Authors (including presenting author) :
Cheng CWR(1)
Affiliation :
(1)Molecular Imaging and Medical Cyclotron Centre, Department of Diagnostic Radiology, School of Clinical Medicine, LKS Faculty of Medicine, The University of Hong Kong
Introduction :
HKU-MIMCC has been producing prescribed radioactive tracers for clinical diagnosis and research purpose since 2013, under licences issued by the Drug Office and Radiation Board of the Department of Health, with compliance to EANM guidelines. Routine Quality Control (QC) tests on the radiopharmaceuticals are performed pre-release and post-release for every batch as per European Pharmacopeia (EP) monograph or product specification from patentee.
Objectives :
(1) To modify QC tests according to EP revision; (2) To implement post-market surveillance on the radiopharmaceuticals as quality assurance measure and (3) To identify risks on the usage of radioactive tracers.
Methodology :
QC tests were developed by pharmacists and chemists prior to EP revision effective from 01 January 2024. Batch record, SOP and QC report form were revised according to QC criteria in EP 11.1 for Sodium [1-11C]acetate, EP 11.3 for 2-[18F]FDG and EP 11.4 for [18F]PSMA-1007. Since January 2024, written feedback was collected monthly from clients on the number of case(s) and description of adverse effect or sub-optimal quality issue. Data were then analyzed to evaluate the distribution, safety, efficacy and quality of radioactive tracers.
Result & Outcome :
Number of successful productions in 2024 for radioactive tracers 2-[18F]FDG, Sodium [1-11C]acetate, [18F]Flutemetamol and [18F]PSMA-1007 were 289, 48, 33 and 15 respectively, with two occasions of synthesizer failure encountered and the centre was notified immediately to reschedule all bookings with their patients. Modifications on QC tests include update of specifications in release criteria, additional measurements for half-life and radionuclidic impurities. These changes were implemented in trial period and every production without non-compliance. Total number of doses administered to patients was 11407, while 139 (1.2%) dispensed doses were cancelled before injection. The most common reasons for cancellation were PET/CT machine failure (24.5%), followed by deterioration of patient's physical condition such as admitted to hospital, fever, infected, unstable glucose level or blood pressure. Throughout 2024, there was no adverse effect or sub-optimal quality issue reported by the clients.
