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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.)

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ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods.

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Appendix 7Research Implications from Adverse Drug Reactions In Children

Outputs 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 implicationKey discussion pointsNext steps summary
DosingWork 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
  • What extrapolation methods have/have not been used in literature, of those used which are successful?
ADRIC outputsLCAT and avoidability tools
The discussion focused primarily on the LCAT as this tool is fully completed:
  1. Develop an ‘app’ for assessment tools
  2. Use tools in RCTs to improve ADR reporting
  3. Use tools in real world sense to improve practice – would give a consistent approach to assessments
  4. Test outputs elsewhere, e.g. other hospitals and settings
LCAT e-learning tool
  1. Test elsewhere
  2. Conduct a larger RCT of LCAT e-learning tool to determine effect of clinician assessment of ADR causality
  3. Use in real world and medical training could improve how the LCAT is used in practice
  • Use outputs in randomised controlled trials to improve reporting
  • Use outputs in real world scenarios to improve practice
  • Hypothesis testing RCT of effect of LCAT e-learning tool on clinician assessment of ADR causality
QuantificationThere are knowledge gaps in the quantification of ADRs in a variety of settings not included in the ADRIC study:
  1. Other sites outside specialist tertiary care (e.g. District General Hospitals) – explore variation across settings, variation across age at other sites
  2. Neonates
  3. Theatres and critical care
  4. A&E
  5. Long-term side effects
  6. Post discharge and in the home setting
  7. Other settings: primary and community care
There are also benefits of evaluating long-term side effects, which was not looked at in ADRIC.
What lessons from the adult studies can be extrapolated to children?
  • Explore ADRs in settings where data are not yet described, e.g. neonates, critical care, community settings and primary care and long term/longitudinally
Risk–benefit evaluationThere 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?
  • What are parents’ views on risk–benefit evaluation? What are children’s views on risk–benefit evaluation? How do these differ and vary across the child and young person’s age spectrum?
InterventionsDevelopment of interventions that could reduce harm to be given alongside high-risk drugs identified by ADRIC
  • Development of targeted interventions for identified high-risk drugs
MonitoringADRIC 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
  • Observational study of ADRs in children following discharge after surgery
  • RCT of treatment regimens designed to minimise pain, vomiting and postoperative complications in early discharged children

RCT, randomised controlled trial.

Copyright © Queen’s Printer and Controller of HMSO 2014. This work was produced by Smyth et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK262744

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