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).

Chitto, Giuseppe

Di Domenico, Elvira

Gandolfo, Patrizia

Ria, Francesco

Tafuri, Chiara

Papa, Sergio

United Arab Emirates

2017-02-23T22:54:22Z

2017-02-23T22:54:22Z

2013-12

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.

https://www.ncbi.nlm.nih.gov/pubmed/24329569

CRP-EPUB-57955

1874-4729

https://hdl.handle.net/10161/13674

eng

Bentham Science Publishers Ltd.

Curr Radiopharm

Cost-Benefit Analysis

Drug Compounding

European Union

Female

Guideline Adherence

Humans

Italy

Male

Occupational Exposure

Patient Safety

Quality Control

Radiation Protection

Radiopharmaceuticals

Risk Assessment

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).

Journal article

Ria, Francesco|0000-0001-5902-7396

https://www.ncbi.nlm.nih.gov/pubmed/24329569

208

214

4

Clinical Science Departments

Duke

Radiology

School of Medicine

Published

6