BackgroundLittle 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.MethodsUsing 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.ResultsRegistered 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.ConclusionsAEs 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.

AimTo perform a nationwide investigation of paediatric drug use at Swedish hospitals, including an analysis of off-label drug use.MethodsAll paediatric hospitals in Sweden were invited to register all prescriptions to children, aged between 0 and 18, during two separate 2-day-periods in 2008. Data were reported and analysed with respect to licence status and proportion of and reasons for off-label drug use.ResultsData on 11 294 prescriptions to 2947 paediatric patients were received. Drugs associated with pain relief, infection, prematurity, nutrition and surgery or anaesthesia were most commonly used. Paracetamol was the most frequently used drug on-label and also among the most commonly used off-label drugs. Nearly half (49%) of all administered prescriptions concerned unlicensed drugs, off-label drugs or extemporaneously prepared drugs. The corresponding rate among neonates was 69%. Lack of paediatric information in the Summary of Product Characteristics was the main reason for off-label classification.ConclusionsPaediatric off-label drug use is common at Swedish hospitals, and nearly half of all prescriptions were not documented for use in children. The findings emphasize a need for paediatric clinical studies as well as compilation of existing clinical experience and scattered evidence, particularly for drug treatment in infants and neonates.

Little is known about the safety of buprenorphine (BUP) in breastfeeding. The aim of this work was to investigate the transfer of buprenorphine and its main active metabolite, norbuprenorphine (n-BUP), into human milk and to determine the drug dose and effects in exposed infants. Seven lactating women, who were maintained on BUP treatment because of previous opiate addiction, were studied in an open observational study. All mothers had a strong wish to breastfeed their newborn infants. Buprenorphine samples for analysis were collected from the urine of 6 infants together with breast milk, blood, and urine from their mothers during a 24-hour period in the week after birth. One mother-infant pair was studied at 9 months of age. Buprenorphine and n-BUP were analyzed by a liquid chromatography/mass spectrometry method suitable for handling different matrices. Buprenorphine and n-BUP were found in low levels in the infants' urine. Breastfed infants were exposed to a calculated BUP dose per kg bodyweight less than 1%, with an average milk/plasma area under the curve of 1.7 (range, 1.1-2.8) for BUP and 0.7 (range, 0.4-1.2) for n-BUP. These data support the use of BUP during breastfeeding. However, the authors recommend that infants be monitored closely.