OBJECTIVE: To determine the extent of unlicensed and off-label use of medicines in hospitalised children in the intensive care units of a tertiary care teaching hospital.
METHODS: A prospective, observational exploratory study was conducted on medicines prescribed to children admitted to the 3 intensive care units of Universiti Kebangsaan Malaysia Medical Centre (UKMMC).
RESULTS: A total of 194 patients were admitted to UKMMC, 168 of them received one or more drugs. Of 1,295 prescriptions, 353 (27.3 %) were unlicensed and 442 (34.1 %) were for off-label use. Forty-four percent of patients received at least one medicine for unlicensed use and 82.1 % received at least one medicine off-label. Preterm infants, children aged 28 days to 23 months, patients with hospital stays of more than 2 weeks, and those prescribed increasing numbers of medicines were more likely to receive medicines for unlicensed use. Term neonates and patients prescribed increasing numbers of medicines had increased risk of receiving medicines for off-label use.
CONCLUSION: Prescribing of medicines in an unlicensed or off-label fashion to the children in the intensive care units of UKMMC was common. Further detailed studies are necessary to ensure the delivery of safe and effective medicines to children.
OBJECTIVE: This study aimed to estimate and critically appraise the evidence on the prevalence, causes and severity of medication administration errors (MAEs) amongst neonates in Neonatal Intensive Care Units (NICUs).
METHODS: A systematic review and meta-analysis was conducted by searching nine electronic databases and the grey literature for studies, without language and publication date restrictions. The pooled prevalence of MAEs was estimated using a random-effects model. Data on error causation were synthesised using Reason's model of accident causation.
RESULTS: Twenty unique studies were included. Amongst direct observation studies reporting total opportunity for errors as the denominator for MAEs, the pooled prevalence was 59.3% (95% confidence interval [CI] 35.4-81.3, I2 = 99.5%). Whereas, the non-direct observation studies reporting medication error reports as the denominator yielded a pooled prevalence of 64.8% (95% CI 46.6-81.1, I2 = 98.2%). The common reported causes were error-provoking environments (five studies), while active failures were reported by three studies. Only three studies examined the severity of MAEs, and each utilised a different method of assessment.
CONCLUSIONS: This is the first comprehensive systematic review and meta-analysis estimating the prevalence, causes and severity of MAEs amongst neonates. There is a need to improve the quality and reporting of studies to produce a better estimate of the prevalence of MAEs amongst neonates. Important targets such as wrong administration-technique, wrong drug-preparation and wrong time errors have been identified to guide the implementation of remedial measures.
METHODS AND ANALYSIS: This is a prospective direct observational study that will be conducted in five neonatal intensive care units. A minimum sample size of 820 drug preparations and administrations will be observed. Data including patient characteristics, drug preparation-related and administration-related information and other procedures will be recorded. After each round of observation, the observers will compare his/her observations with the prescriber's medication order, hospital policies and manufacturer's recommendations to determine whether MAE has occurred. To ensure reliability, the error identification will be independently performed by two clinical pharmacists after the completion of data collection for all study sites. Any disagreements will be discussed with the research team for consensus. To reduce overfitting and improve the quality of risk predictions, we have prespecified a priori the analytical plan, that is, prespecifying the candidate predictor variables, handling missing data and validation of the developed model. The model's performance will also be assessed. Finally, various modes of presentation formats such as a simplified scoring tool or web-based electronic risk calculators will be considered.
DESIGN: Parallel-group randomised controlled trial with a 1:1 allocation ratio.
SETTING: Two regional tertiary neonatal intensive care units.
PATIENTS: 150 preterm infants less than 35 weeks gestation with birth weight between 1.0 and 1.5 kg were recruited.
INTERVENTIONS: Infants were enrolled to either 2-hourly or 3-hourly interval feeding after randomisation. Blinding was not possible due to the nature of the intervention.
MAIN OUTCOME MEASURES: The primary outcome was time to achieve full enteral feeding (≥100 mL/kg/day). Secondary outcomes include time to regain birth weight, episode of feeding intolerance, peak serum bilirubin levels, duration of phototherapy, episode of necrotising enterocolitis, nosocomial sepsis and gastro-oesophageal reflux.
RESULTS: 72 infants were available for primary outcome analysis in each group as three were excluded due to death-three deaths in each group. The mean time to full enteral feeding was 11.3 days in the 3-hourly group and 10.2 days in the 2-hourly group (mean difference 1.1 days; 95% CI -0.4 to 2.5; p=0.14). The mean time to regain birth weight was shorter in 3-hourly group (12.9 vs 14.8 days, p=0.04). Other subgroup analyses did not reveal additional significant results. No difference in adverse events was found between the groups.
CONCLUSION: 3-hourly feeding was comparable with 2-hourly feeding to achieve full enteral feeding without any evidence of increased adverse events.
TRIAL REGISTRATION NUMBER: ACTRN12611000676910, pre-result.
CONCLUSION: Exposing preterm infants to either 12 h cyglical lighting or continuously dim environment did not have any significant effect on their weight gain during the neonatal period.
METHODS: A web-based survey was sent to neonatologists from 16 provinces representing 59.6% (824.2 million) of the total population of China on October 2015 and December 2017.
RESULTS: A total of 117 and 219 responses were received in 2015 and 2017, respectively. Compared to 2015, respondents in 2017 were more likely to resuscitate infants <25 weeks of gestation (86% vs. 72%; p < 0.05), but few would resuscitate infants ≤23 weeks of gestation in either epoch (10% vs. 6%). In both epochs, parents were responsible for >50% of the costs of intensive care, but in 2017, significantly fewer clinicians would cease intensive care (75% vs. 88%; p < 0.05) and more would request for economic aid (40% vs. 20%; p < 0.05) if parents could not afford to pay. Resource availability (e.g. ventilators) was not an important factor in either initiation or continuation of intensive care (~60% in both epochs).
CONCLUSION: Cost is an important factor in the initiation and continuation of neonatal intensive care in a developing country like China. Such factors need to be taken into consideration when interpreting outcome data from these regions.