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13th June 2024
Standard concentration infusions (SCIs) and ‘smart-pumps’ are recognised as best practice for delivering high-risk medications in the paediatric setting. Implementation is complex, requiring multi-stakeholder involvement – a factor leading to delays in implementation into European hospitals. Children’s Health Ireland (CHI) developed a smart-pump drug library of SCIs and led a project to expand its use across acute paediatric and neonatal settings in Ireland. Here, Dr Moninne Howlett PhD, chief pharmacy information officer at CHI, shares how this project came together.
Critically ill paediatric patients routinely require the delivery of high-risk medications via infusion pumps. Key medication error prevention strategies include the replacement of traditional individualised weight-based infusions with standard concentration infusions (SCIs), and the use of computerised infusion devices known as smart-pumps.1,2
Using customised drug libraries, pre-set dose limits and dose calculations based on programmed patient weights, smart-pumps can be highly effective in reducing serious and occasionally fatal medication errors.3 Before initiation of our project, weight-based infusions and traditional pumps were used in all paediatric and neonatal intensive care units in Ireland.
In 2012, a smart-pump drug library of paediatric SCIs was developed and implemented into Ireland’s largest paediatric intensive care unit (PICU) in CHI at Crumlin and its operating theatres. This initiative was in response to substantial evidence on the inaccuracies and risks associated with individualised weight-based infusion preparations4–7 and aligned with recommendations from safety bodies including the Institute for Safe Medication Practices.2,8
At the time of initial drug library development, the use of traditional infusion pumps and weight-based infusions – requiring complex calculations during prescribing, preparation and administration of paediatric infusions – was still common in many European hospitals.9,10
A key consideration during initial development, and subsequently during its iterative expansion, was safety and usability across the full spectrum of the paediatric patient population. Within individual wards, and even in adjacent beds, patient weights can range from <1 kg to >100 kg.
The CHI drug library has, from the outset, been designed by specialist paediatric pharmacists, with multidisciplinary input, to mitigate against the particular risks associated with this complex patient cohort.
The use of a range of weight bands, care areas and judicious setting of concentrations, safety limits and naming conventions allowed the original library (four weight bands and 42 drug lines) to be extended to continuous and intermittent infusions for more than 250 medications, presented within five weight bands and four care areas.
This level of drug library development also highlights the expanding role of the hospital pharmacist and evolution of pharmacy informatics as a specialist field.
Having invested a significant amount of time and expertise in this endeavour, CHI sought to distribute the output as widely as possible throughout acute neonatal and paediatric services. Initial efforts focussed on the other PICU and theatres within CHI’s second large tertiary paediatric hospital, in addition to paediatric transport services, which are run out of the two CHI PICUs.
Simultaneously, through a multidisciplinary collaboration with neonatal ICU (NICU) specialist pharmacists, nurses and doctors, a neonatal-specific sub-library was developed to support the specific needs of infants in NICU and the neonatal transport services.
This component of the project received endorsement from Ireland’s National Clinical Programme for Paediatrics and Neonatology. Key factors leading to this national health service level support were the high volume of movement of sick infants and children across services and access to evidence derived from research undertaken in the originator site.
This research identified a reduction in prescribing error rates from 27.5% to 5.1% on implementation of SCIs and smart-pumps, drug library compliance of 98.9% and with high levels of user satisfaction.11,12
Following the success of these early phases of expansion, achieved between 2014 and 2019, the use of smart-pumps and the SCI drug library was extended to the emergency departments and urgent care centres in the CHI hospitals, subsequently followed by their general wards.
This latter phase occurred during the Covid-19 pandemic, by which time a CHI-funded dedicated smart-pump team was in place, consisting of 1.5 whole time equivalent (WTE) nurses and a 0.5 WTE pharmacist. This team developed and co-ordinated a highly structured nurse training programme involving a two-stage training process.
This training model, used within CHI and external hospitals, utilises a train-the-trainer component and incorporates infusion pump training, followed by drug library training, including SCI preparation and competency self-assessment. Amended training sessions are offered to nursing students, pharmacy and medical staff.
Subsequent phases of the project included expansion to the care of children across Ireland’s paediatric network of 19 hospitals and within adult ICUs. This required revision of existing governance structures, ultimately leading to formal recognition and approval of the CHI drug library as a national standard of care by Ireland’s Health Service Executive; operational control remains with CHI.
