(278) Utilisation and safety of Glycopyrronium Bromide 1mg/5ml oral solution for sialorrhoea in the paediatric population in the UK: Interim results from a non-interventional post authorisation safety study

Publication Number: 937

Background: The Glycopyrronium Bromide (GB) study is being conducted to monitor use and safety of GB 1mg/5ml oral solution as licensed for the symptomatic treatment of severe sialorrhoea in children aged ≥ 3 years with chronic neurological conditions in the UK.

Objectives: To describe the use of GB across the UK, examine off-label use and safety, and quantify provision of educational material.

Methods: Paediatric teams have been recruited with support from the UK Clinical Research Networks. The study began patient (pt) recruitment in November 2021. Pts < 18 years, initiated on GB 1mg/5ml as part of their routine clinical care for sialorrhoea, are identified by the recruited paediatric teams and invited to take part. Following consent, the paediatric team is requested to extract information from the pt’s medical notes onto electronic data capture forms at 3 monthly time intervals, up to 12 months after the first prescription (secondary data collection). Pts or their parents/guardian/carer can also complete questionnaires at 6 and 12 months (primary data collection) and the pt’s GP is contacted at 12 months, given consent. Data on pt characteristics, drug utilisation and adverse events are collected in the study; descriptive statistics are presented.

Results: To date, 9 eligible pts have been recruited to the study; median age 6 years [IQR 6-9], five male. Drooling severity was reported as moderate n < 5 (off-label), severe n < 5, profuse n < 5. Mean dose was 2.3ml (range 1-4), all doses were prescribed at a frequency of three times daily; n < 5 pts were started on a dose lower than dose level 1 for their weight category (off-label use). No pt had taken GB (any strength) prior to starting.
For 2 of the 9 pts, the paediatric teams had received educational material (i.e., ‘checklist for healthcare professionals’); for 3 pts the paediatric team had received the ‘reminder card to caregiver’ and subsequently given this to the parent/carer.
Adverse events have been reported in n < 5 pts by the paediatric teams as follows: allergic rash, seizures, difficulty sleeping, focal seizures, allergic reaction to drug, chickenpox, lip blister, spot-like rash, pneumonia, chest infection and febrile seizure. No primary data has been reported to date.

Conclusions: The GB study is currently ongoing. For pts enrolled, GB 1mg/5ml was mostly prescribed in accordance with the product label but with some off-label use. The combined secondary data and primary data collection model provides a framework suitable to evaluate the safety of medicines where there is potential for under-ascertainment of outcomes through one data collection method alone.