Epidemiology of Adverse Drug Reactions in the Newborn

Aranda, Jacob V.; Portuguez-Malavasi, Ana; Collinge, Judith M.; Germanson, Terri; Outerbridge, Eugene W.

doi:10.1159/000480994

Cited by 29 publications

(14 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Eosinophilia in neonates is suggested to be a cellular response to external antigens to which they are exposed through gastroinestina l and respiratory tract or intravenous routes [4]. However, in our study, as well as in certain other reports, exposure to various antigens (total parenteral nutrition, catheters, various drugs, endotracheal tubes) was not signi cantly different in babies with and without eosinophilia [5,9]. The cytokinemediated response to infective process through IL-5, IL-3 and GM-CSF seems to explain the rise of eosinophil cell count in sepsis.…”

Section: Discussioncontrasting

confidence: 76%

Eosinophilia in sick neonates

Manoura¹,

Hatzidaki²,

Korakaki³

et al. 2002

Haematol.

View full text Add to dashboard Cite

Eosinophilia is common in the neonatal period. However, its causes, pathomechanism and clinical significance are still unknown. Previous reports have described that eosinophilia may be associated with numerous conditions (establishment of an anabolic state, drug reactions, response to foreign antigens, chronic lung disease, erythropoietin treatment and infections). The aim of this study was to evaluate the possible association of various conditions, especially infection, with eosinophilia and to clarify whether recognition of increase in eosinophil count is of any clinical significance in the management of a sick neonate. Fifty-six neonates with eosinophilia (absolute eosinophil count > 700/mm3) and 55 control neonates matched for gestational age, birth weight and hospitalization days were included in the study. A significant difference between the two groups was found only in blood transfusions, immuno-globulin treatment, specific antibiotic treatment and infectious disease. However, neonates who develop sepsis and are treated with antibiotics and immuno-globulin are more often transfused. It can thus be concluded that the main relationship observed is between eosinophilia and infection whereas the other associations are secondary. The relative risk factor for infection when the absolute eosinophil count is > 700/mm3, is 1.58, with a confidence interval 1.30-1.91. Eosinophilia seems to be a reliable indicator of sepsis while normal absolute eosinophil count does not exclude infection. Infection should be strongly considered in the evaluation of a sick neonate with eosinophilia.

show abstract

Section: Discussioncontrasting

confidence: 76%

Eosinophilia in sick neonates

Manoura¹,

Hatzidaki²,

Korakaki³

et al. 2002

Haematol.

View full text Add to dashboard Cite

show abstract

“…In a prospective study (1977) on the epidemiology of ADRs in 200 consecutively admitted neonates, 136 ADRs occurred in 60 neonates (30%), 20 were life threatening, 24 were moderate (prolonged hospital stay) and ∼50% of patients had multiple ADRs . However, it is doubtful to what extent these observations can still be applied to contemporary neonatal intensive care units (NICUs).…”

Section: Drug Use Safety and Adverse Drug Reactions In Neonates And mentioning

confidence: 99%

“…It may be more reasonable to use ‘an unintended and harmful effect resulting from the use of medications intended for diagnostic or therapeutic reasons (irrespective of the dose)’ as a broader definition, because of the common practice of prescribing drugs off label and unlicensed and the absence of dose guidance in this population . Obviously, this definition results in overlap with errors related to inappropriate drug administration, commonly referred to as medication errors (e.g.…”

Section: Introductionmentioning

confidence: 99%

“…Finally, adverse drug reactions and medication errors relate to the broader and growing field of research on iatrogenesis, i.e. any adverse condition occurring as a result of a diagnostic procedure or treatment by a medical care provider (Figure ) . Although the research related to iatrogenesis is of obvious relevance to improve outcome and, despite the fact that some of the methods can also be applied to generate more insights into the incidence and prevention of ADRs in neonates or infants, this review aims to focus on the broader ADR definition including medication errors.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Adverse drug reactions in neonates and infants: a population‐tailored approach is needed

Allegaert

Anker

2015

Brit J Clinical Pharma

View full text Add to dashboard Cite

Drug therapy is a powerful tool to improve outcome, but there is an urgent need to improve pharmacotherapy in neonates through tailored prevention and management of adverse drug reactions (ADRs). At present, infants commonly receive off‐label drugs, at dosages extrapolated from those in children or adults. Besides the lack of labelling, inappropriate formulations, (poly)pharmacy, immature organ function and multiple illnesses further raise the risk for ADRs in neonates and infants. Pharmacovigilance to improve the prevention and management of ADRs needs to be tailored to neonates and infants. We illustrate this using prevention strategies for drug prescription and administration errors (e.g. formulation, bedside manipulation, access), detection through laboratory signalling or clinical outlier data (e.g. reference laboratory values, overall high morbidity), assessment through algorithm scoring (e.g. Naranjo or population specific), as well as understanding of the developmental toxicology (e.g. covariates, developmental pharmacology) to avoid re‐occurrence and for development of guidelines. Such tailored strategies need collaborative initiatives to combine the knowledge and expertise of different disciplines, but hold promise to become a very effective tool to improve pharmacotherapy and reduce ADRs in infants.

show abstract

“…The rate of ADRs has been reported to increase exponentially with exposure to 4 or more medications . A tertiary care NICU study reported that 15% of neonates received more than 10 medications with 30% experiencing at least 1 ADR …”

mentioning

confidence: 99%

An Algorithm to Detect Adverse Drug Reactions in the Neonatal Intensive Care Unit

Lehr

Lieh-Lai

et al. 2013

The Journal of Clinical Pharma

Self Cite

View full text Add to dashboard Cite

Critically ill newborns in neonatal intensive care units (NICUs) are at greater risk of developing adverse drug reactions (ADRs). Differentiation of ADRs from reactions associated with organ dysfunction/immaturity is difficult. Current ADR algorithm scoring was established arbitrarily without validation in infants. The study objective was to develop a valid and reliable algorithm to identify ADRs in the NICU. Algorithm development began with a 24-item questionnaire for data collection on 100 previously suspected ADRs. Five pediatric pharmacologists independently rated cases as definite, probable, possible, and unlikely ADRs. Consensus "gold standard" was reached via teleconference. Logistic regression and iterative C programs were used to derive the scoring system. For validation, 50 prospectively collected ADR cases were assessed by 3 clinicians using the new algorithm and the Naranjo algorithm. Weighted kappa and intraclass correlation coefficient (ICC) were used to compare validity and reliability of algorithms. The new algorithm consists of 13 items. Kappa and ICC of the new algorithm were 0.76 and 0.62 versus 0.31 and 0.43 for the Naranjo algorithm. The new algorithm developed using actual patient data is more valid and reliable than the Naranjo algorithm for identifying ADRs in the NICU population. Because of the relatively small and nonrandom samples, further refinement and additional testing are needed.

show abstract

Epidemiology of Adverse Drug Reactions in the Newborn

Cited by 29 publications

References 9 publications

Eosinophilia in sick neonates

Eosinophilia in sick neonates

Adverse drug reactions in neonates and infants: a population‐tailored approach is needed

An Algorithm to Detect Adverse Drug Reactions in the Neonatal Intensive Care Unit

Contact Info

Product

Resources

About