The absence of a defined national governance structure to support such a concrete operational level intervention was one of the more difficult elements of the project and necessitated an innovative and iterative approach to governance.
Another key challenge was the lack of centralised funding or allocated budgeting. This challenge persists with responsibility for financing infusion pump hardware remaining with individual sites.
Differences between individual hospitals in aspects such as access to dedicated paediatric and/or neonatal nursing staff and location of care for infants and children within non-specialist paediatric hospitals are further challenges.
Furthermore, patients journey within and between sites depending on their needs, transitioning to and from centres of greater or lesser specialisation and scale according to the nature and stage of their illness and the proximity of these facilities to their homes. This can significantly impact and complicate the choice of drug library, pump management and delivery of training.
Despite these difficulties, this project continues to successfully improve patient safety and support clinicians in the delivery of highly complex, challenging and often urgent delivery of what can be life-saving medication infusions.
To date, implementation has occurred in all areas of CHI, all level-3 NICUs, paediatric and neonatal transport services, 58% of Ireland’s 19 neonatal units, and 23% of paediatric network sites.
The success of this project, recently published in the International Journal of Clinical Pharmacy,13 has been recognised not only in Ireland but also referenced internationally by other regions looking to achieve standardisation of paediatric infusions.14–16
A key benefit of progressing the standardisation of infusion processes at a national level is the opportunity it provides to move away from nurse-prepared infusions at the bedside to centralised preparation by hospital pharmacies or commercially prepared ready-to-administer infusions.1
Specialist hospital pharmacists, working effectively within multi-disciplinary teams, can effectively lead on the delivery of standardisation of infusions at a national level.
This multi-phase project has successfully developed a smart-pump drug library of standard concentration infusions suitable for paediatric and neonatal patients across the Irish acute hospital sector.
In a constrained public health service with limited pharmacy and other specialist resources, collaboration and innovative governance structures have enabled wide-scale implementation of internationally recognised best practices for the safe administration of IV medications in paediatrics.
Dr Moninne Howlett BSc (Pharm) PhD
Chief pharmacy information officer, Children’s Health Ireland, and honorary clinical associate professor, Royal College of Surgeons in Ireland
Dr Howlett would like to thank her fellow study authors:
Sharon Sutton MPharm MPSI
Senior pharmacist, Children’s Health Ireland
Eimear McGrath RGN RCN
Clinical nurse education facilitator, Children’s Health Ireland
Cormac V. Breatnach MRCPI, FJFICMI
Consultant paediatric intensivist, Children’s Health Ireland
1. Neonatal Paediatric Pharmacists Group. Standardising intravenous infusion concentrations in children in the UK 2023.
2. American Society of Health-System Pharmacists. Standardize 4 Safety Initiative – Pediatric Continuous Infusion Standards 2020.
3. Institute for Safe Medication Practices. ISMP Targeted Medication Safety Best Practices for Hospitals 2024.
4. McLeroy PA. The rule of six: calculating intravenous infusions in a pediatric crisis situation. Hosp Pharm 1994;29(10):939–40, 43.
5. Parshuram CS et al. Systematic evaluation of errors occurring during the preparation of intravenous medication. CMAJ 2008;178(1):42–8.
6. Parshuram CS et al. Discrepancies between ordered and delivered concentrations of opiate infusions in critical care. Crit Care Med 2003;31(10):2483–7.
7. Aguado-Lorenzo V et al. Accuracy of the concentration of morphine infusions prepared for patients in a neonatal intensive care unit. Arch Dis Child 2013;98(12):975–9.
8. Institute for Safe Medication Practices. 2018-2019 Targeted Medication Safety Best Practices for Hospitals 2018.
9. Campino A et al. Medicine preparation errors in ten Spanish neonatal intensive care units. Eur J Pediatr 2016;175(2):203–10.
10. Oskarsdottir T et al. A national scoping survey of standard infusions in paediatric and neonatal intensive care units in the United Kingdom. J Pharm Pharmacol 2018;70(10):1324–31.
11. Howlett MM et al. The Impact of Technology on Prescribing Errors in Pediatric Intensive Care: A Before and After Study. Appl Clin Inform 2020;11(2):323–35.
12. Howlett MM et al. Direct Observational Study of Interfaced Smart-Pumps in Pediatric Intensive Care. Appl Clin Inform 2020;11(4):659–70.
