Implementation of an outsourcing activity for radiopharmaceutical preparation

Introduction
A local economic analysis has revealed the development of a gallium-68 (⁶⁸Ga) radiopharmaceutical preparation activity is not financially viable due to the limited patient cohort and the substantial expenses of germanium-68/68Ga generators and cold kits. Despite the short half-life of ⁶⁸Ga, a centralized production with outsourcing (OS) of these preparations to other hospitals has been considered. Since 2019, OS as led to cost reduction in drugs and consumables for all served hospitals, while enabling them to benefit from innovative examinations . The implementation this OS has required several steps, as radiopharmaceutical preparations are subject to both drug and radionuclide regulations.

Objective
The objective of this work is to present the necessary steps for the implementation of an OS of radiopharmaceutical preparations and to provide a feedback on this activity.

Method
Firstly, a practical feasibility study was conducted to define the pharmaceutical process: order management, preparation, packaging, shipping, quality control, and release. Three requests were submitted in parallel to agencies, authorization for the possession and use of ⁶⁸Ga (Autorité de Sureté Nucléaire, ASN), authorization for the distribution of ⁶⁸Ga (ASN), and authorization for radiopharmaceutical preparation distribution (Agence Régionale de Santé). A quality management system was implemented, and various processes were validated. Finally, contracts with partners were drafted and signed.

Results
All necessary authorizations were obtained. The activity started in late 2019 with 110 patients (3 centers). In the following 2 years, 362 patients benefited from the OS (5 centers), and in 2023, 157 patients (6 centers). During the first 3 years, only preparation of [⁶⁸Ga] radiolabelled Somakit TOC^® was offered. In 2022, an investigational drug dossier was submitted for the preparation of [⁶⁸Ga]Ga-PSMA-11, which is subject to compassionate use authorization. In our department, 392 patients received [68Ga]Ga-Somakit TOC® and 23 patients received [68Ga]Ga-PSMA-11.

Discussion
The outsourcing of radiopharmaceutical preparations is an innovative solution that facilitated the deployment of the ⁶⁸Ga activity in multiple nuclear medicine departments by sharing costs and centralizing expertise. From the preparation of the radiopharmaceutical to its injection into the patient, the process must be meticulously established. In this activity where time is critical, the roles of each party must be clearly defined to ensure perfect synchronization between the supplying institution, the transporter, and the receiving institution.

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