Medication misadventures ASHP Reports
A SHP REPORTS
Suggested definitions and relationships among
medication misadventures, medication errors,
adverse drug events, and adverse drug reactions
Am J Health-Syst Pharm. 1998; 55:165-6
Definitions
Medication misadventure: An iatrogenic hazard
or incident
• That is an inherent risk when medication therapy is
indicated.
• That is created through either omission or commis-
sion by the administration of a medicine or medi-
cines during which a patient may be harmed, with
effects ranging from mild discomfort to fatality.
• Whose outcome may or may not be independent of
the preexisting pathology or disease process.
• That may be attributable to error (human or system,
or both), immunologic response, or idiosyncratic
response.
• That is always unexpected or undesirable to the
patient and health professional.1,2,a
Medication error: Any preventable event that
may cause or lead to inappropriate medication use or
patient harm while the medication is in the control of
the health care professional, patient, or consumer. Such
events may be related to professional practice, health
care products, procedures, and systems, including pre-
scribing; order communication; product labeling, pack-
aging, and nomenclature; compounding; dispensing;
distribution; administration; education; monitoring;
and use.3,b
Adverse drug event (ADE): An injury from a
medicine (or lack of an intended medicine).4,c
Adverse drug reaction (ADR): Any unexpected,
unintended, undesired, or excessive response to a med-
icine that
• Requires discontinuing the medicine (therapeutic or
diagnostic),
• Requires changing the medication therapy,
• Requires modifying the dose (except for minor dos-
age adjustments),
• Necessitates admission to a hospital,
• Prolongs stay in a health care facility,
• Necessitates supportive treatment,
• Significantly complicates diagnosis,
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• Negatively affects prognosis, or
• Results in temporary or permanent harm, disability,
or death.
Consistent with this definition, an allergic reaction
(an immunologic hypersensitivity occurring as the re-
sult of unusual sensitivity to a medicine) and an idio-
syncratic reaction (an abnormal susceptibility to a
This is a draft document developed by the American
Society of Health-System Pharmacists (ASHP). ASHP wel-
comes comments. Forward comments to the ASHP Profes-
sional and Scientific Affairs Division, 7272 Wisconsin
Avenue, Bethesda, MD 20814, fax 301-657-1615, e-mail
ppsad@ashp.org.
Readers interested in more information can order the
ASHP Guidelines on Preventing Medication Errors in Hos-
pitals (document 336), the ASHP Guidelines on Adverse
Drug Reaction Monitoring and Reporting (document 334),
and an article about seven priority ideas (document 382)
through the ASHP fax-on-demand service (301-664-8888).
To order the proceedings of a 1994 interdisciplinary con-
ference on understanding and preventing drug misadven-
tures (AJHP. 1995; 52:369-416) call (301-657-4383), or fax
(301-657-1251) ASHP customer service and request publi-
cation R623.
medicine that is peculiar to the individual) are also
considered adverse drug reactions.5,d
Discussion
A. The terms “drug,” “medicine,” and “medication”
have variable usage but, for purposes of this doc-
ument, should be understood as follows. In this
document (except in direct quotes), “medica-
tion” is used as an adjective (as in “medication
error”). In this document, the substance con-
sumed by or administered to a patient is termed a
“medicine.” Some preference for the term “med-
icine” over “drug” appears to be developing, be-
Vol 55 Jan 15 1998 Am J Health-Syst Pharm 165
ASHP Reports Medication misadventures
cause, in society, the latter often has the connota-
tion of illicit use. However, in certain word com-
binations “drug” is still prevalent in common
usage (e.g., “adverse drug reaction,” “adverse
drug event”).
B. In the diagram (Figure 1), the collective term for
all the events is “medication misadventures.”
C. Many medication errors lead to no injury (section
A in the diagram). In other words, for the A errors,
there is no overlap with adverse drug events
(ADEs). There may be no injury because the error
never reached the patient or because it was trivial
(e.g., the medicine was administered slightly off
schedule without consequence).
D. Some medication errors (those in overlaps B and
C in the diagram), however, do lead to injuries.
Therefore, they are both medication errors and
ADEs.
E. Some adverse drug reactions (ADRs) (those in over-
lap C in the diagram) are caused by medication
errors. They are preventable ADRs. Some examples:
• An injury resulting from administering penicillin
to a patient known to be allergic to penicillin.
• Renal damage resulting from an extra dose or
overdose of a medicine.
• A hypotensive flushing reaction resulting from
administering vancomycin too fast.
• An adverse effect resulting from administering
iron dextran without first administering a test
dose.
Each of these was a medication error; each should
have been preventable with proper systems and
attention; each led to an unintended injury; and,
since each was an injury, it also was an ADE.
F. Some ADRs occur even without any mistake.
These are the ADRs in section D in the diagram.
An allergic reaction to penicillin when the allergy
was unknown would be of this type.
G. Some injuries are expected and are unavoidable
(section E in the diagram) and are not the result of
any mistake. An example is hair loss during anti-
neoplastic therapy. Expected “side effects” are
ADEs.
H. The diagram is illustrative only. The sizes of the
parts of the diagram are imprecise. Better research
on the true prevalence of each type of event would
help establish appropriate sizes for the parts.
166 Am J Health-Syst Pharm Vol 55 Jan 15 1998
Figure 1. Relationships among medication misadventures.
This diagram was inspired by Bates DW et al. Relationship
between medication errors and adverse drug events. J Gen
Intern Med. 1995; 10:199-205.
Medication
Errors
ADEs
C ADRs
B
D
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E
A
Medication Misadventures
a
In this definition, the words “medication” and “medicine”
have been substituted for the word “drug.” The referenced
version of the definition, in point 2, said “. . . during which a
patient is harmed. . . .” Many medication errors, however, lead to
no harm; yet they are misadventures in the sense that they are
undesirable. Hence, the terminology of “. . . during which a patient
may be harmed. . . .” In point 5, the referenced definition said “. . .
is always unexpected and thus unacceptable. . . .” Some adverse
events are expected, however, and have to be accepted. Hence the
terminology “. . . is always unexpected or undesirable to the patient
and. . . .”
b
The word “medication” is quoted directly. If the usage referred
to in footnote a above were adopted, the word “medicine” would
be preferred in the phrase “while the ‘medication’ is.”
c
The referenced definition used the term “medication” rather
than “medicine.” The referenced definition said an adverse drug
event is “an injury from a medication.” While that is correct as far
as it goes, injuries can also result from omitting doses of medicines.
d
The referenced definition used the word “drug” rather than
“medicine” or “medication.”
References
1. Manasse HR Jr. Medication use in an imperfect world: drug
misadventuring as an issue of public policy, part 1. Am J Hosp
Pharm. 1989; 46:929-44.
2. Manasse HR Jr. Medication use in an imperfect world: drug
misadventuring as an issue of public policy, part 2. Am J Hosp
Pharm. 1989; 46:1141-52.
3. United States Pharmacopeial Convention. National council
focuses on coordinating error reduction efforts. Qual Rev
(newsletter). 1997; no. 57:1-4.
4. Bates DW, Cullen D, Laird N et al. Incidence of adverse drug
events and potential adverse drug events: implications for
prevention. JAMA. 1995; 274:29-34.
5. American Society of Health-System Pharmacists. ASHP guide-
lines on adverse drug reaction monitoring and reporting. Am J
Health-Syst Pharm. 1995; 52:417-9.