Quality and Safety Considerations for Radiopharmaceutical Therapy in the Radiation Oncology Environment: An ASTRO Safety White Paper.

Abstract

Radiopharmaceutical therapy (RPT) is the latest topic in a series of white papers published by ASTRO addressing quality processes and patient safety. The availability of radiopharmaceutical agents for therapeutic use has broadened patient treatment options; although generally administered systemically, their effects are targeted to cellular receptors or the tumor microenvironment. Radiation oncology is well suited to delivering RPT because clinicians are already experienced in radiation safety, treatment delivery, and ongoing patient care. This paper focuses on the logistics of initiating and/or maintaining an RPT program in radiation oncology and includes collaborating with other medical specialties. The white paper addresses the safety processes and workflow considerations for alpha- and beta-emitting radionuclides used for RPT. ASTRO convened a multidisciplinary task force, composed of experts from radiation oncology, nuclear medicine, medical and health physics, to provide consensus on key workflows and processes for RPT. Recommendations were created using a consensus-building methodology and task force members indicated their level of agreement based on a 5-point Likert scale, from "strongly agree" to "strongly disagree." A prespecified threshold of ≥75% of raters who select "strongly agree" or "agree" indicated consensus. Content not meeting this threshold was removed or revised. Establishing an RPT program in radiation oncology requires specific infrastructure for receiving, storing, preparing, and administering radiopharmaceuticals by staff with expertise in specific infusion methods. RPT cases benefit from a multidisciplinary approach led by a radiation medicine physician and authorized user with support from additional personnel trained in RPT. A comprehensive quality management program must be developed to comply with applicable regulations and standards, including the handling of radioactive materials. Participation in incident reporting and external audits of a practice's overall quality assurance processes is encouraged. Using the guidance provided, authorized users can assess the viability of starting an RPT program, develop the necessary infrastructure, and sustain a safe, high-quality RPT program that includes radiation oncology.