| 1. |
- Andersson, Åsa C., et al.
(författare)
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Manipulated Oral and Rectal Drugs in a Paediatric Swedish University Hospital, a Registry-Based Study Comparing Two Study-Years, Ten Years Apart
- 2023
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Ingår i: Pharmaceuticals. - : MDPI. - 1424-8247. ; 16:1
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 2. |
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| 3. |
- Challis, Pontus, et al.
(författare)
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Association of Adherence to Surfactant Best Practice Uses with Clinical Outcomes among Neonates in Sweden
- 2021
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Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 4:5
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Tidskriftsartikel (refereegranskat)abstract
- Importance: While surfactant therapy for respiratory distress syndrome (RDS) in preterm infants has been evaluated in clinical trials, less is known about how surfactant is used outside such a framework.Objective: To evaluate registered use, off-label use, and omissions of surfactant treatment by gestational age (GA) and associations with outcomes, mainly among very preterm infants (GA <32 weeks).Design, Setting, and Participants: This population-based cohort study used registry data for 97377 infants born in Sweden between 2009 and 2018. Infants did not have malformations and were admitted for neonatal care. Data analysis was conducted from June 2019 to June 2020.Exposures: Timing and number of surfactant administrations, off-label use, and omission of use. Registered use was defined by drug label (1-3 administrations for RDS). Omissions were defined as surfactant not administered despite mechanical ventilation for RDS.Main Outcome and Measures: In-hospital survival, pneumothorax, intraventricular hemorrhage grade 3 to 4, duration of mechanical ventilation, use of postnatal systemic corticosteroids for lung disease, treatment with supplemental oxygen at 28 days' postnatal age and at 36 weeks' postmenstrual age. Odds ratios (ORs) were calculated and adjusted for any prenatal corticosteroid treatment, cesarean delivery, GA, infant sex, Apgar score at 10 minutes, and birth weight z score of less than -2.Results: In total, 7980 surfactant administrations were given to 5209 infants (2233 [42.9%] girls; 2976 [57.1%] boys): 629 (12.1%) born at full term, 691 (13.3%) at 32 to 36 weeks' GA, 1544 (29.6%) at 28 to 31 weeks' GA, and 2345 (45.0%) at less than 28 weeks' GA. Overall, 977 infants (18.8%) received off-label use. In 1364 of 3508 infants (38.9%) with GA of 22 to 31 weeks, the first administration of surfactant was given more than 2 hours after birth, and this was associated with higher odds of pneumothorax (adjusted OR [aOR], 2.59; 95% CI, 1.76-3.83), intraventricular hemorrhage grades 3 to 4 (aOR, 1.71; 95% CI, 1.23-2.39), receipt of postnatal corticosteroids (aOR, 1.57; 95% CI, 1.22-2.03), and longer duration of assisted ventilation (aOR, 1.34; 95% CI, 1.04-1.72) but also higher survival (aOR, 1.45; 95% CI, 1.10-1.91) than among infants treated within 2 hours of birth. In 146 infants (2.8%), the recommended maximum of 3 surfactant administrations was exceeded but without associated improvements in outcome. Omission of surfactant treatment occurred in 203 of 3551 infants (5.7%) who were receiving mechanical ventilation and was associated with lower survival (aOR, 0.49; 95% CI, 0.30-0.82). In full-term infants, 336 (53.4%) of those receiving surfactant had a diagnosis of meconium aspiration syndrome. Surfactant for meconium aspiration was not associated with improved neonatal outcomes.Conclusions and Relevance: In this study, adherence to best practices and labels for surfactant use in newborn infants varied, with important clinical implications for neonatal outcomes.
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| 4. |
- Dillner, Pernilla, et al.
(författare)
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Identifying neonatal adverse events in preterm and term infants using a Paediatric Trigger Tool
- 2023
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Ingår i: Acta Paediatrica. - 0803-5253 .- 1651-2227. ; 112:8, s. 1670-1682
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 5. |
- Nydert, Per, et al.
(författare)
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Chitosan as a carrier for non-viral gene transfer in a cystic-fibrosis cell line
- 2008
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Ingår i: Biotechnology and applied biochemistry. - 0885-4513 .- 1470-8744. ; 51:Pt 4, s. 153-7
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Tidskriftsartikel (refereegranskat)abstract
- The gene transfer mediated by chitosan in CFBE41o(-) (a cystic-fibrosis bronchial epithelial cell line) and HEK (a human embryonic kidney cell line) has been evaluated. Polyplexes based on chitosan and PEI (polyethyleneimine) using a luciferase and enhanced green fluorescent protein reporter plasmid showed that the transfection efficacy of polyplexes in the CFBE41o(-) cell line was poor compared with that in HEK cells. In the highly differentiated cystic-fibrosis bronchial epithelial cell line the narrow-size-distributed chitosan shows enhanced transfection at a low pH compared with PEI. The enhanced transfection at lower pH could be a result of damage to the cell surface or changes in the cell-surface charge, leading to better penetration of the cell membrane.
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| 6. |
- Nydert, Per, et al.
