SALUS Project at a glance

SALUS Project aims to increase patient safety by enabling secondary use of electronic health records for post-market safety studies.

The SALUS project is exploring new ways of accessing and analyzing data found in electronic health records to provide an infrastructure that will enable execution of safety studies for mining and analyzing real-time patient data. In this way, patient safety can be ensured through early detection of rare adverse events; the pharmaceutical industry can provide faster medication innovation by decreasing time to market for new, safe and effective drugs, and at the same time the load of overwhelmed medical practitioners can be reduced.

Use of Electronic Health Records

Electronic health records (EHRs) provide a huge but still under-utilized source of information on the real world use of medicines. Although EHRs are primarily utilized for patient care, they also contain a broad range of clinical information highly relevant for safety analysis. EHR data available in clinical care systems can clearly complement and strengthen existing post-marketing safety studies based on data from spontaneous reporting systems. Relative to spontaneous reports, EHRs cover extended parts of the underlying medical histories, include more complete information on potential risk factors, and are not restricted to patients who have experienced a suspected Adverse Drug Events (ADEs).

The cost of ADEs for public health

Despite pre-marketing clinical trials, ADEs impose a remarkable burden on the health care systems: they are estimated to be responsible for 6.5% of hospital admissions, complicate at least 1 in 7 in-patient episodes, and account for considerable morbidity, mortality, and extra costs. An impact assessment carried out for the EU Commission has estimated that ADEs cause 197,000 deaths per year in the EU, at a total cost of €79 billion [1]. As a consequence, post-marketing surveillance of drugs and prevention of ADEs still remains a major public health issue.

A need for post-marketing monitoring of drugs

Post-marketing studies and clinical trials are the central momentum to gather additional information about a product’s safety, efficacy, and optimal use, by collecting side effects and ADEs. However, due to the limited size and duration of clinical trials drugs may still have serious side effects after they are marketed. The risk of rare events, and delayed effects of drugs must therefore be continuously monitored. Current post-market safety surveillance is largely based on reports of suspected adverse drug reactions sent to the regulatory bodies by health care professionals, and in some countries by patients themselves. However, the reporting rate of adverse drug events is very low, partially due to overloaded medical personnel that find detecting adverse events to be difficult and that do not always see ADE reporting as a priority.

The SALUS solution for access to EHRs

Can we then use the EHRs gathered in hospitals and national health information systems to continue to monitor the safety of drugs after they are marketed? Would this help us to carry out safety studies on a proactive basis? SALUS, an R&D project co-financed by the European Commission’s 7th Framework Programme (FP7), is attempting to answer these questions. As part of the project, solutions for access to EHRs are being built to strengthen the post-market safety studies in order to monitor and validate drug safety.

SALUS project is developing two tools to relieve the burden of ADE reporting for health care professionals.

  1. The ADE Notification Tool automatically screens the electronic heath records, and by the help of pre-defined adverse event detection rules, it notifies the physician about the possibility of an adverse drug event by presenting relevant parts of the medical summary of the patient, highlighting the suspected events.
  2. The ADE Reporting Tool, accesses the EHRs for extracting the available information from the EHRs into the individual case safety reports to avoid double data entry. These tools aim to assist the healthcare professionals for delivering timely feedback to the regulatory bodies via semi-automatic EHR supported adverse event reporting.

Benefit from SALUS at Pharmacovigilance Centres

The SALUS project is also developing mechanisms to strengthen the existing drug safety studies carried out in pharmacovigilance centers by developing tools to combine the strength of spontaneous reports with those of EHRs.

Vigibase, The WHO database of spontaneous reports, collects case reports from 111 participating countries and is maintained by UMC, one of the SALUS partners. The number of spontaneous reports in VigibaseTM is growing more and more each year reflecting a trend of greater use of drugs, growing awareness of their risks and improvements in the reporting system.  On behalf of the WHO International Programme for International Drug Monitoring, UMC analyzes VigiBaseTM for potential ADE signals.  The main objective is to find new ADEs previously unknown or incompletely documented.

In SALUS we have developed tools that can be used by UMC to validate potential ADE signals. De-identified medical summaries of a selected group of patients can now be retrieved from EHRs, so that the characteristics of the reported cases can be compared with the selected reference patient groups. The aim is to determine if there are explanations more likely to cause the reported adverse event other than exposure to the drug of interest.

Number of ADE reported cases in Vigibase per year. Uppsala Monitoring Center Report n61(UR61), April 2013, http://www.who-umc.org/

Number of ADE reported cases in Vigibase per year. Uppsala Monitoring Center Report n61(UR61), April 2013, http://www.who-umc.org/

With the SALUS tool set, it is also possible to screen electronic healthcare records to detect and analyse temporal patterns between a drug of interest and potential adverse drug events. It will also be possible to trace the reported case safety reports back to the EHRs to collect additional information on the extended parts of the underlying medical history of the patient.

Deployment and clinical validation of the SALUS tool set

SALUS project will finalize these toolsets by spring 2014. The tools will be deployed at Uniklinikum Dresden, the largest hospital structure Saxony, Germany, and in the Lombardy Region in Italy covering a population of 9.9 million citizens with about 215 million yearly records. Clinical validation will be carried out during August 2014-January 2015.

You can download a PDF version of this infosheet from here.

For more information about SALUS Project, please check the Web site: http:www.salusproject.eu

Contact point: Dr. Gokce Banu Laleci Erturkmen, email:gokce[at]srdc.com.tr

[1]  http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A7-2010-0159&language=EN