Strategies implementation to reduce medicine preparation error rate in neonatal intensive care units

Campino, Ainara; Santesteban, Elena; Pascual, P.; Sordo, Beatriz; Arranz, Casilda; Unceta, Maria; Lopez-de-Heredia, Ion

doi:10.1007/s00431-015-2679-1

Cited by 22 publications

(26 citation statements)

References 13 publications

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“…Our data produced better results than those previously published which displayed preparation error rates of 54.7% and 29% . As regards the variability in error rates observed in the literature and in this study, it appears that the risk of medication errors due to the preparation step might be very high.…”

Section: Discussioncontrasting

confidence: 62%

Quality control and stability of ketamine, remifentanil, and sufentanil syringes in a pediatric operating theater

Bourdon¹,

Simon

Lannoy

et al. 2019

Pediatric Anesthesia

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Summary Background Transforming a drug from its commercial form into a ready‐to‐use drug is common practice, especially in pediatrics. However, the risk of compounding error is real and data on drug stability in practice are not always available. Aims The aim of this study was to assess, in real conditions, both the error rate and stability of three drugs: ketamine, remifentanil, and sufentanil. Methods A new rapid and easy‐to‐use high‐performance liquid chromatography method with a diode array detector has been developed and validated to quantify these drugs and detect their degradation products. Over a 1‐month period, 151 syringes were collected in the postanesthesia care unit. Seventy‐three were stock solution syringes containing a 10‐fold dilution of commercial drugs and 78 were serial dilution syringes made from successive dilutions of stock solutions. A comparison between real and expected concentrations as well as the detection of possible degradation products was carried out on these samples. Results All stock solution syringes had good chemical stability throughout the working day. A 4‐µg/mL remifentanil serial dilution syringe, however, had to be discarded as a degradation peak was detected. Overall, 15.3% (95% CI, 9.5‐21.1%) of syringes had a drug concentration outside the ±10% acceptability range, that is, 11.0% (95% CI, 3.7‐18.2%) and 19.5% (95% CI, 10.6%‐28.4%) of stock and diluted syringes respectively, with drug amounts ranging from −25.3% to 22.0%. The highest error rates were observed with sufentanil syringes: 20% and 28% for stock solution and serial dilution, respectively. Conclusion The study shows that stock solution syringes prepared in advance are chemically stable throughout the day, unlike certain serial dilution syringes, indicating that the latter should be prepared just before administration to ensure chemical stability. Our results show that the error rate for serial dilution syringes is twice that of stock solution. Different safety measures are under discussion and have to be further studied.

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Section: Discussioncontrasting

confidence: 62%

Quality control and stability of ketamine, remifentanil, and sufentanil syringes in a pediatric operating theater

Bourdon¹,

Simon

Lannoy

et al. 2019

Pediatric Anesthesia

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“…a combination of any of the previous themes; n = 18). [100][101][102][103][104][105][106][107][108][109][110][111][112][113][114][115][116][117] A detailed summary of each individual study included in the review is presented in Table 2.…”

Section: Overview Of Included Studiesmentioning

confidence: 99%

Interventions to reduce medication errors in neonatal care: a systematic review

Nguyen

Mosel

Grzeskowiak

2017

Therapeutic Advances in Drug Safety

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Background: Medication errors represent a significant but often preventable cause of morbidity and mortality in neonates. The objective of this systematic review was to determine the effectiveness of interventions to reduce neonatal medication errors. Methods: A systematic review was undertaken of all comparative and noncomparative studies published in any language, identified from searches of PubMed and EMBASE and referencelist checking. Eligible studies were those investigating the impact of any medication safety interventions aimed at reducing medication errors in neonates in the hospital setting. Results: A total of 102 studies were identified that met the inclusion criteria, including 86 comparative and 16 noncomparative studies. Medication safety interventions were classified into six themes: technology (n = 38; e.g. electronic prescribing), organizational (n = 16; e.g. guidelines, policies, and procedures), personnel (n = 13; e.g. staff education), pharmacy (n = 9; e.g. clinical pharmacy service), hazard and risk analysis (n = 8; e.g. error detection tools), and multifactorial (n = 18; e.g. any combination of previous interventions). Significant variability was evident across all included studies, with differences in intervention strategies, trial methods, types of medication errors evaluated, and how medication errors were identified and evaluated. Most studies demonstrated an appreciable risk of bias. The vast majority of studies (>90%) demonstrated a reduction in medication errors. A similar median reduction of 50-70% in medication errors was evident across studies included within each of the identified themes, but findings varied considerably from a 16% increase in medication errors to a 100% reduction in medication errors. Conclusion: While neonatal medication errors can be reduced through multiple interventions aimed at improving the medication use process, no single intervention appeared clearly superior. Further research is required to evaluate the relative cost-effectiveness of the various medication safety interventions to facilitate decisions regarding uptake and implementation into clinical practice.

