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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. [ABSTRACT FROM AUTHOR]

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 and 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. [ABSTRACT FROM AUTHOR]

Background: Long term treatment of pediatric patients with oral anticancer drugs (OADs) requires the parents/caregivers to prepare the drug at home. The handling procedures in the home setting are, however, not regulated by Swedish law and the parents are often left without guidance on how to handle OADs in a safe way. Aim: The aim of this study was to increase understanding of how OADs are handled by parents/caregivers in the home setting before and after an intervention. Methods: Parents of pediatric cancer patients were observed and videotaped during their handling of OADs in the home setting before and after the intervention. During the intervention, the parents were provided with written instructions, movie clips and practical training on handling the OADs. Four checklists were used to compare and score the four handling procedures (measuring an oral suspension, cutting tablets, dissolving tablets, and opening capsules) for each parent before and after the intervention. Results: The intervention significantly improved the OAD handling procedures among the studied parents. The median score for correct handling was 19% (IQR: 3.6 to 30%) before the intervention and 89.5% (IQR: 71.5 to 94.5%) after the intervention (p < 0.0001). Conclusions: An intervention comprising practical training and information presented in different forms improved the handling of OADs at home by parents. There is an urgent need to implement this method in all oncology centers in Sweden, educate HCPs to standardize the presentation of information. There is also a great need to provide parents with age-appropriate oral drug formulations from the local hospital pharmacies in Sweden. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to describe the experiences of parents handling oral anticancer drugs in a home setting. Methods: Parents of children with cancer were recruited from a paediatric oncology ward in Sweden to participate in an interview. The interviews were transcribed verbatim and subjected to qualitative content analysis. Results: We found the following categories and subcategories: parents' views on the provided information—lack of, too little or contradictory information, and parents' preferences for information delivery; safety over time; correct drug dose; and drug administration. As time passed, most parents adapted to their child's illness, felt safer and found it easier to take in and process any given information. Parents preferred information in different formats (written, movie clips and orally) and in their mother tongue. Many parents were aware of the importance of giving an accurate dose to their child and described the process of drug administration as overwhelming. Conclusion: Parents need to be provided with accurate, timely, nonconflicting and repeated information—in different forms and in their mother tongue—on how to handle oral anticancer drugs at home. [ABSTRACT FROM AUTHOR]

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 < 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 < 0.0001 and from 35% to 7% 2019, p < 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. [ABSTRACT FROM AUTHOR]

Aim: The aims were to characterise paediatric medication errors and to identify the prevalence of known high‐alert substances in these errors. Methods: All paediatric drug‐related incident reports and complaints nationally reported to the Health and Social Care Inspectorate in Sweden 2011‐2017 regarding inpatients were characterised by context and modal details. In addition, drug use at a university hospital was matched to local incident reports. Drug substances were classified using three high‐alert lists. Results: On a national level, there were 160 reports (2.5 per 10 000 patients) in which the three high‐alert lists were found in different degrees (17/35/47%). Morphine (n = 12), vancomycin (n = 11) and potassium (n = 7) were most frequently involved. Eighty per cent of the reports concerned patients aged 0‐6 years. Intravenous was the most common route of administration (66%). On a university hospital level, the prevalence of all types of drug incidents reports was 1.7% among all inpatients. The prevalence of local incident reports involving high‐alert substances was almost double that of non‐alert substances. Conclusion: Existing high‐alert drug lists are relevant for paediatric inpatients. A higher awareness and usage of such lists among hospital staff prescribing, dispensing and administering drugs to children may have the potential to reduce medication errors. [ABSTRACT FROM AUTHOR]

This study aims to evaluate pediatrician's acceptance, perception and use of Electronic Prescribing Decision Support Systems (EPDSS) at a tertiary care using Extended Technology Acceptance Model (TAM2). Qualitative research methodology was applied. Semi-structured questions were developed according to TAM2 model. Pediatricians perceived that the EPDSS is useful and they showed a favorable attitude. However, perceived ease of use and output quality appeared to affect use of EPDSS. Concerns were expressed about complicated screens, difficulty to read and view medication overview of the patient, the navigation requires many clicks and medication system don't meet their need. End users have difficulty of ordering drugs for ploy-clinical patients and they were unable to cancel or stop medications. Junior pediatricians were influenced by senior colleague since they can get better advice about medication order than the system. Applying TAM2 framework has revealed that pediatrician's attitude and acceptance of electronic prescribing system. This study has identified factors that are important for end user acceptance as well as suggestions for system improvement. Although pediatricians are positive to the usefulness of EPDSS, it appears there are some acceptance problems due to ease of use concern and usability issues of the system. [ABSTRACT FROM AUTHOR]

