According to the CDC, in July of 2000, the three leading causes of death were heart disease at 724,859 per year, cancer at 541,532 per year, and stroke at 158,448 per year. A recent study in Drug Safety looks at how to quantify the much lesser known number of deaths caused by adverse drug events or ADEs for short.

Adverse drug events (ADEs) present the single greatest risk of harm to patients in hospitals. An adverse drug event is an unwanted or harmful side effect experienced following the administration of a pharmaceutical or combination of pharmaceuticals. In the United States ADEs account for an estimated 218,000 deaths each year and cost from $30 to $130 billion each year.

“The direct medical costs associated with ADEs have been estimated to be in the range of $US30 billion to $US130 billion annually in the US alone. These estimates are even more meaningful when compared with other high cost conditions or diseases, such as diabetes mellitus ($US45.2 billion), obesity ($US70 billion), and cardiovascular disease ($US199.5 billion). Drug-related mortality has been estimated to claim 218,000 lives annually.”

Traditional efforts to detect ADEs have focused on voluntary reporting and tracking of errors. However, “health-related accreditation bodies estimate that as many as 95% of all ADEs are not reported.” In fact, although ADE reporting is mandatory for pharmaceutical companies, it is voluntary for healthcare professionals. Because of this voluntary system ADEs are rarely reported to the FDA.

“Between mid-1997 and mid-1998, physicians reported 2,083 ADEs to the FDA. If one assumes that 1997 is a typical reporting year, US physicians report an ADE to the FDA once every 336 years, based on the number of licensed physicians in the US. During the same reporting period, pharmacists in the US reported 7,406 ADEs to the FDA. US pharmacists fare a bit better in the frequency analysis, reporting an ADE to the FDA once every 26 years, based on the number of licensed pharmacists in the US.”

The authors indicate that the current voluntary reporting system is not sufficient to identify and reduce deaths from pharmaceuticals. The authors also suggest that changes to a more active reporting system would be greatly beneficial in reducing this high cost in lives and money. They also note that systematic reviews are almost entirely focused on “efficacy data” and are rarely on ADEs.

Source: Drug Safety, 2004, Vol. 27, No. 11, pp. 757-761
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