Adverse event reporting.pdf

tems failures, with the goal of redesigning systems to reduce the likelihood of patient
injury. The key conceptual point here, and the heart of a non-punitive approach to
error reporting, is the recognition that adverse events and errors are symptoms of
defective systems, not defects themselves. Reporting, whether retrospective (adverse
events and errors) or prospective (“hazards”, or “errors waiting to happen”) provides
the entry point into investigation and analysis of systems’ defects, which, if skillfully
done, can lead to substantial system improvements. Reporting is one way to get this
type of information, but not the only way (see Section 4).
Ideally, internal reporting systems should go hand in hand with external reporting
systems, by identifying and analysing events that warrant forwarding to external
reporting agencies. Conversely, external reporting systems are most effective when
they are an extension of internal systems.
Process
What is reported
Types of reports
Reporting systems may be open-ended and attempt to capture adverse events and
close-calls along the entire spectrum of care delivery, or may focus on particular
types of events, such as medication errors or pre-defined serious injuries. In general,
focused reporting systems are more valuable for deepening the understanding of
a particular domain of care than for discovering new areas of vulnerability. While
these guidelines focus on reporting systems related to adverse events and medical
errors, other types of health-related reporting systems focus on medical devices,
epidemiological outcomes such as emergence of antimicrobial resistance, post-marketing
medication surveillance, and specific areas such as blood transfusions.
Formats and processes vary from prescribed forms and defined data elements
to free-text reporting. The system may allow for reports to be submitted via mail,
telephone, electronically, or on the World Wide Web.
Types of events
Adverse events. An adverse events is an injury related to medical management,
in contrast to a complication of disease (6).Other terms that are sometimes used
are “mishaps”, “unanticipated events” or “incidents”, and “accidents”. Most authorities
caution against use of the term accident since it implies that the event was
unpreventable.
Adverse events are not always caused by an error. For example, one form of
adverse drug event, “adverse drug reaction” is, according to the WHO definition, a
complication that occurs when the medication is used as directed and in the usual