Adverse drug reactions in neonates: could we be documenting more?

Hawcutt, Daniel B; O’Connor, Olya; Turner, Mark A.

doi:10.1586/17512433.2014.956090

Cited by 10 publications

(9 citation statements)

References 114 publications

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“…There were 10 YC reports for antibiotics (trimethoprim [ n = 3], benzylpenicllin [ n = 2], gentamicin [ n = 2], ceftazidime [ n = 2], clindamycin, erythromycin and metronidazole [ n = 1 for each]. Despite well publicized safety concerns, there were no reports for codeine, ceftriaxone or ritonavir‐boosted lopinavir (Kaletra) over the 10‐year period.…”

Section: Resultsmentioning

confidence: 99%

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Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001–2010: content and utility analysis

Hawcutt

Russell

Maqsood

et al. 2016

Brit J Clinical Pharma

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AIMSThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card [YC] Scheme) to collect 'suspected' adverse drug reaction (ADR) data. We aim to describe the content and utility of YC reports received for patients aged <2 years. METHODSData on all ADRs reported using YC in infants aged <2 years from the years 2001-10 were supplied by the MHRA. RESULTSFor infants age <2 years, 3496 suspected ADRs were reported using YC (paternal medication pre-conception n = 3, transplacental n = 246, transmammary n = 30, neonates n = 97, infant n = 477, and vaccinations n = 2673), averaging 0.96 YC per day. There was a male preponderance (male 49.1%, female 44.4%, unknown 6.5%), and only 34 (1.0%) of YC reports stated a gestational age. The medications most frequently reported were: transplacental and transmammary (fluoxetine, n = 21 and n = 4 respectively), neonate (swine flu vaccine, n = 8) infant (oseltamivir, n = 37) and vaccines (meningococcal vaccine, n = 693). Paternal, transmammary, neonatal and infant YC did not reflect clinical concerns raised by the UK regulator. Transplacental and vaccination reports did correlate with some of the changes in practice and clinical alerts received. CONCLUSIONSThe frequency of YC reports for those <2 years is low, neonates are poorly represented, and recording of gestational age is poor. With the exception of vaccinations, spontaneous reports alone are not currently generating the data required, and important safety messages from the regulator do not match reporting patterns. Additional reporting strategies are required to improve the quantity and quality of suspected ADR data in young children.

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Section: Resultsmentioning

confidence: 99%

“…Other spontaneous reporting schemes aid identification of significant ADRs in neonates , but significant under‐reporting is recognized (up to 95% of all ADRs are not reported) . While spontaneous reporting is unlikely to be complete, we speculated that the YC Scheme would have useful functionality in neonates and infants.…”

Section: Introductionmentioning

confidence: 98%

Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001–2010: content and utility analysis

Hawcutt

Russell

Maqsood

et al. 2016

Brit J Clinical Pharma

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“…3 Neonates are subject to different ADR profiles in comparison to older children and adults. 4,5 The development of a child from conception to adulthood is dynamic, and changes in organ function and body composition affect pharmacodynamics and pharmacokinetics. 6 Neonates born preterm are subject to further variation in drug absorption, distribution, metabolism and excretion.…”

Section: Introductionmentioning

confidence: 99%

Prospective identification and causality evaluation of suspected adverse drug reactions in neonates

Roberts

Hawcutt

Turner

2020

Brit J Clinical Pharma

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Neonates experience adverse drug reactions (ADRs), but under-reporting of suspected ADRs to national spontaneous reporting schemes in this population is particularly high. A prospective observational study collected suspected neonatal ADRs at a tertiary neonatal unit. Cases were analysed for causality by six assessors using three existing methods. Sixty-three suspected ADR cases were identified in 35/193 neonates (18.1%). The proportion of suspected ADRs where the drug was prescribed "off-label" was 30/68 (44.1%). When 34 cases were assessed for causality using three methods, global kappa scores of less than 0.3 for each tool suggested only "fair" inter-rater reliability. Neonatal ADRs can be captured and occur from a variety of drugs affecting many organ systems. The current tools for assessing causality need to be adapted before they can reliably assess neonatal ADRs.

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“…Finally, the scale could also be used in routine clinical care and for postmarketing pharmacovigilance. Neonates are vulnerable to adverse drug reactions (ADR) in clinical care, but these events are under-reported 27. NAESS was developed to classify AEs, which would complement neonatal algorithms used to identify ADRs 6 7.…”

Section: Discussionmentioning

confidence: 99%

Development of a neonatal adverse event severity scale through a Delphi consensus approach

et al. 2019

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BackgroundAssessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed.MethodsA stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation.ResultsNeonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available.DiscussionThe INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.

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Adverse drug reactions in neonates: could we be documenting more?

Cited by 10 publications

References 114 publications

Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001–2010: content and utility analysis

Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001–2010: content and utility analysis

Prospective identification and causality evaluation of suspected adverse drug reactions in neonates

Development of a neonatal adverse event severity scale through a Delphi consensus approach

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