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Smyth RL, Peak M, Turner MA, et al. ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods. Southampton (UK): NIHR Journals Library; 2014 Jun. (Programme Grants for Applied Research, No. 2.3.)
ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods.
Show detailsOutputs from a discussion group: what are the research implications of the burden of adverse drug reactions in paediatrics?
Symposium: Drug Safety in Children – Adverse Drug Reactions In Children
Atlantic Tower by Thistle Hotel, Liverpool
Friday 26 April 2013
14.00–15.00
Participants
Professor Munir Pirmohamed (Moderator), Professor Matthew Peak, Professor Sir Alasdair Breckenridge, Professor Deborah Ashby, Professor Michael W Beresford, Dr Andrew Rose, Dr Jamie Kirkham, Dr Sudeep Pushpakom, Dr Amitabh Shankar, Dr Petr Jirasek, Dr Virginia Ramos-Martin, Charlie Orton, Norkasihan Ibrahim, Mohammed Amali, Dave Delaney, Catherine Birch, Beth Conroy.
Key implication | Key discussion points | Next steps summary |
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Dosing | Work with industry to develop adaptive licensing. In literature how do researchers extrapolate from adults to children? Explore what has been used, what has not been used and utility of methodologies. Use findings to develop a gold standard practice for extrapolation and apply to drugs identified as high risk within ADRIC Take forward drugs highlighted by ADRIC as a focus for further study, monitor the PK/PD of these drugs and aim to develop risk models – they may not differ across age |
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ADRIC outputs | LCAT and avoidability tools The discussion focused primarily on the LCAT as this tool is fully completed:
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Quantification | There are knowledge gaps in the quantification of ADRs in a variety of settings not included in the ADRIC study:
What lessons from the adult studies can be extrapolated to children? |
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Risk–benefit evaluation | There is a need to explore the balance of safety vs. efficacy. Is there too much focus on safety in monitoring at the expense of potential benefit? Is the weight between efficacious outcomes and safety of patients always sensible? This subject is currently less understood in children than adults. For further work, one paediatric area could be focused on, e.g. paediatric oncology What are parental views of risk–benefit evaluation? What are the children’s views? How do the decision making differences between children and parents for particular drugs differ? Does the benefit/risk comprehension and decision differ with age, e.g. from pre-school to adolescence? |
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Interventions | Development of interventions that could reduce harm to be given alongside high-risk drugs identified by ADRIC |
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Monitoring | ADRIC has highlighted a need to understand better the morbidities associated with anaesthesia and surgery in children. This requires a study that can follow-up and monitor children in the community and home setting to assess the incidence of ADRs following surgery, compare these according to the anaesthetic and postoperative drugs, surgical procedures and their comorbidities. An observational study could lead to an assessment of which children should be discharged on the day of surgery and for those who are, RCTs will be able to assess the most appropriate treatment regimens to prevent pain, vomiting and other postoperative complications Explore active reporting, passive reporting and the difference between them Communicate and collaborate with industry in the development and refinement of monitoring systems within paediatric pharmacovigilance |
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RCT, randomised controlled trial.
- Research Implications from Adverse Drug Reactions In Children - ADRIC: Adverse D...Research Implications from Adverse Drug Reactions In Children - ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods
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