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“…Such a strategy should be based on prevention through drug prescription and administration errors prevention (e.g., formulation, bedside manipulation, access) strategies, detection through laboratory, or clinical outlier data signaling (e.g., reference laboratory values, overall high morbidity), and subsequent assessment. Both papers of Campino et al fit perfectly in such a preventive strategy [5,6]. However, once a signal has been detected, the differentiation of Btrue^ADRs from confounding events associated with immaturity, organ dysfunction, or underlying diseases remains difficult.…”

Section: Neonatal Clinical Pharmacy: How To Cope With Neonatal Formulmentioning

confidence: 95%

“…As a recent illustration, we refer to the evaluation of the use of uncoated mini-tablets instead of syrup for neonates. Uncoated mini-tablets offer the potential of a single formulation for different age groups and [5,6,10,11,13,15], and pharmacovigilance [7,8] in neonates, but should also shift towards medicines and product development driven by neonatal pathophysiology [9] avoid the need for specific excipients or taste-masking compounds [10,15].…”

Section: Neonatal Clinical Pharmacy: How To Cope With Neonatal Formulmentioning

confidence: 99%

“…The study group hereby evaluated the impact of a structured intervention (protocol standardization, education) on the number of errors and documented significant improvements in both calculation errors (1.35 to 0 %) and accuracy (54.7 and 38.3 % to 38.3 and 14.6 % in NICU and HP, respectively) [6]. This intervention paper follows on a previous paper which described a pre-intervention phase [5] and illustrates the potential impact of preventive strategies on the extent of drug errors.…”

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confidence: 99%

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Neonates and medicines: a roadmap to further improve neonatal pharmaceutical care

Allegaert

Sherwin

2016

Eur J Pediatr

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The treatment of newborns with safe and effective medicines is of critical importance for their outcome and subsequent quality of life. Despite this, it is still a common practice to prescribe medicines to neonates outside the label, extrapolating from dosing regimens and indications validated in older populations and based on non-neonatal pathophysiology. In a recent meta-analysis (2015) evaluating 829 (1994-2012) studies on prescribing practices in pediatric hospital care, off-label and unlicensed medicines prescriptions ranged from 12 to 71 % and 0.2 to 48 %. These authors hereby reconfirmed that (pre)term neonates were still most commonly exposed to off-label and unlicensed medicines [12].The federal US legislation and similar European initiatives have resulted in a relevant increase in pharmacological studies in children, with a subsequent significant increase in label changes. Unfortunately, too few included drug label changes specific to neonates. To further illustrate this, there were 406 pediatric label changes (Food and Drug Administration, 1997-2010), but only 23 drugs resulted in 11 labeled indications (e.g., linezolid, rocuronium, remifentanil, sevoflurane, stavudine, nevirapine) for neonates. The absence of label change was most commonly because of unproven efficacy, despite the fact that these compounds (e.g., paracetamol, caspofungin, valganciclovir) are likely relevant for neonates [14]. This may largely reflect the difficulties to proof efficacy due to heterogeneity in patients, variability in outcome variables, and uncertainty on biomarkers, in addition to demonstrating safety (risk of adverse drug events) in neonates. Despite the significant improvements in the knowledge on pharmacotherapy in older children, neonates still remain therapeutic orphans [2,14].In this issue of the journal, Campino et al. report on the rate of errors (calculation or accuracy) in intravenous medicine preparations when performed either bedside in 10 Spanish neonatal intensive care units (NICUs) or in hospital pharmacy (HP) services. The study group hereby evaluated the impact of a structured intervention (protocol standardization, education) on the number of errors and documented significant improvements in both calculation errors (1.35 to 0 %) and accuracy (54.7 and 38.3 % to 38.3 and 14.6 % in NICU and HP, respectively) [6]. This intervention paper follows on a previous paper which described a pre-intervention phase [5] and illustrates the potential impact of preventive strategies on the extent of drug errors.Development of a roadmap to improve neonatal pharmaceutical care should aim to improve the knowledge on clinical pharmacology, clinical pharmacy, and approaches to improve the knowledge and use of neonatal pharmacovigilance initiatives [1]. Another keystone component of such a roadmap should focus on neonatal drug development, i.e., drug development driven by neonatal pathophysiology (Fig. 1).

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Strategies implementation to reduce medicine preparation error rate in neonatal intensive care units

Cited by 22 publications

References 13 publications

Quality control and stability of ketamine, remifentanil, and sufentanil syringes in a pediatric operating theater

Quality control and stability of ketamine, remifentanil, and sufentanil syringes in a pediatric operating theater

Interventions to reduce medication errors in neonatal care: a systematic review

Neonates and medicines: a roadmap to further improve neonatal pharmaceutical care

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