Difference between revisions of "Drug Safety Content"
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<h2> 2. The Problem </h2> | <h2> 2. The Problem </h2> | ||
+ | <h4> This content profile is one of a family of content profiles designed to extend the power and value of RFD </h> | ||
<p> Physicians who encounter adverse drug events are requested to report these events to the FDA. This reporting is voluntary and spontaneous, and, by most estimates, covers less than 1% of reportable events. Despite this low reporting rate, the spontaneous reporting system (SRS) remains the primary source of potential adverse events. To increase the value of the SRS we need to improve recognition of adverse drug events (ADEs), decrease the burden of reporting, and improve the quality of the data in the report. </p> | <p> Physicians who encounter adverse drug events are requested to report these events to the FDA. This reporting is voluntary and spontaneous, and, by most estimates, covers less than 1% of reportable events. Despite this low reporting rate, the spontaneous reporting system (SRS) remains the primary source of potential adverse events. To increase the value of the SRS we need to improve recognition of adverse drug events (ADEs), decrease the burden of reporting, and improve the quality of the data in the report. </p> | ||
<p> The overall goal of this effort is to create a new business model for post-market safety reporting by employing the Retrieve Form Data capture (RFD) standard, the HL7 Individual Case Safety Report, and novel design to collect higher quality data directly from electronic medical records (EMR) and make it easier for physicians to report these events. This can positively impact public health as a whole in our country. </p> | <p> The overall goal of this effort is to create a new business model for post-market safety reporting by employing the Retrieve Form Data capture (RFD) standard, the HL7 Individual Case Safety Report, and novel design to collect higher quality data directly from electronic medical records (EMR) and make it easier for physicians to report these events. This can positively impact public health as a whole in our country. </p> |
Revision as of 07:54, 13 March 2008
1. Proposed Profile: Drug Safety Content
- Proposal Editor: Landen Bain, CDISC Liaison to Healthcare
- Editor: Michael Ibara, Head of Pharmacovigilance Information Management, Pfizer
- Date: January 2008
- Version: 1.0
- Domain: Patient Care Coordination