Introduction: To investigate the dosing accuracy using split tablets in paediatric patients. Methods: Five brands of tablets (Alvedon®(paracetamol), Catapresan®(clonidine), Hydrocortone®(hydrocortisone), Prednisolon® (prednisolon) and Tavegyl®(clemastine) were split into halves and quarters by hand or by using a tablet splitter. The resulting halves and quarters were weighed. Results: Three out of the five tablet brands passed the test in the Ph. Eur. (European Pharmacopoeia) for subdivision of tablets when split once and when split twice to yield quarters only one of the tablets passed the test. When also applying the limit for relative standard deviation (RSD) from the US Pharmacopoeia only one of the tablet halves passed and the other two was just outside the limit. None of the tablet quarters passed the RSD limit. Conclusion: Our results indicate that tablets larger than 8 mm might be split once. Tablets should not be split more than once, due to uncertainty in dose accuracy. There is a need for more commercially available age-appropriate formulations. Extemporaneously prepared formulations should be considered as an alternative to the use of split tablets. [ABSTRACT FROM AUTHOR]

Background Little is known about adverse events (AEs) in pediatric patients. Record review is a common methodology for identifying AEs, but in pediatrics the record review tools generally have limited focus. The aim of the present study was to develop a broadly applicable record review tool to identify AEs in pediatric inpatients. Methods Using a broad literature review and expert opinion with a modified Delphi process, a pediatric trigger tool with 88 triggers, definitions, and descriptions including AE preventability decision support was developed and tested in a random sample of 600 hospitalized pediatric patients admitted in 2010 to a single university children's hospital. Four registered nurse-physician teams performed complete two-stage retrospective reviews of 150 records each from either neonatal, surgical/orthopedic, medicine, or emergency medicine units. Results Registered nurse review identified 296 of 600 records with triggers indicating potential AEs. Records (n = 121) with only false positive triggers not indicating any potential AEs were not forwarded to the next review stage. On subsequent physician review, 204 (34.0%) of patients were found to have had 563 AEs, range 1-27 AEs/patient. A total of 442 preventable AEs were found in 161 patients (26.8%), range 1-22. Overall, triggers were found 3,598 times in 417 (69.5%) records, with a mean of 6 (median 1, range 0-176) triggers per patient. The overall positive predictive value of the triggers was 22.9%, (range 0.0-100.0%). The final pediatric trigger tool, developed with a second Delphi round, required 29 triggers. Conclusions AEs are common in pediatric patients and most are preventable. The main contributions of this study are to further develop and adapt trigger definitions, including AE preventability decision support, to introduce new triggers in pediatric care, as well as to apply pediatric triggers in different clinical specialties. Our findings resulted in a national pediatric trigger tool, and might also be adapted internationally. The pediatric trigger tool can help healthcare organizations to measure and analyze the AEs occurring in hospitalized children in order to improve patient safety. [ABSTRACT FROM AUTHOR]

The nucleoside analog 2-chlorodeoxyadenosine (Cladribine, CdA) is used in the treatment of patients with several hematological malignancies. After administration of CdA, the major catabolite measured in plasma and urine is 2-chloroadenine (CAde). This study was performed to determine the pharmacokinetics after oral and intravenous (iv) infusion of CdA in patients treated for chronic lymphocytic leukemia and to evaluate the toxicity of CAde to leukemia cells in vitro. CdA and CAde were also determined in plasma from 31 patients and in urine from 16 patients with reversed-phase high-performance liquid chromatographic. The toxicity of CdA and CAde was also determined in leukemic cells from 7 patients by fluorometric microculture cyotoxicity assay. Five times more CAde was quantified after oral treatment compared with an iv infusion of CdA. After iv infusion, the half-life was the same for CdA and CAde, but after oral administration the half-life was doubled for CAde. Excreted amount of CAde in urine constituted about 1.1% after iv infusion and 4.7% after oral CdA treatment. In vitro exposure of leukemia cells to CAde showed that it was eight times less toxic as compared to CdA. We conclude that CAde has a lower cytotoxic effect than CdA but may contribute significantly to the cytotoxicity after oral administration. [Copyright &y& Elsevier]

Background Aim Method Results Conclusions The shift of treatment of paediatric cancer patients to include more care at home puts a lot of pressure on health care professionals (HCPs) to prepare and train parents on safe and correct drug handling at home. Parents must take in and understand the information presented to them while coping with their own fear related to their child's cancer diagnosis. In Sweden, parents are expected to handle and manipulate oral anticancer drugs (OADs) in the home setting. There is however a lack of a standardized method to inform and educate parents on how to handle OADs in a correct way at home.To describe parents' experiences of handling OADs at home after participating in an educational intervention.Educational intervention in the present study aimed to improve parents' knowledge in key concepts that is, handling OADs at home by using information presented in different forms. Fifteen parents to 12 children with cancer were recruited from a paediatric oncology ward in Sweden to participate in an interview. The interviews were transcribed verbatim and subjected to qualitative content analysis.Parents' experiences are presented in categories: Relieved stress, Awareness of own exposure, Facilitated my everyday life, Parents need continued support individually. The educational intervention resulted in both positive and negative feelings, increased awareness of drug exposure and correct drug handling at home. Practical training and information presented in different ways facilitated the process of drug handling. To handle the drug correctly at home parents requested to be trained and informed in the beginning of their child's oral drug treatment. In addition, parents requested to be individually approached by HCP to get answers to questions and concerns.This educational intervention study shows promising results for the method used by HCPs to inform and educate parents on complicated topics such as handling OADs at home. [ABSTRACT FROM AUTHOR]

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., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2023. Re-use permitted under CC BY. Published by BMJ.)

