FDAnews Drug Daily Bulletin

Consumers Playing a Greater Role in Postmarket Surveillance

June 11, 2008

Consumers became the major source of adverse event reports to the FDA in 2006, replacing physicians.

In 1998, consumers reported 23,691 adverse events as compared with 48,314 physician reports. In 2006, however, that trend reversed. That year saw 127,475 consumer reports versus 113,444 physician reports, according to FDA data, which was posted last week on the agency’s website.

Consumers reported 174,216 adverse events in 2007 — 53,216 more than reported by physicians, according to the data.

Although the agency’s reported information has limitations, the increase in consumer-reported adverse events is significant and could indicate greater awareness of drug safety issues. For example, drug safety concerns with GlaxoSmithKline’s anti-diabetes medication Avandia (rosiglitazone maleate) were widely reported by the media last year. Merck’s market withdrawal of Vioxx (rofecoxib) in 2004 also was highly publicized.

One limitation in examining the data is that some adverse event submissions do not have the reporter listed on the form, or there are multiple reporters for one adverse event. For example, in 2007 there were 397,902 instances of an identifiable reporter for an adverse event. However, the FDA entered a total of 364,449 direct, 15-day and periodic reports into the adverse reporting system during that same year, a discrepancy of more than 30,000.

The FDA also posted adverse event report data from other healthcare professionals, which show that the role of pharmacists in reporting adverse events has diminished. While total adverse events entered into the agency’s reporting system more than tripled from 106,384 in 1998 to 376,902 in 2007, pharmacist reports only increased from 18,193 to 21,343 during that same time frame.