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Research

Paediatric Medicines Research Unit at Alder HeyThe paediatric medicines research unit is a collaboration between Alder Hey, Liverpool Women’s NHS Foundation Trust, Liverpool John Moores University, the University of Liverpool and the University of Central Lancashire.

The unit conducts research which contributes to the safe and effective use of new and existing medicines for children.

Meet the team

Unit leads

Alder Hey

Liverpool John Moores University                                     

University of Central Lancashire                                

University of Liverpool

Pharmacy Research Students

Formulations

Background

When developing and prescribing medicines for children it is important to consider how suitable the product (or formulation) is for them. One important factor is the acceptability of the medicine to the child who needs to take it. Acceptability includes how straightforward it is to prepare the dose, how easy it is to take and how it tastes.

Some of the medicines given to children are designed for adults, this means that it may not be straightforward to prepare a dose for a child. Tablets, patches and capsules may give a dose that is too much for a child. If a tablet is too big for a child then the tablet must be split. Suppositories, or patches used on the skin are often cut to give the dose needed for the age or weight of the baby or child. Sometimes injections or liquid medicines for babies and small children are too strong and must be diluted down so that we can measure the right amount. All these processes are examples of manipulation.

Our Research

Manipulation of DRugs In Children (MODRIC)

This study identified when and why medicines for children need to be manipulated. Using the findings of this study, guidance for healthcare professionals was produced.

For further information about this study, please see the publications listed below or contact Professor Tony Nunn: A.J.Nunn@liv.ac.uk

This research was funded by:  NIHR Research for Patient Benefit (RfPB), Grant Reference Number PB-PG-0807-13260

Publications

  1. Ainscough L P, Ford J L, Morecroft C W, Peak M, Turner M A, Nunn A J, Roberts M. Accuracy of Intravenous and Enteral Preparations Involving Small Volumes for Paediatric Use: A Review. European Journal of Hospital Pharmacy. 2017 Published Online First: 05-Jan-2017 doi:10.1136/ejhpharm-2016-001117
  2. Richey RH, Hughes C, Craig JV, Shah UU, Ford JL, Barker CE, Peak M, Nunn AJ, Turner MA. A systematic review of the use of dosage form manipulation to obtain accurate doses to inform use of manipulation in paediatric practice. International Journal of Pharmaceutics. 2017; 518(1-2): 155-166. Final version published online: 04-Jan-2017. doi: 10.1016/j.ijpharm.2016.12.032
  3. Nunn A, Richey R, Shah U, Barker C, Craig J, Peak M, et al. Estimating the requirement for manipulation of medicines to provide accurate doses for children. European Journal of Hospital Pharmacy: Science and Practice. 2012.
  4. Richey RH, Craig JV, Shah UU, Ford JL, Barker CE, Peak M, et al. The manipulation of drugs to obtain the required dose: systematic review. Journal of Advanced Nursing. 2012; 68(9): 2103-12.
  5. Richey RH, Shah UU, Peak M, Craig JV, Ford JL, Barker CE, et al. Manipulation of drugs to achieve the required dose is intrinisic to paediatric practice but is not supported by guidelines or evidence. BMC Pediatrics. 2013;13:81.

Age Inappropriate Formulations

Children sometimes need to be administered medicines that are not specially designed for them. This research aims to find out when, why and how this happens. We will ask parents what they think about needing to use medicines not specially designed for children. We will also provide feedback to manufacturers who make medicines for children.

For further information about this study, please contact Jennifer Duncan: jennifer.duncan@alderhey.nhs.uk

Palatability of Liquid Formulations

Methotrexate is used to treat children with variety of diseases.. It is available as tablets or a liquid to be taken by mouth. This study aims to compare methotrexate tablets and liquid to find out how acceptable they are to children who need to take methotrexate for rheumatology conditions.

For further information about this study, please see:

http://www.hra.nhs.uk/news/research-summaries/the-palm-study-palatability-and-acceptability-of-liquid-methotrexate/

Age-appropriate Hydrocortisone Formulations

Hydrocortisone is frequently prescribed for children and young people, but available formulations aren’t designed for this age group. Parents or carers may need to cut a hydrocortisone into halves or quarters in order to give the required dose to a child. This research aims to determine whether hydrocortisone tablet halves and quarters contain the intended amount of hydrocortisone. In addition, we are exploring how actual administrations of manipulated tablets of hydrocortisone affect biomarkers of cortisol response in children.

For further information about this study, please see the publication(s) listed below or contact Professor Matthew Peak: matthew.peak@alderhey.nhs.uk

MEDICINES SAFETY

Background

Many medicines prescribed for children are not authorised for use in this age group. Many common medicines have not been tested properly or at all in children; frequently medicines are administered to this age group based on how they work in adults, and the doses used are often a best guess. This means that children are at a high risk of suffering serious and unexpected side effects (adverse drug reactions) from many medicines prescribed by doctors or available at the chemist.

Our Research

Adverse Drug Reactions In Children (ADRIC)

This research aimed to establish the causes, severity and preventability of adverse drug reactions (ADRs) for a range of medicines administered to children. The study explored the experiences of parents and children in whom ADRs were identified.  It also aimed to find out what healthcare professionals think their role is in the context of preventing, managing and communicating with families about ADRs in children.

