Real world data on utilisation and safety of Movicol paediatric plain among children <2 years

Date of ISAC Approval: 
23/07/2019
Lay Summary: 
Movicol paediatric plain is a medication used for constipation in children aged 2 years and over in many countries worldwide. Sometimes medication use is associated with side effects also known as adverse events. These adverse events have been shown to occur at known frequencies in populations taking the medication and are listed on the summary of product characteristics (SmPC) and package leaflet (PL) documents associated with the medication. This study aims to investigate the use of Movicol paediatric plain in children under 2 years of age in the UK and whether these children experience any side effects while using the medication. This study will look at reasons for clinical consultations while children are using the medication to identify and quantify side effects It will also look at clinical consultations prior to starting the medication to describe their medical history.
Technical Summary: 
This cohort study will assess the use of Movicol paediatric plain in children under 2 years and its safety profile during treatment. All patients that have been prescribed Movicol paediatric plain will be identified and the safety profile will be analysed. Categorical data will be presented as tabulations; continuous data will be described using appropriate summary statistics. Reasons for consultations will be tabulated using grouping based on clinical code levels to allow for patterns to be identified and quantified as individual recording variation may preclude signal detection. Incidence risks will be calculated for safety events.
Health Outcomes to be Measured: 
- Reasons for consultations during primary care treatment to identify all adverse events [including potential risks (e.g. fluid/electrolyte shifts, including hyperkalaemia and hypokalaemia), as well as listed events in the SmPC including allergic reactions (including anaphylactic reaction), dyspnoea, allergic skin reactions (including angioedema, urticaria, pruritus, rash, erythema), electrolyte disturbances (particularly hyperkalaemia and hypokalaemia), headache, abdominal pain, borborygmi, diarrhoea, vomiting, nausea, anorectal discomfort, abdominal distension, flatulence, dyspepsia, peri-anal inflammation and peripheral oedema - Hospitalisation details occurring during treatment and recorded by the primary care physician will be identified from the Referral file and reasons for consultations. In addition, the Referral file and reasons for consultations will be explored to identify potential sequelae of adverse events related to electrolyte disturbances, abdominal pain, peripheral oedema, diarrhoea and vomiting - Dose and duration of treatment - Demographics of patients - Prior medical history (reasons for consultations) - Test results at baseline and during treatment - Hospitalisation details occurring during treatment identified from reasons for consultations during primary care treatment - Exploratory analyses of efficacy outcomes identified from reasons for consultations during primary care treatment and/or test results during treatment (exploratory analyses will be undertaken as there is likely to be a significant level of missing information related to efficacy outcomes)
Collaborators: 

Professor Saad Shakir - Chief Investigator - Drug Safety Research Unit
Mr Bharat Amlani - Collaborator - Norgine
Dr Debabrata Roy - Corresponding Applicant - Drug Safety Research Unit
Dr Elizabeth Lynn - Collaborator - Drug Safety Research Unit
Fatma Akriche - Collaborator - Norgine
Dr Vicki Osborne - Collaborator - Drug Safety Research Unit