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FDA's Adverse Event Reporting System (AERS) Needs Improvement.

Reports of Potential Drug Side Effects by Physicians, Pharmacists, Patients, and Manufacturers.

The Adverse Event Reporting System, or AERS, is the FDA's system to monitor potential side effects of a prescription drug after it has been approved for use by patients in the U.S. This system is often referred to as the MedWatch program. Experts have estimated that as few as ten percent of possible drug reactions are reported to the FDA through AERS, or MedWatch. Under the current system, the FDA relies upon voluntary reports of possible drug adverse reactions from physicians, pharmacists and patients; drug companies are required to inform the FDA about reports of adverse events involving use of their prescription medications.

 
 
 
 

PioneeringMed is a healthcare technology services company employing innovative techniques to streamline and automate the Adverse Event Reporting Process.

   
 

We have built web-based services to supply customers with operational efficiencies, cost savings, and improved
timeliness in processing of healthcare information

   
 

eMedSafety will be a web-based service dedicated to adverse event processing. Site administrators will log into eMedSafety to easily create reports when one of their patients experiences an adverse event.

They will use digital versions of their own customized forms as well as the forms required by their IRB, pharmaceutical company sponsors, and regulators. eMedSafety will help administrators route notices using the Internet, capture signatures electronically, index reports to help clinicians monitor potential safety issues, and maintain records to support compliance audits.

 

Most of a site's adverse event processing burden is a result of SAEs that occur at other clinical sites. These "off-site SAEs" result in hundreds of incoming SAE notices and protocol change bulletins that must be read, keyed into the unique forms used by this particular site and its IRB, routed to the appropriate physicians, signed, returned and retained all according to the prescribed timelines and procedures needed to maintain FDA compliance. Today, these processes begin when sites receive paper-based forms that arrive by mail and fax, producing time- and laborintensive data entry work for highly paid, skilled nurses. eMedSafety will intercept the incoming forms and convert the data into the site's own, customized electronic forms to be approved and routed with the click of a mouse, and tracked and stored online.

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