*ASTER

‘ASTER’ stands for:  “ADE Spontaneous Triggered Event Reporting”.  The ASTER study was conceived as a proof of concept for a new model of gathering and reporting spontaneous adverse drug events (ADEs).

Click here to link to a recent presentation that describes the ASTER Study. 

ASTER is a collaboration of the following organizations and individuals:

ASTER implemented automated ADE collection in an ambulatory clinic electronic health record (EHR), using a flexible standard for data collection known as “Retrieve Form for Data” (RFD) from CDISC and Integrating the Healthcare Enterprise (IHE).  CRIX International hosted the application.  The application allows direct downloading of data from the EHR and direct submission to the FDA in the proper formats for electronic reporting of individual case safety reports (ICSRs).

Michael Ibara ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it / 212- 733-6194) is the overall study contact responsible for coordinating the various groups’ efforts. Pfizer is involved because we see the need to improve the quality of spontaneous reports in order to improve drug safety.  We hope the ASTER pilot can demonstrate how a national system might work, and can provide us with a deeper understanding of the challenges associated with improving safety surveillance.

We have received excellent input and feedback from healthcare providers, other pharmaceutical companies and FDA on this initiative.  The pilot went live in December 2008 and will be completed in June 2009. 

Following is an outline of the process employed by ASTER:

1.      The physician discontinues a drug due to an adverse event (AE) in the Partners LMR (longitudinal medical record);

2.      This will automatically trigger a prepopulated adverse event report which appears directly in the LMR;

3.      The physician will complete a small amount of additional information and release the form;

4.      The form is received and processed by CRIX International who will put the form in the proper format for electronic reporting to FDA.  This study will test both the current International Conference on Harmonization (ICH) E2B ICSR standard as well as the developing Health Level 7 (HL7) ICSR standard;

5.      FDA will receive a ‘triggered’ report which is equivalent to a reported spontaneous adverse event from the ambulatory care physician.

To have a scalable, workable solution for reporting spontaneous ADEs, we must address the system as whole.  In a complex system, solving one problem can create others.  If we increase the number of number of high-data-quality reports of adverse events, we must increase the downstream capacity to handle these events.  A complete solution involves:

- Point of care issues (e.g., recognition, burden of reporting);

- Technologies and standards that will enable a new solution;