13. Howlett MM et al. Implementation of a national system for best practice delivery of paediatric infusions. Int J Clin Pharm 2024;46(1):4–13.
14. Crowley K. Standard Drug Concentrations in the Cardiac Intensive Care Unit. In: Critical Care of Children with Heart Disease (eds Munoz R et al) 2020;Springer:pp 725–8.
15. Sutherland A et al. Developing Strategic Recommendations for Implementing Smart Pumps in Advanced Healthcare Systems to Improve Intravenous Medication Safety. Drug Saf 2022;45(8):881–9.
16. Howlett M. Reducing medication errors for children. Health Manager [Internet]; Nov 2016.
4th March 2022
The different anaesthetic methods used in the closed reduction of paediatric foreman fractures currently lacks sufficient evidence to guide clinicians in their choice of treatment. The was the conclusion of a study by researchers from the Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Paediatric diaphyseal fractures of the radius and ulna (bone forearm fractures) are the third most common fracture in the paediatric population, accounting for between 13 and 40% of all childhood fractures. Anaesthesia is required to provide adequate pain relief and methods include procedural sedation and analgesia (PSA), haematoma block (HB) and intravenous regional anaesthesia (IVRA). In a 2018 systematic review of PSA and HB, the authors concluded that HB was a safe and effective alternative to PSA among adult and paediatric patients. Other anaesthetic methods include infraclavicular blocks which involve the use of anaesthetics such as lidocaine and prilocaine and residual neuromuscular block, although the comparative efficacy of these methods has not been assessed.
For the present study, the Singaporean team sought to synthesise the current evidence from randomised controlled trials to determine the most effective analgesia with respect to pain reduction within an emergency care setting for the closed reduction of paediatric forearm fractures.
All of the main databases including PubMed and EMBASE were searched and the researchers focused on randomised trials including patients under 18 years of age with a forearm fracture treated with closed reduction within emergency departments. Additional criteria applied were that these studies should involve at least one comparison of different methods. The team set the primary outcome as pain during reduction and several secondary outcomes including of pain after reduction, adverse effects, satisfaction, success of reduction.
Anaesthetic methods and pain during reduction
A total of 9 studies including 936 patients were included in the final analysis. All of the studies were single centre, randomised trials and compared different aspects including the main methods of anaesthesia, the drugs used, administration route and the use of adjuncts.
However, for the primary outcome of pain during reduction, all of the included trials were considered to be at risk of bias and consequently, given the high degree of heterogeneity, a meta-analysis of the finding was not undertaken.
In trying to pull together the disparate findings, the authors noted the infraclavicular block seemed to result in better pain outcomes, satisfaction scores and fewer cases of hypoxia compared with PSA in one of the studies. In addition, lidocaine led to better pain outcomes compared to prilocarpine when used in IVRA in another study. The researchers added that the quality of the evidence was generally low.
In their conclusion, the researchers suggested that infraclavicular block should be further investigated and that more adequately powered trials using standardised methods are required. However, there was a distinct lack of good quality evidence to inform the anaesthesia decision-making process. They suggested that more valuable evidence would likely arise after publication of the results of an on-going trial to evaluate the sedative and analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for reduction of closed distal forearm fractures compared to intravenous ketamine.
Citation
Goh AXC et al. Comparative efficacy of anaesthetic methods for closed reduction of paediatric forearm fractures: a systematic review Emerg J Med 2022
7th September 2021
The National Institute for Health and Care Excellence (NICE) has approved the use of the monoclonal antibody Cosentyx (secukinumab) as an option for the treatment of plaque psoriasis in children and young people aged six to 17 years of age. It is only recommended where the psoriasis area and severity index (PASI), which is a measure of disease severity, is greater than 10 (meaning moderate to severe disease) and where other systemic therapies have been unsuccessful. The systemic therapies mentioned in the guidance are ciclosporin, methotrexate, as well as phototherapy, although Cosentyx can also be used in cases where any of these treatments are contra-indicated. In addition, NICE has recommended use of Cosentyx only where the manufacturer provides the drug in line with an agreed commercial arrangement.
