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Background: Lack of child-friendly dosage forms and strengths often leads to manipulation of medicines at hospital units or by caregivers in the home setting. One alternative to manipulating dosage forms is the use of extemporaneous preparations. In Sweden, these are produced according to good manufacturing practice by a few extemporaneous pharmacies. Objectives: To compare frequencies of patients administered extemporaneous preparations in two separate years, 10 years apart. Methods: This registry-based study describes and compares the frequency of extemporaneous oral preparations administered to paediatric patients in 2009 and 2019 at a Swedish university hospital. The study included 117 023 oral administrations (to 4905 patients) and 128 638 oral administrations (to 4718 patients) from 2009 and 2019, respectively. Results: The frequency of inpatients administered one or more extemporaneous preparations increased from 22% in 2009 to 40% in 2019 (p<0.0001). The increase was observed in all age groups. The use of some active pharmaceutical ingredients increased (eg, captopril, clonidine, hydrocortisone, melatonin and propranolol), and some active pharmaceutical ingredients decreased between the study years (eg, midazolam and sildenafil). Conclusions: The introduction of new authorised products has decreased the need for manipulation or extemporaneous preparations in some therapeutic groups. There remains, however, a pronounced lack of commercially available child-friendly dosage forms and suitable strengths enabling safe administration of medicines to children, indicated by the large percentage of patients receiving at least one extemporaneous preparation. © European Association of Hospital Pharmacists 2023. Re-use permitted under CC BY. Published by BMJ.

AIM: To explore the incidence and characteristics of inpatient neonatal adverse events in a Swedish setting.

METHODS: A retrospective record review, using a trigger tool, performed by registered nurses and a neonatologist, at a University Hospital. The identified adverse events were categorised by, for example, preventability, severity and time of occurrence.

RESULTS: A random selection of 150 admissions representing 3531 patient days were reviewed (mean [SD] birthweight 2620 [1120]g). Three hundred sixty adverse events were identified in 78(52.0%) infants and 305(84.7%) of these were assessed as being preventable. The overall adverse event rate was 240 per 100 admissions and 102.0 per 1000 patient days. Preterm infants had a higher rate than term infants (353 versus 79 per 100 admissions, p=0.001), however with regard to the length of stay, the rates were similar. Most adverse events were temporary and less severe (n=338/360, 93.9%) and the most common type involved harm to skin, tissue or blood vessels (n=163/360, 45.3%). Forty percent (n=145) of adverse events occurred within the first week of admission.

CONCLUSION: Adverse events were common in neonatal care and many occurred during the first days of treatment. Characterisation of adverse events may provide focus areas for improvements in patient safety.

BACKGROUND: Adverse events (AEs) cause suffering for hospitalised children, a fragile patient group where the delivery of adequate timely care is of great importance.

OBJECTIVE: To report the incidence and characteristics of AEs, in paediatric inpatient care, as detected with the Global Trigger Tool (GTT), the Trigger Tool (TT) or the Harvard Medical Practice Study (HMPS) method.

METHOD: MEDLINE, Embase, Web of Science and Google Scholar were searched from inception to June 2021, without language restrictions. Studies using manual record review were included if paediatric data were reported separately. We excluded studies reporting: AEs for a specific disease/diagnosis/treatment/procedure, or deceased patients; study protocols with no AE outcomes; conference abstracts, editorials and systematic reviews; clinical incident reports as the primary data source; and studies focusing on specific AEs only. Methodological risk of bias was assessed using a tool based on the Quality Assessment Tool for Diagnostic Accuracy Studies 2. Primary outcome was the percentage of admissions with ≥1 AEs. All statistical analyses were stratified by record review methodology (GTT/TT or HMPS) and by type of population. Meta-analyses, applying random-effects models, were carried out. The variability of the pooled estimates was characterised by 95% prediction intervals (PIs).

RESULTS: We included 32 studies from 44 publications, conducted in 15 countries totalling 33 873 paediatric admissions. The total number of AEs identified was 8577. The most common types of AEs were nosocomial infections (range, 6.8%-59.6%) for the general care population and pulmonary-related (10.5%-36.7%) for intensive care. The reported incidence rates were highly heterogeneous. The PIs for the primary outcome were 3.8%-53.8% and 6.9%-91.6% for GTT/TT studies (general and intensive care population). The equivalent PI was 0.3%-33.7% for HMPS studies (general care). The PIs for preventable AEs were 7.4%-96.2% and 4.5%-98.9% for GTT/TT studies (general and intensive care population) and 10.4%-91.8% for HMPS studies (general care). The quality assessment indicated several methodological concerns regarding the included studies.

