ASTER Study Jumpstarts Adverse Event Reporting

By Ann Neuer

July 24, 2009 | Michael Ibara, head of pharmacovigilance information management at Pfizer, has a real passion for improving patient safety. At the recent DIA meeting, he chaired a session on a highly original pilot study focused on a simple way for busy clinicians to report adverse drug events (ADEs) to MedWatch, the FDA’s safety information reporting program. The study, named ASTER—ADE Spontaneous Triggered Event Reporting—is wrapping up its three-month pilot, which was conducted earlier this year at two Partners HealthCare hospitals in Boston—Brigham and Women’s and Massachusetts General Hospital (MGH). 

Michael Ibara
“This was a proof of concept study involving real doctors and real patients. Our intent was to create a new business model using digitized data from electronic health records so doctors could quickly and easily report adverse events. What used to take 36 minutes can now be done in less than a minute!” Ibara says.

The “36 minutes” that Ibara mentions refers to the current MedWatch voluntary reporting form (located on the FDA web site). It is a cumbersome document that can either be printed out or completed online. An estimated 36 minutes are needed to collect the information, review the instructions, do the work, and forward it to FDA. Ibara says it is not realistic to expect busy clinicians to spend such a long time on this task. “So they just don’t report,” he says. 

To create a process that could dramatically cut reporting time, Ibara, through Pfizer, collaborated with other institutions with a strong interest in improving patient safety. His colleagues included Jeffrey Linder, representing Partners HealthCare, and principal investigator on the study; Landen Bain of CDISC; and Lise Stevens of FDA. CRIX International, a not-for-profit organization dedicated to building a common electronic infrastructure for the clinical research industry, provided the technology that enabled the information to be forwarded to FDA. 

Linder explains that 26 doctors with affiliations at either the Brigham or MGH were selected to participate in the study. Doctors were chosen based on two main criteria. “These are doctors who are very busy and who discontinue a lot of drugs in patients due to adverse events,” Linder comments. Despite their workloads, these doctors were keen to participate provided the reporting was straightforward.      

The ASTER study involved signaling doctors electronically when they entered information into the electronic medical record about a patient discontinuing a medication due to an adverse event. At that point, a pre-populated form would pop up advising the doctor that two additional pieces of information were needed—the outcome of the event (death, hospitalization, etc.), and the earliest date of the adverse event. Once complete, the doctor would hit “OK”, and the data would be sent off. Packaged with it would be additional information taken from the medical record, such as the adverse reaction, other medications taken by the patient, demographic data, and laboratory results.

Training was minimal, and after a few attempts, it took the doctors less than a minute to fill out the form. According to Linder, “We did a survey at the end, and overwhelmingly, they said, ‘This is great. It was fast, and didn’t interrupt my workflow at all.’ ” 
Prior to the study, most of the doctors had never reported an adverse event, or did so very rarely. In the three-month study period, more than 200 were reported. Over the next few months, results will be tabulated and studied, and phase II will be planned. By late 2009 or early 2010, the intent is to roll out the next phase to a larger number of physicians, with an eye toward greater acceptance of this program.

“This is a new idea, and my hope is that results will show that improvements in patient safety are actually possible,” says Ibara.


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