A Modified Potency Test Strategy for IV Admixtures Prepared by Robotic Systems
Introduction: Robotic systems are increasingly used for compounding sterile IV admixtures (1-5). In addition to routine gravimetric checks, initial and periodic drug potency analysis by high-performance liquid chromatography (HPLC) is desired to verify the system accuracy. However, the conventional HPLC test procedures often result in unexpected failures (1-2). This study was initiated to develop a modified HPLC test strategy to eliminate the common source of variability and focus the effort on the accuracy of robotic system.
Automated preparation of chemotherapy: quality improvement and economic sustainability.
PURPOSE
The quality and economic implications of manual versus automated preparation of antineoplastic drugs were compared.


METHODS
This four-week study evaluated 10 routinely used antineoplastic drugs (fluorouracil, cyclophosphamide, gemcitabine, trastuzumab, bevacizumab, oxaliplatin, cisplatin, paclitaxel, irinotecan, and etoposide) prepared by manual and automated procedures. The accuracy of the dose of the active ingredient was calculated in terms of percent relative error for the difference between the nominal value indicated on the prescription and the actual value of the drug in the finished product. A comparative economic analysis of the manual and automated preparation procedures was performed by calculating the mean unit cost for each preparation at different production levels. Participating pharmacists and technicians completed a survey rating each preparation method in terms of performance, operator satisfaction, technology, and safety.


RESULTS
Of the 2500 i.v. antineoplastic preparations made in the pharmacy during the four-week study period, 681 were analyzed (348 using the automated procedure and 333 manually). Of these, 17 varied by more than 5% of the prescribed dose, and 1 varied by over 10%. Accuracy, calculated in terms of average percent relative error, was the highest and lowest during manual preparation. The preparation time for individual drugs was always higher when prepared using the automated procedure. A lower mean variable unit cost was observed for preparations made using the automated procedure. Questionnaire results revealed that operators preferred the automated procedure over the manual procedure.


CONCLUSION
Both the automated and manual procedures for preparing antineoplastic preparations proved to be accurate and precise. The automated procedure resulted in substantial advantages in terms of quality maintenance standards and risk lowering.
La gestione del rischio nelle organizzazioni sanitarie italiane:analisi di aspetti culturali e metodologici secondo un approccio "human centred"
The focus of this PhD thesis is on using industrial risk management and human factors engineering theories, in order to understand the specific characteristics of healthcare organisations and to design principles and methodologies for the improvement of patient and health care employee safety. 
 
The present research aims to: 
Explore the Italian state of art in Clinical Risk Management. Which is the Clinical Risk Management organisational configuration in Italian healthcare context? Which specific techniques and methodologies have used in Italian health care systems? 
Individuate and verify the factors influencing the growing and sharing of the safety culture. This investigation begins with the consideration that a fundamental part of risk management is about changing behaviour towards safer care. This change comes about through learning, which takes place at the level of individual health professional, at the organizational systems levels, and at point in between. How much and in which way cultural aspects influence the success of Risk management processes? 
Understand and describe the possibility to transfer human reliability methodologies and theories to healthcare domain. How to develop useful and applicable clinical risk management tools and solutions, basing on Human Factors discipline? 
To attain the established goals, I will, below, in introductory Chapter 1 and in Chapter 3, take a closer look respectively at Industrial Risk Management and Clinical Risk Management. In Chapter 2 I'll investigate the main characteristics of healthcare organisations. In Chapter 4 I'll present the thesis research project, which cover the research process step by step, and in particular introduce the empirical and theoretical gaps, the general objects, the research questions and the research methodology. In Chapter 5 I will introduce the phenomenon of human error. Starting with an overview, we will present models from cognitive psychology and from work sciences. The considerations presented in this chapter are to be used as foundations for the development of a methodology to acquire and judge human errors on the basis of practical operational experience in the healthcare context. In the chapter 5 I will also describe the construct of quality. The four constructs, presented inside the several chapters (Clinical Risk Management, Patient Safety Culture, Quality aspect and Human Factors), will be the theoretical framework that I have investigated. 
Building on the literature review and data collection with a sample of 6 organisations, I'll develop the within case analysis and cross case search for patterns (Chapter 6 and Chapter 7). 
In conclusion, I'll discuss the significance of the results. Chapter 9 summarizes the essential results of the entire endeavour in terms of methodological developments and the analysis of cases studies.