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Adverse Event Reporting Soars As Consumer Submissions Pass Physicians

Executive Summary

The growth in submissions to FDA's Adverse Event Reporting System is being driven primarily by consumers, according to 10 years of data released by the agency

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Record number of serious injuries and deaths reported from prescriptions

The Institute for Safe Medication Practices reported Oct. 23 that serious injuries and deaths associated with drug therapy were reported for a record total of 20,745 people during the first quarter of 2008, including 4,824 deaths. The number of injuries is 38 percent higher than the average for the previous four quarters, while the number of deaths represented a 2.6 fold increase from the previous quarter. Deaths also counted for a greater percentage of serious injuries, 23 percent, compared to the historical average of 16 percent. ISMP culls its data from FDA's MedWatch program and reports submitted through the agency's Adverse Event Reporting System. Consumers currently make up the majority of those reporting to this system, surpassing physician reporting in 2006 (1"The Pink Sheet," June 23, 2008, p. 17)

Record number of serious injuries and deaths reported from prescriptions

The Institute for Safe Medication Practices reported Oct. 23 that serious injuries and deaths associated with drug therapy were reported for a record total of 20,745 people during the first quarter of 2008, including 4,824 deaths. The number of injuries is 38 percent higher than the average for the previous four quarters, while the number of deaths represented a 2.6 fold increase from the previous quarter. Deaths also counted for a greater percentage of serious injuries, 23 percent, compared to the historical average of 16 percent. ISMP culls its data from FDA's MedWatch program and reports submitted through the agency's Adverse Event Reporting System. Consumers currently make up the majority of those reporting to this system, surpassing physician reporting in 2006 (1"The Pink Sheet," June 23, 2008, p. 17)

Pfizer’s Drug Safety Web Site Aims To Reclaim Risk Communication Authority

BOSTON-Pfizer's new Medicine Safety Web site is the first attempt by a pharmaceutical company to reclaim authority over risk communication from FDA

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