.CrossRef
16.
go back to reference Ward RM, Benjamin D, Barrett JS, Allegaert K, Portman R, Davis JM. Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates. Pediatr Res. 2017;81:692–711.CrossRef Ward RM, Benjamin D, Barrett JS, Allegaert K, Portman R, Davis JM. Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates. Pediatr Res. 2017;81:692–711.CrossRef
17.
go back to reference Lewinski D, Wind S, Belgardt C, Plate V, Behles C, Schweim HG. Prevalence and safety-relevance of drug-related problems in German community pharmacies. Pharmacoepidemiol Drug Saf. 2010;19:141–9.CrossRef Lewinski D, Wind S, Belgardt C, Plate V, Behles C, Schweim HG. Prevalence and safety-relevance of drug-related problems in German community pharmacies. Pharmacoepidemiol Drug Saf. 2010;19:141–9.CrossRef
18.
go back to reference Basger BJ, Moles RJ, Chen TF. Application of drug-related problem (DRP) classification systems: a review of the literature. Eur J Clin Pharmacol. 2014;70:799–815.CrossRef Basger BJ, Moles RJ, Chen TF. Application of drug-related problem (DRP) classification systems: a review of the literature. Eur J Clin Pharmacol. 2014;70:799–815.CrossRef
19.
go back to reference van den Anker JN. How to optimize the evaluation and use of antibiotics in neonates. Early Hum Dev. 2014;90(Suppl 1):S10–2.CrossRef van den Anker JN. How to optimize the evaluation and use of antibiotics in neonates. Early Hum Dev. 2014;90(Suppl 1):S10–2.CrossRef
20.
go back to reference Wilbaux M, Fuchs A, Samardzic J, Rodieux F, Csajka C, Allegaert K, et al. Pharmacometric approaches to personalize use of primarily renally eliminated antibiotics in preterm and term neonates. J Clin Pharmacol. 2016;56:909–35.CrossRef Wilbaux M, Fuchs A, Samardzic J, Rodieux F, Csajka C, Allegaert K, et al. Pharmacometric approaches to personalize use of primarily renally eliminated antibiotics in preterm and term neonates. J Clin Pharmacol. 2016;56:909–35.CrossRef
21.
go back to reference Chappell K, Newman C. Potential tenfold drug overdoses on a neonatal unit. Arch Dis Child Fetal Neonatal Ed. 2004;89:F483–4.CrossRef Chappell K, Newman C. Potential tenfold drug overdoses on a neonatal unit. Arch Dis Child Fetal Neonatal Ed. 2004;89:F483–4.CrossRef
22.
go back to reference Kadambari S, Heath PT, Sharland M, Lewis S, Nichols A, Turner MA. Variation in gentamicin and vancomycin dosage and monitoring in UK neonatal units. J Antimicrob Chemother. 2011;66:2647–50.CrossRef Kadambari S, Heath PT, Sharland M, Lewis S, Nichols A, Turner MA. Variation in gentamicin and vancomycin dosage and monitoring in UK neonatal units. J Antimicrob Chemother. 2011;66:2647–50.CrossRef
23.
go back to reference Metsvaht T, Nellis G, Varendi H, Nunn AJ, Graham S, Rieutord A, et al. High variability in the dosing of commonly used antibiotics revealed by a Europe-wide point prevalence study: implications for research and dissemination. BMC Pediatr. 2015;15:41.CrossRef Metsvaht T, Nellis G, Varendi H, Nunn AJ, Graham S, Rieutord A, et al. High variability in the dosing of commonly used antibiotics revealed by a Europe-wide point prevalence study: implications for research and dissemination. BMC Pediatr. 2015;15:41.CrossRef
24.
go back to reference Simpson JH, Lynch R, Grant J, Alroomi L. Reducing medication errors in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2004;89:F480–2.CrossRef Simpson JH, Lynch R, Grant J, Alroomi L. Reducing medication errors in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2004;89:F480–2.CrossRef
25.
go back to reference Stavroudis TA, Shore AD, Morlock L, Hicks RW, Bundy D, Miller MR. NICU medication errors: identifying a risk profile for medication errors in the neonatal intensive care unit. J Perinatol. 2010;30:459–68.CrossRef Stavroudis TA, Shore AD, Morlock L, Hicks RW, Bundy D, Miller MR. NICU medication errors: identifying a risk profile for medication errors in the neonatal intensive care unit. J Perinatol. 2010;30:459–68.CrossRef
26.
go back to reference Esqué Ruiz MT, Moretones Sunol MG, Rodríguez Miguelez JM, Sánchez Ortiz E, Izco Urroz M, Lamo Camino M, et al. Los errores de tratamiento en uma unidad neonatal, uno de los principales acontecimientos adversos. An Pediatr (Barc). 2016;84:211–7.CrossRef Esqué Ruiz MT, Moretones Sunol MG, Rodríguez Miguelez JM, Sánchez Ortiz E, Izco Urroz M, Lamo Camino M, et al. Los errores de tratamiento en uma unidad neonatal, uno de los principales acontecimientos adversos. An Pediatr (Barc). 2016;84:211–7.CrossRef
27.
go back to reference Prot-Labarthe S, Di Paolo ER, Lavoie A, Quennery S, Bussières JF, Brion F, et al. Pediatric drug-related problems: a multicenter study in four French-speaking countries. Int J Clin Pharm. 2013;35:251–9.CrossRef Prot-Labarthe S, Di Paolo ER, Lavoie A, Quennery S, Bussières JF, Brion F, et al. Pediatric drug-related problems: a multicenter study in four French-speaking countries. Int J Clin Pharm. 2013;35:251–9.CrossRef
28.
go back to reference Nguyen MR, Mosel C, Grzeskowiak LE. Interventions to reduce medication errors in neonatal care: a systematic review. Ther Adv Drug Saf. 2018;9:123–55.CrossRef Nguyen MR, Mosel C, Grzeskowiak LE. Interventions to reduce medication errors in neonatal care: a systematic review. Ther Adv Drug Saf. 2018;9:123–55.CrossRef
Metadata
Title
Drug related problems in the neonatal intensive care unit: incidence, characterization and clinical relevance
Authors
Ramon Duarte Leopoldino
Marco Tavares Santos
Tatiana Xavier Costa
Rand Randall Martins
António Gouveia Oliveira
Publication date
01-12-2019
Publisher
BioMed Central
Keyword
Care
Published in
BMC Pediatrics / Issue 1/2019
Electronic ISSN: 1471-2431
DOI
https://doi.org/10.1186/s12887-019-1499-2

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