Professional Documents
Culture Documents
Reporting Systems
and
Disclosing Medication Errors
to Patients and Families
Learning Objectives
• Describe the differences between internal
and external event reporting systems
• Discuss the multidisciplinary role of
tracking medication errors and disclosing
those trends to patients
• List the barriers to disclosing medication
events to patients
Medication Error
Reporting Systems
• Error reporting systems promote the goal of providing the
best possible patient care in a safe, compassionate
environment by helping those involved learn about:
– Potential risks
– Actual errors
– Causes of errors
– Prevention of recurrent events
• Both internal and external systems for reporting and
tracking errors are necessary
• Voluntary and mandatory systems each have strengths
and weaknesses
Definitions
• Adverse drug event (ADE)
– Any injury resulting from medical intervention related to a drug
• Preventable ADE
– ADE that results from an error or equipment failure
• Error
– Failure of a planned action to be completed as intended
• Medication error
– Any preventable event that may cause or lead to inappropriate
medication use or to patient harm while the medication is in
the control of the health care professional, patient, or
consumer
• Close call or near miss
– Medication error that was detected and corrected before it
reached the patient
– Medication error that reached the patient and did not cause
harm because of chance
Purpose of Reporting Systems
• Strong error reporting systems are invaluable in highlighting
hazards related to medication use, including ADEs, medication
errors, close calls, and near misses
• 1999 Institute of Medicine (IOM) report, To Err Is Human,
describes two primary purposes of reporting programs:
– Hold providers accountable for performance and patient safety
– Provide information that leads to new knowledge and improved
patient safety
• Some hospitals resist the IOM’s call to accountability for fear
that ADEs may be publicly disclosed
• Purposes of internal error reporting systems:
– Improved management of individual patients
– Getting timely medical advice
– Providing a record of events
– Obtaining immediate legal counsel
Kohn LT, et al., eds. To Err Is Human: Building a Safer Health System. Washington, DC:
National Academies Press; 2000.
Purpose of
Reporting Systems (continued)
• Ideally
– An error is reported internally, investigated, and error reduction
strategies implemented
– Error reduction strategies are then reported to an external
program
• Purposes of external error reporting systems
– Generate widespread alerts
– Widely disseminate new ways to prevent errors
– Uncover trends and hazards
– Recommend best practices for all health care stakeholders
Responsibility for Reporting
• The best person to report an event is the one who was
involved or who found or witnessed the event
• Most medication errors are reported by nurses or pharmacists
• Everyone associated with health care could potentially make
reports (e.g., pharmacists, physicians, nurses, dentists, techs,
assistants, medical equipment vendors)
• Consumers may report suspected medication errors to:
– External voluntary error reporting programs
– Appropriate licensing boards
– Facility in which error occurred
– Person(s) making the error
• The facility should thoroughly investigate any reported
medication error
Reportable Events, Conditions,
and Priorities
• It is essential to use clear, consistent terminology when
reporting events
• The word “event” is used by many organizations because the
word “incident” has the connotation of being a crisis
• Event has a broad connotation
– Clearly define the types of events and conditions to be reported
• Not knowing what to report is a barrier to reporting
• The categories of conditions and events reportable to error
reporting systems are:
– Risk: hazardous conditions that could lead to an error
– Near misses/close calls: errors that were intercepted and
corrected before reaching the patient
– Errors, no harm: errors that reach the patient but do not cause
harm
– Errors, harm: errors that reach the patient and cause harm
– See textbook page 517 for more detailed information
Reportable Events, Conditions,
and Priorities (continued)
• Provide staff members with examples of adverse occurrences
to minimize confusion about what is desired
• Near misses and conditions that could lead to errors or “less
serious” errors all provide information about the underlying
system-based causes of medication errors
– All of the above should be reported
– Allows systems to be proactive in identifying system failures
– Less devastating to report events not causing harm than to have
to report harmful occurrences
• Institutions should encourage personnel to report events and
not to assume that the problem is already known
• More complete reporting enhances the ability to learn about
errors and to implement appropriate safeguards
Reporting Mechanisms
• Staff must understand both formal and informal (alternative)
methods of reporting events
• Informal lines of communication help to enhance trust and
confidence
• Both formal and informal ways of accepting information
should be part of the event reporting mechanism
• Reports may be submitted by e-mail, especially for external
reporting systems
• The organization that maintains the reporting system should
track the effectiveness and usefulness of the various
systems and make adjustments if necessary
• Event reporting forms with electronic formats are provided by
both internal and external reporting programs
When to Report
• Best approach is to immediately report an event
whether or not it may cause serious harm
• Advantages to immediate reporting:
• An ADE that may not seem serious may, in fact, be serious
• The supervisor can ask questions while the event is fresh in the
reporter’s mind
• An immediate oral report to a supervisor may be more
beneficial than a hastily written report
• Send final reports to risk management within 1 week of
the event unless additional time is requested in the
report
• Report to the external voluntary reporting system after all
the information is gathered
– These systems have specific reporting time frames and all
information may not be available
What Information to Report
• JUST THE FACTS—include a factual description of
what happened and the patient outcome
• Include names of products if the event involves a
problem with labeling or packaging
• Include any additional patient monitoring or testing
performed or medications administered as a result of
the event
• Include explanatory information that describes:
– How the event happened
– What normally happens and how risk was managed
before the event
– Why the event happened
– At-risk behaviors
– How to prevent similar events
What Information
to Report (continued)
• Figure 19-1 in the textbook provides an event reporting
form with questions designed to elicit causative factors
for reporting
• Separate the causative and prevention portions from the
factual to better protect event analysis from discovery
during a lawsuit
• Never include personal or professional opinions,
conclusions, criticisms, accusations, admissions, or
patients’ names in the report