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

Du, Wei; Lehr, Victoria Tutag; Lieh-Lai, Mary; Koo, Winston; Ward, Robert M.; Rieder, Michael J.; Anker, John N. van den; Reeves, Jaxk; Mathew, Merene; Lulic-Botica, Mirjana; Aranda, Jacob V.

doi:10.1177/0091270011433327

Cited by 60 publications

(65 citation statements)

References 39 publications

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“…Neonatal pharmacovigilance has been described (114). Du et al have outlined and tested a method for evaluation of the relation of an adverse event to the administration of a medication (115). They developed a classification of the relation to the medicinal product as definite, probable, possible or unlikely based on the following 13 criteria:…”

Section: Adverse and Serious Adverse Event Reportingmentioning

confidence: 99%

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates

et al. 2016

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Section: Adverse and Serious Adverse Event Reportingmentioning

confidence: 99%

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates

et al. 2016

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“…As a recent illustration, we refer to the evaluation of the use of uncoated mini-tablets instead of syrup for neonates. Uncoated mini-tablets offer the potential of a single formulation for different age groups and [5,6,10,11,13,15], and pharmacovigilance [7,8] in neonates, but should also shift towards medicines and product development driven by neonatal pathophysiology [9] avoid the need for specific excipients or taste-masking compounds [10,15].…”

Section: Neonatal Clinical Pharmacy: How To Cope With Neonatal Formulmentioning

confidence: 99%

“…However, once a signal has been detected, the differentiation of Btrue^ADRs from confounding events associated with immaturity, organ dysfunction, or underlying diseases remains difficult. An algorithm as suggested by Du et al based on 13 questions tailored to neonates has been shown to be more reliable when compared to the Naranjo approach [8].…”

Section: Neonatal Clinical Pharmacy: How To Cope With Neonatal Formulmentioning

confidence: 99%

Neonates and medicines: a roadmap to further improve neonatal pharmaceutical care

Allegaert

Sherwin

2016

Eur J Pediatr

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The treatment of newborns with safe and effective medicines is of critical importance for their outcome and subsequent quality of life. Despite this, it is still a common practice to prescribe medicines to neonates outside the label, extrapolating from dosing regimens and indications validated in older populations and based on non-neonatal pathophysiology. In a recent meta-analysis (2015) evaluating 829 (1994-2012) studies on prescribing practices in pediatric hospital care, off-label and unlicensed medicines prescriptions ranged from 12 to 71 % and 0.2 to 48 %. These authors hereby reconfirmed that (pre)term neonates were still most commonly exposed to off-label and unlicensed medicines [12].The federal US legislation and similar European initiatives have resulted in a relevant increase in pharmacological studies in children, with a subsequent significant increase in label changes. Unfortunately, too few included drug label changes specific to neonates. To further illustrate this, there were 406 pediatric label changes (Food and Drug Administration, 1997-2010), but only 23 drugs resulted in 11 labeled indications (e.g., linezolid, rocuronium, remifentanil, sevoflurane, stavudine, nevirapine) for neonates. The absence of label change was most commonly because of unproven efficacy, despite the fact that these compounds (e.g., paracetamol, caspofungin, valganciclovir) are likely relevant for neonates [14]. This may largely reflect the difficulties to proof efficacy due to heterogeneity in patients, variability in outcome variables, and uncertainty on biomarkers, in addition to demonstrating safety (risk of adverse drug events) in neonates. Despite the significant improvements in the knowledge on pharmacotherapy in older children, neonates still remain therapeutic orphans [2,14].In this issue of the journal, Campino et al. report on the rate of errors (calculation or accuracy) in intravenous medicine preparations when performed either bedside in 10 Spanish neonatal intensive care units (NICUs) or in hospital pharmacy (HP) services. The study group hereby evaluated the impact of a structured intervention (protocol standardization, education) on the number of errors and documented significant improvements in both calculation errors (1.35 to 0 %) and accuracy (54.7 and 38.3 % to 38.3 and 14.6 % in NICU and HP, respectively) [6]. This intervention paper follows on a previous paper which described a pre-intervention phase [5] and illustrates the potential impact of preventive strategies on the extent of drug errors.Development of a roadmap to improve neonatal pharmaceutical care should aim to improve the knowledge on clinical pharmacology, clinical pharmacy, and approaches to improve the knowledge and use of neonatal pharmacovigilance initiatives [1]. Another keystone component of such a roadmap should focus on neonatal drug development, i.e., drug development driven by neonatal pathophysiology (Fig. 1).

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“…Methods to ascertain the causal relationship between an intervention and an adverse event have been proposed [77]. Causality assessment can be difficult at the level of individual babies.…”

Section: Safety Reportingmentioning

confidence: 99%

Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct

Turner

2015

Brit J Clinical Pharma

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In the past, there has been a perception that ethical and practical problems limit the opportunities for research in neonates. This perception is no longer appropriate. It is now clear that research about the medicines used in neonates is an ethical requirement. It is possible to conduct high quality research in neonates if the research team adapt to the characteristics of this population. Good practice involves respecting the specific needs of newborn babies and their families by adopting relevant approaches to study design, recruitment, pharmacokinetic studies and safety assessment. Neonatal units have a unique culture that requires careful development in a research setting. Clinical investigators need to recognize the clinical and ethical imperative to conduct rigorous research. Industry needs to engage with neonatal networks early in the process of drug development, preferably before contacting regulatory agencies. Follow-up over 3-5 years is essential for the evaluation of medicines in neonates and explicit funding for this is required for the assessment of the benefit and risk of treatments given to sick newborn babies. The views of parents must be central to the development of studies and the research agenda. Ethical and practical problems are no longer barriers to research in neonates. The current challenges are to disseminate good practice and maximize capacity in order to meet the need for research among newborn babies.

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

Cited by 60 publications

References 39 publications

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates

Neonates and medicines: a roadmap to further improve neonatal pharmaceutical care

Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct

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