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Salus experience and results
- 1. SALUS experience and results Andrea Migliavacca, LISPA
- 2. Pilots Characterization May 28th , 2015 2SALUS, London, UK LISPA PILOT SITE Regional system (based on public health care system data) Large number of health care providers involved (hospitals, GPs, Pharmacists, Laboratories,….) User Target: GP TUD PILOT SITE Hospital system Based on hospital information system User Target: health care professional in hospital
- 3. Evaluation approach – the map May 28th , 2015 3 . What was evaluated Project / System Viability Social Acceptance Potential Economic Advantage System Usability Efficacy & Efficiency Who was involved Lombardy Region Management Pharmacovigilance Experts Clinicians and Monitors In which way we did it Workshops, Focus Groups, dedicated meeting Real Test Executions SALUS, London, UK
- 4. Evaluation approach – the road May 28th , 2015 4SALUS, London, UK SALUS COMPONENTS Viability Social acceptance Potential economic advantage Usability Efficacy Efficiency 1- ADE Notification Tool RL GPs GPs / Monitor RL/ Monitor RL/ Monitor 2- ICSR Reporting Tool RL GPs RL GPs / Monitor 3- Case Series Characterization Tool RL RL RL RL RL 4- Temporal Pattern Characterization Tool RL RL RL RL RL 5- Temporal Association Screening Tool RL RL RL 6- Patient History Tool RL RL RL RL / Monitor RL / Monitor 7- Post Marketing Safety Study Tool RL RL RL RL RL 8- Audit Record Repository Tool LISPA RL
- 5. Evaluation activities – the journey May 28th , 2015 5 # 2 meetings with Regional Management # 1 focus groups with physicians and pharmacovigilance operators # 1 focus group with Monitors # 2 technical users for evaluation statistic tools # 1 test on field (support for an analysis related to NOACs) # 2 meetings with AIFA SALUS, London, UK
- 6. Evaluation activities – UMC & ROCHE May 28th , 2015 6 UMC Focus group based on questionnaires focused on usability and efficacy 3 pharmacists with experience of pharmacovigilance 1 senior researcher ROCHE Interviews based on questionnaire focused on usability, efficacy and efficiency 1 data analyst 1 epidemiologist SALUS, London, UK
- 7. Evaluation results & lessons learned May 28th , 2015 7SALUS, London, UK Validation axes Results Project / System Viability The system is totally compliant with law and rules (in Lombardy – Italy) Social acceptance It is very relevant a training process to involve GPs in this new approach. It is a good opportunity for redesigning the relation between GPs and Pharmacovigilance Potential economic advantage Lombardy Region about 440 K€ year System Usability System easy to use and to learn Efficacy Could improve the PV governance process Could involve the GPs into the process Efficiency Reduce work time and increase data quality Support code translation (from ICD9 to Meddra)
- 8. Evaluation results & lessons learned May 28th , 2015 8SALUS, London, UK • Patient History Tool • CSC - TPC - TAS • PMSS Researchers • ANT Notification Manager • ICSR (web ADE report) Clinicians • SILD • Terminology Server Semantic layer • Enrich the Regional Healthcare DWH • More value and more usability and interoperability (at regional, national and international level) Regional level Increase efficacy and efficiency in PV process Increase efficacy in governance More quality in ADE report. More value in re use clinical and / or administrative data National level Opportunity to have a smart Sentinel System based on DWH to speed up first check in post market analysis
- 9. Thank you...
Editor's Notes
- Viability can be considered as “The ability to live, especially under certain conditions: e.g. compliancy with rules or laws; and the capacity to operate or be sustained in the future”. Usability “quality attribute that assesses how easy user interface are to use”. Effectiveness of Efficacy (can users successfully achieve their objectives) Efficiency (how much effort and resource is expended in achieving those objectives) Satisfaction (was the experience satisfactory) Social acceptance which represents the “limit to accept by a stakeholder or a user a new tool or a new process because the new tool or new process reduce the means in which people define who they are, what they are, and how they've become to be”. The Potential economic advantage can also be validated as a key factor for future development of SALUS system versus a potential interested market. At this stage this characteristic can be related to “a cost reduction in the process and the economic benefit in reducing elapsed to identify a real risk in drug usage”. Figure 9 illustrates the basic economic rule for this and shows why we specifically address the potential economic advantage of the SALUS system. Efficacy or effectiveness is “the capacity to produce a desired results through the usage of the proposed system”. Efficiency generally describes “the extent to which time, effort or cost is well used for the intended task or purpose”. This characteristic is measured in terms of SALUS system performances through the continuous comparison with state of the art of the pharmacovigilance process.