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)
Giuseppe Chitto, Elvira Di Domenico, Patrizia Gandolfo, Francesco Ria, Chiara Tafuri and Sergio Papa
Affiliation: CDI Centro Diagnostico Italiano S.p.A., 20 via Saint Bon, 20147 Milano, Italy.
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.
Keywords: Quality risk management, quality control, compounding of radiopharmaceuticals, risk assessment, economic
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