„Nothing spurs science on like chatting
with colleagues in the hallways“
Arno Penzias (*1933), Physicist and Astronomer, Nobel Prize winner 1978
Radiopharmaceuticals are considered to be drugs. Therefore the applicable requirements by law (Medicinal Products Act -AMG, Medicinal Products Site Regulation – AMBO) must be fulfilled. Since the procurement of drugs is clearly regulated these processes must be performed through a pharmaceuticals institute. The Isotope pharmacy in the General Hospital is the only one of its kind in Austria. Whether the drugs are produced directly for the patients (for the users) or whether they are acquired, the radiopharmacy is an important partner in both cases.
If it concerns the production of radiopharmaceuticals for routine or clinical studies, it is a stipulation of the applicable rules and regulations that the quality must meet the current state of science and technology. Extensive quality controls as well as certified quality management (ISO 9001:2008) are basic requirements of this. These quality controls are monitored by certified radiopharmacists and are always maintained at the highest level.
For clinical studies it is also necessary to submit the protocol approved by the Ethics Committee to the Authorities. This authority (BASG) then has the right to prohibit the studies if there are justified shortcomings. The basis for these authority notifications are diverse documents which guarantees the security and quality of production/analytics. The authority makes a decision on any prohibition on the basis of these documents.
Many new and specific radiopharmaceuticals are required in order to ensure a comprehensive and purposeful provision. At the same time the personalised diagnostics and the stratification of therapy is a very important area. For this reason it is necessary to develop more precise and selective radiopharmaceuticals. Before new radiopharmaceuticals can be introduced to patients a pre-clinical evaluation is required. The methods of experimental nuclear medicine guarantee these pre-clinical evaluations.