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 in 2002.

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 to MedWatch.

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.