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).
Abstract
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.
Type
Journal articleSubject
Cost-Benefit AnalysisDrug Compounding
European Union
Female
Guideline Adherence
Humans
Italy
Male
Occupational Exposure
Patient Safety
Quality Control
Radiation Protection
Radiopharmaceuticals
Risk Assessment
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Francesco Ria
Research Associate, Senior

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