ADVERSE DRUG REACTIONS MAY CAUSE OVER 100,000 DEATHS AMONG HOSPITALIZED
PATIENTS EACH YEAR
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http://www.ama-assn.org/sci-pubs/sci-news/1998/snr0415.htm#jma71005
Science News Update
News from JAMA and ARCHIVES Journals
Week of April 15, 1998
JAMA REPORTS
ADVERSE DRUG REACTIONS MAY CAUSE OVER 100,000 DEATHS AMONG HOSPITALIZED
PATIENTS EACH YEAR
Study suggests adverse drug reactions are among the top
causes of death in U.S.
CHICAGO-Adverse drug reactions (ADRs) in U.S. hospitals may be responsible for
more than 100,000 deaths nationwide each year, making it one of the leading
causes of death, according to an article in the April 14 issue of The Journal
of American Medical Association (JAMA).
Bruce H. Pomeranz, M.D., Ph.D., and
colleagues from the University of Toronto, analyzed 39 studies of ADRs in the
United States to estimate the incidence of serious and fatal adverse drug
reactions in hospital patients. To obtain overall incidence rates of ADRs in
hospitalized patients, the researchers combined the incidence of ADRs in the
hospital and the incidence of ADRs causing admission to the hospital.
The authors estimated that 2,216,000 hospital patients experienced a serious
ADR and 106,000 deaths were caused by ADRs in the United States. This could
account for 4.6 percent of all causes of recorded death in 1994, making these
reactions between the fourth and sixth leading cause of death.
The World Health Organization defines ADRs as any noxious, unintended and
undesired effect of a drug, which occurs at doses used in humans for
prophylaxis [prevention], diagnosis or therapy. The authors define a serious
ADR as one requiring hospitalization prolonging hospitalization, or one that is
permanently disabling or results in death.
The researchers found no significant correlation between ADR incidence and year
the studies were conducted. They write: "This result seems surprising
since great changes have occurred over the last four decades in U.S. hospitals
that should have affected the incidence of ADRs. Perhaps, while length of
hospital stay is decreasing, the number of drugs per day may be rising to
compensate. Therefore, while the actual incidence of ADRs has not changed over
the last 32 years, the pattern of their occurrence has, undoubtedly
changed," the authors write.
The authors determined that ADRs are one of the leading causes of death by
using the highest and lowest possible estimates. Using the higher estimate
placed ADRs as the fourth leading cause of death, behind heart disease (743,460
deaths), cancer (529,904 deaths) and stroke (150,108 deaths). Using the lower
estimate placed ADRs as the sixth leading cause of death behind those
previously mentioned, as well as pulmonary disease (101,077 deaths) and
accidents (90,523 deaths). ADRs would then rank ahead of pneumonia and
diabetes.
The authors conclude: "While our results must be viewed with some
circumspection because of the heterogeneity among the studies and small biases
in the sample, these data suggest that ADRs represent an important clinical
issue." (JAMA. 1998;279:1200-1205)
Editorial: How Worried Should We Be?
In an accompanying editorial in the
April 15 JAMA, David W. Bates, M.D., M.Sc., of Partners Healthcare Systems, and
Brigham and Women's Hospital, Boston, Mass., cautions that there are several
concerns about the way the study was done, although the authors adhered to the
generally accepted criteria for meta-analyses. "First, an inherent
limitation of meta-analysis is that combining the results of small,
heterogeneous studies does not necessarily bring one closer to truth,
particularly if the processes used to identify and to validate the presence of
the events were heterogeneous. Second, the hospitals studied are probably not
representative of hospitals at large. Such studies are more
likely to be conducted in academic, tertiary care hospitals; these hospitals
have sicker patients, and these patients have more ADRs. Another issue is
whether the sites of care sampled within the institutions were representative
of the institutions."
Dr. Bates adds: "Nonetheless, these data are important, and even if the
true incidence of ADRs is somewhat lower than that reported ... it is still
high, and much higher than generally recognized." (JAMA.
1998;279:1216-1217)
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