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Clarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting

Jonathan R. Nebeker, MS, MD; Paul Barach, MD, MPH; and Matthew H. Samore, MD
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From Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, Utah; and Jackson Memorial Hospital, University of Miami, Miami, Florida.


Ann Intern Med. 2004;140(10):795-801. doi:10.7326/0003-4819-140-10-200405180-00017
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Since the early 1990s, adverse drug events have received significant attention from researchers in quality and patient safety (1). Nationally recognized quality experts have identified adverse drug events as a top safety priority (2) because these events are the most common type of iatrogenic injury (3). Studies have indicated that adverse drug events occur almost daily in medium-sized hospitals and outpatient panels (46). However, despite the high morbidity and mortality, physicians often do not recognize or appropriately treat instances of drug-related harm (78).

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Figure.
Relationships of key terms.

The gray areas represent injuries caused by drug use (adverse drug events). The dark gray area represents harm caused by a drug (adverse drug reactions). The light gray area represents harm from appropriate drug use that is generally excluded from studies of adverse drug events. Medication errors are much more common than adverse drug events, but they result in harm less than 1% of the time (30). Conversely, about one quarter of adverse drug events are due to medication errors(4).

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Farewell to ARMs
Posted on May 22, 2004
Sonal singh
Unity health System,Rochester,NY14626
Conflict of Interest: None Declared

Dr Nebeker and his colleagues attempt to clarify the confusion surrounding the terminology of adverse drug reactions (ADRs) and adverse drug events is commendable but raises several interesting questions (1).

Firstly, the authors fail to mention whether their proposed terminology of adverse drug events extends to adverse events occurring with herbal medications and supplements, which have become increasingly common today.

Secondly, the term "drug" excludes contaminants (such as in herbal medicines) or inactive substances in a formulation (2). So should we be talking about adverse reactions to medicines, ARMs rather than adverse drug reactions (ADRs) (2)?

Clarifying the terminology surrounding adverse events will enable both clinicians and patients bid farewell to ARMs.

REFERENCES

1. Nebeker, J. R., P. Barach, et al. (2004). "Clarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting." Ann Intern Med 140(10): 795-801.

2. Aronson, J. (2004). "HARMful reactions." BMJ 328(7449): 1173-.

Conflict of Interest:

None declared

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