Voluntary error reporting is best
From the May 19 , 1999 issue
In recent years, healthcare organizations, regulatory and
licensing bodies, governmental agencies, accrediting organizations
and even consumers have been promoting more candid disclosure
of medication errors. To that end, ISMP has been a strong
and vocal proponent of establishing a non-punitive voluntary
error reporting program that supports open discussion about
errors. Recently, ISMP has been actively participating in
various government-level public policy discussions to explore
various types of reporting programs. In our discussions, we
have emphasized the following:
Non-punitive and confidential voluntary reporting programs
tend to provide more useful information about errors and their
causes than mandatory reporting programs. A voluntary,
confidential reporting program provides front-line practitioners
with the opportunity to tell the complete story without fear
of retribution. The depth of information contained in these
stories is critical to understanding the error, and reporters
often submit samples of drug labels, packages, written orders
or other pertinent information to help others understand the
error. This information is critical to the identification
of system deficiencies that can be corrected in order to prevent
future errors. Practitioners who are forced to report errors
are less likely to provide this depth of information since
their motivation may be adherence to a requirement, not necessarily
to help others avoid the same tragedy. Further, a voluntary
program encourages practitioners to report hazardous situations
and errors that have the potential to cause serious patient
harm. It is not possible to mandate reporting of these situations.
Therefore, critical information may be lost and proactive
error prevention strategies are less likely.
Potentially the greatest number of error reports may come
from a non-punitive reporting program. Yet the very intent
of most proposed and established mandatory reporting programs
is punitive. For example, one state recently proposed, but
did not implement, a mandatory reporting system designed to
"identify practitioners and facilities which may present a
danger to the public welfare." Even if mandatory programs
offer "amnesty" or "immunity" to individuals who report errors,
those who fail to report must be punished in a mandatory program.
Further, the terms "amnesty" and "immunity" imply that blame
and punishment is indicated when an error occurs, but practitioners
will be forgiven. This concept does not support the culture
change necessary to establish a truly non-punitive environment.
Practitioners do not need to be forced to report errors. They
just need freedom from all forms of punishment, which is possible
only with a voluntary reporting program. Evidence is found
in organizations with policy-driven mandatory reporting systems
that practitioners will not report all detected errors if
there is any fear of retribution.
While a mandatory reporting program may collect larger
numbers of medication errors, it is unlikely to yield much
new information beyond what can be learned from a more streamlined
and effective voluntary reporting program. Too much data
slows error analysis and lessens the effectiveness of subsequent
prevention efforts. If data is needed for epidemiological
research, USP's MedMarx or other data collection systems can
provide needed volume. Further, an effective program should
not require multiple reports of patient deaths and injuries
in order to take action. Instead, action should be taken at
the first sign of a serious problem.
While mandatory reporting programs imply that the individual
at fault must report the error, analysis of serious errors
always reveals multiple system failures that lie outside the
direct control of involved practitioners. Who then must
report the error? The drug company whose product name or label
has repeatedly led to confusion? The practitioner involved?
Which practitioner must report an error that started with
an ambiguous prescription or a wrongly dispensed drug? By
necessity, responsibility for mandatory reporting will likely
fall to designated management staff, not individual practitioners.
Managers may be less inclined or unable to communicate information
beyond that which is required, even with statutory protection.
In the end, it's likely that blame will often fall on practitioners,
primarily nurses who administer the drugs involved in the
errors. Similar problems have been identified with current
established and proposed mandatory reporting programs. For
example, the federal Safe Medical Devices Act of 1990 has
not been successful in gaining practice site compliance with
reporting requirements for user error with medical devices.
Finally, establishing a national mandatory medication
error reporting program when an effective voluntary reporting
program already exists (USP-ISMP Medication Errors Reporting
Program which works in cooperation with FDA) is likely to
confuse practitioners and fragment the reporting process.
In-depth reporting of valuable information to an effective
voluntary program may be reduced in response to establishment
of a mandatory process. Through the USP-ISMP MERP, a wide
scope of medication safety problems have been identified,
their causes have been explored and prevention strategies
have been designed. However, the program lacks sufficient
influence with accrediting bodies and regulatory agencies
to mandate key changes that are known to reduce serious errors.
The resources required to establish a national mandatory error
reporting program will be more effectively directed toward
facilitating implementation of preventative actions based
on the extensive knowledge we already have regarding flaws
in our safety systems. It would best serve the public to focus
legislation on protection of information collected through
voluntary reporting and assuring that appropriate quality
improvement activities occur at all levels. When errors are
committed with malicious intent, licensing boards, public
authorities and departments of health should handle such issues.
In other situations, information from voluntary reporting
programs can be shared with appropriate agencies and authorities
to promote safe medication practices in all organizations.