For Pharmaceuticals

Adverse Event Reports Hit Record High
by Sharon Phillips

According to FiercePharma, the number of deaths (4,825) and serious injuries (21,000) associated with prescription drugs during the first quarter of this year was higher than it's ever been.1 These numbers represent nearly a threefold increase over the previous quarter, and a 38-percent increase over last year's quarterly average.

Whether the coincidence of the spike of adverse event reports and the timing of the Accountability Act represents a cause-and-effect relationship or is purely accidental is anyone's guess.

According to the Institute for Safe Medication Practices, the Pfizer stop-smoking drug Chantix reported the most adverse reports, with 1,001 injuries and 50 deaths. Chantix attracted widespread media attention for the psychiatric effects--even suicide attempts--seen in some of its users. FiercePharma notes that the high publicity may have boosted the number of reports.

Chantix is still being marketed by Pfizer, which warns consumers of possible adverse events. The drug has been banned for use by pilots and air traffic controllers by the FAA (Federal Aviation Administration).2

The second most reported drug associated with adverse events was the blood thinner heparin, the subject of a much-publicized recall and international investigation.3 During the first quarter of this year, heparin was linked to 779 injuries and 102 deaths. The adverse reactions associated with lot numbers that were known were traced back to contamination of the raw heparin with oversulfated chondroitin sulfate.4

Inherent Statistical Shortcomings
FiercePharma notes that the Institute for Safe Medication Practices took its stats from the FDA's adverse events reporting system, which can be problematic for a couple of reasons. The first reason is that adverse events often go unreported, resulting in understated numbers of cases. The second reason is that individual reports don't prove that the drug caused the problem. These two shortcomings, however, tend to offset one another, rather than having an additive effect.

Timing Coincides with Introduction of "Accountability Act"
The timing of the spike of adverse events coincides with the introduction of a bill (known as "the Drug and Device Accountability Act") that is currently being evaluated by the U.S. Senate. The bill proposes to make companies more responsible for the drugs (and medical devices) they market to the public. It will give the FDA the authority to impose high fines on companies that misrepresent, conceal, or fail to report important information in their product submissions and related documentation. The fines would apply not only to companies, but also their senior officers and directors--who, in addition to being fined, could face prison sentences (of up to 20 years.)5

Whether the coincidence of the spike of adverse event reports and the timing of the Accountability Act represents a cause-and-effect relationship or is purely accidental is anyone's guess.

References
1 FiercePharma, 10-23-08 posting. The full story in the LA Times may be read at: http://www.latimes.com/news/nationworld/nation/la-sci-drugs23-2008oct23,0,3729962.story.
2 FiercePharma, 5-22-08 posting. The full story in the LA Times may be read at http://articles.latimes.com/2008/may/22/nation/na-smokedrug22.
3 FiercePharma 5-12-08 posting. The full story may be read at http://online.wsj.com/article/SB121037857970382109.html?mod=googlenews_wsj.
4 FiercePharma 7-31-08 posting. The full story in the Chicago Tribune may be read at http://archives.chicagotribune.com/2008/jul/30/business/chi-wed-heparin-fda-baxter-jul30.
5 Drug and Device Accountability Act of 2008: How Execs can Avoid Jail Time. This whitepaper may be read at: http://www.mastercontrol.com/downloadables/?sales=170

Sharon Phillips is a marketing communication specialist at MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (www.mastercontrol.com).

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