Providing and administering RLT
This section of the Novartis RLT Institute is designed to help health care professionals (HCPs) understand radiation safety procedures for providing and administering radioligand therapies (RLTs) manufactured by Novartis. It is based on guidelines from regulatory agencies, including the Nuclear Regulatory Commission (NRC), the Department of Transportation (DOT), and the United States Pharmacopeia (USP). Topics include safe transport, administration, and postadministration protocols to prepare the patient and room for subsequent use.
Receiving, handling, and storage
Delivery
Transportation regulation
The transport of radioactive material (RAM), including RLTs, is governed by multiple regulatory bodies to ensure safety and compliance.1
Within the US, the DOT and the NRC share responsibility under a Memorandum of Understanding, while the International Air Transport Association (IATA) oversees the air transport of hazardous materials both domestically and internationally.1,2
DOT regulations address requirements for packaging, shipper and carrier responsibilities, documentation, and the transportation of all levels of RAM, from exempt quantities to very high levels1
IATA Dangerous Goods Regulations outline standards for the preparation, acceptance, and handling of dangerous goods, including RAM, in compliance with international air transport regulations2
RAM transportation
RLTs are transported from the pharmaceutical manufacturing site or radiopharmacy to the clinic. HCPs are not typically involved in, or licensed for, the transport process; their role is limited to receiving the material at their site.3
RLTs can be transported by highway or air under regulations set by the DOT and IATA.2,4 DOT limits air shipment of RAM, however, exceptions are made for radiopharmaceuticals that are small, short-lived, and lightweight, as these often require expedited delivery to hospitals and medical laboratories.4
Delivery within the facility
Upon arrival at the RLT facility, the RAM package will be delivered to the hot lab via the route(s) predetermined in the RAM license and designed to minimize exposure to the public and staff.3