(författare)
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Cross-sectional study identifying high-alert substances in medication error reporting among Swedish paediatric inpatients
- 2020
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Ingår i: Acta Paediatrica. - : WILEY. - 0803-5253 .- 1651-2227. ; 109:12, s. 2810-2819
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 7. |
- Nydert, Per, et al.
(författare)
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Drug Use and Type of Adverse Drug Events-Identified by a Trigger Tool in Different Units in a Swedish Pediatric Hospital.
- 2020
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Ingår i: Drug, Healthcare and Patient Safety. - 1179-1365. ; 12, s. 31-40
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: The objectives of our study were to determine drug use, type and incidence of all adverse event associated with drug or drug-related processes (Adverse Drug Events, ADE) among pediatric inpatients in relation to hospital unit and length of stay.Patients and Methods: 600 pediatric (0-18 years) admissions at a Swedish university hospital during one year were included and stratified in blocks to 150 neonatal, surgical/orthopedic, medicine and emergency-medicine unit admissions, respectively. Adverse events were identified from medical records using a pediatric trigger tool. All triggers identifying an adverse event related to drugs and drug-related devices were included. Data on drug use were extracted from the hospital drug-data warehouse.Results: In total, 17794 daily drug orders were administrated to 486 (81.0% exposed) admissions. Parental nutrition, potassium salts and morphine constituted half of all high-risk drugs prescribed. Two-thirds of intravenous irritating drug doses consisted of vancomycin, esomeprazole and meropenem. In 129 (21.5%) admissions, at least one ADE was identified, out of which 21 ADE were classified as more severe (National Coordinating Council Medication Error Reporting Prevention-Index, NCCMERP≥F). The ADE incidence was 47.4 (95% confidence interval: 39.4-57.3) per 1000 admission days and varied by unit category. In neonatal units, 56.9 (49.5-65.4) ADEs/1000 admission days were detected, in surgery/orthopedic 54.2 (40.3-72.8), in medicine 44.1 (33.1-58.7), and in emergency-medicine 14.3 (7.7-26.7) ADEs/1000 admission days were found. The most common types of ADEs were identified by triggers that were not directly aiming at drugs including insufficiently treated pain (incidence peaking already in the first days), skin, tissue or vascular harm (peaking at the end of the first week) and hospital-acquired infections (peaking in later admission days).Conclusion: Adverse drug events are common in pediatric patients. The incidence of ADEs and type of ADE varies by hospital unit and length of hospital stay.
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| 8. |
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| 9. |
- Nydert, Per
(författare)
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Off-label drug use, medication errors and adverse drug events : among Swedish pediatric inpatients
- 2020
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: In pediatrics, treatment with drugs is an important and fully integrated part of everyday medical practice. However, authorized drugs specified to be used in children are often lacking which leads to off-label use, i.e. outside of approved product monographs. Another challenge is medication errors (ME) which is an important cause of adverse drug events (ADE) in hospitalized children. The consequences and effects of these conditions are largely unknown. Studies within the field of pediatric, and especially neonatal, drug safety are lacking. Unsafe drug use may be an important and unrecognized contributor to suboptimal health in this vulnerable group with limited capacity for drug metabolism and excretion. Aim: The general aim of the thesis was to explore the magnitude of drug safety issues within Swedish pediatric inpatients. More specifically we aimed to investigate; I. National extent of off-label drug-use, II. Contents in national ME incident reports, III. Type of ADEs in a pediatric inpatient setting and IV. The views of pediatricians on a clinical decision support system (CDSS) to aid in prescribing drugs. Methods: In the four papers we used different study approaches. In paper I we performed a descriptive cross-sectional study based on collection of drug charts during two time-points. In paper II we used an analytic cross-sectional register-based study on Lex Maria incident reports and complaints from the Health and Social Care Inspectorate. In paper III we carried out a cohort study using a chart review with a pediatric trigger tool covering 600 admissions stratified in four different units, and in paper IV we used qualitative semi-structured interviews with pediatricians. Results: Paper I showed that half of all drug orders received by pediatric inpatients was outside approved product monographs, extemporaneously prepared or unlicensed. In paper II the ME reports indicated frequent occurrence of substances from three previously known high-alert lists with specified error characteristics among the different drug handling processes. In paper III we showed that skin/tissue/vascular harm, omission of analgesic drug therapy and hospital acquired infections are the most abundant ADEs as identified by an extended set of medical record triggers. In paper IV the CDSS-experiences of pediatricians emerged into six categories being: use, benefit, confidence, situations of disregards, misgivings/risks and development potential. Conclusions: Paper I found a similar situation in Sweden regarding off-label and unlicensed drug use as in many other countries. Paper II found that the existing high-alert lists are relevant for pediatric inpatients and suggested the use of process dependent high-alert lists. Paper III found that ADEs are common in pediatric inpatients and that the incidence varied with ADE-type, depending on ward and time after admission. In paper IV the experiences of pediatricians after the implementation of a CDSS gave insights on usability and the need for future developments.
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| 10. |
- Unbeck, Maria, et al.
(författare)
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Validation of triggers and development of a pediatric trigger tool to identify adverse events.
- 2014
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Ingår i: BMC Health Services Research. - : Springer Science and Business Media LLC. - 1472-6963. ; 14
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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