Standardised regulations for small-scale preparation of unlicensed radiopharmaceuticals across Europe are needed to ensure quality, support access to these drugs and address the rapid development of new treatments, a new study has concluded.
The study reviewed national regulations in nine countries to examine how unlicensed radiopharmaceuticals are prepared in authorised hospital pharmacies and the standards adhered to for these facilities, personnel and processes, providing an overview of different national regulatory frameworks.
The findings indicated extreme differences in the use and availability of radiopharmaceuticals across Europe.
While approved radiopharmaceuticals are preferred for clinical use, their limited availability has led to unlicensed small-scale preparation of these drugs, regulated by directives, regulations and the rules adopted by EU Member States. Each Member State can interpret the directives as they see fit and introduce changes as long as the objective of the directive is met.
The researchers analysed the national regulation of radiopharmaceuticals in nine countries: France, Italy, Belgium, Germany, Denmark, Finland, Spain, Austria and the UK. They described how unlicensed radiopharmaceuticals are prepared and sought to discover how each nation interprets and implements the Directive 2001/83/UE for preparing them.
The researchers also examined the minimum quality and safety standards for radiopharmaceutical preparations and the educational requirements for radiopharmacists.
The findings highlight a need for ‘harmonised regulation’ across Europe to allow quality assurance of unlicensed radiopharmaceuticals and to ensure the continued availability of the medications, the researchers concluded.
They emphasised the need for proper training for the medical and pharmaceutical personnel involved in preparing and administering these medications, warning that a failure to implement legislation could result in continued discrepancies in patient access to quality radiopharmaceuticals and compromised care outcomes across Europe.
Reference
Moya, E et al. Radiopharmaceutical small-scale preparation in Europe: will we be able to harmonize the situation? EJNMMI Radiopharm Chem 2024; Sep 5: DOI: 10.1186/s41181-024-00281-z.
