A Mixed-Methods Analysis of Medication Safety Incidents Reported in Neonatal and Children's Intensive Care.

BACKGROUND: Critically ill neonates and paediatric patients may be at a greater risk of medication-related safety incidents than those in other clinical areas. OBJECTIVE: This study aimed to examine the nature of, and contributory factors associated with, medication-related safety incidents reported in neonatal and paediatric intensive care units (ICUs). METHODS: We carried out a mixed-methods analysis of anonymised medication safety incidents reported to the National Reporting and Learning System that involved children (aged ≤ 18 years) admitted to ICUs across England and Wales over a 9-year period (2010-2018). Data were analysed descriptively, and free-text descriptions of harmful incidents were examined to explore potential contributory factors associated with incidents. RESULTS: In total, 25,567 eligible medication-related incident reports were examined. Incidents commonly occurred during the medicines administration (n = 13,668 [53.5%]) and prescribing stages (n = 7412 [29%]). The most commonly implicated error types were drug omission (n = 4812 [18.8%]) and dosing errors (n = 4475 [17.5%]). Neonates were commonly involved in reported incidents (n = 12,235 [47.9%]). Anti-infectives (n = 6483 [25.4%]) were the medications most commonly associated with incidents and commonly involved neonates. Incidents that were reported to have caused patient harm accounted for 12.2% (n = 3129) and commonly involved neonates (n = 1570/3129 [50.2%]). Common contributing factors to harmful incidents included staff-related factors (68.7%), such as failure to follow protocols or errors in documentation, which were often associated with working conditions, inadequate guidelines, and design of systems and protocols. CONCLUSIONS: Neonates were commonly involved in medication-related incidents reported in children's intensive care settings. Improvements in staffing and workload, design of systems and processes, and the use of anti-infective medications may reduce this risk.

Incidence and prevalence of intravenous medication errors in the UK: a systematic review.

Objectives: Medication error is the most common type of medical error, and intravenous medicines are at a higher risk as they are complex to prepare and administer. The WHO advocates a 50% reduction of harmful medication errors by 2022, but there is a lack of data in the UK that accurately estimates the true rate of intravenous medication errors. This study aimed to estimate the number of intravenous medication errors per 1000 administrations in the UK National Health Service and their associated economic costs. The rate of errors in prescribing, preparation and administration, and rate of different types of errors were also extracted. Methods: MEDLINE, Embase, Cochrane central register of clinical trials, Database of Abstracts of Reviews of Effectiveness, National Health Service Economic Evaluation Database and the Health Technology Appraisals Database were searched from inception to July 2017. Epidemiological studies to determine the incidence of intravenous medication errors set wholly or in part in the UK were included. 228 studies were identified, and after screening, eight papers were included, presenting 2576 infusions. Data were reviewed and extracted by a team of five reviewers with discrepancies in data extraction agreed by consensus. Results: Five of eight studies used a comparable denominator, and these data were pooled to determine a weighted mean incidence of 101 intravenous medication errors per 1000 administrations (95% CI 84 to 121). Three studies presented prevalence data but these were based on spontaneous reports only; therefore it did not support a true estimate. 32.1% (95% CI 30.6% to 33.7%) of intravenous medication errors were administration errors and 'wrong rate' errors accounted for 57.9% (95% CI 54.7% to 61.1%) of these. Conclusion: Intravenous medication errors in the UK are common, with half these of errors related to medication administration. National strategies are aimed at mitigating errors in prescribing and preparation. It is now time to focus on reducing administration error, particularly wrong rate errors.

Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: the SLEEPS (Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation) study.

BACKGROUND: Children in paediatric intensive care units (PICUs) require analgesia and sedation but both undersedation and oversedation can be harmful. OBJECTIVE: Evaluation of intravenous (i.v.) clonidine as an alternative to i.v. midazolam. DESIGN: Multicentre, double-blind, randomised equivalence trial. SETTING: Ten UK PICUs. PARTICIPANTS: Children (30 days to 15 years inclusive) weighing ≤ 50 kg, expected to require ventilation on PICU for > 12 hours. INTERVENTIONS: Clonidine (3 µg/kg loading then 0-3 µg/kg/hour) versus midazolam (200 µg/kg loading then 0-200 µg/kg/hour). Maintenance infusion rates adjusted according to behavioural assessment (COMFORT score). Both groups also received morphine. MAIN OUTCOME MEASURES: Primary end point Adequate sedation defined by COMFORT score of 17-26 for ≥ 80% of the time with a ± 0.15 margin of equivalence. Secondary end points Percentage of time spent adequately sedated, increase in sedation/analgesia, recovery after sedation, side effects and safety data. RESULTS: The study planned to recruit 1000 children. In total, 129 children were randomised, of whom 120 (93%) contributed data for the primary outcome. The proportion of children who were adequately sedated for ≥ 80% of the time was 21 of 61 (34.4%) - clonidine, and 18 of 59 (30.5%) - midazolam. The difference in proportions for clonidine-midazolam was 0.04 [95% confidence interval (CI) -0.13 to 0.21], and, with the 95% CI including values outside the range of equivalence (-0.15 to 0.15), equivalence was not demonstrated; however, the study was underpowered. Non-inferiority of clonidine to midazolam was established, with the only values outside the equivalence range favouring clonidine. Times to reach maximum sedation and analgesia were comparable hazard ratios: 0.99 (95% CI 0.53 to 1.82) and 1.18 (95% CI 0.49 to 2.86), respectively. Percentage time spent adequately sedated was similar [medians clonidine 73.8% vs. midazolam 72.8%: difference in medians 0.66 (95% CI -5.25 to 7.24)]. Treatment failure was 12 of 64 (18.8%) on clonidine and 7 of 61 (11.5%) on midazolam [risk ratio (RR) 1.63, 95% CI 0.69 to 3.88]. Proportions with withdrawal symptoms [28/60 (46.7%) vs. 30/58 (52.6%)] were similar (RR 0.89, 95% CI 0.62 to 1.28), but a greater proportion required clinical intervention in those receiving midazolam [11/60 (18.3%) vs. 16/58 (27.6%) (RR 0.66, 95% CI 0.34 to 1.31)]. Post treatment, one child on clonidine experienced mild rebound hypertension, not requiring intervention. A higher incidence of inotropic support during the first 12 hours was required for those on clonidine [clonidine 5/45 (11.1%) vs. midazolam 3/52 (5.8%)] (RR 1.93 95% CI 0.49 to 7.61). CONCLUSIONS: Clonidine is an alternative to midazolam. Our trial-based economic evaluation suggests that clonidine is likely to be a cost-effective sedative agent in the PICU in comparison with midazolam (probability of cost-effectiveness exceeds 50%). Rebound hypertension did not appear to be a significant problem with clonidine but, owing to its effects on heart rate, specific cardiovascular attention needs to be taken during the loading and early infusion phase. Neither drug in combination with morphine provided ideal sedation, suggesting that in unparalysed patients a third background agent is necessary. The disappointing recruitment rates reflect a reluctance of parents to provide consent when established on a sedation regimen, and reluctance of clinicians to allow sedation to be studied in unstable critically ill children. Future studies will require less exacting protocols allowing enhanced recruitment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN02639863. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 71. See the NIHR Journals Library website for further project information.