Using the findings of this study, the research team developed the following:

  1. A new tool which helps its users to decide how likely it is that a child’s signs or symptoms are/were related to a medicine they have taken (the Liverpool Causality Assessment Tool)

To access an electronic version of this tool, follow this link:

http://www.pmidcalc.org/22194808

  1. A new tool which helps its users to decide whether an ADR could have been avoided (the Liverpool Avoidability Assessment Tool)

To access an electronic version of this tool, follow this link:

http://www.pmidcalc.org/28046035

  1. Information about ADRs for Parents

http://www.medicinesforchildren.org.uk/search-for-a-leaflet/side-effects-from-childrens-medicines/

  1. Information about ADRs for Children & Young People

http://www.alderhey.nhs.uk/wp-content/uploads/Side-effects-from-medicine-information-for-children-aged-9-14-year-old-PIAG-45.pdf

http://www.alderhey.nhs.uk/wp-content/uploads/Side-effects-from-medicines-information-for-young-people-aged-14-and-over-PIAG-51.pdf

  1. An e-learning package about the Liverpool Causality Assessment Tool which supports the training of Healthcare Professionals

This research was funded by:  NIHR Programme Grant for Applied Research (PGfAR), Grant Reference Number RP-PG-0606-1170

For further information about this study, please see https://www.journalslibrary.nihr.ac.uk/pgfar/pgfar02030/,  the publications listed below or contact Professor Matthew Peak: matthew.peak@alderhey.nhs.uk

Publications

  1. Arnott J, Hesselgreaves H, Nunn AJ, Peak M, Pirmohamed M, Smyth RL, et al. Enhancing Communication about Paediatric Medicines: Lessons from a Qualitative Study of Parents’ Experiences of Their Child’s Suspected Adverse Drug Reaction. PLoS One. 2012;7(10):e46022-e.
  2. Gallagher R, Mason J, Bird K, Kirkham J, Peak M, Williamson P, et al. Adverse drug reactions causing admission to a paediatric hospital. PL0S ONE. 2012;7(12):e50127. doi:10.1371/journal.pone.0050127.
  3. Thiesen S, Conroy EJ, Bellis JR, Bracken LE, Mannix HL, Bird KA, et al. Incidence, characteristics and risk factors of Adverse Drug Reactions (ADRs) in hospitalised children – a prospective observational cohort study of 6601 admissions. BMC Medicine. 2013;11(237):doi:10.1186/741-7015-11-237.
  4. Conroy, E. J., Kirkham, J. J., Bellis, J. R., Peak, M., Smyth, R. L., Williamson, P. R. and Pirmohamed, M. (2015), A pilot randomised controlled trial to assess the utility of an e-learning package that trains users in adverse drug reaction causality. International Journal of Pharmacy Practice, 23: 447–455. doi:10.1111/ijpp.12197
  5. Bracken LE, Nunn AJ, Kirkham JJ, Peak M, Arnott J, Smyth RL, et al. (2017) Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool. PLoS ONE 12(1): e0169393. doi:10.1371/journal.pone.0169393

Improving Adverse Drug Reaction (ADR) Reporting

We know that the majority of ADRs that occur are not reported to the national regulator (the Medicines & Healthcare products Regulatory Authority – MHRA). Suspected ADRs in children and babies are particularly poorly reported. In collaboration with other hospitals in the region, Alder Hey is working on a project which aims to increase the quality and quantity of ADR reports about medicines used in children, with the aim of improving patient safety. There will be particular focus on reports from families and from young people themselves.

For further information about this study please contact Dr Dan Hawcutt:  D.Hawcutt@liverpool.ac.uk

MEDICINES OPTIMISATION

Background

Medicines optimisation aims to help patients to make the most out of their medicines. The Royal Pharmaceutical Society outlines four principles of medicines optimisation. These relate to the patient’s experience of needed to use medicines, the use of evidence-based medicines, medicines safety and value for money from medicines. Further information can be found here:

http://www.rpharms.com/what-we-re-working-on/medicines-optimisation.asp

Our Research

PROMOTE Study – Procalcitonin monitoring in paediatric outpatient parenteral antimicrobial therapy

The paediatric Outpatient Parenteral Antimicrobial Therapy (pOPAT) service supports the delivery of intravenous antibiotics in the patient’s home. This study investigates the usefulness of a blood test which can help doctors understand if the antibiotics are working properly to treat the infection. We also want to find out parents’ and children’s views on the experience of being monitored like this at home.

For further information about this study, please see:

http://www.hra.nhs.uk/news/research-summaries/promote-procalcitonin-monitoring-in-paediatric-opat/

Medicines in Schools

Using questionnaires, this research aimed to understand how medicines are managed at school and the perspectives of children, their parents, school staff and healthcare professionals in relation to this.

For further information about this study, please contact Dr Louise Bracken: louise.bracken@alderhey.nhs.uk

Evaluation of the introduction of a pharmacy-technician supported paediatric medicines administration system

In some children’s hospitals, in order to reduce the risk of medication error, medication preparation and administration is carried out by one registered nurse and checked by another. In a pilot study at Alder Hey we have made a change to this. For some of the working day, one of the nurses involved in this process is replaced by a suitably trained pharmacy technician. We are assessing the impact of this new way of working on medicines optimisation, healthcare staff, children and their families.

For further information about this study, please contact Mrs Catrin Barker: catrin.barker@alderhey.nhs.uk

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