CONCLUSION: The reported incidence of AEs is highly variable in paediatric inpatient care research, and it is not possible to estimate a reliable single rate. Poor reporting standards and methodological differences hinder the comparison of study results.

This is a registry-based study with the aim of describing and comparing the frequency of manipulations of solid oral and rectal medicines in 2009 and 2019 at inpatient units and an emergency department in a paediatric hospital within a Swedish university hospital. All patients aged 1 month-18 years with oral or rectal administrations were included. In total, 140,791 oral and rectal administrations were included in 2009, and 167,945 oral and rectal administrations were included in 2019. The frequency of patients receiving at least one manipulated oral medicine decreased between the study years, both in inpatient units and in the emergency department (from 19% to 17%, p = 0.0029 and from 11% to 5%, p &lt; 0.0001, respectively). The frequency of patients receiving a manipulated rectal medicine also decreased between the study years, both in inpatient units and in the emergency department (from 22% to 10%, p &lt; 0.0001 and from 35% to 7% 2019, p &lt; 0.0001, respectively). The results show a decrease in the manipulation of both oral and rectal medicines to paediatric patients in 2019 compared to 2009. Even though this implies a safer practice, there is still a pronounced lack of child-friendly dosage forms and suitable strengths enabling the safe administration of medicines to sick children. 

AIM: Studies on frequencies of manipulated medicines in paediatric care are common, but there is little knowledge of experiences of pharmacists and registered nurses in this area. The aim of this study was to explore registered nurses' and pharmacists' reasoning in the manipulation of medicines to paediatric inpatients.

METHODS: Semistructured interviews with twelve registered nurses and seven pharmacists were performed at a Swedish paediatric university hospital. The interviews were transcribed verbatim and analysed using content analysis.

RESULTS: Four major categories emerged from the analysis of the interviews: medicines management, knowledge, consulting others and organisation. Medicines management involved the process of drug handling, which is prescribing, reconstitution or manipulation and administration. Knowledge concerned both the knowledge base and how healthcare personnel seek information. Consulting others involved colleagues, registered nurses and pharmacists, between registered nurses, pharmacists and physicians and between registered nurses, pharmacists and caregivers. Organisation covered documentation, time and working environment.

CONCLUSION: Both pharmacists and registered nurses stated that manipulation of medicines to paediatric patients was often necessary but felt unsafe due to lack of supporting guidelines. Pharmacists were natural members of the ward team, contributing with specific knowledge about medicines and formulations.

BACKGROUND: Many instruments for measurement of peripheral venous catheter (PVC)-related phlebitis are available, but no consensus exists on their applicability in clinical practice. This absence of consensus affects the ability to identify and compare proportions of PVCs causing phlebitis within and across hospitals as the range varies between 2% and 62% in previous studies. We hypothesised that the instruments' ability to identify phlebitis varies. The aim of this study is to illustrate the complexity of application of phlebitis instruments to a clinical dataset.

METHODS: In this cross-sectional study, we applied 17 instruments for phlebitis identification (divided into three groups [instruments using definitions, severity rating systems, and scoring systems]) to PVCs in adult patients admitted to 12 inpatient units at Karolinska University Hospital in Sweden. We calculated the proportion of PVCs causing phlebitis on the basis of each instrument's minimum criterion for phlebitis. We also analysed each instrument's face validity. We compared proportions using the Z test.

FINDINGS: On the basis of data collected between Feb 2, 2009, and Feb 20, 2009, May 18, 2009, and June 5, 2009, and Feb 8, 2010, and Feb 26, 2010, we applied 17 instruments for phlebitis identification (eight instruments using definitions, seven severity rating systems, and two scoring systems) to 1175 observed PVCs in 1032 patients. The highest number of PVCs causing phlebitis generated by definitions was 137 (11·7%), by severity rating systems was 395 (33·6%), and by scoring systems was 363 (30·9%). The proportion generated by instruments using definitions was significantly different to that of both the severity rating (difference 21·9% [95% CI 18·6-25·2]; p<0·0001) and scoring (19·2% [12·0-26·4]; p<0·0001) systems. Proportions did not differ significantly between severity rating systems and scoring system (difference 2·7% [95% CI -1·1 to 6·6]; p=0·16). The proportion within instruments ranged from less than 1% to 28%. We identified face validity issues, such as use of indistinct or complex measurements and inconsistent measurements or definitions.

INTERPRETATION: Our study highlights several concerns regarding instruments to measure phlebitis published in the scientific community. From a work environment and patient safety perspective, clinical staff engaged in PVC management should be aware of the absence of adequately validated instruments for phlebitis assessment. We suggest that researchers within the field of PVC come together in a joint research programme aiming to develop valid and reliable methods that accurately identify PVC-related adverse events that also includes decision support for clinical staff concerning clinical indications for PVC removal. Such actions could lead to a revised view on what is best practice for management of PVCs.