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 < 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 < 0.0001 and from 35% to 7% 2019, p < 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.

Background: The aim of this study was to use Body Surface Area (BSA) data calculated with the Mosteller equation to test potential new equations that estimate BSA using Body Weight (BW) alone in children aged 0-18 years.Mosteller's equation, the golden standard at our hospital, was used to calculate the BSA in infants and children aged 0-18 years using BW and height data from 27,440 hospital visits by 20,635 patients over one year., Methods: The best fit of three nonlinear regression equations (third-order polynomial, Meeh-type, and modified Boyd self-adjusting-type) to a plot of the calculated Mosteller BSA values versus BW was then investigated. The correlation between the BSA values estimated by these equations and the Mosteller BSA values was established by the Spearman rank correlation test. Bias and precision were evaluated as outlined by Sheiner and Beal. Measured and estimated BSA values were compared using the Eksborg plot., Results: The estimated BSA values from all three equations and the BSA values from the Mosteller equation were closely correlated ( P  < .0001). The third-order polynomial and Meeh-type equations overestimated BSA by 0.13% and 0.40%, respectively, while the Boyd self-adjusted-type equation underestimated BSA by 0.060%. For the entire pediatric population, the best fit was obtained with the Meeh-type equation: 99.2% of the Meeh/Mosteller BSA ratios were within the range of 0.9-1.1 when compared with 98.3% and 97.2% for the polynomial and Boyd-type equations, respectively., Conclusion: A single Meeh-type equation can be used to predict the results of Mosteller equation when H is not available with high precision and accuracy in children aged 0-18 years, including term neonates. We now plan to include the results of this study in CPOE systems in Sweden to improve drug dosage in all children., Competing Interests: None., (© 2020 Publishing services provided by Elsevier B.V. on behalf of King Faisal Specialist Hospital & Research Centre (General Organization), Saudi Arabia.)

Objectives: Subsequent dosing errors after implementing an Electronic Medical Record (EMR) at a pediatric hospital in Sweden led to the development, in close collaboration with the clinical profession, of a Clinical Decision Support System (CDSS) with Dose Range Check and Weight Based Dose Calculation integrated directly in the EMR. The aim of this study was to explore the understanding and experiences of the CDSS among Swedish pediatricians after one year of practice., Methods: Semi-structured interviews with physicians at different levels of the health care system were performed with seventeen pediatricians working at three different pediatrics wards in Stockholm County Council. The interviews were analysed with a thematic analysis without pre-determined categories., Results: Six categories and fourteen subcategories emerged from the analysis. The categories included the use, the benefit, the confidence, the situations of disregards, the misgivings/risks and finally the development potential of the implemented CDSS with Weight Based Dose Calculation and Dose Range Check., Conclusions: A need for CDSS in the prescribing for children is evident to support the prevention of medication errors. After implementing a CDSS, organized efforts are crucial to understand the need for further development based on the practical knowledge of the clinical profession. Different contextual settings of health care organisations do affect the way how physicians think and act in work. When implementing a CDSS in practice we need to describe and analyse the context where the CDSS should be used as well as the prescribers' needs in work., Competing Interests: Conflict of interest: No Competing Interests.

Background and Objectives: Clofarabine (CAFdA), one of the newer nucleoside drugs is undergoing a phase II clinical trial for the treatment of pediatric refractory/relapsed acute myeloid and lymphocytic leukemia. Although CAFdA is structurally similar to the clinically established analogs fludarabine and cladribine (CdA), its metabolism and mechanism of actions are significantly different. The present study investigates the in vitro cytotoxicity of CAFdA and CdA in mononuclear cells isolated from 52 patients with chronic lymphocytic (CLL) and acute myeloid leukemia (AML)., Design and Methods: We incubated the leukemic cells with drugs for 48 hours and cytotoxicity was then evaluated by the MTT dye assay. We also determined the levels of deoxycytidine and deoxyguanosine kinase with radio-chemical substrate-based assays and used a high performance liquid chromatographic method to measure cellular nucleotides in leukemia cells after 2 hours' incubation., Results: Using equimolar concentrations of CAFdA and CdA, the in vitro cytotoxicity for the population was significantly higher with CAFdA than with CdA (median EC50 for CAFdA 0.12 microM and for CdA 0.15 microM, p<0.001). From the individual estimates the difference in cytotoxicity between CAFdA and CdA was more pronounced in cells from CLL patients (median EC50 for CAFdA 0.08 microM and for CdA 0.16 microM p<0.001) than in those from AML patients. We also found that CAFdA was phosphorylated more efficiently than CdA. No correlations were detected in this study between the levels of CdA and CAFdA nucleotides, enzymes levels and the in vitro responses., Interpretation and Conclusions: The greater in vitro cytotoxicity and cell metabolism of CAFdA compared to CdA confirm the high activity of CAFdA and encourage clinical trials with CAFdA in leukemic patients.