(177) Utilisation and Safety of IV Bolus Formulation of Akis® for use in the Prevention and Treatment of Post-operative Pain in the UK Secondary Setting

Publication Number: 838

Background: This post-authorisation safety study, proposed by the marketing authorisation holder, is being conducted to examine the utilisation and safety of IV bolus formulation of Akis® in the prevention or treatment of post-operative pain in order to resolve specific safety concerns related to the use of the product via IV bolus.

Objectives: To assess the utilisation and safety of IV bolus formulation of Akis® for use in the prevention and treatment of post-operative pain in the UK secondary setting.

Methods: Prescribers/centres within the specialties of anaesthesia and surgery have been recruited with support from UK Clinical Research Networks. Eligible patients are any adult patient (≥18 years) prescribed Akis® for IV bolus administration (25mg/ml; 50mg/ml; 75mg/ml), as a pre-filled syringe and/or ampoule. Information extracted from patient medical records on to data collections forms (DCFs) includes patient demographics, drug utilisation and adverse events reported on the same day following treatment and up to date of discharge. Descriptive statistics are presented.

Results: A total of 142 patients have been recruited and 139 DCFs submitted in the period from 26th January 2022 (study start) to 23rd January 2023. A total of 13 patients experienced events within 24 hours of the Akis® administration and n < 5 patients experienced events more than 24 hours after the Akis® injection. Seven of these patients were female and six were male, with an age range of 25 to 61 years. Most patients experienced one or two events. Pain (n=6) and procedural nausea (n=6) were the most common events experienced by patients within 24 hours of the Akis® injection. Fluid replacement (n < 5) and pain in extremity (n < 2) were the most common events experienced by patients more than 24 hours after the Akis® injection.

Conclusions: The study is reporting interim results and is currently ongoing. A total of 142 patients have been recruited; 13 patients experienced events within 24 hours of the Akis® injection and n < 5 patients experienced events more than 24 hours after the Akis® injection. However, some of these events may be related to the surgical procedure. The following events: ‘peripheral swelling’, ‘oedema peripheral’ and ‘oedema’ may reflect the important identified risk of oedema included in the Risk Management Plan for this product, however, causality and severity assessments have not been conducted at this stage.