Risk assessment and economic impact analysis of the implementation of new European legislation on radiopharmaceuticals in Italy: the case of the new monograph chapter Compounding of Radiopharmaceuticals (PHARMEUROPA, Vol. 23, No. 4, October 2011).

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Chitto, Giuseppe
Di Domenico, Elvira
Gandolfo, Patrizia
Ria, Francesco
Tafuri, Chiara
Papa, Sergio

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An assessment of the new monograph chapter Compounding of Radiopharmaceuticals has been conducted on the basis of the first period of implementation of Italian legislation on Good Radiopharmaceuticals Practice (NBP) in the preparation of radiopharmaceuticals, in keeping with Decree by the Italian Ministry of Health dated March 30, 2005. This approach is well grounded in the several points of similarity between the two sets of regulations. The impact on patient risk, on staff risk, and on healthcare organization risk, has been assessed. At the same time, the actual costs of coming into compliance with regulations have been estimated. A change risk analysis has been performed through the identification of healthcare-associated risks, the analysis and measurement of the likelihood of occurrence and of the potential impact in terms of patient harm and staff harm, and the determination of the healthcare organization's controlling capability. In order to evaluate the economic impact, the expenses directly related to the implementation of the activities as per ministerial decree have been estimated after calculating the overall costs unrelated to NBP implementation. The resulting costs have then been averaged over the total number of patient services delivered. NBP implementation shows an extremely positive impact on risk management for both patients receiving Nuclear Medicine services and the healthcare organization. With regard to healthcare workers, instead, the implementation of these regulations has a negative effect on the risk for greater exposure and a positive effect on the defense against litigation. The economic impact analysis of NBP implementation shows a 34% increase in the costs for a single patient service. The implementation of the ministerial decree allows for greater detectability of and control over a number of critical elements, paving the way for risk management and minimization. We, therefore, believe that the proposed tool can provide basic criteria for analysis that could be used by other organizations setting about completing the same process.







Francesco Ria

Assistant Professor of Radiology

Dr. Francesco Ria is a medical physicist and he serves as an Assistant Professor in the Department of Radiology. Francesco has an extensive expertise in the assessment of procedure performances in radiology. In particular, his research activities focus on the simultaneous evaluation of radiation dose and image quality in vivo in computed tomography providing a comprehensive evaluation of radiological exams. Moreover, Francesco is developing and investigating novel mathematical models that, uniquely in the radiology field, can incorporate a comprehensive and quantitative risk-to-benefit assessment of the procedures; he is continuing to apply his expertise towards the definition of new patient specific risk metrics, and in the assessment of image quality in vivo also using state-of-the-art imaging technology, such as photon counting computed tomography scanners, and machine learning reconstruction algorithms.

Dr. Ria is a member of the American Association of Physicists in Medicine task group 392 (Investigation and Quality Control of Automatic Exposure Control System in CT), of the American Association of Physicists in Medicine Public Education working group (WGATE), and of the Italian Association of Medical Physics task group Dose Monitoring in Diagnostic Imaging.

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