Project

The SafeChemo project aims at:
1) providing a system solution for the challenges related to cytostatics management
2) being proactive versus the evolving regulations towards workers’ safety in the compounding area
3) providing the knowledge needed to reengineer the process and validate the service

The ultimate results should be:

* increased safety,
* increased efficiency and
* increased cost-effectiveness.

In order to achieve these goals SafeChemo introduces:

• state of the art automation (robotics and software)
• a thorough validation model to assess the service performance
• reengineering and implementation services
• maintenance and assistance services

SafeChemo will be market validated in the following test sites:

• The RAP Pharmacy (part of the Copenhagen University Hospital) in Denmark
• The Imperial College Healthcare NHS Trust in the United Kingdom
• The General Hospital of Bolzano in Italy

The SafeChemo turn-key approach includes:

1) A series of automation modules:

• the MedArchiver ONCOPLAN© e-prescription software module, allowing the definition of standard and/or specific protocols, interface to all available clinical data, automated calculation of doses, definition of all prescription details such as speed, route, administration time etc.;
• the MedArchiver CYTOPLAN© production scheduling software module, which allows processing of all incoming prescription data, dispatching of prescription to multiple machines, organizing production cycles etc.
• the CYTOCARE© robotics for the preparation of injectable solutions in a sterile environment, allowing the automated compounding of drugs in final solutions, a highly precise check on drug, dose, volume and other relevant parameters, labeling of final compounded preparations;
• the MedArchiver Oncoplan MAR© medication administration software module, allowing a point-of-care double check of patient and dose to be administered.

2) A validation model to assess:

• microbiological safety
• precision
• performance
• cross-contamination
• workers’ safety
• return on investment

3) The reengineering and implementation services to analyze the current cytostatics management circuit and support process change

4) The maintenance and assistance services

The workflow shown in the upper right corner (see SafeChemo workflow),  provides a basic overview of the reengineered process foreseen within a healthcare organization after the introduction of the SafeChemo service.

The SafeChemo service will be market validated in leading healthcare institutions in Denmark, Italy and the UK.

• The SafeChemo specific objectives can be listed as follows:

 

Objective	How it will be measured	Expected results
Error reduction	Comparison of error levels between manual and automated system, automated dose calculations, greater consistency in the preparation of doses, efficiency of redundancy/buffers to prevent errors	Significant decrease in prescription, transmission, transcription, documentation, preparation errors versus the manual system.
Reduced reliance on Pharmacists and Nursing staff trained in oncology compounding	Number of preparations automatically handled by the system; easiness of system use, efficiency of redundancy and buffers to prevent errors	Increased production capacity Decreased human labour Decreased learning curve for professionals
Increased safety for pharmacy staff i.e. minimisation of exposure risks, needle stick injuries, cumulative strain disorders etc.	Number of preparations automatically handled by the system; reduction of operator contact time with cytostatics	Decreased human labour Enhanced results from exposure tests
Increased product protection from potential contamination sources by means of closed system technology	Comparison of contamination levels with the manual and automated system	Decreased contamination versus manual system
Increased system efficiency	Reduction of wasted products, increased batching possibilities, reduction of waiting time for patients, electronic management and monitoring of the entire cytostatics preparation cycle	Increased satisfaction level from professionals (measured through specific questionnaires)
Increased patient satisfaction	Reduction of errors, reduction of waiting time, increased safety, perceived increased efficiency	Increased satisfaction level from patients (measured through specific questionnaires)
Reduced cost	Reduction of waste, automation of activities previously performed by pharmacy staff	Decreased cost per patient

In order to produce reliable results in terms of market validation of the SafeChemo platform, the three hospitals involved are performing a detailed analysis of the current cytostatics preparation cycle, including the organizational challenges linked to a distributed scenario (multi-centre, home patients etc.). Activities are divided into:
a) Patient related activities, and
b) Preparation related activities.

Performance criteria have been set, as well as evaluation methods, in order for the validation tests run in the three pilot sites to be comparable (ex. laboratory tests to assess operator’s exposure).

Additionally the three hospitals have agreed on a cost evaluation model, which will allow defining total cost of a cytostatic preparation in the current scenario – including prescribing, transmission, preparation etc. This tool will eventually enable final assessment of the system’s cost effectiveness.

Finally, a set of questionnaires to gather data on satisfaction levels for personnel and patients will contribute to a complete overview of the system tangible and intangible benefits.