From the February 6, 2003 issue
To reduce the risk of errors, effective reporting programs
are essential to learn about the breakdowns that occur in
the medication use process. However, as detailed below, responses
to a recent ISMP Survey on Internal and External Reporting
from over 300 staff clinicians, middle managers, and administrators
suggest that we need to do more to promote voluntary reporting
of medication safety issues to both internal and external
reporting programs (Tables are included on page 4 of the attached
PDF formatted newsletter).
Frequency of reporting: As expected, respondents
submitted medication safety issues more frequently to internal
reporting programs than to external reporting programs such
as the USP-ISMP Medication Errors Reporting Program (MERP)
and FDA MedWatch. However, differences were noted with the
most frequent types of reports submitted to each type of
program. The most frequent reports to internal programs
were medication errors that did not reach patients or those
that reached patients but caused no harm. hazardous conditions
that could cause errors were among the least frequent safety
issues reported to internal programs. In comparison, hazardous
conditions that could lead to an error were the most frequently
reported safety issues submitted to the MERP. But in all,
it was disappointing to learn that just one in ten respondents
reported a medication safety issue or error to the MERP
When harmful errors occur, they appear to be reported more
often to internal programs than to external programs. Over
half of respondents had reported at least one harmful error
within their organization, but only one in ten had submitted
a harmful error to MERP or MedWatch. Adverse drug reactions
(ADRs) also were among the most frequent types of medication
safety issues reported to internal programs and MedWatch.
Yet, ADRs reported to internal programs far exceeded those
submitted to MedWatch. While almost half of respondents
reported more than five ADRs to internal programs, less
than one in ten reported more than five ADRs to MedWatch,
suggesting that information crucial to post-marketing surveillance
may be missing in the MedWatch database.
Motivational factors: Nine out of ten respondents
were motivated to report errors to internal and external
reporting programs because they believed the information
would be used to enhance patient safety. Respondents felt
equally motivated to report problems to internal programs
and the MERP to help avoid needless tragedies, but felt
this factor was much less motivational for reporting problems
More respondents felt rewarded for reporting to the MERP
than to internal programs or MedWatch. However, with only
half of respondents reporting this as a motivational factor,
more must be done to reward clinicians for voluntary reporting
of medication safety issues. Likewise, more respondents
trusted that their name would remain confidential when reporting
problems to MERP than to internal programs or MedWatch.
About a quarter of respondents did not feel confidentiality
was a motivator.
Promoting error reporting: As expected, the
survey showed that internal reporting programs were more
frequently promoted than external reporting programs. Yet,
at best, only two thirds of respondents felt that accrediting
bodies, risk managers, and quality improvement staff promoted
internal reporting frequently. Even fewer felt that middle
managers and staff educators promoted internal reporting.
Organizational trustees or senior leaders were among the
least likely to encourage staff to report errors internally.
Professional organizations were cited as the most frequent
promoters of the MERP, closely followed by professional
publications and newsletters. But again, only about a third
of respondents had seen ongoing evidence of promotion during
the year, and more than half told us that middle mangers,
professional licensing bodies, risk managers, and quality
improvement staff had never promoted reporting to
the MERP. The pharmaceutical industry and medical product
vendors, staff and academic educators, local and federal
government agencies, and trustees and senior leaders were
the least likely to promote reporting to MERP.
MedWatch was promoted less frequently than the other reporting
programs in our survey. One in three respondents had frequently
witnessed ongoing promotion by accrediting bodies, professional
publications and newsletters, and professional organizations.
But surprisingly, local and federal government agencies
were among the least frequent entities to promote this government-run
program, closely followed by staff and academic educators,
the pharmaceutical industry and medical product vendors,
and middle managers.
Conclusions: This survey offers us a glimpse
of how frequently we, collectively as stakeholders in patient
safety, take the time to encourage front-line practitioners
to report medication safety issues to internal and external
programs, and perhaps to speculate as to why this may not
be happening. Legal impediments likely represent one noteworthy
reason for low frequency of encouraging clinicians to voluntarily
report errors, especially harmful ones, to external programs.
Thus, legislation to protect this information from disclosure
is pivotal to increasing our knowledge about medication
errors. Survey findings also suggest that some healthcare
providers may have limited knowledge of voluntary external
reporting programs, especially academic and staff educators,
trustees and senior leaders, middle managers, and people
involved with professional licensing boards. This is particularly
unsettling because these individuals often are in the best
position to influence public policy, mentor clinicians,
and assure that the future generation of healthcare practitioners
are well informed about the internal and external voluntary
error reporting programs and their immense value.
As subscribers to this newsletter, you can help to increase
awareness of the MERP and MedWatch, and encourage reporting
to these programs, as well as to internal reporting programs.
Reporting medication safety issues is crucial in the workplace.
But it's equally important to report ADRs to MedWatch for
post-marketing surveillance, and medication errors and hazardous
conditions to MERP (FDA receives all MERP reports) for collective
learning and impact on preventing medication errors.
The complete tables with findings appear on our web site.