Serious injuries, disabilities, and deaths related to the use of prescribed
medications nearly tripled in recent years, according to research based on
Food and Drug Administration (FDA) data.
The total annual incidents of these events rose from 34,966 in 1998 to
89,842 in 2005, a 2.6-fold increase, according to a study in the September 10
Archives of Internal Medicine. A total of 467,809 such incidents were
reported over that eight-year period to the FDA's Adverse Event Reporting
System (AERS). The AERS is described as the world's largest database of
voluntary spontaneous reports of adverse drug reactions and medication errors
for prescription drugs, biological products (except vaccines), and
over-the-counter drugs. The voluntary reports are submitted directly to the
FDA by medical professionals and consumers through MedWatch or to drugmakers,
which must forward them to the FDA.
The researchers determined that the rise in injuries and deaths was
attributed to "a minority of important drugs." Drugs most
associated with injuries and deaths were disproportionately painkillers and
immune-system modifiers. Just 298 approved medications (20 percent) accounted
for 87 percent, or 407,394, of the injuries and deaths reported.
The adverse impact of medications was disproportionate among adults and
children. A proportionately higher number of elderly patients were injured or
died from medications, while proportionately fewer children were affected.
Although researchers expected 13.8 percent of children under age 18 to have
serious complications, based on the number of prescriptions written for this
population group, only 7.4 percent of reports of serious adverse events
People aged 65 and older accounted for 33.6 percent of the serious adverse
events reported, although the number of prescriptions written for this age
group led researchers to expect they would account for only 23.6 percent.
The causes behind the increase were varied, according to the study authors.
Twenty-five percent of the rise in adverse events, they estimated, was likely
due to population growth and more intense use of medication therapy. Another
15 percent of the increase was attributed to 13 "biotechnological
products," including immuno-modulators created through genetic
engineering, which were new to the market in the study period. The number of
serious adverse events associated with 13 prominent biotechnology products
grew nearly 16-fold, from 580 in 1998 to 9,181 in 2005.
Contrary to the researchers' expectations, a modest and declining share of
serious adverse events were linked to drugs that were the subject of safety
withdrawals. Drugs linked to safety withdrawals accounted for less than 10
percent of serious adverse events reported and declined from 26.4 percent of
health incidents in 1999 to less than 1 percent in 2005.
Alfred Herzog, M.D., chair of APA's Committee on Patient Safety, said that
the jump in reported adverse impacts of medication was probably at least
partially linked to stepped-up reporting requirements that many states
implemented in the early part of this decade. However, the ongoing shortage of
nurses and hospital beds may have led to revisions of administrative
medication guidelines that are more expedient but offer less protection to
Among psychiatric medications, the antipsychotic clozapine was the most
frequent drug suspected in death and serious nonfatal outcomes, with 3,277
such cases reported over the eight years. The next highest ranked was the
antipsychotic risperidone, which was the suspect drug in 1,093 deaths or
serious injuries during the study period.
The study excluded any adverse events reported as part of FDA drug trials."
Health professionals" provided 70 percent of all adverse event
reports, including 82 percent of all reported deaths.
Future efforts to improve drug safety, wrote the study authors, will
require "more accurate and capable systems to monitor
postmarketing" injury and death. The growing toll shows that the
existing system is inadequate to protect patients and underscores the need for
legislative, institutional, and policy changes.
The increase of adverse health events underscores the urgency for Congress
to require electronic prescribing in Medicare, according to the Pharmaceutical
Care Management Association (PCMA).
"This study found that seniors are disproportionately affected by
serious adverse drug events, which underscores why we need to require
e-prescribing in Medicare immediately. Requiring e-prescribing in Medicare
could prevent up to 1.9 million medication errors over the next decade,"
said Mark Merritt, president and CEO of PCMA, in a statement
E-prescribing technology aims to avoid adverse drug events by providing
physicians with a comprehensive patient medication history and automatic
electronic safety alerts before the prescription is sent to the pharmacy. A
recent study by the Gorman Health Group also concluded that requiring
e-prescribing in Medicare could prevent up to 1.9 million medication errors
over the next decade.
"Serious Adverse Drug Events Reported to the Food and Drug
Administration, 1998-2005" is posted at<http://archinte.ama-assn.org/cgi/content/short/167/16/1752>.▪