The outcome of interest when using Cosentyx is the achievement of a PASI75, i.e., a 75% improvement in disease severity, after 12 weeks of treatment. If such an improvement has not occurred, then NICE recommends stopping Cosentyx. A further point in the guideline is that where a clinician considers that secukinumab is the most appropriate therapy, the least expensive option should be used and it has been increasing recognised that there are huge potential and achievable savings for the NHS through the use of biosimilars,
In making its decision, NICE received information on the comparative clinical efficacy of other biologics used in psoriasis including etanercept, adalimumab and ustekinumab. The committee noted from studies that secukinumab was more effective than etanercept, based on a higher proportion of participants achieving a PASI75 and that the efficacy was comparable with ustekinumab. Although there were no direct comparisons of Cosentyx with adalimumab in the paediatric population, a network meta-analysis submitted by the manufacturer, showed that adalimumab was as effective as ustekinumab. Furthermore, there were no differences in safety outcomes for Cosentyx compared with other similar biologics.
Source. NICE 2021
24th August 2021
Over the course of the pandemic, the role of children in the transmission of COVID-19 has been investigated and there is a general sense that children do not play and important role. This perception was re-iterated in a review from May 2020 of over 47 articles which also concluded that children are unlikely to be the main drivers of the pandemic. Nevertheless, one important source of infection is through household transmission, with one analysis of 54 studies and over 77,000 participants, indicating a household transmission rate of 16.6%. But to what extent are young people responsible for household transmission? Some studies examining the transmission of COVID-19, have suggested that it was more likely from those aged 20 years or less. In contrast, a recent systematic review concluded that there is a reduced transmission potential both from and to, individuals younger than 20 years of age.
In trying to more closely examine the relationship between age and household transmission, a team from the Health Protection, Public Health Ontario, Canada, undertook an age analysis where the index case of COVID-19 was a paediatric household member between June and December 2020. They divided paediatric index cases into four age grouping; 0 – 3, 4 – 8, 9 – 13 and 14 – 17 years. Since other factors might have been responsible for the transmission, the team also sought information on school/child-care factors. The main outcome of interest was secondary household transmission of COVID-19 infection by a paediatric index case between one and fourteen days after the paediatric index case. In determining cases, the team compared symptom onset dates of cases within the household. Regression analysis was used to identify the odds of household transmission, adjusting for gender, month of disease onset and mean family size.
Findings
There was a total of 6,280 private households with a paediatric index case for which the mean age was 10.7 years (45.6% female). From this total, 27.3% experienced a secondary household transmission of COVID-19. In the fully adjusted model, the odds of transmission of COVID-19 for children aged 0 – 3 years was significantly higher than those aged 14 – 17 years (odds ratio, OR = 1.43 (95% CI 1.17 – 1.75). This association was found irrespective of factors such as the presence of symptoms, or with any school/child-care outbreaks. It was also found that children aged 4 – 8 years had a significantly higher odds for transmission (OR = 1.40) compared to those aged 14 to 17 years although this was absent among children aged 9 – 13 (OR = 1.13, 95% CI 0.97 – 1.32).
In their discussion, the authors noted that as the number of paediatric cases increases worldwide, children were likely to play an important role as vectors for the transmission of COVID-19. Moreover, their data indicated that it was the younger rather than older children who would be the source of infection.
Citation
Paul LA et al. Association of Age and Pediatric Household Transmission of SARS-CoV-2 Infection. JAMA Pediatr 2021
23rd July 2021
Elevated levels of low-density lipoprotein cholesterol (LDL-C) leads to the development of atherosclerosis and is a risk factor for cardiovascular disease. Some evidence suggests an association between childhood obesity and the subsequent risk of biochemical abnormalities in adults. Nevertheless, there is a lack of longitudinal data linking the presence of childhood cardiovascular risk factors with adult disease. Furthermore, little is known about the extent to which risk factors such as LDL-C levels vary during childhood and how this might contribute towards atherosclerosis and adverse cardiovascular outcomes in adult life. A better understanding the childhood trajectories of LDL-C cholesterol could lead to improved preventative strategies. In trying to shed more light on this topic, a team from the Division of General Medicine, Columbia University, Irving Medical Centre, New York, turned to data available in the International Childhood Cardiovascular Cohort (i3C) Consortium. While children virtually never experience adverse cardiovascular events, the i3C is the first longitudinal cohort study designed to locate adults with detailed and repeated childhood biological, and physical measurements and includes over 10,000 individuals from several countries. The Irving Medical Centre team used data from i3C individuals who had at least one LDL-C measurement between the ages of 3 and 17 years of age and extracted demographic and body mass index information from these participants. The team considered LDL-C levels greater than 160mg/dl (4.14mmol/l) as consistent with probable familial hypercholesterolaemia (FH) and used the more stringent criteria of an LDL-C of greater than 160mg/dl on at least two occasions and a level of LDL-C of 190mg/dl or greater as a threshold for FH. In order to examine LDL-C trajectories during childhood, the team fitted a linear model of LDL-C against age, adjusting for sex, ethnicity and body mass index.