FUNDING: None.

BACKGROUND: Reminder systems in electronic patient records (EPR) have proven to affect both health care professionals' behaviour and patient outcomes. The aim of this cluster randomised trial was to investigate the effects of implementing a clinical practice guideline (CPG) for peripheral venous catheters (PVCs) in paediatric care in the format of reminders integrated in the EPRs, on PVC-related complications, and on registered nurses' (RNs') self-reported adherence to the guideline. An additional aim was to study the relationship between contextual factors and the outcomes of the intervention.

METHODS: The study involved 12 inpatient units at a paediatric university hospital. The reminders included choice of PVC, hygiene, maintenance, and daily inspection of PVC site. Primary outcome was documented signs and symptoms of PVC-related complications at removal, retrieved from the EPR. Secondary outcome was RNs' adherence to a PVC guideline, collected through a questionnaire that also included RNs' perceived work context, as measured by the Alberta Context Tool. Units were allocated into two strata, based on occurrence of PVCs. A blinded simple draw of lots from each stratum randomised six units to the control and intervention groups, respectively. Units were not blinded. The intervention group included 626 PVCs at baseline and 618 post-intervention and the control group 724 PVCs at baseline and 674 post-intervention. RNs included at baseline were 212 (65.4 %) and 208 (71.5 %) post-intervention.

RESULTS: No significant effect was found for the computer reminders on PVC-related complications nor on RNs' adherence to the guideline recommendations. The complication rate at baseline and post-intervention was 40.6 % (95 % confidence interval (CI) 36.7-44.5) and 41.9 % (95 % CI 38.0-45.8), for the intervention group and 40.3 % (95 % CI 36.8-44.0) and 46.9 % (95 % CI 43.1-50.7) for the control. In general, RNs' self-rated work context varied from moderately low to moderately high, indicating that conditions for a successful implementation to occur were less optimal.

CONCLUSIONS: The reminders might have benefitted from being accompanied by a tailored intervention that targeted specific barriers, such as the low frequency of recorded reasons for removal, the low adherence to daily inspection of PVC sites, and the lack of regular feedback to the RNs.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN44819426.

Background: Clinical practical guidelines (CPGs) may enhance evidence-based practice, but require implementation. Computer reminders have previously shown various effects in supporting implementation; in a concomitant study, we found no effect on complications in peripheral venous catheters (PVCs) or registered nurses' (RNs) adherence to a CPG in pediatric care. Yet, there is a need to determine how reminders operate in particular contexts.

Aim: To depict if, in what context, and how computer reminders regarding evidence-based management of PVC in pediatric care are applied according to RNs' actions and experience.

Methods: Qualitative data from nonparticipant observations and interviews with 18 RNs in four intervention units at a pediatric hospital were analyzed with content analysis.

Findings: Attention given to the computer reminders varied; the RNs noticed them in units where there was an agreement about the management and recording of PVCs, but not elsewhere. Rather, computer reminders did not facilitate adherence to the PVC-CPG where the CPG was not acknowledged from the start. RNs who knew how to manage PVCs had peer support and received additional reminders, which suggested that the computer reminders added to the significance of PVCs in pediatric care.

Linking evidence to action: While the computer reminders alone did not support CPG implementation, they further increased the attention to PVCs in contexts where there was a readiness to change along with a supportive culture. We suggest further studies tailoring implementation strategies to include electronic means if there is a beneficial context.

Aim: The aims of this study were to describe the characteristics of peripheral venous catheters (PVCs), including dwell time and reasons for removal, and explore predictors for PVC-related complications. 

Methods: We included PVCs in 2032 children - 484 neonatal and 1548 paediatric - from 12 inpatient units. Data were retrieved from the patient record system, and predictors for complications were explored using logistic regression analyses. 

Results: Just over one-third (35.4%) of the PVCs were removed due to complications, in particular infiltration and occlusion (51.9 and 48.4/1000 PVC days, respectively). PVC survival time was shorter in neonatal than paediatric patients (4 versus 5days), and infiltration was more frequent in neonatal patients (92.8 versus 38.7/1000 PVC days). Infiltration was associated with younger age (odds ratio 0.97) for neonatal patients and with younger age (OR 0.96), insertion in the bend of the arm (OR 1.48) or ankle (OR2.81) for paediatric patients. Occlusion was, both for neonatal and paediatric patients, associated with longer dwell time (OR 1.32 and 1.22 respectively), insertion in the ankle (OR 5.00 and 3.51) or foot (OR 3.47 and 1.99). 

Conclusion: PVC-related complications, particularly infiltration and occlusion, were more common in hospitalised children but decreased with the child's age.