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Regulatory Focus™ > News Articles > AHRQ Plans Patient-Based Adverse Event Reporting System

AHRQ Plans Patient-Based Adverse Event Reporting System

Posted 12 September 2012

Adverse event reporting could become more widespread under a new system proposed by the Agency for Healthcare Research and Quality (AHRQ).

In a 10 September Federal Register posting, the agency, which acts to collect and analyze data about the quality and efficiency of care in the US, said it had submitted to the Office of Management and budget (OMB) a request to approve its prototype for a Consumer Reporting System for Patient Safety Events.

AHRQ said the system is aimed at collecting information from patients, as opposed to healthcare professionals, regarding safety events using standardized definitions and formats. Present adverse event reporting can be fragmented and difficult for patients to understand or use. AHRQ's Federal Register posting notes that many adverse events go unreported either because patient data is not accepted or because of the poor quality of submissions.

AHRQ aims to change that dynamic, it said. "AHRQ recognizes that the unique perspective of health care consumers could reveal important information that is not reported by health care providers," it said. "Patient reports could complement and enhance reports from providers and thus produce a more complete and accurate understanding of the prevalence and characteristics of medical adverse events."

The prototype of the system has already been developed, the agency explained, and now requires testing to ensure it is able to record consumer data about patient safety events. The research is set to be carried out by the RAND Corporation, widely known for providing healthcare research services.

Though the system does not focus on the use of healthcare products such as pharmaceuticals and medical devices directly, because the products are widely used in healthcare settings overseen by AHRQ the system may eventually come to provide safety signals to the US Food and Drug Administration (FDA) about the safety and use of some products.


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