CDISC Blog

Philadelphia, Pennsylvania

29 November 2011

At the end of November, I had the opportunity to sit in on an Electronic Health Record (EHR) Roundtable discussion, which was organized by Tufts Center for Drug Development, CDISC and HL7 and took place at the GlaxoSmithKline complex in central Philadelphia, PA. There were exciting updates about the status of EHRs globally, with primary topics of discussion revolving around the expansion of EHR usage to assist in promoting safety and to enable research.

EHRs are gradually being adopted worldwide. Already, nations like Singapore have adopted nationwide EHR systems. One of the greatest hurdles to the adoption of EHRs for research has been regulatory ‘approval.’ Acceptance by regulatory entities of EHRs is critical for expanded adoption, but at the present moment there continue to be concerns voiced and misperceptions communicated, which encourages the continued practice of inefficient re-entry of data from paper.

EHRs have the ability to promote better drug safety. Currently, adequate drug safety profiles are unavailable, which can cause harm to the patient. Often the side effects of a new drug are unknown until its release into the market. Spontaneous reports can assist in the public’s understanding of potential side effects, but they tend to only offer limited information about known problems, and always after those problems occur. In addition, they are very cumbersome and are therefore not always provided by busy clinicians. There is interest in utilizing electronic healthcare databases to follow drugs for scientific results, but as of yet the data is not standardized to the degree that it can actually be used; in fact, most of the available data is sent in via fax.

A potential solution to this problem was first demonstrated by the ASTER Project (ADE Spontaneous Triggered Electronic Reports). ASTER enables adverse event reporting through current EHR systems. When a doctor discontinues prescription of a drug for a patient, s/he is prompted with a series of short questions to determine if this is due to an adverse event from the drug. ASTER offers the opportunity to follow event details that are not recorded in an EHR, as it is not regulatory information. After about 20 minutes, a MedWatch report, derived from the EHR, is delivered to the FDA to report on the adverse event. When ASTER was tested previously, 20% of these reports were deemed as “serious,” 100% had height/weight and lab data, and 91% of participating physicians had not submitted any ADE reports the prior year. ASTER’s ease of use, and the opportunity to report adverse events at the point of care within 60 seconds (vs. 34 minutes for a fax report), makes this innovative approach an essential step in enabling safer, more effective drugs. This breakthrough process and astounding results would seem to encourage uptake; the fact that this has not happened was the topic of discussion for the Roundtable attendees. The same process is available for ‘serving up’ electronic case report forms for clinical research studies. This was discussed by Jason Colquitt, who is on the Board of the EHR Association and a leader for Greenway (an EHR provider). The case study for research done at a site in Georgia was shared by the group.

Both Dr. Rebecca Kush and Mr. Landen Bain attended the EHR Roundtable and presented on behalf of CDISC. For more information, or to watch video clips of their presentations, please visit http://www.cdisc.org.

The next step is to find a protocol and a sponsor willing to take advantage of this opportunity to leverage the current increase in adoption of EHRs to expand the potential pool of clinicians willing to do research (and the potential patient population) by streamlining the process significantly and thus making it easier for them to participate. The overarching goal is to improve the quality of research and patient safety.

Kubick, Wayne. “EHR/EDC Interoperability: We Have Met the Enemy and He is Us.” Applied Clinical Trials. 5 July 2011.

Kush, Rebecca. “Transforming Medical Research with Electronic Health Records.” iHealth Connections 1.1 (2011): 16-20. Print.

Andrea Vadakin Manager of Public Relations

Clinical Data Interchange Standards Consortium

21 December 2011