[What do we expect from Radiopharmacy software?]

Area of Science:

• Radiopharmacy
• Health Informatics
• Regulatory Compliance

Background:

• The Radiopharmaceutical Health Products (RHP) circuit involves complex processes for radiopharmaceutical drugs, preparations, and radioactive medical devices.
• Current RHP circuits require computerization for efficiency and adherence to medicinal product and artificial radioelement legislation.
• Existing software solutions lack specific legislation, not being classified as medical devices or prescription/dispensation aids.

Purpose of the Study:

• To establish a minimum set of specifications for radiopharmaceutical software products.
• To address the unique requirements of radiopharmacy within the RHP circuit.
• To guide software publishers in developing tools tailored for radiopharmaceutical practices.

Main Methods:

• A working group under the Société Française de Radiopharmacie (SoFRa) developed the specifications.
• Analysis of risk maps from various hospital structures informed the global synthesis of processes, settings, interfaces, and requirements.
• Incorporation of specific radiopharmacy needs, including radioactive decay, complex chemical synthesis, and traceability.

Main Results:

• A comprehensive set of specifications for radiopharmaceutical software has been created.
• The specifications cover unique radiopharmacy considerations like radioactive decay and traceability.
• These guidelines will facilitate the development of adapted software tools for the RHP circuit.

Conclusions:

• Standardized software specifications are crucial for the effective computerization of the RHP circuit.
• The developed specifications ensure that software meets the specialized demands of radiopharmacy.
• This initiative will lead to improved tools for managing radiopharmaceutical processes and enhancing patient safety.