Findings
A total of 15,045 children with a mean age of 9.9 years (48.7% male) were included in the analysis. Overall, 2.8% of children had an LDL-C greater than 160mg/dl and 0.6% had values exceeding 190mg/dL. Using the more stringent criteria, 1% of children had elevated LDL-C levels (> 160mg/dL) on two occasions and 0.3%, levels above 190mg/dl, consistent with FH. Using the linear model it could be seen that mean LDL-C cholesterol levels increased from age 3 to 10 years, decreased from age 10 to 15 but then increased again to reach adult levels. LDL-C levels were consistently and significantly higher in female children and those of Black ethnicity or with a higher body mass index.
In a discussion of their findings, the authors noted how LDL-C levels peaked between ages 9 and 11 and that these levels were comparable to those aged 18 years. This, the authors suggested, highlighted the importance of childhood lipid screening from as early as 9 years of age.
Citation
Zhang Y et al. Low-Density Lipoprotein Cholesterol Trajectories and Prevalence of High Low-Density Lipoprotein Cholesterol Consistent with Heterozygous Familial Hypercholesterolemia in US Children. JAMA Pediatr 2021
24th June 2021
The European Medicines Agency, has extended the licensed indication for teriflunomide to include its use in children from 10 years of age. The drug is used for the treatment of relapsing-remitting multiple sclerosis, a chronic, inflammatory, autoimmune disease that affects an estimated 2.8 million people worldwide. However, MS is not purely an adult disease and it is estimated that over 30,000 cases occur in those 18 years or less. This paediatric MS is normally defined as an MS with an onset before the age of 16 years (sometimes before the age of 18 years). There are also noticeable differences between paediatric MS adult disease. For instance, more than 98% of those with paediatric MS experience a relapsing-remitting pattern (compared to 84% in adults) and children have a three-fold greater (than adults) rate of disease relapse. Moreover, paediatric MS has a negative impact on a child’s psychological wellbeing, affecting their self-image, role functioning, mood, cognition as well as an adverse effect on schooling.
The mode of action of teriflunomide in MS is thought to be related to its effects on the proliferation of stimulated lymphocytes. The drug selectively and competitively blocks the enzyme, dihydro-orotate dehydrogenase, which plays a key role in the de novo synthesis of pyrimidines and which are required in proliferating lymphocytes. An oral formulation of the drug was approved by the EU in 2013 for the use in adults based on the results of four studies involving over 2700 adults with relapsing-remitting MS.
The extension of the license for paediatric use was granted by the European Medicines Agency (EMA) based on the results of the TERIKIDS study, which is a 96-week, randomised, double-blind, placebo-controlled, parallel-group Phase III study of teriflunomide in paediatric RMS patients. Participants receive either placebo or teriflunomide (based on body weight equivalent to 14mg in adults) and the eligibility criterion is that patients had greater than one or two relapses within the last 12 or 24 months. The study enrolled patients, aged 10–17 years, with a mean age of 14.6 years (67% female) with 109 in the teriflunomide and 57 in the placebo arms. The primary endpoint was the time to first confirmed relapse and one of the secondary outcomes was MRI lesion number.
A summary of the results were presented at the 2020 EAN Virtual Congress which revealed how teriflunomide reduced the risk of clinical relapse by 34% relative to placebo (75.3 vs 39.1 weeks), however, this reduction was not statistically significant (hazard ratio, HR = 0.66, 95% CI 0.66–1.10, p =0.29). The MRI analysis revealed that teriflunomide significantly reduced the number of T1 gadolinium (Gd)-enhancing lesions per MRI scan (relative reduction 75%; p<0.0001) as well as the number of new and enlarging T2 lesions per MRI scan (relative reduction 55%, p=0.0006). Furthermore, overall incidences of adverse events and serious adverse events were similar in the teriflunomide and placebo groups (88.1% vs 82.5%, and 11.0% vs 10.5%) respectively and there were no deaths. Overall, teriflunomide appeared to be well tolerated.
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